IPSEN Manufacturing Ireland Ltd. ANNUAL ENVIRONMENTAL … · 2014. 12. 16. · 11th November 2008 was sent to Enterprise Ireland in Shannon for Toxicity testing in their Aquatic Toxicity

IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 Page 1 of 46 ______________________________________________________________________________________________

IPSEN Manufacturing Ireland Ltd.

ANNUAL ENVIRONMENTAL REPORT

2008

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…………………………………………………………………………………………….34 2.7 Energy & Water Consumption........................................................................................ 34 2.7.1 Energy Consumption .................................................................................................. 34 2.7.2 Water Consumption................................................................................................... 36 2.8 Environmental Incidents & Complaints .......................................................................... 36 2.9 Spending on Environmental Protection 2008……………………………………………….37 2.10 Summary of Agency Monitoring and Enforcement......................................................... 37 2.10.1 Monitoring ................................................................................................................. 37 2.10.2 Audits and Inspections ............................................................................................... 37 Pollution Emission Register .................................................................................................. 38 3.1 Method of Measurement ................................................................................................ 38 3.2 Mass Balance Methodology ........................................................................................... 39 3.2.1 Acetonitrile .............................................................................................................. 39 3.2.2 Dichloromethane..................................................................................................... 39 3.2.3 Dimethylformamide ...................................................................................................... 40 4. Management of the activity ............................................................................................ 42 4.1 Environmental objectives and Targets and Management Programme 2008.................. 42 4.1.1 Review of 2008 Objectives........................................................................................... 42 4.2 Objectives for 2009…………………………………………………………………………….42 4.3 Public Information .......................................................................................................... 44


List of Tables

Table 1. Emissions to SE2 …………………………………………………………………..... 8Table 2. Compliance Monitoring of Emissions to SE2 for 2008 …………………………... 9Table 3. VOC Analysis of SE2 …………………………………………… 10Table 4. Toxicity Analysis of SE2 10Table 5. Pre-discharge Firewater Pond Analysis 11Table 6. Results of Air Emissions from A3 during 2008 ………………… 12Table 7. Mass Air Emissions from Emission point A3 13Table 8. Total Hazardous Waste 2008 …………………………………………………….... 15Table 9. Total Non-Hazardous Waste 2008 ……………………………………………….... 15Table 10. Details of Hazardous Waste sent off-site for Disposal/Recovery 16Table 11. Details of Hazardous Waste sent off-site for Disposal/Recovery ………………. 20Table 12. Details of Non-Hazardous Waste sent off-site for Disposal/Recovery ………… 33Table 13. Expenditure on Environmental Protection 2008 ………………………………….. 38Table 14. PER ………………………………………………………………………… 41Table 14. Environmental Management Programme 2009…………………… 43

List of Figures

Figure 1. SE2 Emissions 2006 to 2008 ………………………………………………………. 9 Figure 2. A3 Emissions 2006 to 2008………………………………………………………... 14Figure 3. Total Production 2006 to 2008…………………………………………………….. 33Figure 4. Total Waste Produced per gram of Product 2006 to 2008……………………... 34Figure 5. Waste Composition 2008 …………………………………………………………... 34Figure 6. Energy Use 2008 ……………………………………………………………………. 35Figure 7. Energy Consumption per gram of Product 2006 to 2008………………………. 36Figure 8. Electricity Consumption per gram of Product 2006 to 2008……………………. 36Figure 9. Water Consumption per gram of Product 2006 to 2008…………………………. 37

APPENDICES Appendix 1 – Ground Water Monitoring Report Appendix 2 – 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 2008.

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 groups 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 2008 here were 82 employees at IMIL. The production output in 2008 was 39.8 kg of API.

1.1 ORGANISATIONAL STRUCTURE IMIL employs science graduates for all production and quality functions. Responsible persons are as follows: Dr. Finbar Larkin : Managing Director Catherine Cummins, MSc : Head of Quality Sarah Mahon : Head of Finance and Administration Dr. Tom Loughman : Head, Chemical Process Development Mr. James Byrne : Head of Plant Operations

Ms Olivia Cronin : EHS Manager (New since August ’08)


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 two of the groundwater monitoring points, MW1 and MW2 on the 8th September 2008 and was monitored at the third groundwater monitoring point on the 10th December 2008. The old MW3 location had been built over due to an extension to the existing production building so a new location, agreed by the agency was drilled on 2nd December 2008.

