Attachment C · 2017-07-18 · Position: Engineering Director Experience: Over twenty years...

Attachment C Site Organisational Structure Technical Qualifications of Relevant Staff Relevant Site Environmental Policies and SOPs

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Global Quality

Site Quality Head (Bray)

John Cooney

Head of Finance

Tony Grannell

Engineering (P2)

Director

William Murphy

Site Quality Head (GC)

Director

Geraldine McCann

API Man Ops

Director

Graham Grogan

DP Man Ops

Director

Christian Storo

Technical Services

Director

Paul Ryan

FY 2016

Planning

Director

M. Hamasumi

Finance

Manager

Mary Foran

Takeda Ireland Organisation Chart

API Manufacturing

Manager

Robert Downing

Process Dev. Lab

Manager

Kenneth Stack

Engineering

Director

Donal Brady

Automation

Manager

David MacCarthy

Logistics

David McLoughlin

QC& Microbiology

Manager

Troy Whelan

Quality

Compliance

Paula Walsh

Quality Assurance

Johanna

Whelehan

Tabletting

Manager

Vincent Freyne

Packaging

Manager

Deirdre

ConnaughtonProcess

Development

Manager

Brendan Donohoe

IS-IT Business

Partner- Ireland

Vacant

Engineering

Manager

John Dunne

Planning,

Supply Chain

Manager

Gerry White

Logistics

Manager

Amy Wiktorski

HR

Manager

Amanda Lawlor

Admin &

Communications

Victoria

Hampson

Procurement

Manager

David Lowney

BOARD OF DIRECTORS (Note board titles here)

James Dinniss Director(Exec)

Paul Keogh Director(Exec)

Tony Grannell Director(Exec)

John Cooney Director(Exec)

Hans-Christian Meyer Director(Non-Exec.)

Naritoshi Imaizumi Director(Non-Exec.)

Global Assignments:

Bray: 3 to (BPR)

Bray 1 to TOB

30th

November 2016

OPEX

Pat Macken

Quality Services &

Improvement

Manager

Ed Ball

Elizabeth Muzen

Quality Head

Europe Plants

Quality Assurance

Marie Thorne

Global IT

Kevin Wallace

IS-IT Area BP

UK & Ireland

QC & Microbiology

Manager

Jennifer Cullen

QP Function

Manager

Nikhil Sant

Quality Systems

Barry MatthewsQuality Systems

Niamh Lennon

Quality Compliance

Niamh Lennon

Quality Services &

Improvement

Geraldine McCann

Validation Specialist

Eoin Daly

Regional Procurement

Lars Chorfixen

RPOL

Site Plant Director

(Bray)

James Dinniss

Site Plant Director

(Grange Castle)

Paul Keogh

GMS

Hans-Christian Meyer

Head of Liquids and

Solids Europe/CIS

Global Quality

Michael Bohane

Elaine Shannon

Maintenance

Manager

Brian Delaney

Supply Chain

Director

Andy Hagerty

HR & EHS

Director

Lauren Messing

GC Operations Bray Operations Quality Shared ServicesShared Services

EHS & AGILE

Manager

Vladimir Gorskiy

Admin GC

Breda HarkinsEHS

Maintenance

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PM GROUP

Takeda Ireland Ltd (Grange Castle) Ninlaro Project

IE0311985-REF-0042, Issue 1 25/05/2017

IE0311985-REF-0042_1_01.DOCX Page 1 of 2

Technical Knowledge and Qualifications of Relevant Employees

Donal Brady

Position: Engineering Director

Experience:

Over twenty years professional experience within engineering, operations and process management, predominately in the Pharmaceutical sector.

Qualifications:

2010 Master of Business Administration (MBA), University College Dublin.

1995 Bachelor of Chemical Engineering (BEng), University College Dublin.

Aileen Stack

Position: EHS Engineer

Experience:

15 years working within EHS

Qualifications:

BSc in European Environmental Engineering Science, MSc in Environmental Health & Safety Management

Keith O’Neill

Position: EHS Engineer

Experience:

2008-2017 EHS Engineer, Takeda Ireland Limited (Grange Castle)

2003- 2008 Environmental, Health and Safety Specialist, Ipsen Manufacturing Ireland Ltd.

2001-2003 Health and Safety Officer, Ipsen Manufacturing Ireland Ltd.

1995-2001 Synthesis Laboratory Supervisor, Kinerton Ltd.

1990-1995 Synthesis Technologist, Kinerton Ltd.

Nov 1988-June1989 Production Operator, Sterling Drug.

Jun 1988-Nov 1988 Production Operator, Klinge Pharma.

Qualifications:

2015-2016 Professional Certificate in Environmental Management, UCD. (Level 9 minor)

2007-2009 Masters in Science (Emergency Management), Dublin City University. (Level 9)

2003-2005 Diploma in Safety, Health and Welfare at Work, University College Dublin. (Level 8)

1998-2000 Diploma in Management and Employee Relations, National College of Ireland. (Level 7)

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PM GROUP


IE0311985-REF-0042, Issue 1 25/05/2017

IE0311985-REF-0042_1_01.DOCX Page 2 of 2

1989-1990 National Diploma in Science, Cork Regional Technical College. (Level 7)

1985-1988 National Certificate in Science, Cork Regional Technical College. (Level 6)

1980-1985 The North Monastery, CBS, Cork

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• Integrated Pollution Prevention and Control Licence (IPPCL) P0693-01.

3.2 Associated Documents:

• SOP-ENV-GEN-001 "Communications-Public requests for Information on Environmental Performance"

• SOP-ENV-GEN-002 "Environmental Occurrences" • Site Glossary

3.1 Documents Referenced:

3. REFERENCES:

This scope of this document is to define; • The Environmental Management Policy Statement and • The responsibilities of individuals and departments, in relation to Environmental

Management at TILGC.

2. SCOPE:

The purpose of this document is to define the overall Environmental Management Policy at Takeda Ireland Limited (Grange castle)-TILGC.

1. PURPOSE:

Effective Date: Circulation Codes Area of Work Code:

(This Section is for use bv Document Control Onlvl

Aileen Newman Originator: EHS Enaineer Date:

Keith O'Neill Reviewed Bv: EHS Enaineer Date:

Damian Crowley Reviewed Bv: Production/EHS Director · Date:

Greg Timmons Reviewed Bv: President Date:

Niamh Mccullagh Aooroved Bv: oueutv Director Date:

DOCUMENT APPROVAL:

TAKEDA IRELAND UMITED lGl{ANGE CASTLEl Document Tvoe: PoliN I Document No.: POL-049 Revision No.: 00 I Sunersedes: NIA -, Paae No.: 1 of 4

Title: ENVIRONMENTAL MANAGEMENT POUCY

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• Ensure employees, contractors and visitors under their control are made aware of and comply with, environmental management procedures.

• Ensure that employees, for whom they are responsible, receive adequate environmental training and instruction appropriate to the tasks they are performing.

• Consider, communicate and support where appropriate any representation about environmental management from the personnel for whom they are responsible.

• Monitor the activities of visitors and contractors within their area to ensure environmental protection.

• Provide leadership and set examples through good work practices considering environmental responsibilities.

4.4 Executive I Team Leader: It is the responsibility of the Executives/ Team Leaders to:

• Ensure compliance with the IPPCL. • Be aware of all current and proposed environmental legislation relevant to TILGC. • Ensure environmental management systems in place comply with all relevant

national and European environmental legislation, standards, codes of practice and accepted behaviour.

• Liaise with relevant regulatory bodies. • Develop effective environmental management programmes and systems. • Promote Environmental Awareness and Training. • Lead in the development and delivery of environmental related training. • Review when appropriate SOP's and other relevant documentation for compliance

with applicable standards and regulations. • Coordinate environmental audits. • Review and approve all environmental management related documents. • Ensure appropriate records are maintained.

4.3 EHS Engineer; It Is the responsibility of EHS Engineer to:

• Ensure that employees, for whom they are responsible, receive adequate environmental training and Instruction appropriate to the tasks they are performing.

• Ensure that employees, for whom they are responsible, are held accountable for their performance in relation to environmental management.

• Ensure that thorough and prompt investigations are carried out on all reported incidents in accordance with the current procedures.

• Ensure environmental management is an agenda item at all relevant meeting.

4.2 Managers: It is the responsibility of Managers to:

• Communicate to all managers that they are accountable for actively implementing environmental management programmes as an integral part of their function.

• Ensure all necessary resources are provided to support Environmental Management.

4.1 Directors: It is the responsibility of Directors to:

4. RESPONSIBILITIES:

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvoe: Policy I Document No.: POL·049 Revision No.: 00 1 Sunersedes: N/ A I Paae No.: 2 of 4


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o At a minimum meet, and where appropriate exceed, the requirements of all relevant legislation and corporate standards.

o Promote the concepts of continuous improvement and pollution prevention through the setting and review of environmental objectives and targets.

o Provide all of the necessary information and resources to achieve objectives and targets.

o Provide necessary training and support to employees so they can carry out their environmental management responsibilities effectively and professionally.

o Promote the adoption of environmentally sound practices by contractors, suppliers and customers.

o Implement a documentation system which will ensure that all documents required by the IPPCL and environmental management system are generated and adequate records are kept.

o Keep up to date with all relevant environmental and energy management legal requirements.

o Make our environmental management policy and records available to the public and interested parties.

o Communicate our policy to all TILGC employees. o Ensure the Environmental Management Policy is reviewed regularly.

To achieve our goal and to set the standard, TILGC will:

7. REQUIREMENTS:

7.1 ENVIRONMENTAL MANAGEMENT POUCY STATEMENT: • Takeda is a global company which researches, develops, manufactures and markets

a wide variety of pharmaceuticals. Takeda strives towards better health for individuals and progress in medicine by developing superior pharmaceutical products. TILGC regards environmental management as an integral and essential part of good business practice. TILGC is committed to achieving and maintaining a high standard of environmental quality in all our operations.

For other relevant definitions refer to site glossary.

6. DEFINITIONS:

• Not applicable. DRC-13-051

S. REASON FOR UPDATE:

• Comply with the environmental management systems and procedures. • Discourage improper conduct or behaviour that may compromise compliance with

environmental regulations or TILGC's IPPCL. • Attend training and undergo assessment in relation to environmental management as

appropriate to their work. • Immediately report all environmental occurrences. • Not to interfere with or misuse any environmental monitoring equipment and/or

environmental systems.

4.5 TILGC Employee/Embedded contractors: It is the responsibility of TILGC employees and Embedded Contractors to:

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Type: Policy I Document No.: POL-049 Revision No.: 00 I Suoersedes: N/ A I Page No.: 3 of 4


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N/A 9. PROCESS MAP:

N/A 8. PROCEDURE:

• Responsibilities of individual personnel will be defined in Job Descriptions, signed by the relevant employee.

• It is TILGC's policy that the primary responsibilities of the EHS department will not be delegated.

• TILGC management Is also responsible for monitoring the effectiveness of the Environmental Management System.

7.2 General: • The participation and commitment of all TILGC employees is required to meet our

environmental management goals. These employees are made aware of and recognise the importance of complying with TILGC systems and procedures.

• TILGC management fully endorses the stated policy and controls and acknowledges that it is their ultimate responsibility to ensure that the conditions required to attain the environmental management objectives are present.

TAKEDA IRELAND LIMITED (GRANGE CASTLE} Document Tvoe: Policv I Document No.: POL-049 Revision No.: 00 I Sunersedes: N/ A I Paae No.: 4 of 4

Title: ENVIRONMENTAL MANAGEMENT POLICY

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• To raise the alarm as set out in SOP-EHS-GEN-252 "Fire Alarm Evacuation of Staff contractors and Visitors," when any spill is observed and deemed to be a beyond the scope of the minor spill deanup.

• Report the details of the spillage to the Emergency Coordinator immediately at the fire assembly point.

4.1 All Personnel: It is the responsibility of all personnel to:

4. RESPONSIBIUTIES:

• POL-036, "Accident Prevention Policy." • EOP-ENG-001-Fl, "Fire Alarm Event Form" • SOP-EHS-GEN-259, "Waste Management" • SOP-EHS-GEN-251, "EHS Unplanned Event Management" • Site glossary


• SOP-EHS-GEN-262, "Surface Water System." • SOP-EHS-GEN-252, "Fire Alarm Evacuation of Staff Contractors and Visitors." • SOP-EHS-GEN-254, "Minor Spill Response." • SOP-EHS-GEN-252. "Fire Alarm Evacuation of Staff, Contractors and Visitors.


3. REFERENCES:

• This procedure applies to all spills assessed as major spills within the boundaries of TILGC.

• Any major spills associated with materials on the way to or from TILGC but outside the boundary are dealt with by the Emergency Services and are outside the scope of this SOP. However assistance to the emergency services will be given when requested.

• Discharges that are planned as part of routine operations are risk assessed and appropriate systems are put In place to prevent the discharge from becoming an uncontrolled release. These discharges are outside the scope of this SOP.

2, SCOPE:

The purpose of this SOP is to outline the procedure to be followed in the event of a major spillage at Takeda Ireland Limited (Grange Castle) (TILGC) in order to affect an efficient and safe response thereby minimising any harm being caused to people or the environment.

1. PURPOSE:

Location or Area of Work Code: Effective Date: Circulation

'This section is for use by Document Control Only)

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document TvDe: SOP I Document No.: SOP-EHS-GEN-253 Revision No.: 1.0 I Page 1 of 8

Title: EMERGENCY RESPONSE TEAM PROCEDURE

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• This SOP forms part of the TILGC Emergency Management Plan and TILGC's Accident Prevention Policy.

6. HEALTH, SAFETY AND ENVIRNOMENTAL:

• EC: Emergency Coordinator • Minor Spill: Releases of any chemical where the total size does not exceed 5 Litres or 1

metre in diameter. They are handled as per SOP-EHS-GEN-254. • Major Spill: Releases of chemicals where the total size exceeds 5 Litres or the 1 metre in

diameter or, the release of any which is above the thresholds set down in the Minor Spill Response and requires a site evacuation.

• Uncontrolled release: release of solid, liquid, gas in a manner that causes danger to human health and the Environment.

5. DEFINmONS

• Follow all instructions given by the ERT Leader. • Isolate the spill area, identify the spill. • Report all information relating to the spill to the ERT Leader.

4.5 ERT Members: It is the responsibility of the ERT Members to:

• Ensure the safety of ERT and site personnel. • Assemble the ERT. • Ensure adequate PPE is worn. • Assign tasks to ERT members. • Issue incident report to EC. • Fulfil all responsibilities as detailed in SOP-EHS-GEN-252.

• Review the spillage details from Security and decide if support from the emergency services is required.

• Discuss with the ERT Leader proposed actions and assessments of the situation as it unfolds.

• Fulfil all responsibilities as detailed in SOP-EHS-GEN-252. • Complete form FORM-EHS-GEN-295.

4.4 ERT Leader: It is the responsibility of the ERT Leader to:

4.3 Emergency Co-ordinator: It is the responsibility of the Emergency Co-ordinator (EC) to:

• Immediately notify the designated Emergency Coordinator (EC) of all reported spillages.

• When requested by site personnel, raise the alarm from the Gatehouse. • Provide as much information as possible to the EC based on report received from

person who identified the spill. • Call the Emergency Services as directed by the Emergency Coordinator.

4.2 security: It is the responsibility of Security to:

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• Maps of the site are available in the ERT Folder in the Muster Station and at Security in the Fireman Pack. The maps include details of: , Site drainage , Topographic features and structures , Adjacent facilities > Building plans for entry

7 .4 Site Control:

• Using the windsock located at the tank farm as a reference, all personnel should stay upwind of any outdoor spill.

• All contaminated soil must be identified and reported to the EHS Engineer for evaluation.

• Blue Beacons are activated around the Heat Transfer Fluid Skid when the ammonia detection system detects a leak of ammonia. The system is automatically shut down and the beacons highlight the alarm locally.

7 .3 Outdoor Spills:

• When there is a threat of fire or explosion, the ERT may use foam/water attack to place a blanket over the flammable material.

• Where possible, spills should be pumped to appropriate containment such as tanks. Pumping to drums and IBCs etc must be carried out with the appropriate rated equipment.

• The type, quantity and location of spill will determine the appropriate action.

7.2 Spill Response Guidelines:

• Spill material e.g. pillows, wipes are disposed of as hazardous materials.

• After the spill has been cleaned, the ERT will decontaminate all equipment.

• The ERT leader will direct ERT members to gather equipment and consumables in order to clean up the spill.

> Fireman coat, trousers, gloves and boots will be used when flammable materials are involved. All other PPE must be worn over this PPE.

, Gas suits will be used for Methanol and corrosive materials. , Chemical suits will be used for all other materials. > Self Contained Breathing Apparatus will be used as standard for all entries in areas

where a major spill has taken place.

• The basic ERT PPE Is as follows:

• Appropriate assessments and evaluations are made throughout ERT responses to ensure all relevant information from the control panel are communicated between stakeholders and that the correct Emergency Response Equipment is used.

7.1 General

7. REQUIREMENTS

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Fig. 1 - Diagram of Site Zoning

• The Support Zone connects the Contamination Reduction Zone via an Access Control Point. The Support Zone is the safe area where all support operation occurs. The Support Zone should be monitored periodically to ensure that site activities or change of wind direction has not impacted the area.

7.7 Support Zone {Cold Zone}:

• The Contamination Reduction Zone should be large enough to allow for proper set up and decontamination and to prevent support personnel from getting close to Exclusion Zone.

• The Contamination Reduction Zone Is the transition area between the Exclusion Zone and the Support Zone. The Contamination Reduction Zone reduces the possibility that the Support Zone will become contaminated. Within the Access Control Points of the Contamination Reduction Zone a Decontamination Corridor is established.

7.6 Contamination Reduction Zone {Warm Zone}:

• Access to and from the Exclusion Zone should be restricted to Access Control Points. These serve to regulate the number of people entering and leaving the Exclusion Zone, as well as ensuring site control procedures are followed.

• The Exclusion Zone is the area where the emergency is either known or expected to occur and exposure will likely occur. The hotline separates the area from the rest of the site. The hotline is established initially by either visual examination or air monitoring data. The hotline should be physically secured or clearly marked with hazard tape.

7.5 Exclusion Zone {Hot Zone}:

• To limit personnel exposure, as well as containing migration of hazardous wastes offsite, work zones will be established. Using the site maps, three main areas will be marked see Figure 1 below; , The Exclusion Zone (hot zone) , Contamination Reduction Zone (warm zone) > Support Zone (cold zone)

• Site maps will be updated as the incident progresses e.g. marking of prevailing wind direction.

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• All waste must be disposed of as per instructions from the EHS Engineer.

• The spill area must be damp mopped where relevant. The floor must be tested with pH paper if the spill was corrosive.

• All spills absorbent must be collected and removed using a non spark producing broom and shovel.

• Absorbent must be poured on the spill from the outside in towards the centre until all the liquid is fully absorbed.

• Attempts must not be made to clean up until containment is complete.

• Initiate containment using pillows or other appropriate equipment. Surround the spill with absorbent pigs or blankets beginning with the leading edge of liquid flow and working around the perimeter of spills.

• The source of the spill must be isolated where possible.

• ERT members will take two fully charged fire extinguishers to the spill area.

• ERT members must take care not to step over or through spills due to slipping hazard.

• Spill bins are located in strategic locations around the site.

• All ERT members must wear protective clothing and locate showers and eyewashes near the spill before cleanup is started.

7 .8 Spill Cleanup - General:

WIND ~ DIRECTION

ACCESS CONTROL POINT

DECONTAMINATION CORID OR

ACCESS CONTRO POINT

HOT ZONE CONTAMINATION REDUCTION ZONE

SUPPORT ZONE

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• The source of the spill should be controlled as quickly as possible.

• If any material discharges to the storm drains, as a general precaution, the flow from the attenuation ponds must be isolated immediately.

• Any direct entry points to the Griffeen River must be protected from the flow of any spill by implementing the following precautions as outlined in SOP-EHS-GEN-260, "Surface Water System"; , Close valve at exit of lower attenuation pond. , Close valve between the upper attenuation and lower

attenuation pond. > Tum off pump servicing the ornamental pond.

• All sewers and storm drains must be protected from a spill in order to prevent contamination of the Griffeen River and the public sewer.

8.4 Isolate Area {ERT Members) • The first team must cordon off the area and establish the Hot

Zone and the Warm Zone.

8.3 Agree Response {ERT Members) • Following consultation with the EC, the team will agree on the

appropriate response in line with ERT Training.

8.3 Recording (Emergency Coordinator) • The Emergency Coordinator must record the evacuation using

form FORM-EHS-GEN-295, providing information on the following: ;;.. Name of person that raised the alarm. , Location of spill. »- Identification of spill, if known. , Quantity of spill. ;. Time spill occurred or time first noticed. , Employees involved.

8.2 ERT Muster (ERT Members) • Discuss with the Emergency Coordinator the incident. • One team member to be appointed to record the events in form

FORM-EHS-GEN-295, "Emergency Response Team- Spill Response" and observe the area and the associated activities.

8.1 Assess as a major event {All Personnel) • When a spill is observed that requires evacuation activate the

break glass unit in the area. • When no break glass unit is in the area contact Security and ask

them to raise the alarm from the Gatehouse. • Provide as much detail as possible about the incident, location,

personnel involved, material involved if known at this point to the Emergency Coordinator at the fire assembly point.

• Do not attempt to deal with the incident.

Refer to Process Map attached

8. STEP BY STEP PROCEDURE:

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8.8 Complete Response (ERT Leader) • When the chemical spill has been Identified, the SDSs and the

Dangerous Goods Emergency Action Code List must be consulted so that appropriate action can be taken.

• SDSs for all bulk and packaged chemicals are in the Fire Man pack at Security and in the ERT Folder in the Muster Station.

• Direct ERT Members to clean-up the spill as per the appendices attached to this SOP.

• Refer also to section 8.8 Spill Cleanup-General.

8.7 Notify all relevant personnel (ERT Leader) • Notify all relevant personnel as required by this SOP.

8.6 Identify Spill (ERT Leader) • It is CRITICAL to determine the type of chemical spilled prior to

any further action. • ERT members must be alert to broken containers or leaking

pipes. The use of pH paper, chemical classification strips or other diagnostic equipment may be required to determine the identity of the spill.

• Identify the spill type by referring to appendix 1, 2, 3 and 4 of this SOP.

8.5 Report back to ERT Leader (ERT Members) • The next team will enter the hot zone and report to the ERT leader

details of: > location and source of spill. , Adjacent hazards (electrical, chemical). , Volume and status (is it increasing in size?) , Temperature of spill. , Presence of people or casualties

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FORM-EHS-GEN-295, "ERT Event Log." Appendix 1, "Overview of Major Spill Response Appendix 2, "Solvent Spill". Appendix 3, "Corrosive Response" Appendix 4, "Water Spill."

11. Index of Attachments

Complete Spill Notify all End Response as relevant Identify Splll Report back to

directed by ERT personnel ERT Leader

Leader ERT

ERT Leader ERT Leader ERT Leader ERT Members

Isolate Area ERT

Members

Agree Response ERT

Members '---~-_J

ERT Member Emergency Co·

ordl ator Recortllng of

evacuation on form HS-EMG·

002·Fl

ERT Muster Raise alarm

AH Personnel All Personnel

"Procedure for Responding to Major Spills"

9. Process Map:

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Time: Date:

Title Name Contact

Emergency Co-ordinator

ERT leader

Scribe Assianed Role 1

2

3

4

5 1,

6 - 1-

7 -·

8

9

10 Other Other Contact made with EC Details of Emergency

Roll call Status Missing persons

Location of Emergency

Materials and Volumes Involved Confirmed Fire

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document TYDe: FORM I Document No.: FORM-EHS-GEN-295 Revision No.: 00 I Paae 1 of 2

Title: ERT EVENT LOG

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EPA Export 18-07-2017:03:17:29

Time Detail Action Required

..

TAKEDA IRELAND UMITED /GRANGE CASTLE\ Document Type: FORM I Document No.: FORM-EHS-GEN-295 Revision No.: 01 I Paae 2 of 2

Title: ERT EVENT LOG

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EPA Export 18-07-2017:03:17:29

• Integrated Pollution Prevention Control Licence (IEL) P0693 • POL-024 "Environmental Management" • FORM-EHS-GEN-343, "Environmental Logsheet."


• SOP-EHS-GEN-260 "Surface Water System" • SOP-EHS-GEN-261 "Operation of Neutralisation Tanks T-1763 and T-1764" • SOP-EHS-GEN-262, "Operation of the Wastewater Treatment Plant." • SOP-EHS-GEN-263 "Bunds- Inspection and Management" • SOP-EHS-GEN-251 "EHS Unplanned Event Management." • SOP-EHS-GEN-274, "Management of Bulk Liquid Waste." • SOP-QA-SYS-150 "Document Review and Change Process" • Site Glossary


3. REFERENCES:

This SOP applies to all daily and weekly inspections conducted by EHS personnel as part of site IEL compliance and industry best practice.

2. SCOPE:

The purpose of this SOP is to detail and document daily and weekly inspections.

1. PURPOSE:


(This Section is for use bv Document Control Only)

TAKEDA IRELAND LIMITED (GRANGE CASTLE} Document TvDe: SOP I Document No.: SOP-EHS-GEN-266 Revision No.: 1.0 I Page No.: 1 of 5

Title: ENVIRONMENTAL SYSTEMS DAILY AND WEEKLY INSPECTION

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• The DCS environmental checks; information is obtained from the DCS system.

• Each form will be assigned a unique number: o ELS: Environmental Log sheet c XX: Current year o VY: Current week number

• The form contains checks that are either required under the IEL P0693-01, EPA guidance and industry best practice

• The form is completed by EHS or designated trained staff. • The inspection format and frequency is designed to ensure that the integrity of named

systems, abatement, containment, storage and monitoring equipment and structures is operating correctly and fully functional.

• In the event of an issue being observed which could impact the functionality of any EHS related system the form will record the observation or issue. Appropriate EHS investigation and Unplanned Event follow up will then take place as necessary.

• The main aspects of the site EHS systems that are inspected on a daily an weekly basis, Include but are not limited to the following:

o Pollution of the surface water and groundwater o Surface water valve closures o Noise pollution o Vapours released to atmosphere, a Waste Tank levels, to enable forecasting the requirement of tankers. a Leakages/spillages that may have the potential to pollute the

environment o Loss of containment; uncontrolled release into a bund, to sewer o Loss of abatement o Loss of continuous monitoring o Breach in ELV o Reports made to EHS

7.1 General

7. REQUIREMENTS:

• N/A

6. HEALTH, SAFETY and ENVIRONMENTAL:

For other relevant definitions refer to the Site Glossary.

• Environmental Log Sheet (ELS): Document which provides for the documentation of environmental checks carried out at TILGC.

S. DEFINmONS:

• Prepare/revise the Environmental Log Sheet. • Review and Update ELS as appropriate • Review completed ELS. • Conduct Daily and Weekly Inspections and record findings using the ELS • Record any abnormalities and report and record as per SOP-EHS-GEN-251.

4.1 m£..;, It is the responsibility of EHS to:


TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Tvoe: SOP I Document No.: SOP-EHS-GEN-266 Revision No.: 1.0 I Paae No.: 2 of 5


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o The appearance and quality of the surface water o The TOC Biotectors o Fault Messages o TOC Reading o TDC Chemicals o Oxygen Concentrator o Appearance of the Ornamental Pond

• Security monitor alarms associated with the TOC Biotectors on a 24/7 basis using the Distribution Control System. If there is an alarm (high or low pH and high TOC), EHS are notified as per SOP-EHS-GEN-261.

• In addition and to confirm that the Biotector is operating correctly, it is checked on a daily basis by EHS/Designee

• The TOC analyser are checked on a daily basis;

7.4 TOC Analysers

Levels in the waste tanks and Bulk Caustic and Acid tanks are recorded daily. These tanks include: T-1751, T-1752, T-1753, T-1781, T-1763, T-1764, T-1021 and T-1031 on a daily basis.

7.3 Tank Levels

• The surface water system discharges on a continuous basis. • Security monitor XV-1781-02 on a 24/7 basis using the Distribution Control System. If the

valve closes EHS are notified as per SOP-EHS-GEN-261 and are informed what alarm caused the closure.

• In addition and to confirm that the valve is operating correctly, it is checked on a daily basis by EHS/Designee.

• The surface water system is the drainage system for the collection and discharge of surface water at TILGC.

• The operation and management of the surface water system is described in SOP-EHS-GEN- 260 "Surface Water System".

• The following are checked on a daily basis during surface water discharge o Outflow valve position (XV-1781-02) o Outflow pH o Outflow TOC o Max pH at outflow o Min pH at outflow o Max TOC at outflow

7.2 Subsection 1.1 'Surface Water System'

• Each subsection of the form contains relevant checks and sections to record information that is reported.

• Any report made on an observation or issue must be done in a timely manner depending on the severity of the issue or observation.

• Investigations and root cause is determined as per SOP-EHS-GEN-251.

• Section 1 (DCS checks) consists of the following sections: o Surface Water System o Tank Farm-Waste tank levels

• Section 2 (On site Inspections) consists of the following sections: o Surface Water system o Bund Inspections o Overhead Pipeline Inspections

TAKEDA IRELAND UMITED (GRANGE CASTLE} Document Type: SOP I Document No.: SOP-EHS-GEN-266 Revision No.: 1.0 I Page No.: 3 of 5


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• Review and ensure completion. • Ensure Record Unplanned Events as per SOP-EHS-GEN-251.

8.4 Review of Form ( EHS)

8.3 Observations • Document all observations in either of the comments sections provided.

• Conduct Overhead pipeline inspection as per section 2.0 "Onsite Environmental Inspections."

8.2 Weekly Inspection (EHS)

• GR0972 Surface water System • GR0924, record levels in waste tanks • Check Online TOC analyser as per section 2.1 "Surface Water

System." • Record any faults and report. • Reset TOC analyser when issue is resolved. • Conduct bund inspection and pump out of bunds as per SOP-EHS

GEN-263.

8.1 Daily Inspection (EHS) Record the data in the check sheet, from the DCS on each of the following graphics:

PROCEDURE:

• The overhead pipelines are walked weekly to confirm integrity • Pipes, flanges and valves that are used for transferring water, steam, solvent, waste,

nitrogen and air are inspected, where no permanent provision for containment exists. • Where a weep, leak or damage is observed, the observation is recorded in the form and the

issue is appropriately escalated, documented and investigated as per SOP-EHS-GEN-251.

The management of overhead pipeline inspections at TILGC is as follows:

7.8 Overhead Pipeline Inspection

• The wind sock Is checked on a daily basis.

7.7 Wind Sock

• The bund inspections are visual checks carried out to ensure bunds are dry and free of contaminants and have not suffered loss of physical integrity.

7.6 Prefabricated Bund Inspections

• The check on the bunds is carried out on a daily basis.

