ipsen manufacturing ireland ltd. annual … · licence register number :- p0117-01 name :- ipsen...

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 1 ______________________________________________________________________________________________

IPSEN Manufacturing Ireland Ltd.

ANNUAL ENVIRONMENTAL REPORT

2010

Integrated Pollution Prevention Control Licence.

Reg. P0117-01


Contents

1. Introduction ....................................................................................................................................4 1.1 Organisational Structure ................................................................................................................4 1.2 Ipsen EHS policy............................................................................................................................5 2.1 Groundwater Monitoring ................................................................................................................6 2.2 Effluent Emissions .........................................................................................................................7 2.2.1 Volatile Organic Compound determination through emission point SE2 ...............................9 2.2.2 Summary of the Toxicological Testing Report on emissions through SE2 ............................9 2.3 Firewater Pond.............................................................................................................................10 2.4 Emissions to Air………………………………………………………………………………................10 2.5 Waste Management……………………………………………………………………………………..14 2.6 Noise………………………………………………………………………………………………………31 2.7 Energy & Water Consumption .....................................................................................................32 2.7.1 Energy Consumption ...........................................................................................................32 2.7.2 Water Consumption ............................................................................................................34 2.8 Environmental Incidents & Complaints ........................................................................................35 2.9 Spending on Environmental Protection 2010…………………………………………………………36 2.10 Summary of Agency Monitoring and Enforcement ......................................................................36 2.10.1 Monitoring ................................................................................................................................36 2.10.2 Audits and Inspections..............................................................................................................36 3.0 Pollution Emission Register .........................................................................................................37 3.1 Method of Measurement ..............................................................................................................37 3.2 Mass Balance Methodology.........................................................................................................37 3.2.1 Dimethyllformamide ................................................................................................................38 3.2.2 Dichloromethane .....................................................................................................................39 3.2.3 Acetonitrile ..............................................................................................................................40 4.0 Management of the activity ..........................................................................................................43 4.1 Environmental objectives and Targets and Management Programme 2010 ...............................43 4.1.1 Review of 2010 Objectives .........................................................................................................43 4.2 Objectives for 2011……………………………………………………………………………………...43 4.3 Public Information ........................................................................................................................48


List of Tables

Table 1. Emissions to SE2 …………………………………………………………………..... 7Table 2. Compliance Monitoring of Emissions to SE2 for 2010 …………………………... 8Table 3. VOC Analysis of SE2 ………………………………………………………………... 9Table 4. Toxicity Analysis of SE2……………………………………………………………... 10Table 5. Pre-discharge Firewater Pond Analysis…………………………………………… 10Table 6. Results of Air Emissions from A3 during 2010 …………………………………… 11Table 7. Mass Air Emissions from Emission point A3……………………………………… 12Table 8. Total Hazardous Waste 2010 …………………………………………………….... 14Table 9. Total Non-Hazardous Waste 2010 ……………………………………………….... 15Table 10. Details of Hazardous Waste sent off-site for Disposal/Recovery……………… 16Table 11. Details of Non-Hazardous Waste sent off-site for Disposal/Recovery ………… 30Table 12. Expenditure on Environmental Protection 2010 ………………………………….. 36Table 13 Annual Solvent usage for PER…………………………………………………….. 37Table 14. PER …………………………………………………………………………………… 42Table 15. Environmental Management Programme 2010…………………………………… 44Table 16: Environmental Management Programme 2011…………………………………… 47

List of Figures

Figure 1. SE2 Emissions 2008 to 2010 ………………………………………………………. 8 Figure 2. A3 Emissions 2008 to 2010………………………………………………………... 13 Figure 3. Total Production 2008 to 2010…………………………………………………….. 30 Figure 4. Total Waste Produced per gram of Product 2008 to 2010……………………... 31 Figure 5. Waste Composition 2010 …………………………………………………………... 31 Figure 6. Energy Use 2010 ……………………………………………………………………. 32 Figure 7. Energy Consumption per gram of Product 2008 to 2010………………………. 33

Figure 8. Electricity Consumption per gram of Product 2008 to 2010……………………. 34 Figure 9. Water Consumption per gram of Product 2008 to 2010…………………………. 35

APPENDICES Appendix 1 – Ground Water Monitoring Report Appendix 2 – Process effluent monthly reports Appendix 3 – E-PRTR


1. INTRODUCTION This document contains information required under the IPC licence with regard to submission of an Annual Environmental Report for the year 2010.

Licence Register Number :- P0117-01 Name :- Ipsen Manufacturing Ireland Ltd. Location of Site:- Blanchardstown Industrial Park, Blanchardstown, Dublin 15.

IMIL is part of the Ipsen group. Ipsen is a European pharmaceutical group with over 20 products on the market and a total worldwide staff of 4,000. IMIL is a bulk API (active pharmaceutical ingredient) producer of two of the group’s main strategic products Decapeptyl® and Somatuline® which are used for a range of life threatening diseases. IMIL commit to producing these products in an environmentally responsible manner such as to, where practical, minimise the environmental impact of our operations.

IMIL has been approved by the United States Food and Drug Administration (FDA) and the Irish Medicines Board (IMB) for the manufacture of peptides and the plant is operated in compliance with Good Manufacturing Practices (GMP). At the end of 2010 here were 90 employees at IMIL. The production output in 2010 was 32 kg of API.

1.1 ORGANISATIONAL STRUCTURE IMIL employs science graduates for all production and quality functions. Responsible persons are as follows: Aidan Murphy : Managing Director Catherine Cummins, MSc : Head of Industrial Development Ciaran Dunne : Head of Quality Sarah Mahon : Head of Finance and Administration Dr. Tom Loughman : Director, API Development James Byrne : Head of Plant Operations

Olivia Cronin : EHS Manager


1.2 IPSEN EHS POLICY

IMIL policies and procedures on site reflect the guiding principles of the Ipsen Corporate policy. The policy is detailed as follows:


2. DATA

2.1 GROUNDWATER MONITORING

To monitor the impact of IMIL‘s activities on the surrounding environment the quality of groundwater around the site, both upstream and downstream is monitored annually. There are three monitoring wells in total on the site. MW1 is located in the car-park to the north of the production building, MW2 is located at the site boundary to the southeast of the production building and MW3 is located to the south of the building. The groundwater flow direction beneath the site was surveyed by White, Young Green Environmental and Planning (Ireland) Limited in 2005 and was determined to flow in a south/south westerly direction. As MW1 is up gradient of the site it is considered representative of background water quality on the site. Note: The nearest surface water body is the river Tolka located approximately 2km to the southwest of the site. The groundwater on site was sampled from the three groundwater monitoring points, MW1, MW2 and MW3 on the 23rd August 2010.

The samples from each well were tested for a comprehensive range of organic and inorganic parameters listed below. Metals and Inorganics Total petroleum hydrocarbons PolyChlorinated BiPhenyls Volatile Organic Compounds Semi-Volatile Organic Compounds Organochlorinated pesticides

2.1.1 Groundwater monitoring Findings 2010 The groundwater flow direction was found to flow in a south/south westerly direction resulting in MW-1 being the hydraulically upgradient well. The topographical gradient on site is from north to south. Concentrations of organo-chlorinated pesticides, VOC’s, SVOC’s, PCB’s Mineral Oil, DRO, PRO and BTEX were not detected above their respective EPA IGV’s for any of the three wells which is consistent with previous monitoring rounds. Chloride and sulphate are the only elevated parameters encountered in the groundwater underlying the site. The chloride concentration is highest in MW-1, the hydraulically upgradient well, which indicates an off-site source of the chloride and sulphate concentrations. This is consistent with previous monitoring rounds. The elevated concentrations may be as a result of a leaking sewer outside of the Ipsen boundary. The groundwater quality was found to be good in MW2 and MW3 with no exceedances of elevated parameters. Overall the groundwater quality in MW1 was good, with only chloride and sulphate exceeding the threshold value in the


wells. The groundwater quality in MW3 has improved as previously exceedances were recorded in the well.

Overall a review of the groundwater monitoring results over the period 2001 to 2010 showed that the groundwater quality beneath the Ipsen site is good and has improved and currently operations at the site are not impacting the underlying groundwater however and off site source of chloride and sulphate is impacting one of the wells.

The ground water monitoring report containing details of the results obtained can be found as an attachment in Appendix 1.

2.2 EFFLUENT EMISSIONS

Effluent emissions to the sewer consist of equipment, glassware washings and dumped water from the water purification generation system. All emissions are monitored continuously by the building management system for Temperature, Flow and pH. A weekly composite sample is taken and analysed for Biological Oxygen Demand, Chemical Oxygen Demand, Suspended Solids, Detergents and Sulphates. The results are based on data generated from weekly analysis of 24-hour composite samples and from continuous flow measurement. An average monthly emission figure is calculated from the analysis and the total flow for that month during the reporting period. This average figure was then used to calculate a yearly emission level in kilograms. The licensed emission is based on 365 days of production 24 hours per day.

Table 1. Annual Emissions to SE2

SS Parameter BOD (kg) COD (kg) (kg)

Detergents (kg)

Sulphates (kg)

Volume (m3)

2010 Emissions 6.9 59.8 14.1 0.6 166 2605 2009 Emissions 29.7 100.5 24.3 7.4 80.2 2429 2008 Emissions 25.3 226.9 18 2.9 44.9 1698 Licensed Emissions

14600.0 29200.0 5840.0 1460.0 14600 14600

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 8 ______________________________________________________________________________________________ Figure 1. SE2 Emissions 2008 to 2010

BODCOD

SS

Detergents

Sulphates

Volume

2010 Mass emissions (Kgs)

2009 Mass emissions (Kgs)

2008 Mass emissions (Kgs)Licensed Mass Emissions(kg)

0

5000

10000

15000

20000

25000

30000

kg

Comparison of SE2 Emissions in 2008-2010 with the IPPC Licence specification

2010 Mass emissions (Kgs)2009 Mass emissions (Kgs)2008 Mass emissions (Kgs)Licensed Mass Emissions(kg)

This graph shows that the total annual emissions recorded for each Licence parameter are consistently below the IPC Licence specification.

Table 2 presents the % Compliance of each SE2 licence parameter during the reporting period. See appendix 2 for monthly reports for SE2.

Table 2. Compliance Monitoring of Emissions to SE2 for 2010

Parameter Frequency Number of Analyses

Number of Non-Compliant

Analyses

% Compliance

BOD Weekly 50 0 100 COD Weekly 50 0 100

Detergents Weekly 50 0 100 Sulphates Weekly 50 0 100

Suspended Solids Weekly 50 0 100 pH Continuous 70,080 1 100

Temperature Continuous 70,080 0 100 Flow Continuous 70,080 0 100


During 2010, there was one non compliance in relation to an emission to the sewer, SE2 which caused the pH to drop below the lower licence limit of 6 to 3.6. The flow that left the site at pH < 6 was small, approximately 1900L. The flow goes to Ringsend waste water treatment plant for further treatment and NOT directly to any river. This incident was assigned an incident number and was fully investigated and tracked to closure on the site’s EHS event register.