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

Overall the results of the groundwater quality was found to be good in MW1 and MW2 with only chloride concentrations exceeding the EPA IGV in both up-gradient and down-gradient wells. Chloride is the main parameter affecting the groundwater quality beneath the site and it was detected in each of the three wells. Based on the concentrations detected in the up-gradient well the elevated chloride appears to be as a result of an off-site source of contamination. MW3 also had exceedences of Sulphate and aluminium. It is believed that the reason for this was as a result of recent construction works on site i.e. building 2 extension which was reviewed by the agency. 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 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)

2008 Emissions 25.3 226.9 18 2.9 44.9 1698 2007 Emissions 35.4 113.9 11.9 1.7 58.8 1690 2006 Emissions 14.9 192 9.9 1.9 10.1 684.5 2005 Emissions 5.7 15.1 2.3 0.8 10.9 491.8

Licensed Emissions 14600.0 29200.0 5840.0 1460.0 14600 14600

IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 Page 8 of 46 ______________________________________________________________________________________________ Figure 1. SE2 Emissions 2005 to 2008

BODCOD

SS

Detergents

Sulphates

Volume

2008 Mass emissions (Kgs)2007 Mass Emissions (kg)

2006 Mass Emissions (kg)2005 Mass Emissions (kg)

Licensed Mass Emissions(kg)

0

5000

10000

15000

20000

25000

30000

kg

Comparison of SE2 Emissions in 2005-2008 with the IPPC Licence specification

2008 Mass emissions (Kgs)2007 Mass Emissions (kg)2006 Mass Emissions (kg)2005 Mass Emissions (kg)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.

Table 2. Compliance Monitoring of Emissions to SE2 for 2008

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 0 100

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

During 2008 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 13th to the 14th of November 2008. 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

13th - 14th November 2008 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 on the 10th and 11th November 2008 was sent to Enterprise Ireland in Shannon for Toxicity testing in their Aquatic Toxicity Laboratory. In 2008 the species and tests were as follows, Method 2: Marine Bacterium: Method 6.2 based on BS EN ISO 11348-3:1999: ‘ Water quality – Determination of the inhibitory effect of water samples on the light emission of Vibrio fischeri (Luminesescent 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 Paramter Concentration % vol. / vol

Toxic units Comments

48 h LC50 to Tisbe battagliai

> 32 < 3.1 30% mortality occurred at 32% vol./vol. 10% mortality occurred at 10% vol.vol. No mortality occurred at 3.2% vol./vol.

5 min EC50 to vibrio fischeri

> 32 <2.2 < 1% light inhibition occurred at 45% vol./vol. - compared to the control

15 min EC 50 to Vibrio fischeri

> 32 <2.2 < 1% light inhibition occurred at 45% vol./vol. - compared to the control


The data for 2008 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 2008. All the results (except 5-Jul-08 – see note below table) obtained prior to discharge were within specification as shown in Table 3 below. Table 5: Pre- discharge Firewater Pond Analysis

Date of Discharge pH 6-9 COD < 50mg/L TOC < 20mg/L 03-Dec-08 7.94 21 6.6 23-Apr-08 7.79 21 <20 05-Jul-08 * 10 * 100 * 10.1 * 12-Aug-08 9 13 7.8 01-Sep-08 8 14 7.8 16-Oct-08 7.5 11 7.2

Note: * On the 5-Jul-08, high pH and COD results were found after sampling the fire water rentention pond. The results were reported to the EPA and Fingal County Council and approval was granted to discharge to the pond to sewer. It was concluded that the elevated pH and COD were due to run off of rain water from newely laid concrete in building 2.

2.4 Emissions to Air

Sampling and subsequent analysis of the A3 Emission point was conducted by ASEP at Queen’s University Belfast. During 2008 the EPA carried out one analysis of the A3 emission point on the 6th May 2008. All results carried out on site in 2008 can be seen in Table 6 below. On Review of Air monitoring report Ref. Report No- P0117-01AVR08-1 issued by EPA on the 15th July 2008 for sampling carried out on the 6th May, the report stated in error that DCM measured results were in compliance with license limits as DCM was being measured under T.A. Luft Class II and not T.A. Luft Class I as it should have been. Ipsen notified the agency once this error was noticed and a ‘Notification of Non-Compliance’ was issued to Ipsen on the 18th September 2008. The results found by the EPA recorded DCM levels in the order of 111.64 mg/m3 which exceeded license requirements for TA Luft Class I ( 20 mg/m3 @ mass flow of >0.1kg/h). An investigation into efficiency of carbon absorber was instigated immediately on site. Modifications were made to the Carbon Adsorber to improve efficiency of unit. Increased frequency of monitoring was also implemented for a 6 month period to ensure that problem was rectified. Monitoring since modifications were made have shown for further non-compliances with license limits.