• The operation and management of bunds at TILGC Is described in SOP-EHS-GEN-263 "Bunds- Inspection and Management"

• The bund inspections are the physical checks carried out on bunds at TILGC; • The checks on the bunds must contain the minimum;

a Condition of the bund o Requirement for pumping o Any spills or leakages into bunds

7 .s Sund Inspections

TAKEDA IRELAND UMITED f GRANGE CASTLEl Document Tvoe: SOP I Document No.: SOP-EHS-GEN-266 Revision No.: 1.0 I Page No.: 4 of 5


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FORM-EHS-GEN-FORM-343 "Environmental Logsheet"

10. INDEX OF ATTACHMENTS:

Document ot,t,ervetlona •net clauJfy when required

•• Unpl•nned l!\J•nts

c Start )1----·I c:~~~ I EMS EMS

9. PROCESS MAP:

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvoe: SOP I Document No.: SOP-EHS-GEN-266 Revision No.: 1.0 I Page No.: 5 of 5


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• Respond only to minor spills and only when considered safe to do so. • Place appropriate labels on contaminated waste resulting from a minor spill. • Handle and dispose of all spill materials in accordance with EHS advice and local area

procedures. • Raise the alarm following an assessment of the spill indicating that it is a major spill. • Inform area supervisor that an incident occurred. • Inform the EHS Engineer of any spill kit items used. • Replace used items in spill kits.

4.1 All Personnel: It is the responsibility of all personnel to:

4. RESPQNSIBIUTIES:

N/A


• SOP-EHS-GEN-EHS-253 "Emergency Response Team Procedure." • SOP-EHS-GEN-252, "Fire Alarm Evacuation of Staff, Contractors and Visitors." • TILGC's, Emergency Management Plan. • SOP-EHS-GEN-266, "Environmental Log Sheet-Content and Format" • SOP-EHS-GEN-259, "Waste Management"


3. REFERENCES:

This SOP applies to all minor spills both liquid and powder as set out in attachment 1- Minor Spill Response Overview. For spills outside the scope of this procedure the Initial action and response of Attachment-1 must be followed.

2. SCOPE:

The purpose of this SOP is to outline the actions be taken in the event of a minor spillage.

1. PURPOSE:

Effective Date: Circulation Location or Area of Work Code:

(This Section is for use by Document Control Onlvl

TAKEDA IRELAND UMITED {GRANGE CASTLE) Document Type: SOP I Document No.: SOP-EHS-GEN-254 Revision No.: 1.0 I Paae No.: 1 of S

Title: MINOR SPILL RESPONSE

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;. Identify the cause of the spill , Identify the material , Ensure the source of the spill has been isolated , Ensure no other hazards are present e.g. electricity or ignition sources j,' Review the SDS to ensure the general precautions are sufficient.

7 .1 General: • Hazardous liquid spills may be classified as minor if the spill is less than SL

volume or 1 meter in diameter and only when one chemical is involved. • Water may be classified as minor if less than lOOL or it poses no danger to people

in the immediate area. • Powder spills may be classified as minor if the spill can be cleaned up by local

personnel and there is no risk of an explosion or contamination of an emission point. These include gram quantity spills in laboratory and manufacturing areas. Where a catastrophic failure of process containment occurs resulting in uncontrolled releases of charged solids, the alarm must be raised immediately.

• If spill size increases to greater than 5 L volume or 1 metre in diameter the spill must be classified as major and the alarm must be raised activating the break glass unit. Further response to this category of spill is managed through SOP EHS-GEN-253.

• Personnel should not endanger themselves and should notify anybody who could be affected by the spill.

• Minor spills may only be cleaned up by personnel who have been trained to do so. • Before any personnel begins the cleanup of spill they must;

7. REQUIREMENTS:

• Always refer to Safety Data Sheets (SDSs) of hazardous material and wear appropriate PPE as directed by the SDSs. All SDS are located on Sharepolnt.

6. HEALTH. SAFETY and ENVIRONMENTAL:

• Spill: Is an unplanned or accidental flow from a container resulting in loss or waste of liquid/powder which poses a risk of contamination to personnel. BGU: Is a break glass unit which will sound the alarm when pressed

5. DEFINITIONS:

• Ensure that the training programme is appropriate to the site needs for minor spills. • Ensure that induction and annual refresher training contains details of the

appropriate Emergency Procedures relevant to this procedure. • Provide assistance and technical advice to personnel to ensure that there is effective

and safe response to minor spills. • Ensure that spill kits contain all required items.

4.2 EHS Engineer: It is the responsibility of the EHS Engineer to:

• Provide as much detail as possible regarding the incident, location, personnel involved, material involved if known to the Emergency Coordinator, raise an unplanned event.

• Take direction from ERT and Emergency Coordinator, this will arise if the spill is assessed to be beyond the scope of this procedure.

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document TvDe: SOP I Document No.: SOP-EHS-GEN-254 Revision No.: 1.0 I Paae No.: 2 of 5


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8.7 Is spill contained? (All Personnel} • Turn off any machines involved (in the case of flammable materials the

area should be checked with an LEL detector to ensure a flammable atmosphere is not present which could be impacted by a spark from an electrical switch)

• Try to switch off the source of the spill ( close valves etc.) • Check that the spill is contained (in a container or bund) • If the spill is not contained proceed to step 8.8.

8.5 Identify Spilled Material (All Personnel} • Identify the material that has spilled as quickly as possible and its

associated hazards by using the SDSs or labels. • If you are unsure about the hazards of the material consult or contact the

EHS Engineer.

8.6 Put on appropriate PPE (All Personnel) • Put on the appropriate PPE as directed in the SDSs. Standard clean up

PPE: Goggles, laboratory coat or disposal splash proof coveralls, gloves as listed in the SOS, safety shoes

• SDSs are located on the Health and Safety Homepage of SharePolnt or from the EHS Engineer.

8.4 Isolate Area (All Personnel) • Isolate the area from unauthorised access by erecting a barrier using tape

or signs around the impacted area.

8.3 Raise Alarm (All Personnel) • When a spill is observed that requires evacuation activate the break glass

unit in the area. • When no break glass unit is in the area contact security and ask them to

raise the alarm from the Gatehouse. • Provide as much detail as possible about the incident, location, personnel

involved, material involved if known at this point to the Emergency Coordinator at the fire assembly point.

• Do not attempt to deal with the incident.

8.2 Is this a major spill? (All Personnel) • Classify the spill as either a major or minor spill. Refer to attachment 1 for

guidance. • For major spills proceed to step 8.3. • For minor spills proceed to step 8.4.

8.1 Assess the Risk (All Personnel) • Assess what the immediate risk of the spill is, using attachment 1 as a

guide and inform the area supervisor.


8. PROCEDURE:

, If resources are required to assist in the minor spill cleanup or there is any uncertainty as to how to clean up the minor spill, the EHS Engineer is contacted.

• No spillage can be flushed to drain or to the local authority sewer. • Spill kits are located in the appropriate locations throughout the facility including

laboratory areas, all levels of Pl, external areas around tank farm, utility buildings, drumstore and warehouse and receiving areas.

TAKEDA IRELAND LIMITED {GRANGE CASTLE) Document TvDe: SOP I Document No.: SOP-EHS-GEN-254 Revision No.: 1.0 I Page No.: 3 of 5


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8.12 Remove Waste Drum(s) (EHS) • Remove sealed labelled drum(s)to the appropriate waste holding area (as

agreed with the EHS Engineer).

8.13 Replace items in spill kit (EHS/Cleaners) • Replace all items in the spill kit that was used during the incident after

notifying the EHS Engineer of the Spill items used.

8.11 Contain and Clean-up Spill (All Personnel) • Use absorbent socks to contain the spill area, ensuring that the spill

cannot spread. • Mats must be placed around the spill and in an overlapping pattern cover

the spill fully.Ensure that all surfaces are dry in order to reduce the risk of slips.

Determine Corrective action (EHS) • Advise on correct clean up and disposal.

8.10

Raise UE (All personnel) • Record as unplanned event.

Report to EHS ( All Personnel) • Investigate and Identify root cause.

8.9

8.8 • If the spill has been isolated proceed to step 8.9.

TAKEDA IRELAND LIMITED (GRANGE CASTLE\ Document Type: SOP I Document No.: SOP-EHS-GEN-254 Revision No.: 1.0 I Paae No.: 4 of 5


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10. INDEX OF ATTACHMENTS: Attachment 1 "Minor Spill Response Overview"

All Per50nnel

Obtain labels Notify 8-15 Remove Wasta

Engineer cl Sp 1114-----~ Drums to Items used appropriate waste

storage area. Bag I Dnlm absorbent materials

EHS Engineer All Personnel

Al Personnel Record as unplanned

where necessary

Repll!lal Items tn spl'I ki:t

Investigate and identify root

cause. Al Personnel

Clean-up sp,11 using 1---~ Report to EHS absorbent materials

Reassess Situation

AIIPe=Mel AU Personnel

Put on 14-----t Identify spi led appropriate PPE material

Contact Security at SSS or Ch2 and ask them to

raise alarm from Gatehouse

AIPerscMel AIIPet50nnel

Contain spin

Activate the BGU, SOP 8-15· -----Yes------1 ls then! a BGU?

GEN-252

Yes

Al Per50nnel

Isolate area

Al Personnel Al Per10nnel

Assess Risk

"Procedure for Minor Spill Response"

9. Process Map:

TAKEDA IRELAND LIMITED (GRANGE CASTLE} Document TvDe: SOP I Document No.: SOP-EHS-GEN-254 Revision No.: 1.0 I Page No.: 5 of 5


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EPA Export 18-07-2017:03:17:30

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• Industrial Emissions Licence P0693-01


• SOP-EHS-GEN-272, "Environmental Log Sheet" • SOP-EHS-GEN-251, "EHS Unplanned Event Management." • SOP-EHS-GEN-264, "Wastewater Testing Procedure." • Site Glossary


3. REFERENCES:

1. Normal operation and management of the surface water system 2. Emergency operation and management of the surface water system

This SOP applies to the following:

2. SCOPE:

The purpose of this SOP is to describe the operational procedure and management of the surface water system at TILGC.

1. PURPOSE:


(This Section is for use by Document Control Only)

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Type: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Page No.: 1 of 11

Title: SURFACE WATER SYSTEM

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• CAPA: Corrective and Preventative Action • Emergency Observer: TILGC Employee or Security personnel who has witnessed a

situation where a pollutant could potentially enter the surface water system. • EPA: Environmental Protection Agency • Task Trained Personnel: TILGC Employee who has been trained on the operation of the

surface water system during emergency situations. These people include but are not limited

S. DEFINITIONS:

• Respond to the closure of XV-1781-02. • Conduct investigation. • Record an incident where necessary. • Raise an UE where necessary. • Report to the EPA where necessary.

4.4 Maintenance/EHS Manager It is the responsibility of the Maintenance/EHS Manager to:

• Contact the EHS Engineer in the event of an emergency situation. • Activate the "Site Evacuation Shutdown" button in the gatehouse when necessary. • Monitor Graphic GR0972 on the DCS during out of office hours. • Notify the EHS Engineer if XV-1781-02 closes. • Conduct an inspection of the site following the closure of XV-1781-02 and record any

issues. • Report the valve closure to the Maintenance/EHS Manager.

4.3 security: It is the responsibility of Security to:

• During office hours contact the EHS engineer in the event of an emergency situation. • Outside office hours contact Security in the event of an emergency situation.

4.2 Emergency Observer: It is the responsibility of the Emergency Observer to:

• Ensure all necessary personnel are trained in the emergency operation of the Surface Water System in accordance with this SOP.

• Monitor the Surface water system Graphic GR0972 and firewater retention tank in accordance with SOP-EHS-GEN-266.

• Close the actuated valve when required. • Report any unusual surface water appearances/occurrences to the EHS Engineer. • Contact the EHS engineer in the event of an emergency operation of the surface

water system. • Compile continuous monitoring data for reporting purposes. • Where XV-1781-02 closes; conduct an inspection of the site as part of the

investigation. • Raise Unplanned Events in accordance with SOP-EHS-GEN-251. • Notify the Maintenance/EHS Manager in the event of an emergency operation of the

Surface Water System. • Co-ordinate remedial actions and CAPA's as required. • Notify the EPA when required as per the IEL.


4. RESPONSIBIUTIES:

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Tyge: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Paae No.: 2 of 11


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-- -- - - - ~ - - . Max Locatlon Type Make/Model Containment Max Flow

Rate (1/s) - - {I} 1 Firewater Pump House Bypass Klargester NSBD003 175 3 2 Drumstore/Warehouse Forecourt Bvoass klaraester NSBD003 175 3 3 HTF Skid Forecourt Kiarciester KZE 7.600 n/a 4 Ad1acent to Utllltv Bulldlnci Bvoass Klarciester NSBD003 175 3 5 Admln Bulldlno Car Park Bvoass BMS PB2 175 80 6 Adjacent to Firewater Full Klngspan Class 1 1250 125 Retention Tank Retention MB125

• There are 6 separators that are part of the Surface Water Drainage system. These retain silt and small amounts of diesel or oil from entering the surface water drainage system. Details of these separators are presented in the table below.

7.2 Separators

If the level of water in the Ornamental Pond drops, it is topped up via South Dublin County Council (SCDD) water supply. This is controlled via a level sensor.

• There are a number of separators on the Surface Water Drainage System. These are described in section 7.2 of requirements.

• Water from the firewater retention tank is only discharged back into the Surface Water System only after it has been confirmed that no contamination has occurred and water quality is within alarm and trigger limits. This must be approved by EHS.

• If the outlet valve XV-1781-02 is closed for any reason or if the velocity of the surface water is greater than 13 1/s the excess water overflows into the firewater retention tank.

• Surface water collected from hard standing areas, excluding bunded areas, on the site is transported via the Surface Water Drainage System to the inlet monitoring chamber. From here it flows through a Class 1 interceptor and continues to the outlet monitoring chamber prior to discharge to the River Griffeen.

• An overview of the surface water system is presented in Appendix 1.

7.1 Normal Operation of the Surface Water System

7. REQUIREMENTS:

• When operating the actuated valve (XV-1781-02) manually using the hand wheel, no additional lever device such as a wheel key or wrench should be applied. This may cause damage to the valve and/or actuator or may cause the valve to become stuck in the seated/back position.

• Surface Water discharges directly into the River Griffeen. In an emergency situation the actuated valve (XV-1781-02) on the discharge must be closed immediately and the relevant authorities notified if necessary.



to EHS engineers, security, plant technologists and engineering technicians. A list of task trained personnel is compiled and maintained by the EHS Engineer and is kept at the security gatehouse.

• UE: Unplanned Event.

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document TvDe: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Page No.: 3 of 11


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• There is one forecourt separator on site which is located in the vicinity of the HTF skid. This separator is designed for higher risk areas such as a petrol forecourt and it will hold up to 7,800 L of Oil. As oily water enters the separator the oil rises to the top. The separated water then passes through the core tube assembly. This assembly consists of a closure device in the form of a float. As the level of oil accumulates and forms a floating layer, the float is pushed downwards. The plate then seals on the base and prevents oily water being discharged to the surface water system. A schematic of this system is presented in Figure 2.

Separation Chamber

Figure 1: Bypass Separator

Slit and/ I Grit Coalescer

011

-• Outlet

Inlet Chamber

Separation Chamber

Inlet Outlet Chamber Chamber

... ...

Inlet__., _. Outlet

• There are 3 Klargester separators on site. This type of separator is designed for low risk areas such as car parks and it will hold up to 175 L of oil. The unit will treat a flow of up to 3 1/s. The bypass unit has 3 chambers, an inlet chamber, a separation and outlet chamber. The inlet chamber will hold silt and grit build up ("'300 I). Flow enters the inlet chamber of the unit, flow settles and oil rises to the top of the tank. The oil and water mixture is drawn from the bypass chamber down the vortex pipe, the flow (containing the oil) rises to the top of the tank. Separated water enters the coalescer and the flow rises up the transfer pipe. Flow then enters the outlet chamber and into the surface water drainage system. A schematic of this system is presented in Figure 1.

TAKEDA IRELAND UMITED (GRANGE CASTLE'l Document Type: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Paae No.: 4 of 11


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• The surface water system is monitored in accordance with IEL requirements.

• The actuated valve (XV-1781-02) on the discharge pipe from the Surface Water System to the River Griffeen normally remains in the open position. This ensures that there is minimum overflow into the firewater retention tank therefore providing maximum volume for collection of surface run-off in the event of a fire or storm event.

7 .3 Design Philosophy

Figure 3: BP2 Separator

• There is one Kingspan Class 1 MB125 separator on site which is located adjacent to the firewater retention tank. This type of separator is designed for low risk areas and it operates similarly to the Klargester separators. Full retention separators treat the full flow that can be delivered by the drainage system, which is normally equivalent to the flow generated by a rainfall intensity of 6Smm/hr. As a Class 1 separator it is designed to achieve a concentration of less than Smg/1 of oil under standard test conditions.

-IJJl>.OUtlet

Figure 2: Forecourt Separator

• There is one BMS BP2 separator on site which is located adjacent to the administration building car park. This type of separator is designed for low risk areas and it operates similarly to the Klargester separators. As contaminated water enters the first chamber, pollutants float to the surface. Due to the internal design a vortex formation occurs at the by-pass pipe resulting in the pollutants being skimmed off the surface and become trapped. The uncontaminated water is then allowed to discharge from the interceptor. When the storm flow intensity increases, the vortex pipe floods and restricts the flow from the first chamber to the retention chamber. The water level increases in the first chamber, hydraulic pressure increases, forcing the majority of the water through the bypass weir into the chamber to discharge to storm drains. A schematic of this system is presented in Figure 3.

Closure Plate Float valve

. .. . . ... . • l!_ .... . . . ..... Oil

. •': . . . . . . . . . .. . . . . . . : .. ·. ··· .. _. Outlet Inlet _.



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• The hydrobrake is a device which restricts the discharge flow to within IEL requirements. The hydrobrake is set at the desired flow rate and should not be adjusted.

o If limits detailed In table 1 are exceeded, o If the fire alarm Is activated or o If emergency operation of the system is required.

• The actuator valve (XV-1781-02) is normally operated electronically by the DCS. It is normally in an open position but will be closed in the following situations;

o Actuator valve (XV-1781-02) on the discharge from the surface water system to the River Griffeen.

o Flow restricting Orifice-Hydrobrake

• There are a number of controls on the surface water system that include the following;

7 .4 Surface Water System Controls

Discharge Conductivity Value DCSAlarm Valve

~ Clo~ >20 mg/I v' PH

TOC >30 mg/I v' HH v' > 9.0 vHH v' > 8.8 vPH - ·-- - pH < 6.7 v' PL < 6.5 v' LL v'

Fire Alarm l:ia v' General v

Table 1: Surface Water System: Alarms and Interlocks

• Details of the alarms and interlocks are presented in Table 1 below.

• If the pH or TOC monitoring measurements are outside specified limits or if the fire alarm is activated DCS alarms are triggered and in some cases the actuated valve closes shut to prevent discharges to the River Griffeen.

• This monitoring routine consists of regular visual inspections and continuous pH and TOC measurements.

TAKEDA IRELAND LIMITED (GRANGE CASTLEl Document TvDe: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Paae No.: 6 of 11


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• Locally (Electrically): If the DCS fails or if there are no DCS users on site the valve can be operated locally if necessary using the valve's local electrical controls. The actuator is controlled using the red (3) and black (2) selector on the front of the actuator. The red selector toggles between LOCAL (6), REMOTE (7) and STOP (8) and the black control is used to CLOSE (9) and OPEN (10) the valve (see Figure 5). To close the valve;

o Move the red selector (3) toggle to the LOCAL position (6) then (Figure 5)

o Remotely via the DCS o Locally-electrically o Locally-manually o At gatehouse by activating emergency push button

• Remotely (DCS): The valve can be operated by the DCS by two methods 1) automatically and 2) manually. The DCS operates the valve automatically when prompted to do so via the activation of an alarm which triggers it to close. The DCS operates the valve manually when instructed to do so by a DCS user.

• It may be operated by any of the following methods;

Figure 4: Surface Water System Actuator Valve (XV-1781-02)

• The status of the valve will be displayed on the actuator indicator display window (1). o If it displays closed limit the valve is in a closed position and o If it displays open limit the valve is In an open position.

• Actuator Valve (XV·1781·02) is a Rotork valve model type IQT 1000. This is presented in Figure 4.

7.5 Operation of Actuator Valve (XV-1781-02)

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document TvDe: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Page No.: 7 of 11


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o Activation of the Fire Alarm o Activation of DCS alarms and interlocks on the system o Spills outside contained/bunded areas of the site o other situations where contaminants may potentially reach the surface water system.

• Emergency operation of the Surface Water System is considered necessary under the following circumstances;

7 .6 Initiating Emergency Operation of the Surface Water System

• At Gatehouse: An alternative method of operating the valve if there are no DCS users available is to activate the "Site Evacuation Shutdown" button in the gatehouse. This is done by requesting security initiate a site evacuation.

Figure 6: Manual Operation of Actuator Valve (XV-1781-02)

Please note: The actuator will remain with the hand wheel drive selected until electrical operation takes place when it will automatically return to motor drive.

o Move the red selector (3) toggle to the LOCAL (6) position then (Figure 4} o Depress the Hand/Auto lever (5) into the hand position. When the clutch is engaged

the Hand/Auto lever should be released. (Figure 6) o Turn the hand wheel (4) clockwise until the "CLOSED LIMIT" is displayed on the

actuator indicator display window (1). (Figure 4) If there is no display on the window physically check that the valve Is closed

o Move the red selector (3) toggle to the STOP position (8).

• Locally (Manually): If the DCS fails and local electrical control of the valve is offline It may be closed manually. To do this (refer to Rgure 5 and 6)

Figure 5: Front of Actuator Valve (XV-1781-02)

• B.Stop

9J ,o.opeo

6. Local 9. Close

o Move the black selector (2) clockwise to the CLOSE position (9) until "CLOSED LIMIT" is displayed on the actuator indicator display window (1) (Figure 4)

TAKEDA IRELAND UMITED (GRANGE CASTLE\ Document Tvoe: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Paae No.: 8 of 11


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8.8 Close Actuator Valve (XV-1781-02) (EHS) • Close actuator valve by whatever method is available/quickest.

1) Using DCS controls 2) Using Local Electrical Control

8.7 Actuator Valve (XV-1781-02) Opened/Closed? (Emergency Observer ) If the actuator valve is open proceed to step 8.6 • If the actuator valve is closed proceed to step 8. 7

8.6 Establish Status of Actuator Valve {XV-1781-02) {Emergency Observer/ EHS) • Contact the control room and request status of valve. • If this is not possible go to the valve and check the actuator indicator

display window.

8.5 Establish if EHS Engineer is on site? (Emergency Observer) • If "Yes" contact EHS Engineer and explain emergency. • If "No" contact Security and explain emergency.

Emergency Operation of Surface Water System required? (Emergency Observer) • If "Yes" go to step 8.2. • If "No" no action is required.

8.4

8.3 Valve closure during out of office hours (Emergency observer/ security)

• Emergency observer notifies Security. • Security conduct inspection of site to determine whether or not

there is contamination. • Proceed to step 8.9

8.2 Determine cause of contamination (EHS} • Conduct site inspection to identify source of contamination • Sample chambers and test for pH and COD as per SOP-EHS-GEN-

264. • Once pH and COD are within licence limits and following approval

from EHS Engineer, reopen XV-1782-02. • Conduct visual inspection • During out of office hours proceed to step 8.3.

8.1 Automatic Closure of Actuated Valve XV-1781-02 due to out of specification pH or TOC (EHS/Security)

• Record pH and TOC from GR0972 • Check trends on DCS • Establish cause of valve closure.

Refer to Process Map attached (if applicable)

8. PROCEDURE:

• During the Emergency Operation of the Surface Water System the actuator valve (XV-1781- 02) on the discharge must be closed,

• Only task trained personnel may operate the Surface Water System during emergency situations.

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document Tvoe: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Page No.: 9 of 11


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8.10 Initiate UE (EHS Engineer) • Investigate and determine the root cause of the valve closure. • Record findings • Initiate an UE where necessary in accordance with SOP-EHS-GEN-251 • Report incident to Management/Relevant Authorities in accordance

with SOP-EHS-GEN-251 where necessary.

8.9 Notify the EHS Engineer or Maintenance/EHS Manager • Contact the EHS Engineer as soon as possible after the discharge has

been stopped. • Contact the Maintenance/EHS Manager in the event of a valve closure

during out of office hours. Note: During office hours the EHS Engineer may have already been notified as per step 8.2. However if the EHS Engineer was not on site request Security to contact the EHS Engineer or Maintenance/EHS Manager.

3) Using Local Manual Controls 4) Use of "Site Evacuation Shutdown" button in Security Gatehouse

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document Tvpe: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Page No.: 10 of 11


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Appendix 1 SOP-EHS-GEN-260 "Overview of Surface Water System." SOP-EHS-GEN-260 "Local Operation of Actuator Valve (XV-1781-02)" Appendix 2 "Local operation of the actuated valve XV-1781-02." Appendix 3, SOP-EHS-GEN-260 "Map of Surface Water Drainage System."


EHS Engineer

Conduct Investigation

Initiate UE if necessary

e urn System to

Normal o eratlons

/ ' Emergency·,

e,;-,, Operation '> .z._equlred? / EHS

<, Engineer I I Maintenance .__ -N.,.0 __._ Manager

251

Establish Status of Actuator

Valve

Security

Contact EHS Engineer/

Maintenance Manager

EHS Engineer/ Maintenance Mana er

Contact Security

EHS Engineer

Close Actuator -----1 Valve

End Record TOC and .----i.i pH

I No

Emergency A. Emergency /' Emergenc:y Observy Observer Observer...--------,

Out of specification..., y ~-•··-" ,,. E E~S -, , N pH roe - e.......- ngoneer ,-

-, or ' on Site? ,,, / ,/' <,

"1 Emergency Yes

Observr'-e=r _ _._ _ __,

"Procedure for Emergency Operation of Surface Water System"

9. PROCESS MAP:

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document Tvoe: SOP I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Page No.: 11 of 11


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Power Cut 1. Maintains current position 2. Battery-local OPEN/CLOSE

ens· ny rom Wiii not open automatically If alarmi'.:lears

Enters river south of bridge under Grand canal

Monitoring Chamber Hydrobrake

outlet valve

Monitoring Overfto,y OUlet

Class 1 Interceptor

pH TOC Monitoring Chamber rflow

Monitoring Monitoring Chamber

flrewllter Retention Tank

Ove

Capacity of Flrewate.- Retention Tank I Is 2230 m3

Flrewate.- Retention Tank Is sized to facllltate a 1:20 yea.- storm occurrlng In conjunction with a fire event and a 1:100 year storm In Isolation.

Surface Water will automatically flow ~ Into the firewater retention tank If; - 1. XV·1781·02 ls closed due to activation of trigger values or a fire event 2. Flow of Surface Water Is [n excess of 13 1/s)

Discharge from Firewater Retention pond only occurs Orta! It Is confirmed that no contamination has occurred and water quality Is within alarm and trigger llmlt values

Sl.08

Stonn Gully

City Water filtration unit (Ul631; backwash) Rainwater Fire fighting water

Pl Bulldfn!1 Wale.- Addition Automatic from SOCC mains to maintain level

! ~-- n -n ·- ~ntZIIPond

Ornamental Pond Normal Volume ca,J25m>

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvoe: APPENDIX 1 I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Page No.: 2 of 2

Title: OVERVIEW OF SURFACE WATER SYSTEM

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Please note: The actuator will remain with the hand wheel drive selected until electrical operation takes place when it will automatically return to motor drive.

To close the valve manually; o Move the red selector (3) toggle to the LOCAL (6) position then o Depress the Hand/Auto lever (5) Into the hand position. When the clutch Is engaged the

Hand/Auto lever should be released. o Turn the hand wheel ( 4) clockwise until the "CLOSED LIMIT" Is displayed on the actuator

Indicator display window (1). If there Is no display on the window physically check that the valve Is closed

o Move the red selector (3) to ..--..

2. Manual Operation

8. Stoo 10. Ooen

7. Remote

6. Local

To close the valve electronically; o Move the red selector (3) toggle to the LOCAL position (6) then o Move the black se!ector (2) clockwise to the CLOSE position (9) until "CLOSED LIMIT" Is

displayed on the actuator Indicator display window (1)

1. Electronic Operation

Actuator Valve (XV-1781-02) as depicted above Is a rotork valve model type IQT 1000. The status of the valve will be displayed on the actuator Indicator display window (1). If It displays closed limit the valve Is In a closed position and If It displays open limit the valve Is In an open position.

The actuator Is controlled using the red (3) and black (2) selectors on the front of the panel. The red selector toggles between LOCAL (6), REMOTE (7) and STOP (8) and the black control ls used to CLOSE (9) and OPEN (10) the valve.

Figure 3: Surface Water System Actuator Valve (XV-1781-02)

3. Local/Remote/ Stop Switch

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvoe: APPENDIX 2 I Document No.: SOP-EHS-GEN-260 Revision No.: 2.0 I Paae No.: 1 of 1

Title: LOCAL OPERATION OF ACTUATOR VALVE (XV-1781-02'\

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----- E :ii'2 ----·=~- . -- _........,., ~

SDCC Water Supply

Separators

- Foul Water Drains

Process Water Drains

- Surface Water Drains

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document Type: APPENDIX 3 I Document No.: SOP-EHS-GEN-260 Revision No.:2.0 I Page No.: 1 of 1

Title: MAP OF SURFACE WATER DRAINAGE SYSTEM

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• Industrial Emissions Licence (IEL) Licence (Number P0693-01)


3.1 Documents Referenced: • SOP-EHS-GEN-278, Communications- Public Requests for Information on

Environmental Performance and Management of Environmental Complaints • SOP-EHS-GEN-251, "EHS Unplanned Event Management • SOP-GEN-ADM-058, "Management of all TILGC Service Suppliers"

3. REFERENCES:

This SOP applies to routine environmental monitoring as required by TILGC's IEL and any other non-routine environmental monitoring carried out by TILGC.

2. SCOPE:

The purpose of this SOP is to detail the procedure for managing the environmental monitoring programme at TILGC.

1. PURPOSE:



TAKEDA IRELAND UMITED (GRANGE CASTLE} Document Type: SOP I Document No.: SOP-EHS-GEN-277 Revision No.: 1.0 I Page No.: 1 of 6

Title: ENVIRONMENTAL MONITORING

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• Not applicable



s, DEFINITIONS: • AQC: Analytical Quality controls. • CEN: Certified European Norm. • COC: Chain of Custody. • Continuous Monitoring: This is carried out during all days of operations and in the case of

emissions, when emissions are taking place. It is defined as constant monitoring. • Daily Monitoring: This is carried out during all days of operation and in the case of

emissions, when emissions are taking place. It is defined as one 24 hour period from 0:00 to 24:00 inclusively.

