Pfizer Biotechnology Ireland - Environmental Protection · PDF file2010 was the first full...

Pfizer Biotechnology Ireland

2010 Annual Environmental Report

Integrated Pollution Prevention Control License

P0864-01

1

Executive Summary: 2010 was the first full year of operation for Pfizer Biotechnology Ireland at

Shanbally having commenced operations under IPPC P0864-01 in June

2009.

The facility is designed to use the Monoclonal antibody (Mabs) platform for

the production of Phase II and Phase III Clinical Trial medicinal products

The Environmental Management System is based on the ISO 14001 model

and had been scheduled for certification; however the announcement in May

2010 that the facility would be divested from Pfizer in 2011 put this plan on

hold.

The facility was constructed using Pfizer’s ‘Green Building’ design philosophy

and having secured the sustainability award of the ISPE in 2009 the data

enclosed demonstrates that very significant further progress was

accomplished in terms of resource conservation.

The Environmental Management Programme (EMP) outlined in this report will

demonstrate a focus on improved environmental performance, specifically in

the areas of water, energy and resource conservation. A phased plan has

been implemented geared towards continuous improvement in all business

areas not least of which is those areas of the sites which may have an

environmental impact.

Continuous improvement is a core principle of the facility and this is

demonstrated in the 2010 achievements and the 2011 plan.

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Contents

1. Introduction 4 1.1 General 4

1.2 Facility Overview 5 1.3 Organisation Chart for Environmental Management 13

1.4 Water Emissions Monitoring Data 14

1.5 Air Emissions Monitoring Data 15

1.6 IPPC Licence Compliance 15 1.7 Noise Survey 18

1.8 Waste Arisings 19

1.9 Resource Utilisation 24

1.10 Environmental Incidents and Complaints 25 1.11 Genetically Modified Micro-Organisms 25

2. Management of the Activity 26 2.1 Introduction

2.2 Status Report on Schedule of Objectives and Targets (2009)

2.3 Environmental Management Plan 2009

3. Pollution Release and Transfer Register (PRTR) 39

4. Bund Integrity Assessment Report 39 5. Tank and Pipeline Testing and Inspection 39 6. Environmental liabilities and Residual Management 39 7. Licence Specific Reports 41 Attachment I – Environmental, Health and Safety Policy 42

Attachment II - Energy Management audit 43

Attachment III – Site Noise Survey 64

Attachment IV – Solvent Management Programme 92

Attachment V – PRTR: Pollution Release and Transfer Register 98

3

1. Introduction 1.1 General At the Shanbally Biotechnology facility the responsibility for Environmental

Compliance and IPPC management rests with the Engineering and EHS

Team, where the specific Environment Health and Safety responsibilities

reside with the EHS Lead.

Through 2010 as demonstrated in the Environmental Management

Programme, efforts focused on embedding the EMS and optimising

compliance controls.

The announcement of the site divestiture in the first half of the year did divert

resources midway through the year as focus was required to change towards

the completion of an Environmental Due Diligence report in support of the site

sale effort.

1.2 Facility Overview 1.2.1 Introduction The Pfizer Monoclonal Antibodies (MAbs) facility was constructed at

Shanbally, Ringaskiddy, County Cork, for the manufacture of Phase II &

Phase III Drug Substance candidate therapies.

The clinical trial and initial product launch facility is designed to manufacture,

purify, formulate and bulk fill mammalian cell culture derived proteins. These

will form the Active Pharmaceutical Ingredient (API) in products intended for

human use. The facility includes two 2500 litre production bioreactors. In

addition, the facility includes a warehouse in which the raw material and

finished goods will be stored, Quality Control and Process Science

Laboratories and Administration areas.

The facility operates on the site formerly occupied by the ADM (Archer

Daniels Midland) plant, which closed in 2006 and as part of the divestiture of

4

this site - ADM surrendered its IPC license. During this process an audit of the

site was conducted by the EPA to verify that all the required terms of the

decommissioning and demolition met the agreed DMP (Decommissioning

Management Plan) criteria and the license surrender was accepted on that

basis.

1.2.2 The Installation and Its Activities 1.2.2.1 Overview The facility comprises of a main building and a guard house. The main

building has five main areas:

• Production area,

• Warehouse,

• Laboratory/office area,

• Utility area (or Central Utility Plant),

• Plant mechanical area.

The production area is predominantly on the second floor of the three storey

central part of the building. The central utilities plant is be located on the

ground floor of the central block. The engineering support facilities are located

on the ground floor and lower mezzanine in the central block and also the

plant mechanical area is located on the top floor of the central block.

The warehouse is in the Western annex to the main building. The main

storage areas are located in the single storey annex with ancillary facilities

such as sampling, gowning and freezers on the ground floor of a two storey

section, with mechanical services on the first floor.

The laboratories & offices are located in the two-storey Southern section of

the main building. The staff support facilities (i.e. canteen, locker rooms,

hygiene etc.) are located on the ground floor.

Retained from the previous operations on Site were tanks from the old aerobic

Waste Water Treatment Plant – one of which now serves as the diversion

tank for Storm Water emission limit value exceedances. The large storage

5

facility and portakabin complex which served as the base for the construction

and commissioning activities, through mid 2010 have been retained.

1.2.2.2 Production Area The production area processes include innoculum lab, cell culture, purification

and process support functions. Cell culture includes seed bioreactors,

production bioreactors, and recovery / harvest unit operations. Purification

includes buffer hold, purification, formulation and bulk fill. The Process

Support areas include the dispensary and parts wash, as well as media and

buffer preparation areas.

1.2.2.3 Warehouse Raw materials and finished goods are stored in the warehouse. Separate

Cold Rooms, Fridges and Freezers are provided for storage of raw material

and finished products. Secured access controlled Cell Bank storage is also

included in the warehouse.

A material sampling (Quality Control Inspection) area is provided in the

warehouse for material inspection and sampling. Separate dispensing areas

are provided for handling buffer and media solutions at large volumes. A kit

staging area is also provided.

Spare parts are stored predominantly in the engineering & maintenance

storage area.

Fork trucks, pallet trucks and drum handling equipment and lifts are utilised

for materials management. Predominantly the raw materials are received in

drums, subdivided into containment bags and charging canisters.

6

1.2.2.4 Laboratory/Office The laboratories are situated on the second level of the

Laboratory/Administration area. These house the laboratory facilities for two

separate functions:

o Quality Control Laboratory

o Process Sciences Laboratory.

Quality Control Laboratory

The Quality Control laboratory will carry out the following functions:

o Raw Material Testing

o In-Process Control Testing

o Final Drug Substance Testing

o Microbiological Testing

o Drug Product Testing

o Stability testing

The Quality Control Laboratory contains a range of analytical equipment to

enable the perquisite range of testing to be carried out on site. The separate

laboratories and support areas and their functions within Quality Control are

as follows:

o General Laboratory,

o Two Microbiology Laboratories,

o Stability Laboratory,

o Support rooms such as wash up area, sample receipt,

autoclave and steriliser room, chemical store, document store,

and meeting rooms. These are shared with Technical Services.

Process Sciences Laboratory

The Process Sciences Laboratory carries out the following functions:

o Process characterisation work on new products

o Process optimisation work

o Plant support

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o Raw material use tests

o Process validation support

o Working cell Bank Storage

The Process Sciences Laboratory is divided into Upstream and Downstream

Processing areas. The Upstream area uses wave reactors and laboratory

scale bioreactors to mimic the Upstream Plant processes. These are used for

process characterisation work, raw material evaluations, support of plant trials

and plant process investigations and process validation studies.

The Downstream area houses chromatography and filtration equipment to

mimic the Downstream Plant processes and is used for similar activities,

studies and investigations as the Upstream area.

The Quality Control and Process Sciences Laboratories are fitted with fume

hoods, biosafety cabinets, refrigerators, freezers, incubators and are supplied

with high quality water, gases and other services / utilities for a fully

functioning laboratory.

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1.2.2.5 Utility Area (or Central Utility Plant) The central utility plant (internal area) contains the Water-for-Injection

generation and storage, Reduced Ion Water generation and storage, clean

steam generation, biowaste inactivation, process waste water pre-treatment

(equalisation, neutralisation), plant steam boiler, heating ventilation and air

conditioning chillers, process chiller, the compressed air system, clean-in-

place systems and temperature control modules associated with the process

vessels.

Externally are located cooling towers and pumps, utility water tank and

pumps, bulk gas storage (carbon dioxide and oxygen), chemical treatment

systems, laboratory gases (bottles), emergency generator (with integral fuel

oil storage tank) and rotary uninterruptible power supply system (UPS).

1.2.2.6 Plant Mechanical Area The plant mechanical area holds the Air Handling Units (AHU’s) and HVAC

hot water system.

1.2.2.7 Guard House There is a guard house adjacent to the main gate, which is manned by

Security 24/7. All visitors, deliveries etc. to the facility are required to report to

the guard house on arrival.

1.2.2.8 Working Hours Flexible work patterns are employed in the operation of the facility, which can

extend to 24 hour 7 day per week activity, depending on production

schedules.

1.2.2.9 Production Process The Pfizer MAbs Biotechnology Facility employs well characterised

genetically modified mammalian cell cultures in order to produce therapeutic

proteins. These well defined cell lines have a long history of over two decades

of safe use in large-scale production operations.

9

Cell Culture is designed according to Biosafety Level 1 - Large Scale (BL1-

LS) per the United States National Institute of Health (NIH) guidelines and

meets the requirements of Containment Level 2 (CL2) per European Union

Council Directive 98/81/EC (26 October 1998). The facility is currently

licensed for the contained use of Class 1 GMM’s, as per GMO Permit Number

G-0299-01.

The liquid biowaste from manufacturing is inactivated prior to being combined

with the process effluent waste. The combined waste streams are then pH

neutralised (pH 6-9) prior to discharging to the adjacent Pfizer Ringaskiddy

API plant for further treatment (aerobic).

Cell Culture The cell lines are stored in a cell bank from where the cells are transported to

the inoculation preparation laboratory located in the cell culture suite, and

thawed. The cells are then combined with appropriate media and put under

the necessary physical conditions for cell growth. The cells are passed

through a series of flasks and then into Wave Biotech cell culture bags

ranging in size from 250ml to 2L to 20L to 100L and finally transferred to a

500L seed bioreactor. The final cell culture stage is performed in a 2500L

production bioreactor. The production bioreactor is inoculated (with product

from the 500L seed bioreactor) and maintained at desired backpressure,

temperature, agitation, pH, and air flow/dissolved oxygen, generally for

approximately two week cell culture cycle. The raw cell culture broth is the

product of this operation, and contains media components, cell mass, host

cell protein and other by-products.

The bioreactors are cleaned between batches with dilute solutions of clean-in-

place materials. After cleaning each bioreactor in turn they are sterilised in

place with clean steam. The bioreactors are then ready to be filled with media

for the next cell culture operation.

All cell based operations are carried out in closed equipment and before any

cell containing equipment is opened, either chemical or thermal inactivation of

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the cells is carried out to prevent operator contact or other release to the

general production area.

Cell Culture Harvest The product is harvested from the raw cell culture broth by passing through a

centrifugation step, followed by several stages of filtration which remove cell

mass and produce a clarified harvest broth which contains the desired product

protein. For each batch, the filter system is thermally inactivated (with clean

steam) prior to change-out of the (containment) filter cartridges and the

system is cleaned between batches with clean-in-place solutions and rinsed

with water. After each clarification, the depth filter cartridges are inactivated

and disposed of as solid waste.

.

Purification Operations The purification process takes the clarified harvest broth and passes it

through viral inactivation, chromatography purification steps, ultrafiltration and

viral removal to remove unwanted components and produce the final product

to the required specification.

Final Fill and Bulk freezing Formulation solution is then added to the concentrated product. The bulk-

purified, formulated protein is filled into bags, and frozen and stored at

-40 degrees Celsius.

The bulk product is then sent to a sister Pfizer Aseptic Production Plant for

formulation into the final product.

Waste Management Liquid waste which could potentially contain genetically modified micro-

organisms material will, depending on the quantities, either be routed to the

biological waste heat inactivation system or to the decontamination

autoclaves.

All solid material which could potentially be contaminated with genetically

modified micro-organisms will be either chemically or thermally pre-treated

11

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on-site to ensure deactivation prior to disposal as non-hazardous waste off-

site, or sealed in double bags and placed in biowaste sealed containers and

sent for disposal by incineration.

1.2.2.10 Plant utilities The following plant utilities are in place:

o Potable Water,

o Domestic Water,

o Compressed Air Generation,

o Process and Instrument Air,

o Process Chilled Glycol,

o HVAC Chilled Water,

o HVAC Heating Hot Water,

o Cooling Tower Water,

o Plant Steam and Condensate,

o Natural Gas.

o Clean utilities in the facility will include:

o Reduced Ion Water (RIW),

o Water-for-Injection (WFI),

o Clean Steam (CS),

o Clean Condensate,

o Clean Air,

o Clean-in-Place (CIP),

o Oxygen,

o Carbon Dioxide,

o Liquid Nitrogen.

1.3 Organisational Chart for Environmental Management ,

Site Leader

Engineering & EHS

Team Leader

Finance/Supply Chain

Team Leader

General Administration

Production Team Leader

Tech. Serv. Team Leader

RFT Team Leader HR Team Leader Quality Team Leader

Maintenance/

Utility Lead EHS Lead

EHS Specialists (2)

ENG/ EHS Administration

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1.4 Water Emissions Monitoring Data

1.4.1 EMISSIONS TO SEWER

Emissions to Sewer Overview:

The facility does not have a standalone waste water treatment plant but

instead equalises and neutralises process effluents in accordance with IPPC

license P-0864-01, for aerobic treatment at the adjacent Pfizer Ringaskiddy

(API) Waste Water Treatment Plant. Procedures and a close working

relationship are in place to ensure no negative impact on the

The IPPC license stipulates emission limit values of 240m³ of process waste

water may be transferred daily to the Ringaskiddy facility and a maximum of

1000kg of COD.