This non-compliances was reported to the EPA in accordance with condition 4 of Ipsen’ IPC licence (P0117-01).

During 2010 the EPA and Fingal County Council carried out regular analysis of the effluent from SE2. All results were in compliance with the licence.

2.2.1 VOLATILE ORGANIC COMPOUND DETERMINATION THROUGH EMISSION POINT SE2

A composite sample of the effluent was taken over a 24 hour period during the 18th and 19th of August 2010. The sample was sent to TMS Environment Ltd. Tallaght Dublin 24 for analysis. Method: Modified version of US EPA Method 524.2 plus screenings for

Acetonitrile, Dimethylformamide and Methanol.

Table 3. Results of VOC detection from SE2

Composite Sample Date Result

18th Aug 2010 No Volatile Organic compounds were detected above the limit of detection of the method

2.2.2 SUMMARY OF THE TOXICOLOGICAL TESTING REPORT ON EMISSIONS THROUGH SE2

A composite sample of the effluent taken over a 24 hour period during the 18th and 19th August 2010 was sent to Enterprise Ireland in Shannon for Toxicity testing in their Aquatic Toxicity Laboratory. In 2010 the species and tests were as follows, Method 2: Marine Bacterium: Method 6.2 based on ISO 11348-3:1999; ‘Water quality – Determination of the inhibitory effect of water samples on the light emission of Vibrio fischeri (Luminescent bacteria test) – Part 3: Method using freeze-dried bacteria’ Method 3: Marine Copepod: Method 6.3 based on ISO 14669:1999 ‘Water quality – Determination of acute lethal toxicity to marine copepods (Copepoda, Crustacea)’


Table 4. Toxicity data for emissions through point SE2

Test Results

Test Parameter Concentration % vol. / vol

Toxic units Comments

48 h LC50 to Tisbe battagliai

> 32 < 3.1 No mortality occurred at 32% vol./vol.

15 min EC50 to vibrio fischeri

> 45 <2.2 No light inhibition occurred at 45% vol./vol. - compared to the control

30 min EC50 to Vibrio fischeri

> 45 <2.2 No light inhibition occurred at 45% vol./vol. - compared to the control

The data for 2010 shows that toxicity levels of emissions to sewer from IMIL exhibit negligible effect on the test species exposed to the effluent.

2.3 FIREWATER POND

Surface water from the site and all bunds is collected in the Firewater Retention Pond. The Firewater retention pond was discharged to the surface water drain on six occasions during the reporting period in 2010. All the results obtained prior to discharge were within specification as shown in Table 5 below. Table 5: Pre- discharge Firewater Pond Analysis

Date of Discharge pH 6-9

COD < 50mg/L

TOC < 20mg/L

03-Feb-10 6.92 45 < 0.3 16-Mar-10 7.95 41 17.6 20-Apr-10 7.98 10 2.4 04-Aug-10 9.03 48 6.5 19-Oct-10 8.16 15 9.1 23-Dec-10 6.91 10 0.3

2.4 Emissions to Air

Sampling and subsequent analysis of the A3 Emission point was conducted by ASEP at Queen’s University Belfast. All results carried out on site in 2010 can be seen in Table 6 below. The sampling technique applied to collection of Volatile Organic emissions from the emission point was adsorbent trapping with subsequent thermal desorption analysis via GC-MS.


The emission data presented was obtained by the calculation of an average hourly rate which was obtained from ASEP analysis for the reporting period. This was then used to calculate the total emissions for the year. The duration of emission in the calculation is based on the total amount of hours in a year. The Licensed Mass Emissions were calculated as follows (see Table 7 below):

Licensed Mass Emission = Average Mass Flow /hr × Duration of the emission Duration of emission = total hours in a year = 8760 Note: IPPC licence Emission Limit values are: TA Luft Organics Class I : 20 mg/m3 (@ mass flows > 0.1 kg/hr) TA Luft Organics Class II : 100 mg/m3 (@ mass flows > 2 kg/hr) TA Luft Organics Class III : 150 mg/m3 (@ mass flows > 3 kg/hr)

Table 6: Results from Air Emission Point A3 during 2010.

Emission Point Reference A3 Reporting Period 2010 IPPC Licence No P0117-01 Schedule 1 (ii) TA Luft Class 1

Sample Date Analyte Concentration Mass Flow mg/m3 kg/hr

04-Mar-10 Dichloromethane 5 0.0108 15-Mar-10 Dichloromethane 36 0.0721 14-Apr-10 Dichloromethane 7.1 0.0097 25-May-10 Dichloromethane 6.1 0.0138 27-Jul-10 Dichloromethane 57 0.0442

21-Sept -10 Dichloromethane 0.5 0.0005 15-Nov-10 Dichloromethane 5.9 0.0107

Mass Emission = 202.48 kg

TA Luft Class 2 Sample Date Analyte Concentration Mass Flow

mg/m3 kg/hr 04-Mar-10 Toluene 0.2 0.0004 15-Mar-10 Toluene 39 0.0781 14-Apr-10 Toluene <0.1 0.0002 25-May-10 Toluene 0.2 0.0005 27-Jul-10 Toluene 0.6 0.0005 21-Sep-10 Toluene 0.5 0.0005 15-Nov-10 Toluene 0.5 0.0009

Mass Emission = 101.49 kg TA Luft Class 3

Sample Date Analyte Concentration Mass Flow mg/m3 kg/hr

04-Mar-10 Alcohol 1.2 0.0026 04-Mar-10 Acetonitrile 1.1 0.0024 04-Mar-10 Acetone na na


15-Mar-10 Alcohol 36 0.0721 15-Mar-10 Acetonitrile 27 0.0541 15-Mar-10 Ammonia 0.5 0.0005

14-Apr-10 Alcohol 0.9 0.0012 14-Apr-10 Acetonitrile 2.9 0.0137 14-Apr-10 Ammonia <0.5 0.0007

25-May-10 Alcohol 0.5 0.0011 25-May-10 Acetonitrile 4 0.009

Ethyl Acetate

27-Jul-10 Alcohol 3 0.0023 27-Jul-10 Ethyl Acetate na na 27-Jul-10 Acetonitrile 25 0.0194

21-Sep-10 Alcohol 0.5 0.0005 21-Sep-10 Acetonitrile 0.5 0.0005

15-Nov-10 Alcohol 0.5 0.0009 15-Nov-10 Acetonitrile 2.2 0.004

Mass Emission = 230.01 kg

Table 7: Mass Air Emissions from Emission point A3

Parameter TA Luft Class 1

TA Luft Class 2

TA Luft Class 3

Total TA Luft Organics

2010 Mass Emissions (Kg) 202.5 101.5 230 534 2009 Mass Emissions (Kg) 139 40 128 307 2008 Mass Emissions (kg) 438 41 243 722

Licensed Mass Emissions(kg) 876 4380 6570 11826

Figure 2 outlines the organic emissions through emission point A3 and compares the emissions in kg in 2010, 2009, 2008 and 2007 to the licence limit in kg. Note: The carbon in the Carbon Bed absorber was changed out in 2009.


Figure 2: A3 Emissions 2008 to 2010

TA Luft Class I

TA Luft Class 2

TA Luft Class 3

Total TA Luft O

rganics

2010 Mass Emissions (kg)

2009 Mass Emissions (kg)

2008 Mass Emissions (Kg)

Licensed Mass Emissions(kg)

0

2000

4000

6000

8000

10000

12000

kg

Comparison of A3 Emissions in 2008-2010 with the IPPC Licence specification

2010 Mass Emissions (kg)2009 Mass Emissions (kg)2008 Mass Emissions (Kg)Licensed Mass Emissions(kg)

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 14 ______________________________________________________________________________________________ 2.5 WASTE MANAGEMENT

All documentation relating to waste disposal / recovery i.e. certificates of disposal /recovery, TFS and C1 documentation etc. is maintained on site at IMIL. Hazardous liquid waste is generated during chemical synthesis, purification and drying stages of the production processes. In 2010 a total of 779.37 tonnes of hazardous waste was produced. Hazardous waste is either sent for recovery or for incineration. Non-hazardous waste originates from the canteen, refuse bins and periodic building projects on site. During 2010 a total of 47.66 tonnes of non hazardous waste was produced. Cardboard, paper, plastic, timber, metal and glass are recycled. Non recyclable material is sent for landfill.

Table 8: Total Hazardous Waste 2010

European Waste Code

Quantity T/Year

Description of Waste

Waste Treatment Operation

Off site recovery

Off site disposal

Location of Treatment

07 05 03 114.3 Dichloromethane R2 Yes Abroad 07 05 03 618.228 Aqueous

Organic D10 Yes Abroad

07 05 04 21.68 Aqueous Organic

D10 Yes Abroad

07 05 13 0.662 Lab glassware waste

D10 Yes Abroad

13 01 10 4.220 Waste vacuum oil

D10 Yes Abroad

13 01 13 0.022 Hydraulic Oil D10 Yes Abroad 13 03 07 0.03 Silicon Oil D10 Yes Abroad 13 08 99 0.005 Oil contaminated

with R1318 D10 Yes Abroad

15 01 10 5.383 Empty drums D10 Yes Abroad 15 02 02 3.349 Solid Hazardous

waste D10 Yes Abroad

16 05 08 3.676 Mixed solvent & packaged waste (sprinkler foam & P3 Oxonia Active)

D10 Yes Abroad

16 05 06 0.919 Mixed packaged waste (lab smalls containing ammonium persulphate (15%)

D10 Yes Abroad

16 05 07 3.522 Aqueous solution containing 1% Nalco 8539 corrosion inhibitor

D10 Yes Abroad

16 02 13 0.962 Waste Electrical – Mixed WEEE

R13 Yes Off site in Ireland

20 01 21 0.044 Spent Fluorescent tubes



20 01 35 0.99 Mixed WEEE waste


06 01 01 0.254 Sulphuric acid D10 Yes Abroad 06 01 04 0.009 Phosphoric acid

packed as lab smalls

D10 Yes Abroad

06 01 06 0.155 Plastic Drum of TFA

D10 Yes Abroad

18 01 03 0.96 Biological/Micro waste

D10 Yes Abroad

Total 779.37 Total Hazardous Waste = 779.37 Tonnes

Table 9: Total Non-Hazardous Waste 2010

European Waste Code

Quantity T/Year

Description of Waste

Waste Treatment Operation

Off site recovery

Off site disposal

Location of Treatment

20 03 01 14.1 Canteen/ Plant waste D1 Yes Offsite in Ireland

17 09 04 22.5 Construction Waste D1 Yes Offsite in Ireland

20 01 01 11.06 Cardboard / Paper R5 Yes Offsite in Ireland

Total 47.66 Total Non-Hazardous Waste 2010 = 47.66 Tonnes

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 16 ____________________________________________________________________________________________________________________________________________________ Table 10: Details of Hazardous Waste Sent Off-Site for Disposal/Recovery 2010

C1 No. TFS Cons

Pickup Date Stream Weight No.

