Servier International B.V. · Servier International B.V ., operating as Servier (Ireland)...

Servier International B.V.

Annual

Environmental

Report

2008 IPC LICENCE REGISTER NUMBER 128

May 2009

May 2009 of 45

ANNUAL ENVIRONMENTAL REPORT (AER)

Revision no. 1.0 Date issued May 2009

TABLE OF CONTENTS

May 2009 of 45

SECTION

CONTENTS PAGE NO.

1.0 INTRODUCTION 4

2.0 SUMMARY INFORMATION 5

2.1 Self-monitoring data 5

2.1.1 Emissions to sewer 5

2.1.2 Emissions to atmosphere 8

2.1.3 Waste management 6

2.2 Agency monitoring and enforcement 7

2.3 Energy and water consumption 8

2.3.1 Energy consumption 8

2.3.2 Water consumption 8

2.4 Environmental incidents and complaints 9

2.4.1 Environmental incidents 9

2.4.2 Environmental complaints 9

2.4.3 IPC Licence non-compliances 9

2.5 AER returns worksheet 10 - 12

3.0 ENVIRONMENTAL MANAGEMENT 13

3.1 Environmental Management Programme (EMP) Report 13 – 14

3.2 Schedule of Environmental Objectives and Targets 14

3.3 Pollution Emission Register, (PER) 14

4.0 LICENCE SPECIFIC REPORTS 15

4.1 Groundwater monitoring 15 – 17

4.2 Noise monitoring 18

4.3 Bund integrity testing 19 – 20

4.4 Surface water monitoring 21

4.5 Emissions to sewer 22 – 45



SUMMARY INFORMATION

May 2008 of 45

1.0 Introduction Servier International B.V., operating as Servier (Ireland) Industries Limited, Gorey Road, Arklow

Co. Wicklow, was issued with an Integrated Pollution Control Licence (IPC) by the Environmental Protection Agency in accordance with the Environmental Protection Agency Act, 1992 on 21st

November 1996 - IPC Licence Register Number 128. The main activity of the Arklow site is the manufacture and packaging of solid oral dose pharmaceuticals. The Pharmaceutical Plant began manufacturing in 1989. A Chemical Synthesis Plant was built in 1991 and manufactured active ingredient until July 2003. Over the past number of years a number of building extensions have been developed, extending packaging and warehouse facilities, while existing facilities have undergone renovations, most recently included a sizeable extension to the existing packaging and warehouse facility and a new formulation plant. Since ceasing production in the chemical synthesis plant in 2003 and despite continued developments, Servier no longer falls within the scope of the IPPC licensing directive.

Under the direction of the Agency, Servier are in the process of surrendering their IPC

licence and have agreed new water discharge licences from Wicklow County Council.

Documentation relating to the surrender has been submitted to the Agency and an Exit

Audit was carried out by Inspector Michelle Purcell on 07/05/09. Since commencing manufacturing, Servier has maintained a very high level of environmental awareness and protection. This was recognised when in June 2005 the company was awarded the international ISO 14001 Environmental Management Systems Standard by the National Standards Authority of Ireland. Since this time the company have also achieved the OHSAS 18001 Occupational Health and Safety Management System Standard. During 2008 Servier became members of Repak. The company is a member of the Irish Responsible Care group and has contributed environmental performance data to national reports issued by Responsible Care and PharmaChem Ireland Group. Since IPC Licensing the Company has maintained an excellent environmental record. Over the past decade compliance with licence conditions has ranged from 95% to 100%. This Annual Environmental Report, (AER) is presented for the calendar year 2008.



SUMMARY INFORMATION

May 2008 of 45

2.0 Summary Information

2.1 Self monitoring data

2.1.1 Emissions to sewer

Table 1

Volume (m3) 12719 14062 15223 25550

pH ---- ---- ---- ----

BOD 1628 279 519 36500

COD 1825 1896 2429 58400

Total solids 1872 1965 2549 58400

Suspended solids 278 541 268 15330

Sulphates 345 212 430 30660

All data is based on annual values, including licence limits.