Table 1.4

Parameter

Mean (Daily)

Limit (Daily)

Emission (per Annum)

Flow (m³) 87.1 240 31,688

COD (kg) 26.1 1000 9,474.4

N (kg) 0.65 n/a 236

P (kg) 0.46* n/a 166.8*

BOD (kg) 14.7* n/a 5,357.3*

Note* Estimate based on weekly sampling

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It is readily evident from the above flow and COD data that the process norms

are within the permissible levels as defined in the IPPC license.

Warning and action limits established have been maintained for the emission

limit values as per IPPC License, so as to ensure that the forward feeding of

process waste water ceases prior to any Emission Limit value being

approached and that the Wastewater Treatment System goes into a

recirculation mode, with correction in the case of pH and plant stoppage in the

case of where a potential COD or flow exceedance was imminent.

1.4.2 EMISSIONS TO SURFACE WATERS

Interpretation of Surface Water Data

Continuous monitoring of discharges to Surface Waters is provided by the

online TOC & pH analysers, located at the outfall analysing station. This data,

along with the daily visual inspections, indicates that there was no

contamination of surface water during the AER reporting period and no

diversions due to pH or TOC excursions to the facility firewater diversion

collection tank occurred.

1.5 Air Emissions Monitoring Data IPPC License P0862-01 places no specific air monitoring requirements on the

facility at this time and hence has no air emissions monitoring data was

generated for this reporting period.

1.6 IPPC Licence Compliance There were no exceedances of any of the prescribed emission limit values

during the reporting period. The site had established both warning and action

limits around its discharge parameters, and this has ensured compliance.

15

There were 4 unannounced visits by Environmental Protection Agency

personnel for the purpose of collecting process effluent and storm water

samples. All results were well within the permissible emission limit values.

There was one announced inspection by the EPA which focused on the sites

GMO permit G-0299-01. No non conformances were noted.

Figure 1 Process Effluent Volume Discharge Compliance

Flow Compliance Data2010

0

20

40

60

80

100

120

140

160

180

200

03-D

ec-09

22-Ja

n-10

13-M

ar-10

02-M

ay-10

21-Ju

n-10

10-A

ug-10

29-S

ep-10

18-N

ov-10

07-Ja

n-11

26-Feb

-11

Day

m3

509

Operating Limit 200m3/DayLicense Limit 240 m3/day

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Figure 2 Process Effluent COD Compliance

COD Compliance Data2010

0.00

50.00

100.00

150.00

200.00

250.00

300.00

03/12

/09

22/01

/10

13/03

/10

02/05

/10

21/06

/10

10/08

/10

29/09

/10

18/11

/10

07/01

/11

Day

CO

D K

g/D

ay

Series1

Operating Limit 500 Kg/DayLicense Limit 1000 Kg/Day

Figure 3 Process Effluent pH Compliance

pH Compliance Data2010

6.0

6.5

7.0

7.5

8.0

8.5

03-D

ec-09

22-Ja

n-10

13-M

ar-10

02-M

ay-10

21-Ju

n-10

10-A

ug-10

29-S

ep-10

18-N

ov-10

07-Ja

n-11

Day

pH

pH

Operating Limits pH 6.5 - 8.5License Limits pH 6.0 - 9.0

17

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1.7 Noise Survey

SUMMARY

Day and night-time noise monitoring was carried out in accordance with IPPC Licence P0864-01. Both the daytime and night-time noise levels measured at the site boundary monitoring positions were within the respective limits of 55dB LAeq during the daytime and 45 dB LAeq during the night-time. While daytime ambient noise levels in excess of the IPPC licence limit values were measured during the course of the surveys at noise sensitive locations NSL1, NSL2, NSL3, NSL5, NSL6 and NSL7, the findings of the noise surveys were that the noise levels were neither dominated nor significantly influenced by noise emissions from the Pfizer Biotechnology facility. Similarly, whereas night-time ambient noise levels in excess of the IPPC licence limit values were measured at noise sensitive locations NSL1 and NSL6, the measured noise levels were primarily attributable to passing traffic noise on the N28 and R610 at the respective monitoring points.

1.8 Waste Arisings: 1.8.1 Annual waste arising for 2009 is summarized in the attached Tables. Records for hazardous waste shipments sent off-site

including waste contractor documentation. C1 Consignment forms are held on site and are available for viewing.

19

Waste Description

EWC Code

QuantityMT/year

Haulier/ Broker Further Treatment (Method, Location & Undertaker)

Recovery,reuse or recycling (Method, Location &Undertaker)

Final Disposal(Method, Location & Undertaker)

Medical/ Sharps/ Bio Hazardous Waste

18 01 03*

0.02

SRCL W0054-02

SRCL W0054-02 [D9] 520 Beech Rd Western Ind. Est. D 12W0054-02n/a

n/a

Greenstar Landfill, Ballynagran, W 0165-02, Ballynagran, Co Wicklow

Empty Containers 15 01 10* 1.89 Veolia ES Technical Solutions, W0050-02 Corrin, Fermoy, Cork, Ireland

n/a

n/a

Sava,A 51 G00 508 [D10] A 51 V00605 [R1] ,Osterwete 1,.,Brunsbuttel,D- 25541,Germany

Chemically Contaminated Process Waste. Sodium Hydroxide

07 05 13* 5.528 Veolia ES Technical Solutions, W0050-02 Corrin, Fermoy, Cork, Ireland

n/a

n/a


Chemically Contaminated Process Waste. Sodium Hydroxide


n/a

n/a

Veolia Environmental Services, AG 8233, Briges Rd Ellesmere Port, Cheshire L65 4EQ, United Kingdom

Chemically Contaminated Process Waste. Isopropyl Alcohol


n/a

n/a


Antifoam, Oils 07 05 04* 1.797 Veolia ES Technical Solutions, W0050-02 Corrin, Fermoy, Cork, Ireland

n/a

Veolia Blending Plant. W0052-02 Corrin, Fermoy, Cork,

n/a

20

Waste Description

EWC Code

QuantityMT/year


Recovery,reuse or recycling (Method, Location &Undertaker)

Final Disposal(Method, Location & Undertaker)

Solvents 07 05 04* 0.425 Veolia Environmental Services Technical Solutions

n/a

n/a


Waste/Expired Inorganics,


n/a n/a Sava,A 51 G00 508 [D10] A 51 V00605 [R1] ,Osterwete 1,.,Brunsbuttel,D- 25541,Germany

Waste/Spent Sanitization Agents


n/a

n/a


Corrosive Waste – Acidic Sulphuric and Acetic Acid


n/a

n/a


Inks & Toner 08 03 18 0.373 Veolia ES Technical Solutions, W0050-02 Corrin, Fermoy, Cork, Ireland

n/a

Source Imaging [R13] WP 124/06. Unit 2 Banagher Enterprise Centre, Offaly

Waste Electrical Electronic Equipment (WEEE)

07 01 04* 0.2 KMK W0113/03 n/a KMK,W0113-03, [R4]Cappincur Industrial Estate, Daingean Road, Tullamore,

21

Waste Description

EWC Code Quantity MT/year


Recovery, reuse or recycling (Method, Location & Undertaker)

Final Disposal (Method, Location & Undertaker)

Paper & Cardboard

20 01 01 17.73

Greenstar Environmental Services W0173-01 Forge Hill, Cork

n/a

R13 Veolia Environmental Services W0173-01.Forge Hill, Cork [R13]

General Waste 20 03 01 .3 Veolia Environmental Services W0173-01 Forge Hill, Cork

n/a n/a East Galway Landfill, Galway. [D1] W0178-01

Timber 20 01 38 20.58 Veolia Environmental Services W0173-01 Forge Hill, Cork

n/a Veolia Environmental Services W0173-01.Forge Hill, Cork [R13]

Metal 17 04 05 14.38 Cork Metal WCP LK -08-589-01

n/a Cork Metal, Dublin Hill Cork WCP LK -08-589-01 [R4]

Glass 20 01 02 3.83 Rehab Recycling 08/04 Reg.WMC.146/03

n/a Rehab Recycling Partnership [R13] Monaghan Rd. Cork

22

23

Waste Description

EWC Code Quantity MT/year

Haulier/ Broker

Further Treatment (Method, Location & Undertaker)

Recovery, reuse or recycling (Method, Location & Undertaker)

Final Disposal (Method, Location & Undertaker)

Plastic Packaging and containers

20 01 39 2.96

Veolia Environmental Services W0173-01 Forge Hill, Cork

Veolia Environmental Services W0173-01.Forge Hill, Cork [R13]

Process waste water

16 10 02 26,223 n/a Pfizer Ringaskiddy API IPPC License P0013-04 [D8]

Pfizer Ringaskiddy API IPPC License P0013-04 [D7]


16 02 14 0.276 KMK W0113-03

KMK,W0113-03, [R4]Cappincur Industrial Estate ,Daingean Road, Tullamore, Offaly ,Ireland


16 02 16 0.02 KMK W0113-03

KMK,W0113-03, [R4]Cappincur Industrial Estate ,Daingean Road, Tullamore, Offaly ,Ireland

24

1.9 Resource Utilisation 1.9.1 Resource Utilization Summary:

The resource summary below details the quantities of Electricity, Natural Gas and

water that the facility consumed during 2009. During much of this period the facility

was under construction and in the process of non routine commissioning activities, so

these figures cannot be considered as indicative of those that would be consumed

during routine manufacturing.

Resource Utilization Units

Electricity 5539.6 MW hr

Natural Gas 4936.7 MW hr

Water 44,382 M³

Substantial resources and technology were applied to the design and installation of

the Utility infrastructure for the site and this was key to the sustainability award

received by the site.

25

1.10 Environmental Incidents and Complaints No complaints were received as a result of the onsite activities during this reporting

period.

An event took place on July 25th, which involved the loss of a single (non hazardous)

general refuse sack, which contained paper towels, from our dedicated waste

contractors vehicle in the vicinity of Rafeen Cross (on the N28). As soon as the site

was notified of this, site personnel were dispatched to retrieve the non hazardous

refuse sack for proper disposal.

The Agency was informed on the day of the discovery of this occurrence

Corrective actions were implemented with the Contractor involved in order to ensure

there was no reoccurrence.

1.11 GMM (GENETIC MODIFIED MICROORGANISM) EPA CONSENT

The facility was granted a First time Contained Use Permit for the use of Class 1 GMM

in October 2008 (G0299-01). The necessary control systems have been put in place in

order to comply with all requirements of this permit.

26

2. Management of the Activity 2.1 Introduction An environmental management plan has been established for the site in accordance

with the IPPC license and this is based on the ISO 14001 standard.

27

2.2 Status Report on Schedule of Objectives and Targets (January – December 2010) Pfizer Shanbally Environmental Management Programme December 2010 (Incorporating targets and objectives) Aspect No. 1: Emissions to Surface WatersObjective Target Action Status Optimising surface water discharge controls

1.1

Set Action and Warning limits for TOC and pH on Surface water Discharge

1. Collate for 6 Months. 2. Complete statistical

analysis 3. Submit proposed Action

and Warning levels to Agency for approval.

4. Once Limits are approved update control parameters on Surface Water SCADA Control System

5. Update Standard Operating procedure EHS-10-3026

Complete

1.2

Complete an ERT (Emergency Response Team) drill involving a scenario where there is a release to surface water

1. Define the drill scenario and schedule the group to action the drill. 2. Monitor the response of the ERT personnel. 3. Optimise process based on outcome of drill (i.e. Update ERT training and/or procedures as necessary)

Complete

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Aspect No. 2: Emissions to Process Sewer/Waste Water Objective Target Action Status Quantify Process Wastewater Baseline data and Assess changes/ abnormal events

2.1

Determine baseline for Process effluent during normal operations.

1. Collate and trend weekly and Monthly analytical data.

Complete

2.2

Develop system for tracking and Monitoring Waste Discharges.

1. Production operations to report non routine (e.g. ‘Buffer hold’) discharges to Engineering-EHS 2. Put formal system in place to manage & approve non-routine discharges

Complete

29

Aspect No. 3: Noise Emissions Objective Target Action Status Establish Baseline Noise data for site boundary

3.1

Determine boundary noise 1. Select suitable monitoring locations.

2. Seek Agency approval

Complete Complete

3.2

Conduct Noise Survey Execute noise survey in accordance with requirements

Monitoring complete & repeated annually

Complete

30

Aspect No. 6: Hazardous waste generation and DisposalObjective Target Action Status6 (a) Hazardous Waste Control

6.1

Optimise waste segregation practices on-site

2. Implement internal waste auditing programme

CompleteOngoing continuous improvement programme in place

Q3 2011

6.2

Ensure that only audited waste contractors are engaged for Waste Management activities

1 Review facilities engaged versus approved database.

Complete

6 (b)Hazardous waste reduction Programme

6.3 Review hazardous waste classifications (secondary contaminated) in order to ensure non-hazardous waste fractions can be excluded from hazardous classification.