Packages Unit Type Description of Waste Haulier Disposer / Recoverer

EWC No.

Disposal Method

B597714 313214 20/10/2010 Mixed Packaged Waste 0.254 1 200L T/H Plastic Sulphuric Acid QYL AVG 060101* D10

Total Weight for EWC No: 060101* is 0.254 T C1 No. TFS

Cons Pickup Date Stream Weight No.


EWC No.

Disposal Method

B597714 312974 20/10/2010 Mixed Packaged Waste 0.009 1 32L O/T Plastic Phosphoric Acid packed as lab smalls

QYL Indaver NV 060104* D10




EWC No.

Disposal Method

B556243 312691 22/04/2010 Mixed Packaged Waste 0.155 4 200L Lacquered combi

Containing a plastic drum of Trifluoroacetic acid (TFA) QYL AVG 060106* D10




EWC No.

Disposal Method

B555207 312355 21/01/2010 Mixed Solvents 22.38 1 Bulk Tank Methanol 1.00%, Isopropanol 6.50%, Dichloromethane 0.92%, Acetonitrile 14.00%, Ethyl Acetate 0.01%, Acetic Acid 0.05%, Toluene 0.01%, Dimethylformamide 3.50%, Dimethylacetamide 0.01%, Water 74.00%

JPR AVG 070503* D10

B555205 312355 02/02/2010 Mixed Solvents 23.28 1 Bulk Tank Water 74.00%, Acetonitrile 14.00%, Isopropanol 6.50%, Dimethylformamide 3.50%, Methanol 1.00%, Dichloromethane 0.92%, Acetic Acid 0.05%, Ethyl Acetate 0.01%, Dimethylacetamide 0.01%, Toluene 0.01%

UTT AVG 070503* D10


JPR AVG 070503* D10

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 17 ____________________________________________________________________________________________________________________________________________________


JPR AVG 070503* D10


JPR AVG 070503* D10


JPR AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10


JPR AVG 070503* D10



UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10


JPR AVG 070503* D10


UTT AVG 070503* D10



UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10

B597717 313248 28/10/2010 Mixed Solvents 22.92 1 Bulk Tank Dichloromethane 93.5%,Isopropanol 2%, Dimethylformamide 2%, Trifluoroacetic Acid 2.5%,

UTT BIP Organics Ltd

070503* R2



UTT AVG 070503* D10


UTT AVG 070503* D10


UTT AVG 070503* D10

B555213 311978 09/02/2010 Dichloromethane 18.48 1 Bulk Tank Dichloromethane 93.5%,Isopropanol 2%, Dimethylformamide 2%, Trifluoroacetic Acid 2.5%,


070503* R2


JPR BIP Organics Ltd

070503* R2



070503* R2

B597612 311978 15/07/2010 Dichloromethane 24.32 1 Bulk Tank Dichloromethane 93.5%,Isopropanol 2%, Dimethylformamide 2%, Trifluoroacetic Acid 2.5%


070503* R2



070503* R2

Total Weight for EWC No: 070503* is 732.528 T


C1 No. TFS



EWC No.

Disposal Method

B597704 312697 11/08/2010 Bulk Solvents 21.68 1 Bulk Tank Methanol 1.00%,Isopropanol 6.50%,Dichloromethane 0.92%,Acetonitrile14.00%, Ethyl Acetate 0.01%,Acetic Acid 0.05%,Toluene 0.01%,Dimethylformamide 3.50%, Dimethylacetamide 0.01%,Water 74.00%

UTT AVG 070504* D10




EWC No.

Disposal Method

B555209 312692 28/01/2010 Mixed Packaged Waste 0.263 4 200L Steel Combi

Laboratory waste-Glass ware(pipettes/vials) contaminated with traces of Acetonitrile, HPLC Solvent, Dichloromethane, Acetic Acid, Silica, Peptides

QYL AVG 070513* D10



QYL AVG 070513* D10



QYL AVG 070513* D10

B597714 313215 20/10/2010 Mixed Packaged Waste 0.137 2 Pallet Box (UN approved 4G)

Polypropylene piping contaminated with Acetontrile, Acetic acid, Methanol, Toluene and DMF

QYL AVG 070513* D10




EWC No.

Disposal Method

B555209 312691 28/01/2010 Mixed Packaged Waste 0.043 2 25L T/H Steel Waste Vacuum Pump Oil(Shell Tellus oil T 100)

QYL AVG 130110* D10


QYL AVG 130110* D10


QYL AVG 130110* D10



QYL AVG 130110* D10


QYL AVG 130110* D10


QYL AVG 130110* D10


QYL AVG 130110* D10


QYL AVG 130110* D10


QYL AVG 130110* D10




QYL AVG 130110* D10


QYL AVG 130110* D10

B597714 312974 20/10/2010 Mixed Packaged Waste 0.023 1 25L T/H Plastic Offspec unused Vacuum Pump Oil (Shell Tellus oil T 100)



QYL AVG 130110* D10








EWC No.

Disposal Method

B597714 312706 20/10/2010 Mixed Packaged Waste 0.022 2 20L T/H Plastic Hydraulic Oil QYL AVG 130113* D10




EWC No.

Disposal Method

B597714 313214 20/10/2010 Mixed Packaged Waste 0.014 1 20L T/H Plastic Silicon Oil QYL AVG 130307* D10 B597714 313214 20/10/2010 Mixed Packaged Waste 0.016 1 25L T/H Plastic Silicon Oil QYL AVG 130307* D10



C1 No. TFS Cons

Pickup Date Stream Weight No.


EWC No.

Disposal Method

B597714 313214 20/10/2010 Mixed Packaged Waste 0.005 1 25L T/H Steel oil contaminated with R1318 QYL AVG 130899* D10




EWC No.

Disposal Method

B555209 312328 28/01/2010 Mixed Packaged Waste 0.268 12 200L T/H Steel Empty drums contaminated with Dimethylformamide (DMF)

QYL AVG 150110* D10

B555209 312328 28/01/2010 Mixed Packaged Waste 0.153 4 200L Polylnd Stl Empty drums contaminated with Trifluoroacetic acid (TFA)

QYL AVG 150110* D10

B555209 312443 28/01/2010 Mixed Packaged Waste 0.008 1 200L T/H Plastic Empty drum contaminated with Dimethylacetamide


B555209 312328 28/01/2010 Mixed Packaged Waste 0.035 2 200L T/H Steel Empty drum contaminated with Triethylamine

QYL AVG 150110* D10

B555209 312328 28/01/2010 Mixed Packaged Waste 0.007 2 25L T/H Steel Empty drum contaminated with Toluene

QYL AVG 150110* D10

B555209 312328 28/01/2010 Mixed Packaged Waste 0.084 4 200L T/H Steel Empty drum contaminated with Methanol

QYL AVG 150110* D10

B555209 312328 28/01/2010 Mixed Packaged Waste 0.022 1 200L T/H Steel Empty drum contaminated with Piperidine

QYL AVG 150110* D10

B555209 312328 28/01/2010 Mixed Packaged Waste 0.053 3 200L T/H Plastic Empty drum contaminated with Acetic Acid

QYL AVG 150110* D10

B555209 312328 28/01/2010 Mixed Packaged Waste 0.008 6 10L T/H steel Empty drum contaminated with DIC (Di-isopropylcarbodimide)

QYL AVG 150110* D10


QYL AVG 150110* D10

B555220 312692 24/02/2010 Mixed Packaged Waste 0.007 2 25L T/H Steel Empty Drums contaminated with Ethanol

QYL AVG 150110* D10


QYL AVG 150110* D10




QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10

B555220 312328 24/02/2010 Mixed Packaged Waste 0.016 1 200L T/H Steel Empty drum contaminated with Ethyl Acetate

QYL AVG 150110* D10


QYL AVG 150110* D10





QYL AVG 150110* D10






QYL AVG 150110* D10


QYL AVG 150110* D10

B556241 312443 16/04/2010 Mixed Packaged Waste 0.016 1 200L T/H Steel Empty Drum Previously Containing Methyl T-Butyl Ether





QYL AVG 150110* D10



B556241 312328 16/04/2010 Mixed Packaged Waste 0.349 2 200L T/H Steel Empty Drum Previously Containing Oil (Shell Tellus 100)

QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10

B597657 312328 03/06/2010 Mixed Packaged Waste 0.015 1 200L T/H Steel Empty drum contaminated with Ethyl Acetate

QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10




QYL AVG 150110* D10









QYL AVG 150110* D10




QYL AVG 150110* D10






QYL AVG 150110* D10




QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10




QYL AVG 150110* D10




QYL AVG 150110* D10


QYL AVG 150110* D10

B597714 313217 20/10/2010 Mixed Packaged Waste 0.03 2 200L T/H Steel Empty drum contaminated with QYL AVG 150110* D10


Methanol B597714 313217 20/10/2010 Mixed Packaged Waste 0.011 1 200L T/H Steel Empty drum contaminated with

Piperidine QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10

B597714 313217 20/10/2010 Mixed Packaged Waste 0.027 1 200L T/H Steel Empty drum of mixed solvent - 70% Water and 30% Acetonitrile

QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10


QYL AVG 150110* D10

B597714 313217 20/10/2010 Mixed Packaged Waste 0.01 1 200L T/H Plastic Empty drum contaminated with Dimethylacetamide (DMA)

QYL AVG 150110* D10




EWC No.

Disposal Method


Solid waste (Packing Material contaminated with Isopropyl Alcohol, Acetonitrile)

QYL AVG 150202* D10

B555209 312344 28/01/2010 PPE and waste Carbon bags

0.208 2 Pallet Box (UN approved 4G)

PPE from Labs (gloves, tyveks etc) with traces of Lab chemicals e.g. flammables, corrosives, Irritants, harmful substances

QYL AVG 150202* D10



QYL AVG 150202* D10


0.111 1 Pallet Box (UN approved 4G)


QYL AVG 150202* D10



QYL AVG 150202* D10


0.436 4 Pallet Box (non UN approved)


QYL AVG 150202* D10



QYL AVG 150202* D10



PPE and waste Carbon bags QYL AVG 150202* D10







PPE and waste Carbon bags QYL Indaver NV 150202* D10

B597631 313215 26/08/2010 Mixed Packaged Waste 0.105 2 200L O/T Steel Solid waste (Packing Material contaminated with Isopropyl Alcohol, Acetonitrile)

QYL AVG 150202* D10


0.238 2 Cardboard box PPE and waste Carbon bags QYL AVG 150202* D10

B597625 313215 28/09/2010 Mixed Packaged Waste 0.129 2 200L O/T Steel Solid waste (Packing Material contaminated with Isopropyl Alcohol, Acetonitrile) double bagged in liners

QYL AVG 150202* D10



B597714 313215 20/10/2010 Mixed Packaged Waste 0.086 1 200L O/T Steel Solid waste (Packing Material contaminated with Isopropyl Alcohol, Acetonitrile)

QYL AVG 150202* D10






EWC No.