• LOD: Limit of Detection • Per Batch Monitoring: This relates to monitoring of COD, pH and Suspended Solids of

effluent prior to release from T-1769 to the sewer. • Monthly Monitoring: This is carried out at least twelve times per year and is defined as the

first to the last day of any calendar month inclusive. • Quarterly Monitoring: This is carried out at least four times per year and Is defined as all

or part of a period of three consecutive months beginning on the first day of January, April, July and October.

• Annual Monitoring: This is carried out at least once per year and is defined as all or part of a period of the first day of January to the last day of December inclusive.

• Biannual Monitoring: This is carried out at least twice per year and is defined as all or part of a period of consecutive months beginning on the first day of January and July.

4.2 Maintenance/EHS Manager It is the responsibility of Maintenance/EHS manager to: • Ensure that reporting of non-compliant monitoring results is performed accordingly.

• Determine when environmental monitoring should be carried out as required by TILGC's IEL.

• Employ an external contractor to carry out TILGC's environmental monitoring. • Ensure that all environmental monitoring is carried out as required by TILGC's IEL. • Ensure that all results from monitoring are inputted Into the IEL Management and

Reporting Database. • Inform the Maintenance/EHS Manager where monitoring results are out of

specification and are not compliant with limits as per the IEL. • Where there is a breach in the ELV, record, investigate and determine the root cause

as per SOP-EHS-GEN-251. • Report monitoring results which are non-compliant with TILGC's IEL to the EPA.

4.1 EHS Engineer: It is the responsibility of EHS Engineer to:

4. RESPQNSIBIUTIES:

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• Formal approval of Service Supplies will be in accordance with SOP-GEN-ADM-013, 'Management of all TILGC Service Suppliers'.

o The criteria outlined in the EPA's Checklists/Guidance "Basic Air Monitoring Checklist for EPA Licensees", "Checklist for the audit of External/Internal Laboratory" and "Air Emissions Monitoring Guidance Note #2 (AG2)" - these criteria have been combined into Contractor Assessment Form (Appendix 2) which can be forwarded to the client for completion;

o Accreditation to ISO 17025; o Listed on EPA's register of quality controlled labs; o For noise monitoring contractors, conducts monitoring in accordance with the EPA

Guidance Note for Noise: Licence Applications, Surveys and Assessments In Relation to Scheduled Activities NG4 );

o Has a current client list of IEL licensed facilities in the pharmaceutical sector; o Has the ability to take and analyse samples at short notice; and o Has a guaranteed turnaround time between sampling and reporting of results.

• Some of the environmental monitoring required by TILGC will be carried out by an external contractor. Criteria to be considered when selecting an external monitoring contractor includes but is not limited to the following:

7.2 External Monitoring Process

• Potential external contractors to carry out TILGC's environmental monitoring will be researched by the EHS Engineer.

• Monitoring is normally carried out at the beginning of each period to ensure adequate time is allowed for analysis and reporting.

o As part of an environmental programme c As a request by the EPA o For process optimisation o For investigative purposes

• Additional non-routine environmental monitoring may be required but is not limited to the following situations;

• Routine monitoring refers to all monitoring required under condition 11.1 of TILGC's IEL.

• Appendix 1 shows the schedule for routine environmental monitoring as required by TILGC's IEL.

7.1 General

7. REQUIREMENTS:

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• Monitoring reports should meet the criteria outlined In the EPA's Checklist 'Checklist - Assessment of Results by Licensee' ( criteria also included in the Contractor Assessment FORM-EHS-GEN-314).

• Upon receipt of monitoring results all monitoring results are inserted into IEL Management and Reporting Database and compared with the IEL Emission Limit Values or in their absence relevant standards/guideline values.

• A hardcopy of the monitoring results must be filed in the EHS Monitoring results folder • The EHS Engineer/Designee shall in accordance with Condition 4 of TILGC's IEL notify the

agency if any emission does not comply with the requirements of the licence. • The Engineering Director, Malntenance/EHS Manager and EHS will be kept informed of all

monitoring results which are non-compliant with TILGC's IEL. • All monitoring results shall be made available for the public to view in accordance with SOP

EHS-GEN-278 "Communications- Public Requests for Information on Environmental Performance and Management of Environmental Complaints."

7 .3 Results of Monitoring

• Each sample sent for external analysis must be accompanied by a Chain of Custody Form - if this is not supplied by the Monitoring contractor, the Chain of Custody Form FORM-EHS GEN-315 may be used instead.

• YY is the year the sample was taken e.g. 2011 is 11 and ZZ refers to the sequence the sample was taken in e.g. the first sample is 01 and the seventh sample is 07. Example: The first groundwater sample taken from emission point MP-WG-01 in January 2011 will have a reference number of WGOl-11-01.

Monitorina Point Reference Code xxxx MP-WW-01 (Wastewater) (T-1769) WW01 MP-WG-01 (Groundwater) WG01 MP-WG-02 WG02 EP-WS-01 <Surface water) WS01 MP-Pl-02 <VOC) P102 Waste Analvsis WST MP-NS-01 CNolsel NS01 MP-NS-02 NS02 MP-NS-03 NS03 MP-NS-04 NS04

• Each sample sent for external analysis will have a unique number. This number is in the following format XXXX-YY-22. Where XXXX is the emission point reference as denoted by the IEL as follows:

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8.13 File Results with Chain of Custody Form (EHS Engineer) • File results along with the Chain of Custody form in the EHS

8.12 Input Results into Database (EHS Engineer) • Input Results into the IEL Management and Performance Monitoring

Data Base.

8.11 Results compliant to IEL? (EHS Engineer) • If the results are compliant with the IEL continue to step 8.12. • If the results are not compliant with the IEL continue to step 8.15.

8.10 Check Results (EHS Engineer) • Check results against the IEL Emission Limit Values

8.9 File COC Form (EHS Engineer) • File the COC form in the EHS Environmental Monitoring Folder • Await return of results. • When results have returned continue to step 8.10.

8.8 Dispatch Sample (EHS Engineer) • Dispatch sample with a copy of COC.

8.7 Fill out COC Form (EHS Engineer) • Fill out the appropriate Chain of Custody.

8.5 Analyse Sample (EHS Engineer/Designee) • Analyse the sample and record all the details in the Environmental

Laboratory Logbook. • Continue to step 8.10.

8.6 Contact External Contractor (EHS Engineer) • Contact the external contractor and schedule a time for the monitoring

to take place.

8.4 Take Sample (EHS Engineer/Designee) • Take sample as per SOP-EHS-GEN-265 • Continue to the next step.

8.3 Is External Monitoring Required (EHS Engineer) • Determine if external monitoring is required • If external monitoring is required go to step 9.6 • If monitoring is internal continue to step 9.4

8.2 Is Monitoring Required (EHS Engineer) • Determine if monitoring is required. • If monitoring is required continue to step 9.3 • If monitoring is not required no further action Is required.

8.1 Refer to Schedule of Routine Environmental Monitoring (EHS Engineer) • At the beginning of each monitoring period refer to TILGC's schedule of

routine environmental monitoring


8. STEP BY STEP PROCEDURE:

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Appendix 1: Schedule of Routine Environmental Monitoring as required by TILGC's IEL FORM-EHS-GEN-314 'Environmental Monitoring Contractor Assessment'. FORM-EHS-GEN-315'Chain of Custody'.


9. PROCESS MAP:

~ No

EHS Engineer EHS Engineer rrange

Refer to the Monitoring of Start schedule of Ye Yes required

monitoring Parameters with External

Contractor

EHS Engineer/Oeslgnee No EHS Engineer/ Oeslgnee

Analyse Sample Take Sample

EHS Engineer EHS Engineer EHS Engineer EHS Engineer

Check Results AleCOCForm Dispatch Complete/Sign- Sample off COC form

EHS Engineer EHS Engineer

Input results Report results to Into database Director, End

Productlon/EHS

SOP·EHS·GEN· 251

EHS Engineer

File results with Make Monitoring End File COC form Folder available

EHS Engineer SOP·EHS·GEN· 278

Report Results (EHS Engineer) • Report all non-conforming results to the EPA as outlined in the SOP

EHS-GEN-251, "EHS Unplanned Event Management." • Inform the Director of Production and EHS of all non-conforming

results. • No further action required.

8.15

Environmental Monitoring Folder. Make Monitoring Folder Available (EHS Engineer) • Ensure Environmental Monitoring Folder is available for public

inspection as required by SOP-EHS-GEN-278 • No further action required.

8.14

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*Routinely Internal monitoring; however, these may be sent externally if required.

- - - Emission Point

' Parameter Frequency Reference - - - TA Luft Class I

MP·P1-02 TA Luft Class II Monthly

TA Luft Class III (VOC U-1723) Flow

THC Continuous ,_ - - - -- - - - - - - -

Flow Flow

Continuous* pH Temperature COD Per Batch Discharge* BOD

MP-WW-01 Suspended Solids

(Trade Effluent Sulphates (as S04)

to sewer) Detergents (as MBAS) Phosphates (as P04-P) Monthly Ammonia (as N) Fats, 011, Grease Toluene Organohalogens Organic Solvents Quarterly Toxlclty/Resplrometry Biannually

- -- - - - -- - - - T ~ -

pH Continuous* EP·WS-01

(surface water) TOC Visual Inspection Dally

- - - - - -- pH

MP-WG-01 COD MP-WG-02 Total Ammonia Biannually

(ground water) Conductivity Trace Organics

MP-NS-01 MP-NS-02 Noise Annually MP·NS-03 MP·NS-04

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Type: APPENDIX I Document No.: SOP-EHS-GEN-277 Revision No.: 1.0 I Paae No.: 1 of 1

Title: SCHEDULE OF ROUnNE ENVIRONMENTAL MONITORING

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• Safety, Health and Welfare at Work Act, 2005 • Safety, Health and Welfare at Work (General Application) Regulations 2007 • Fire Services Act,1981 and 2003 • 659999:2008 Fire safety code of practice for the design, management and use of

buildings • Building Regulations, Technical Booklet M, 2004, Access for People With Disabilities • Building Regulations, Technical Booklet B, 2006, Fire Safety • Fire Safety, a guide to implementing legislation, Michael McMahon,2001 • NOA (2002), Building for Everyone, The National Disability Authority.


• SOP-EHS-GEN-253, "Emergency Response Team Procedure." • SOP-EHS-GEN-254, "Minor Spill Response"


3. REFERENCES:

This SOP applies to the management, control, response and prevention of fire on site.

2. SCOPE:

The purpose of this SOP is to outline the management systems for effective responses to incidents involving fire or where an evacuation of the site is required during an emergency.

PURPOSE: 1. 1.



TAKEDA IRELAND UMITED (GRANGE CASTLE} Document TvDe: SOP I Document No.: SOP-EHS-GEN-252 Revision No.: 1.0 I Page No.: 1 of 10

Title: FIRE ALARM EVACUATION OF STAFF, CONTRACTORS AND VISITORS

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4.5 Emergency Co-ordinator: It is the responsibility of the Emergency Response Co-ordinator to: • Proceed immediately to the Security Gatehouse on hearing alarm or receiving

notification from security. • Activate ERT if required and inform ERT Leader of nature of emergency and details

received to date.

• Contact the Emergency Co-ordinator for all fire alarms. • Printout the evacuation roll call list and provide this to the Emergency Co-ordinator. • Switch barrier operation from automatic to manual. • Take directions from Emergency Co-ordinator as required.

4.4 Security: It is the responsibility of Security to:

• Arrange search and rescue of missing persons based on information provided by Emergency Co-ordinator.

• Report any location where there is evidence of smoke or fire to the Emergency Co- ordinator.

• Note the name and location of anyone unable, or unwilling, to evacuate the building. • Take directions from Emergency Co-ordinator as required. • Report to the EHS Engineer any unsafe conditions relating to fire and evacuation that

they observe.

4.3 ERT Leader: It is the responsibility of the ERT Leader to:

• Advise site management on regulatory requirements for any changes to site building or activities.

• Fulfil the requirements of Emergency Coordinator as set out in the site emergency plans and procedures.

• Arrange two emergency evacuation drills per year. • Ensure relevant training and awareness is delivered in the appropriate manner to all

site personnel. For personnel who are on site for short periods of time, this can be conducted as part of contractor or visitor induction.

4.2 EHS Engineer: It is the responsibility of the EHS Engineer to;

• Sound the alarm by breaking the nearest Break Glass Unit if fire or an emergency requiring a site evacuation Is observed.

• Stop what they are doing, leave the building. • Swipe out at the assembly point. • Follow instructions when directed by the designated Incident Coordinator/ ERT at the

time of the emergency. • Co-operate and participate in any drills which take place on site. • Report any indications of fire to Security without delay. • Ensure all Visitors that you are responsible for are evacuated to the assembly point. • Remain at the Assembly point until directed by Emergency Coordinator. • Report to the EHS Engineer any unsafe conditions of fire detection, prevention and

fighting equipment.

4.1 All personnel: It is the responsibility of all personnel on site (including non TILGC personnel) to:

4 RESPQNSIBIUTIES:


Title: FIRE ALARM EVACUATION OF STAFF. CONTRACTORS AND VISITORS

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7. 2 Cause and Effect • All automated responses to alarm activations are detailed in the site cause

and effect drawings. • These are controlled documents that take precedence over all procedures

• Personnel are not permitted to discuss emergency situations with the news media. All enquiries must be forwarded to the Plant Director. This is to ensure that the media is furnished with accurate information and additional copycat incidents or crank calls are not precipitated by incorrect or inappropriate statements from uninformed sources.

• Personnel are not permitted to use heaters unless approval has been obtained from the EHS dept. This will be on a case by case basis. The standard on the site is not to use open filament heaters.

• All fire alarm components must remain unobstructed at all times. If there is a requirement to obstruct such devices or disable a detection point a Fire Protection Impairment Permit must be obtained.

• Manual call points (break glass units) are located strategically throughout all buildings, in most cases at emergency exits.

• All main buildings on site are equipped with an automatic fire detection and alarm system, which is connected directly to the Security Gatehouse.

• Emergency lighting is installed at key locations throughout all buildings. In the event of failure of the mains power supply, the Emergency Lights will activate on battery power and last for approx. two hours.

• Maintained and unmaintained Emergency Exit signs identify emergency exit locations from all rooms within buildings. These lead directly or indirectly to an open space.

7.1 General: • Emergency exits and entrances must be kept clear at all times.

7 .1 Requirements:

7 REQUIREMENTS:

• Not applicable

6 HEALTH. SAFETY and ENVIRONMENTAL:

• Not applicable.

5 DEFINmONS:

• Organise completion of evacuation check sheet to establish the status of the evacuation.

• Ensure that a nominated person contacts the emergency services if required. • Liaise with the emergency services. • Only permit re-entry to buildings after emergency has been controlled.

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Evacuation: Evacuation alarm sounds and Public Address system will announce that there Is an evacuation. Beacons will flash in the building affected . All automatically closing fire doors will close . All magnetically held security doors will release. In the event that a door does not release green break glass units situated at the door exit will release locks. Lifts will travel to the ground floor and the doors will open. Lifts will not be available in an emergency and no attempt should be made to use them. All doors and windows must be closed . Leave all work equipment in a safe condition and switch off power supplies, except for lighting and leave the area straight away. Follow the evacuation route/signs and proceed to the assembly point in the Administration building car park. If you have visitors, ensure your visitors accompany you to the assembly point. Do not collect personal belongings . Do not run; always walk in an orderly fashion to the assembly point . At the assembly point, inform the person carrying out the roll call that you are present.

7.7 •

• • •

•

• •

•

•

• • •

7 .6 Oxygen Deficient Atmosphere • At determined set points, these sensors initiate a gas tone across the public

address systems in the relevant building and a flashing beacon in the relevant room.

7.5 Flammable Atmosphere Detection • Sensors reach a lower set point and a pre-alarm signal is sent to the Fire

Alarm system. • The Public Address system will state that an alarm is being investigated. • When the sensor reaches the higher set point, a building evacuation is

initiated by the Fire Alarm system. • Where a gas sensor detects gas or vapour a horn will sound and a blue

beacon will flash in the affected area. Any personnel within this area should evacuate it Immediately.

• Work equipment should be made safe In preparation for evacuation should this be required.

7.4 Break Glass Unit • When personnel come upon an event or situation or where there has been

an uncontrolled release of materials (solid or liquid) which presents real danger to people, they activate the BGU as per SOP-EHS-GEN-253 and SOP-EHS-GEN-254.

• All activations of a break glass unit will result in a site evacuation. • BGUs are located strategically through buildings.

7.3 Smoke Detection: • Smoke detection operates on a "double knock" system. • A single knock (where a single smoke detector activates), is Indicated as a

fire on the fire alarm control panel but no public address or sirens are sounded.

• A double knock, depending on the location will result in a building or site evacuation.

• Vesda systems operate in electrical rooms. They default to a double knock response for all activations.

and where relevant proposed change controls.

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Signal to DCS

Gas Shutdown

Fire door holder release

Access door override

1-- Lift to ground

- o evacua e

f-t, Flashing fire beacon

r- PNVA Speakers

t t

Investigation by I Emergency

Coordinator and ERT Leader

Double Knock I Single Knock f--1111 Signal to DCS

Fire Event on FACP

Call point activated

or 2 or more

smoke detectors activated

Fire Alarm Response Diagram

One smoke detector activated

• Wait at the assembly point and do no re-enter the building until the Emergency Co-ordinator gives the all clear.

• Any person refusing to leave a building in the event of an emergency may put others at risk if a search and rescue is initiated. Any such conduct will be considered a serious breach of Health and Safety procedures.

• If trapped in a room, use a telephone to contact Security and seal any cracks with material available to slow the entry of smoke. Tell Security your exact location.

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7.10.4 Class D Fires: Class D fires are fires involving combustible metals, such as magnesium, titanium, zirconium, aluminium, and sodium. Specialized extinguishing agents have been developed to control and extinguish fires of this type. Normal extinguishing agents generally should not be used on metal fires, as there is a danger of increasing the intensity of the fires because of a chemical reaction between some extinguishing agents and the burning metal (frequently there is

7 .10.3 Class C Fires: Class C fires are fires involving gases. Dry chemicals, carbon dioxide and vaporizing liquids are suitable.

1.10.2 Class B Fires: Class B fires are fires involving flammable or combustible liquids, greases and similar products which can be extinguished by smothering or breaking the chain reaction. Dry powders, foams, vaporizing liquids, carbon dioxide, and water fog all can be used as extinguishing agents depending on the circumstances of the fire.

1.10.1 Class A Fires: Class A fires are fires involving common (ash producing) combustible materials, which can be extinguished by the use of water or water solutions. Materials in this category include wood based materials, cloth, paper, rubber and certain plastics. Fires in these materials can also be extinguished by special dry chemicals for use on Class A, B and C fires. These provide a rapid knock down of flames and form a fire retardant coating, which prevents reflash.

7.10 Fire Extinguisher Selection: • In order to extinguish a fire successfully, it is necessary to use the most

suitable extinguishing agent. The selection of extinguishing agent is made based on the classification of fire, which varies according to the fuel.

7.9 Disabled Persons: • The EHS Engineer will conduct specific risk assessments and develop

emergency evacuation plans for any person on site who may have a condition that affects their ability to evacuate in a timely manner

• The plans will detail how a disabled person within any building is evacuated by a dedicated team.

• A team will be dispatched to evacuate the person. • In the event of a drill exercise, the person will be informed so they are in no

danger. • If a disabled person is on the second floor of the Admin building that person

should, if possible, follow the escape route to the nearest of the two shelter points on the top of the relevant stairwells.

• The dedicated communication system will be used to notify Security or Reception of their presence at the shelter point.

• This information is conveyed to the Emergency Coordinator who will initiate a rescue team

7 .8 fire Wardens: • The role of fire wardens defaults to the ERT. • This is possible due to the size of the site, ERT training, complex access

systems and sophisticated and time efficient roll calls. • Before opening any door to a room which does not have a vision panel, check

if the door handle or the door is hot by touching with back of hand. Where doors are hot the door must not be opened but the location reported to the Emergency Co-ordinator.

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• Only personnel trained on the use of fire extinguishers are permitted to use them in the event of fire. If personnel are not trained they must break the nearest Break Glass Unit, evacuate immediately and contact the Emergency Co-ordinator at the Security gatehouse.

• Before using portable fire extinguishers the nearest break glass unit must be activated.

• Portable extinguishers are designed to enable a person discovering a fire to carry an extinguishing agent to the fire area for a fast attack.

• Never pass a fire to get to an extinguisher. • Never let a fire get between you and an escape route. • The agent is quickly expelled from the extinguisher. In most cases

continuous application can only be sustained for one minute. • There are four basic steps for using hand-held portable extinguishers.

7.10.7 Operation of Fire Extinguishing Equipment:

Fires Involving •• Electrical i--i--~

Equipment

c

••• ._ A

B

Foam Powder Class of Fire

Extinguisher Type

7.10.6 Summary of extinguisher types in use

1.10.s Class E Fires: Cooking oil fires, because of their high auto-ignition temperatures and difficult to extinguish. Conventional extinguishers are not effective for cooking oil fires, as they do not cool sufficiently or may even cause flash back, so putting the operator at risk. An extinguisher has been developed to deal specifically with fires resulting from cooking oils and fats. It has the capability to fight fires in deep fat fryers of up to 75 litres capacity. It contains a specially formulated wet chemical which, when applied to the burning liquid, cools and emulsifies the oils, extinguishing the flames, sealing the surface and preventing re-ignition.

violent reaction with water which may result in the spreading of the fire and/or explosion). Sand, graphite, various other dry powder extinguishing agents and salts of different types can be used on metallic fires. No one method of extinguishment has proven effective for all fires involving metals.

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7 .13 Evacuation Drills • Evacuation drills will be arranged by the EHS Engineer at a frequency of no

less than twice per year. • One evacuation drill in each year will be announced prior to the event via e

mail and preceded by a message on the public address. This e-mail will also serve as a reminder of evacuation procedures and communicate basic requirements to be observed during the drill.

• A second evacuation drill of that year will normally be un-announced and Is a test of the current evacuation and emergency plan to ensure its effectiveness in an emergency situation.

• During evacuation drills delegated persons will act as observers and a de-brief meeting will be held after each drill to identify any organisational or procedural shortcomings. Where shortcomings are observed the Emergency Response Procedure will be updated accordingly.

• Observations made during a drill are recorded on FORM-EHS-GEN-309 at the time of the evacuation.

• A summary of all observations and overview of drill is completed by the EHS Engineer and recorded on FORM-EHS-GEN-310

• All actions arising from evacuation drills are tracked on the EHS Actions Database.

• The EHS Engineer will carry out a periodic workplace fire inspection. Inspection results are recorded on FORM- EHS-GEN-308.

• Actions arising from fire workplace inspections are recorded in the EHS Actions Database or site maintenance management system.

• Inspections of access and egress routes, emergency exits and fire systems including the fire alarm are inspected as part of department walk around and Security procedures and are documented and reported to EHS if there are issues.

1.12 Fire Inspection:

• The control of emergencies is greatly assisted if key personnel can be quickly identified by all personnel and officers of the emergency services.

• To aid this identification, ERT are garbed with Fire Fighting Equipment and other relevant personnel with be wearing Hi-Viz vests identifying the role of the wearer.

7.11 Identification of Key Personnel:

0 o Pull the pin o Aim the extinguisher nozzle at the base of the flames o Squeeze the handle while holding the extinguisher upright o Sweep the extinguisher from side to side covering the area of the fire with the

extinguishing agent • If an attack with one portable extinguisher fails, personnel must leave

the area immediately and close any doors to confine the fire.

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Tvoe: SOP I Document No.: SOP-EHS-GEN-252 Revision No.: 1.0 I Paqe No.: 7 of 10


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8.11 Return to work authorized (Emergency Co-ordinator) • Following confirmation from the ERT Leader that the area is safe and

following assessment, the Emergency Co-ordinator may authorize re entering site buildings or areas after an evacuation

8,1 Activate Evacuation Alarm (Person discovering fire) • Break the nearest Break Glass Unit (BGU) to activate the alarm.

8.2 Evacuate to designated Assembly Point and Swipe Out (All Personnel) • Evacuate to the nearest assembly point immediately. • Using access card, swipe out at dedicated reader

8.3 Form ERT (Emergency Co-ordinator) • Emergency Co-ordinator contacts ERT Leader via radio and provides

information on the nature of the emergency

8.4 Prepare Roll Call List (Security) • Security barriers are switched from automatic to manual control • Roll Call list is printed from Access System • Hand to Emergency Co-ordinator

8.5 carry out Roll Call (Emergency Co-ordinator) • Roll call is carried out at assembly point for all evacuees

8.6 All persons accounted for? (Emergency Co-ordinator) • Inform ERT Leader of status of personnel

8.7 ERT informed Search and Rescue required (Emergency Co ordinator) • ERT Leader will organise search for missing person(s) based on

information provided the Emergency Response Co-ordinator on last known location

8.8 Can Emergency be brought under control? (ERT Leader) • ERT Leader will determine if available resources and personnel are

available to enable control of emergency • When emergency is brought under control ERT leader must inform

Emergency Response Co-ordinator that there is no further risk to site personnel, go to section 9.11.

• If support from Emergency Services is required, ERT Leader informs Emergency Coordinator. Go to section 9.9.

8.9 call Emergency Services (Emergency Co-ordinator) • The Emergency Co-ordinator either contacts the emergency services

directly or delegates this responsibility to a member of staff • In the case of the latter, the Emergency Coordinator must confirm that

the services have been contacted and records the time this was carried out.

• The Emergency Service called will be based on the nature of the emergency

8.10 Assist Emergency Services (Emergency Response Co-ordinator/ERT) • Assistance to the Emergency Services will be based on the nature of the

emergency


8 PROCEDURE:

TAKEDA IRELAND UMITED (GRANGE CASTLE\ Document Tvoe: SOP I Document No.: SOP-EHS-GEN-252 Revision No.: 1.0 I Paae No.: 8 of 9


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10 INDEX OF ATTACHMENTS: • FORM-EHS-GEN-308 "Fire Inspection Checklist" • FORM-EHS-GEN-309 "Observation Report Form" • FORM-EHS-GEN-310 "Evacuation Drill Monitoring Form" • FORM-EHS-GEN-311 "Evacuation Recording Form"" • FORM-EHS-GEN-312 Assessment of Evacuation of Person With A Disability Worksheet" • Attachment 1 - Emergency Layout - Admin Ground Floor • Attachment 2 - Emergency Layout - Admin first Floor • Attachment 3 - Emergency Layout - Drumstore • Attachment 4 - Emergency Layout - Utility Building • Attachment 5 - Emergency Layout - Warehouse • Attachment 6 - Emergency Layout - Pl Level 1 • Attachment 7 - Emergency Layout - Pl Level 2 • Attachment 8 - Emergency Layout - Pl Level 3 • Attachment 9 - Emergency Layout - Pl Level 4 • Attachment 10 - Emergency Layout - Pl Level 5

l Assist I (- Emergency 5~~~~ency ~--llloi1 Emergency ----~ End

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Activate I Evacuation r----

Alarm J Start

Emergency Co-ordinator All Personnel

Person Discovenng Fire/Emergency

"Evacuation Procedure" 9 PROCESS MAP:

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document Tvoe: SOP I Document No.: SOP-EHS-GEN-252 Revision No.: 1.0 I Paae No.: 9 of 9


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3.2 Associated Documents: • POL-009 "TILGC Safety statement"

• Safety, Health and Welfare at Work Act, 2005

3. REFERENCES: 3.1 Documents Referenced:

• SOP-EHS-GEN-273, "First Aid"

• SOP-EHS-GEN-260, "Surface Water System."

• SOP-EHS-GEN-253, "Emergency Response Team Procedure."

• Site Glossary

2. SCOPE: This SOP applies to the management of all aspects of Unplanned Events which occur:

• On the TIL Grange Castle site regardless of who is involved, i.e. employee, contractor or

visitor.

• All offsite events which may be deemed to require a TILGC investigation by regulation or

Site Management, including life cycle of transported materials from site.

occurrence;

• Outline the procedure for reporting to Global EHS;

• Outline the procedure involved where TILGC must notify the Regulatory Authorities

where an event occurs which falls under the statutory reporting requirements;

• Outline the procedure involved in reporting internally to site management and relevant

personnel;

1. PURPOSE: The purpose of this SOP is to:

• Outline how Unplanned Event reporting and follow up is managed and investigated at

Takeda Ireland Limited (Grange Castle)(TILGC);

• Outline how an effective investigation and root cause analysis are conducted with the

aim of preventing the Event from re-occurring or reducing the consequence of re-

Effective Date: Circulation Codes Location or Area of Work Code:

(This Section is for use by Document Control Onlvl


Title: EHS UNPLANNED EVENT MANAGEMENT

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4.2 Area Owner: Team Leaders/Executives/Managers/Directors: An Area Owner can be a Team Leader, Executive, Manager or Director, the designation is

agreed between Management and Staff. Table of Area Owners is set out in Appendix 1.

It is the responsibility of Area Owner to:

• Confirm when notified that the notification to him or her is appropriate. If not

appropriate they must contact the relevant Area Owner and in their absence the EHS

Department.

• Make an assessment of the actual or the potential consequences of the Unplanned Event

to determine the appropriate response, this may require, but not limited to, shutdown of

systems and/or evacuating areas, initiating ERT/First Aid response and/or offsite

emergency service response.

• When safe to do so, complete the relevant sections of the Unplanned Event Form.

• Notify the relevant managers and staff as outlined in this procedure.

• Ensure that all necessary information is available to support the investigation.

• When an unplanned event results in a person requiring first aid or medical treatment,

the area owners responsibility defaults to that persons direct line supervisor/manager. If

however additional technical and process knowledge etc. is required to fulfil all duties,

the supervisor /manager can request additional support from the Manager responsible

for the process or equipment etc.

4. RESPONSIBIUTIES:

4.1 Employees and Contractors: The primary responsibility of all employees and contactors is to ensure they do not put

themselves or others at risk. However as outlined in site training and site inductions, it is

the responsibility of employees and contractors to:

• Report all Unplanned Events which they become aware of to the relevant area owner or

contact as soon as possible. If they are unaware of who to contact they must contact

Security and ask for EHS to be informed.

• HSA IRl Accident Form

• HSA IR3 Dangerous Occurrence Form

• GMS Reporting Forms

• Process Safety Leading and Lagging Metrics: CCPS Publication 2011

• Process Safety Incident Evaluation Tool

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvce: SOP I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paae No.: 2 of 12


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4.6 Occupational Health Nurse:

It is the responsibility of the Occupational Health Nurse to:

• Manage any medical cases in accordance with HR-OH-0041 'Medical case management'

policy.

• Provide updates to relevant persons as to the status of any employee suffering an

injury or ill health.

