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Janssen Biologics Annual Environmental Report 2012
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Contents 1 Introduction ......................................................................................................................... 3
1.1 Licence Registration Number and Site Details. ............................................................. 3 1.2 Description of Site Activities ......................................................................................... 3 1.3 Company Environmental, Health and Safety Policy ..................................................... 4 1.4 Organisational Structure for Environmental Management. ........................................... 5
2 Summary Information .......................................................................................................... 6 2.1 Emissions to Water/Sewer ........................................................................................... 6 2.2 Fish Toxicity Testing .................................................................................................... 6 2.3 Organic compounds Screening .................................................................................... 7 2.4 Groundwater Monitoring............................................................................................... 7 2.5 Storm Water Emissions ............................................................................................... 8 2.6 Emissions to Air ........................................................................................................... 9 2.7 WWTP Odour Abatement Biofilter. ............................................................................... 9 2.8 Energy Consumption ..................................................................................................10 2.9 Water Consumption. ...................................................................................................10 2.10 Waste Management ....................................................................................................10 2.11 Noise Monitoring .........................................................................................................11 2.12 Agency Monitoring and Enforcement ..........................................................................11 2.13 Environmental Incidents and Complaints ....................................................................12 2.14 Submission of Summary Information...........................................................................12
3 Management of the Activity ................................................................................................15 3.1 Schedule of Environmental Objectives and Targets ....................................................15 3.2 Environmental Management Programme (EMP) .........................................................16
4 Additional Requirements: ...................................................................................................22
Appendix 1: Effluent Solvent Analysis 2012
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1 Introduction
1.1 Licence Registration Number and Site Details. IPPC Licence Register Number: P0778-01 Licensee Name: Jannsen Biologics (Ireland) Ltd. Address: Barnahely Ringaskiddy Co. Cork Telephone Number: 021 - 4973000 Contact Name: Mr. John Lynch
EHS Specialist
1.2 Description of Site Activities Jannsen Biologics is a biotechnology company involved in the manufacture of antibodies and therapeutic proteins derived from cell cultures of genetically modified microorganisms. The process can be divided into two stages:
Cell Culture in which cells form a specific working cell line are grown under controlled conditions and the protein from these is then harvested using process called Protein-A affinity chromatography.
Purification in which the product is taken through a series of purification steps including viral inactivation, cation/anion exchange chromatography and viral filtration before being filled and frozen as finished product.
Products currently approved for manufacture at the site include:
CNTO 148- Used in the treatment of Rheumatoid Arthritis.
CNTO 1275- Used in the treatment of Psoriasis and Multiple Sclerosis
CNTO 136- used in the treatment of Auto-immune disease.
CNTO 328- used for the treatment of Castleman’s disease.
JNJ 0443- used for the treatment of chronic pain.
CNTO 888- used in the treatment of Idiopathic Pulmonary Fibrosis.
CR-8020 FluMab for Toxicology and Phase 1 clinical batch manufacturing-used in the treatment of seasonal influenza.
CNT-0812 for Phase 1 and Phase 2 clinical batch manufacturing-used in the treatment of fibrotic diseases.
CNT-06785 for phase 2 manufacturing-used in the treatment of chronic obstructive pulmonary disease.
CNT-01959 for phase 3 manufacturing- used in the treatment of psoriasis and rheumatoid arthritis.
CNT-06141 for phase 1 and phase 2 manufacturing- used in targeting oncology indications.
CNT-06261 for phase 1 and phase 2 clinical batch manufacturing- used in the treatment of seasonal influenza.
CNT-03157 for phase 1 and phase 2 clinical batch manufacturing- used in the treatment of asthma.
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Production quantities increased from a total value of 68.4 kg in 2010 to 96.4 kg in 2011 to 78.3 in 2012.
The number of employees currently is 300. The plant operates continuously 24/7 due to the continuous operation of the bioreactors. There is no shutdown period.