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

Table 6: Results from Air Emission Point A3 during 2008.

Emission Point Reference A3 Reporting Period 2008 IPPC License No P0117-01 Schedule 1 (ii) TA Luft Class 1: Emission Limit Value = 20 mg/m3 (at mass flows > 0.1 kg/h)

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

31-Jan-08 Dichloromethane 36 0.0642 29-Feb-08 Dichloromethane 30 0.0467 25-Apr-08 Dichloromethane 94 0.0205 06-May-08 Dichloromethane 112 0.2 04-Jul-08 Dichloromethane 17 0.0219 16-Sep-08 Dichloromethane 6.4 0.02 31-Oct-08 Dichloromethane 31 0.0658 26-Nov-08 Dichloromethane 3.1 0.0069 12-Dec-08 Dichloromethane 11 0.0036

Mass Emission = 437.61 kg Note: * Result on the 6th May is as explained in section 2.4 TA Luft Class 2: Emission Limit value = 100 (at mass flows > 2kg/h)


31-Jan-08 Toluene 1.7 0.003 29-Feb-08 Toluene 5.3 0.0082 25-Apr-08 Toluene 0.6 0.0013 04-Jul-08 Toluene 0.9 0.0012 16-Sep-08 Toluene 0.8 0.002 31-Oct-08 Toluene 8.8 0.0187 26-Nov-08 Toluene 0.2 0.0004 12-Dec-08 Toluene 1.9 0.0023

Mass Emission = 40.62 kg


TA Luft Class 3: Emission limit value is 150 (at mass flows > 3 kg/h)


31-Jan-08 Alcohol 9.1 0.0162 31-Jan-08 Acetonitrile 51 0.091

29-Feb-08 Alcohol 12 0.0187 29-Feb-08 Acetonitrile 8.4 0.0131

25-Apr-08 Alcohol 12 0.0261 25-Apr-08 Acetonitrile 3.5 0.0076

04-Jul-08 Alcohol 3.2 0.0041 04-Jul-08 Acetonitrile n/a Not analysed

16-Sep-08 Alcohol 1.7 0.0042 16-Sep-08 Ethyl Acetate 0.4 0.001 16-Sep-08 Acetonitrile 0.7 0.0017

31-Oct-08 Alcohol 2.5 0.0053 31-Oct-08 Acetonitrile 8.9 0.0189

26-Nov-08 Alcohol 0.4 0.0009 26-Nov-08 Acetonitrile 0.5 0.0011

12-Dec-08 Alcohol 1.1 0.0014 12-Dec-08 Acetonitrile 2.9 0.0036

Mass Emission = 243 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

2008 Mass Emissions (kg) 438 41 243 722 2007 Mass Emissions (kg) 307 0 295 602 2006 Mass Emissions (kg) 526 0 277 803 2005 Mass Emissions (kg) 389 0 405 794

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 2008, 2007, 2006 and 2005 to the licence limit in kg.


Figure 2: A3 Emissions 2005 to 2008

TA Luft Class I

TA Luft Class 2

TA Luft Class 3

Total TA Luft O

rganics

2008 Mass Emissions (Kg)

2007 Mass Emissions (kg2006 Mass Emissions (kg

2005 Mass Emissions (kgLicensed Mass Emissions(kg)

0

2000

4000

6000

8000

10000

12000

kg

Comparison of A3 Emissions in 2005-2008 with the IPPC Licence specification

2008 Mass Emissions (Kg)2007 Mass Emissions (kg2006 Mass Emissions (kg2005 Mass Emissions (kgLicensed Mass Emissions(kg)

IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 Page 14 of 46 ______________________________________________________________________________________________ 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 2008 a total of 975.31 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 2008 a total of 30.5 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 2008