Disposal Method

B623388 B623388

26/11/2010 Waste Electrical - Mixed WEEE

0.481 2 Metal Cage Mixed WEEE CMC Rehab Recycling (Tallaght)

160213* R13

B623388 B623388


0.241 1 Pallet (WEEE) Electric pallet truck CMC Rehab Recycling (Tallaght)

160213* R13

B623388 B623388


0.24 1 Pallet (WEEE) Air Dryer CMC Rehab Recycling (Tallaght)

160213* R13




EWC No.

Disposal Method


0.146 2 200L Steel Combi

Sharps/glassware (no free liquid) contaminated with traces of Lab chemicals e.g. flammables, corrosives, Irritants, harmful substances

QYL AVG 160506* D10


0.269 4 200L Steel Combi





0.153 2 200L O/T Steel Sharps/glassware (no free liquid) contaminated with traces of Lab chemicals e.g. flammables, corrosives, Irritants, harmful substances

QYL AVG 160506* D10

B597625 313215 28/09/2010 Mixed Packaged Waste 0.13 2 200L O/T Steel Sharps/glassware (no free liquid) contaminated with traces of Lab chemicals e.g. flammables, corrosives, Irritants, harmful substances

QYL AVG 160506* D10

B597714 313215 20/10/2010 Mixed Packaged Waste 0.169 3 200L O/T Steel Sharps/glassware (no free liquid) contaminated with traces of Lab chemicals e.g. flammables, corrosives, Irritants, harmful substances

QYL AVG 160506* D10

B597714 313214 20/10/2010 Mixed Packaged Waste 0.009 1 60L O/T Plastic Lab Smalls containing Ammonium Persulphate 15% Solution

QYL AVG 160506* D10



QYL AVG 160506* D10




EWC No.

Disposal Method

B556243 312691 22/04/2010 Mixed Packaged 3.522 4 Composite IBC Aqyeous solution containing 1% Nalco 8539 corrosion inhibitor

QYL AVG 160507* D10




EWC No.

Disposal Method

B556243 B556243

22/04/2010 mixed solvent waste 0.034 2 20L T/H Plastic P3 Oxonia Active CMC AVG 160508*

B556243 312691 22/04/2010 Mixed Packaged Waste 3.525 4 Composite IBC AR-FFFP sprinkler foam mixed with water in concentrations from 5% mix to 100%

QYL AVG 160508* D10

B556243 312692 22/04/2010 Mixed Packaged 0.117 6 Bags Amberlite Resin mixed with a small amount of activated carbon

QYL AVG 160508* D10




EWC No.

Disposal Method

B623388 B623388


0.044 2 Coffin Waste Spent Fluorescent Tubes CMC Rehab Recycling (Tallaght)

200121* R13



C1 No. TFS



EWC No.

Disposal Method

B597685 B597685


0.99 3 Metal Cage Mixed WEEE including electronic calculators,pumps,keyboards,mice,printers,cables

CMC Rehab Recycling (Tallaght)

200135* R13

Total Weight for EWC No: 200135* is 0.990 T Total Weight for Ipsen Manufacturing Ireland Limited: 779.37 T

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 30 _____________________________________________________________________________________________

Table 11: Details of Non-Hazardous Waste sent off-site for Recovery/Disposal 2010

Figure 3. Total Production 2008-2010

Total Production 2008 to 2010

0

5

10

15

20

25

30

35

40

45

2008 2009

Year

Kgs

of P

rodu

ct

2010

Quant. Waste Broker Haulier Recovery Disposal Waste Material

MT Description Contractor Contractor Plant Refuse 14.1 Canteen/Plant n/a Thorntons n/a Thorntons

Construction Waste

22.5 Construction waste

n/a Thorntons n/a Thorntons

Cardboard/ Paper 11.06 General n/a Thorntons / Shred-It

Thorntons / Shred-It

n/a


Figure 4. Total Waste Produced per Kilogram of Product 2008- 2010

Tonnes waste produced per kg product 2008 to 2010

0.00

5.00

10.00

15.00

20.00

25.00

30.00

2008 2009

Year

Tonn

es w

aste

per

kg

prod

uct

2010

Figure 5. Waste Composition 2010

Waste composition 2010

Process Aqueous OrganicProcess ChlorinatedOther HazardousOther non-Hazardous

75%

6%

14%

6%

2.6 NOISE There was no perimeter noise survey performed in 2010. This is not a requirement of the IMIL IPPC licence. For information purposes a site


noise survey was conducted in August 2001 and a copy of the full report was submitted to the agency with the 2001 AER.

2.7 ENERGY & WATER CONSUMPTION

2.7.1 ENERGY CONSUMPTION

Total energy consumption increased by approximately 22% in 2010 over 2009. The main reasons for this are the addition of (a) a new contractor’s compound, (b) the construction and expansion of the site’s existing building 2. The extension is a 744 m2, two storey API development facility (laboratory and offices) to the south end of the existing building 2. The extension incorporates 2 new laboratories on the ground floor and offices and meeting rooms on the upper floor, (c) The on-going construction of a new building 3 which is a new Warehouse and Engineering Building. In addition to the above, it can be noted that increased gas usage can be attributable to a very cold winter in November and December with 11 days < 00C in 2011 versus 3 days below 00C in 2009.

Figure 6. Energy Use

Energy Use 2010

Electricity

Gas

55%45%


In 2010, the site initiated some energy efficiency programmes for example (a) Power settings on laptops and PC’s modified to the Energy Star

guidelines in order to save power when PCs not in use. By implementing these settings the company will save 4000 euro over 3 years but the programme will also help to reduce output of C02 by 43 Tons which is equivalent to planting 9 acres of trees OR taking 7 cars off the road

(b) An Operation Excellence (OE) team was set up in 2010 to look at reducing energy consumption on site. Some of the main changes implemented on site during the year included (i) adjusting the schedule requirements across AHUs providing an

annualised reduction of 535, 000 kWh. (ii) Fire water pump house temperature control and heat tracing

thermostat installation. On site for fire protection water and emergency showers were found to be have non-functioning or no installed thermostat and thus they were continuously on. Room temperature reduced to 10C. Thermostat installed on heat tracing and set to 4C to prevent water from freezing providing and annualised saving of 28,000kWh.

Total annualised saving from all improvements was approximately 583,000kWh providing a carbon footprint reduction of 210 tonnes CO2 annually.

Figure 7. Energy Consumption / Kilogram of Product 2008-2010

MWhrs/kg of product 2008 to 2010

0

20

40

60

80

100

120

140

160

180

200

220

2008 2009

Year

MW

hrs

per

kg

of p

rodu

ct

2010

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 34 _____________________________________________________________________________________________ Figure 8. Electricity Consumption/Kilogram Product 2008-2010

Electricity Consumption per Kg product 2008 to 2010

0

10

20

30

40

50

60

70

80

90

100

2008 2009

Year

Elec

tric

ity M

Whr

/kg

prod

uct

2010

2.7.2 WATER CONSUMPTION Water is used in the manufacturing process and for cleaning equipment. Water is purified before it is used in the process. The waster consumption for 2010 was estimated to be a 6% increase over 2009. Annual usage calculated to be 11,500 m3. The reason for the estimate is due to the fact that the site’s water meter owned by Fingal County Council failed to operate correctly for a large portion of the year. This was reported to Fingal several times but the water meter was not fixed before the end of the year. Based on this estimate, there has been an increase (18%) estimated per kilogram of product in 2010 over 2009. This is due to a new purified water system coming on line and increased numbers on site as a result of new staff being hired and project activity.


Figure 9. Annual Water Consumption per Kilogram of Product 2008-2010

Water consumption per Kg of Product 2008 to 2010

0

50

100

150

200

250

300

350

400

2008 2009

Year

m3

wat

er /k

g pr

oduc

t

2010

2.8 ENVIRONMENTAL INCIDENTS & COMPLAINTS No complaints were received from any source regarding IMIL or any of the activities conducted therein. One environmental incident was recorded in 2010. This was in relation to an emission to sewer, SE2 which caused the pH to drop below the licence limit of 6 to 3.6. The flow that left the site at a pH < 6 was small.

In the above case, it should be highlighted that the flow goes to Ringsend Treatment plant for further treatment and NOT directly to any river. The incident was assigned an incident number, was investigated and tracked on the site’s EHS Event register and the non-compliance was reported to the EPA in accordance with condition 4 of Ipsen’s IPC licence (P0117-01).


2.9 SPENDING ON ENVIRONMENTAL PROTECTION 2010

Table 12. Expenditure on Environmental Protection 2010

Item

Expenditure (€)

Effluent Toxicity Study 1100 Effluent VOC Study 255

Air Monitoring 5,150 Ground Water Monitoring 3,201

Hazardous Waste Disposal 348,044 Cardboard/Paper Recycling 3,489

EPA 8,464 Fingal County council 2,381

Total 372,084

2.10 SUMMARY OF AGENCY MONITORING AND ENFORCEMENT During 2010 no enforcements actions were made against IMIL. All monitoring (except that reference in section 2.2 & 2.8 above) and inspections were in compliance with IPPC licence and the general provisions of all waste and environmental legislation.

2.10.1 MONITORING One air emission monitoring visit was conducted by Euro Environmental on behalf of the agency and monthly visits by Fingal County Council were conducted during 2010 to ensure compliance with process effluent emissions leaving site. All external monitoring results were in compliance with the licence.

2.10.2 AUDITS AND INSPECTIONS The agency carried out an inspection of the site on the 19th March 2010. No non-compliances were raised.


3.0 POLLUTION EMISSION REGISTER

Reporting Period: 2010 The following materials have been tracked for IMIL’s Pollution Emissions Register.

Table 13: Annual Solvent Usage for PER

Annual Usage ( MT) Material 2008 2009 2010

Dichloromethane (DCM) 236 163 154.7 Acetonitrile (MeCN) 62.4 68 63.1 Dimethylformamide (DMF)

38.5 32 30.5

3.1 METHOD OF MEASUREMENT

Material usage was tracked by both inventory and Building Management Systems. Process waste identification and quantification was determined via Gas Chromatography (GC ) and the disposal documentation. Emissions to air were determined directly by analysis of stack emissions via GC-MS through emission point A3 (Carbon Bed Stack). Emissions to water / sewer were determined directly by GC - MS / GC on an annual basis.

3.2 MASS BALANCE METHODOLOGY

Mass Balance on each material tracked was calculated as follows;

Input Output 1. Total quantity of material

delivered onto site in 2010 (T)

2. Quantity of material in

process waste tanks at end of year 2009 (T)

3. Quantity of material in

process solvent tanks at end of year 2009 (T)

1. Quantity of waste material sent off site in 2010 (T)

2. Emissions (T): (i) SE2 (ii) A3 3. Quantity of material in

solvent tanks at end of year 2010 (T)

4. Quantity of material in waste

tanks at end of the year 2010 (T)


Note: As seen in previous years, it was determined from mass balances below that there appears to be an issue with our sampling procedure on site which is affecting the accuracy of our mass balances. There appears to be still much variation in our sample analysis. Samples taken from the tanks are currently not recirculated and hence good mixing of the materials is not achieved. In December 2010, a new in-line sampler was installed on the waste tanks in the tank farm, it is believed that this should aid in taking a homogeneous sample from the tanks.