Licensed Mass

Emissions (kg)Parameter

Mass Emissions

(kg)

(2006)

Mass Emissions

(kg)

(2007)

Mass Emissions

(kg)

(2008)

2.1.2 Emissions to atmosphere N/A



SUMMARY INFORMATION

March 2008 of 45

2.1.3 Waste management Figure 1 shows the increasing trend in paper and cardboard recycling.

Paper and cardboard recycling

0

20

40

60

80

100

120

140

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Year

Tonne

Figure 2 shows the ultimate disposal type for waste generated in 2008.

47% 13%

20%

20%

Incinerated Landfilled Re-used Recycled



SUMMARY INFORMATION

May 2009 of 45

2.2 Agency monitoring and enforcement During the reporting period of January to December 2008 the Agency did not carry out any sampling. The agency conducted an Inspection in April 2008 which focussed on the IPC Licence surrender process. In May 2008 the company were successfully re-certified to the ISO 14001 Environmental Management System Standard by the NSAI.



SUMMARY INFORMATION

May 2009 of 45

2.3 Energy and Water Consumption

2.3.1 Energy consumption

Types of fuels used include light fuel oil, natural gas and electricity. The increase in energy consumption can be attributed to the sizeable building expansions opened in 2008.

Table 2

Std boxes produced 63,541,000 76,592,478 88,802,000

Heavy fuel oil 0 0 0

Light fuel oil 161 159 451

Natural gas 4384 3602 7215

Electricity 4236 4453 7007

Coal 0 0

TOTAL, (Megawatts) 8781 8214 14673

Energy per box,

(Megawatts)0.00017

2006

0.00014

2007 2008

0.00011

2.3.2 Water consumption

The total water consumed during 2008 from a municipal supply was 29,106 m³.

Table 3

Std boxes produced 63571000 76592478 88802000

Water consumption, (m3) 20521.06 22648 29106

Litres per box 0.32 0.30 0.33

2008

0.00033

2007

0.00030

2006

Water per box (m3) 0.00032



SUMMARY INFORMATION

May 2009 of 45

2.4 Environmental incidents and complaints

2.4.1 Environmental incidents There were no environmental incidents during 2008.

2.4.2 Environmental complaints

There were no environmental complaints during 2008.

2.4.3 Summary of IPC Licence non-compliances

Date Non-compliance Cause Corrective action

24/06/08 Waste water volume

discharged to sewer exceeded

licence limit.

High production demands N/A



licence limit.




licence limit.




licence limit.




licence limit.




licence limit.




licence limit.




SUMMARY INFORMATION

May 2009 of 45

2.5 AER Returns Worksheet

Table 4



SUMMARY INFORMATION

May 2009 of 45

Table 4 (cont’d) 4.3 RELEASES TO WASTEWATER OR SEWER | PRTR# : P0128 | Facility Name : Servier International B.V. | Filename : P0128_2008.xls | Return Year : 2008 |29/05/2009 16:01

8 8 16 21 6 6 6 6

SECTION A : PRTR POLLUTANTS

QUANTITY

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/Year

0.0 0.0 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)

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/Year

238 Ammonia (as N) M PER Analytical method 313.0 313.0 0.0 0.0

303 BOD M PER Analytical method 519.0 519.0 0.0 0.0

306 COD M PER Spectrophotometer 2429.0 2429.0 0.0 0.0

327 Nitrate (as N) M PER Analytical method 1.7 1.7 0.0 0.0

343 Sulphate M PER Spectrophotometer 430.0 430.0 0.0 0.0

240 Suspended Solids M PER Analytical method 268.04 268.04 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



SUMMARY INFORMATION

May 2009 of 45

Table 5 (cont’d) 5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE | PRTR# : P0128 | Facility Name : Servier International B.V. | Filename : P0128_2008.xls | Return Year : 2008 | 29/05/2009 16:01

5 19

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

(HAZARDOUS WASTE

ONLY)

Within the Country 15 01 01 No 123.59 Paper and cardboard R3 M Weighed Offsite in Ireland

Veolia Environmental

Services Ballymount, Dublin 24

Within the Country 15 01 02 No 247.22 Plastic R3 M Weighed Offsite in Ireland



Within the Country 20 01 38 No 26.22 Wood R3 M Weighed Offsite in Ireland



Within the Country 15 01 03 No 81.3 Wooden pallets R3 M Weighed Offsite in Ireland Woodfab Industries Arklow, Co.Wicklow

Within the Country 20 01 02 No 3.0 Glass R3 M Weighed Offsite in Ireland Rehab Recylcing Clondalkin, Dublin 12

Within the Country 20 01 25 No 0.55 Cooking oil R3 M Weighed Offsite in Ireland



Within the Country 20 01 36 No 1.65 Electonic waste R4 M Weighed Offsite in Ireland Irish Lamp Recycling

Kilkenny Road, Athy, Co.