1. Conduct classification for the following waste streams: - o Cleaning Materials o Secondary Contaminated Chemical Waste from Production (Media Prep, Buffer Prep, Purification, Cell Culture), And Warehouse 2. Revise SOPs for any revisions to classifications for operations personnel

Complete

6.4 Generate hazardous waste quantitative baseline

1. Collate and trend all hazardous waste types and quantities

Complete

6.5 Assess opportunities to reduce, reuse and recycle

1. Implement reduction measures in line with Objective 6.2 and 6.4. 2. Use baseline obtained in Objective 6.4 to set quantifiable targets


Q3 2011

31

Aspect No. 7: Non Hazardous waste Generation Recovery/DisposalObjective Target Action Status Non-Hazardous Waste Reduction Programme

7.1

Optimise non-hazardous waste segregation

1. Install baler for cardboard and plastics


Q3 2011

7.2

Optimise non-hazardous waste segregation

2. Optimise design of non-hazardous waste handling area to improve logistics and segregation on-site

Ongoing:5S system being applied to the Waste management Area

Q3 2011

7.3 Generate non-hazardous waste quantitative baseline

1. Collate and trend all nonhazardous waste types and quantities.

Compete


1. Use baseline obtained in Objective 7.3 to set quantifiable Targets

Compete

7.5

Establish Site recycling team

Nominate Team members Incorporated into Energy/Resource Team - Complete

32

Aspect No. 8: Water Usage and ConservationObjective Target Action Status Water Conservation and use Reduction

8.1

Verify water flow meters and totalisers

1. Calibrate Flow meters. Complete

8.2

Generate Site wide map of water usage and discharge

1.Map Process Water distribution points and downstream user points within buildings (i.e. RIW and WFI) 2. Collate all information from water usage data gathering and build within overall site map.

Complete

8.3 Achieve full optimisation of water usage across the site

1. Optimise Utility RIW regeneration rates

Complete

8.4 Evaluate water re-use projects

1. Investigate RIW Reuse opportunity – e.g. cooling Tower make up. 2. Implement opportunities for reuse as highlighted by the Site water use map


Q3 2011

33

Aspect No. 10: Raw Materials Objective Target Action StatusIdentification of Reduction Fugitive Emissions

10.1

Monitor and target reduction in fugitive emissions from solvent use on site

Identify areas and operations where pre-prepared IPA wipes can be used for the purpose of sanitizing equipment and surfaces

ongoing Q3 2011

34

Aspect No. 11: EnergyObjective Target Action Status Energy Use Reduction and Efficiency

10.1

Create energy policy for the Site

1. Write energy policy for the Site 2. Get approval from the SST

Complete

10.2

Implement Site Energy Team

1. Establish a Site Wide energy team with representation from engineering, operations and purchasing 2. Establish project charter and team goals

Complete

10.3

Complete Energy Audit

1. Determine the nature and extent of the Energy Audit 2. Complete the audit

Complete

10.4

Review design and energy efficiency

1. Review energy design intent of major utility systems and energy efficient design features. 2. Review actual performance of energy efficient design and major utility systems


Q3 2011-

10.5

Record and measure energy usage

1. Set up a system to enable natural gas and electricity usage to be trended. 2. Trend usage and profile significant energy users.


Q3 2011-

10.6

Initiate Energy Awareness Programme

1. Site Energy Team to develop an energy awareness programme so that the Site personnel take ownership.

Complete. Ongoing Resource Conservation Awareness initiatives in place.

Q2 2011-

10.7

Energy Reduction and Efficiency.

1. Identify key targets to be achieved over the next 3 years.

Ongoing Q2 2012

35

2.3 Environmental Management Plan 2010 1.0 To Improve environmental management on site Objective No Target Plan Responsibility Status1.1 Training and Awareness 1. Develop and roll our

further environmental awareness programme

EHS Specialist Ongoing

1.2 ISO 14001:2004 Certification 1. Further align EHS management systems with standard requirements. 2. Evaluate time line & future plan for site certification

EHS Lead Further progression deferred due to site divestiture.

2.0 To reduce waste generation on site

Objective No Target Plan Responsibility Status2.1 Optimise non-hazardous waste

segregation 1. Optimise design of non-hazardous waste handling area to improve logistics and segregation on-site

Ongoing: 5S system being applied to the Waste Management Area

Q3 2011

2.2

Assess opportunities to reduce, reuse and recycle.

1. Use baseline obtained in Quantifiable Targets

Ongoing – working with TWM vendor to progress identified opportunities

Q3 2011

36

3.0 To reduce water consumption Objective No Target Plan Responsibility Status3.1 Generate Site wide map of

water usage and discharge 1. Map Process Water distribution points and downstream user points within buildings (i.e. RIW and WFI) 2. Collate all information from water usage data gathered and build within overall site map.

Energy Team/ Energy Lead

Complete

3.2 Implement water use reduction based on findings of 3.1

1. Optimise CIP water usage on key vessels


Ongoing, potential reductions identified

3.3 Evaluate water re-use projects 1. Investigate RIW Reuse opportunity – e.g. cooling Tower make up. 2. Implement opportunities for reuse as highlighted by the Site water use map


Q1 2011

37

4.0 To increase waste recovery and recycling: Objective No Target Plan Responsibility Status4.1 Optimise waste segregation

practices on-site 1. Implement internal waste auditing programme

EHS Specialist Ongoing

4.2 Review hazardous waste classifications (secondary contaminated) in order to ensure non-hazardous waste elements are be excluded from hazardous streams.

1. Conduct classification for the following waste streams: - o Cleaning Materials o Secondary Contaminated Chemical Waste from Production (Media Prep, Buffer Prep, Purification, Cell Culture), and Warehouse

EHS Specialist Q3 2011


1. Implement reduction measures in line with Objective 4.1 and 4.2

EHS Specialist Q3 2011

38

5.0 To improve energy and utility efficiency Objective No Target Plan Responsibility Status5.1 Review design and

energy efficiency

Review actual performance of energy efficient design and major utility systems.

Energy Team/ Energy lead

Q3 2011-

5.2 Record and measure energy usage

Trend usage and profile significant energy users

Energy Lead Ongoing.

5.3 Initiate Energy Awareness Programme

1 Organise Energy Awareness day 2. Site Energy Team to develop an energy awareness programme so that the Site personnel take ownership


Scheduled May 2011

5.4 Energy Reduction and Efficiency.

1. Identify key targets to be achieved over the next 3 years


Q4 2012

5.5 Drive Carbon Footprint Reduction Use Monitoring and Targeting software package to target reduction opportunities


Q3 2011

3. Pollution Release and Transfer Register (PRTR)

The Pollution Release and Transfer Register for the facility has been uploaded

electronically to the Electronic reporting workbook and a copy is attached at

the end of this report. (See attachment 5)

4. Materials Storage

All structures required to retain liquid from spills leaks etc., were tested as part

of the facility construction and commissioning through 2008 and 2009. There

was no requirement for testing other structures in 2010.

Three new prefabricated bunded chemical storage units were installed in the

past year to facilitate safer and more ergonomical chemical storage

for waste water treatment and clean in place (CIP) chemical storage and

dispensing appropriate meet the additional

The certification for these units is available upon request.

5. Pipeline Testing and Inspection

The specified pipelines required were tested as part of the facility construction

and commissioning, and passed the required standard.

The Test packs for the above were included in the 2009 AER

6. Environmental liabilities and Residual Management

Pfizer Global Environmental, Health and Safety have established procedures in

relation to Acquisition and Divesture of Real Property. These procedures will

apply at the Pfizer MAbs SSF site. Pfizer Biotechnology Ireland’s responsibility

is to ensure that any business divesture involving real property is preceded by

39

an environmental due-diligence investigation to assess and quantify potential

environmental liabilities associated with the transaction.

This Environmental Liability Risk Assessment (ELRA) for the Pfizer

Monoclonal Antibodies (MAbs) Facility constructed at Shanbally, Ringaskiddy,

Co. Cork has been undertaken in accordance with the methodology outlined in

the EPA Guidance Document.

Environmental risks associated with the operation of the plant were identified

with reference to the Environmental Impact Statement for the facility and

Process Hazard Reviews carried out for the plant. Likelihood and severity

factors were assigned to the risks in order to determine the extent of the

potential liability from unplanned events impacting on the environment.

This Environmental Liabilities Risk Assessment report was included as an

appendix in the 2009 report.

In general, the risk associated with abnormal activities on-site is considered to

be acceptable and therefore the environmental liability costs would be covered

by Pfizer’s public liability insurance

The Decommissioning Management Plan (DMP) was prepared to comply

with Condition 10 of Pfizer Biotechnology Ireland’s IPPC licence – P0894-01. In

particular, the Plan has been developed to satisfy the following sub-clauses -

10.2 and 10.3 of Condition 10.

In accordance with the EPA Guidance on Environmental Liability Risk

Assessment, Residuals Management Plans and Financial Provision (EPA

2006), the risk classification tool was used, and the Screening and Operational

Risk Assessment is included as Attachment 7 to this report. The Assessment

found that the site has a risk category of 2, and therefore a residuals

management plan is not required.

This report was reviewed as an element of the 2010 annual environmental

review and found to contain sufficient provision in relation to the biotechnology

manufacturing facility.

40

7. Licence Specific Report Attachment 1 – Environmental, Health and Safety Policy

Attachment 2 - Energy Management audit

Attachment 3 – Environmental Noise Survey

Attachment 4– Solvent Management Plan

Attachment 5- PRTR: Pollution Release and Transfer Register

41

Attachment I – Shanbally Environmental, Health & Safety Policy

42

Attachment II - Energy Management Audit ` Pfizer Shanbally 2010 Energy Report

43

Contents EXECUTIVE SUMMARY ............................................................................................... 45 INTRODUCTION ............................................................................................................. 46

Electrical Consumption 2010 .............................................................................................. 47 NATURAL GAS CONSUMPTION 2010 ..................................................................... 48 WATER CONSUMPTION 2010 ................................................................................... 48 ELECTRICAL ENERGY USAGE SPLIT SHANBALLY ......................................... 49

Utilities ................................................................................................................................ 49 Hvac .................................................................................................................................... 49 Process Equipment .............................................................................................................. 49 Freezers ............................................................................................................................... 49 Lighting ............................................................................................................................... 49 UPS Generator Flywheel system ......................................................................................... 49 Lab Autoclaves and Washers .............................................................................................. 50 Low voltage loads ............................................................................................................... 50

NATURAL GAS ENERGY USAGE SPLIT SHANBALLY....................................... 51 Hot Water Boiler ................................................................................................................. 51 Cell Culture ......................................................................................................................... 52 Cip System .......................................................................................................................... 52 Glass washers ...................................................................................................................... 52 Autoclaves ........................................................................................................................... 52 WFI Loop Heater ................................................................................................................ 52 Bio Inactivation ................................................................................................................... 53 WFI Generation ................................................................................................................... 53 Clean Steam ......................................................................................................................... 53 Steam Trapping ................................................................................................................... 53

POTABLE WATER USAGE SPLIT SHANBALLY .................................................. 54 RIW water generation. ........................................................................................................ 54 Cooling tower Cooling Load ............................................................................................... 54 Steam Make-up Water Usage .............................................................................................. 54 Autoclaves and Washers ..................................................................................................... 54 Site potable water usage ...................................................................................................... 54

CO2 EMISSIONS 2010 SHANBALLY ......................................................................... 55 ISPE FACILITY OF THE YEAR AWARD FOR SUSTAINABILITY .................... 56

Green Building and Low energy systems ........................................................................... 56 Use of Existing Assets ......................................................................................................... 56 Recycling and Energy Initiatives ........................................................................................ 56 Variable Frequency Drives .................................................................................................. 57 HVAC .................................................................................................................................. 57 Lighting ............................................................................................................................... 58

PROJECTS COMPLETED 2010 .................................................................................. 59 Optimise Cooling tower flow-rate ....................................................................................... 59 Shutdown Burco Boilers in silent hours .............................................................................. 59 Optimise AHU 301,302 weekly and at Weekends .............................................................. 59 Optimise AHU 303 .............................................................................................................. 59 RIW Concentrate recovery .................................................................................................. 59 Rebalance Glycol Recirc loop ............................................................................................. 59 Complete QRM ON LAB AHU 306 ................................................................................... 60 Feed cooling tower direct from mains supply ..................................................................... 60 Optimise lighting lighting controls in facility ..................................................................... 60

44

Fit VSD to HVAC extract system on Main Lab ................................................................. 60 ENERGY MANAGEMENT........................................................................................... 61 OPPORTUNITIES FOR ENERGY SAVING 2011 ..................................................... 62

WFI sanitisation water recovery ......................................................................................... 62 Warehouse AHU optimisation ............................................................................................ 62 AHU 307 Optimisation ....................................................................................................... 62 AHU-301 Administration HVAC enthalpy control ............................................................ 62 AHU-302 Canteen HVAC enthalpy control ....................................................................... 62 AHU-303 Engineering HVAC enthalpy control ................................................................. 62 AHU-306 Laboratory HVAC enthalpy control ................................................................... 63 AHU-305 Warehouse HVAC enthalpy control .................................................................. 63

Facility Pfizer Shanbally, Ringaskiddy, Cork.

Title Energy Audit Shanbally

Document Title Energy Audit Report

Prepared By Neil McCarthy.