European Waste Code

Quantity T/Year

Description of Waste

Waste Treatment Operation

Off site recovery

Off site disposal

Location of Treatment

07 05 03 162 Dichloromethane R2 Yes Abroad

07 05 03 798.6 Aqueous Organic D10 Yes Abroad

07 05 13 1.53 Lab glassware waste D10 Yes Abroad

13 01 10 2.46 Waste vacuum oil D10 Yes Abroad

15 01 10 8.91 Empty drums D10 Yes Abroad

15 02 02 1.45 Filter packing material D10 Yes Abroad

20 01 35 0.36 Mixed WEEE R13 Yes Offsite in Ireland

Total 975.3 Total Hazardous Waste = 975.3 Tonnes

Table 9: Total Non-Hazardous Waste 2008

European Waste Code

Quantity T/Year

Description of Waste

Waste Treatment Operation

Off site recovery

Off site disposal

Location of Treatment

20 03 01 22 Canteen/ Plant waste D1 Yes Offsite in Ireland

17 09 04 3 Construction Waste D1 Yes Offsite in Ireland

20 01 01 5.52 Cardboard / Paper R5 Yes Offsite in Ireland

Total 30.5 Total Non-Hazardous Waste 2008 = 30.5 Tonnes

IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 Page 15 of 46 ____________________________________________________________________________________________________________________________________________________ Table 10 : Details of Bulk Hazardous Waste Sent Off-Site for Disposal/Recovery 2008

C1 No. TFS Cons Pickup Date Stream weight Unit Type Description of Waste Haulier Destination Disposal Method

B442627 310941 11/01/2008Mixed Solvent Waste 22.46 Bulk Tank Aqueous Organic UTT AVG D10

B442640 310941 21/01/2008Mixed Solvent Waste 21.26 Bulk Tank Aqueous Organic JPR AVG D10










IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 Page 16 of 46 ____________________________________________________________________________________________________________________________________________________





B442041 311390 06/06/2008Mixed Solvent Waste 21.26 Bulk Tank Aqueous Organic JPR Kommunekemi a/s D10

B442045 311390 13/06/2008Mixed Solvent Waste 22.02 Bulk Tank Aqueous Organic UTT Kommunekemi a/s D10

B442053 311390 20/06/2008Mixed Solvents 21.72 Bulk Tank Aqueous Organic UTT Kommunekemi a/s D10

B483452 311390 27/06/2008Mixed Solvents 21.3 Bulk Tank Aqueous Organic JPR Kommunekemi a/s D10


B483458 311390 14/07/2008Mixed Solvents 20.64 Bulk Tank Aqueous Organic TPI Kommunekemi a/s D10

B483463 311390 21/07/2008Mixed Solvents 22.6 Bulk Tank Aqueous Organic TPI Kommunekemi a/s D10


B483428 311390 05/08/2008Mixed Solvents 21.46 Bulk Tank Aqueous Organic TPI Kommunekemi a/s

D10






B483448 311451 01/09/2008Mixed Solvents 0.01 200L T/H Plastic Aqueous Organic QYL AVG D10





B483816 311453 16/10/2008Mixed Solvents 21.54 Bulk Tank Aqueous Organic UTT AVG D10

B483823 311453 28/10/2008Mixed Solvents 21.76 Bulk Tank Aqueous Organic JPR AVG D10




B482728 311819 09/12/2008Mixed Solvents 21.62 Bulk Tank Aqueous Organic JPR AVG D10 - 70493 21/01/2008Dichloromethane 18 Bulk Tank Chlorinated Waste UTT

P & R Disposal Limited R2

- 70493 14/03/2008Dichloromethane 21 Bulk Tank Chlorinated Waste JPR


- 311596 30/04/2008Dichloromethane 21.5 Bulk Tank Chlorinated Waste JPR






- 311596 30/07/2008Dichloromethane 21.5 Bulk Tank Chlorinated Waste UTT


- 311596 03/09/2008Dichloromethane 21 Bulk Tank Chlorinated Waste UTT




Total Weight for EWC No: 070503* is 960.60 MT


Table 11 : Details of other Hazardous Waste Sent Off-Site for Disposal/Recovery 2008

C1 No. Load TFS Cons Pickup Date Stream weight Unit Type Description of Waste Haulier Destination Disposal

Method

B442638 250 310936 17/01/2008Mixed Packaged Waste 0.14200L Steel Combi

Lab glassware waste LS AVG D10


Lab glassware waste LS AVG D10


Lab glassware waste QYL AVG D10











Total Weight for EWC No:070513* is 1.530 MT

IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 Page 20 of 46 ____________________________________________________________________________________________________________________________________________________ Table 11: Continued : Details of other Hazardous Waste Sent Off-Site for Disposal/Recovery 2008

C1 No. TFS Cons No. Pickup Date Stream weight Unit Type Description of Waste Haulier Destination Disposal

Method

B442638 310937 17/01/2008Mixed Packaged Waste 0.1325L T/H Steel Waste Vacuum Oil LS AVG D10