Kildare

Within the Country 20 01 21 Yes 0.114 Flourescent light tubes R4 M Weighed Offsite in Ireland Irish Lamp Recycling


Kildare


Kildare WCP/WW/51/05B

Within the Country 20 01 36 No 0.315 Printer cartridges R5 M Weighed Offsite in Ireland Jack and Jill Foundation

Johnstown Manor,

Johnstown, Naas, Co. Kildare

Within the Country 20 01 08 No 0.45 Un-cooked food R3 M Weighed Onsite in Ireland Servier (Ireland) Industries

Gorey Road, Arklow, Co.

Kildare

Within the Country 20 01 40 No 5.829 Metal waste R3 M Weighed Offsite in Ireland



Within the Country 20 03 01 No 12.24 Canteen wastes D1 M Weighed Offsite in Ireland



Within the Country 20 01 99 No 41.025 General waste, garbing, packaging, etc. D1 M Weighed Offsite in Ireland



To Other Countries 07 05 13 Yes 71.639

Mixed pharmaceutical waste, (eg tablets,

filters, contminated garbing, etc.) D10 M Weighed Abroad Ekokem Oy Ab

PO Box 181 Fin 11101,

Riihhimaki, Finland

PO Box 181 Fin 11101,

Riihhimaki, Finland YSO/119/2007

To Other Countries 07 05 04 Yes 7.858 Labotatory waste solvents D10 M Weighed Abroad Ekokem Oy Ab

PO Box 181 Fin 11101,

Riihhimaki, Finland

PO Box 181 Fin 11101,

Riihhimaki, Finland YSO/119/2007

Method Used



ENVIRONMENTAL MANAGEMENT

May 2009 of 45

3.0 Environmental Management

3.1 Environmental Management Programme, (EMP) Report

Licence Objectives Licensee Targets and Reports Department

Responsible

Time

Scale

1 Process modifications resulting in improved yields, elimination or reduction of wastes or the use of alternative less hazardous materials.

It is planned to install a process waste water drain in the raw materials warehouse. This allows for waste water from cleaning to be directed to waste water treatment system for neutralisation prior to discharge. [Currently this water is collected and transported to a process waste water drain]

Engineering 2008

Report:

A process waste water drain has been installed in the raw

material warehouse for disposal of water from cleaning the

sampling booth.

2 Improved process control (equipment and management) to reduce waste.

There were no objectives and targets for 2008.

3 Improvements in equipment cleaning procedures resulting in reduced materials usage or alternative materials usage.


4 Maintenance and calibration of control and monitoring equipment.

The company plans to improve its existing groundwater protection measures by installing a fifth monitoring well. It is planned to locate this well on the southern section of the site to provide baseline data for future expansion. Once installed, this well will be incorporated into the bi-annual monitoring programme.

EHS 2008

Report:

This target has not been implemented, but has been given a

revised target date of Sept 2009.

5 Improvements in treatment/abatement systems to reduce emissions.

In conjunction with planned production increases and the construction of a second production plant the company will investigate means of further improving our waste water balancing and discharge system. A new system will give constant quality water to the proposed new municipal waste water treatment plant.

EHS and

Engineering 2008

Report:

A new waste water treatment system has been installed at out

new UPA 2 production facility. This system uses best

available technology for controlling, monitoring and sampling

of waste water.



ENVIRONMENTAL MANAGEMENT

May 2009 of 45

Licence Objectives Licensee Targets and Reports Department

Responsible

Time

Scale

6 The use of alternative treatment/abatement systems


7 Recovery, reuse, recycling of waste material both on-site and off-site.

During 2008 the company will become members of REPAK. Through Repak membership the company will help fund recycling initiatives throughout the country.

Logistics and EHS

2008

Report:

In December 2008 Servier became members of Repak,

(membership number 5454).