• Continual review of the employee until the case is medically closed.

4.5 Directors I Managers I Designee: It is the responslbility of Directors/Managers /Designee to:

• Attend and/or make resources available for attending investigations and associated

meetings for Unplanned Events relevant to their area and/or staff.

• Assume the EHS responsibilities if EHS personnel are absent.

Aid".

4.4 Occupational First Aider:

It is the responsibility of the Occupational First Aider to:

• Record and forward all First Aid treatments in accordance with SOP-EHS-GEN-273, "First

4.3 EHS:

It is the responsibility of EHS to:

• Assess, when contacted, who the relevant Area Owner is and to communicate the

Unplanned Event to the Area Owner and request the Area Owner to initiate the

assessment.

• Act as the Area Owner as required in circumstances where the relevant Area Owner is

not contactable or unavailable to fulfil the function.

• Act as Area Owner where the Unplanned Event crosses a number of Departments or if

there is potential for a significant EHS Unplanned Event to occur.

• Review all Unplanned Event reports in a timely manner and process according to the

workflows in this procedure induding:

o Assemble an investigation team where required.

c Organise investigation meetings as required.

o Record, track and communicate corrective and preventive actions

• Act as the responsible person to inform regulatory Authorities and Global EHS if

required.

• Provide workshop and scenario training where relevant to Area Owners on potential

Unplanned Events.



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• Process Safety Incident: An unplanned or uncontrolled loss of primary containment of any

material including non-toxic and non-flammable materials (e.g. steam, hot condensate,

nitrogen, compressed C02 or compressed air) from a process, or an undesired event or

condition that, under slightly different circumstances, could have resulted in a loss of

primary containment of a material.

• Dangerous Occurrence: A Dangerous Occurrence is an Unplanned Event that is outlined

in the General Application Regulations. Please refer to HSA link.

http://www. hsa. ie/ eng/ Publications_ and_ Forms/Forms/ IR3 _form_ ma y09. pdf

• Environmental Reportable Incident: Any incident that falls within the ranking of 1-5 EPA

Environmental Impact Assessment Criteria.

https://www.epa.ie/pubs/advice/licensee/Guidance%20to%20hcensees.pdf

• Incident: An Incident is defined as an Unplanned Event that results in damage to

equipment and/or property and/or requires the attendance of a First Aider and potentially

further Medical attention and/or notification to a Regulatory Authority of a Dangerous

Occurrence.

• Near Miss: An Unplanned Event or condition that did not result in injury, illness, or damage

to people, plant, process and the environment- but had the potential to do so. A Near Miss

does not require notification to Regulatory Authorities or First Aid attention and has three

essential elements:

~ an event occurs, or the discovery of a potentially unsafe situation

~ the event or unsafe situation had reasonable potential to escalate

, the potential escalation would have led to adverse impacts.

• Unplanned Event: Is the term used onsite to initiate the reporting and recording of any

unplanned event or condition that may or may not have resulted in injury, illness, or

damage to people, plant, process and the environment. All Events remain as Unplanned

Events until they are classified by EHS and Occupational Health Nurse when required.

S. DEFINITIONS:

4.7 Human Resources Manager:

It is the responsibility of the Human Resources Manager to:

• Ensure, In conjunction with the Occupational Health Nurse, that each applicable case is

effectively medically managed.

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document Tvne: SOP I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paae No.: 4 of 12


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• As soon as is reasonably Practical: Immediately after the Unplanned Event is under

control, not before remedial actions commence. (e.g. in the case of a spill as soon as the spill

has been contained before cleanup operations is initiated).

• Environmentally Significant: Pollution as defined in article 4 (2) the Protection of the

Environment Act 2007.

• EDEN: Application for Licensing Data and Environmental Reporting.

• Occurrences Involving Dangerous Goods: For occurrences involving dangerous goods,

assessment against the categories listed on 1.8.5 of European Agreement Concerning the

International Carriage of Goods by Road(ADR) is made and when confirmed that the

occurrences is subject to notification, the notification is made using the model for report as

listed in 1.8.5.4 of the ADR.

• Reportable Diseases: Where an employee is diagnosed, or is suspected of, suffering from

an occupational related disease, the HSA must be notified immediately. Notification of such

diseases will be carried out in consultation with the occupational Health Professionals used by

TILGC.

• First Aid: Any Event where a person requests the attention of a First Aider, Irrespective if

treatment was given or not.

• HSA Reportable Incident (External Report): A HSA reportable incident is one in which an

employee cannot perform their normal work activities for more than three days. The days

lost do not include the day upon which the occupational injury or illness occurred. All days

are counted Including weekends and non-scheduled work days.

, A lost time accident is one in which an employee misses at least one day of their

scheduled work days following an injury/ illness.

, The day lost does not include the day upon which the occupational injury or illness

occurred.

, Accidents that happened within the company premises or on business travel are included.

This includes work related travel, but does not include travel to and from work

(commuting).

> Contracted employees working under the control of Takeda are to be included.

Employees of contractors working under supervision from their own organization are to

be excluded.

• GMS Lost Time Accident (Internal Report): The following definition is our Corporate LTA definition:

TAKEDA IRELAND UMITED (GRANGE CASTLE} Document Tvi,e: SOP I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paae No.: 5 of 12


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• If First Aid Is required then Security is contacted and a First Aider is requested to

attend the area. This is conducted by the person requiring First Aid or if they are

unable then a witness. Details of location and persons affected are passed on to

Security who then Informs the relevant available First Aiders.

• After receiving First Aid treatment, and where no other treatment is required and the

person is returning to work, the First Aider contacts the person's Manager/Designee to

hand over the First Aid form.

• If an investigation has not already commenced, it must be initiated at this stage by

the Manager/Designee.

• If the injured person is sent off site for further medical treatment, the First Aider must

complete the "Injured person referral form", which accompanies the injured person to

the Doctor, Clinic or A & E.

• The First Aider must inform the casuality's Manager/Designee if they have been sent

for further treatment.

• The Manager/Designee must then arrange transport, ensure a First Aider accompanies

the injured person and that all relevant referral forms, SDS's etc. accompany the

casualty.

7. 2 First Aid All First Aid treatment and Management of casualties Is set out in the First Aid procedure. The

following illustrate the process of managing the Unplanned Event and relevant documentation.

7. REQUIREMENTS:

7.1 Reporting: When an Unplanned Event occurs, the key objectives of a person who witnesses or who is

involved is to determine if an alarm needs to be raised immediately, if anyone is injured and

requires First Aid or if staying there presents a risk to them. These processes are set out in

the Site Emergency Procedures and related training. To darify the relationship between these

actions and documenting and communicating Unplanned Events the following sections have

been compiled to assist staff onsite. If a scenario is not covered in the following section then

refer to the EHS Department for guidance.


N/A


TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvoe: SOP I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paae No.: 6 of 12


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7 .4 EHS Impact Assessment • EHS complete a review of the documentation submitted. In the case where EHS are

contacted when off site and when documentation is not to hand the relevant sections

below pertaining to Regulatory Bodies will still be conducted when required.

• EHS assign an Unplanned Event number and log in the tracking database.

• EHS review all sections of the form to ensure it has been completed adequately and

signed. Where they have not, EHS will discuss with the Manager/Designee Owner and

rectify.

• A preliminary review of the Unplanned Event is conducted to determine the

appropriate follow up action required, if any.

• Where reporting to external Regulatory bodies is required, EHS will compile the

appropriate communication and submit to the appropriate Authority as soon as

reasonably practical.

• Where a root cause investigation is deemed necessary EHS will chair and invite all

relevant stakeholders.

• The outcome and associated actions from the root cause will be tracked on the

Unplanned Events tracking database.

7 .3 Completing Documentation

• The Unplanned Event form must be completed by the Manager/Designee immediately

or as soon as reasonably practical after the event.

• All sections of the form must be completed with as much information available at the

time. Supplementary information can be added at a later stage if required.

• Each area will have their own Unplanned Event form in booklets. These booklets are in

triplicate. The following sets out where each copy resides:

, The original is detached, scanned and emailed to the reporting group email and

the original is left in the EHS inbox in the Engineering Office.

;.... The second copy (Carbon Copy) is detached and posted locally on a designated

board.

, The third copy is held in the book for that area.

• For all First Aid Events the Manager/Deslgnee must then scan the First Aid form and

Unplanned Event form, if available, and send by email to EHS, OHN and HR.

• This notification email should be sent as soon as possible after the Manager/Designee

is informed of the First Aid treatment by the First Aider and preferably within 24 hours

or by the next working day.



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7.7 Reporting to Regulatory Bodies • All events are assessed and classified to determine if they breach a condition of the IED

Licence or fall within specified definitions set out in regulations requiring reporting to a

regulatory body.

7.6 Corporate Incident Reporting

All Unplanned Events are assessed to determine their impact and classification. In order to

determine reporting requirements if any to Corporate, the table in Appendix 2 is used. Any

Event falling Into a reportable category must be reported to the Corporate Unplanned Event

Reporting email group within the timeframe outlined in Appendix 2.

• When the First Aid Report form has been completed by the Manager/Designee it is

sent to the First Aid email group.

;. Plant Director ,. Engineering Director .. Quality Director ,. ~ HR Director ,. ,. HR Business Partner ::,... OHN ~ EHS ,.

7 .5 Internal Communication • All First Aid requests are routed through Security, who in tum contacts a First Aider.

• All Unplanned Events are communicated to the Manager/Designee.

• Where there is any ambiguity by a staff member as to who owns the area, then EHS

must be contacted to clarify.

• The Manager/Assigned Area Owner assesses the Unplanned Event and initiates the

appropriate response, which may include an Emergency response.

• When the Unplanned Event form has been completed by the Manager/Assigned Area

Owner it is sent to the group reporting email, "Unplanned Event Reporting" and in

addition to the

;. Manager

,,. Designees

• "Unplanned Event Reporting" email includes the following people:

• When an event occurs that falls within the definition of a Process Safety Event, EHS

will use the Process Safety Incident Evaluation Tool to determine the Severity of the

event. This tool is available through the Centr for Chemical Process Safety Website.

http://www.aiche.org/sites/default/files/docs/pages/PSIEvaluat1onTool_v3.02.xls

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvoe: SOP I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paae No.: 8 of 12


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EHS-UE-[Current Year]-[XXX] where:

UE- Unplanned Event

XXX = Sequential Number

7.9 Report Numbering:

EHS will assign a report number to the report form on receipt. The report number will be in

the format of:

7.8 Investigation:

The first priority on site during any event is to protect people, the environment and plant.

However running alongside this is the investigation process which starts when the event is

notified to the Manager/Designee.

• The investigation process starts when the event is notified

• The area, plant and equipment etc. are assessed

• People affected and witnesses are interviewed

• When possible, photographs should be taken and a sketch/layout drawing of the

incident scene should be included with the unplanned event form.

• If the condition of the incident scene is such that another injury or Incident is likely to

occur, the scene must be made safe. Otherwise, the scene must be preserved to ensure

evidence required for the investigation is not removed or compromised.

• The responsibility for preserving the scene rests with the area owner.

• The area owner should use signage, barriers, or whatever Is necessary to prevent persons

from entering the area until the investigation team has examined the scene.

• The form is completed and sent to EHS for review

• EHS determine if the significance of the event requires a formal Investigation

• The investigation team should include the following members:

~ EHS Engineer-Lead

, Individual(s) directly involved in the incident

»- Manager/designee of area in which incident occurred.

:;.. Manager/designee of person/s who received first aid or medical treatment

> Any person with knowledge to assist in the investigation

~ An investigation meeting must then take place in order to establish the root cause

of and identify any corrective actions which are required and lessons learnt.

• EHS will determine from the classification/ category of the event if reporting the event

to an external regulatory body is required. The bodies relevant to the site operations

are the EPA, HSA, SDCC, Inland Fisheries board



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7.11.2 Record Keeping: • Legislation requires that a record ls kept of any accident or dangerous occurrence which is

required to be notified to the HSA for a period of 10 years from the date of the accident or

dangerous occurrence and for environmental related events to the EPA for a minimum of

7 years

• All other records for non-notifiable accidents, such as first aids etc., will be kept for a

period as determined by current legislation, common practices or company requirements.

• Fatal Accidents must be reported immediately by telephone in the first instance with

details of the name of the deceased, brief particulars and the location of the accident and

within 5 working days of a fatality supply the H.S.A with a written report

• Non-fatal accidents should be reported as soon as possible,

• The Dangerous Occurrence can be reported online on the H.S.A's Website.

• The current contact telephone numbers, fax numbers and postal address of the H.S.A are

available in the Emergency Management Plan stored on SharePolnt, the ERT room or at

Security.

7.11.1 Tracking of Actions: • Where corrective actions are required, EHS will communicate them to the appropriate

owner in a timely manner.

• EHS will allocate corrective actions to the appropriate owner with a recommended

timeframe for completion.

• EHS will track such actions and will send out monthly update reports on outstanding

actions to the relevant owner.

• EHS will report to either the H.S.A or the E.P.A immediately when required.

• The EPA is notified by the ALDER/ EDEN system and this is then followed by a phone call.

• The H.S.A is notified in the case of Dangerous Occurrences, Lost Time Accidents, and

Incidents involving the transport of dangerous goods.

• EHS will report to Corporate all events which are classified by Corporate as reportable.

7 .10 Follow-up: 7 .11 Once the report has been submitted and all subsequent investigations completed, EHS

will manage all follow up tasks. These are set out as follows:

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document TvDe: SOP I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paqe No.: 10 of 12


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9.Process Map: N/A

8.1.1. Issue report for review and approval(EHS Engineer) Send report to all investigation team for review and comment.

8.1.0 Prepare investigation report (EHS Engineer) • Prepare report based on information gathered at investigation meeting. • Determine contributory factors, root cause and corrective actions. • Assign close out date for corrective actions. • Assign owners for corrective actions.

8.9 Hold investigation meeting (Investigation Team) • Hold investigation meeting.

llJI. Gather information for investigation meeting (Investigation Team) • Correlate all relevant information for review.

U Assemble investigation team and call meeting (EHS Engineer) • If investigation required, select and contact relevant investigation team

U Assessment of Incident (EHS Engineer) • Conduct review to determine if follow up investigation and external reporting is

required • Complete Environmental Follow up report if required

8.5 Preserve Scene of Incident (Area Owner) • When required, place barriers and make the area safe.

M Complete the Unplanned Event Management Form {Area Owner) • Complete the form using local book of forms. • Scan and send to relevant email group. • Original passed to EHS inbox in Engineering Office, copy posted locally

y First Aid treatment and documentation • When required treatment is given, form is completed and handed to Area Owner • Area Owner scans the completed form and emails to relevant email group. • If further medical treatment is required, Area Owner organises transport and

relevant documentation to accompany casualty and First Aider when they leave site.

8.2 Decide if First Aid is needed or not {Observer/Area Owner) • Contact Security on extension 555 or channel 2 on the radio. • Give details of location and assistance required.

8.1 Observe Unplanned Event (Observer/affected person) On observing the Unplanned Event, take note of any relevant information and inform the relevant area owner.

8 STEP BY STEP PROCEDURE:

TAKEDA IRELAND UMITED {GRANGE CASTLE} Document Type: SOP I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paae No.: 11 of 12


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FORM-EHS-GEN-292, "Unplanned Event FORM·EHS·GEN-293, "Environmental Follow up" FORM·EHS·GEN-294, "Witness Report." FORM-EHS-GEN-346, "Notification to the HSA." FORM-EHS-GEN-347, "Accident Incident Flash Report." FORM-EHS-GEN-348," Accident Incident Follow up Report. N

FORM·EHS-GEN-349, "Root Cause Investigation" FORM-EHS-GEN-350, "Supplemental Recording."

10. Index of attachments

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Tvne: SOP I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paae No.: 12 of 12


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Area/Plant/Person 'Area Owner - Co -Area Owner Comments~ ~ _ When first aid or Supervisor of person medical treatment required affected

Pl Building Plant Team Leader

Tankfarm Plant Team Leader Logistics Executive Solvent Deliveries EHS Engineer Bulk Waste Maintenance & EHS Non-permit works Manager

DrumStore/WareHouse Logistics Executive

Utility Buildings Maintenance & EHS Manager

External Utility Areas Malntanance & EHS Manager

WWTP EHS Engineer

QC Lab QC Manager

PD Lab PD Lab Manager

Admln Building Maintenance & EHS Manager

Security Gatehouse Maintenance & EHS Manager

Internal Roadways Maintenance &. EHS Manager EHS Engineer J Surface water drains

voe EHS Engineer

Firewater Retention Tank EHS Engineer

Fire detection, protection EHS Engineer and Gas Alarm System

Waste Compound EHS Engineer

T-1781 EHS Engineer

Caustic Scrubber:SC-1721 EHS Engineer

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Type: APPENDIX I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Page No.: 1 of 1

Title: APPENDIX 1 AREA OWNER

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• Near miss incident which may cause severe injury if employee involved.

• Independent of Level land Level 2 all releases of hazardous substances exceeding 5 Kg

• Any other incident with EHS concerns with which the site would like assistance

• Any financial penalty or fine of less than $10,000 US. Any interruption and/or unplanned event or evacuation of less than 4 hours duration

• Accident without day off and accident with day off during commuting

Regional EHS;

• Any spills, releases or emissions equal to or greater than the legal threshold or reportable quantities, or being a potential risk to public health or the environment,

• Any interruption and/or unplanned evacuation of 4 hours to one shift duration or incident that results in a response from the emergency services.

Level3 Incidents will be reported in the monthly EHS report to Corporate EHS and

Level la Incidents must be reported within 24 hrs to GMSO and Corporate EHS • Any work related injury/ Illness possibly with one or more day off. A flash report must

be sent reference Form-HR-Gen-0722 Accident/ Incident Flash Report.

• A follow up report must then be completed as soon as possible reference Form-HR-Gen- 0723 Accident/ Incident Follow up Report.

Level2b Incidents will be reported within 5 days to Corporate EHS and Regional EHS

• Any incident that results in an immediate risk to human health or the environment, or significantly interrupts operations or requires evacuation for more than one shift ,

• any government "stop work orders" or penalties or fines of $10,000 US or more, or

• any explosion in the process

Level 1 Incidents must be reported upon occurrence to GMSO and Corporate EHS • Any work related fatality or life threatening work-related injury or illness of an

employee, contractor or visitor

• Any spill, releases or emissions that result in an immediate risk to human health or the environment,

TAKEDA IRELAND UMITED (GRANGE CASTLE} Document Tvoe: APPENDIX I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paae No.: 1 of 1

Title: APPENDIX 2 CORPORATE EHS

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., C0<por'1!e [HS

., Reqt;'loll EHS

' "

I lr1antbl penaly or -Ol leSS 111:in S 10,000 US 2 inlem¢rln ..- tl!lpQfWIC(I nent or

ev:rcuat1an DI less lhlln .i holn Gur.l!IDn Ye• ......,.. 3 - lllddfflt wi:n EH9 concems w.111n,11icll lhe - llopett

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Ropan --~-··-!> • Re,ilCrl.11 CMS • Regtc:nJt EHS

Spill, release, emission or incident

Ye:.. l,,IIOMftfrrr , ~ $ Yilthout day Oii -- ROPOtl ··> , Corpo,ale~H

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Annual eHS Perfonnance Data

Month,y ~eport

corp EHS Monthy Report toGMSO

,,,_ FollOW·Up Report

Process

Accident I Inc.dent happens

Flash Report

Overview of GMS Incident/Accident Reporting

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document Tvoe: APPENDIX I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Page No.: 1 of 1

Title: APPENDIX 2 CORPORATE EHS

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Category Classificatio1 Impact on the Environment

1 Minor No contamination, localised effects Minor effect on air quality as evidenced by dust or odour Complaint(s) ELV breaches An emission which does not comply with the requirement of the licence (A pattern of repeated minor incidents should be taken into account when considerina the level of response)

2 limited Simple contamination, localised effects of short duration Local limited impact to water, land and air Notification to and short term closure of potable water Extractors reauired

3 Serious Simple contamination, widespread effects of extended duration Significant effects on water quality Major damage to an ecosystem (e.g. significant impact on fish population) Longer term closure of potable water extractors Significant reduction in amenity value Significant Damage to agriculture or commerce SiQnificant lmoact on man -- 4 Very Serious Heavy contamination, localised effects of extended duration

'5 catastrophic Very heavy contamination, widespread effects of extended duration

TAKEDA IRELAND UMITED (GRANGE CASTLE'\ Document Type: APPENDIX I Document No.: SOP-EHS-GEN-251 Revision No.: 1.0 I Paae No.: 1 of 1

Title: APPENDIX 3 EPA CLASSIFICAnON

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EPA Export 18-07-2017:03:17:31

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• POL-019 "Environmental and Energy Management" • Integrated Pollution Prevention and Control Licence (IPPCL) Reg No. P0693-01 • EU Tranfrontier Shipment of Waste Regulations (Council Regulation EEC No.

259/1993) • Waste Management Act 1996 • Hazardous Waste Directive {Council Directive 91/689/EC) • European communities (Classification, Packaging and Labelling of Dangerous

Preparations) Regulations, 2008 • European Agreement for the Carriage of Dangerous Goods by Road, ADR, 1

January 2011 • Global EHS Guidelines of the Pharmaceutical Production Division


• SOP-ENV-WST-002 "Waste Documentation" • SOP-ENV-WST-003 "Waste Service Providers-"Selection, Approval and Review" • SOP-ENV-MON-001 "Management of Environmental Monitoring"


3. REFERENCES:

This SOP applies to the description of waste streams at TILGC and the appropriate handling, storage, labelling and disposal of these waste streams.

2. SCOPE:

The purpose of this SOP is to describe the procedure for handling hazardous and non hazardous wastes at Takeda Ireland Limited (Grange Castle) (TILGC).

1. PURPOSE:



Irene Baker Originator: EH5 Enaineer Date:

Keith O'Neill Reviewed By: EH5 Enaineer Date:

Paul Keogh Reviewed By: API Manufacturina Manaaer Date:

Damian Crowley Reviewed Bv: Director - Production/EH5 Date:

Geraldine Mccann Aooroved Bv: Oualitv Director Date:

DOCUMENT APPROVAL:

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Tv1>e: SOP I Document No.: SOP-ENV-WST-001 Revision No.: 01 I Suoersedes: 00 I Paae No.: 1 of 10

Title: WASTE MANAGEMENT

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• Transfer waste from staging area in the Liquid Drum Store to the external Waste Chemstore.

• Contact EHS when a shipment of packed waste off site is required. Complete a list of packed waste ready for disposal and provide to EHS.

• Check appropriate labeling on packed waste prior to shipment. • Ensure waste is palleted and wrapped for shipment. • Load delivery vehicle with packed waste shipment as directed by the waste

service provider/driver. • Management of waste vehicle from when it arrives on site including parking,

loading and dispatch.

4.5 Manufacturing Operations:

• Contact Manops to arrange transfer of hazardous laboratory waste from the laboratory to storage.

4.4 QC and PDD Laboratory Personnel:

• Ensure correct labelling, storage and disposal of waste in their area.

4.3 Department Managers: It is the responsibility of Department Managers to:

• Use the appropriate waste disposal routes as described in this SOP. • Clearly label all hazardous waste containers prior to use. • Ensure that lids on waste containers are kept closed at all times when not in use. • Ensure the outside of waste containers are clean prior to removal to storage. • Transfer any waste generated by them to the appropriate waste receptacle. • Seek advice from the EHS Engineer if the appropriate labelling, storage or disposal

route of a waste stream cannot be determined. • Not remove any waste from site without EHS approval. • Ensure all hazardous liquid waste is transported in a manner to minimise damage

and/or spillage. • Ensure that any waste spill Incidents (on-site and off-site) they become aware of

are promptly communicated to EHS. • Inform EHS if waste labels stocks are running low.

4.2 TILGC Employee: It is the responsibility of TILGC Employee's to:

• Ensure TILGC complies with all of the IPPCL requirements In relation to waste. • Provide advice and guidance as to the appropriate labelling, storage and disposal of

waste. • Maintain a Waste Profile Database which includes waste types, classifications,

hazards and origins. • Ensure that waste is only disposed of using disposal routes and waste service

providers approved by the EPA. (Refer to TILGC working copy of the IPPCL on the Intranet).

• Ensure the drum/container used for a waste stream is approved under the ADR and CPL Regulations for the material it is carrying.

• Arrange shipments of packed hazardous waste. • Where specified arrange collections of non-hazardous waste streams. • Retain records as generated.


TAKEDA IRELAND UMITED (GRANGE CASTLE} Document Type: SOP I Document No.: SOP-ENV-WST-001 Revision No.: 01 I Supersedes: 00 I Paae No.: 2 of 10


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• Waste sent off-site for recovery or disposal can only be carried by an authorised waste contractor.

• Waste can only be disposed/recovered of only as specified in; o Schedule 3(i) Hazardous wastes for Disposal/Recovery and o Schedule 3(ii) Other Wastes for Disposal/Recovery

8.2 IPPCL Requirements: • Requirements in italics are as per IPPCL P0693-01.

• All other waste collections are done on a request basis and must be requested via the EHS Engineer.

• Collections of non-hazardous waste (MOW, MMW and Cardboard) occur periodically. There is no requirement to arrange a collection unless the receptacle is full prior to the next scheduled collection.

• A list of all approved waste service providers and disposal routes is detailed In the IPPCL which is available on the Intranet.

• The EHS Engineer must be informed when a waste receptacle becomes full.

• Waste service providers should be selected, approved and reviewed in accordance with SOP-ENV-WST-003 "Waste Service Providers-Selection, Approval and Review".

8.1 Genera I: • Records of waste consignments should be recorded in accordance with SOP

ENV-WST-002 "Waste Documentation".

8. REQUIREMENTS:

• SDS's should be consulted when dealing with all hazardous waste.


• Hazardous Waste: This includes all waste designated as 'hazardous' under the Hazardous Waste Directive (Council Directive 91/689/EC) and any waste which appears on the hazardous waste list or is prescribed under the Waste Management Act 2006 and also displays one or more of the properties indicated in the second schedule of the Waste Management Act 2006.

• MDW: Mixed Dry Waste. • Non-Hazardous Waste: All waste which is not classified as hazardous waste. • MMW: Mixed Municipal Waste. • WEEE: Waste Electronic and Electrical Equipment.

6. DEFINITIONS:

• As per DRC-12-134.

5. REASON FOR UPDATE:

• When re-using fibre keg drums that previously contained intermediates, ensure previous labels are defaced.

TAKEDA IRELAND LIMITED (GRANGE CASTLE} Document Tvpe: SOP I Document No.: SOP-ENV-WST-001 Revision No.: 01 I Supersedes: 00 I Paae No.: 3 of 10


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• Summary details of each waste stream are illustrated in Appendices 1 and 2 of this SOP.

8.3 Waste Streams: • Waste Streams at TILGC are divided into two main categories;

o Hazardous and o Non-hazardous.

o The tonnages and EWC Code fit the materials listed in Schedule 3(i) and 3(ii) of the IPPCL.

o The names of the agent and carried of the waste, and their permit details.

o Details of the ultimate disposal/recovery destination facility for the waste and its appropriateness to accept the consigned waste stream, to include permit details and issuing authority.

o Written confirmation of the acceptance and disposal/recovery of any hazardous waste consignments sent off-site.

o Details of all wastes consigned abroad for recovery and classified as 'Green' in accordance with EU Tranfrontier Shipment of Waste Regulations (Council Regulation EEC No. 259/1993). The rationale for the classification must form part of the record.

o Details of any rejected consignments. o The results of any waste analysis. o The tonnages and EWC Code for the waste materials listed in Schedule

3(i) and 3(ii) of the IPPCL.

• A full record, which shall be open to inspection by the EPA at all times, must be kept on matters relating waste management operations and practices on site. This record shall as a minimum contain details of the following;

• Waste sent off-site shall be analysed as per SOP-ENV-MON-001 Management of Environmental Monitoring.

• No waste classified as green list waste in accordance with the EU Transfrountier Shipment of Waste Regulations (Council Regulation EEC No. 259/1993, as amended) shall be consigned for recovery without the prior agreement of the EPA.

• All waste must be clearly labelled and appropriately segregated.

• While awaiting collection, recovery or disposal all waste must be stored in designated areas protected, as may be appropriate, against spillage and leachate run-off.

• All waste transferred to another person must be packaged and labelled in accordance with National, European and any other standards which are in force in relation to labelling.

• No amendment or variation in any agreed waste classification or consignment or haulage or disposal or recovery arrangements can be made without prior written agreement of the EPA.

• No waste outside the scope of Schedule 3(i) and 3(ii) may be disposed of/recovered either on-site or off-site without prior notice to and prior written agreement of the EPA. Such communications can only be sent by the EHS department.

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvoe: SOP I Document No.: SOP-ENV-WST-001 Revision No.: 01 l SuDersedes: 00 I Paae No.: 4 of 10


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• Large Volume Solids: This waste stream consists of Carbon from the voe unit and the Tank Farm and HTF molecular sieve. The packaging of these

• Chemicals: This waste stream consists of discarded organic chemicals, laboratory chemicals and unwanted chemicals. The packaging of these materials will depend on the composition and load. The EHS Engineer schedules the collection of this waste stream. They are sent for incineration with the service provider.

These drums are normally stored in the drumstore. The EHS Engineer schedules the collection of these drums. They are sent for incineration with the service provider.

o Absorbents- Used spill kits o Disposable PPE- Suits, mop hats, masks, gloves, shoe covers which

are potentially contaminated with API or Intermediates o Filters- Solvent, process liquids, process filter cloths, downflow

booths, HEPA, Air filters (Exit), Oily o Process- Spent activated carbon o Packaging- Liners, fibre drums, pallets (hazardous) o RPE- Cartridges o Utilities-Metal (hazardous) o Wipes- Solvent and/or solids, Oily

• Solids contaminated with flammable solvent and/or chemical powders and/or acid or caustic: This waste is solid contaminated waste which may consist of but is not limited to the following items.

• Drummed Liquids: This waste stream consists of used/unused drummed solvents and/or reagents and liquid waste from the QC and PDD laboratory. This waste is either pumped into the waste tanks (T-1751 or T-1752) or removed directly off site by the service provider for Incineration/recovery.

8.4 Hazardous Waste Streams: • Bulk Liquids: This waste stream consists of the following WWA, and WWB.

This waste is pumped directly from Pl to the waste tanks T-1751 and T-1752. (T-1753 is currently not in use). Waste may also be pumped directly into the waste tanks via a diaphragm pump. Once the volume in the tanks reaches a certain level an empty tanker is ordered to remove the waste from the tank. The waste is then analysed to determine the composition of the waste and depending on it's composition it is removed offsite by the service provider for incineration/recovery treatment or biological/chemical/physical treatment.

• The following waste streams are currently present at TILGC; this list is not exhaustive, if any waste arises outside this list the EHS engineer must be informed.