Executive Summary This energy audit report is conducted per a review of annual usage in Pfizer Shanbally in 2010. Energy consumption at the site was analysed and Table 1 estimates the energy consumption and associated costs for Shanbally operations for 2010

Energy Usage Cost

kWh % € %

Electricity 5,592,512 41.8% €410,446 56.5%

Natural Gas 7,758,995 58.11% €249,128 34.3% Water [m3] 71,671 N/A €66,842 9.7% Table 1 Energy Usage and Cost Shanbally 2010

45

Introduction The purpose of this energy review is to give a detailed overview of the energy performance in Pfizer Shanbally plant in Ringaskiddy, Cork in 2010. This report will outline the breakdown of energy usage within the facility The report will also detail the projects implemented in 2010 to achieve the 5% energy reduction target set-out by Pfizer. Shanbally is a newly opened facility and is part of the Pfizer Specialty Bio-Pharmaceutical division. In 2010 this unit within the Pfizer Organisation was challenged with achieving a 5% energy reduction. This has been achieved and the following report will outline how this target was met. This report also outlines potential projects in the Pipeline for 2011 to continue delivering the 5% energy reduction target required by Pfizer.

46

Energy Use Profile Electrical Consumption 2010 In 2010 Pfizer Shanbally was forecasted to use 6,658,471 Kwhe. The site achieved a total energy consumption of 5,592,512 Kwhe which equates to a total energy reduction on budget of 16%

Figure one Annual energy Consumption Shanbally 2010

47

Natural Gas Consumption 2010 In 2010 Pfizer Shanbally was forecasted to use 8,814,614Kwhth. The site achieved a total energy consumption of 7,758,995Kwhth which equates to a total energy reduction on budget of 12%

Figure two Shanbally natural gas consumption actual versus forcast 2010 Water Consumption 2010 In 2010 Pfizer Shanbally was forecasted to use 142,000 m3. The site achieved a total water usage of consumption of 71,761 m3 which equates to a total energy reduction on budget of 50%

48

2 ELECTRICAL ENERGY USAGE SPLIT SHANBALLY

Electrical energy usage in Shanbally is broken down in the following manner.

Figure three electrical load split Pfizer Shanbally

2.1 UTILITIES

Utilities accounts for 28% of the site electrical energy with an estimated usage 2.072 Gwh per annum

2.2 HVAC

Hvac accounts for 26% of the site energy with an estimated usage of 1.92 Gwh per annum

2.3 PROCESS EQUIPMENT

Process equipment is estimated to consume in the order of .99 Gwh per annum

2.4 FREEZERS

Site low temperature freezers are estimated to consume 8.95% at .648 Gwh per annum

2.5 LIGHTING

Lighting is estimated to consume 4.83% of the site energy consumption at .350 Gwh per annum

2.6 UPS GENERATOR FLYWHEEL SYSTEM

UPS flywheel system is estimate to consume 4.96% of the site energy at .360 Gwh per annum

49

2.7 LAB AUTOCLAVES AND WASHERS

The lab autoclaves and washers are estimated to consume .87% of the site energy at .063Gwh per annum

2.8 LOW VOLTAGE LOADS

Electrical Low voltage loads account for 8.62% of the site energy usage at .625 Gwh

50

3 NATURAL GAS ENERGY USAGE SPLIT SHANBALLY

Natural Gas energy usage in Shanbally is broken down in the following manner. The following is a list of the major users of thermal energy in the facility.

Figure four natural gas supply split Shanbally

3.1 HOT WATER BOILER

The site hot water boiler consumes 67% of the total site thermal load. The Hot water system supplies the reheat batteries within the facility. The following is a breakdown of the Hot water consumers.

AHU Area Supplied Heating Load (kWh)

AHU 301 Admin 175,487 AHU 302 Canteen 127,145 AHU 303 Maintenance 238,531 AHU 304 Dispensary 429,005

AHU 305-01 Warehouse 319,893 AHU 305-02 Warehouse 123,165 AHU 306 -01 Labs 849,403 AHU 306 -02 Micro Lab 119,316

AHU 307 Mfg Corr Grade-CNC 709,715 AHU 308 Mfg Support Corr Grade-D 585,347 AHU 309 Seed Lab Grade-C 168,276 AHU 310 Cell Cult Grade-D 150,534 AHU 311 Purif-1 Grade-C 328,380 AHU 312 Purif-2 Grade-C 299,629 AHU 313 Buffer Prep Grade-D 21,843 AHU 314 Clean Glass Grade-C 237,971

Table 2 Hot Water Boiler Energy Split

51

4

Figure 4 Electrical split of HVAC Hot water thermal energy usage.

4.1 CELL CULTURE

Cell Culture is estimated at .5% of the site energy consumption at .0035 Gwh energy consumed.

4.2 CIP SYSTEM

Cip system is estimated at 1% of site energy consumption at .0705 Gwh

4.3 GLASS WASHERS

Glass washers use at .5% of the site energy consumption is estimate at .0.0347 Gwh

4.4 AUTOCLAVES

Autoclaves are estimate at .51% of the site energy consumption at .0383 Gwh

4.5 WFI LOOP HEATER

The WFI loop re-heater is utilised to maintain the WFI loop at 72 C and to reheat the WFI post the cooling for system use. This is estimated to consume 3.8% of the site energy consumption at .28 Gwh of thermal energy consumed.

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4.6 BIO INACTIVATION

Bio inactivation is injection of direct steam to cell culture to ensure GMO is not discharged from the facility. This thermal energy usage is estimated at .49% of site energy use at .0363 Gwh

4.7 WFI GENERATION

Water for injection is generated on site using a Steris multi effect still. The unit is highly efficient using 6 effects to generate the required water for the facility. The WFI system is estimated to consume 14% of the site energy consumption at .9994 Gwh

4.8 CLEAN STEAM

Clean steam is used on site to maintain sterility of the seals on the Bio processing equipment. Clean steam is also used for autoclave systems and system Steam in Place. This system is estimated to consume 13% of the site energy consumption at .9595 Gwh.

4.9 STEAM TRAPPING

The facility has two steam headers in place. A low pressure 4 bar header and an 8 bar steam header. The trapping on these two headers is estimated at .8% of the site consumption at .295 Gwh

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5 POTABLE WATER USAGE SPLIT SHANBALLY

Shanbally incoming water is used in the following areas on site.

5.1 RIW WATER GENERATION.

This process is the main feed for the onsite WFI still and for process usage. This system is estimated to use on the region of 39,000 M3 of potable water per annum 54% of the site potable water consumption

5.2 COOLING TOWER COOLING LOAD

This potable water usage is to provide cooling for the site cooling tower systems, This system is estimated to use in the region of 8000 m3 of potable water 11% of the site potable water usage.

5.3 STEAM MAKE-UP WATER USAGE

This system is estimated to use 1700 m3 of potable water per annum 2.3% of the site potable water usage.

5.4 AUTOCLAVES AND WASHERS

These systems are estimated to use in the region of 15,000 m3 per annum 21% of the site potable water usage.

5.5 SITE POTABLE WATER USAGE

The remainder of the water system feeding canteen toilets and ancillary systems is estimated in the region of 3000 m3 4.2% of the site potable water usage.

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6 CO2 EMISSIONS 2010 SHANBALLY

In 2010 Shanbally emissions amounted to 3017 tonne of C02 from electricity consumption and 1448 tonne of C02 from Natural gas usage on site. Total site C02 usage of 4463 tonne of C02 The following table outlines the emissions on a monthly basis.

Commodity Electricity Natural Gas Total Dec-09 240 131 371Jan-10 241 104 345Feb-10 242 120 362

Mar-10 266 127 392Apr-10 247 117 364May-10 252 117 369Jun-10 265 128 393Jul-10 283 131 413

Aug-10 266 126 392Sep-10 255 125 380Oct-10 231 110 341Nov-10 229 112 341

Tonnes (Metric) CO2 Equivalent 3017 1448 4463Table three monthly C02 emissions Shanbally

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7 ISPE FACILITY OF THE YEAR AWARD FOR SUSTAINABILITY

In 2010 the Facility of the Year Award for Sustainability was presented to Shanbally Monoclonal Antibodies Small Scale Facility project. This award was achieved by applying the green building tool design developed in Pfizer. High emphasis was placed on energy efficient design, waste minimisation, and waste recycling

7.1 GREEN BUILDING AND LOW ENERGY SYSTEMS

– Built to industry best practices for sustainability and Pfizer’s green building guidelines.

– The use of an eco-seal, grey, insulated roof membrane to reduce the heat island effect, with high insulation levels for heat loss and site orientation to optimise solar gain.

– The inclusion of energy-efficient fixtures and equipment

– Minimised air change rates to meet comfort conditions and classification standards

7.2 USE OF EXISTING ASSETS

– Pfizer Ringaskiddy Waste Water Treatment Plant.

– Existing Tank for storm water retention.

– Gas, electrical and city water supplies from adjacent site with local metering, no municipal infrastructure required.

– Pfizer Ringaskiddy Fire Main System

7.3 RECYCLING AND ENERGY INITIATIVES

– 176,000 cubic feet of crushed rubble from the old ADM facility for Building Substructure

– 141,000 cubic feet crushed rock and stone from site excavation used as backfill beneath the building and roads

– 70,500 cubic feet of topsoil were set aside and re-used for landscaping works

– 1,000,000 cubic feet of excavated material have been used on site for general fill and landscaping

– Construction recycling centre

56

– A lighting management system across all floors. projected cost saving of €61,000 per annum

– 250 kVA Flywheel UPS. No lead acid batteries.

7.4 VARIABLE FREQUENCY DRIVES

– (VFDs) were extensively utilized in all utility Equipment, Air compressors, chillers , Coolant pumping, cooling tower systems, water treatment systems

– Production equipment, agitators, pumps, Centrifuge

– Waste treatment systems, Agitators and pumps on VSD technology

7.5 HVAC

- Variable Air Volume (VAV) systems

- High efficiency plug fans, with aerofoil blade.

- Wide volume flow range and extremely high operating efficiencies.

- Direct drive to minimise transmission losses

- Off Coil temperature reset

- Grade C 25 AIR Changes,

- Grade D 15 air changes

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7.6 LIGHTING

- Energy efficient light fittings,

- Motion sensor lighting management system was implemented to switch off lighting in unoccupied areas

- Lighting reactive to LUX levels and switch accordingly

- Natural light in the processing suite was maximized through the extensive use of glass walls and glazing

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8 PROJECTS COMPLETED 2010

8.1 OPTIMISE COOLING TOWER FLOW-RATE

This project entailed throttling and rebalancing all cooling tower water usage points to ensure optimal flow. Flow rates to air compressors, Hvac chillers ,process glycol chillers and return flow rates to cooling tower water systems were optimised. This resulted in a reduction of 66.58 MWH of electrical energy consumed

8.2 SHUTDOWN BURCO BOILERS IN SILENT HOURS

This project is relatively minor in the overall scheme. It was pursued as it is a visible effort in the main canteen area to reduce the electrical energy of the facility. It entailed fitting a timer to the electrical supply to the burco boiler. At 18:00 hrs in the evening the electrical supply to this unit is switched off. It has resulted in an estimated reduction of 740 Kwh per annum.

8.3 OPTIMISE AHU 301,302 WEEKLY AND AT WEEKENDS

This project involved optimising the usage patterns of the main Administration and Canteen areas. The building temperatures and occupancy were surveyed for administration building HVAC AHU-301 and the Canteen HVAC unit AHU-302. These units are shutdown at 18:00, restarted at 07:00 during the week and shutdown for 12 hours at the weekends. This has resulted in an estimated saving of 15.4 Mwh per annum.

8.4 OPTIMISE AHU 303

This is a non GMP air handler that feeds the engineering building and ancillary corridors. Each of the room areas were surveyed and room air change rates were reduced on the basis of temperature heat gain, occupancy, and comfort. It was determined the design basis of room areas had changed allowing turn down of the areas. This initiative has resulted in a reduction of energy in the order 407 Mwh.

8.5 RIW CONCENTRATE RECOVERY

The Riw generation plant was evaluated for potential water recovery. It was ascertained the Riw reject stream had potential for recovery. Reuse of this water in the cooling tower systems was evaluated and determined unsuitable due to the Chloride levels and over supply of water for cooling tower water reuse. It was determined a better use was to recycle the water to the start of the RIW system for reuse within the plant itself. In excess of 10 m3 per day is being recovered and as a result 10m3 less is being discharged to drain. A second R.O was fitted to the outlet of the reject stream to recover the water to the start of the RIW plant. This has led to a reduction of 3720 m3 per annum.

8.6 REBALANCE GLYCOL RECIRC LOOP

This project entailed throttling and rebalancing all process glycol usage points to ensure optimal flow. Flow rates to the plant headers were optimised and throttled. This resulted in a reduction of 34 MWH of energy consumed

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8.7 COMPLETE QRM ON LAB AHU 306

A quality risk assessment was completed on the main Laboratory building. It was determined the air change rates in accordance with ISPE,Minimum extract and Pfizer guidelines could be turned down significantly. Ancillary Rooms fed off the air handler were turned down on the basis of heat gain occupancy and comfort. This resulted in a reduction of energy in the order of 624 Mwh.

8.8 FEED COOLING TOWER DIRECT FROM MAINS SUPPLY

Site mains water supply to the facility process cooling tower was fed through a break tank on site and re-pumped to the mains cooling tower. The supply to the cooling tower was re-routed directly to the mains eliminating he requirement for pumping. This resulted in a reduction of energy in the order of 8 Mwh.