3.2.1 DIMETHYLFORMAMIDE

Solvent Name: Dimethylformamide (DMF)

CAS Number: 68 - 12 - 2

Mass Balance

Inputs Outputs 1. Total quantity

of material delivered onto site in 2010

2. Quantity of

material in process waste tanks at end of year 2009

3. Quantity of

material in process solvent tanks at end of year 2009

31.92 T

0.257 T

5.495 T

1. Quantity of waste material sent off site in 2010

2. Emissions: (i) SE2 (ii)A3 3. Quantity of material in

solvent tanks at end of year 2010

4. Quantity of material in waste tanks at end of the year 2010

25.522 T 0 0

6.896 T

1.55 T

Total 37.67 T Total 33.96 T

Mass Balance Deviation = 3.7 T % Deviation = 9.8%


3.2.3 DICHLOROMETHANE

Solvent Name: Dichloromethane(DCM)

CAS Number: 75 - 09 - 2

Mass Balance

Inputs Outputs

1. Total quantity of material delivered onto site in 2010

2. Quantity of


3. Quantity of


153.92 T

8.0175 T

12.67 T





145.476 T

0

0.202 T

11.932 T

16.638 T


Mass Balance Deviation = 0.36 T % Deviation = 0.21 %


3.2.2 ACETONITRILE

Solvent Name: Acetonitrile (MeCN) CAS Number: 75 - 05 – 8

Mass Balance

Inputs Outputs

1. Total quantity of material delivered onto site in 2010

2. Quantity of


3. Quantity of


64.36 T

0.106 T

16.749 T





66.852 T

0

0.230 T

18.043 T

2.35 T


Mass balance deviation = - 6.26 T % Deviation = - 7.7 %

Note: This mass balance indicates continued issues with sampling on site. The mass balance for acetonitrile is indicating a negative variation on outputs versus inputs. While the variation is high, the fact that all acetonitrile coming on site is accounted for indicates that there is no large loss of acetonitrile being lost to the environment. This fundamentally points to a sampling concern for Acetonitrile. A new in-line sampler was fitted to the waste tanks in the tank farm, it is believed that this should help with the accuracy of the mass balance going forward.


Note: An overall Mass balance of all solvents was also undertaken i.e. Dimethylformamide, Dichloromethane and Acetonitrile. Material Inputs (T) Outputs (T) Dimethylformamide 37.67 33.96 Dichloromethane 174.61 174.25 Acetonitrile 81.22 87.48 Totals 293.5 T 295.69 T

Overall mass balance deviation: - 2.2 T

% Deviation = - 0.75 %

The above overall mass balance for total ‘solvents in’ reflects well with the total mass of ‘solvents out’ for the year. While the individual solvent component mass balances do vary to some extent as can be seen in the previous tables, this final mass balance points more to inhomogeneities in the waste tank sampling. Further, the apparent accumulation of acetonitrile which is not feasible may possibly explain the apparent losses of Dimethylformamide i.e. the sampling is generating these inconsistencies.

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 42 ___________________________________________________________________________________________________________________________________________________

Table 14. Pollution Emissions Register

FACILITY IDENTIFICATION Facility Name IPSEN

Manufacturing Ireland Ltd.

IPC Register No. P0117-01 National Grid Reference 3086E

2408N

Reporting Period 01-2010 to 12-2010 (mm-yy to mm-yy) Production Units/Amount 32 Kilograms Employee No. 90 POLLUTANTS

SUMMARY

Outputs (T)

Pollutant Name CAS No. Input Gross (T) Usage

(T) Air MOM Liquid MOM Waste MOM Product MOM Recovery Unaccounted

Effluent Dichloromethane 75 - 09 -2 174,610 174,610 0.139 M 0 M 174,250 M 0 M 0 360 kgs

DimethylFormamide 68- 12 - 2 37,670 37,670 0 M 0 M 33,960 M 0 M 0 3710 kgs Acetonitrile 75-05-08 81,220 81,220 0.047 M 0 M 87,480 M 0 M 0 6260 kgs

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 43 _____________________________________________________________________________________________________

4.0 MANAGEMENT OF THE ACTIVITY

4.1 Environmental Objectives and Targets and Management Programme 2010 The key objectives for 2010 are listed in Table 15 below. A review of the status of these objectives is given in the table. 4.2 Objectives for 2011 The key Objectives and Targets established in the Environmental Management Programme for 2011 are detailed in Table 16 below:

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 44 _________________________________________________________________________________________________________________________________________________

Table 15: Environmental Management Programme 2010

Table 15: ENVIRONMENTAL MANAGEMENT PROGRAMME 2010 Environmental

Objectives Targets Target

Date Responsible Status

1 Reduce Energy Consumption

• Site objective to reduce Energy consumption on site by 2.5% over 2009 figures. (OE project, continued from 2009).

Q4 2010 Technical Services

Total Energy reduction by initiatives in 2010 was 583,000 kWh providing a carbon footprint reduction of 210 tonnes CO2 annually. An Operational Excellence team was set up in 2010 to review and implement proposed changes. The main changes implemented were (a) implementing and adjusting schedule requirements across AHUs providing an annualised reduction of 535,000kWh. In addition to creating a system of control to prevent uncontrolled schedule changes. (b) Fire water pump house temp control and heat tracing thermostat installation. On site for fire protection water and emergency showers found to be have non-functioning or no installed thermostat and thus continuously on. Thermostat installed on heat tracing and set to 4C to prevent water from freezing providing and annualised saving of 28,000kWh Additional local Meters installed on several distribution boards to improve energy monitoring ability were installed in Dec 2010.


(c) Power settings on laptops and PC’s modified to the Energy Star guidelines in order to save power when PCs not in use. By implementing these settings the company will save 4000 euro over 3 years but the programme will also help to reduce output of C02 by further 43 Tons which is equivalent to planting 9 acres of trees OR taking 7 cars off the road.

2 Reduce volume of solvent waste used on site and hence quantity of hazardous waste produced.

• Continue to identify opportunities to reduce quantities of solvents used in processes on site and hence quantity of hazardous waste produced.

Q 4 2010

Technical Services

There has been approximately 10% reduction in the quantity of hazardous waste produced on site. 779.37 T in 2010 versus 871.93 T in 2009. Some projects that were run on site included: (1) A project to lower the quantity of

a known impurity in one of the site products, Lanreotide resulted in a reduction in solvent waste of 20,200 L in 2010.

(2) Yield improvements in Triptorelin Synthesis resulted in a decrease in solvent usage by 6.6% per gram of crude material synthesized, this is a solvent reduction of 8085.86 L per synthesis batch.

(3) Significant yield improvements in Lanreotide have resulted in approximately 15,000 L further savings in waste generation on an annual basis.

3

Continuous Environmental Improvement - Training

• Continue to run environmental awareness programmes on site for all personnel.

Q4 2010

EHS

Environmental awareness training run on site to cover gaps and new starters.

4

Identify opportunities for improvement to Emergency

• Continued training of ERT team in terms of response to chemical spill

Q2 2010

EHS ERT training carried out throughout 2010. This included chemical spill


Response procedures, including minimising effects of any Emergency on the Environment.

incidents to improve proficiency. • Carry out at least 1 chemical spill

response drill with ERT members

response training with practical exercises.

6 Mass Balance Improvement • Improve accuracy of sampling on site to reduce variation in results and improve accuracy of overall end of year mass balance. Explore opportunities to improve mixing in waste tanks prior to sampling.

Q2 2010 Logistics New in-line waste sampler installed in December 2010. This should help reduce inaccuracies with sampling procedure. Full effects of this should be observed throughout 2011.

7 Maintenance and calibration of control and monitoring Equipment

• Ensure all Maintenance and calibration of control and monitoring equipment is maintained for 2010

Q4 2010 Engineering/ EHS

Maintenance and calibration of control and monitoring equipment was maintained for 2010.

8 Outsourcing of weekly Environmental testing.

• Effective outsourcing of weekly Environmental testing required for Process effluent to accredited Laboratory. Ensure audit of proposed Laboratory is carried out and documented.

Q1 2010 Quality Weekly process effluent composite sample now being sent to accredited external vendor. Vendor approved and audited by site personnel.


Table 16: Environmental Management Programme 2011

Table 15: ENVIRONMENTAL MANAGEMENT PROGRAMME 2011 Environmental

Objectives Targets Target

Date Responsible Status

1 Reduce Energy Consumption

• Site objective to reduce Energy consumption on site by 2.5% over 2010 figures.

Q4 2011 Operations

2 Reduce volume of solvent waste used on site and hence quantity of hazardous waste produced.

• Continue to identify opportunities to reduce quantities of solvents used in processes on site and hence quantity of hazardous waste produced.

Q 4 2011

Industrial Development

3

Continuous Environmental Improvement - Training

• Continue to run environmental awareness programmes on site for all personnel.

Q3 2011

EHS

4

Identify opportunities for improvement to Emergency Response procedures, including minimising effects of any Emergency on the Environment.

• Identify all reasonably foreseeable emergency response scenarios and ensure an action plan for such scenarios is documented and training is rolled out to ERT.

Q4 2011

EHS / ERT team

6 Carbon Footprint (Corporate initiative)

• Carbon footprint for Ispen Dublin site to be produced by end Q4 2011.

Q3 2011 Operations

7 Maintenance and calibration of control and monitoring Equipment

• Ensure all Maintenance and calibration of control and monitoring equipment is maintained for 2010

Q4 2010 Engineering/ EHS

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 48 _________________________________________________________________________________________________

4.3 PUBLIC INFORMATION

It is IMIL‘s policy to respond in a positive and open manner to any genuine enquiries from the public regarding the environmental effects of our operations. Upon receipt of an information request or enquiry from a member of the public an appointment will be scheduled and an IMIL management representative, with the required training and qualifications, will be made available. It is IMIL‘s objective that a copy of our environmental programme and progress as well as details of environmental performance results should be available at this meeting.

Copies of the most recent Annual Environmental Report and the three most recent reports relating to emission to the sewer, Air and Firewater Pond Discharge are kept at reception.

No requests for information on IMIL‘s Environmental record were received from the public in 2010

IMIL received no complaints from any source relating to the environmental impact of any activity conducted on site.