• If a waste stream is not illustrated in Appendices 1 and 2 or the Waste Profile Database, the EHS engineer must be consulted to assist with the appropriate storage and labelling.

• A Waste Profile Database is maintained by EHS and is available on the Intranet for reference. This database includes at a minimum TILGC waste code, description, origin, hazard and required packaging.

TAKEDA IRELAND LIMITED {GRANGE CASTLE\ Document Type: SOP I Document No.: SOP-ENV-WST-001 Revision No.: 01 I Sunersedes: 00 I Paae No.: 5 of 10


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8.5 Non-Hazardous Waste Streams: • MDW (Mixed Dry Waste): This waste stream consists of but is not limited to

the following; o Plastics: Fizzy drink bottles, oven ready meal trays, milk bottles,

washing up liquid bottles, carrier bags, bin liners, margarine tubs, yoghurt pots, packaging, plastic cutlery, plates and cups, cereal box liners, bottle caps, drinking straws, meat trays, CD jackets

o Aluminium Cans-Drink Cans o Light cardboard-Cereal boxes, milk cartons, egg cartons, pizza

boxes, tea boxes, packaging o Steel and Tin Cans- Food, steel and tin cans

• Paint, Ink, Adhesive and Sealant: This waste stream consists of hazardous paint, ink, adhesive and sealant. These are collected from source and transferred to a 200L steel drum is normally kept in the drumstore. The EHS Engineer schedules the collection of paint, ink, adhesive and sealant.

• Aerosol Cans: This waste stream consists of used hazardous aerosol cans. These are collected at source and transferred to a 30L UN container normally kept in the drumstore. The EHS Engineer schedules the collection of aerosol cans.

• Printer cartridges and Toner Bottles: This waste stream consists of hazardous printer cartridges and toner bottles. These are collected at source and transferred to Waste Compound 1. The EHS Engineer schedules the collection of printer cartridges and toner bottles for recycling.

• WEEE: This waste stream consists of redundant computers and electrical equipment. WEEE Is collected at source and stored in a receptacle in Waste Compound 2. The EHS Engineer schedules the collection of WEEE for recycling.

• Fluorescent Tubes: This waste stream consists of used fluorescent tubes. These tubes are collected at source and transferred to the lamp coffin in Waste Compound 2. The EHS Engineer schedules the collection of fluorescent tubes for recycling.

• Mixed Oils: This waste stream consists of waste mixed oils. Waste oils are collected at source (red safety cans can be used for this purpose); they are then transferred to 200L steel drums In the drumstore. The EHS Engineer schedules the collection of mixed oil for recycling.

• Batteries: This waste stream consists of used hazardous (Pb; Ni-Cd, Hg) batteries. Small batteries are collected In the battery collection receptacles located in the admin building and the Engineering workshop. Larger batteries will be stored on a bunded pallet in Waste Compound 2. The EHS Engineer schedules the collection of batteries for recycling.

• Reagent and Solvent Drums: This waste stream consists of contaminated used and/or empty reagent and solvent drums. These will normally be stored ln the drumstore prior to collection. The EHS Engineer schedules the collection of these drums for recycling.

materials will depend on the composition and load. The EHS Engineer schedules the collection.

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Type: SOP I Document No.: SOP-ENV-WST-001 Revision No.: 01 I SuDersedes: 00 I Page No.: 6 of 10


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• Wood: This waste stream consists of wood packaging, wood, wooden pallets and sawdust. It is collected from source and transferred to the wood skip located in Waste Compound 3. The EHS Engineer schedules the collection of the wood skip for recycling.

• Construction and Demolition Waste: This waste consists concrete, bricks, slates, tiles etc. This waste is collected from source and the receptacle is dependant on the load. The EHS Engineer schedules the collection of construction and demolition waste for recycling.

• Glass: This waste stream consists of uncontaminated brown and clear glass. The brown and clear glass is segregated into three 90L wheelie bins located in Waste Compound 1. The EHS Engineer normally schedules glass collections for recycling.

• Metals: This waste stream consists of uncontaminated stainless steel, copper and other metals. It is collected from source and transferred to the Skip in Waste Compound 3. Temporary storage may occur at the Engineering Workshop. The EHS Engineer schedules the collection of these bins.

Receptacles for this waste stream are placed in the canteen. Waste collected from these receptacles is transferred to the 200 L wheelie bins located in Waste Compound 1. There are regular scheduled collections of these wheelie bins.

• Compost: This waste stream is compostable and consists of but is not limited to the following;

o Food (Cooked, Uncooked, Out of Date) o Vegetable matter, o Paper napkins, paper towels, food soiled cardboard or paper; o Eggs and dairy products; o Teabags, coffee grounds and paper filters;

• Confidential Paper: This waste stream consists of confidential waste paper. Receptacles for this waste stream are located in offices. There are regular scheduled collections of these bins.

Waste collected from these receptacles transferred to a 1,100 L bins in Waste Compound 1. There are regular scheduled collections of these wheelie bins.

• Non-confidential Paper: This waste stream consists of non contaminated office paper, magazines, junk mail, and lightweight cardboard. Receptacles for this waste stream are located in offices.

• Cardboard: This waste stream consists of both lightweight and heavyweight non contaminated cardboard packaging. This waste stream is collected in an 1,100 L wheelie bin located in Waste Compound 1.

• MMW (Mixed Municipal Waste}: This waste stream consists of contaminated packaging not suitable for recycling. Receptacles for this waste stream are placed In the canteen and offices. Waste collected from these receptacles is transferred to the 1,100 L wheelie bins located in Waste Compound 1. There are regular scheduled collections of these wheelie bins.

There are site wide collection receptacles for this waste stream; waste collected from these receptacles is transferred to the MDW skip in Waste Compound 1. There are regular scheduled collections of this skip.

TAKEDA IRELAND UMITED (GRANGE CASTLE\ Document Tvoe: SOP ] Document No.: SOP-ENV-WST-001 Revision No.: 01 I Suoersedes: 00 I Paae No.: 7 of 10


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9.4 Place material in appropriate receptacle (TILGC Employee) • Place the material into the appropriate receptacle.

Note: If the appropriate waste stream cannot be determined the EHS Engineer must be consulted.

9.3 Determine waste stream (TILGC Employee) • Consult Appendices 1 and 2 of this SOP and/or EHS. • Establish what waste stream the material belongs to.

9.2 Label and store material (TILGC Employee) • Label and store the material in accordance with the relevant SOP.

Note: Assistance from the Department Manager may be required to determine if the material is a waste material.

9.1 Is the material a waste? (TILGC Employee) • Determine If the material in question is actually a waste material. • If no proceed to step 9.2 • If yes proceed to step 9.3


9. PROCEDURE:

• If a waste stream is not detailed in this map the EHS Engineer must be consulted to determine an appropriate storage area.

• Waste storage area's are illustrated In Appendix 3 - Waste Storage Map.

• Temporary storage of waste's are present at point of use prior to transfer to the appropriate waste storage area.

• The Liquid Drumstore Is utilised as a staging area for waste prior to being moved externally to a Chemstore located outside the Liquid Drum Store prior to transfer offslte.

• All drums/containers used for storage of waste must be in good condition. Drums/containers used for transporting materials classified as Dangerous Goods must have the appropriate UN marking.

8.7 Storage:

• In the absence of an appropriate waste label, contact EHS.

• Hazardous Waste Stream labels are provided in folders at point of use and are filed according to a TILGC Waste Stream Code.

• All hazardous waste must be labelled with labels that Indicate the contents. Where possible transport labels provided by the Waste Service Provider are used. These labels are organised by EHS or representative and comply with ADR Requirements for the transport of hazardous materials by road.

• Non·hazardous waste receptacles are labelled according to contents, e.g. cardboard, and may come pre-labelled.

8.6 Labelling:

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Type: SOP I Document No.: SOP-ENV-WST-001 Revision No.: 01 I Suoersedes: 00 I Page No.: 8 of 10


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"Procedure for Waste Management"

10. PROCESS MAP:

9.8 Document Collection (EHS Engineer) • Ensure the waste service provider has all the required documentation as

detailed in SOP-ENV-WST-002 "Waste Documentation". • Record details of the waste collection in accordance with SOP-ENV-WST-

002 "Waste Documentation".

Note: Some waste streams are collected on a regular scheduled basis; the EHS Engineer is not required to schedule a collection in these cases. (e.g. MOW Skip)

9.7 Arrange Waste Collection (EHS Engineer) • Establish the approved waste disposal route and service provider for the

waste stream. • Contact the approved waste service provider, giving details of the waste

ready for collection, and arrange a collection date. • If required Inform relevant personnel of the expected collection date.

Note: If there is no designated area for storage of a particular waste stream the EHS Engineer must be consulted.

9.6 Store Waste (TILGC Employee) • Ensure the waste is stored in the designated area as illustrated in

Appendix 3 - Waste Management Map.

Note: Labelling is only required when the waste receptacle in not already pre-labelled. (e.g. the 1,100 L bins are already pre-labelled)

9.5 Label packaging (TILGC Employee) • If necessary label packaging with the appropriate waste label.

Note: If the appropriate packaging cannot be determined the EHS Engineer must be consulted.

• If necessary package material as illustrated In appendices 1 and 2 or as per Waste Profile Database.

TAKEDA IRELAND UMITED (GRANGE CASTLE} Document Type: SOP I Document No.: SOP-ENV-WST-001 Revision No.: 01 I Supersedes: 00 I Paqe No.: 9 of 10


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11. INDEX OF ATTACHMENTS: Appendix 1: Waste Flow-Hazardous Appendix 2: Waste Flow-Non-Hazardous Appendix 3: Waste Storage Map

TILGC Employee TILGC Employee TILGC Employee TILGC Employee

Determine Place material in Start Yes Waste Stream appropriate Label

receptacle

EHS Engineer EHS Engineer TILGC Employee

Label and store In accerdance End Document Arrange Store

with the Collection Collection relev1nt SOP

SOP-ENV-WST- 002

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Tvpe: SOP I Document No.: SOP-ENV-WST-001 Revision No.: 01 I Sunersedes: 00 I Paae No.: 10 of 10


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• POL-049 "Environmental Management" • Waste Management (Movement of hazardous waste) regulations, 1998 (5.I. No. 14 of

1998) • Waste Management (Shipment of Waste) regulations, 2007 (S.I. No. 419 of 2007) • Waste Management (Collection Permit) regulations 2007 (S.I. 820 of 2007) as

amended by the Waste Management (Collection Permit) (Amendment) Regulations 2008 (S.I. No. 87 of 2008).

• EC Regulation 1013/2006 on Shipments of Waste • Waste Framework Directive {2006/12/EC) • Global EHS Guidelines of the Pharmaceutical Production Division • Integrated Prevention Pollution Control Licence (IPPCL) P0693-0l


• SOP-ENV-WST-001 "Waste Management" • SOP-ENV-WST-003" Waste Service Providers-Selection, Approval and Review" • SOP-GEN-ADM-013 "Management of All Service Suppliers" • Site Glossary


3. REFERENCES:

This SOP applies to the documentation in relation to the transfer and disposal/recovery of hazardous and non-hazardous waste from TILGC.

2. SCOPE:

The purpose of this SOP is to describe the documentation requirements for the transfer and disposal/recovery of waste from site as required by the IPPCL and relevant waste legislation.

1. PURPOSE:



Aileen Newman Originator: EH5 Engineer Date:

Clodagh Farrell Reviewed By: Environmental Tecbnotoaist: Date:

Alan Kelly Reviewed Bv: OPEX/EH5 Director Date:

Niamh Mccullagh Annroved Bv: Oualitv Director Date:

DOCUMENT APPROVAL:

TAKEDA IRELAND LIMITED (GRANGE CASTLE} Document Tvoe: SOP I Document No.: SOP-ENV-WST-002 Revision No.: 02 l Su1>ersedes: 01 I Page No.: 1 of 10

Title: WASTE DOCUMENTATION

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• Consignor: A producer or holder of waste who causes such a waste to be moved from the premises at which it is being held. This is the person who generates the waste that requires movement. This will be TILGC for all cases in relation to this SOP.

• Carrier: A person who undertakes the movement of waste, other than consignor. This is the person who collects the waste from TILGC. In the case of bulk liquid waste a transport company such as B.P. McKeefry's would be a carrier.

• Consignee: A person to whom waste is moved for recovery or disposal. This is the person who TILGC sends waste to for recovery/disposal. In the case of bulk liquid waste the consignee could be a broker such as Veolia or an incineration site such as Ellesmere Port.

• Waste Transfer Form (WTF): The WTF is a mandatory consignment document used for tracking and controlling the movement of hazardous waste within Ireland and Is used to ensure that the consignment is delivered to an authorised facility. It documents the volume and type of waste, date of transfer, waste generator, name/location of treatment/recovery (where applicable) and name of transporter.

• Notifier: A person arranging a shipment of hazardous waste. • DCC: Dublin City Council, the national authority for the administration of consignment

documents. • TFS: Transfrontier Shipment Document. This is a document that is required to move

hazardous waste outside the Republic of Ireland and records the shipment date, name of transporter and name and location of treatment/recovery (where applicable).

6. DEFINITIONS:

Reference DRC-13-291

5. REASON FOR UPDATE:

• Collect non-hazardous waste collection dockets • Record non-hazardous waste collections • Submit non-hazardous waste collection record and dockets to the EHS Engineer

4.3 Security: It is the responsibility of Security to:

• Ensure waste is transported from site in compliance with the IPPCL • Ensure waste service provides are approved in accordance with SOP-ENV-WST-003


• Maintain the Hazardous Waste Database • Ensure waste is transported from site in compliance with the IPPCL • Ensure waste service provides are approved in accordance with SOP-ENV-WST-003 • Ensure all documentation relevant to a waste consignment is retained and filed

appropriately • Review and verify non-hazardous waste reports • Review and close hazardous waste consignment documentation files

4.1 Environmental Technologist: It is the responsibility of Environmental Technologist to:


TAKEDA IRELAND LIMITED (GRANGE CASTLEl Document Type: SOP I Document No.: SOP-ENV-WST-002 Revision No.: 02 I Suoersedes: 01 I Paae No.: 2 of 10


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o ENV-GEN-002-Fl "Waste Documentation Checklist" o WTF Form with Summary and Notifier - carrier Part completed o Confirmation of waste acceptance

• For consignments of hazardous waste the following documents should be kept on file as part of a each hazardous waste consignment where applicable;

• If waste is transported directly outside of the Republic of Ireland a WTF form is not required. The movement is covered solely by the TFS.

---+j TILGC I 1-

I I HilZudous Wi1Ste Shtpment I

Cert11CSte al Recovery/ I Letter or 0estruc1ion

I WTF FDl'm I I Cer1fecale or Recovery/

I I Leiter of Oestrudion and

y Olsposill I I Trilnsfer Stiltlon I CoPVotTFS

I llnside Ille Republic I I TFS l al Ireland I I I I Outside ,11e I I Dlsposal I

Republic or Ireland I

• If waste is moved to a transfer station before transporting it outside of the Republic of Ireland, both a WTF form and a TFS are required to cover the movement.

• A TFS is required for all consignments of hazardous waste outside of the Republic Ireland.

• A WTF form is required for all hazardous waste consignments within the Republic of Ireland.

• Each consignment of hazardous waste will have a unique identification number The identification number will be in the format WST-XX-XXX, where:

XX: Refers to the year in which the waste consignment was initiated. YYY: Refers to the next consecutive number.

8.2 Hazardous Waste

• All documentation in relation to waste consignments must be kept indefinitely or for a minimum of seven years. As per IPPCL P0693-01 "Records shall be retained on-site for a period of not less than seven years and shall be available for inspection by the Agency at all reasonable times"TILGC's policy is to keep all such records indefinitely.

• Waste must be transported in accordance with SOP-ENV-WST-001 "Waste Management".

8.1 General

8. REQUIREMENTS:

• Not applicable.


TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Type: SOP I Document No.: SOP-ENV-WST-002 Revision No.: 02 I Supersedes: 01 I PaQe No.: 3 of 10

Title: WASTE DOCUMENTAnON

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o The tonnages and EWC Code for the materials listed in Schedule 3(i) and 3(ii) of the IPPCL.

o The names of the agent and carrier of the waste, and their permit details. o Details of the ultimate disposal/recovery destination facility for the waste and its

appropriateness to accept the consigned waste stream, to include permit details and issuing authority.

o Written confirmation of the acceptance and disposal/recovery of any hazardous waste consignments sent off-site.

• A full record, which shall be open to inspection by the EPA at all times, must be kept on matters relating waste management operations and practices on site. This record shall as a minimum contain details of the following;

• Requirements in italics are as per IPPCL P0693-01.

8.4 IPPCL Requirements

• Monthly reports of waste types and quantities are received from the non-hazardous waste vendor and retained on file by the Environmental Technologist.

• A report on non-hazardous waste is normally received from the non-hazardous waste service provider on a monthly basis. This report is reviewed, verified and filed by the Environmental Technologist.

• ENV-WST-002-F2 "Non-Hazardous Waste Collection-Record" will be filed and kept with waste collection dockets by the Environmental Technologist.

• Non-hazardous waste collection dockets must be kept by security and submitted to the Environmental Technologist along with ENV-WST-002-F2 "Non-Hazardous Waste Collection Record" on a monthly basis.

• Non-hazardous waste collections should be accompanied with a waste collection docket (supplied by the waste service provider).

• Non-hazardous waste collections must be recorded by security on ENV-WST-002-F2 "Non Hazardous Waste Collection-Record".

• Consignments of non-hazardous waste will not have a unique identification number.

8.3 Non-Hazardous Waste

• Details of all hazardous waste consignment will be inputted into the hazardous waste database.

• When all relevant documentation has been received in relation to a waste consignment the file must be reviewed and closed.

• All documentation in relation to a waste consignment must be filed together with the Hazardous Waste documentation checklist ENV-GEN-002-Fl.

• Relevant sections of the Hazardous Waste documentation checklist ENV-GEN-002-Fl shall be completed upon receipt of each of the documents as detailed above.

o Completed WTF Form with consignee part completed (Photocopy from consignee) o TFS o Certificate of Disposal/Recovery

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Type: SOP I Document No.: SOP-ENV-WST-002 Revision No.: 02 I SuDersedes: 01 I Paqe No.: 4 of 10


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• The competent for Ireland is Dublin City Council; they are responsible for issuing TFS documents.

o the competent authority of dispatch for the country or area from which the waste consignment originates;

a the competent authority of destination for the country or area where the authorised facility is located in which the consignment is received for recovery or disposal;

o the competent authority of transit for the country through which the waste is transported on route to the destination facility.

• All EU member states have designated a national competent authority, responsible for implementing both EU and national TFS Regulations within their jurisdiction. Countries outside the EU operate under an agreement whereby nominated competent authorities supervise international waste movements. There are 3 competent authorities involved with the transfrontier shipment of waste:

• For all consignments of hazardous waste and for certain consignments of non-hazardous waste outside of the Republic of Ireland, it is necessary to obtain the consent of the Competent Authorities of dispatch and from the Competent Authorities in the country of destination and any transit countries that the waste may pass through, prior to transporting the waste. Consent for this is obtained via a TFS document.

8.6 Transfrontier Shipment

Notifier (person organising - Completes the WTF Summary, the the shipment), that is, Notifier address and the Notifier-Carrier the consignee, e.g. Veolia, Fermoy Part online;

- Downloads the form and signs as the Notifier before providing the WTF to the waste carrier

Carrier (person who transfers - Signs the WTF as the carrier the waste) e.g. BP McKeefry's (the form must accompany the waste

shioment durlnq transit) Consignee (person receiving - Completes the consignee part the waste) e.g. Veolia, Kylemore online, thereby validating

Road. acceotance of the load.

• The following parties must complete relevant information on the WTF Form and the Form must accompany the waste movement at every stage:-

• WTF Forms must be completed (Online) for every consignment of hazardous waste leaving the site. They are purchased online from DCC, who are the responsible administration for the onllne electronic system.

8.5 WTF Forms

o Details of all wastes consigned abroad for recovery and classified as 'Green' in accordance with EU Transfrontier Shipment of Waste Regulations (Council Regulation EEC No. 259/1993). The rationale for the classification must form part of the record.

o Details of any rejected consignments. o The results of any waste analysis. o The tonnages and EWC Code for the waste materials listed in Schedule 3(i) and 3(ii)

of the IPPCL.

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Type: SOP I Document No.: SOP-ENV-WST-002 Revision No.: 02 I Sus,ersedes: 01 I Paae No.: 5 of 10


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• A TFS is valid for one year, and may be used for a single consignment or a specified number of consignments.

• Within 3 working days of receiving the waste, the receiving facility must provide confirmation in writing that the waste has been received. This confirmation shall be contained in or annexed to the movement document (Annex lB). The facility must send signed copies of the movement document (Annex 18) containing this certificate to both the notifier and the Competent Authority (ies) concerned.

• After consent has been given the notifier will complete the movement document movement tracking form (Annex 18) and send a copy to the Competent Authorities concerned at least 3 working days before transporting the waste. The movement document (Annex lB) and a copy of the notification document (Annex lA) shall accompany the consignment.

• When notification has been given the Competent Authority retains a copy of the notification and transmits the original to the Competent Authority of the destination, with copies sent to any of the Competent Authority (ies) of Transit, within 3 working days of the official receipt of the notification. The Competent Authority of the destination then sends an acknowledgement notice to the notifier and the other Competent Authorities concerned. Once the notifier receives this acknowledgement consignments may be scheduled.

• To submit an application/notification the notifier must apply in writing (notification form (Annex lA)) to the Competent Authority for a requisition number outlining proposals in relation to the description, waste code, origin and destination of the waste. A unique reference number is to each notification issued for tracking purposes. Each notification must be accompanied by;

o The notification fee o Copy of a contract drawn up between the notifier and the consignee of the waste o A financial guarantee o Name of the carrier indicating their Waste Collection Permit Number o Detailed waste description o Transport Itinerary.

• There are four main stages involved in the consignment of waste which include; o Submitting an Application/Notification o Assessing and Transmitting the Notification o Moving the Waste o Waste Processing

o A notification form (Annex lA) o A movement tracking form (Annex 18)

• The TFS is a two-part document comprising of;

• Some wastes are more strictly controlled than others. The TFS regulation sets out a system for the classifying waste into three lists:

o The green list: In broad terms, green listed wastes are non-hazardous and easily recyclable, such as paper and plastic. These wastes may move across international borders within the EU without having to request permission or advance notification. A TFS is not required.

o The amber list: When green wastes are mixed ("co-mingled"), they become amber listed wastes. They then do require pre-notification and prior written consent before they can be exported. Consequently as a waste becomes somewhat more difficult to recover or somewhat more hazardous it goes onto the amber list. A TFS is required.

o The red list: This covers particularly dangerous wastes. A TFS is required.

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Type: SOP I Document No.: SOP-ENV·WST·002 Revision No.: 02 l SuDersedes: 01 I Paae No.: 6 of 10

Title: WASTE DOCUMENTAnON

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• The database will contain, at a minimum, the following information relating to Waste: o Waste Identification Number: The unique identification number of the Waste

Consignment (reference section 8.2). o Enquiry Number: The Enquiry number of the Waste Service Provider. o EWC Code: The European Waste Catalogue Code of the Waste. o Quantity: The weight of the waste transported. o Description: A description of the waste. o Waste Treatment Operation: Recover/Disposal Code as defined in the Waste

Framework Directive (2006/12/EC). These codes are available in the database. o Date of Collection: The date waste was collected. o Waste Service Provider: Name of the Waste Service Provider. o Waste Licence Number: The number of the Waste Service Providers Waste

Licence. o Waste Collector: The name of the waste collector. o Waste Collection Permit Number: The number of the Waste Collectors Permit

Number. o Final Destination: The name of the final destination of the waste. o Waste Licence Number: The number of the Waste Licence of the Final Destination. o Complete WTF Form: The date the completed WTF form was received. o Cert of Disposal/Destruction: The date the certificate of disposal/destruction was

received. o TFS: The number of the Transfrontier Shipment Document where applicable. a Date of Receipt: The date the TFS was received. o Date Verified and Closed: The date the waste consignment documentation was

verified and closed.

• The Hazardous Waste Database is maintained on SharePoint

8.8 Hazardous Waste Database

• A certificate of recovery/letter of destruction is a document which is received from the waste facility confirming the recovery/disposal of the waste after the waste has been recovered or disposed of. Depending on the waste stream it may take some time for TILGC to receive this document as the waste may be stored at the facility for a period before disposal/recovery. In any event this time period must not exceed 18 months (6 months at waste transfer station and 12 months at final disposal facility). A copy of the TFS will accompany this document If the waste was transported outside of the Republic of Ireland for Recovery/Disposal.

• Hazardous waste consignment files cannot be closed until all of the necessary documentation is received by TILGC, this documentation includes;

o Letter of Acceptance and/or completed WTF form o Certificate of Recovery/Letter of Destruction and TFS (where applicable).

• The letter of acceptance is a letter from the waste facility stating that they have accepted TILGC's waste. This letter is normally accompanied by a copy of the completed WTF form. Some waste facilities do not provide a letter of acceptance, In these instances a complete WTF form will suffice.

8.7 Closure of Hazardous Waste Consignments

• TILGC normally engages the services of a waste broker to obtain a TFS

TAKEDA IRELAND UMITED (GRANGE CASTLE} Document Tvoe: SOP I Document No.: SOP-ENV-WST-002 Revision No.: 02 I Su1>ersedes: O 1 I Page No.: 7 of 10


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9.8 Receipt of Cert of Recovery/Letter of Destruction (Environmental Technologist) • Upon arrival of Certificate of Recovery/Letter of Destruction and TFS

where applicable: o Ensure the details of the document(s) match the details in the

9. 7 Receipt of Letter of Acceptance (Environmental Technologist) • Upon arrival of the completed WTF form and/or Letter of Acceptance:

a Ensure the details of the document(s) match the details In the consignment

o Update the Hazardous Waste Database o Add it to the relevant file o Complete Section 4.2 of Hazardous Waste Checklist ENV-WST-001-

Fl

9.6 File Documents (Environmental Technologist) • File the original WTF and the Hazardous Waste Checklist ENV-WST-

001-Fl together with all other relevant documentation in the appropriate folder

9.5 Check Waste Collection Permit (Environmental Technologist/Designee) • Check the Waste Collectors Waste Collection Permit • If the vehicle registration does not appear on the permit request to see

the Waste Collectors Permit Card or other form of verification that the vehicle is permitted to collect waste under the waste collection permit

• Complete section 3 of Hazardous Waste Checklist ENV-WST-001-Fl

9.4 Return Relevant Sections to the Waste Contractor (Environmental Technologist/Designee • Retain a copy of the WTF Form and a WTF Annex where applicable • Return the remainder of the WTF form and the WTF Annex where

applicable to the Waste Contractor • Complete section 2 of Hazardous Waste Checklist ENV-WST-001.,,Fl

9.3 Complete Relevant Sections of the WTF Form (Environmental Technologist/Designee) • Check details of the WTF form • Ensure the details correspond with the waste consignment

9.2 Check EWC Codes are Approved (Environmental Technologist/Designee) • Check all EWC Codes detailed on the Waste Consignment have been

approved by the EPA • Complete Sections 1 of the Hazardous Waste Checklist ENV-WST-001-

Fl

9.1 Ensure Waste Service Provider is approved and that all Documents are Valid (Environmental Technologist/Designee) • Ensure Waste Seivice Provider is listed on the Waste servlce Providers

Table and that valid copies of waste licences, permits and insurances are on file

Refer to Process Map attached "Management of Hazardous Waste Documentation"

9. PROCEDURE:

TAKEDA IRELAND UMITED <GRANGE CASTLE'\ Document Type: SOP I Document No.: SOP-ENV-WST-002 Revision No.: 02 I Suoersedes: 01 I Paae No.: 8 of 10


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9.18 Review Records Environmental Technologist) • Review the Non-Hazardous Waste Collection Record Form ENV-WST-

9.17 Give form and Dockets to the EHS Engineer (Security) • At the end of every month give the completed Non-Hazardous Waste

Collection Record Form ENV-WST-002-F2 to the EHS Engineer along with the waste collection dockets

9.16 Record Waste Collection (Security) • At the beginning of every month download and print the Non

Hazardous Waste Collection Record Form ENV-WST-002-F2 from Sharepoint.

• Record all non-hazardous collections on the Non-Hazardous Waste Collection Record Form ENV-WST-002-F2

• Keep all waste collection dockets with this form

9.15 Request Waste Collection Docket (Security) • At the time of collection request a waste collection docket from the

waste service provider

9.14 Inform Security (Environmental Technologist) • Inform security of what regular collection services have been set up • Inform security of any once off collections that have been arranged

9.13 Arrange Collection (Environmental Technologist) • Arrange for a regular scheduled collection or • Arrange a once off collection

9.12 Check EWC Codes are Approved (Environmental Technologist) • Check all EWC Codes detailed on the Waste Consignment have been

approved by the EPA

9.11 Ensure Waste Service Provider is approved and all Documents are Valid (Environmental Technologist) • Ensure waste service provider is listed on the waste service provider

table and that valid copies of waste licences, permits and insurances are on file

Refer to Process Map attached "Management of Non-Hazardous Waste Documentation"

9.10 Close File (Environmental Technologist) • Close the file on the waste consignment • Complete section 4.5 of Hazardous Waste Checklist ENV-WST-001-Fl

9.9 Review File (Environmental Technologist) • Ensure file contains all of the required documents and that they all

correlate • Complete section 4.4 of the Hazardous Waste Checklist ENV-WST-001-

Fl

consignment o Update the Hazardous Waste Database o Add It to the relevant file o Complete section 4.3 of Hazardous Waste Checklist ENV-WST-001-

Fl

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Type: SOP I Document No.: SOP-ENV-WST-002 Revision No.: 02 I Sunersedes: 01 I Paae No.: 9 of 10


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11. INDEX OF ATTACHMENTS: Form ENV-WST-002-Fl "Hazardous Waste Checklist" Form ENV-WST-002-F2 "Non-Hazardous Waste Collection-Record"

Review Monthly reports from

Service Provider

Environmental Tech isl

Review Records

Environmental T echnologisl

Start

Environmental Environmental Envlronmenlal Technologisl T echnologlst T echnologisl

Ensure all Check ewe Arrange Documents are Codes are

Valid Approved Collection

Securly Secu1Hy Environmental Technologist

Record Waste Request Waste

Collection Collection Inform security Docket

ENV-WST-002· F2

End

"Management of Non-Hazardous Waste Documentation"

End

File Documents

Ensure Waste Carrier signs

WTFform

Return WTF Form to the

Waste Conector

Environmental Tachnologisl

Environmental Technologist

Give form and dockets to the EHS Engineer

....__ Check Details of the WTF Form

Check EWC Codes are Approved

Security

services are approved by the

EPA

Check all

Environmenlal Technol 1st

Environmental Environmental Tech no Isl Techn

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Start approved by the Documents are

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Environmental Environmenlal Environmental T echnologlst Technologist T echnologisl

Receipt of Letter of Acceptance RleAII Check Waste

and Completed Documents Collection Permit WTFForm

Erwironmenlal Erwlronmenlal Environment el Tectmologlst Techno Technologist

Receipt of Certificate of Review File Close File

Recovery/Letter of Destruction/TFS

Environmental Techno isl

Environmental T ec:hnologisl

"Management of Hazardous Waste Documentation"

10. PROCESS MAP:

9.20 File Documents (Environmental Technologist) • File the Waste Collection Dockets and Non-Hazardous Waste Collection

Record Form ENV-WST-002-F2 in the appropriate folder • No further action required

9.19 Review and retain Monthly reports from vendor (Environmental Technologist) • Review and retain monthly reports (type/quantities) from service

supplier on file.