8.9 OPTIMISE LIGHTING LIGHTING CONTROLS IN FACILITY

Site lighting is managed through an automated lighting system. Each zone of the facility lighting was investigated and optimised. Process, interstitial, administration, utility and canteen areas were all set-up. The lighting control optimisation resulted in a reduction of 560 Mwh per annum

8.10 FIT VSD TO HVAC EXTRACT SYSTEM ON MAIN LAB

All fume cupboard extracts were evaluated. It was determined with the sash at the maximum height the flow rate was well in excess of the .5 m/s required. A VSD was fitted to the laboratory extract fans and set to deliver .5m/s with all the fume cupboard sashes at the maximum height. When the sashes are closed the VSD unit reacts to a fixed static pressure resulting in energy savings. This has resulted in a reduction of 26 Mwh per annum

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9 ENERGY MANAGEMENT

Energy management is an all-encompassing process that should include every aspect of an organisation from finance, human resources and public relations to maintenance, purchasing and planning. In Shanbally this has been achieved by the monthly meeting of the site energy team. The site is also engaged in the Pfizer energy program which requires the facility to achieve a 5% energy reduction. The site energy projects are tracked in the Pfizer Energy portal and this forms the basis of the site energy management system at the Shanbally facility. The energy portal ensures that energy intensive operations are proceduralised and hence operated in a consistent and energy efficient manner. A monthly site energy poster campaign is in place to raise awareness at the facility. In 2010 and on site energy awareness day was held on site. This energy day was themed around energy awareness in the home. Site utility consumption is also tracked within the energy portal. This demonstrates visibly the site energy performance for Shanbally Management and the Specialty Bio-Pharmaceutical division. At the end of 2010 E-sight was brought on line at the Pfizer facility. An EPI Tracker has been built to track the site energy performance. The implementation of Energy Performance Indicators (EPI’s) to monitor the ongoing use of energy onsite is an extremely beneficial tool in identifying periods of energy underperformance. The EPI with effective limits has been set against a period of optimum operation. The EPI tracker now allows issues such as degrading equipment or inefficient operation to be identified as early as possible thus increasing productivity and reducing waste. A weekly report now runs from e-sight that populates the tracker. This ensures the energy management of the system is continously tracked for abnormal operation.

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10 OPPORTUNITIES FOR ENERGY SAVING 2011

In 2011 the following areas of energy saving opportunity have been identified.

10.1 WFI SANITISATION WATER RECOVERY

On start-up of the WFI water recovery skid hot WFI water is flushed to drain. This water is high grade WFI water suitable for re-use. This water will be directed back to the start of the RIW system and reused in the water process.

10.2 WAREHOUSE AHU OPTIMISATION

The warehouse air handler will be investigated and turned down to meet the requirement for mean kinetic temperature. There are currently 6 probes located in the warehouse area. The area is low occupancy and the key driver for this air handler is to achieve and average temperature of 20c with RH less than 65% RH. The air handler air changes will be reduced and system program set-up to ramp-up to meet temperature and RH requirements as required.

10.3 AHU 307 OPTIMISATION

AHU 307 is a Controlled non classified corridor area feeding the production suite. There are no minimum air requirements for this air handler except to meet pressure cascade, temperature and environmental conditions. Currently this air handler is set-up with air requirements to satisfy a grade D environment. This air handler air change rate will be challenged and reduced to meet the above conditions.

10.4 AHU-301 ADMINISTRATION HVAC ENTHALPY CONTROL

Shanbally air handlers have automated dampers on the fresh air and return dampers. The administration air handler will be set-up to utilise free cooling when available and minimum intake air when outside conditions are above the return temperature and RH in the return ducts to minimise energy utilised in the de-humidification process.

10.5 AHU-302 CANTEEN HVAC ENTHALPY CONTROL


10.6 AHU-303 ENGINEERING HVAC ENTHALPY CONTROL


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10.7 AHU-306 LABORATORY HVAC ENTHALPY CONTROL


10.8 AHU-305 WAREHOUSE HVAC ENTHALPY CONTROL


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Attachment III Site Noise Survey

Pfizer Biotechnology Ireland Noise Survey

IPPC Noise Report 2011

64

65

DOCUMENT CONTROL SHEET

Client Pfizer Biotechnology Ireland

Project Title Environmental Noise Survey

Document Title IPPC Noise Report 2011

Document No. MCE0688Rp001F01

This Document Comprises

DCS TOC Text List of Tables List of Figures No. of Appendices

1 1 22 1 1 4

Rev. Status Author(s) Reviewed By Approved By Office of Origin Issue Date

D01 Draft D. Kingston A. Ryan A. Ryan Cork March 2011

F01 Final D. Kingston A. Ryan A. Ryan Cork April 2011

Pfizer Biotechnology IrelandINAL

TABLE OF CONTENTS

1 ...................................................................................................... 1 INTRODUCTION1.1 ......................................................................................................... ............................................................................................................................................... 1

Existing Environment

1.2 ......................................................................................... ............................................................................................................................................... 1

Noise Assessment methodology

1.3 .......................................................................................................... ............................................................................................................................................... 2

Monitoring locations

2 .................................................................................................. 4 SURVEY RESULTS2.1 ...................................................................................................... ............................................................................................................................................... 4

Site Boundary locations

2.1.1 ............................................................................. 4 Southern Site Boundary: B1

2.1.2 .............................................................................. 4 Western Site Boundary: B2

2.2 .................................................................................................. ............................................................................................................................................... 5

Noise Sensitive Locations

2.2.1 .............................................. 5 NSL1 – Port of Cork/Deepwater Berth Entrance

2.2.2 ................................................................................ 6 NSL2 – Shanbally Church

2.2.3 .............................................. 6 NSL3 – Local Road West of Pfizer Golf Course

2.2.4 ..................................................... 7 NSL4 – Residential Property at Ballyfouloo

2.2.5 ............................................ 7 NSL5 – Residential Property at Monkstown Rise

2.2.6 ........................... 8 NSL6 – Monkstown Road - Residential Property “Corr Iasc”

2.2.7 .................................. 8 NSL7 – Monkstown Demesne – Residential Properties

3 ............................................................................................................ 10 DISCUSSION3.1 ..................................................................................................... ............................................................................................................................................. 10

site Boundary Locations

3.1.1 ................................................................................... 10 Daytime Measurement

3.1.2 ............................................................................... 10 Night-Time Measurement

3.2 .................................................................................................. ............................................................................................................................................. 10

Noise Sensitive Locations

3.2.1 ................................................................................... 10 Daytime Measurement

3.2.2 ............................................................................... 11 Night-Time Measurement

4 ......................................................................................................... 12 CONCLUSION

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list of Tables

Table 1.1: Description of Noise Monitoring Locations ................................................................... 2 Table 2.1: Noise Measurements at B1 .......................................................................................... 4 Table 2.2: Noise Measurements at B2 .......................................................................................... 5 Table 2.3: Noise Measurements at NSL1 ...................................................................................... 5 Table 2.4: Noise Measurements at NSL2 ...................................................................................... 6 Table 2.5: Noise Measurements at NSL3 ...................................................................................... 6 Table 2.6: Noise Measurements at NSL4 ...................................................................................... 7 Table 2.7: Noise Measurements at NSL5 ...................................................................................... 7 Table 2.8: Noise Measurements at NSL6 ...................................................................................... 8 Table 2.9: Noise Measurements at NSL7 ...................................................................................... 9

list of figures

Figure 1 – Noise Monitoring Locations ........................................................................................ 19 Figure 2 – B1 – 1/3 Octave Frequency Profile .............................................................................. 1 Figure 3 – B2 – 1/3 Octave Frequency Profile .............................................................................. 1 Figure 4 – NSL1 – 1/3 Octave Frequency Profile .......................................................................... 2 Figure 5 – NSL2 – 1/3 Octave Frequency Profile .......................................................................... 2 Figure 6 – NSL3 – 1/3 Octave Frequency Profile .......................................................................... 3 Figure 7 – NSL4 – 1/3 Octave Frequency Profile .......................................................................... 3 Figure 8 – NSL5 – 1/3 Octave Frequency Profile .......................................................................... 3 Figure 9 – NSL6 – 1/3 Octave Frequency Profile .......................................................................... 4 Figure 10 – NSL7 – 1/3 Octave Frequency Profile ........................ Error! Bookmark not defined.

appendices

APPENDIX A Noise Survey Details

APPENDIX B Glossary of Terms

APPENDIX C Noise Monitoring Locations

APPENDIX D 1/3-Octave Frequency Profile Graphs

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11 INTRODUCTION RPS was commissioned by John F. Morrissey of Pfizer Biotechnology Ireland, Shanbally, Ringaskiddy, Co. Cork to conduct a noise survey in accordance with Condition 6.12 of Pfizer Biotechnology’s IPPC Licence (Reg. No P0864-01), and to prepare a Technical Report giving full details of the noise surveys, results and conclusions. Condition 6.12 of the licence states that

“The licensee shall carry out a noise survey of the site operations annually. The survey programme shall be undertaken in accordance with the methodology specified in the ‘Environmental Noise Survey Guidance Document’ as published by the Agency.”

In addition Schedule B.4 specifies the following Licence limits and condition for noise levels at noise sensitive receptors:

Daytime: LAeq30mins 55dB(A)

Night: LAeq30mins 45dB(A)

Note 1: There shall be no clearly audible tonal component or impulsive component in the noise emission from the activity at any noise sensitive location.’

RPS subsequently visited the site on March 14th and 15th 2011 to conduct a day and night-time noise survey at the noise sensitive locations. Noise measurements were also carried out at specific site boundary locations. Survey details are outlined in Appendix A. The findings of the survey are summarized in this report, (a summary of the terminology used in this report is given in Appendix B). 11.1 EXISTING ENVIRONMENT The Pfizer Biotechnology site is located in Shanbally, Ringaskiddy, Co. Cork, which lies in the greater lower estuary area of Cork Harbour. The site is bounded to the north by the shoreline of Monkstown Creek – further to the north can be considered a residential area of Lower Monkstown and amenity walk along Ballinaclashet (Monkstown) Creek. To the east, the site shares a boundary with the Pfizer Ringaskiddy API plant, which is overlooked by the Port of Cork. To west, the site shares a boundary with the Pfizer golf and social club. Shanbally village and residential housing bound the golf course to the west. To the north, the site is bounded by the N28 and vacant agricultural land. The site operates on a 24-hour basis, therefore night-time noise levels were measured at the nearest noise sensitive locations, in accordance with the requirements of Condition 6.12 and Schedule B4. 11.2 NOISE ASSESSMENT METHODOLOGY A noise survey was conducted on the boundary of the site, and at the nearest noise sensitive locations. A description of each location is included in Table 1 and illustrated in Figure 1 Noise Monitoring Location Map provided in Appendix C.

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In addition, 1/3-octave band noise frequency was also measured to assess potential tonal components, which may be used to identify specific noise sources at the sensitive receptors. In accordance with ISO 1996 – 2, a source is described as having a tonal component at a particular frequency when it is clearly audible or exceeds the level of the adjacent band by 5dB or more. Note: Where a definitive tone is detected at noise sensitive receptors, a 5dB penalty is incurred, which is added to the overall LAeq to determine the rating level. However, this is also dependent upon noise emissions from the Pfizer facility being the source of the tonal component. The 1/3-octave frequency analysis graphs are attached as Figures 2 – 10, provided in Appendix D.

11.3 MONITORING LOCATIONS

The survey included ambient environmental noise measurements at both on-site locations and noise sensitive locations within the surrounding area of the Pfizer Biotechnology Plant at Ringaskiddy. Table 1.1: Description of Noise Monitoring Locations

Location Reference Description

B1 Southern Site Boundary B2 Western Site Boundary

NSL 1 Port of Cork/Deep Water Berth Entrance NSL 2 Shanbally Church car park NSL 3 Residential property overlooking Pfizer Golf Course NSL 4 Residential properties at Ballyfouloo NSL 5 Residential properties at Monkstown Rise NSL 6 Monkstown Road - Residential property “Corr Iasc”NSL 7 Monkstown Demesne – residential properties

The following equipment was used for the noise survey:

• Brüel & Kjær Type 2260 Sound Level Meter

• Brüel & Kjær Type 4231 Sound Level Calibrator Measurements were made at a height of 1.5m above ground level, and measurements were free field, taken at least 2m from reflecting surfaces. The weather conditions were in accordance with the requirements of ISO 1996: Acoustics – Description and Measurement of Environment Noise. Weather conditions were fine during both the daytime and nigh-time surveys with very slight breezes and dry conditions throughout. See Appendix A for details of weather data during the surveys.



The instrumentation was checked and calibrated before and after the survey period to ensure no drift in the instruments sensitivity had occurred. Further survey details are included in Appendix A.



12 SURVEY RESULTS

A summary of the measured noise levels is presented below for each of the monitoring locations. The noise monitoring locations are illustrated in Figure 1 - Appendix C. 1/3rd-octave band analysis was measured at all locations during the survey period to assess the presence of tonal components in the measured noise. Graphs of frequency analysis trends (1/3 Octave Frequency Profiles) are shown in Appendix D. Figures 2 – 10 (provided in Appendix D) illustrate the measured frequency analysis at the two site boundary locations and at the seven noise sensitive locations, while the plant was in operation. 2.1 SITE BOUNDARY LOCATIONS

2.1.1 Southern Site Boundary: B1

The dominant noise source at this location during the daytime was road traffic noise associated with traffic passing on the N28 Ringaskiddy Road. During brief periods in the absence of passing traffic, noise from birds in the area was a notable noise source. Plant noise was just slightly audible on the western side of the Biotechnology facility during lulls in the absence of traffic noise. The dominant noise source at this location during the night-time was intermittent traffic noise associated with cars passing on the N28. A low level of plant noise was audible from the northern and western side of the Pfizer API facility and the western side of the Pfizer Biotech facility, noted as a background noise source. There was no noise from birds noted at this position during the night-time survey. Tonal noise was not detected from either daytime or night-time measurements at B1. Table 2.1: Noise Measurements at B1

Measurement Time

Measurement Duration LAeq LAmax LAmin LA10 LA90

12:40 30 mins 50.6 66.4 37.9 54.2 41.0 00:06 30 mins 40.3 60.5 30.1 39.4 31.4

12.1.2 Western Site Boundary: B2

The dominant noise source at B2 during the daytime survey was traffic on the N28, similar to the survey at B1. Additional noise sources noted included noise from birds in the area and plant noise from the Biotech facility. Noise from people on the golf course and walkers on the soccer pitches near the monitoring location were influential at times also. A van arrived and parked in the car park adjacent to the soccer pitch, with the engine running for a period during the survey also. The dominant noise source at B2 during the night-time was a combination of plant noise from the northern side of the Pfizer API facility and the western side of the Pfizer Biotech facility.