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 _________________________________________________________________________________________________

Appendix 1 – Groundwater Monitoring Report

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 _________________________________________________________________________________________________

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 ___________________________________________________________________________________________________________________________________________________

Appendix 2 – SE2 Process effluent quarterly reports

Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: January- MarchSchedule: 5(i)Monthly Report: January 2010

Final Effluent Limit Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Temperature Daily Max. < 42 oC 12.3 12.8 12.2 13.3 13.8 13.0 12.2 12.8 13.3 12.2 12.2 10.7 10.4 10.7 12.2 13.3 13.8 13.8 13.3 12.2 12.8 13.3 12.2 12.8 13.3 13.2 12.8 12.8 12.8 12.8 12.2

pH Daily Max. Range 6-10 8.1 8.1 8.1 8.4 8.1 8.0 7.9 8.0 8.1 8.1 8.1 7.4 7.6 8.1 8.1 7.8 7.9 7.9 7.8 7.7 7.7 7.6 8.0 8.0 8.0 8.1 8.1 8.0 8.0 8.1 8.3

Daily Min. 7.3 7.6 7.6 7.4 5.7 7.1 7.1 7.0 6.9 6.9 7.0 7.1 6.9 7.3 7.2 7.2 7.2 6.1 7.1 6.8 7.1 7.1 7.0 7.0 6.8 6.9 6.9 6.6 6.9 6.8 6.9

BOD (mg/l) 1000 2.7 1.4 7.5 2.2 3.5

COD (mg/l) 2000 7.0 15.8 18.7 30.0 17.9

SS (mg/l) 400 2.0 6.5 4.5 5.0 4.5

Detergents (mg/l) 100 0.1 0.1 0.2 0.2 0.2

Sulphate (mg/l as SO4) 1000 16.8 24.4 24.5 19.1 21.2

Outflow (m3) per day 40 8.2 12.5 7.8 8.4 9.5 8.3 12.2 13.3 12.1 6.8 3.9 0.5 9.0 4.6 7.4 9.1 9.3 8.8 9.5 9.5 9.4 8.6 3.5 4.6 9.3 8.8 9.0 3.4 8.6 12.6 10.0 258.4

Hourly Max. 5 0.5 1.0 0.5 0.8 0.7 0.7 1.4 1.4 1.6 0.8 0.5 0.3 0.8 0.7 0.7 0.8 0.8 0.8 0.7 0.8 0.8 0.8 0.7 0.7 0.7 0.7 0.7 0.6 0.7 1.0 0.7

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: January- MarchSchedule: 5(i)Monthly Report: February 2010

Final Effluent Limit Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Temperature Daily Max. < 42 oC 13.3 12.8 12.8 13.8 13.8 13.3 14.8 14.8 13.8 13.2 12.8 12.5 13.8 14.3 14.8 13.3 13.5 13.3 13.3 13.3 13.0 13.3 12.8 13.3 12.8 13.3 13.8 13.8

pH Daily Max. Range 6-10 8.3 8.3 8.1 8.2 8.2 7.4 8.1 8.2 8.1 8.1 8.7 8.4 8.1 8..1 8.1 8.1 8.2 8.1 8.3 8.4 8.3 8.4 7.7 7.7 7.6 7.6 7.6 7.6

Daily Min. 6.9 6.9 6.1 6.9 6.9 7.1 7.1 6.5 6.5 6.9 6.6 6.1 6.9 6.9 6.5 6.6 6.6 6.9 6..9 6.8 6.9 6.9 7.6 7.6 7.6 7.6 7.6 7.6

BOD (mg/l) 1000 1.0 1.0 1.0 2.6 1.4

COD (mg/l) 2000 13.2 21.6 16.1 23.3 18.6

SS (mg/l) 400 4.5 4.5 4.0 3.5 4.1

Detergents (mg/l) 100 0.2 0.4 0.2 0.3 0.2


Outflow (m3) per day 40 7.8 8.1 4.1 3.6 5.8 2.6 3.2 4.4 9.7 8.9 9.0 11.9 11.5 10.2 7.4 7.8 8.0 7.0 8.2 9.1 8.9 8.7 7.7 7.6 7.3 6.4 6.5 6.8 207.9

Hourly Max. 5 0.7 0.6 0.7 0.7 0.6 0.2 0.5 0.5 0.8 0.7 0.9 1.1 1.3 1.1 0.6 0.7 0.7 0.6 0.7 0.7 0.7 0.8 0.7 0.8 0.7 0.7 0.7 0.7

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: January- MarchSchedule: 5(i)Monthly Report: March 2010




Daily Min. 7.6 7.6 7.6 7.5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 4.2 3.5 7.3 7.5 7.3 7.5 7.5 7.4 7.4 7.5 7.4 7.4 7.3 7.4 7.3 7.1 7.0

BOD (mg/l) 1000 1.0 6.7 1.0 1.0 2.4

COD (mg/l) 2000 19.0 19.2 12.1 8.2 14.6

SS (mg/l) 400 7.6 6.0 2.0 6.0 5.4

Detergents (mg/l) 100 0.3 0.2 0.1 0.1 0.2


Outflow (m3) per day 40 3.4 8.5 9.6 9.4 9.7 9.1 9.2 14.4 8.2 10.3 11.9 10.8 8.1 8.5 8.3 9.3 7.8 8.1 8.3 8.0 8.0 9.2 8.5 8.0 9.4 8.2 8.4 8.2 8.6 8.7 11.5 277.7

Hourly Max. 5 0.7 0.7 0.8 0.8 0.8 0.7 0.8 1.2 0.6 1.2 1.1 0.8 0.4 0.5 0.4 0.9 0.4 0.5 0.4 0.4 0.4 0.7 0.6 0.4 0.8 0.7 0.6 0.7 0.6 0.6 1.0

Low pH on the 16th March reported to the EPA.Note: Probe calibrated on the 15th March - no non compliance

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: April-JuneSchedule: 5(i)Monthly Report: April 2010

Final Effluent Limit Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Temperature Daily Max. < 42 oC 13.6 13.8 13.8 13.8 13.8 15.3 15.3 14.3 14.7 13.8 14.6 15.8 15.3 17.4 15.3 16.3 14.8 14.8 17.4 16.8 15.3 17.9 17.9 17.4 16.3 16.3 17.4 16.8 16.3 17.4

pH Daily Max. Range 6-10 7.5 7.6 8.1 8.0 8.1 8.0 7.9 7.9 7.8 7.8 7.7 7.8 7.9 7.9 7.7 7.8 8.1 8.0 8.0 8.1 7.9 7.9 7.9 8.1 7.9 8.0 8.2 7.9 8.0 8.1

Daily Min. 6.9 6.9 7.0 7.4 7.6 7.5 7.3 7.0 6.8 6.8 7.0 7.4 7.0 6.7 6.9 6.7 7.1 7.2 7.2 7.1 7.3 7.1 7.1 7.0 7.0 7.2 6.9 7.1 7.0 7.2

BOD (mg/l) 1000 1.1 1.0 2.1 1.3 4.2 2.0

COD (mg/l) 2000 25.9 9.1 47.4 19.2 22.1 24.7

SS (mg/l) 400 10.0 4.0 7.0 6.0 7.6 6.9

Detergents (mg/l) 100 0.3 0.1 0.3 0.2 0.3 0.3

Sulphate (mg/l as SO4) 1000 68.2 34.3 47.6 45.4 29.0 44.9

Outflow (m3) per day 40 8.7 8.6 8.7 8.5 8.3 8.5 8.9 13.8 11.6 9.4 8.4 8.3 8.7 8.6 8.4 8.6 8.4 8.6 8.2 9.1 10.9 8.3 6.1 7.3 8.2 7.6 7.3 7.0 6.0 7.2 256.5

Hourly Max. 5 0.8 0.7 0.7 0.8 0.7 0.8 0.8 1.7 1.1 0.9 0.7 0.8 0.7 0.7 0.7 0.8 0.8 0.8 0.8 0.8 1.1 0.8 0.8 0.7 0.7 0.1 0.8 0.8 0.7 0.7

Note: Fingal Sample taken on the 26th April 2010

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: April-JuneSchedule: 5(i)Monthly Report: May 2010




Daily Min. 7.3 7.4 7.4 7.0 7.0 7.1 7.2 7.3 7.3 7.2 6.8 6.5 7.0 6.5 7.0 7.4 6.9 6.8 6.5 6.7 6.7 6.8 6.9 6.5 7.0 7.1 7.0 7.0 7.3 7.2 7.0

BOD (mg/l) 1000 2.2 13.3 2.6 6.0

COD (mg/l) 2000 12.7 32.3 35.0 26.7

SS (mg/l) 400 4.0 3.5 4.0 3.8

Detergents (mg/l) 100 0.2 0.2 0.2 0.2

Sulphate (mg/l as SO4) 1000 30.6 33.5 66.9 43.7

Outflow (m3) per day 40 8.6 8.4 8.8 7.2 5.7 6.8 7.0 8.6 9.0 6.9 8.9 11.7 8.4 8.0 8.7 9.1 8.1 10.4 13.5 13.4 12.9 11.8 12.4 9.9 5.5 5.8 6.2 4.6 3.6 4.3 5.1 259.3

Hourly Max. 5 0.8 0.7 0.7 0.8 0.8 0.8 0.7 0.8 0.7 0.8 0.8 1.1 0.8 0.8 0.7 0.7 0.8 0.9 1.0 1.0 0.9 0.9 0.9 0.9 0.8 0.6 0.7 0.6 0.7 0.6 0.7

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: April-JuneSchedule: 5(i)Monthly Report: June 2010


Temperature Daily Max. < 42 oC 19.9 19.4 20.4 19.9 17.9 17.9 17.9 19.4 19.4See note

See note

See note

See note 18.9 19.4 19.5 19.4 19.4 18.4 18.4 18.9 20.4 20.9 20.9 21.4 18.9 18.9 19.3 20.7 20.9

pH Daily Max. Range 6-10 7.6 8.0 8.1 8.2 7.6 7.6 7.6 7.9 7.8See note

See note

See note

See note 8.0 7.8 7.6 7.8 10.1 7.8 7.9 8.0 7.8 7.6 7.4 7.5 7.7 7.7 7.6 7.8 7.7

Daily Min. 5.6 6.5 7.1 6.9 6.9 7.1 7.0 7.1 7.1See note

See note

See note

See note 7.1 7.1 7.0 6.9 4.3 7.2 7.3 6.9 6.6 6.4 6.2 6.9 7.0 7.1 6.6 6.9 7.0

BOD (mg/l) 1000 1.0 1.2 1.0 3.6 1.7

COD (mg/l) 2000 7.0 9.0 16.8 17.5 12.6

SS (mg/l) 400 20.5 4.0 4.1 6.0 8.6

Detergents (mg/l) 100 0.2 0.1 0.2 0.1 0.2


Outflow (m3) per day 40 6.9 8.6 4.7 5.3 2.4 3.6 3.5 4.6 4.1See note

See note

See note

See note 5.3 5.5 4.8 5.0 4.1 2.8 3.0 4.4 7.6 9.1 4.8 4.7 3.5 2.9 4.7 4.8 5.6 126.2

Hourly Max. 5 0.8 1.1 0.7 0.7 0.2 0.3 0.3 0.3 0.4See note

See note

See note

See note 0.6 0.6 0.6 0.5 0.5 0.5 0.5 0.6 1.0 1.0 0.7 0.7 0.6 0.7 0.6 0.7 0.6

Note: Calibration of Probe took place on the 18th June 2010No Data from 10th to 13th June - Ref unplanned event ~64375. This was over a weekend. The site does not operate over a wkend so impact deemed to be negligle.