002-F2 and compare with report received from the waste service provider

• Clarify any discrepancies with the waste service provider

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tv1>e: SOP I Document No.: SOP-ENV-WST-002 Revision No.: 02 I SuDersedes: 01 I Paae No.: 10 of 10


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EPA Export 18-07-2017:03:17:32

• POL-049 "Environmental Management" • Integrated Pollution Prevention and Control Licence IPPCL P0693-01 • Global EHS Guidelines of the Pharmaceutical Production Division


• SOP-ENV-WST-001 "Waste Management" • SOP-ENV-WST-002 "Waste Documentation" • SOP-GEN-ADM-013, "Management of all TILGC Service Suppliers" • Site Glossary


3. REFERENCES:

This SOP applies to all service providers who supply waste management services to TILGC.

2. SCOPE:

The purpose of this SOP is to describe the procedure for selecting, approving and reviewing waste service providers at TILGC.

1. PURPOSE:


This Section is for use bv Document Control Onlvl

Aileen Newman Oriainator: EHS Enoineer Date:

Alan Kelly Reviewed Bv: OPEX!EHS Director Date:

Niamh Mccullagh ADDroved Bv: Oualitv Director Date:

DOCUMENT APPROVAL:

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Tvne: SOP I Document No.: SOP-ENV-WST-003 Revision No.: 02 I Sunersedes: 01 l Paae No.: 1 of 6

Title: WASTE SERVICE PROVIDERS-SELECTION, APPROVAL. AND REVIEW

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• Only appropriately designed and qualified facilities and contractors shall be used for waste management services by TILGC.

8.2 Approval of Waste Service Providers

• Waste service providers for TILGC will be selected on the basis of ability regulatory compliance, reputation, stability, availability, and location. If there is a change in circumstances in relation to any of the above TILGC may review and possibly discontinue the service that is provided.

8.1 Selection of Waste Service Providers

8. REQUIREMENTS:

• Not applicable



• Registration Cert: Issued by the Local Authority for the temporary storage of hazardous waste (less than 6 months).

• WEEE Registration Certificate: Registration Certificate under WEEE regulations SI 340 of 2005.

• Waste Collection Permit: This is issued by the Local Authority and authorises waste collection activates. Holders of a waste collection permit can only collect waste within the jurisdiction of the issuing Local Authority and permits are reviewed every two years.

• Waste Licence: This is issued by the EPA and defines the nature of environmentally acceptable waste management activities at a waste facility.

• Waste Permit: The local authority issues this permit. It legitimates the operation of waste infrastructure that is not big enough or does not pose a treat to the environment to warrant a waste licence. It is usually issued for the temporary storage of non-hazardous waste for more than 6 months.

• Waste Service Providers Table: This is the table of waste service providers that are currently approved for the provision of services to TILGC by the EPA. This table can be found in the IPPCL which is available on Sharepoint. The table details all of the waste streams, waste service providers and disposal routes that are currently approved for use at TILGC.

6. DEFINITIONS:



• Identify and establish if waste service providers are suitable for use at TILGC • Ensure TILGC is in possession of all documents required by the EPA in relation to

the waste service provider • Approve waste service providers using ENV-WST-003-Fl • Update the Waste Service Providers Table and input updated Waste Service

Providers Table Into the IPPCL • Routinely review approved waste service providers



TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document Type: SOP I Document No.: SOP-ENV-WST-003 Revision No.: 02 l Sunt!!rsedes: 01 I Paae No.: 2 of 6

Title: WASTE SERVICE PROVIDERS-SELECTION. APPROVAL. AND REVIEW

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o Where possible have written consent from the operator of each permitted or licensed facility to which it is proposed to transfer waste, confirming that the facility will accept the waste for recovery or disposal from the licensee and specifying the

o Have contact details of the permitting or licensing authority if this authority is not within the state.

o Waste collection permits of the contractor transporting the waste (To determine what licenses and/or permits the waste services provider is required to have the EPA decision tree (Appendix 1) must be consulted. This Is also available on the EPA website.)

o The waste license or waste permit of the ultimate disposal/recovery destination facility; and

• Prior to the use of any new waste service provider TILGC shall obtain copies of and retain on file;

• Waste sent off-site for recovery or disposal can only be carried by an authorised waste contractor.

• Requirements in italics are as per IPPCL P0693-01.

8.4 EPA Requirements

• Site audits of facilities will be conducted on a required basis - e.g. for information gathering purposes or if compliance issues have been identified by the EHS Engineer with the waste service provider.

• After a review has been carried out, if it is determined that there has been significant changes with the waste service provider, the approval process shall be carried out again. Significant changes can include but are not limited to the following;

o Increased/decreased capacity for treating waste o Change of location o Change in treatment process o Change in documentation required by the EPA o Change in licence/permit conditions o Breach of licence/permit conditions o Change of management

• Reviews may also be carried out if there are any changes in circumstances for the waste service provider that TILGC have become aware of.

• Waste Service Provider Documentation will be reviewed on an annual basis, (prior to completion of the Annual Environmental Report) to ensure all of the information provided in the initial approval is still valid.

8.3 Review of Waste Service Providers

• Following approval for use in accordance with Environmental Compliance activities, the waste service supplier must be formally approved for use in accordance with the Management of all TILGC Service Suppliers SOP-GEN-ADM-013.

• When the waste service providers table has been updated, the waste service providers table will be updated in TILGC's annotated version of the IPPCL which is available on the SharePoint.

• Where feasible audits will be conducted on proposed waste service providers sites prior to approval. When this is not feasible desk-based audits are conducted in terms of permitting and treatment capabilities and capacities. The Waste Service Providers-Approval Form ENV WST-003-Fl must be completed In order to approve a waste service provider for use.

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Tvoe: SOP I Document No.: SOP-ENV-WST-003 Revision No.: 02 I Supersedes: 01 I Paae No.: 3 of 6

Title: WASTE SERVICE PROVIDERS-SELECTION. APPROVAL AND REVIEW

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9.6 Complete Approval Form (EHS Engineer) • Complete the Waste Service Providers Approval Form ENV-WST-003-

Fl

Note: Site Audits may not be feasible for all waste service providers due to their geographical location. Site Audits are not conducted on waste service providers who remove small volumes of non-hazardous waste.

9.5 Conduct Audit (EHS Engineer) • Where feasible conduct a site audit of the waste service provider. • Where a site audit is not feasible conduct a desk based audit.

9.4 Request Copies of Documentation (EHS Engineer) • Request copies of all relevant documentation from the waste service

provider.

9.3 Determine Documentation Required (EHS Engineer) • Consult the EPA decision tree (Appendix 1) to determine what

documentation (e.g. licenses and/or permits) is required by the EPA for the proposed service provider.

• Determine what insurance policies the proposed waste service provider has in place.

• Complete Section 3 of the Waste Service Providers Approval Form ENV-WST-003-Fl.

9.2 Determine Waste Activities (EHS Engineer) • Determine the waste activities of the proposed waste service provider.

Note: Advice may be sought from industry groups such as Pharma Chemical Ireland or from other IPPC licensed facilities

9.1 Select Potential Waste Service Providers (EHS Engineer) • Identify the waste stream(s) that requires treatment/disposal or

recovery • From experience, consultation and research identify potential waste

service providers that may be suitable for the treatment/disposal or recovery of the waste stream(s)

Refer to Process Map attached "Procedure for Selection, Approving and Reviewing Waste Service Providers"

9. PROCEDURE:

• Waste can only be disposed/recovered of only as specified in Schedule 3(i) Hazardous wastes for Disposal/Recovery and Schedule 3(ii) Other Wastes for Disposal/Recovery, and, those which have been subsequently agreed with the EPA. These schedules have been incorporated into Waste Service Providers Table.

• A copy of the waste collection permit will be requested from each Hazardous Waste contractor before removing waste from site. This is not possible for non-hazardous waste collections due to the frequency/time of collections. However the waste collection permit is verified prior to commencement of the service and it is checked upon any review of the waste service provider.

waste types that will be accepted inclusive of weekly and monthly tonnage quotas where possible.

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Type: SOP I Document No.: SOP-ENV-WST-003 Revision No.: 02 I Supersedes: O 1 I Paae No.: 4 of 6

Title: WASTE SERVICE PROVIDERS-SELECTION. APPROVAL AND REVIEW

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9.14 Significant Changes (EHS Engineer) • Have there been significant changes with the waste service provider

since approval was obtained? • If "No" no further action in required • If "Yes" go to 9.2

9.13 Review Waste Service Provider (EHS Engineer) • Review documentation requirements on an annual basis to ensure all

information is still correct.

9.12 Update IPPCL {EHS Engineer) • Update the IPPCL with the updated waste service providers list

9.11 File Documents (EHS Engineer) • File the Waste Service Providers Approval Form ENV-WST-003-Fl with

all relevant documents.

9.10 Update Waste Service Providers Table (EHS Engineer) • Update the waste service providers table to include the details of the

waste service provider

9.9 Approve Waste Service Provider(EHS Engineer) • Approve Waste Service Provider in accordance with SOP-GEN-ADM-

013, "Management of all TILGC Service Suppliers" • Inform the Waste Service Provider that TILGC have approved are the

use of their services

9.8 Inform Waste Service Provider (EHS Engineer) • Inform the waste service provider that their services will not be

required by TILGC at the present time • No further action is required

9.7 Waste Service Provider Approved? (EHS Engineer) • Determine if the waste service provider is approved and sign off the

Waste Service Providers Approval Form ENV-WST-003-Fl • If "Yes" proceed to step 9. 9 • If "No" proceed to step 9.8 • Inform the Waste Service Provider that TILGC have approved are the

use of their services

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Type: SOP I Document No.: SOP-ENV-WST-003 Revision No.: 02 I Sunersedes: 01 I Page No.: 5 of 6

Title: WASTE SERVICE PROVIDERS-SELECTION, APPROVAL. AND REVIEW

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Fl

11. INDEX OF ATTACHMENTS: Form ENV-WST-003-Fl "Waste Service Providers-Approval Form" Appendix 1 "EPA Decision Tree for Determining Requirements for a Waste Activity"

Complete Approval Form

Review Waste 1--....iservlce Provider 1----------~

End

Conduct Audit

EHS Engineer

Fl EHS Engineer

Determine Docu mentatlon

Required

EHS Engineer

Request Relevant

Documents

EHSEn ineer

Update IPPCL

Add to Approved List of1---....i Waste Service

Providers

Fl

EHS Engineer EHS Engineer

Inform Waste Service Provider

Fiie Documents

No

EHS No Engineer

EHS Engineer

EHS En ineer

Determine Waste Activities Start

Fl

Yes EHS Engineer EHS Engineer

Select Potential i-----...i Wute Service

Provider

"Procedure for Selecting, Approving and Reviewing Waste Service Providers"

10. PROCESS MAP:

TAKEDA IRELAND UMITED (GRANGE CASTLE} Document Tvne: SOP I Document No.: SOP-ENV-WST-003 Revision No.: 02 l Sunersedes: 01 I Paae No.: 6 of 6

Title: WASTE SERVICE PROVIDERS-SELECTION1 APPROVAL .. AND REVIEW

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TAKEDA IRELAND LIMITED (GRANGE CASTLEl Document TvDe: FORM I Document No.: ENV-WST-003-Fl Revision No.: 02 Suoersedes: 01 I Paae No.: 1 of 1

Title: WASTE SERVICE PROVIDERS-APPROVAL FORM 1.0 General

.. "

- . 1.1 Waste Service Provider:

1.2 Pri>posed'Servlce to TILGC: - -ft

1.3 Location of Site:

- - 1.4 Contact/Rosltlon: -- - ·-- - 1.5 Ptione (Office): -,. '

1.6 Ptione (Mobile): ..

- -- - - - - 1.7 ·e-mail:

1.8 Fax: - ' "

- - - - 2.o·waste TActlvlty: --- .. -- ~ - ·-·-

- - - Description Facllity can 'accept waste €apaclty

(Y/N) - 2.1 Waste Type/Types

-- - ..

- . ·- - . - - - ·- ·- - -- - - - -- - -- ·- - - -

-- - ·- -- - -- - -- - - ·- - - - - - ... ·-- - - - - --

3.0 Documentation ~ulrements for Waste Service Provider -- - -- - -· - - -- -- - - - .. - - -~

Copy l~ed/on file - -,expiry Date - (YJN)

3.1 I Waste Ucence/Pernilt: - -- -- . . _ ..... - --· -~ - ,. - .

3.2 Waste Gollection Pennlt: . - 3.3 C;ertlflcate of RegJstratton: - - - -.M-- - - ~-· ·--- •-3.4 WEEE Registration Cert: - ·- - -

3.5 Letter of acceptance from waste service provider

3.6 other: (Specify) ~ ,. , ___ -- - - - 1, - -- ,- - 4.0 Comments - -- -

- ·- - -

5.0 App_l'_!>~! _ -- - -- -··· - - - - ~

5.1 Approved for Use: (Y/N) Date:

'5.2 Signed: - "- -- --.-. "Position:·

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Please refer to Energy System File for details of Roles and Responsibilities

4. RESPONSIBIUTIES:

• N/A


• Site Glossary


3. REFERENCES:

This scope of this document Is to define the Energy Purchasing Policy Statement

2. SCOPE:

The purpose of this document Is to define the overall Energy Purchasing Policy at Takeda Ireland Limited (Grange Castle)-TILGC.

1. PURPOSE:




William Murphy Reviewed By: Enaineerina Director Date:

Greg Timmons Reviewed av: President Date:


DOCUMENT APPROVAL:

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvoe: Policv I Document No.: POL-051 Revision No.: 01 I Supersedes: 00 I Paae No.: 1 of 2

Title: ENERGY PURCHASING POLICY

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N/A 9. PROCESS MAP:

N/A 8. PROCEDURE:

• TILGC management fully endorses the stated policy and controls and acknowledges that it Is their ultimate responsibility to ensure that the conditions required to attain the energy purchasing objectives are present.

7.2 General

• Facilitate appropriate financing of energy efficiency investments • Be aware of and utilize where appropriate accelerated capital allowances available for

energy efficient equipment. • Consider, during the design stage, the economic, environmental and technical

feasibility of installing alternative/renewable energy systems when designing a large non-industrial building.

• Inform suppliers that procurement is partly evaluated on the basis of energy performance when procuring energy services, products and equipment that have, or can have, an impact on significant energy use.

• Assess energy use, consumption and efficiency over the planned or expected operating lifetime when procuring energy using products, equipment and services which are expected to have a significant impact on the sites energy performance.

• Define and document energy purchasing specifications, as applicable for effective energy use.

• Review like for like changes to determine if more energy efficient equipment is available.

• Pay excise duty, called the natural gas carbon tax, on natural gas supplied to site. • Periodically review alternative energy suppliers. • Be aware and utilise where applicable programmes established by SEA! for the

promotion of best practices. • Communicate the Energy Purchasing Policy to all TILGC employees. • Ensure the Energy Policy is reviewed regularly and updated as necessary.


Takeda is a global company which researches, develops, manufactures and markets a wide variety of pharmaceuticals. Takeda strives towards better health for individuals and progress in medicine by developing superior pharmaceutical products. TILGC regards energy management as an integral and essential part of good business practice.

7.1 Energy Purchasing Policy Statement:

7. REQUIREMENTS:

• For other relevant definitions refer to Site Glossary.

6. DEFINITIONS:

TAKEDA IRELAND LIMITED (GRANGE CASTLE'\ Document TvDe: Policv I Document No.: POL-051 Revision No.: 01 I Suoersedes: 00 I Paae No.: 2 of 2

Title: ENERGY PURCHASING POLICY

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• Integrated Pollution Prevention and Control Licence (IPPCL) P0693-01.


• SOP-ENV-GEN-001 "Communications-Public requests for Information on Environmental Performance"

• SOP-ENV-GEN-002 "Environmental Occurrences" • Site Glossary


3. REFERENCES:

This scope of this document is to define; • The Environmental Management Policy Statement and • The responsibilities of individuals and departments, in relation to Environmental

Management at TILGC.

2. SCOPE:

The purpose of this document is to define the overall Environmental Management Policy at Takeda Ireland Limited (Grange Castle)-TILGC.

1. PURPOSE:

(This Section is for use bv Document Control Onlvl '


-


Keith O'Neill Reviewed By: EHS Enaineer Date:

Damian Crowley Reviewed By: Production!EHS Director Date:

Greg Timmons Reviewed Bv: President Date:


DOCUMENT APPROVAL:

TAKEDA IRELAND UMITED (GRANGE CASTLE} Document Type: Policv I Document No.: POL-049 Revision No.: 00 I Suoersedes: NIA I Paae No.: 1 of 4

Title: ENVIRONMENTAL MANAGEMENT POLICY

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• Ensure employees, contractors and visitors under their control are made aware of and comply with, environmental management procedures.


• Consider, communicate and support where appropriate any representation about environmental management from the personnel for whom they are responsible.

• Monitor the activities of visitors and contractors within their area to ensure envi ronmenta I protection.

• Provide leadership and set examples through good work practices considering environmental responsibilities.

4.4 Executive I Team Leader: It is the responsibility of the Executives/ Team Leaders to:

• Ensure compliance with the IPPCL. • Be aware of all current and proposed environmental legislation relevant to TILGC. • Ensure environmental management systems in place comply with all relevant

national and European environmental legislation, standards, codes of practice and accepted behaviour.

• Liaise with relevant regulatory bodies. • Develop effective environmental management programmes and systems. • Promote Environmental Awareness and Training. • Lead In the development and delivery of environmental related training. • Review when appropriate SOP's and other relevant documentation for compliance

with applicable standards and regulations. • Coordinate environmental audits. • Review and approve all environmental management related documents. • Ensure appropriate records are maintained.



• Ensure that employees, for whom they are responsible, are held accountable for their performance in relation to environmental management.

• Ensure that thorough and prompt investigations are carried out on all reported incidents In accordance with the current procedures.

• Ensure environmental management is an agenda item at all relevant meeting.

4.2 Managers: It is the responsibility of Managers to:

• Communicate to all managers that they are accountable for actively implementing environmental management programmes as an integral part of their function.

• Ensure all necessary resources are provided to support Environmental Management.

4.1 Directors: It is the responsibility of Directors to:

4, RESPONSIBIUTIES:

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document TvDe: Policv I Document No.: POL·049 Revision No.: 00 I Suoersedes: N/ A l Paae No.: 2 of 4


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o At a minimum meet, and where appropriate exceed, the requirements of all relevant legislation and corporate standards.

o Promote the concepts of continuous improvement and pollution prevention through the setting and review of environmental objectives and targets.

o Provide all of the necessary information and resources to achieve objectives and targets.

o Provide necessary training and support to employees so they can carry out their environmental management responsibilities effectively and professionally.

o Promote the adoption of environmentally sound practices by contractors, suppliers and customers.

o Implement a documentation system which will ensure that all documents required by the IPPCL and environmental management system are generated and adequate records are kept.

o Keep up to date with all relevant environmental and energy management legal requirements.

o Make our environmental management policy and records available to the public and interested parties.

o Communicate our policy to all TILGC employees. o Ensure the Environmental Management Policy is reviewed regularly.


7. REQUIREMENTS:

7.1 ENVIRONMENTAL MANAGEMENT POUCY STATEMENT: • Takeda is a global company which researches, develops, manufactures and markets

a wide variety of pharmaceuticals. Takeda strives towards better health for individuals and progress in medicine by developing superior pharmaceutical products. TILGC regards environmental management as an integral and essential part of good business practice. TILGC is committed to achieving and maintaining a high standard of environmental quality in all our operations.

For other relevant definitions refer to site glossary.

6. DEFINmONS:

• Not applicable. DRC-13-051


• Comply with the environmental management systems and procedures. • Discourage improper conduct or behaviour that may compromise compliance with

environmental regulations or TILGC's IPPCL. • Attend training and undergo assessment in relation to environmental management as

appropriate to their work. • Immediately report all environmental occurrences. • Not to Interfere with or misuse any environmental monitoring equipment and/or

environmental systems.

4.5 TILGC Employee/Embedded Contractors; It is the responsibility of TILGC employees and Embedded Contractors to:

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Tvpe: Policy I Document No.: POL-049 Revision No.: 00 I Supersedes: N/A l Paae No.: 3 of 4


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N/A 9. PROCESS MAP:

N/A 8, PROCEDURE:

• Responsibilities of individual personnel will be defined in Job Descriptions, signed by the relevant employee.

• It is TILGC's policy that the primary responsibilities of the EHS department will not be delegated.

• TILGC management is also responsible for monitoring the effectiveness of the Environmental Management System.

7,2 General: • The participation and commitment of all TILGC employees is required to meet our

environmental management goals. These employees are made aware of and recognise the importance of complying with TILGC systems and procedures.

• TILGC management fully endorses the stated policy and controls and acknowledges that it is their ultimate responsibility to ensure that the conditions required to attain the environmental management objectives are present.

TAKEDA IRELAND UMITED (GRANGE CASTLE} Document TvDe: Policv I Document No.: POL-049 Revision No.: 00 I Sunersedes: N/ A I Paae No.: 4 of 4


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As set out in the 2005 SHWW Act the responsibility for safety and health is placed directly on directors and managers who control the work activities on site. The regular day to day

Site Management Structure

4. RESPONSIBIUTIES:

•

3.2 Associated Documents: • Guidelines on Risk Assessments and Safety Statements: H.S.A Publication(2006) • Guidance for Directors and Senior Manager Responsibilities for Workplace Safety and

Health: H.S.A Publication(2007)

• Safety, Health and Welfare at Work Act, No. 10 of 2005 • TPC Global EHS Guidelines • SOP-HS-GEN-066, Permit to Work • SOP-QA-SYS-150, Document Review and Change Process. • POL-021, Permit to work • POL-019, Accident Prevention Policy • Site Glossary


3. REFERENCES:

This Safety Statement is a document, required under Health and Safety Legislation (Ref. 3.1), which outlines TILGC's commitment to the safety and health of all employees, visitors and contractors on site and identifies the hazards and risks assessed. The Safety Statement also provides details on TILGC's responsibilities for health and safety, their commitment to comply with legal obligations, the protective and preventative measures in place, health and safety resources available and the arrangements used to fulfill these responsibilities. References to plans and procedures to be used in the event of an emergency are also included as well as specific duties for certain personnel who are both responsible for health and safety and are required to carry out certain tasks as outlined in the statement. This policy will cover relevant issues set out in Global EHS Guidelines from TPC.

2. SCOPE:

This Safety Statement (Policy) is provided In accordance with the Safety, Health and Welfare at Work Act 2005, Section 20, which requires Takeda Ireland Limited (Grange Castle) (TILGC) to specify the manner in which the safety, health and welfare of employees will be managed at work.

1. PURPOSE:



TAKEDA IRELAND UMITED (GRANGE CASTLEl Document Type: Policy I Document No.: POL-009 Revision No.: 5.0 I Paae No.: 1 of 13

Title: SAFETY STATEMENT

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• Stress the importance attached to safety and health by establishing and monitoring goals for Directors/ Managers.

• Communicate to all Directors/ Managers that they are accountable for actively implementing safety and health programmes as an integral part of their function.

• Ensure that all necessary resources are provided to safeguard the safety and health of all TILGC employees, visitors and contractors.

• Ensure the board members have a clear understanding of the key safety and health issues for TILGC and where appropriate are continually appraised of risks likely to arise

The primary responsibility for all matters relating to site safety resides with the President. Specific operational and strategic issues are delegated by them through the management structure. It is his responsibility to:

4.1 President:

As TILGC have an EHS team, appropriate systems are in place to manage day to day operational requirements such as risk assessments, legislative updates, reviewing and developing appropriate control strategies. If appropriate when a managerial decision is required on an Issue potentially impacting on the safety and health on personnel on site, a communication is made to the Maintenance Manager informing him of the issues. The Maintenance Manager may escalate the issue to the Engineering Director who in turn may bring it to the attention of the President.

Safety and Health Management Structure

I Greg Timmons I President

I I WUiam Murphy I Engineering Director

I

I Donal Brady I MalnlenilOCe Manager

I Directors/Managers I Safety Committee Safely Representative Team Leaders/ EHS Engineeni

Supervisors (Names Posted on (Name Posted on Keith O'NeHV Notice Boards) Notice Boards) Alleen Newman

In addition this structure clearly defines safety and health responsibilities on site. The following chart outlines the structure which fulfils these aims:

TILGC recognise the importance of having an appropriate safety and health reporting and management structure to ensure that all safety and health obligations are fulfilled and issues are managed correctly at the appropriate level and time.

Individual responsibilities for all staff in relation to safety and helath are also stated in the 2005 Act and are captured in this document.

management, control and direction of TILGC are the responsibility of the President and his management team.

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• All employees, for whom they are responsible, receive adequate safety training and instruction appropriate to the tasks they are performing.

• All employees, for whom they are responsible, are held accountable for their performance in relation to health and safety.

• Thorough and prompt investigations are carried out on all reported incidents, accidents, near misses and dangerous occurrences in accordance with the incident/accident reporting and investigation safety procedure.

• Health and Safety is an agenda item at all relevant meetings.

It is the responsibility of all Directors/ Managers to ensure:

4.5 Directors/Managers:

• Ensure that systems are in place to communicate the Safety Statement to new staff when they start and to existing staff on an annual basis or when the contents of the Safety Statement have been altered.

• Develop effective EHS programmes and systems. This can be done electronically or through the site document management system, whichever is appropriate.

• Ensure EHS systems in place comply with all relevant national and European Health and Safety legislation, standards, codes of practice and accepted behaviour.

• Review, when appropriate, the Safety Statement, SOPs and any other relevant documentation for compliance with applicable standards and regulations.

• Promote EHS training and awareness programmes. • Advise on all aspects of Health and Safety within the company. • Assist in the development and delivery of safety related training. • Be aware of all current health and safety legislation and proposed legislation, which

will affect health and safety within TILGC. • Act as a liaison person between the company and all health and safety regulatory and

statutory bodies in relation to health and safety matters. • Co-ordinate site safety and health-audits. • Provide input into establishing and tracking progress relating to long term health and

safety goals and objectives. • Analyse causes of accidents and incidents and ensure that action is taken to prevent

reoccurrence. • Ensure appropriate records are maintained. • Ensure an evacuation procedure is in place and is tested regularly.

It Is the responsibility of the EHS Engineer to:

The EHS Engineer will report directly to Maintenance Manager .. The EHS Engineer will advise management on all matters relating to safety.

4.4 EHS Engineer:

The Maintenance Manager is the front line manager with responsibility for the management of the EHS department. It is the responsibility of the Maintenance Manager to provide support to the EHS Engineers in the management of operational issues and when appropriate to inform the Engineering Director of issues with the potential of impacting on safety and health of personnel on site.

4.3 Maintenance Manager:

In addition to the general requirements on all Directors and Managers, the Engineering Director, in the absence of the President, assumes responsibilities for Health & Safety decisions which would normally be made by the President.

4.2 Engineering Director

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For relevant definitions refer to the Site Glossary.

5. DEFINITIONS:

• Take reasonable care for their own safety, health and welfare and that of any other person who may be affected by their acts or omissions while at work.

• To ensure they are not under the influence of an intoxicant to the extent they are endangering their own safety, health and welfare at work or of any other person.

• To co-operate fully with all provisions taken by TILGC for ensuring their safety, health and welfare and the safety, health and welfare of other employees, contractors and visitors.

• Not to engage in improper conduct or behaviour that is likely to endanger his or her own safety, health and welfare or of any other person.

• To attend training and undergo assessment as appropriate relating to the safety, health and welfare of their work as required by TILGC.

• Use in such manner so as to provide the protection Intended, any suitable appliance, protective clothing, convenience, equipment or other means or thing provided for securing their safety, health or welfare while at work.

• To immediately report all incidents and dangerous occurrences to a team leader/manager.

• Report to their team leader/manager, without unreasonable delay, any defects in plant, equipment, and place of work or system of work, which might endanger safety, health or welfare, of which an individual becomes aware.

• Not to interfere with or misuse any appliance, protective clothing, convenience, equipment or other means or thing provided for securing the safety, health or welfare of persons arising out of work activities.

In accordance with the requirements of Section 13 of the Safety, Health and Welfare at Work Act 2005, employees have the following responsibilities:

4.8 Employees;

• TILGC recognise the important role of the site Safety Representative and will support him or her in the execution of his or her duties.

• TILGC will accommodate the biennial election of a site Safety Representative.

• The name of the TILGC Safety Representative Is posted on site notice boards.

4. 7 Safety Representative:

It is the responsibility of the Team Leader/Supervisors to: • Be involved in the preparation of the risk assessment for their area of

responsibility. • Ensure that employees, contractors and visitors under their control are made

aware of and comply with the companies Safety Statement. • Ensure all employees, for whom they are responsible, receive adequate safety

training and instruction appropriate to the tasks they are requested to perform. • Consider, communicate and support, where appropriate, any representation about

health and safety from the personnel for whom they are responsible. • Monitor the activities of visitors and contractors within their area to ensure their

health and safety. • Provide leadership and set example though safe work practice and behaviour.

4.6 Team Leader/Supervisors:

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• The roles and responsibilities of those personnel who manage and perform activities having an effect on the occupational health and safety of the organisations activities and facilities are defined within Section 4.0.

6.3 Health and Safety Resources:

• It is the policy of TILGC that TILGC will prevent accidents from occurring, where reasonably practical and that the TILGC facility will be designed to guarantee a high level of protection for employees, contractors, visitors and the environment by appropriate means, structures and management systems.

• Specific details of the site Accident Prevention Policy are contained in POL-019.

6. 2 Accident Prevention Policy Statement:

TILGC is a bulk pharmaceutical manufacturing facility. TILGC is committed to the management of its business to the highest health and safety and welfare standards. It is the policy of TILGC to comply with all national and European safety, health and welfare legislation, standards and Codes of Practice. TILGC will also follow corporate guidelines in and endeavour to implement TPC Global EHS Guidelines. In keeping with the regulations mentioned above TILGC will ensure the following: • Ensure, so far as is reasonably practicable, the safety, health and welfare of all

employees while at work and to provide such information, instruction, training and supervision needed for this purpose.