There was very little passing traffic noted on the N28 during the night-time survey and there was no noise from birds noted in the area during the night-time at this location. There were no tonal components detected at B2 during the daytime or night-time surveys. Table 2.2: Noise Measurements at B2

Measurement Time


14:06 30 mins 46.5 72.9 38.7 47.8 40.6 00:46 30 mins 38.7 57.0 36.6 39.6 37.4

2.3 NOISE SENSITIVE LOCATIONS

2.3.1 NSL1 – Port of Cork/Deepwater Berth Entrance

The daytime measurement at NSL1 was dominated by road traffic noise associated with traffic passing through Ringaskiddy village on the N28, and occasional traffic entering and leaving the Port of Cork Deep Water Berth site. The Fastnet Line Ferry “Julia” was berthed at the Ferry Terminal and was an additional influential noise source during the daytime survey. Noise emissions from the ferry were dominant periodically when traffic noise abated slightly during brief periods when traffic was not passing. The funnel (exhaust) noise from the Julia Ferry was a steady and continuous noise source throughout the survey but there were no loading or disembarking operations during the survey. An additional noise source noted towards the end of the measurement period was the engine of a tugboat “Gerry O’Sullivan”. The engine of the tugboat was started approximately six minutes before the end of the measurement period. Prior to this the tugboat that was tied-up at the jetty near the Julia ferry was silent, i.e. there were no noise emissions from the tugboat for the majority of the measurement period. Plant noise was not audible from the Pfizer facility. The dominant noise source at NSL1 during the night-time overall was intermittent traffic passing on the N28 although there was generally very little traffic passing. In the absence of traffic noise, plant noise to the west was noted but was not considered significant. It was not possible to determine if the plant noise was from the Pfizer API facility but it was considered most likely. Noise levels were also influenced by occasional noise from birds on the water near the monitoring position. Neither the Julia Ferry nor the Gerry O’Sullivan tugboat was present in the area during the night-time survey. A tonal component was detected during the daytime survey at 31.5Hz. The noise level at 31.5Hz was 39.2dB (see Appendix D – Figure 3) and it is considered that the source of the tonal component was engine/exhaust noise from the Gerry O’Sullivan tugboat. There was no tonal component detected at NSL1 during the night-time survey. Table 2.3: Noise Measurements at NSL1

Measurement Time


13:18 30 mins 65.1 79.7 53.5 69.6 55.4 01:28 30 mins 46.7 73.3 33.0 38.6 34.6



2.3.2 NSL2 – Shanbally Church

The daytime noise survey at NSL2 was dominated by road traffic noise from the N28. In addition noise associated with cars arriving at and leaving the car park was significant at times due to the proximity to the sound level meter in the car park. Noise from people in the car park was an influential source also. During brief periods in the absence of passing traffic on the N28, noise from birds in the area was notable also. No plant noise was audible from the Pfizer Biotechnology or API facilities during the daytime. The dominant noise source at NSL2 during the night-time survey was occasional passing traffic on the N28. The maximum noise level noted during the night was due to a motorcycle that passed at approximately 02:13, although it was not tonal. Plant noise in the distance to the east was only just audible in the absence of any traffic noise although it was not a significant noise source. Tonal noise was not detected at NSL2 during either the daytime or night-time surveys. Table 2.4: Noise Measurements at NSL2

Measurement Time


15:22 30 mins 59.4 77.1 41.5 62.0 48.6 02:05 30 mins 45.1 69.9 28.4 47.0 30.2

2.3.3 NSL3 – Local Road West of Pfizer Golf Course

During the daytime measurement at NSL3 the dominant noise source was intermittent traffic on the local road adjacent to the monitoring position. Traffic noise on the N28 was audible but not significant. In the absence of traffic on the local road, the dominant noise source was birds in the area with background noise associated with traffic on the N28. No noise was audible from the Pfizer facility. Noise from people on the Golf Course was audible but not significant. The dominant noise source at NSL3 during the night-time was distant traffic on the N28 and R610. Additional noise sources included occasional noise from birds in Monkstown Creek and noise due to dog barking in the distance to the northeast. No traffic passed on the local road during the night-time noise survey. Plant noise was only just audible from the Pfizer facility in the distance to the east. A tonal component was detected during the daytime survey at 80Hz. The noise level at 80Hz was 38.0dB (see Appendix D – Figure 5). The source of the tonal component during the survey was a pick-up truck that passed slowly on the local road during the survey. There was no tonal component detected at NSL3 during the night-time survey. Table 2.5: Noise Measurements at NSL3

Measurement Time


14:46 30 mins 56.3 78.0 30.2 54.0 36.0 02:39 30 mins 31.2 61.0 25.3 31.2 26.8



2.3.4 NSL4 – Residential Property at Ballyfouloo

The dominant noise source at NSL4 during the daytime was road traffic noise associated with intermittent traffic passing on the R610 Monkstown Road. During brief periods in the absence of passing traffic, noise from birds in the area was dominant. Noise from airplanes passing overhead was also influential at times as three airplanes passed overhead during the daytime survey period. No plant noise was audible from the Pfizer Biotechnology or API facilities during the daytime. The dominant noise source at this location during the night-time was a central heating boiler, which was running at a nearby residential property throughout the survey period. Occasional noise from birds in Monkstown Creek was noted also. No plant noise was audible from the Pfizer facility and no traffic passed on the road during the measurement period. Tonal noise was not detected at NSL4 during either the daytime or night-time surveys. Table 2.6: Noise Measurements at NSL4

Measurement Time


16:02 30 mins 52.5 67.0 32.9 56.8 37.2 03:20 30 mins 30.5 56.1 25.6 31.6 26.6

2.3.5 NSL5 – Residential Property at Monkstown Rise

The dominant noise source at NSL5 during the daytime survey was traffic on the R610. Occasional traffic on the local road adjacent to the residential properties was significant at times also. Noise from birds in the area was a significant noise source and dominant during brief periods in the absence of passing traffic. Noise from two soundings of the foghorn on the ferry berthed at Ringaskiddy was noted during the survey also. Plant noise from the Pfizer facility was not audible due to the level of noise from other sources in the area. The dominant noise source at NSL5 during the night-time was occasional passing cars on the R610. Occasional noise was noted from birds at Monkstown Creek. A low level of plant noise was audible from the Pfizer API facility but was not considered a significant noise source. Tonal noise was not detected from either the daytime or the night-time measurements at NSL5. Table 2.7: Noise Measurements at NSL5

Measurement Time


16:38 30 mins 62.3 78.4 36.6 67.2 40.4 03:59 30 mins 42.2 70.1 26.3 32.2 27.8



2.3.6 NSL6 – Monkstown Road - Residential Property “Corr Iasc”

The daytime noise survey at NSL6 was dominated by traffic on the R610. Noise from birds in the area was significant also and additional noise was noted from people in the area. Noise from two tugboats was also noted during the survey as the tugboats passed upriver. The Julia ferry departed Ringaskiddy at approximately 17:25 but was not noted as a significant noise source during the survey due to the dominance and proximity of traffic noise on the adjacent R610 Monkstown Road. No plant noise was audible from the Pfizer API or Biotechnology facilities due to the dominance of traffic noise during the survey. The night-time survey at NSL6 was dominated by occasional passing traffic on the R610 but there was much less traffic passing during the night-time compared with the volume of traffic that was passing during the daytime survey. In the absence of passing traffic, noise from birds in Monkstown Creek was noted. Noise from the Pfizer API facility to the south was audible in addition to noise from a source to the northeast towards Rushbrooke. The noise emanating from both the Pfizer API facility and the source in the Rushbrooke was notable as background noise but was not dominant. Tonal noise was not detected at NSL6 during either the daytime or night-time surveys.

Table 2.8: Noise Measurements at NSL6

Measurement Time


17:15 30 mins 67.4 88.1 39.2 72.6 42.8 04:39 30 mins 47.5 77.8 30.8 36.2 32.6

2.3.7 NSL7 – Monkstown Demesne – Residential Properties

The daytime survey at NSL7 was dominated by noise from children playing in the area and dog barking. Noise from birds in the area was significant throughout the survey also. A car passed in the Demesne during the survey period. Background noise was noted from traffic on the R610 but was not considered significant at the monitoring position in the Demesne. A siren on what was assumed to be an ambulance was noted passing on the R610 at approximately 18:17 and was considered to be a potentially tonal noise source. The maximum noise level recorded during the survey was due to a dog barking in a wooded public area of the Demesne near the monitoring position. No plant noise was audible during the daytime survey. The dominant noise source at NSL7 during the night-time survey was the sound of a breeze blowing in the trees at the monitoring position. Noise from an airplane passing overhead at high altitude was noted briefly during the survey. Noise from birds was noted during the survey and became more significant as the measurement period elapsed, with noise from birds becoming more dominant than the sound of the breeze blowing in the threes for approximately the final 10-minutes of the measurement period. No plant noise was audible from the Pfizer Biotechnology or API facilities during the night-time survey. A tonal component was detected during the daytime survey at 630Hz. The noise level at 630Hz was 54.4dB (see Appendix D – Figure 9). The source of the tonal component during



the survey was considered to be a siren on what was assumed to be an ambulance passing on the R610 (Monkstown Road) during the survey period. There was no tonal component detected at NSL7 during the night-time survey. Table 2.9: Noise Measurements at NSL7

Measurement Time


17:58 30 mins 59.3 80.8 34.0 51.2 37.0 05:17 30 mins 39.4 61.0 32.4 41.4 36.0



3 DISCUSSION

3.1 SITE BOUNDARY LOCATIONS

3.1.1 Daytime Measurement

The daytime ambient (LAeq) noise levels at the site boundary monitoring positions ranged from 46.5dB LAeq at B2 to 50.6dB LAeq at B1. The daytime ambient noise levels at the noise sensitive locations ranged from 52.5dB LAeq at NSL4 to 67.4dB LAeq at NSL6. It is noteworthy that the highest daytime ambient noise level at the site boundary positions (i.e. 50.6dB LAeq at B1) is lower than the lowest ambient noise level at the noise sensitive locations (i.e. 52.5dB LAeq at NSL4). The daytime noise limits as specified in the IPPC licence were not exceeded by any noise sources on-site at the Pfizer Biotechnology facility. The ambient noise levels recorded at both site boundary monitoring positions were within the limit criteria specified in the licence for the facility (i.e. 55dB LAeq during the daytime). There were no tonal components detected at the site boundary monitoring positions during the daytime surveys.

3.1.2 Night-Time Measurement

The night-time ambient (LAeq) noise levels at the site boundary monitoring positions ranged from 38.7dB LAeq at B2 to 40.3dB LAeq at B1. The night-time ambient noise levels at the noise sensitive locations ranged from 30.5dB LAeq at NSL4 to 47.5dB LAeq at NSL6. The night-time noise limits as specified in the IPPC licence were not exceeded by any noise sources on-site at the Pfizer Biotechnology facility. The ambient noise levels recorded at both site boundary monitoring positions were within the limit criteria specified in the licence for the facility (i.e. 45dB LAeq during the night-time). There were no tonal components detected at the site boundary monitoring positions during the night-time surveys.

3.2 NOISE SENSITIVE LOCATIONS

3.2.1 Daytime Measurement

As outlined above, the daytime ambient noise levels at the noise sensitive locations ranged from 52.5dB LAeq at NSL4 to 67.4dB LAeq at NSL6. Traffic was noted as the predominant noise source at the majority of noise sensitive monitoring locations. Additional noise sources noted included operations at the Port of Cork ferry terminal at Ringaskiddy and tug boats operating on the river and lower harbour areas. Birds in proximity to monitoring points and birds in Monkstown Creek in addition to people and children in proximity to the monitoring points were noted also. Dog barking and occasional airplanes passing overhead were influential at times at a number of monitoring points as outlined in Section 2. Plant noise was not audible at the noise sensitive locations during the daytime surveys.

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Tonal components were detected at NSL1 (39.2dB at 31.5Hz), NSL3 (38dB at 80Hz) and NSL7 (54.4dB at 630Hz). The sources of the tonal components were not attributable to noise emissions from the Pfizer facility.

3.2.2 Night-Time Measurement

As outlined above, the night-time ambient noise levels at the noise sensitive locations ranged from 30.5dB LAeq at NSL4 to 47.5dB LAeq at NSL6. Plant noise was only just audible at NSL2, NSL3 and was noted more clearly as a background noise source at NSL1 and NSL5 during the night-time surveys, but it was not apparent whether the plant noise was attributable solely to the Pfizer API facility or the Pfizer Biotech facility. A low level of plant noise was audible at NSL6 from what was considered to be the Pfizer API facility in combination with a low level of plant noise from the northeast towards the Rushbrooke area. It is noted that the ambient noise levels measured at NSL1 (46.7dB LAeq) and NSL6 (47.5dB LAeq) were raised above the night-time noise limit of 45dB(A). However, the dominant noise source noted at NSL1 during the night-time survey was traffic noise on the N28, and the dominant noise source noted at NSL6 during the night-time was traffic noise on the R610. Plant noise from what was considered to be the Pfizer API facility was audible at both NSL1 and NSL6 during the night-time surveys but it is noted that the background noise levels at both locations were 34.6dB LA90 and 32.6 dB LA90 respectively, which is a more accurate indication of the noise levels in the area without the influence of passing traffic during the night. No tonal components were detected at any of the noise sensitive locations during the night-time surveys.