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: July-SeptemberSchedule: 5(i)Monthly Report: July 2010




Daily Min. 6.4 6.9 7.1 7.1 6.9 6.8 6.9 6.8 6.9 6.9 7.1 6.8 6.6 6.3 6.9 6.9 7.1 7.0 6.6 7.0 6.9 6.9 6.8 6.3 6.0 6.9 6.7 7.0 6.8 6.9 6.9

BOD (mg/l) 1000 1.2 1.0 1.7 1.6 1.2 1.3

COD (mg/l) 2000 16.0 7.0 47.9 20.0 23.7 22.9

SS (mg/l) 400 2.5 4.0 6.0 4.0 2.0 3.7

Detergents (mg/l) 100 0.1 0.1 0.3 0.1 0.3 0.2


Outflow (m3) per day 40 1.7 5.2 3.0 3.5 4.5 4.2 8.0 8.0 4.9 3.5 2.3 4.4 4.1 6.6 11.1 11.2 2.5 3.4 5.0 5.0 5.0 9.8 8.0 13.7 6.3 12.6 11.6 4.1 5.4 5.6 3.8 187.9

Hourly Max. 5 0.8 0.6 0.6 0.6 0.5 0.5 0.9 0.8 0.5 0.6 0.5 0.5 0.5 0.6 0.8 1.2 0.6 0.5 0.6 0.5 0.6 1.1 1.3 1.8 1.1 1.1 0.2 0.7 0.5 0.6 0.6

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: July-SeptemberSchedule: 5(i)Monthly Report: August 2010




Daily Min. 7.1 7.3 7.0 6.9 7.1 7.1 7.1 7.1 6.6 6.6 6.9 6.9 6.9 7.1 7.0 6.9 6.3 6.7 6.5 5.6 6.5 6.9 6.6 6.4 6.4 6.5 6.5 6.6 6.8 6.9

BOD (mg/l) 1000 1.8 1.0 1.0 1.8 1.4

COD (mg/l) 2000 19.0 24.0 16.7 19.0 19.7

SS (mg/l) 400 4.5 9.0 3.5 9.4 6.6

Detergents (mg/l) 100 0.2 0.1 0.2 0.2 0.2


Outflow (m3) per day 40 3.3 2.7 5.0 5.1 7.3 9.2 3.3 3.1 4.4 5.0 4.8 5.1 4.7 3.0 2.9 6.1 4.6 13.0 9.5 12.9 17.2 17.2 13.2 15.1 15.1 10.1 4.5 2.7 3.8 7.1 221.2

Hourly Max. 5 0.6 0.6 0.5 0.6 0.6 1.1 0.6 0.5 0.8 0.6 0.6 0.6 0.6 0.6 0.5 1.0 0.6 1.1 1.0 1.1 1.4 1.0 1.2 1.1 1.2 1.0 1.0 0.5 0.5 1.0

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: July-SeptemberSchedule: 5(i)Monthly Report: September 2010


Temperature Daily Max. < 42 oC 20.4 20.4 20.4 20.4 18.4 18.9 19.4 19.4 18.9 18.9 x x 18.9 18.9 19.4 18.9 18.9 17.9 17.4 18.4 18.9 18.8 18.9 18.9 17.9 17.9 18.9 18.4 17.9 18.9

Daily Max. Range 6-10 7.6 8.1 8.0 7.7 7.7 8.0 7.9 8.2 8.1 8.1 x x 7.6 7.6 7.8 7.8 10.1 7.7 8.0 7.9 8.2 8.1 7.9 7.9 7.8 7.9 7.9 7.8 7.7 7.8

Daily Min. 6.6 6.6 6.4 6.4 6.7 6.2 6.5 6.2 6.4 6.4 x x 6.3 6.5 6.6 6.5 5.3 6.7 na 6.4 5.9 6.6 6.4 6.6 6.6 6.8 6.5 6.8 6.9 6.7

BOD (mg/l) 1000 2.7 1.2 1.2 1.1 2.2 1.7

COD (mg/l) 2000 25.0 17.6 14.9 23.8 14.3 19.1

SS (mg/l) 400 3.5 4.0 4.6 4.5 2.5 3.8

Detergents (mg/l) 100 0.2 0.2 0.2 0.2 0.2 0.2


Outflow (m3) per day 40 4.4 4.6 5.0 5.5 3.6 8.2 5.1 6.6 6.5 5.7 2.2 1.6 3.5 5.6 1.7 6.1 8.9 3.4 6.6 9.2 7.7 6.1 4.8 5.2 3.2 2.5 5.1 5.9 4.6 3.8 152.9

Hourly Max. 5 0.6 0.6 0.5 0.5 0.6 1.1 0.7 1.0 1.3 0.6 0.3 0.3 0.6 0.6 0.6 0.5 1.1 0.6 0.7 1.0 1.0 0.7 0.6 0.6 0.5 0.5 0.6 0.7 0.7 0.5

Issued by: Date:Note: BMS Data system failure from 11-13th Sep. Note: Facility does not operate shift or weekend work so no process operations on the 11th and 12th Sep. Also back up data available.Note: Probe calibration on the 17th September 2010.Note: ESB Power outage for approximately 2 hrs on Sunday the 19th Sept 2010. Site does not operate at weekends so no processing occuring at this time. No impact in these 2 hrs.pH before and after outage was within licence limits.


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: October-DecemberSchedule: 5(i)Monthly Report: October 2010




Daily Min. 6.2 7.0 6.9 7.0 7.3 7.3 7.1 7.1 7.2 7.5 7.7 7.6 7.7 7.6 7.6 7.7 7.7 7.2 7.2 7.4 7.3 7.3 7.5 7.6 7.8 7.6 7.6 7.6 7.5 7.3 7.5

BOD (mg/l) 1000 1.4 1.0 1.2 9.6 3.3

COD (mg/l) 2000 16.5 7.5 8.2 24.1 14.1

SS (mg/l) 400 4.0 2.0 4.0 5.5 3.9

Detergents (mg/l) 100 0.1 0.1 0.1 0.1 0.1


Outflow (m3) per day 40 4.0 3.4 3.3 5.1 6.0 6.0 6.4 9.0 5.9 5.9 5.4 5.5 4.9 4.8 4.8 3.6 3.9 5.3 5.7 5.3 4.7 4.8 3.4 4.0 4.3 5.5 5.1 6.4 7.8 4.0 4.0 158.4

Hourly Max. 5 0.6 0.6 0.6 0.6 0.6 0.6 0.6 1.2 0.7 0.6 0.7 0.7 0.7 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.7 1.1 0.6 0.5

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: October-DecemberSchedule: 5(i)Monthly Report: November 2010




Daily Min. 7.5 7.4 7.4 7.0 7.7 7.8 7.8 7.9 7.5 7.6 7.1 7.0 7.8 7.8 7.2 7.7 7.6 7.6 7.6 7.9 7.4 7.5 7.5 7.4 7.5 7.6 7.7 7.8 7.4 6.1 Mass

BOD (mg/l) 1000 1.8 2.9 1.6 2.7 2.3 0.507155

COD (mg/l) 2000 19.7 14.4 21.9 24.6 20.2 4.54185

SS (mg/l) 400 6.0 6.0 2.5 6.0 5.1 1.155185

Detergents (mg/l) 100 0.4 0.1 0.1 0.2 0.2 0.041835


Outflow (m3) per day 40 5.3 10.5 5.9 5.9 5.8 6.5 6.6 7.2 13.1 11.6 7.1 7.1 6.5 7.3 7.3 6.2 5.2 9.2 7.6 7.0 5.8 6.6 9.0 7.7 7.7 7.1 8.2 9.0 8.5 6.9 225.4

Hourly Max. 5 0.6 1.8 0.8 0.8 0.7 0.6 0.6 0.7 1.0 1.2 1.0 0.9 0.4 0.4 0.5 0.4 0.6 0.7 0.8 0.4 0.3 0.4 1.0 0.7 0.7 0.7 1.0 0.7 0.8 0.8

Issued by: Date:


Ipsen Manufacturing Ireland Ltd.EHS Dept.Effluent Discharge ( SE2)IPPC Licence No. P0117-01Reporting Period: October-DecemberSchedule: 5(i)Monthly Report: December 2010


Temperature Daily Max. < 42 oC 13.3 14.8 14.29 12.76 12.8 12.8 12.2 11.7 12.3 Note 1 Note 1 12.2 15.0 14.8 12.8 13.8 13.3 10.7 10.7 11.7 10.7 11.7 10.7 10.7 10.2 9.7 10.7 11.2 11.7 12.2 12.8

pH Daily Max. Range 6-10 8.6 8.4 8.4 8.6 8.6 8.6 8.4 9.5 8.2 Note 1 Note 1 8.3 8.3 8.3 8.4 8.4 8.6 8.1 8.1 8.2 8.3 7.9 8.0 8.1 7.9 8.4 8.5 8.6 8.4 8.3 8.1

Daily Min. 7.4 7.3 7.4 7.4 7.4 7.4 7.1 5.2 7.4 Note 1 Note 1 7.7 7.5 7.6 8.0 7.8 7.7 7.6 7.6 7.5 7.4 6.4 7.7 7.5 7.6 7.4 7.3 7.3 7.2 7.1 7.0

BOD (mg/l) 1000 1.1 6.2 3.0 Note 3 3.4

COD (mg/l) 2000 27.3 35.2 117.0 26.0 51.4

SS (mg/l) 400 4.5 4.4 20.0 4.0 8.2

Detergents (mg/l) 100 0.3 0.2 1.0 0.3 0.5


Outflow (m3) per day 40 7.5 7.1 10.0 7.0 7.0 8.4 8.4 11.8 8.0 1.6 7.9 9.3 6.0 3.9 14.7 22.7 22.1 15.9 14.3 13.0 9.9 10.1 6.4 9.9 7.1 6.0 4.0 6.0 7.6 273.4

Hourly Max. 5 0.7 0.7 1.2 0.6 0.6 1.1 0.7 1.1 0.7 - - 0.7 1.5 1.9 0.6 1.1 1.0 1.5 1.9 1.6 1.8 1.1 1.3 1.3 0.9 1.1 0.7 0.7 0.7 0.6 0.7

Note 1: No flow on Friday from 18.00 to Sunday as a result of B1 essential power shut down due to CHW upgrade. Note: Site does not operate weekends and it was ensured that no activities were planned for 10th to 11th Dec.Note 2: Calibrations took place on the 8th Dec 2010Note 3: External company Alcontrol unable to preform BOD as company was closing for Christmas on the 23rd which did not allow enough time to preform test. Note: All other results were well with licence limits

Issued by: Date:

IPSEN Manufacturing Ireland AER 2010, Licence No. P0117-01 ______________________________________________________________________________________

Appendix 3 – E-PRTR

| PRTR# : P0117 | Facility Name : Ipsen Manufacturing Ltd | Filename : P0117_2010.xls | Return Year : 2010 |

Guidance to completing the PRTR workbook

Version 1.1.11REFERENCE YEAR 2010

1. FACILITY IDENTIFICATIONParent Company Name Ipsen Manufacturing Ltd

Facility Name Ipsen Manufacturing LtdPRTR Identification Number P0117

Licence Number P0117-01

Waste or IPPC Classes of ActivityNo. class_name

5.6

The manufacture of pesticides, pharmaceuticals or veterinary products and their intermediates, not included in paragraphs 5.12 to 5.17.