1.3 Company Environmental, Health and Safety Policy Janssen Biologics (Ireland) regards health, safety and environmental protection as an integral part of our business practice and are committed to managing all aspects of our operations in a safe and environmentally responsible manner. In line with Our Credo, we recognise our responsibilities and we believe that our approach to environmental, health and safety management will benefit our employees, contractors, visitors, customers, local community and other stakeholders; both now and in the future. We are committed to meeting all applicable regulatory and corporate requirements, including the requirements of our Integrated Pollution Prevention and Control Licence. We implement and maintain an Environmental Health & Safety Management System to address all environmental health and safety aspects of our operations. As part of this system, we set ourselves environmental health and safety objectives and targets for continuous improvement, measure our performance and make such information publicly available where necessary. All levels of management are committed to, and accountable for, implementing, maintaining, measuring, and improving the environmental, health and safety performance of the Company. We are committed to designing and operating our facilities in a safe and environmentally responsible manner. We assess the environmental, health and safety implications of our operations and implement controls as necessary. We seek to improve our performance through technological development, evaluate the use of clean technology, seek to conserve energy and resources, minimise waste and prevent pollution at each opportunity. We foster a culture that encourages safe and environmentally responsible behaviour by clearly defining the responsibilities of all who work here and we further endeavour to promote health, safety and care for the environment through proactive cooperation and consultation with our stakeholders, including statutory authorities, industry groups, our employees and our neighbours. We believe that all accidents are preventable and are determined to create an injury free site. We are all responsible for achieving this goal and, as such, are committed to making environmental, health and safety an integral part of our operation.
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1.4 Organisational Structure for Environmental Management. The EH&S team are responsible for all aspects of Environmental Management on-site. Specific environmental programmes are supported by other site personnel. A detail of company organisational structure relating to EHS and responsibility for specific management programmes is outlined below:
Management Programmes
Table 1: 2012 Organisational Structures for Environmental Management.
EHS Team Leader Simon Garrett
Industrial Hygienist Loretta Mathews
EHS Specialist John Lynch
EHS Specialist Paul O’ Sullivan
EHS Specialist John Lynch
Occupational Health Nurse Sinead Mooney
Site Leader Kyran Johnson
EHS Specialist
Ruth Earley
Chemical Management Ken O’ Doherty
Emergency Preparedness Trevor Malone
Air Philip Sheehan
Water Philip Sheehan
Waste
Alan Noonan
Tanks
Donncha Collins
Energy
Liam O’ Leary
Management Systems
Simon Garrett
Warehouse
Mick Walsh
Contractor Management
Anne Canniffe
External EHS Engagement
Simon Garrett
External Supply Chain
Denis Sweeney
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2 Summary Information
2.1 Emissions to Water/Sewer Emission to sewer values from emission point SE1 as per Schedule C.3.2 are detailed in table 2 below.
Mass Emissions (Kg)
Parameter 2010 2011 2012 TLV
Volume (m3) 42,714 33,138 38,477 292,000
Suspended Solids 46 133 77 14,600
BOD 144 199 100 17,520
COD 1,903 2,488 4,117 87,600
Total Nitrogen 387 431 445 23,360
Total Phosphorus (as P) 352 96 123 5,840
Sulphate (SO4) 2,734 1,524 1,192 58,400
Oils, Fats & Greases 427 304 <192 5,840 Table 2: 2011 Emissions to Sewer.
Production output increased by 14% from 2011 to 2012. (Ref: EMP TAR 22).
2.2 Fish Toxicity Testing Results of fish toxicity Testing carried out on final effluent in October as per Schedule C.3.2 are detailed in table 3 below.
Test Parameter Concentration (%vol/vol) Toxic Units
48h LC50 to Tisbe battagliai > 32 <3.1
30 min EC50 to Vibrio fischeri >45 <2.2 Table 3: 2012 Fish Toxicity Testing.
Comments: 48h LC50 to Tisbe battagliai: No mortality occurred at 32% vol/vol. 30 min EC50 to Vibrio fischeri: Less than 3% light inhibition occurred at 45% vol/vol.
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2.3 Organic compounds Screening Results of annual organic solvent screening of WWTP effluent emission point SE1, as per Condition 6.11 are detailed in Appendix 1.