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4 CONCLUSION

Day and night-time noise monitoring was carried out in accordance with IPPC Licence P0864-01. Both the daytime and night-time noise levels measured at the site boundary monitoring positions were within the respective limits of 55dB LAeq during the daytime and 45 dB LAeq during the night-time. While daytime ambient noise levels in excess of the IPPC licence limit values were measured during the course of the surveys at noise sensitive locations NSL1, NSL2, NSL3, NSL5, NSL6 and NSL7, the findings of the noise surveys were that the noise levels were neither dominated nor significantly influenced by noise emissions from the Pfizer Biotechnology facility. Similarly, whereas night-time ambient noise levels in excess of the IPPC licence limit values were measured at noise sensitive locations NSL1 and NSL6, the measured noise levels were primarily attributable to passing traffic noise on the N28 and R610 at the respective monitoring points. Plant noise was not audible during the daytime surveys at the noise sensitive monitoring locations. Plant noise was only just audible at two noise sensitive locations (NSL2, NSL3), was noted more clearly as a background noise source at two other noise sensitive locations (NSL1 and NSL5), and was noted in combination with plant noise from the northeast at one noise sensitive location (NSL6) during the night-time surveys. It was considered that the plant noise that was audible at the different noise sensitive locations was associated with the Pfizer API facility as opposed to the Pfizer Biotech facility. At the locations where plant noise was more clearly audible (i.e. NSL1, NSL5 and NSL6) as opposed to only just audible (NSL2 and NSL3), the plant noise still was not noted as a significant noise source at the noise sensitive locations NSL1, NSL5 and NSL6. The background noise level at NSL1 was 34.6dB LA90, NSL5 was 27.8dB LA90 and 32.6dB LA90 at NSL6. These background noise levels are a more accurate indication of the noise levels at each of the respective noise sensitive locations without the influence of passing traffic during the night and the potential noise levels in the area due to plant noise at each location respectively. The background noise levels in each case are significantly lower than the night-time noise limit of 45dB LAeq. While the Pfizer Biotechnology site is audible on occasion during lulls in traffic, it does not impose on the noise environment to a significant extent nor does it dominate the character of the noise environment in the area. It is the conclusion of this assessment that the operation of the Pfizer Biotechnology Plant does not contribute to elevated noise levels at noise sensitive locations surrounding the site. Furthermore, the plant does not contribute to tonal or impulsive components at these locations. The noise emissions associated with operations at the Pfizer Biotechnology facility are within the IPPC license emission limit values of 55dB LAeq during the daytime and 45 dB LAeq during the night-time at all noise monitoring points. It is notable that the ambient (LAeq) noise levels at both of the site boundary monitoring positions (i.e. B1 and B2) were lower than the ambient noise levels at all of the noise sensitive monitoring locations during the daytime and

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were lower than the ambient noise levels at a number of the noise sensitive monitoring locations during the night-time (i.e. NSL1, NSL2, NSL5 and NSL6). The night-time ambient level at the boundary position B2 was also lower than the ambient noise level at the noise sensitive location NSL7 during the night.


APPENDIX A Noise Survey Details

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A.1 Location of Survey

Pfizer Biotechnology Ireland Shanbally, Ringaskiddy, Co. Cork

A.2 Date & Time of Survey

March 14th 2011 12:40 – 18:28 March 15th 2011 00:06 – 05:47

A.3 Weather Conditions

March 14th 2011 Dry and bright conditions. Wind conditions calm (0.4m/s - 1.6m/s). Temperature 8.3 – 14.9ºC.

March 15th 2011 Dry but cold conditions. Wind conditions generally calm

with occasional slight breeze (0.3m/s – 2.7m/s) Temperature 3.8 – 6.1ºC.

A.4 Personnel Present During Survey

Darragh Kingston - Acoustic Consultant RPS Group

A.5 Instrumentation

Brüel & Kjær Type 2260 Investigator Brüel & Kjær Type 4231 Sound Level Calibrator

A.6 Calibration

Before and after the survey the measurement apparatus was check calibrated to an accuracy of +0.24dB using the Type 4231 Sound Level Calibrator. The calibration produces a sound pressure level of 94.0dB re 2x10-5Pa at a frequency of 1kHz.

A.7 Methodology

Sample periods at the noise-sensitive locations and boundaries consisted of thirty-minute measurements during night-time and daytime surveys. All measurements were carried out in accordance with ISO 1996: Description and Measurement of Environmental Noise (Parts 1, 2 and 3).

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APPENDIX B Glossary of Terms

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In order to understand the terms used, appropriate definitions are outlined as follows: - LAeq Is the A-weighted equivalent continuous sound level during a sample time

period and effectively represents an average value i.e. the average level recorded over the sampling period and includes all noise events. The closer the LAeq value is to either the LAF10 or LAF90 value indicates the relative impact of the intermittent sources and their contribution. The relative spread between the values determines the impact of noise on the background. The LAeq value has been found to correlate well with human tolerance of noise, and is the value normally used in setting and monitoring industrial noise limits.

LAF10 Refers to those levels in the top 10 percentile of the sampling interval; it is the

level that is exceeded for 10% of the measurement period. It is used to determine the intermittent high noise level features of locally generated noise, i.e. the higher noise levels present in the ambient noise.

LAF90 Refers to those levels in the lower 90 percentile of the sampling interval; it is

the level that is exceeded for 90% of the measurement period. It is used to estimate a background level. It tends to exclude short events such as occasional cars passing (but less so for regular passing traffic), dogs barking, aircraft flyovers etc.

LAMax The LAMax is the maximum reading measured at the sound level meter. It gives

an indication of the highest noise produced by a varying noise source. LAMin The LAMin is the minimum reading measured at the sound level meter. It gives

an indication of the lowest noise produced by a varying noise source. A-weighting is the process by which noise levels are corrected to account for the non-

linearity of human hearing. dB(A) A logarithmic noise scale (decibel). The “A” indicates that a frequency

weighting has been applied to take account of the variation in the sensitivity of the human ear as a function of frequency.

All quoted noise levels are relative to 2x10

-5 Pa.

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APPENDIX C Noise Monitoring Locations

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NSL1

NSL2

NSL3

NSL4

NSL6

NSL5

NSL7

B1 B2

Figure 1 – Noise Monitoring Locations

Location

Reference Description

B1 Southern Site Boundary

B2 Western Site Boundary

NSL1 Port of Cork/Deep Water Berth Entrance

NSL2 Shanbally Church car park

NSL3 Residential property overlooking Pfizer Golf Course

NSL4 Residential properties at Ballyfouloo

NSL5 Residential properties at Monkstown Rise

NSL6 Monkstown Road - Residential property “Corr Iasc”

NSL7 Monkstown Demesne – residential properties

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APPENDIX D 1/3 Octave Frequency Profile Graphs

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B1 - 1/3 Octave Frequency Profile

0

10

20

30

40

50

6012

.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d P

ress

ure

(dB)

Day (12:40)

Night (00:06)

Figure 2 – B1 – 1/3 Octave Frequency Profile

B2 - 1/3 Octave Frequency Profile

0

10

20

30

40

50

60

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

Day (14:06)

Night (00:46)

Figure 3 – B2 – 1/3 Octave Frequency Profile


NSL1 - 1/3 Octave Frequency Profile

0

10

20

30

40

50

6012

.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)Day (13:18)

Night (01:28)

Figure 4 – NSL1 – 1/3 Octave Frequency Profile


0

10

20

30

40

50

60

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Sou

nd P

ress

ure

(dB)

Day (15:22)

Night (02:05)




0

10

20

30

40

50

6012

.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Sou

nd P

ress

ure

(dB)

Day (14:46)

Night (02:39)


NSL 4 - 1/3 Octave Frequency Profile

0

10

20

30

40

50

60

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Sou

nd P

ress

ure

(dB)

Day (16:02)

Night (03:20)




0

10

20

30

40

50

60

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Sou

nd P

ress

ure

(dB

)

Day (17:15)

Night (04:39)



0

10

20

30

40

50

60

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

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8k

12.5

k

20k

Frequency (Hz)

Soun

d P

ress

ure

(dB

)

Day (17:58)

Night (05:17)


Pfizer B iotechnology IrelandINAL

Attachment IV Solvent Management Plan

Solvent Management Programme March 2011 1. Introduction The Solvent Management Plan (SMP) is generated as per Condition 6.7 of the IPPC Licence (Register No. P0864-01) for the facility. Condition 6.7 states: ‘The licensee shall prepare a programme, to the satisfaction of the Agency, for the identification and reduction of fugitive emissions using an appropriate combination of best available techniques. This programme shall be included in the Environmental Management Programme” As required this SMP follows the specific guidance within Annex III of Council Directive 1999/13/EC ‘on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations’. The following section presents the solvent usage on site, including details of storage, containment and disposal of the principal solvents used on site. The solvents used in manufacturing on site are:- Glacial Acetic Acid (100%) Isopropyl Alcohol (70%) Ethyl Alcohol (17.5% and 24%) 2. Scope The Solvent Management Programme for the Shanbally facility will be limited the above three solvents, these being the only three solvents demonstrating sufficient volatility to be encompassed by the relevant directive/legislation. Laboratory use of solvents, where usage is of the order of kilo’s per month are not deemed to be in scope as any released that may occur are in laboratory fumehoods which vent to licensed minor emission points and hence do not constitute “fugitive emissions” 3. Action Programme In line with the site goals/corporate requirements, - the facility chemical handling operations are geared towards minimising all emissions and maximising resource use effectiveness. To this end an ongoing programme of solvent use oversight is in place and included in the Environmental Management Programme. See 2010 AER


3. Solvent Use Matrix Solvent Inventory

(kg) Inventory (kg) (@100%)

Usage 2010 (kg)

Usage (kg) (@100%)

Ultimate Fate

Loss (kg)

Ethyl Alcohol(17.5%)

750 131.25 4,087 715.2 Wastewater/ Haz. Waste

0.35

Ethyl Alcohol(24%)

1200 288 0 0 (Stored Material)

<0.01

IsoPropyl Alcohol (70%)

165

115.5

367

257

Atmosphere/ Haz. Waste

245kg (95%)

IsoPropyl Alcohol (70%)

35 24.5 196 137.5 Atmosphere/ Haz. Waste

129.5

Acetic Acid (Glacial)

525

525

280.5

280.5

Wastewater/ Haz. Waste

<0.1

4. Glacial acetic Acid – Inputs and Outputs 4.1 GLACIAL ACETIC ACID INPUTS Glacial Acetic Acid used on site for buffer make up and pH control Acetic acid is stored in 2.5 and 10L plastic bottles/drums, either in the internal warehouse flammable storage units or externally in the GMP (Good Manufacturing Practices) bunded storage ‘chemstores’. Until the containers are opened no fugitive emissions emanate from the containers or storage area. When required the containers are brought to the warehouse dispensary where the liquid is dispensed into the required charges under GMP conditions. The area where these materials are dispensed is vents to two minor emission points and therefore this emission is not classified as fugitive emissions. Continuous improvement processes endeavour to minimise the time taken to perform tasks and the time that personnel are required to work with such hazardous materials and hence by minimising such handling the potential for emissions is also reduced. The preprepared sealed charges are transported to the manufacturing suites. There using either welded tube technology or high containment docking equipment, the charges are added to make up vessels or batches as required. Emissions from these transfers are deemed to be minimal with little or no scope for further improvement and hence are not considered to constitute fugitive releases.


4.2 GLACIAL ACETIC ACID OUTPUTS Essentially all dispensed glacial acetic acid is subsequently directed to process effluent. There the vast majority of any free acetic acid will be neutralised with sodium hydroxide to form sodium acetate. Given the low concentrations at which either the acetate salt or free acid are likely to exist extremely low potential losses are envisaged prior to aerobic digestion in the adjacent aerobic waste water treatment plant. Alternatively empty unclean containers with trace amounts of acetic acid are sealed and shipped for incineration or if possible they are triple rinsed with water and disposed of as non hazardous waste. Such rinsate is deemed to be insignificant based on the quantities used and hence not considered to be a source of fugitive emissions.

Acetic Acid (Glacial) usage Vapour Pressure 1.52kPa 20C Use Preparation of Buffers and Chromatographic eluents Container type 10L drum & 2.5Lbottles Inventory (kg) 525 Usage (2010) (kg) 280.5 Potential for Fugitive Emissions Very low Controls All containers sealed prior to dispensing

Dispensed acid sealed in dispensary for transfer to manufacturing 5. ETHYL ALCOHOL INPUTS & OUTPUTS 5.1 ETHYL ALCOHOL INPUTS Ethyl Alcohol is used as a 17.5% solution (stored in 205L drums) for the transfer and preservation of chromatographic resins in the Down Stream manufacturing area. The resins used arrive on site as a slurry in 20% Ethyl Alcohol (5kg Resin and 5kg Ethyl Alcohol per 10L carboy. The Alcohol is stored in dedicated bunded storage units until required for dispensing in the Warehouse Dispensary, any emissions that may occur during this The 17.5% solution is pumped into sealed bags within a transport unit, prior to transfer to the manufacturing area. Transfers within the manufacturing area are sealed and hence there are no fugitive emissions


5.2 ETHYL ALCOHOL OUTPUTS Ethyl Alcohol solutions that are to be disposed of are directed to the Process Waste collection infrastructure and subsequently to the Waste Equalization tank prior to neutralization and transfer off site for aerobic digestion. Given the very low concentrations of alcohol that can exist in this system at times of use it is deemed that the potential for fugitive release is exceptionally low. Surplus alcohol or reject/expired alcohol solutions are packaged for shipment in sealed containers and shipped off site as hazardous waste.