8 Reduction in fugitive emissions


9 Prevention of incidents with the potential for environmental consequences and the preparation and implementation of contingency plans in the event of an incident.


10 Savings in energy and material usage.

It is planned to investigate the possibility of using groundwater well number 1 as a supplementary water source. The well offers a safe yield of 17 m

3 per day. A

feasibility study into using this natural water source will be conducted. If successful this could reduce water requirements from Arklow’s municipal supply by 40%.

Engineering and Dalkia

2008

Report: This target remains on-going. See Section 3.2 for more

information.

3.2 Schedule of Environmental Objectives and Targets, (2009 to 2013).

Not applicable due to licence surrender.

3.2.1 Summary of Objectives and Targets, (2009 to 2013).

Not applicable due to licence surrender.

3.3 Pollution Emission Register, (PER). There is no Pollution Emission Register required for 2008.



LICENCE SPECIFIC REPORTS

May 2009 of 45

4.0 Licence Specific Reports

4.1 Groundwater Monitoring

MONITORING WELL 1 MONITORING WELL 2

Date sampled: 14/01/08 Date sampled: 14/01/08

Date of analysis: 15/01/08, 16/01/08 and 18/01/08

Date of analysis: 16/01/08

RESULTS RESULTS

COD 27 mg/l COD mg/l

pH 7.21 pH

Other Other

Oils fats greases < 1 mg/l Oils fats greases < 1 mg/l

Toluene < 0.5 mg/l

Isopropyl alcohol < 2 mg/l

Ethyl acetate < 2 mg/l



Date of analysis: 15/01/08, 16/01/08 and 18/01/08


RESULTS RESULTS


pH 727 pH

Other Other

Oils fats greases < 1 mg/l Oils fats greases < 1 mg/l

Toluene < 0.5 mg/l

Isopropyl alcohol < 2 mg/l

Ethyl acetate < 2 mg/l




May 2009 of 45



Date of analysis: 27/03/08 Date of analysis: 27/03/08

RESULTS RESULTS

COD 5 mg/l COD 91 mg/l

pH 7.64 pH 7.35

Other Other

n/a n/a




RESULTS RESULTS


pH 7.63 pH 8.50

Other Other

n/a n/a




RESULTS RESULTS


pH 7.80 pH 7.71

Other Other

n/a n/a




RESULTS RESULTS


pH 7.51 pH 7.73

Other Other

n/a n/a




May 2009 of 45

MONITORING WELL 4

Date sampled: 31/10/08

Date of analysis: 31/10/08 and 03/11/08

RESULTS

COD 42 mg/l

pH 7.3

Other

DRC < 2.5 µg/l

Mineral oil < 2.5 µg/l

TPH < 2.5 µg/l




RESULTS RESULTS


pH 7.11 pH 7.11

Other Other

n/a n/a




May 2009 of 45

4.2 Noise Monitoring

4.2.1 Noise monitoring on-site

Table 5

Noise

emission ref.

number

Noise source description

Measurement

refernce

distance (m)

Actual Result;

dB(A) Leq (3 mins)

Sound Presure

Limit;

dB(A) Leq (3 mins)

N1 Dust collector (N101) 4 66.6 80

N6 Stand-by generator 3.5 65.4 91

4.2.2 Noise monitoring off-site

Table 6

Location Location descriptionActual Result;

dB(A) Leq (15 mins)

Sound Presure

Limit;

dB(A) Leq (15 mins)

1Gorey Road, close to "Knockmore" housing

estate.70.1 * 55

2Minor road leading to "Moneylands Farm",

close to "Avalon" housing estate50.7 * * 55

3Site boundary to the side of the restaurant

building57.6 55

Note:

No. of cars: 127

No. of vans: 9

No. of HGV: 6

No. of cars: 1

No. of vans: 0

No. of HGV: 0

* During monitoring traffic on the road was as follows;

* * During monitoring traffic on the road was as follows;




May 2009 of 45

4.3 Bund integrity testing During 2008 bund integrity testing was conducted by Cedar Building Company Limited. Two bunds were assed over a period of 3 days. All bunded areas passed the integrity test, (test reports attached).