B442638 310937 17/01/2008Mixed Packaged Waste 0.32200L T/H SteelWaste Vacuum Oil LS AVG D10

B442606 311448 19/02/2008Mixed Packaged Waste 0.0525L T/H Steel Waste Vacuum Oil LS AVG D10

B442662 311448 28/03/2008Mixed Packaged Waste 0.0225L T/H Steel Waste Vacuum Oil QYL AVG D10

B442662 311448 28/03/2008Mixed Packaged Waste 0.39200L T/H SteelWaste Vacuum Oil QYL AVG D10

B442662 B442662 28/03/2008Mixed Packaged Waste 0.0325L T/H Steel Waste Vacuum Oil min AVG D10




B442043 B442043 11/06/2008Mixed Packaged Waste 0.2200L T/H SteelWaste Vacuum Oil IND AVG D10

B483473 311452 01/08/2008Mixed Packaged Waste 0.1325L T/H Steel Waste Vacuum Oil QYL AVG D10 B483473 311452 01/08/2008Mixed Packaged Waste 0.21200L T/H SteelWaste Vacuum Oil QYL AVG D10






B483836 311452 10/11/2008Mixed Packaged Waste 0.0725L T/H Plastic Waste Vacuum Oil QYL AVG D10




C1 No. TFS Cons No. Pickup Date Stream weight Unit Type Description of

Waste Haulier Destination Disposal Method

B442638 311443 17/01/2008Mixed Packaged Waste 0.97200L T/H Steel Empty Drums LS AVG D10


B442638 311443 17/01/2008Mixed Packaged Waste 0.04200L T/H Plastic Empty Drums LS AVG D10

B442638 311124 17/01/2008Mixed Packaged Waste 0.12200L Polylnd Stl Empty Drums LS AVG D10

B442638 311443 17/01/2008Mixed Packaged Waste 0.02200L T/H Steel Empty drums QYL AVG D10

B442638 311443 17/01/2008Mixed Packaged Waste 0.0125L T/H Steel Empty drums LS AVG D10



B442638 311124 17/01/2008Mixed Packaged Waste 0.04200L T/H Plastic Empty drums LS AVG D10

B442638 311441 17/01/2008Mixed Packaged Waste 0.1310L T/H steel Empty drums LS AVG D10




B442638 311443 17/01/2008Mixed Packaged Waste 0.02200L T/H Plastic Empty drums QYL AVG D10





B442606 311443 19/02/2008Mixed Packaged Waste 0.06200L T/H Steel Empty Drums QYL AVG D10


B442606 311441 19/02/2008Mixed Packaged Waste 0.0110L T/H steel Empty Drums LS AVG D10




B442662 311124 28/03/2008Mixed Packaged Waste 0.11200L Polylnd Stl Empty Drums LS AVG D10 B442662 311443 28/03/2008Mixed Packaged Waste 0.0125L T/H Steel Empty Drums QYL AVG D10



B442662 311443 28/03/2008Empty Drums 0.02200L T/H Steel Empty Drums QYL AVG D10


B442662 311443 28/03/2008Mixed Packaged Waste 0.0410L T/H steel Empty Drums QYL AVG D10

B442662 311443 28/03/2008Mixed Packaged Waste 0.0125L T/H Plastic Empty Drums QYL AVG D10






B442018 311455 29/04/2008Mixed Packaged Waste 0.03200L Polylnd Stl Empty Drums QYL AVG D10









B442018 B442018 29/04/2008Mixed Packaged Waste 0.0110L T/H steel Empty Drums min AVG D10





B442043 B442043 11/06/2008Mixed Packaged Waste 0.03200L T/H Steel Empty Drums IND AVG D10 B442043 311443 11/06/2008Mixed Packaged Waste 0.0125L T/H Steel Empty Drums QYL AVG D10



B442043 B442043 11/06/2008Mixed Packaged Waste 0.02200L T/H Steel Empty Drums IND AVG D10























B483806 311443 07/10/2008Mixed Packaged Waste 0.0125L T/H Steel Empty Drums QYL AVG D10 B483806 311443 07/10/2008Mixed Packaged Waste 0.03200L T/H Steel Empty Drums QYL AVG D10





B483806 B483806 07/10/2008Mixed Packaged Waste 0.0110L T/H steel Empty Drums min AVG D10













B482726 B482726 09/12/2008Mixed Packaged Waste 0.03200L Polylnd Stl Empty Drums mi5 AVG D10