• Ensure, so far as is reasonably practicable, that third parties are not exposed to risks to health and safety through TILGC activities.

• Communicate the Safety Statement to all employees and communicate essential elements of the Safety Statement to contractors through Contractor Induction or communication.

• Provide and maintain such plant, tools and equipment as are necessary to ensure, as far as is reasonably practicable, that work can be carried out safely and without risk to health.

• Consult with all employees on matters of Health and Safety. • Provide, so far as is reasonably practicable, safe systems of work and to ensure

that proper means of access and egress exist and are maintained at all times. • Provide suitable protective clothing and equipment where hazards cannot be

eliminated. • Provide and maintain welfare facilities such as bathroom facilities, drinking water

and canteen etc. • Appropriate Occupational Hygiene monitoring will be conducted and

actions/results from this will be acted upon to ensure the safety of all employees at TILGC.

• Provide, where necessary, a competent person to advise and assist in securing the safety, health and welfare of employees.

• Promote continuous improvements by setting targets and objectives. • Make available information concerning activities that affect health and safety to

employees and other affected third parties. • Keep up to date with all relevant health and safety legal requirements and to

keep a register of all the applicable acts, statutory instruments, standards and guidelines.

• Appropriate provision will be made for the development, Implementation and review of all EHS Plans and activities.

6. REQUIREMENTS:

6.1 SAFETY POLICY STATEMENT:

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• When established area risk assessments are communicated by EHS to the area team leader or manager and then by that person to all employees In the area.

• A record of all training will be kept All area and task risk assessments will be available electronically for access by anyone at all times through the TILGC Share Point.

• Where English is not the first language of someone coming onto site or where a person may have difficulty in reading or understanding English, EHS will endeavour to communicate all relevant risks in a form that that person understands.

6.6 Communication of Hazards and Risk:

An essential element of risk management at TILGC is compliance with the Nine General Principles of Prevention. They are: • The avoidance of risks. • The evaluation of unavoidable risks. • The combating of risks at source. • The adaptation of work to the individual, especially as regards the

design of places of work, the choice of work equipment and the choice of systems of work, with a view, in particular, to alleviating monotonous work and work at a predetermined work rate and to reducing their effect on health.

• The adaptation of the place of work to technical progress. • The replacement of dangerous articles, substances or systems of work

by non-dangerous or less dangerous articles, substances or systems of work.

• The development of an adequate prevention policy in relation to safety, health and welfare at work, which takes account of technology, organisation of work, working conditions, social factors and the influence of factors related to the working environment.

• The giving collective protective measures priority over individual protective measures.

• The giving of appropriate training and instructions to employees.

6.5 Principles of Prevention:

Each Risk Assessment is carried out using a quantitative risk assessment method where the risk is assessed as to whether it is acceptable or not. Risk assessments are carried out in consultation with various stakeholders including team leaders, managers and employees and the Safety Representative. Control measures are recommended and implemented where reasonably practicable and in accordance with health and safety legislation.

A Hazard Identification and Risk Assessment procedure is in place for the on-going identification of hazards, the assessment of risks and the implementation of reasonably practicable control measures. The hazard identification process assesses the hazards posed by normal, abnormal and emergency activities on site to all personnel having access to the site, such as employees, contractors and visitors.

6.4 Hazard identification and Risk Assessment:

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• Job description.

As required under section 10 of the Safety, Health and Welfare at Work Act 2005, TILGC will provide training as required, to safeguard the safety, health and welfare of employees. Management in conjunction with EHS and the Training and Development Department identifies all health and safety training needs of employees. When identifying training needs, the following will be taken into consideration:

6.10 Training:

• EHS journals and publications. • Health and Safety Authority, their website and newsletters. • Government Publications Offices (Health and Safety Legislation). • Pharma-Chemical Ireland (PCI). • Irish Business and Employers Confederation (IBEC). • Institute of Occupational Safety and Health (IOSH). • National Standards Association of Ireland {NSAI). • British Standards Institution (BSI).

Relevant Health and Safety legal requirements are identified and accessed from the following sources:

6.9 Health and safety Legislation Updates:

Following the review, Risk Assessment documents will be amended as necessary and processed as per SOP-QA-SYS-150, Document Review and Change Process.

Risk Assessments will be reviewed when: • There has been a significant change in the matters to which it relates. • There is any reason to believe that the Risk Assessment is no longer valid. • An incident occurs.

6.8 Review of Risk Assessments:

In addition to the Risk Assessments carried out under the hazard identification and risk assessment procedure, other specific Risk Assessments will be carried out where required under current legislation. Examples of this include: • Chemical Risk Assessments, • Pregnant Worker Risk Assessments, • Confined Space Risk Assessments, • Assessments relating to explosion protection.

6. 7 Specific Risk Assessments:

Appropriate slgnage for emergency exits, fire hydrants, fire extinguishers, potentially hazardous areas and the storage of hazardous materials will be posted in the appropriate locations throughout the site. This will communicate locally and immediately, hazards present and the required actions to be taken when in that area.

• Hazards, which are currently applicable to the activities at TILGC, are listed in Appendix 1 along with associated risks and control measures.

• These hazards are also actively communicated through the EHS Induction Training, on the job training and passively through document management and electronic storage of Information.

Hazards:

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Due to the nature of certain materials used on site, the site is required to operate under the ATEX regulations. Where there is a possibility of an explosive atmosphere in an area, the entrance into the area is marked with an EX sign. There are a number of site controls to enable access into ATEX areas and for tasks to be carried out safely within these areas.

6.13 ATEX

The site maintains a Permit to Work Management System for all works assessed as coming within the scope of Permit to Work. The overarching document that sets out the site approach to this area is contained with POL-021, Permit to Work. Permits are used for all permit activities, i.e. for activities that are not normal activities for TILGC operations or activities that are hazardous and any other miscellaneous unanticipated hazardous activity like construction related snagging work. This procedure is defined in SOP-HS-GEN-66, Permit to Work. Based on an assessment of the various risks involved with the work activity further permits are issued for high risk or hazardous activities as required. Procedures detailing the responsibilities and requirements of special permits are detailed in the SOP-HS-GEN-066.

6.12 Permit to Work:

• All contractors coming on site will attend TILGC EHS induction. • Where the contractor activity requires specialised training, e.g. Confined

Space Entry, it is the responsibility of the contractor company to provide such training to their employees.

• Copies of relevant training certificates must be submitted with the contractor's safety documentation before work is permitted on site.

• TILGC will ensure, as far as is reasonably practicable, the safety of visitors and contractors while on site. All visitors and contractors within the TILGC site are subject to the same safety rules and procedures as TILGC employees.

• Contractors must report any incidents, accidents, near misses, dangerous occurrences and first aids to their own supervisor/manager and their TILGC contact. All contractor incidents will be Investigated in accordance with TILGC's incident/accident reporting and investigation procedure.

6.11 Contractors:

• Role and responsibilities of TILGC EHS. • Relevant safety and health legislation. • Safety Statement. • Emergency response procedures for injury, fire, evacuation. • Incident/accident reporting and investigation. • Hazard identification and risk assessment. • Site hazards, associated risks and control measures. • Safe systems of work using permits. • Hazardous material management including chemical safety and

dangerous goods. • ATEX procedures and controls. • Safety Signage.

At a minimum, all TILGC employees will attend EHS induction where this induction will cover:

• Area and task Risk Assessments. • Competencies of person. • Relevant legislation.

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Facilities will be made available when required for staff who are pregnant or are nursing mothers. TILGC will work with staff member to ensure all accommodations and facilities are appropriate to the requirements of the situation.

The overriding priority when such an issue arises is to ensure the wellbeing of the employee and their fellow workers. All welfare facilities will be maintained in a hygienic condition by a contract cleaning company. Drinking water is provided and is accessible to all employees. Dedicated eating areas are provided for the taking of meals by all employees.

If an employee becomes aware that he/she is suffering from a disease or health impairment which would likely affect his/her work performance in such a way to pose a threat to the wellbeing of an another employee, he/she must inform their manager or the site occupational physician/occupational health nurse .

The physician will communicate directly with the staff member and will be available to clarify any issues or concerns that the staff member may have. TILGC will receive a summary of site trends on an annual basis. TILGC may require employees to undergo medical fitness to perform work activities to ensure safety, health and welfare while at work.

As defined in sites procedures and when appropriate, pre-employment medicals are carried out on prospective employees. TILGC will ensure when required, health surveillance appropriate to the risks on site is available to appropriate employees. This will assist In identifying health related working conditions. The surveillance will be appropriate to the risks on site but will include general wellbeing checks. All programmes will be developed in consultation with the site occupational health advisors (physician, nurse and other parties) and with staff.

TILGC are committed to playing a full active part in the health and welfare of its employees. In addition to the statutory obligations TILGC are committed to engage in work programmes to: • Improve the welfare of staff through workplace accident intervention and

prevention and helping TILGC staff through any recovery process. • Dealing with all sensitive issues that a staff member may have and organise

appropriate assessments. • Support through Its occupational health physician and other health and care

professional including Employee Assist Programmes, employees that are either going through or have gone through life altering experiences.

6.15 Occupational Health and Welfare:

• All visitors to site are pre-booked in with Security. • The Security Operations Procedure provides detailed instructions on the

procedure to be followed when visitors arrive on site. • Visitors are not allowed on site without being accompanied by a TILGC

employee who will instruct the visitor on safety procedures as required during the visit.

6.14 Visitors:

Site staff that access or work in these areas receive specific training on ATEX and have the contents of the site Explosion Protection Document explained to them. Contractors are informed at induction as to the requirements under ATEX regulations and activities in ATEX areas are controlled under the site Permit to Work programme.

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The procedure to be followed in the event of an evacuation is: • Alarm sounds and PA/VA system announces that there is either a warning

(requiring personnel to be in a high state of alert and prepared to leave area) or

Evacuation:

First Aid personnel will be offered vaccinations and inoculations as deemed appropriate by the occupational health advisor/s.

In the event that the injured person is unable to contact Security, the person making the contact should give as many details as possible to the First Aider about the injury sustained.

All injuries, no matter how small must be reported. The injured person must Security who in turn will contact an Occupational First Aider. The Occupational First Aider is equipped with the appropriate equipment and has access to the First Aid Room.

First Aid/Personal Injury:

The Emergency Response Team (ERT) is comprised of site staff whose experience, knowledge and training enable them react to onsite incidents and emergencies. All appointments are formally made by the Maintenance Manager.

TILGC Phone System: Extension 555 or 500

Channel 2 Radio Phone:

The most direct and immediate method of contacting the ERT is to make contact with Site Security either by radio phone or phone. Staff must give details of the incident including location. Site Security will ensure the ERT is informed.

Staff are responsible for following site emergency procedures and shall report without delay any situation that may be viewed as an emergency requiring the assistance of the Emergency Response Team or the emergency services.

6.17 Emergency Response Procedures

• The Incident/Accident Reporting and Investigation procedure requires that all incidents, accidents, near misses, first aids and dangerous occurrences be reported to EHS without delay.

• The process outlined in the investigation procedure helps ensure that the root causes of all accidents and incidents are correctly identified. It also helps ensure that there is effective follow up for corrective actions to eliminate unsafe conditions and procedures.

• The accident investigation process is also used to maximise the learning so that risks are reduced and future accidents can be prevented.

• The incident/accident report form is filled out by the team leader/manager responsible for the area where the incident occurred as soon as possible after it happens.

• All first aid must be reported to the Occupational First Aider who must record the first aid and the treatment given.

6.16 Incident/Accident Prevention. Reporting and Notification:

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• Each employee is responsible for the security of his or her work areas. All staff must ensure that the site access controls are fully implemented and maintained.

• Normal access and egress is made through security barrier at the gatehouse. Access control cards are required to gain entry either through the barrier or the pedestrian gate.

• Goods vehicles are allowed onto site but are supervised at all times. • To comply with fire and health and safety regulations, any staff working

outside core hours or at weekends must notify site security. • Staff members are asked to be vigilant at all times and if they see a

member of the public onsite without a contractor or visitors badge to notify security immediately.

• Due to the presence of goods of high consequence, additional security in line

6.19 Security and Site Access:

• TILGC endeavours to consult on all aspects of health, safety and welfare with staff through all stages of policy and procedure development.

• The site risk assessment process will provide a key component of such consultation and staff comments on the assessments will be actively sought and fully evaluated.

• Furthermore, TILGC recognises the resource of staff and the major contribution they can make to the development of the site safety management system. TILGC therefore favours all communications and suggestions related to health and safety and welfare matters from staff. This will be achieved in a variety of ways including staff communicating directly with the EHS department and their manager on health safety and welfare issues, the Safety Representative and the Safety Committee. TILGC will use notice boards, the site email system, briefings and training to communicate relevant health, safety and welfare.

6.18 Representation. Consultation and Communications:

• Raise the alarm by pressing the nearest break glass unit in the area; • If others in the area are unaware of the danger alert them to the fact; • Only fight the fire if you are trained to do and it is safe for you to do so; • Do not allow yourself to become trapped (e.g. In a dead end corridor) as a

result of the fire; • Use the appropriate fire extinguisher for the type of fire; • Aim the fire extinguisher nozzle at the base of the fire; • If a third fire extinguisher is required, you should evacuate from the

area immediately and leave the fire fighting to either the ERT or the fire brigade.

The procedure to be followed in the event that a fire Is discovered is:

Fire Events:

an evacuation. • When requested to do so or when you believe it is required, leave the area

straight away and proceed to the designated assembly point. • Ensure your visitors are evacuated. • Do not collect personal belongings. • Do not run; always walk in an orderly fashion to the assembly point. • At the assembly point, inform the person carrying out the roll call that you are

present. • Wait at the assembly point and do not re-enter the building until the all clear has

been given by the person in charge.

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• TILGC will ensure a continuous improvement-orientated Management System is in place.

• EHS plans will be developed within this system and the subsequent implementation will be assessed for effectiveness.

• These plans will be formulated usually on an annual basis.

6.23 EHS Management Planning and Implementation

• There is the potential to varying degrees for all of these categories to be present in TILGC.

• Appendix 1 is a non-exhaustive list of site hazards that should be referred to when carrying out an area risk assessment.

• As each hazard is assessed in an area, the associated risks are identified and control measures recommended reducing the level of risk to an acceptable level. The control measures listed in the following pages are the minimum required control measures for the site. Some areas may have more specific control measures and if so, will be referred to in that area risk assessment.

• As new hazards are introduced, or if there is a change to the relevant health and safety legislation, this list will be updated and the relevant area risk assessment will be reviewed to reflect the update.

o Biological - bacteria, viruses, insects, plants, birds, animals, and humans, etc., o Chemical • depends on the physical, chemical and toxic properties of the

chemical. o Ergonomic - repetitive movements, improper set up of workstation, etc., o Physical - radiation, magnetic fields, pressure extremes (high pressure or

vacuum), noise, etc, o Psychosocial - stress, violence, etc., o Safety - slipping/tripping hazards, inappropriate machine guarding, equipment

malfunctions or breakdowns

• Hazards categories are as follows:

6.22 Hazards:

• TILGC as an employer are required under legislation to actively enforce site safety rules and procedures.

• Employees have an obligation under legislation to comply with all relevant safety rules and procedure.

• When considered warranted, an employee who breaches safety procedures or policies on site may be disciplined in accordance with the TILGC Disciplinary Procedure.

6.21 Disciplinary:

• At a minimum, the Safety Statement will be reviewed by EHS annually or more frequently if there is a significant change to hazards or control measures in the workplace.

• If any changes are made to the safety statement, these will be communicated to all employees as soon as is reasonably practicable by EHS.

6.20 Review of the Safety statement:

with guidance document on the transport of dangerous goods are in place. For security reasons these measures are not contained in public documents and are thus, not contained in this Safety Statement.

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• In line with the principles of prevention and the hierarchy of controls, PPE will be used either as a last resort or to supplement existing controls.

• All PPE must be approved by the EHS Engineer. • Systems will be in place onsite to ensure PPE is properly maintained, used,

inspected and cleaned. • Training will be provided to all personnel on how maintain, use, inspect, clean

and how to exchange damaged or worn PPE.

6.25 Personal Protective Equipment

6.24 Occupational Hygiene • Occupational hygiene programmes form a core part of a risk management

system. • Hazards such as chemicals, potent products, noise, heat, lighting etc. may

following a risk assessment require to be monitored. • TILGC will use work place monitoring to determine the effectiveness of

controls and quantify the exposure levels to hazards • TILGC will use the findings of risk assessments to determine the appropriate

work place monitoring programme required. • The record of the risk assessment will be a "living" document and will be

reviewed to ensure that it is kept up to date. TILGC will review risk assessment regularly.

• In addition to the review of the risk assessment the occupational hygiene programme may be altered to include additional monitoring following complaints or concerns from staff or contractors, abnormal reports from the occupational surveillance programme.

• Normal document review is required as per standard procedure in the change control system for new or modified plant and equipment.

• Occupational Hygiene monitoring will be conducted and results pertaining to this monitoring will be acted upon to ensure the safety of personnel.

• Where plans are found to be ineffective changes will be made to increase their effectiveness.

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4.2 Maintenance Manager: It is the responsibility of the Maintenance Manager to ensure:

• Maintain this document and update when required.

4.1 ~ It is the responsibility of the EHS Engineer to:


• POL-009 "Safety Statement" • SOP-EHS-GEN-251 "EHS Unplanned Event Management" • OECD Guiding Principles for Chemical Accident Prevention, Preparedness and

Response: Guidance for Industry (including Management and Labour), Public Authorities, Communities and other Stakeholders. 2"d edition 2003

• Takeda Global EHS Guidelines


• Site Glossary


3. REFERENCES:

• This Policy applies to all hazards on site that pose a risk to people and or the environment.

• This policy is subject to an annual review to ensure it satisfies site needs, complies with Takeda Global EHS Guidelines and complies with the Environmental Protection Agency and with H.S.A requirements.

2. SCOPE:

• The primary purpose of this document is to set out an accident prevention policy in the context of the site EHS policy. This policy aims to prevent accidents involving all hazards, in particular those involving hazardous materials and thereby ensuring that appropriate measures are in place to reduce the adverse effects on people and the environment if an accident occurs.

• This policy will cover relevant issues set out in Takeda Global EHS Guidelines.

1. PURPOSE:


(This Section is for use by Document Control Only}

TAKEDA IRELAND LIMITED (GRANGE CASTLE} Document Type: Policy I Document No.: POL-019 Revision No.: 2.0 I Page No.: 1 of 6

Title: ACCIDENT PREVENTION POLICY

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• The organisational structure is appropriate to minimise the risk of an accident or environmental occurrence and to minimise the consequences should one occur.

• All employees are made aware of hazards on site and of the potential for accidents.

• All employees are made aware of environmental systems on site and the potential for environmental occurrences.

The organisational structure on site, the people who operate the management systems on site and the training they receive is an integral part of an accident prevention policy. TILGC will ensure that:

6.2 Organisation. Personnel & Training

• Identify the roles and responsibilities of those involved in the management of hazards and environmental aspects.

• Systematically identify and evaluate the likelihood and severity of hazards/environmental aspects which may arise at our site.

• Implement procedures and instructions for safe and environmentally sound operations.

• Implement procedures for the management of change to our operations. • Identify foreseeable emergencies and tests and reviews emergency plans. • Monitor our performance in meeting these objectives. • Provide for systematic audit, review and updating of all procedures and plans. • Recognise that the nature of activities on site may give rise to hazards for

employees, contractors, visitors, members of the public and the natural and built environment.

• TILGC have obligations to all stakeholders to reduce the risks associated with such hazards to levels as low as is reasonably practicable.

The following criteria constitute a declaration of the TILGC's commitment to maintaining an EHS management system.

TILGC's aim in implementing this system is to reduce the risks associated with an accident hazard to as low as reasonably practicable.

TILGC is committed to achieving high standards of safety and environmental performance and, as such, will ensure that all necessary resources are made available to achieve these. The line of prime responsibility for the management of the site and the authority for affecting change, as well as individual responsibility for EHS, is clearly defined within the Safety Statement - POL-009 and other relevant documents.

6.1 The EHS Management System:

6. REQUIREMENTS:

For relevant definitions refer to the Site Glossary.

5. DEFINITIONS:

• That there is management commitment to the aims of this policy and where relevant resources are made available so that the policy is fully complied with for all relevant activities on site.

TAKEDA IRELAND UMITED (GRANGE CASTLE) Document Tvoe: Pollcv I Document No.: POL-019 Revision No.: 2.0 I Paae No.: 2 of 6

Title: ACCIDENT PREVENTION POUCY

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• The levels of risk are reduced to 'as low as reasonably practicable' (ALARP). • Hazards arising from normal and abnormal operations are identified and their

likelihood and severity assessed. • The identification and evaluation of hazards covers all phases of our

operations including storage, product transfer and control of emissions to the environment.

• Hazard identification extends to evaluating the effects of events originating outside the site, including risks from abnormal meteorological conditions, flooding, power failure, seismic activity and from aircraft impact.

• Identification of hazards, their possible consequences and prevention and control measures are detailed in the EHS management system.

• The results of risk assessments are analysed and areas for improvement identified, prioritised and scheduled.

• The responsibility for coordinating the process of hazard identification and risk assessment lies with the EHS Department.

• Hazard and operability studies will be conducted when required.

The TILGC's policy objectives are to ensure that:

Risk assessment provides information to TILGC to help develop risk acceptability or tolerability criteria against which different objectives can be assessed.

The process of identifying hazards and assessing the risk associated with them is achieved through site risk assessment. Risk assessment is a process that consists of a number of sequential steps, i.e.: hazard Identification; event scenario, assessment; consequence assessment; likelihood assessment; and risk integration and comparison.

6.3 Identification & Evaluation of Hazards

• All employees are trained, where relevant, in procedures needed to ensure that policy objectives are met.

• All employees are aware of their responsibilities in the management of accidents and environmental occurrences and are selected and trained to ensure that they have the necessary skills and experience to perform their duties. The responsibilities of management and employees for accident prevention and environmental protection are set out in written procedures.

• All TILGC's employees have access to safety and environmental information • Employees and their designated safety representative have access to relevant

safety information and to Safety Data Sheets. • Feedback from employees is encouraged on accident prevention and

environmental protection issues in the course of training and EHS inspections. Employees are also encouraged to make suggestions and raise specific concerns, which they may identify during operational activities.

• The necessary resources are made available for training of management and employees in the prevention of incidents, including accidents and environmental occurrences.

• Systems are in place to co-ordinate the EHS management system and ensure its effectiveness.

• Responsibility for EHS training content for employees and contractors lies with the EHS Department.

• All contractors' employees are made aware of the potential for accidents and environmental occurrences and their responsibilities in relation to them. They are trained, where relevant, in procedures needed to ensure that policy objectives are met.

TAKEDA IRELAND LIMITED (GRANGE CASTLE) Document Tvoe: Policv I Document No.: POL-019 Revision No.: 2.0 I Page No.: 3 of 6


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• Procedures are adopted to achieve the Management of Change objectives In respect of changes capable of affecting the control of accidents and environmental occurrences.

• Appropriate post change review procedures are defined and implemented. • Management of change covers both permanent and temporary changes and also

includes urgent operational changes. • Any new installations or storage facilities shall be installed in accordance with

specific procedures. • TILGC shall ensure that an effective change control and management system are

in place to ensure that no modifications or changes to plant, equipment, processes, software (including automated controls),facilities, or procedures compromise EHS.

The TILGC policy objectives are to ensure that:

6.5 Management of Change

• The risk of incidents with the potential for accidental harm to people or the environment is minimised, by exercising control over all aspects of TILGC's operations.

• Standard Operating Procedures including maintenance are adopted and implemented. • Standard Operating Procedures and Work Instructions are revised on a regular basis. • Management shall ensure written and easily accessible standard operating

procedures and instructions, in order to establish the conditions necessary to satisfy the design intent of the installation and maintain its integrity.

• These shall take Into account relevant standards, codes and guidance in order to ensure that equipment, plant and premises provide a safe place of work under both normal and abnormal operating conditions.

• TILGC shall ensure that all employees have personal protective equipment, where necessary, and ensure that such equipment Is maintained in good condition.

• TILGC shall also ensure that regular training is provided in the use of personal protective equipment.

• Employees shall be responsible for using suitable personal protective equipment in accordance with safety procedures and policies. .

• Efforts shall be made to design installations so that the need for personal protective equipment is minimised.

• Procedures shall be established for storage areas, and facilities where hazardous installations are present, to minimise the risks of accidents and, in particular, to prevent degradation of hazardous substances or packages, labels or other markings.

• Procedures shall be established to ensure the proper storage and handling of waste materials

As an IE licensed facility TILGC recognises the absolute requirement for control of all operations. This is largely achieved through having extensive approved procedures and permits that are in turn controlled through both the Quality and EHS management systems. TILGC's policy is to ensure that:

6.4 Operational Control

TAKEDA IRELAND UMITED (GRANGE CASTLEl Document TvDe: Policv I Document No.: POL-019 Revision No.: 2.0 I Paqe No.: 4 of 6


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• The EHS management system and all operations and practices are systematically reviewed for effectiveness and suitability.

• Regular internal audits shall be conducted. • In particular, all relevant procedures are reviewed following any Un planned event

with the potential to escalate.

TILGC's policy objectives are to ensure that:

6.8 Audit & Review

• Procedures are developed, implemented and maintained which actively monitor adherence to all safety and environmental procedures adopted in order to minimise the risk from hazards. Active monitoring Includes inspections of safety and environmental critical plant, equipment and instrumentation at TILGC and checking compliance with training, instructions and safe working practices.

• All accidents and incidents capable of leading to an accident or environmental occurrence are systematically reported and investigated. Investigations examine both the immediate cause of an incident and any underlying causes such as failure of procedures to protect against the occurrence.

• Corrective/preventative actions determined by such investigations are recorded and implemented to a set deadline.

TILGC's policy objectives are to ensure that:

6.7 Monitoring Performance

• Operations are carried out in a manner, which serves to protect the community and the TILGC employees from injury or illness and which avoids damage to the environment.

• An on-site emergency plan has been prepared and maintained, which details the required response of the TILGC personnel in the event of an accident.

• The emergency plan includes arrangements for contacting the emergency services and those people in the surrounding environment that might be affected.

• The relevant personnel are trained in their emergency response duties under the on site plan, together with first aid and fire fighting.

• The emergency plan is tested by means of regular exercises and other appropriate means.

• TILGC shall co-operate fully with the local Fire Services and other emergency services for emergency planning.

• TILGC shall assist response personnel with information, expertise and other resources, as needed.

• Site emergency plans and procedures shall contain clear criteria that establish when public authorities and bodies shall be contacted. These criteria shall make it clear at what stage to contact public authorities and whom to contact.

TILGC's policy is that:

TILGC recognise the pivotal role planning for emergencies has in an accident prevention policy. Based on hazard identification and risk assessment, TILGC shall prepare emergency plans managing any event involving hazards on site, in particular hazardous materials.

6.6 Planning for Emergencies

TAKEDA IRELAND UMITED {GRANGE CASTLE) Document Type: Policy I Document No.: POL-019 Revision No.: 2.0 I Paqe No.: 5 of 6


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• It is in compliance with all of the requirements of its IEL. • Materials are stored in line with best practice and regulatory guidance and that detail

of the storage of all raw materials, products and wastes are maintained. • Appropriate spill or emergency containment measures and structures are provided

and documented. • Bunding and collection systems are appropriate and maintained. • Drawings are maintained of all process, foul and surface water drains. Fabrication,

quality, integrity and testing of these drains shall be in line with regulatory guidance. • The catchment area for each spill or run-off collection system is identified. • Information is retained on possible contamination of ground, groundwater, or surface

water from fire water run-off in the event of a fire on-site and any provision for containment.

• Emissions are appropriately treated prior to release to atmosphere. • Detailed transport methods and routes of material within the site, solid, liquid or gas

transported by pipe, vehicle or person is retained. • Potential points of contamination/areas most at risk are identified and protected.

With the aim to reduce risk of hann to people and or the environment but with a focus on environmental protection, TILGC shall ensure that:

6.9 Environmental Protection Measures

TAKEDA IRELAND UMITED (GRANGE CASTLE\ Document Type: Policv I Document No.: POL-019 Revision No.: 2.0 I Page No.: 6 of 6


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Attachment D Site Development and Operational History Existing and Proposed Project Ninlaro Process Descriptions

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September 2016 Seite 1

Takeda Ireland Limited (Grange Castle) Information

April 2017

2002 Takeda Pharma Ireland Limited established

Since 2002 Facility Design, Environmental Impact Study & Planning

Permission

2003 – 2006

2007

2008

2009

2009

2011

2014

2015

2016

2016

Construction, Commissioning & Validation of API Facility

Start of Commercial Production

FDA Approval for Site Received

Irish Medicines Board Wholesale License Approval

Integration of Takeda Pharma Ireland Limited into Takeda

Ireland Limited (Grange Castle)

Completion of Administration Building Expansion

Start of Key Intermediate Production fro Existing APIs

Start of 24/7 shift work

Designated as Centre of Excellence for API Technology

Investment Announcement for Ninlaro Project

Manufacturing

Key technologies

Active Pharmaceutical Ingredient (API) and Key Intermediate

(KI)

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I

Page 2

Main products

API: Nesina, Rozerem, Takecab

KI: FPN & PSPA for Takecab

SYR-322HCl for Nesina

Main markets

No. of products

Total volume output products

Output bulk (Tons/year)

API for Global markets (incl. Japan)

KI SYR-322HCl for internal use at TILGC

KI PSPA for internal use and supply to Hikari

3 API and 3 KI currently active

Product mix dependant

(based on single product per annum)

106.0 tons Nesina

79.3 tons Rozerem

27.8tons Takecab

12.8 tons PSPA

12.6 tons FPN

56.6 tons SYR-322HCl

Development Capable of producing API for clinical trials

No. of Employees 87 (relating to API business)

Of which; 6 (currently relate to Ninlaro project)

Expansion Plans Introduction of new Ninlaro production facility with increase of

approximately 40 new jobs over the next 2 years

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Dry

• Drying -..... Product Processing

uors I l -------

Pack -Off

Air ...

voe ··················• Adsorption

+ Discharge to Atmosphere

Waste Disposal

• Mother Liquors , Mother Liq : L. ~ L- __ Re.processed ~

Separation Reaction

I lydrogenation

I',,.-·-··• s,ra:b;,g Liquid

: •..................• i I

~ __ _._ r_··_··~······-···· ~--~l ~

Solid/Liquid Mixture - ·-··- •

······················• Gas

--------· Solid

Liquid

Liq Ilea Tai

Tank and D

Sto

Liquid

Raw Material Receipts

' l Solids 5 i Farm rum Warehouse re

t ! uid Dry dcr Product iks Storage

' ! ~ _,,_ .. _ ..