2.4 Groundwater Monitoring
Biannual groundwater monitoring, as per Schedule C.6, of licence was carried out during June and November 2012. Groundwater Analytical Results Major cations and anions All the major ion analytical results were below their relevant groundwater quality standards. Total alkalinity concentrations were similar to the previous sampling round. Total alkalinity values are not considered having any significant environmental importance Chemical oxygen demand (COD) COD results obtained from all four monitoring wells during April and October 2012 monitoring rounds were below the laboratory detection limit which represents a decrease from the previous November 2011 monitoring round where elevated COD was detected on site with the highest concentration in AGW1 (99.2mg/l). Total organic carbon (TOC) TOC concentrations in the monitoring wells on-site in 2012 ranged from 3 to 5mg/l similar to previous rounds and are considered an indicator of the overall purity and organic content of water. Nitrite, nitrate, ammonium and total nitrogen All four samples obtained during the April and October 2012 monitoring rounds detected concentrations of nitrite below the laboratory detection limit, similar to the previous monitoring round. The concentrations of nitrate ranged from 15.9mg/l in AGW4 (October) to 22.8mg/l in AGW2 (April) with no comparison standard exceedance. The Groundwater Regulation S.I. 9 of 2010 nitrate standard of 37.5mg/l has not been exceeded in the groundwater monitoring rounds on-site since 2008 when exceedances on-site were thought to be attributed to surrounding agricultural activities. In April 2012 two of the four monitoring wells (AGW2 and AGW3) detected ammonium concentration results below the laboratory detection limit similar to the previous monitoring round. A trace concentration was detected in AGW1 (0.05mg/l) with a concentration detected in AGW4 of 0.19mg/l which slightly exceeds the IGV of 0.15mg/l and Groundwater Regulation S.I. 9 of 2010 standard of 0.175mg/l. Ammonium was not detected above laboratory detection limits in October 2012 in all four monitoring wells. Total nitrogen concentrations ranged from 5.8mg/l in AGW1 to 23.2mgl/ in AGW4 in April. Total nitrogen concentrations are considered an indictor of the overall purity of water. Nitrogen based compounds can occur in groundwater as a result of natural mineral deposits or anthropogenic sources such as wastewater. Organohalogens (SVOCs and VOCs) The Volatile and Semi-volatile organic compounds (VOCs/SVOCs) concentrations were below the laboratory detection limits of 0.01mg/l in all four monitoring wells analysed in April and October 2012, similar to previous monitoring rounds.
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CONCLUSIONS The groundwater quality for the April and October 2012 groundwater monitoring rounds is generally very good and consistent with previous monitoring rounds with no significant exceedance of the relevant groundwater quality standards. There are no potable groundwater abstractions in the immediate vicinity of the site.
2.5 Storm Water Emissions
Results of weekly monitoring of storm water emission points SEMP2 and SEMP3 as per Schedule C.2.3 are detailed in table 4 below.
No Readings/ 52 weeks
Parameter Value SEMP2 SEMP3
COD < 1 mg/l 45 0
1-50 mg/l 7 31
50-100 mg/l 0 18
100-150 mg/l 0 3
Total Ammonia < 1 mg/l 52 49
< 5 mg/l 0 2
<12mg/l 0 1
Total Nitrogen < 1 mg/l 49 0
1-10 mg/l 3 42
10- 20 mg/l 0 9
20-50mg/l 0 1 Table 4: 2012 Storm Water Emissions.
Warning and Action levels for SEMP2 and SEMP3 have been set as detailed in table 5 below.
Alarm Setting
Parameter pH TOC (mg/l)
High Action Level 9.0 75
High Warning Level 8.5 71
Low Warning Level 6.5 N/A
Low Action Level 6.0 N/A Table 5: 2011 Warning and action alarm settings for SEMP2 and SEMP3.
There were no TOC or pH reading at either SEMP2 or SEMP3 exceeding action levels during 2012.
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2.6 Emissions to Air Emission to air values as per Schedule C.1.2 are detailed in table 6 below.
Boiler Mass Emissions (Kg)
Parameter 2010 2011 2012 TLV
Nitrogen Oxides (as NO2)
7,692 4,729 4993.2 48,618
CO 52 60 0 NA
Particulates 75 0 0 1,241
CO2 3,239,000 3,141,000 3,566,000 N/A Table 6: 2012 Boiler emissions to Air.
Particulate data from dust collector vent points A3-11 and A3-12 detailed in table 7 below.
Mass Emissions (Kg)
Parameter 2010 2011 2012 TLV
Particulates* 0.72 1.3 0.58 350 Table 7: 2012 Particulate Emissions from A3-11 and A3-12. (*Calculation based on 30 mins usage/day)
Total particulate sampling and analysis was not performed on boiler emission points A1-1 and A1-2 as agreed with the EPA as the boilers use natural gas as fuel. Emission point A1-4 is not in use.
2.7 WWTP Odour Abatement Biofilter. Monthly monitoring data of WWTP Odour Abatement Biofilter as per Schedule C.1.1 are detailed in table 8 below.