5.6

The manufacture of pesticides, pharmaceuticals or veterinary products and their intermediates, not included in paragraphs 5.12 to 5.17.

Address 1 Blanchardstown Industrial ParkAddress 2 BlanchardstownAddress 3 Dublin 15Address 4

Country IrelandCoordinates of Location -6.36631 53.4061

River Basin District IEEANACE Code 2120

Main Economic Activity Manufacture of pharmaceutical preparationsAER Returns Contact Name Olivia Cronin

AER Returns Contact Email Address [email protected] Returns Contact Position EHS Manager

AER Returns Contact Telephone Number (01)-8098200 / 8098214AER Returns Contact Mobile Phone Number

AER Returns Contact Fax Number (01)-8098201Production Volume 39.0

Production Volume Units kgsNumber of Installations 0

Number of Operating Hours in Year 0Number of Employees 90

User Feedback/CommentsWeb Address

2. PRTR CLASS ACTIVITIESActivity Number Activity Name50.1 General

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 ? NoIf applicable which activity class applies (as per

Schedule 2 of the regulations) ? naIs the reduction scheme compliance route being

used ? na

AER Returns Workbook


4.1 RELEASES TO AIR Link to previous years emissions data | PRTR# : P0117 | Facility Name : Ipsen Manufacturing Ltd | Filename : P0117_2010.xls | Return Year : 2010 | 24/03/2011 19:528 8 16 16 24 26 6 6 6

SECTION A : SECTOR SPECIFIC PRTR POLLUTANTSPlease enter all quantities in this section in KGs

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/Year0.0 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 PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITY



SECTION C : 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/Year

230 TA Luft organic substances class 1 M OTH

Adsorbent trapping of VOC from emmission point with thermal desorption via GC-MS 202.48 202.48 0.0 0.0






Additional Data Requested from Landfill operators

Landfill: Ipsen Manufacturing LtdPlease enter summary data on the quantities of methane flared and / or utilised

additional_pollutant_no T (Total) kg/Year M/C/E Method CodeDesignation or

DescriptionFacility Total Capacity m3

per hourTotal estimated methane generation (as per

site model) 0.0 N/AMethane flared 0.0 0.0 (Total Flaring Capacity)

Methane utilised in engine/s 0.0 0.0 (Total Utilising Capacity)Net methane emission (as reported in Section

A above) 0.0 N/A

POLLUTANT METHODMethod Used

For the purposes of the National Inventory on Greenhouse Gases, landfill operators are requested to provide summary data on landfill gas (Methane) flared or utilised on their facilities to accompany the figures for total methane generated. Operators should only report their Net methane (CH4) emission to the environment under T(total) KG/yr for Section A: Sector specific PRTR pollutants above. Please complete the table below:

Method Used

Method Used

RELEASES TO AIRPOLLUTANT METHOD

Method Used

POLLUTANT

RELEASES TO AIR

RELEASES TO AIRMETHOD


4.2 RELEASES TO WATERS Link to previous years emissions data | PRTR# : P0117 | Facility Name : Ipsen Manufacturing Ltd | Filename : P0117_2010.xls | Return Year : 2010 | 24/03/2011 19:528 8 16 16 24 24 6 6 6

SECTION A : SECTOR SPECIFIC PRTR POLLUTANTS Data on ambient monitoring of storm/surface water or groundwater, conducted as part of your licence requirements, should NOT be submitted under AER / PRTR Reporting as this onPlease enter all quantities in this section in KGs

QUANTITY



SECTION B : REMAINING PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITY



SECTION C : 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/Year0.0 0.0 0.0 0.0


RELEASES TO WATERS

Method Used

RELEASES TO WATERS

RELEASES TO WATERS

Method Used

POLLUTANTMethod Used

POLLUTANT

POLLUTANT


4.3 RELEASES TO WASTEWATER OR SEWER Link to previous years emissions data | PRTR# : P0117 | Facility Name : Ipsen Manufacturing Ltd | Filename : P0117_2010.xls | Return Yea 24/03/2011 19:52

8 8 16 20 6 6 6 6SECTION A : PRTR POLLUTANTS

Please enter all quantities in this section in KGsQUANTITY



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/Year303 BOD M PER As per licence 6.9 6.9 0.0 0.0306 COD M PER As per licence 59.8 59.8 0.0 0.0240 Suspended Solids M PER As per licence 14.4 14.4 0.0 0.0308 Detergents (as MBAS) M PER As per licence 0.6 0.6 0.0 0.0343 Sulphate M PER As per licence 166.0 166.0 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


4.4 RELEASES TO LAND Link to previous years emissions data | PRTR# : P0117 | Facility Name : Ipsen Manufacturing Ltd | Filename : P0117_2010.xls | Return Year : 2010 | 24/03/2011 19:528 8 16 16 6 6 6 6

SECTION A : PRTR POLLUTANTSPlease enter all quantities in this section in KGs

QUANTITY

No. Annex II Name M/C/E Method Code Designation or Description Emission Point 1 T (Total) KG/Year A (Accidental) KG/Year0.0 0.0 0.0


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/Year0.0 0.0 0.0


RELEASES TO LAND

RELEASES TO LAND



5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE | PRTR# : P0117 | Facility Name : Ipsen Manufacturing Ltd | Filename : P0117_2010.xls | Return Year : 2010 | 24/03/2011 19:525 27 Please enter all quantities on this sheet in Tonnes 5

Quantity (Tonnes per

Year)

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

(HAZARDOUS WASTE ONLY)

Transfer DestinationEuropean 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 / Di sposer / Broker Address of Recoverer / Di sposer / Broker Name and Address of Fi nal Desti nati on i .e. Final Recovery / Di sposal Site (HAZARDOUS WASTE ONLY) Licence / Permit No. of F inal Destination i .e. F inal Recovery / Disposal Site (HAZARDOUS WASTE ONLY)

To Other Countries 07 05 03 Yes 114.3organic halogenated solvents, washing liquids and mother liquors R2 M Weighed Abroad

Indaver Ireland Limited,Waste licence number 36-2/ BS52231H

Indaver Tolka Quay Road,Dublin Port,Dublin 1,.,Ireland

BIP organics Limited,BS52231H,8 Winmarleigh Street,.,Warrington,Cheshire,United Kingdom

Brooks Lane Industrial Estate,Brooks Lane ,Middlewich,Cheschire,United Kingdom

To Other Countries 07 05 03 Yes 618.228organic halogenated solvents, washing liquids and mother liquors D10 M Weighed Abroad



AVG,E2310/33/98,Abfall-Vertwertungs-Gerellschaft mbh,Borsigstrasse 2,Hamburg,D-22113,Germany

Abfall-Vertwertungs-Gerellschaft mbh,Borsigstrasse 2,Hamburg,D-22113,Germany

To Other Countries 07 05 13 Yes 0.662solid wastes containing dangerous substances D10 M Weighed Abroad





To Other Countries 13 01 10 Yes 4.22 mineral-based non-chlorinated hydraulic oils D10 M Weighed Abroad





To Other Countries 13 01 13 Yes 0.022 other hydraulic oils D10 M Weighed Abroad





To Other Countries 13 03 07 Yes 0.03mineral-based non-chlorinated insulating and heat transmission oils D10 M Weighed Abroad





To Other Countries 13 08 99 Yes 0.005 wastes not otherwise specified D10 M Weighed Abroad





To Other Countries 15 01 10 Yes 5.383packaging containing residues of or contaminated by dangerous substances D10 M Weighed Abroad





To Other Countries 15 02 02 Yes 3.349

absorbents, filter materials (including oil filters not otherwise specified), wiping cloths, protective clothing contaminated by dangerous substances D10 M Weighed Abroad





To Other Countries 16 05 08 Yes 3.676discarded organic chemicals consisting of or containing dangerous substances D10 M Weighed Abroad






laboratory chemicals, consisting of or containing dangerous substances, including mixtures of laboratory chemicals D10 M Weighed Abroad





To Other Countries 16 05 07 Yes 3.522discarded inorganic chemicals consisting of or containing dangerous substances D10 M Weighed Abroad





Within the Country 16 02 13 Yes 0.962

discarded equipment containing hazardous components (16) other than those mentioned in 16 02 09 to 16 02 12 R13 M Weighed Offsite in Ireland



Rehab Recycling,WPR 033,Broomhill road,Unit 77,Tallaght,Dublin 24,Ireland

Broomhill road,Unit 77,Tallaght,Dublin 24,Ireland

Within the Country 20 01 21 Yes 0.044fluorescent tubes and other mercury-containing waste R13 M Weighed Offsite in Ireland





Within the Country 20 01 35 Yes 0.99

discarded electrical and electronic equipment other than those mentioned in 20 01 21 and and 20 01 23 containing hazardous components R13 M Weighed Offsite in Ireland





To Other Countries 06 01 01 Yes 0.254 sulphuric acid and sulphurous acid D10 M Weighed Abroad





To Other Countries 06 01 04 Yes 0.009 phosphoric and phosphorous acid D10 M Weighed Abroad



Indaver N.V,MLAVI/9800000485,Poldervlietweg 5,Haven 550,2030 Antwerp,.,Belgium

Poldervlietweg 5,Haven 550,2030 Antwerp,.,Belgium

To Other Countries 06 01 06 Yes 0.155 other acids D10 M Weighed Abroad






wastes whose collection and disposal is subject to special requirements in order to prevent infection D10 M Weighed Abroad

Eco Safe Systems Limited,54-2

Unit 1A,Allied Indusrtrial Estate,Kylemore Road Ballyfermot,Dublin 10,Ireland

Eco Safe Systems Limited,54-2,Unit 1A,Allied Indusrtrial Estate,Kylemore Road Ballyfermot,Dublin 10,Ireland

Unit 1A,Allied Indusrtrial Estate,Kylemore Road Ballyfermot,Dublin 10,Ireland

Within the Country 20 03 01 No 14.1 mixed municipal waste D1 E Weighed Offsite in Ireland Thorton's Recycling,44-2

Killeen Road,Ballyfermot,Dublin 10,.,Ireland

Within the Country 17 09 04 No 22.5

mixed construction and demolition wastes other than those mentioned in 17 09 01, 17 09 02 and 17 09 03 D1 E Weighed Offsite in Ireland Thorton's Recycling,44-2


Within the Country 20 01 01 No 11.06 paper and cardboard R5 E Weighed Offsite in Ireland Thorton's Recycling,44-2


To Other Countries 07 05 04 Yes 21.68other organic solvents, washing liquids and mother liquors D10 M Weighed Abroad





Method Used

ipsen manufacturing ireland ltd. annual … · licence register number :- p0117-01 name :- ipsen...

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