Ethyl Alcohol usage Vapour Pressure 5.81kPa 20C Use Storage and preservation of Chromatographic resins Container type 205L drum & 10L drums (Chromatographic Resin) Inventory (kg) 1,950 Usage (2010) (kg) 715 Potential for Fugitive Emissions Low Controls All containers sealed prior to dispensing

Dispensed Alcohol is sealed in dispensary for transfer to manufacturing and subsequent transfers are also sealed

6 ISOPROPYL ALCOHOL INPUTS & OUTPUTS 6.1 ISOPROPYL ALCOHOL INPUTS Isopropyl alcohol (IPA) is used throughout the classified areas of the facility as a surface sterilisation agent. It is administered either by spraying onto lint free wipes and used to cleanse and disinfect surfaces or as IPA saturated wipes stored in sealed packaging until required to wipe down surfaces of containers and equipment being brought into the classified areas. Storage of these materials is in fireproof bunded storage units until the required for use. Primary Storage 70% IPA is stored in 1L bottles and the two types of 70% presaturated wipes are stored in dispensing containers. Average quantity stored 120L 6.2 ISOPROPYL ALCOHOL OUTPUTS IPA wipe cloths are stored in sealed wipe pouches. Waste bags and containers are sealed so as to prevent further release of vapours. Disposal of IPA wipes and empty or expired 1L bottles is to hazardous waste again in sealed containers . The IPA spray and wipes are used across the site to sanitise work surfaces, external surfaces of production vessels, gowning areas and equipment brought into production areas.


Iso Propyl Alcohol usage Vapour Pressure 4.40 kPa @ 20oC Use Surface disinfection Container type Saturated wipes & 1L spray bottles Inventory (kg) 165 Usage (2010) (kg) 257 Potential for Fugitive Emissions

High

Controls All containers sealed prior to dispensing Post use and surplus/expired materials sealed prior to off site hazardous waste disposal

The IPA use on the site is primarily from 70% IPA 1 litre spray bottles. The spray bottles are stored with the nozzle of the spray bottle kept closed until the spray is required so there are no fugitive emissions. The spray bottles are inherently designed to prevent loss when not in use. The site also uses pre-saturated wipes – these are sealed and are stored in dedicated IPA wipe bins. Therefore there are no fugitive emissions from the storage of the IPA wipes. IPA is used to sanitise surfaces and any equipment introduced into Laboratory and Manufacturing areas. Saturated IPA wipes are also used across the site. IPA wipes do on occasion provide a useful alternative to the 1Lspray bottles for cleaning and sanitising activities. Where ever possible such wipes will be employed in preference to spray bottles as they contribute to reducing the exposure of IPA vapours to personnel and the environment IPA OUTPUTS • IPA usage by the Bio technicians and Cleaning Staff in GMP areas • BioQC Environmental Monitoring • In process and utility sampling activities The results of these determinations are a best estimate and not all streams are not fully quantified but determined for hazard class. IPA Summary Calculations IPA Input Kg Organic Solvent Input 70% IPA Saturated Wipes 137.5 kg IPA 70% IPA Spray Bottles 257 kg IPA IPA Output Kg Organic Solvent Output Fugitive 374.8 kg IPA IPA Waste 19.7kg IPA Fugitive Emission 374.8 kg IPA


SMP Conclusions Total fugitive emissions are calculated as follow: F Total = F Glacial Acetic Acid + F Ethyl Alcohol+ F Isopropyl Alcohol F Total = 0.1 + 0.36 + 374.5 F Total = 374.96 kg Fugitive emissions expressed as a proportion of solvent input are follows: = F Total / I Glacial Acetic Acid + I Ethanol + I IPA * 100 = (374.96 kg / 280.5 kg + 715.2 kg + 394.5) * 100 = 374.96 kg/ 1390.2 kg * 100 = 26.97% The total solvent usage for 2011 was 1,252.7 kg ( 100%) . Pfizer Biotechnology Ireland strives to minimise all emissions from the facility. It is interpreted that the specifics of the VOC directive do not apply to the facility based on the scale of the operation. In compliance with Condition 6.7 of the IPPC Licence a continuous improvement programme is in place which works in concert with site safety programmes to minimise all releases both to protect the environment and minimise/eliminate exposure for personnel on site. The Directive threshold for manufacturing of pharmaceutical products is 50,000kg. Glacial acetic acid and Ethyl Alcohol are very tightly controlled with low fugitive emissions. IPA is the predominant contributor to fugitive emissions accounting for 99.9% of overall fugitive emissions. Given the necessary widespread use and method of application used to ensure that all areas are sanitised to achieve GMP conditions, it is not deemed feasible to achieve fugitive emissions of 5% based on total solvent input of less than 50,000 kg. The 2011 EMP details the sites efforts in optimising use of all sanitizing agents including IPA with a view to effecting reductions where possible. Highly hazardous materials such as Carcinogens, Mutagens, Toxic to Reproduction and Halogenated Volatile Organic Compounds (VOCs) No VOCs with the R-phrases R45, R46, R49, R60, R61 or R40 are used on site - therefore Article 5 paragraphs 6, 7 and 8 of Council Directive 199/19/EC are not considered applicable.


Attachment V Pollution Release Transfer Register 2010


| PRTR# : P0864 | Facility Name : Pfizer Biotechnology Ireland | Filename : P0864_2010.xls | Return Year : 2010 | | PRTR# : P0864 | Facility Name : Pfizer Biotechnology Ireland | Filename : P0864_2010.xls | Return Year : 2010 |

Guidance to completing the PRTR workbookGuidance to completing the PRTR workbook

AER Returns Workbook

Version 1.1.11

REFERENCE YEAR 2010 1. FACILITY IDENTIFICATION

Parent Company Name Pfizer Biotechnology Ireland Facility Name Pfizer Biotechnology Ireland

PRTR Identification Number P0864 Licence Number P0864-01

Waste or IPPC Classes of Activity No. class_name

5.16The use of a chemical or biological process for the production of basic pharmaceutical products.

Address 1 Shanbally Address 2 Ringaskiddy

Address 3 County Cork Country Ireland

Coordinates of Location -8.34516 51.8339 River Basin District IESW

NACE Code 2110 Main Economic Activity Manufacture of basic pharmaceutical products

AER Returns Contact Name Gary Crowley AER Returns Contact Email Address [email protected]

AER Returns Contact Position EHS Lead AER Returns Contact Telephone Number 0215007990

AER Returns Contact Mobile Phone Number 0863916029

AER Returns Contact Fax Number 0215008032 Production Volume 0.0

Production Volume Units n/a Number of Installations 1

Number of Operating Hours in Year 8760 Number of Employees 115

User Feedback/Comments Web Address

2. PRTR CLASS ACTIVITIES Activity Number Activity Name

4(e)

Installations using a chemical or biological process for the production on an industrial scale of basic pharmaceutical products

3. SOLVENTS REGULATIONS (S.I. No. 543 of 2002)

Is it applicable? No Have you been granted an exemption ? No

If applicable which activity class applies (as per Schedule 2 of the regulations) ? n/a

Is the reduction scheme compliance route being used ? n/a

http://www.epa.ie/downloads/advice/aerprtr/completinguploadingtheprtrworkbook/#d.en.30355

4.3 RELEASES TO WASTEWATER OR SEWER Link to previous years emissions data | PRTR# : P0864 | Facility Name : Pfizer Biotechnology Ireland | Filename : P0864_2010.xls | Return Y 12/05/2011 15:47

8 9 17 18 6 6 6 6SECTION A : PRTR POLLUTANTS

Please enter all quantities in this section in KGsQUANTITY

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year12 Total nitrogen M EN ISO 11905-1:1998 236.0 236.0 0.0 0.013 Total phosphorus M EN ISO 6878:2004 166.8 166.8 0.0 0.0

* Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button

SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence)Please enter all quantities in this section in KGs

QUANTITY

Pollutant No. Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year F (Fugitive) KG/Year306 COD M CRM APHA 2005:5220:C 9474.4 9474.4 0.0 0.0303 BOD M CRM APHA 2005:5210:B 5357.3 5357.3 0.0 0.0

OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER

OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER

Method Used

Method Used

POLLUTANT METHOD

POLLUTANT METHOD

5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE

| PRTR# : P0864 | Facility Name : Pfizer Biotechnology Ireland | Filename : P0864 2009-01.xls | Return Year : 2009 |

06/04/2010 09:57

5 24 5 Quantity (Tonnes per

Year) Method Used Haz Waste : Name and

Licence/Permit No of Next Destination Facility Non Haz Waste: Name and Licence/Permit No of Recover/Disposer

Haz Waste : Address of Next Destination

Facility Non Haz Waste:

Address of Recover/Disposer

Name and License / Permit No. and Address

of Final Recoverer / Disposer

(HAZARDOUS WASTE ONLY)

Actual Address of

Final Destination

i.e. Final Recovery /

Disposal Site (HAZARDOU

S WASTE ONLY)

Transfer Destination

European Waste Code

Hazardous Quantity

T/Year

Description of Waste

Waste Treatment Operation

M/C/E

Method Used

Location of

Treatment

Name and Licence / Permit No. of Recoverer

/ Disposer / Broker

Address of Recoverer / Disposer / Broker

Name and Address of Final Destination i.e.

Final Recovery / Disposal Site

(HAZARDOUS WASTE ONLY)

Licence / Permit No. of

Final Destination

i.e. Final Recovery /

Disposal Site (HAZARDOU

S WASTE ONLY)

Within the Country

18 01 03 Yes 0.01 Medical/ Sharps/ Bio Hazardous Waste

D9 M Weighed Offsite in Ireland

SRCL,W0054-02 520 Beech Rd.,Western Ind. Est.,Dublin 12,.,Ireland

SRCL,W0054-02,520 Beech Rd.,Western Ind. Est.,Dublin 12,.,Ireland

.,.,.,.,Ireland

To Other Countries

15 01 10 Yes 2.286 Empty Containers

D10 M Weighed Abroad Veolia Environmental Services Technical Solutions, W0050-02

Corrin, Fermoy, Co.Cork, Ireland

Sava,A 51 G00 508 A51 V00605,Osterwete 1,Brunsbuttle,D-25541,.,Germany

Osterwete 1,Brunsbuttle,D-25541,.,Germany

To Other Countries

07 05 13 Yes 7.354 Chemically Contaminated Process Waste

D10 M Weighed Abroad Veolia Environmental Services Technical Solutions,W0050-02

Corrin,Fermoy, Co.Cork,Ireland



To Other Countries

15 02 02 Yes 1.153 Chemically Contaminated Process Waste


Corrin,Fermoy, Co.Cork,.Ireland



To Other Countries

07 05 04 Yes 0.275 Antifoam, Oils D10 M Weighed Abroad Veolia Environmental Services Technical Solutions,W0050-02

Corrin,Fermoy, Co.Cork, Ireland



Within the Country

07 05 04 Yes 1.106 Solvents, Oils R13 M Weighed Abroad Veolia Environmental Services Technical Solutions,W0050-02




To Other Countries

06 02 05 Yes 0.088 Corrosive Solids Sodium Hydroxide





To Other Countries

16 05 08 Yes 0.021 Waste/Spent Sanitization Agents





To Other Countries

20 01 14 Yes 1.67 Corrosive Waste – Acidic





Within the Country

16 02 13 Yes 0.2 Waste Electrical Electronic Equipment

R4 M Weighed Offsite in Ireland

KMK ,W0113-03 Cappincur Ind Est,Daingean Rd.,Tullamore,Co. Offaly,Ireland

Within the Country

20 01 01 No 5.91 Paper & Cardboard


Veolia Environmental Services,W0173-01

Forgehill, Cork, Ireland

Within the Country

20 03 01 No 131.3 General Waste




Within the Country

20 01 38 No 20.58 Timber R13 M Weighed Offsite in Ireland



Within the Country

17 04 05 No 14.38 Metal R4 M Weighed Onsite in Ireland

Cork Metal,WCP LK-08-589-01

Dublin Hill, Cork, Ireland

Within the Country

20 01 02 No 3.83 Glass R13 M Weighed Offsite in Ireland

Rehab Recycling,WMC 146/03

Monahan Rd., Cork, Ireland

Within the Country

20 01 39 No 2.96 Plastic Packaging and containers




Within the Country

16 10 02 No 26233.0

Process waste water


Pfizer Ireland Pharmaceuticals,P0013-04

Ballintaggart, Ringaskiddy, Co Cork, Ireland

Within the Country

16 02 14 No 0.276 Waste Electrical Electronic Equipment



Within the Country

16 02 16 No 0.02 Waste Electrical Electronic Equipment



Within the Country

08 03 18 No 0.294 Inks & Toners R13 M Weighed Offsite in Ireland

Source Imaging,WP 124/06

Unit 2,Banagher Enterprise Centre,Banagher Enterprise Centre,Co Offaly,Ireland

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