B482726 B482726 09/12/2008Mixed Packaged Waste 0.0110L T/H steel Empty Drums mi5 AVG D10


Total Weight for EWC No: 150110* is 8.910 MT


C1 No. TFS Cons. No. Pickup Date Stream weight Unit Type Description of


B442638 310936 17/01/2008Mixed Packaged Waste 0.22200L Steel Combi

Filter Packing Material LS AVG D10


Filter Packing Material LS AVG D10


Filter Packing Material QYL AVG D10










Filter Packing Material Acetonitrile) QYL AVG D10



C1 No. TFS Cons. No. Pickup Date Stream weight Unit

Type Description of


B442665 B442665 28/03/2008 Waste Electrical - Mixed WEEE 0.36 Item

Stability Chamber (Incubater) min

Rehab Recycling (Tallaght) R13


Grand Total Weight: 975.31MT


Table 12: Details of Non-Hazardous Waste sent off-site for Recovery/Disposal 2008

Figure 3. Total Production 2006-2008

Total Production 2006 to 2008

0

5

10

15

20

25

30

35

40

45

2006 2007 2008

Year

kgs

of p

rodu

ct

Quant. Waste Broker Haulier Recovery Disposal Waste Material

MT Description Contractor Contractor Plant Refuse 22 Canteen/Plant n/a Thorntons n/a Thorntons

Construction Waste

3 Construction waste

n/a Thorntons n/a Thorntons

Cardboard/ Paper 5.5 General n/a Thorntons Thorntons n/a


Figure 4. Total Waste Produced per Kilogram of Product 2006-2008

Total waste produced per kg product 2006 to 2008

0

5

10

15

20

25

30

35

2006 2007 2008

year

Tonn

es w

aste

per

kg

prod

uct

Figure 5. Waste Composition 2008

Waste Composition 2008

Process Aqueous Organic

Process Chlorinated

Other Hazardous

Other non-Hazardous

79%

16%1% 3%


2.6 NOISE There was no perimeter noise survey performed in 2008. This is not a requirement of the IMIL IPC 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 per kilogram of product increased by 24.7% for 2008 versus 2007, this is primarily due to the fact that the new building 2 came on line in the last few months of 2008. Electricity consumption per kilogram of product produced was increased by 8% for 2008 compared to 2007, again this is primarily due to the new building coming on line. Building 2 was required due to the growth of one our products, Lanreotide, and also to provide improved Laboratory and office accommodation for our Quality Department. The new building provides 1800m2 of additional Laboratory, Office and productions space. Approximately 30% of the building is taken up with production equipment while the remainder is offices and Laboratories. A review of the new building was carried out by the EPA on the 24th October 2008.

Figure 6. Energy Use

Energy Use 2008

Electricity

Gas

52%

48%


Figure 7. Energy Consumption / Kilogram of Product 2006-2008

MWhrs / kg of product

152

93

116

0

20

40

60

80

100

120

140

160

2006 2007 2008

Year

MW

hrs

per

kg

of p

rodu

ct

Figure 8. Electricity Consumption/Kilogram Product 2006-2008

Electricity consumption per kg product 2006 to 2008

0

10

20

30

40

50

60

70

2006 2007 2008

Year

Elec

tric

ity M

Whr

/kg

prod

uct


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. There appears to be a significant increase in the quantity of water used on site in 2008 over previous years, however a new more reliable water meter was installed on site in 2008 by Fingal County Council which now indicates more accurately quantity of water consumed on site. The accuracy of previous year’s data can no longer be guaranteed. There would be an increase in water consumed on site in 2008 due to (a) increased production (b) increased numbers on site and (c) the new building extension coming on line.

Figure 9. Annual Water Consumption per Kilogram of Product 2006-2008

Water consumption per kg product 2006 to 2008

0

50

100

150

200

250

2006 2007 2008

year

m3

wat

er /

kg p

rodu

ct

2.8 ENVIRONMENTAL INCIDENTS & COMPLAINTS No complaints were received from any source regarding IMIL or any of the activities conducted therein. Two environmental incidents were recorded on site in 2008. (1) The DCM exceedance from the A3 monitoring point from the carbon

absorber as explained in section 2.4 above and (2) The diversion of the fire water retention pond water to sewer due to

elevated pH and COD as explained in section 2.3 above. Both incidences were logged on the sites ‘Events Register’ and were tracked to closure.