Report 1: UPA 1 Diesel tank bund




May 2009 of 45

Report 2: Chemical waste store bund




May 2009 of 45

4.4 Surface Water Monitoring

SURFACE WATER SURFACE WATER



RESULTS RESULTS


pH 7.74 pH

Other Other

n/a V.O.C.’s < 10 µg/l

SURFACE WATER



Date of analysis: 04/10/08, 15/10/08, 30/10/08

RESULTS RESULTS


pH 6.58 pH 7.06

Other Other

n/a DRC 8.81 µg/l

Mineral oil < 2.5 µg/l

TPH < 2.5 µg/l




May 2009 of 45

4.5 Emission to Sewer

January 2008

TESTMONITORING

FREQUENCYLIMITS

Temperature 25 ºC 18 ºC

pH 6 - 9 6

Biochemical oxygen demand Monthly 1,428 mg/l 4 mg/l

Chemical oxygen demand Daily 2,285 mg/l 111 mg/l

Suspended solids Monthly 600 mg/l 19 mg/l

Sulphates as SO4 Quarterly 1,200 mg/l n/a mg/l

Chlorides Bi-annually Measure n/a mg/l

Nitrate, (as N) Bi-annually Measure n/a ppm

Ammonia Bi-annually Measure n/a ppm

Date of sampling: 15/01/2008

Sample discharged on: 14/01/2008

EMISSIONS TO SEWER

Monthly Sample Analysis

RESULTS




May 2009 of 45

Daily Discharge Volume Chart

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Daily volume licence limit

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Daily C.O.D. licence limit

Month average C.O.D.






May 2009 of 45

February 2008

TESTMONITORING

FREQUENCYLIMITS

Temperature 25 ºC 14.8 ºC

pH 6 - 9 6.76










EMISSIONS TO SEWER


RESULTS




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May 2009 of 45

March 2008

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 6.71




Sulphates as SO4 Quarterly 1,200 mg/l 22 mg/l






EMISSIONS TO SEWER


RESULTS




May 2009 of 45


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May 2009 of 45

April 2008

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 6.64

Biochemical oxygen demand Monthly 1,428 mg/l <2 mg/l









EMISSIONS TO SEWER


RESULTS




May 2009 of 45

. Daily Discharge Volume Chart

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May 2009

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 6.84










EMISSIONS TO SEWER


RESULTS




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May 2009 of 45

June 2008

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 7.09




Sulphates as SO4 Quarterly 1,200 mg/l 15 mg/l

Chlorides Bi-annually Measure 128 mg/l

Nitrate, (as N) Bi-annually Measure <0.09 ppm

Ammonia Bi-annually Measure <0.09 ppm



EMISSIONS TO SEWERMonthly Sample Analysis

RESULTS




May 2009 of 45

.


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May 2009 of 45

July 2008

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 7.34

Biochemical oxygen demand Monthly 1,428 mg/l <2 mg/l









EMISSIONS TO SEWERMonthly Sample Analysis

RESULTS




May 2009 of 45


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May 2009 of 45

August 2008

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 7.32




Sulphates as SO4 Quarterly 1,200 mg/l 35.06 mg/l






EMISSIONS TO SEWER


RESULTS




May 2009 of 45


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May 2009 of 45

September 2008

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 6.84




Sulphates as SO4 Quarterly 1,200 mg/l n/a * mg/l






Note *

EMISSIONS TO SEWER


RESULTS

Sulphates were not measured. Test was conpleted in October.




May 2009 of 45


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May 2009 of 45

October 2008

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 6.87










EMISSIONS TO SEWER


RESULTS




May 2009 of 45


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Daily C.O.D. Chart

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C.O.D. (mg/l)

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C.O.D. (kg)










May 2009 of 45

November 2008

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 6.87










EMISSIONS TO SEWER


RESULTS




May 2009 of 45


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Daily C.O.D. Chart

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C.O.D. (kg)










May 2009 of 45

December 2008

TESTMONITORING

FREQUENCYLIMITS


pH 6 - 9 6.74





Chlorides Bi-annually Measure 86.73 mg/l

Nitrate, (as N) Bi-annually Measure 0.09 ppm

Ammonia Bi-annually Measure 36 ppm



EMISSIONS TO SEWER


RESULTS




May 2009 of 45






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C.O.D. (kg)







Servier International B.V. · Servier International B.V ., operating as Servier (Ireland)...

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