Preparation -··-··-··-··

PM GROUP


IE0311985-REF-0043, Issue 1 01/06/2017

Page 1 of 18

Attachment D Process Description

Introduction

The nature of pharmaceuticals is such that the active ingredients are complex molecules which require complex chemistry to produce them. This chemistry uses a variety of solvents and reagents some of which are significantly hazardous to humans. Thus the processes involved are highly contained and considerable effort is put into this aspect of the design to ensure that firstly the plant operators are not harmed in any way and secondly that others around the plant are not put at risk, both inside and outside the plant boundaries. Considerable numbers of systems are in place to ensure that the materials handled do not escape to the environment to threaten either humans or plant life.

A plan of the overall site indicating the location of the main process activities is shown in Attachment B.2 of this application. This attachment includes a process description of the P1 Production Facility and the P2 Production Facility.

P1 Process Description

The overall process in the P1 Production facility is summarised in the process flow diagram Figure D.1 below. In common with the normal practice in the bulk pharmaceutical industry, the processes carried out in the main production building consist, typically, of:

- Materials Receipts (Figure D.2),

- Preparation and Reaction in multiple steps, including crystallisation or precipitation (Figure D.3),

- Separation and Drying (Figure D.4),

- Dry product processing (Figure D.5)

Each of these steps are detailed in the following sections.

Figure D.1: Overall Process Flow Diagram (P1 Production Facility)

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Preparation and Reaction Stage -

Preparation and Reaction Stage -

Preparation and Reaction Stage

Preparation and Reaction Stage

I ' Discharge lo Atmosphere

via condenser/scrubber --------· Gas .

Solid

Liquid

• tr

Forklift Main lligh extract Drum Storage ~ Production drum handling

Building booth --- A

Pumped Main Filtered Appropriate Tank Farm ,_ Production Manifold

(Bulk Storage) Building

Air Small

Volume Container

lligh Volume Dry Product Storage (IBCs)

Spent Filters

Low Volume Packaging waste

Main Production

Building

Dispensary (Lanunar

Airflow Booth)

Clean Pallel

Discharge 10

~P_a_lle_l> A~tmostcrc

lcon1rols

200 litre Drums

Low Volume Liquids

Bulk Road Tanker

High Volume Liquids

Delivered in original packaging

Solids

PM GROUP


IE0311985-REF-0043, Issue 1 01/06/2017

Page 2 of 18

General Instrumentation and Control

The facility has been provided with a distributed control system (DCS), to control all the elements of the process. The DCS is conventionally arranged with a control room for centralised control and such local control panels as required to carry out local operations adjacent to the equipment.

The DCS is programmed to manufacture each product on a batch-wise basis using a validated procedure and on completion of the required number of batches it then controls the cleaning operations required to prepare the plant for the next product.

Material Receipts

Figure D.2 provides a bulk flow diagram of the material receipts process.

Purpose

A number of different raw materials and reagents (solids, liquids or gases) are used in the process.

Figure D.2: Materials Receipts (P1 Production Facility)

Process Description

Material Receipt (Solids)

A flow diagram of the material receipts process is provided in Figure D.2. Various solid reagents are delivered from the main site warehouse in their original packaging. At the entrance to the main building the bags, drums or other containers are transferred from their original pallet to a clean plastic pallet that is used exclusively inside the building. The clean palletised materials are then taken to a dispensary inside the building where predefined weights (according to menus) of the materials are manually transferred into Intermediate Bulk Containers (IBCs) or Small Volume Containers (SVC) within a laminar air flow booth (LAF). The choice of IBC or SVC is made purely based on the volume of material required in processing.

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PM GROUP


IE0311985-REF-0043, Issue 1 01/06/2017

Page 3 of 18

Filled IBCs are then taken by fork truck and lifted to the top level of the building. At this level there are a series of stations (dedicated IBC discharge areas) where the IBCs can be placed and the contents discharged (from a valve in the bottom of the IBC) under gravity through chutes into the head (preparation) tanks (approx. 8 no.) and reactors (approx. 4-5 no.) on the floor below. The flow is controlled by the discharge station. Empty IBCs are returned to the dispensary for refilling or sent for washing and subsequent reuse for another material.

SVCs are similarly treated to the IBCs but are delivered to the main reactor floor where they are connected and discharged directly to the vessel concerned under gravity.

Material Receipts (Liquids)

Most of the liquid materials used in the process, excluding water, are bulk solvents (e.g. methanol, ethanol, and acetone), hydrochloric acid or sodium hydroxide solution. These solvents are delived to the tank farm by bulk road tankers and pumped into the appropriate tank using a dedicated pump. Separate pumps deliver the liquid to the main production building. These liquids are pumped from the tank farm storage tanks (7 No. fresh solvent tanks, 1 No. HCl tank, 1 No. NaOH tank) through overhead piping to the main production building to the process vessels via manifolds for use in the process.

Small volume liquids, including special solvents and reagents, are delivered to the site in standard 200 litre drums and are stored in the site drum store. They are removed from this drum store and taken to the production building by fork truck. Following a pallet transfer operation, the drums are taken by lift to the fifth level and delivered to a high extract rate drum-handling booth. The liquids are taken from the drums by using a vacuum in the receiving vessel (approx. 9 no.). Empty drums are taken out of the building and stored in the empty drum store located adjacent to the main drum store prior to them being removed from site for appropriate disposal.

Materials Receipts (Gases)

Hydrogen and hydrogen chloride gases are stored in cylinders in dedicated storage locations adjacent to the main production building. These gases are transferred to process vessels through dedicated piping and filters using pressure reducing and batching systems as appropriate. Lab gases are also stored in cylinders in dedicated storage locations and transferred to lab or process as required. Nitrogen is generated on site, however small amounts of liquid nitrogen is delivered to site and stored in cylinders.

Process Control

Process controls for material receipts and transfers include:

- Instrumentation on piping of liquids to production building (i.e. flow, level and pressure sensors, etc.) linked to a DCS system. Adequate alarms and adequate shut-off response is provided to ensure that sufficient control is provided. All liquids are batched into vessels via DCS at set values, as required by the process.

- All solid materials into the production building are weighed and recorded for GMP and stock control purposes. Operator training is also provided to ensure process control.

- Gases are transferred under controlled pressure via the DCS control. Alarms and automatic shut-off response are provided to ensure that control is provided.

Environmental Emissions

Air

Main:

There are no main emissions to air from the Materials Handling activities. All displaced gas from the bulk storage tanks, local storage tanks and process vessels are collected and passed through activated carbon VOC recovery (X-1723 or X-1729).

Minor:

The air flow through the downflow booths are discharged to atmosphere through filters which remove any particulate matter before discharge.

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Scrubber Effluent

Scrubber - - - _.., Effiuent

Dedicated Scrubber

Discharge to

+ Atmosphere

Scrubber Solution

'

' - - .J

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IE0311985-REF-0043, Issue 1 01/06/2017

Page 4 of 18

The HCl tank scrubber (SC-1720) is a minor emission to atmosphere associated with this process.

Potential:

Pressure relief valves are the only potential emissions to air from this process.

Water

There are no direct emissions to surface waters / ground waters from the P1 process unit operation. Washings from empty vessels/containers and scrubber effluent are sent to the appropriate holding tanks (e.g. waste solvent, high COD tank). Bunding is provided to prevent leaks/spillages from reaching drains and surface water / groundwater. These are also directed to appropriate holding tanks.

Waste

Empty liquid storage drums are stored in the empty drum store located adjacent to the main drum store, prior to being removed from site for disposal.

Original packaging from solids are disposed of suitably using a licensed waste contractor.

Gas cylinders are returned to suppliers for reuse.

Preparation and Reaction

Figure D.3 provides a bulk flow diagram of the preparation and reaction process.

Purpose

This process involves the dissolution or suspension of solid raw materials (or liquids or gases) in solvents and then mixing these fluids under the correct conditions in the reactors to initiate the desired reactions.

Figure D.3: Preparation and Reaction (P1 Production Facility)

Process Description

The early steps of the preparation and reaction process are carried out in a set of jacketed vessels (7 no.) in the upper part of the main processing building, the preparation vessels. These vessels are a mixture of

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IE0311985-REF-0043, Issue 1 01/06/2017

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glass lined and stainless steel and are provided with agitators, as required, to dissolve or suspend the reagents. They are also provided with individual heating-cooling package units (therminol heat transfer fluid) to heat or cool the vessel to the correct temperature. These vessels are used for simple functions and are not used for reactions except possibly very simple thermally neutral ones requiring little or no control. Generally the pressure in the vessel is controlled at a very small overpressure by nitrogen gas to ensure the flammable solvents used are maintained in a safe condition. Processing in these vessels is closed at all times to maintain a consistent and high level of containment. This closed operation is extended to the charging of solids to the vessels from stainless steel IBCs via specially designed discharge stations.

The fluids from the preparation vessels are delivered, by gravity, through piping to the reactors (4 no.) located immediately below the preparation vessels. These are similar to the preparation vessels but are larger, up to 3000 litre working volume, glass lined vessels. They are also provided with agitators, heat transfer units, solids charging systems, sampling systems, nitrogen systems and, unlike the preparation vessels, condensers. This combination of ancillaries permit the reactor to operate under a more rigorous set of conditions and permit pressure / vacuum reactions, distillations/refluxing, gas phase reactions as well as exothermic and endothermic reactions. It should be noted that no extreme exothermic reactions are to be undertaken in this facility and those mild exothermic reactions that are undertaken are subject to rigorous safety conditions imposed by Takeda’s management and safety personnel. The processing involves the use of flammable solvents, volatile, pyrophoric and hazardous reagents, in a variety of well controlled reactions. Processing may involve the use of more than one reactor and each vessel is provided with a series of routes through which the reaction mass can be transferred to other reactors, separation equipment or waste systems as required. These routes are partially selected near the base of the reactor or in the adjacent manifold system in the technical area. Transfers are closed and effected by means of a pump, gravity or pressure whichever is appropriate to meet GMP or environmental conditions.

The main reactors are also used as final process vessels in which the product may be purified by crystallisation or precipitation process.

Process Control

- Instrumentation on vessels and pipework in the production building (i.e. flow, level and pressure sensors, etc.) is linked to a DCS system. Adequate alarms and adequate shut-off response is provided to ensure that sufficient control is provided.

- A high level of operator training optimises process control.


Air

Main:

The main emission to air from this process is the VOC recovery (X-1723) and the HCl gas cylinder scrubber (SC-1053).

Potential:

Relief valves and bursting discs are the only potential emissions to atmosphere from this process.

Water

There are no direct emissions to surface waters / ground waters from this process unit operation. Vessel washings are pumped to appropriate holding tanks prior to collection and disposal by licensed contractor. Some aqueous streams with little or no organic contamination may be neutralised and sent to foul sewer. Bunding is provided to prevent leaks/spillages from reaching drains and surface/groundwater. These are also sent to appropriate holding tanks.

Waste

Spent filters, contaminated clothing, waste solvents and waste scrubber solution are disposed of by licensed waste contractors.

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IE0311985-REF-0043, Issue 1 01/06/2017

Page 6 of 18

Hydrogenation

The hydrogenation process is shown on the Preparation and Reaction block flow diagram in Figure D.4.

Purpose

Although the vast majority of the processing is carried out as described in Preparation and Reaction above, certain processes may involve a hydrogenation step involving reaction of an organic intermediate with Hydrogen gas in the presence of a catalyst.

It should be noted that small volumes of hydrogen are kept on site, and that all necessary design precautions are taken.

Process Description

This is a low pressure operation carried out in a single dedicated vessel. The process involves an intermediate dissolved in a solvent being reacted with hydrogen in the presence of a palladium catalyst.

At the completion of the reaction the catalyst is removed from the process fluid by means of a leaf filter. The process fluid is passed on into the main process area as described previously whilst the catalyst is water washed and drummed for processing off-site to recover the palladium. The catalyst is pyrophoric and needs to be correctly handled by trained staff. The hydrogen supply is connected only to this vessel through a dedicated line and the few hydrogen containing vents from the vessel pass to atmosphere through a dedicated scrubber. The scrubber is designed to remove small amounts of solvent from the vent gas stream to control VOC emissions from the Hydrogenator.

Process Control

Instrumentation on vessels and pipework in the production building (i.e. flow, level and pressure sensors, etc.) is linked to a DCS system. The DCS checks that the scrubber is operating before starting the hydrogenation unit. Bursting discs with rupture sensors are provided. The hydrogenator is located in a blast resistant cell, designated to withstand an explosion of hydrogen gas within the cell.


Air

Main:

The Hydrogenator Scrubber (SC-1292) is the only main emission to atmosphere from the hydrogenation process.

Minor:

There are no other minor emissions to atmosphere associated with the hydrogenation process.

Potential:

Relief valves are the only potential emission to atmosphere from this process.

Water

There are no direct emissions to surface waters / ground waters from this process unit operation. Vessel washings are pumped to appropriate holding tanks prior to collection and disposal by licensed contractor, or neutralised and sent to the foul sewer.

Waste

Empty hydrogen cylinders are returned to the supplier for reuse. Waste solvents and waste srubber solution are disposed of by licensed waste contractors.

Spent catalyst is recovered.

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' ' + Waste Disposal by licensed contractor

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IE0311985-REF-0043, Issue 1 01/06/2017

Page 7 of 18

Separation

Figure D.4 provides a bulk flow diagram of the Separation and Drying process.

Purpose

The purpose of the separation stage is to separate solid products/intermediates from the solvents in which they have crystallised or precipitated.

Process Description

Products from the facility are almost always solids. The solids are separated from the solvents (mother liquors) prior to drying with a centrifuge. The resulting wet cake is high in solids but remain wet with the mother liquors. These wet cakes are then washed with solvent or chilled water, depending on the process concerned. The final wet cake is then discharged under gravity, from the centrifuge, by a knife arrangement to a dryer below.

The facility has been provided with two centrifuges carrying out similar duties for different products and intermediates.

Mother liquors from the centrifuges are collected in dedicated vessels and sent from there to waste for disposal or to the process manifold for further processing in the main reactors.

Figure D.4: Separation and Drying Stages (P1 Production Facility)

Process Control

Instrumentation on vessels and pipework in the production building (i.e. flow, level and pressure sensors, etc.) is linked to a PLC system. Adequate alarms and adequate shut-off response are provided to ensure that sufficient control is provided.

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Air

Main:

The main emission to air from this process is the VOC recovery unit (X-1723).

Minor:

There are no minor emissions to air from this process.

Potential:

There are a number of centrifuge relief vents associated with this process which pass directly to atmosphere due to the low design pressure of these systems.

Water

There are no direct emissions to surface waters / ground waters from this process unit operation. Some aqueous streams with little or No organic contamination may be neutralised and sent to foul sewer.

Waste

Mother liquors from the centrifuges are collected in dedicated vessels and sent from there to waste holding tanks, from which they are collected by licensed waste contractors. Spent filters are disposed of by a licensed waste contractor.

Drying

Figure D.4 overleaf provides a bulk flow diagram of the Separation and Drying process.

Purpose

The purpose of this stage of the process is to dry off the solids completely prior to dry product processing.

Process Description

Wet cake from the centrifuges drop under gravity into a dedicated dryer located directly below. The wet cake is either an intermediate or a product that has to be dried prior to further processing.

Drying is usually carried out under vacuum at low temperature, usually well below 100°C.

The dryers are agitated conical dryers with heating and cooling. Each dryer is provided with its own dedicated, dry running, vacuum pump which draws the solvent vapours through a condenser to remove most of the solvent from the gas stream. Vapours discharged from the vacuum pump are sent to a discharge system, common to all the vacuum pumps in the building, which is provided with a condenser to remove more solvent from the discharged stream prior to it being discharged to the plant environmental control devices.

Process Control

Instrumentation on dryers (i.e. flow, level and pressure sensors, etc.) is linked to DCS systems. Alarms and shut-off response are provided to ensure that control is provided.

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IE0311985-REF-0043, Issue 1 01/06/2017

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Air

Main:

Vapours from the drying procedure are drawn through a condenser and then on to VOC recovery (X-1723).

Minor:

There are no minor emissions to air from this process.

Potential:

Relief valves are the only potential emission to atmosphere from this process.

Water

There are no direct emissions to surface waters / ground waters from this process unit operation. Some aqueous streams with little or No organic contamination may be neutralised and sent to foul sewer.

Waste

Waste scrubbing solution is collected and disposed of by a licensed waste contractor. Spent filters are disposed of by a licensed waste contractor.

Dry Product Processing

Figure D.5 overleaf provides a bulk flow diagram of the Dry Product Processing stage.

Purpose

This part of the process mills the solid product into an even granular powder which is ready to be packed and sent off site as product.

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Product Out Pack -Off

~ Discharge To Atmosphere via filler

Hammer Mill

Air N2

Air Mill

Discharge To + Atmosphere via filler

······················•

--------· Liquid

Gas

Solid

IBC Product

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IE0311985-REF-0043, Issue 1 01/06/2017

Page 10 of 18

Figure D.5: Dry Product Processing (P1 Production Facility)

Process Description

Solid, dry products and intermediates are discharged from the process at the base of the dryers into IBCs. These IBCs are then taken into temporary storage or are taken to the east side of the building and introduced into the milling suites. All products leaving the main production building are milled, in nitrogen, either in a hammer mill or in an air-jet mill and then packed into lined drums in a small subdivision suite before being removed from the building and then sent off-site as product. Empty IBCs from the subdivision or milling operations are recycled for refilling with product from the base of the dryers or are sent for washing if there is a campaign changeover. IBCs containing intermediates are held temporarily in the store and then are taken to the fifth level to be discharged into the process as described for reagents and raw materials above.

Process Controls

Transport of final product and intermediates in IBCs (and empty IBCs for recycling) is a manual operation.


Air

Main:

There are no main emissions of solvents/VOCs, however dry filtered nitrogen is discharged direct to atmosphere.

Minor:

Milling process discharges (via filters) to atmosphere (product is milled in nitrogen).

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IE0311985-REF-0043, Issue 1 01/06/2017

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Water

There are no direct emissions to surface waters / ground waters from this process unit operation.

Waste

Spent filters are disposed of by a licensed waste contractor.

Environmental Systems

Purpose

Takeda consider the protection of the environment as a high priority. There is significant investment in containment in respect of material handling and processing systems which also minimises environmental impact. Additional measures are included in the design to further reduce environmental impact.

Process Description

The systems they are adopting can be split into three parts relating to gaseous, liquid and solid wastes. These are described in greater detail elsewhere but, in summary, the systems used include:

Gaseous

- Condensers for primary control of VOCs at source

- Scrubbers for secondary control of VOCs and to control acidic/alkaline gaseous wastes

- VOC Adsorber (activated carbon) for tertiary or end-of-line control

- Direct gaseous emissions are limited to materials such as hydrogen for which there is no safe method of capture but represent no environmental hazard

- Charcoal filters on air emissions from liquid charge booths.

Liquid

- Bunding of tanks, loading/unloading areas to contain any possible spillage

- Solvent wastes are segregated and held prior to removal by road tanker for off-site disposal by an approved waste contractor

- Aqueous wastes with a high COD value are segregated and held in a tank prior to removal by road tanker for off-site disposal by an approved waste contractor

- Aqueous wastes with a low COD value are segregated and held in a tank prior to neutralisation, testing, metering and discharge to the municipal sewer.

Solid

- All solid waste is collected and prepared for off-site disposal by an approved waste contractor

- Hazardous solid waste is segregated and processed separately from non-hazardous waste

- Filters for downflow booths, fugitive powders and particulates etc. Filters on mills, carbon filters for emissions such as exhaust from Drum handling booth.

- Full details of these measures and systems is provided in Section 19 Environmental Considerations.

Process Control

Process control for environmental systems is provided by the DCS system, gas analysers (on VOC recovery), level monitoring (on tanks, bunds, etc.), TOC monitoring (on surface water discharge) with alarms and automated shut-off response as required.

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IE0311985-REF-0043, Issue 1 01/06/2017

Page 12 of 18


All gaseous and liquid systems are integrated into the plant design to ensure that there is complete capture of wastes and appropriate treatment prior to any discharge to storage or off-site system. Laboratory wastes are collected into the systems as described above except the fume cupboards exhausts which are vented to the atmosphere through carbon impregnated filters to control potential VOC emissions.

The emergency vent relief system has been designed to contain any foreseeable events and thus to minimise the risk of any downstream environmental impact. Additionally a Quench Vessel has been added to the system. This Quench vessel cools and condenses small reliefs and renders atmospheric pressure close to zero. Larger reliefs are partially captured giving rise to reduced emissions. The plant design is such that many controls are in place to prevent any relief occurring but if this becomes unavoidable then the quench vessel is in place to reduce the emission to atmosphere to a minimum.

Utilities

The following utilities are supplied to the process in P1 for its operation:

- Steam

Plant Steam at 7-8 barg for all heating purposes including building heating. Steam is raised in a conventional boiler fired with Natural Gas. The boiler arrangement is for 2 no. 6700 kg/hr boilers to be in operation together, with one standby. The boilers are controlled by a modulated firing system with a panel mounted monoprocessor which gives independent control of combustion air dampers and fuel values to ensure maximum efficiency in the operation of the boiler. Due to the low demand for steam on this facility the two boilers are too small to warrant the inclusion of heat recovery on the exhaust. However, to minimise the likelihood of any plume from recovered condensate the flash steam from this system is used to assist deaeration of the boiler feedwater. This provides for heat recovery, thus minimising energy consumption.

- Nitrogen

A Pressure Swing Absorption (PSA) nitrogen generation system provides the majority of the required nitrogen load principally for blanketing and milling operations. A high purity liquid nitrogen supply is also available for specific reactions and to act as a back-up for the PSA during peak demand. The Nitrogen Generator is located within the Utility building and the Liquid Nitrogen Storage Tank and Vaporiser Package is located outside.

- Compressed Air

Compressed air is generated by standard oil-free compressors and after treatment is used for instrumentation and plant air/general purposes. A duty/standby arrangement is in place, which minimises energy consumption.

- Heating Media

Heating and cooling for the process is realised by a heat transfer system which uses Therminol D12. A chiller package (consisting of compressors, pumps and ammonia condensers) cools the therminol to –25° C, whereupon it is circulated throughout the main production building providing the majority of the cooling for the process operations.

Where heating is required then the Therminol is heated by steam to the required temperature and circulated through the heat transfer equipment.

- Water

Two grades of water are prepared for plant operations:

Filtered City Water – used for simple washing operations, showers, drinking and other operations not associated directly with the process.

Pure Water – for operations directly associated with the process. The water purification consists of a raw water break tank and a water softening stage (including regenerable columns and salt saturatos) with further purification by reverse osmosis, continuous deionisation, filtration, and UV sterilisation.

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.. .. -~=± " 1 .... .... -. ~

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IE0311985-REF-0043, Issue 1 01/06/2017

Page 13 of 18

Laboratory

The laboratory performs analytical work relating to processing and to final product approval. Process development activities are also carried out. It is located in the main administration building. It is equipped as a standard laboratory with benching, analytical equipment, fume cupboards and space for 6 to 8 laboratory staff including write-up areas. Contaminated and solvent wastes are collected and transported in closed containers out of the laboratory to the site waste systems. Normal aqueous waste from the sinks is routed directly to the main sewer.

P2 Process Description

The P2 Production Facility will be a high potency dedicated facility capable of manufacturing the product, Ninlaro, from start to finish. The process begins with Active Pharmaceutical Ingredient (API) starting materials and manufacturing of the API (11 different process steps) on a campaign basis. The approved API will be passed from API cold storage within the dedicated API suites into dedicated DP (Drug Product) suites for blending, capsule filling and packaging. The combined dedicated API and DP suites will be housed in the dedicated proposed single story production building mentioned above and will share a main corridor connecting the manufacturing suites to dedicated administration space, labs, in building storage areas and process supporting utilities.

When operational, the P2 Production Facility will be capable of producing 15kg of API and producing 2.7 million capsules per year.

The proposed building layout of the P2 Production Facility is illustrated in Figure D.6 attached. It has a main spine corridor running the length of the building. The identified location for the API suites is on the southern side of the building at the opposite end of the main spinal corridor from an administration block. The DP process suites are located on one side of this main spine while laboratories and in-building product storage occupy the opposite side.

The following sections describe the two processes involved in the production of Ninlaro in the P2 production facility; API and DP and Packaging.

Figure D.6: Proposed Layout of P2 Facility showing API Processing and Support Areas

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0

0

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IE0311985-REF-0043, Issue 1 01/06/2017

Page 14 of 18

Active Pharmaceutical Ingredient (API)

Process Description

The following are the different technologies involved in the production of the API.

- Raw material charging

- Reaction

- 2 phase liquid/liquid extraction

- Distillation

- Filtration

- Drying

Figure D.7 illustrates a Block Flow Diagram of the API Process.

Figure D.7: Block Flow Diagram for API Process (P2 Production Facility)

The API suites will constitute of a High Potency Dedicated Kilo Scale Facility. It will manufacture all 11 different API process steps (see Figure D.7) on a step by step campaign basis for Ninlaro, a commercial product with an API requiring a very high level of containment. The API suites will consist of a single primary

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processing room and a product/intermediate storage room. The API rooms will primarily be built for one specific product. The API suites will be accessed from the main facility corridor via dedicated material air locks (MAL) and people air locks (PALs). The PAL will operate on a gown-in degown-out basis. An adjoining technical space and a clean utilities room will house non product contact supporting utilities, heat transfer systems and purified water systems respectively.

It is envisaged that a flexible single process train or module with a specific equipment set is to be installed initially in a manner such that it can cater for the addition of other equipment items and has an expansion direction available such that a future second process module could readily be installed.

The API process rooms will house an appropriately designed kilo scale commercial plant for the Ninlaro product only. The intended Ninlaro product API has an Occupational Exposure Limit (OEL) determination of 0.1µg/m

3 and as such is a highly potent product. The anticipated output range for the new facility is of the

order of 2.8kg per final API batch. This self-contained highly potent product plant will have API design capacity basis to deliver 15kg/year of the Ninlaro API (Ixazomib Pure) with an initial design batch scale 2.8kg API per batch of Step C3.

This Kilo scale commercial processing module must be flexible to cover the range of capabilities required to efficiently and effectively manufacture all the 11 API processing steps on a step by step campaigned basis. The Ninlaro API process involves a convergent chemical synthesis. Segment A (Steps A1 to A3) is followed by Segment B (Steps B1 to B5). Segment C involves coupling Segment A to Segment B and the associated work up to produce the Ninlaro API (Steps C1 to C3).


Air

The main VOC emissions from the P2 process will be routed back to the existing VOC treatment systems on site and emitted to atmosphere via an existing emission stack (EP-P1-02).

There will be some minor emissions from various rooms in the proposed main production building, but the emissions from these locations will be clean and will be protected by HEPA (High Efficiency Particulate Arrestance) filters.

Water


Waste

Liquid wastes will be segregated into “Solvent”, “Chlorinated “ and “Aqueous” waste break tanks, chemically dosed and pumped to the appropriate existing site storage locations prior to incineration or drummed for appropriate disposal. Liquid waste streams potentially containing highly potent product traces will be appropriately deactivated at the Ninlaro facility prior to transfer to the on-site storage location.

Contaminated solids waste will be bagged and drummed for destruction.

Process Controls

For the API area, it is envisaged that a System Integrator will provide a customised control system for the reactors and ancillary equipment. This will comprise of a PLC and two Operator Interfaces in the production areas.

The Filter Dryer in the API area will be supplied complete with its own control system by the equipment supplier.

The process equipment will be protected by overpressure devices such as rupture discs or pressure relief valves. These devices will vent into a relief collection system within the building and designed to discharge to an emergency relief receiver located outside the building. This will allow for the containment of any discharged process liquids. The relief system to be designed per DIERS recommendations.

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Drug Product (DP) and Packaging

The following are the different technologies involved in the DP and Packaging Process.

- Dry Milling (material de-lumping)

- Powder blending

- Capsule filling

- Capsule weight checking

- Blister Packing (Cold form)

Figure D.8 illustrates a Process Flow Diagram for the DP and Packaging Process.

The DP process equipment will be dedicated to Ninlaro and will be located within three processing rooms. The Ninlaro API will be received from the API manufacturing suite and used to produce Ninlaro 2.3mg, 3.0mg & 4.0mg hard gelatin capsules.

No solvents will be used for the Ninlaro DP manufacturing processes.

Primary packaging of filled Ninlaro capsules will be performed using a blister packer located in a dedicated Primary Packaging room. Filled blisters will be transferred into trays for storage prior to secondary packaging.

A dedicated room will be provided for secondary packaging of blistered Ninlaro capsules. As the requirements for secondary packaging vary from country to country, a variety of equipment will be provided for wallet sealing, cartoning, labelling, etc.

The DP and Primary Packaging rooms will be accessed from the DP Primary Corridor via dedicated PALs and MALs. The DP Primary Corridor will be accessed from the main Production Corridor via a general garbing area.

As the Ninlaro product API has an OEL of 0.1µg/m³ it is a highly potent product. As a result the DP and Primary packaging processes will be designed to provide maximum containment during normal operation. Procedures and control measures will be put in place to deal with interventions to the manufacturing process, disassembly of equipment and unexpected events.

Split butterfly valves with extraction will be used to connect IBC’s to process equipment.

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Secon ary Pack

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IE0311985-REF-0043, Issue 1 01/06/2017

Page 17 of 18

Figure D.8: DP & Packaging Process Flow Diagram


Air

There are no direct emissions to air from this process unit operation.

Water


Waste

There will be no hazardous waste generated during this stage of the process. All non-hazardous waste will be discarded in designated receptacles and sent for recycling/recovery by an appropriately licence waste contractor.

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PM GROUP


IE0311985-REF-0043, Issue 1 01/06/2017

Page 18 of 18

Process Controls

For the Drug Product (DP) & Packaging equipment, it is envisaged that the equipment will be supplied complete with its own standalone control systems. The following is a list of systems that are envisaged that will be supplied with their own control systems:

- Blender

- Capsule Filler

- Blister Packer

- Check weigher for secondary packaging

- Secondary Packaging printing and inspection machine

- Serialisation equipment – Linked to MES/ERP

For the clean utilities (purified water), it is envisaged that the generation skid will be supplied complete with its own standalone control system. The PUW storage and distribution will be controlled by a separate Utilities/QBMS PLC. The PLC will also monitor room environmental conditions (Temperature, Relative Humidity and Pressure). The utilities PLC will also control and monitor the internal and external waste storage tanks. The API area PLC and the Utilities PLC shall share a SCADA system.

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Attachment C · 2017-07-18 · Position: Engineering Director Experience: Over twenty years...

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Transcript of Attachment C · 2017-07-18 · Position: Engineering Director Experience: Over twenty years...