2.9 SPENDING ON ENVIRONMENTAL PROTECTION 2008

Table 13. Expenditure on Environmental Protection 2008

Item

Expenditure (€)

Effluent Toxicity Study 1100 Effluent VOC Study 284.35

Air Monitoring 2550 Ground Water Monitoring 3654

Hazardous Waste Disposal 366,052 Carbon Adsorber 13,809

Cardboard/Paper Recycling 9,789 EPA 8573

Fingal 1230 Total 407,041

2.10 SUMMARY OF AGENCY MONITORING AND ENFORCEMENT During 2008 no enforcements actions were made against IMIL. All monitoring (except that reference in section 2.4 above) and inspections were in compliance with IPPC licence and the general provisions of all waste and environmental legislation.

2.10.1 MONITORING A total of 2 monitoring visits was conducted by the agency and 6 by Fingal County Council during 2008. The result of the A3 monitoring carried out on the 6th May by the agency was not in compliance with the licence. See section 2.4 above for details on ‘Non Compliance’ issued by the agency with respect to an exceedance of DCM from the A3 monitoring point on site. This issue has since been rectified.

2.10.2 AUDITS AND INSPECTIONS The agency carried out an inspection of the site on the 24th October 2008. No non-compliances were raised.

IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 Page 38 of 46 ______________________________________________________________________________________________ 3.0 POLLUTION EMISSION REGISTER

Reporting Period: 2008 The following materials have been tracked for IMIL’s Pollution Emissions Register.

Annual Usage ( MT) Material 2006 2007 2008

Dichloromethane (DCM) 152.9 183 236 Acetonitrile (MeCN) 65.9 73.9 62.4 Dimethylformamide (DMF) 30.4 35.8 34.7

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 2008 (T)

2. Quantity of material in

process waste tanks at end of year 2007 (T)

3. Quantity of material in

process solvent tanks at end of year 2007 (T)

1. Quantity of waste material sent off site in 2008 (T)

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

solvent tanks at end of year 2008 (T)

4. Quantity of material in waste

tanks at end of the year 2008 (T)

Note: It was determined from below mass balances that there appears to be an issue with our sampling procedure on site which is affecting the accuracy of our mass balances. Samples taken from the tankers are currently not recirculated and hence good mixing of the materials is not achieved. A plan for 2009 is in place with regards to sampling procedure to ensure that greater accuracy of the mass balance is achieved going forward.


3.2.1 ACETONITRILE

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

Mass Balance

Inputs Outputs

1. Total quantity of material delivered onto site in 2008

2. Quantity of

material in process waste tanks at end of year 2007

3. Quantity of

material in process solvent tanks at end of year 2007

79 T

2 T

19 T

1. Quantity of waste material sent off site in 2008

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

solvent tanks at end of year 2008

4. Quantity of material in waste tanks at end of the year 2008

98 T

0

0.24 T

0.84 T

12 T

Total 100 T Total 111.1 T

Mass balance deviation = - 11 T . Note: Improvements in sampling procedure to be reviewed in 2009 to help achieve greater accuracy in mass balance.

3.2.2 DICHLOROMETHANE

Solvent Name: Dichloromethane(DCM) CAS Number: 75 - 09 - 2

Mass Balance

Inputs Outputs


2. Quantity of


177.5 T

15.9 T



solvent tanks at end of

165.7 T

0

0.44 T

12.3 T


3. Quantity of


24 T

year 2008 4. Quantity of material in waste tanks at end of the year 2008

21.7 T

Total 217 T Total 200 T

Mass Balance Deviation = 17 T

Note: Improvements in sampling procedure to be reviewed in 2009 to help achieve greater accuracy in mass balance.

3.2.3 DIMETHYLFORMAMIDE

Solvent Name: Dimethylformamide (DMF) CAS Number: 68 - 12 - 2

Mass Balance

Inputs Outputs


2. Quantity of


3. Quantity of


36. 5 T

1.5 T

7.8 T



solvent tanks at end of year 2008

4. Quantity of material in waste tanks at end of the year 2008

41.5 T 0 0

0.9 T

5.7 T

Total 46 T Total 48 T

Mass Balance Deviation = - 2 T Note: Improvements in sampling procedure to be reviewed in 2009 to help achieve greater accuracy in mass balance.

IPSEN Manufacturing Ireland AER 2007, Licence No. P0117-01 Page 41 of 46 ___________________________________________________________________________________________________________________________________________________

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 01-2008 to 12-2008 (mm-yy to mm-yy) Production Units/Amount 39.8 Kilograms Employee No. 82 POLLUTANTS

SUMMARY

Outputs

Pollutant Name CAS No. Input Gross Usage Air MOM Liquid MOM Waste MOM Product MOM Recovery Unaccount

ed Effluent Dichloromethane 75 - 09 -2 217 217 0.44 M 0 M 200 M 0 M 0 17

DimethylFormamide 68- 12 - 2 46 46 0 M 0 M 48 M 0 M 0 - 2 Acetonitrile 75-05-08 100 100 0.243 M 0 M 111 M 0 M 0 -11

IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 42 of 46 _____________________________________________________________________________________________________

4.0 MANAGEMENT OF THE ACTIVITY

4.1 Environmental Objectives and Targets and Management Programme 2008 The key objectives for 2008 were: (a) to maintain 100% Compliance with IMIL’s IPPC licence (b) to improve energy and electrical consumption on site (c) to place increased focus on quantities of waste produced on site 4.1.1 Review of 2008 Objectives IPC Licence Compliance The Data presented in the AER shows that IMIL maintained full compliance with the conditions of the IPC license in 2008 with the exception of the non-compliance issued for an exceedance of DCM from the A3 stack on site (see section 2.4). Resource Use and Energy Efficiency Energy and electrical usage on the site increased in 2008 and the main reasons for this were due to a new building 2 coming on line. As described in section 2.7.1, the new Building 2 was required due to the growth of one our products, Lanreotide, and also to provide improved Laboratory and office accommodation for our Quality Department. The new building provides 1800m2 of additional Laboratory, Office and productions space. Approximately 30% of the building is taken up with production equipment while the remainder is offices and Laboratories. A review of the new building was carried out by the EPA on the 24th October 2008. Areas that focussed on energy reduction on site in 2008 included:

(a) Replacement of all steam traps on site (b) Use of motion sensor lighting throughout the new building 2.

Waste Reduction Programmes A team that was set up to look at improvements in processes on site identified opportunities to reduce solvent usage on site. These opportunities will be realised in 2009. Other Achievements is 2008 A Process Engineering group was established on site during 2008. Part of the function of this group is to carry out a review of existing processes focusing on efficiencies and wastes. A Lean six Sigma programme was initiated on site with three green belts now trained on site. 4.2 Objectives for 2009 The key Objectives and Targets established in the Environmental Management Programme for 2009 are detailed in Table 14 below:

IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 43 of 46 _____________________________________________________________________________________________________

Table 15: Environmental Management Programme 2009 Table 15: ENVIRONMENTAL MANAGEMENT PROGRAMME 2009

Environmental Objectives

Targets Target Date

Responsible Status

1 Reduce Energy Consumption

• Focus on energy reduction programmes on site. Lean Six Sigma team to be set up Q1 2009 to examine all aspects of energy usage.

• Energy Awareness focus to be included as part of EHS week on site

Q3 2009 Q3 2009

Engineering Engineering/EHS

2 Reduce volume of Hazardous waste Shipped from BMS operations in Ireland.

• Reduce quantity of hazardous waste sent off site for incineration by 10% over 2008. - Lean Six sigma team to focus on this area.

• Opportunities identified in 2008 to reduce solvent usage on site to be put in place.

Q 4 2009 Q4 2009

Technical Services

3

Continuous Environmental Improvement

• Carry out an Environmental Liabilities Risk assessment to access site’s Environmental Liabilities and put in place action place to remedy potential risks

• Improve environmental awareness programmes on site

Q4 2009 Q4 2009

EHS EHS

4

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

• Review all emergency response documentation with focus of chemical spill emergency management

• Carry out at least 1 chemical spill response drill with ERT members

Q3 2009 Q3 2009

EHS

5 Ensure continued integrity of over and underground storage tanks

• Ensure integrity testing of eco-drainage system is in place and carried out in 2009

Q2 2009 Engineering

6 Water consumption • Awareness of focus on water consumption to be carried out.

Q4 2009 EHS

7 Maintenance and calibration of control and monitoring Equipment

• Ensure all Maintenance and calibration of control and monitoring equipment is maintained for 2009

Q4 2009 Engineering

IPSEN Manufacturing Ireland AER 2008, Licence No. P0117-01 Page 44 of 46 _________________________________________________________________________________________________

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 2008.

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


Appendix 1 – Ground Water Monitoring Report


Appendix 2 – E-PRTR

Documents

IPSEN Manufacturing Ireland Ltd. ANNUAL ENVIRONMENTAL … · 2014. 12. 16. · 11th November 2008 was sent to Enterprise Ireland in Shannon for Toxicity testing in their Aquatic Toxicity