Emissions (ppm)
Parameter Ammonia Hydrogen Sulphide Mercaptans
Jan 0 0 0
Feb 0 0 0
Mar 0 0 0
Apr 0 0 0
May 0.125 0 0
Jun 0 0.2 0
Jul 0.6 0.2 0
Aug 0.25 0 0
Sep 0 0 0
Oct 0.1 0.1 0
Nov 0 0 0
Dec 0.15 1.5 0 Table 8: 2012 WWTP Odour Abatement Bio-filter.
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2.8 Energy Consumption Energy consumption figures for 2010 to 2012 are detailed in table 9 below.
Energy (MWhrs)
Parameter 2010 2011 2012
Electricity 10,472 9,941 10,402
Natural Gas 14,742 16,947 19,216
Diesel 31 30 19
Biomass 4,279 0 0
Total 29,425 26,918 29,637 Table 9: Energy Consumption.
The Biomass Boiler was taken off-line in April 2010 leading to a direct increase in natural gas usage on-site and an accompanying decreasing usage of biomass fuel types.
2.9 Water Consumption.
Mains water usage on-site for 2010 to 2012 are detailed in table 10 below.
Water (m3)
Parameter 2010 2011 2012
Water 73,518 54,743 61,943 Table 10: 2012 Water Usage.
The increase in volume used in 2012 was as a direct result of reduced rainwater recovery as the rain water harvesting system was being upgraded. This system reduces potable water usage by approximately 25% when operational.
2.10 Waste Management Wastes generated on site during 2012 are details in table 11 below.
Waste Generated (mT)
Parameter
Non-Hazardous
2011
Non- Hazardous
2012
Hazardous 2011
Hazardous 2012
Total 2011
Total 2012
Total 288 315 18 49 306 364
Disposal 88 27 10 48 98 74
Recovery 199 287 8 1 207 288
%Recovery 69 91 44 2 68 74 Table 11: 2011 Waste Generated.
The total waste generated on site during 2012 increased by 19%.
Non-Hazardous waste generated on-site increased by 9%, increase related to new processes notified in 2011.
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There was a 188% increase in quantity of Hazardous Waste generated on-site due to lack of segregation of manufacturing non hazardous wastes from hazardous wastes in 2012. This has been adopted as a program for management in 2013.
2.11 Noise Monitoring Annual noise monitoring was carried out on-site in October 2012 as per Condition 6. Results are detailed
in tables 12 and 13 below (Exceedances of the licence limit are highlighted in bold).
Day-time (dB(A))2012
Location LAeq LA90 LA10
N1 42.9 36.3 43.5
N2 47.3 40.8 49.5
N3 50.5 46.0 53.0
N4 57.8 46.0 62.2
N5 56.4 49.0 61.3
NS1 47.7 43.5 49.5
NS2 54.2 48.8 56.2 Table 12: 2012 Daytime Noise Survey Results.
Night-time (dB(A))2012
Location LAeq LA90 LA10
N1 37.0 34.1 38.8
N2 41.9 40.0 42.8
N3 50.9 43.0 49.6
N4 49.6 43.2 53.1
N5 47.2 44.8 49.1
NS1 42.8 41.2 44.8
NS2 42.6 41.4 44.6 Table 13: 2012 Night-time Noise Survey Results.
These exceedances in License limit were not associated with plant activities and was associated with road noise, ambient natural noise and anthropogenic noise from outside of the facility boundary.
2.12 Agency Monitoring and Enforcement
During 2012 the EPA visited the site on one occasion to sample site emissions to sewer point SE1 and surface water emission point SEMP3 and on a second occasion to audit the facility.
18-Jul-12 11:00-14:00 Martin O'Reilly John Lynch
14-Feb-12 12:00 Dave Galvin John Lynch
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2.13 Environmental Incidents and Complaints There were no environmental incidents recorded for 2012. There were no environmental complaints relating to site-operations during 2012
2.14 Submission of Summary Information.
2011 Summary of Emissions
Company Janssen Biologics (Ireland)
Location address Barnahely, Ringaskiddy, Co.Cork
Contact name Simon Garrett
Telephone 021 497 8248
e-mail [email protected]
Register number PO778 GPS Co-ordinates 176983, 64277
Activity number 4.5 NACE Code 212
Main Activity Manufacture of pharmaceutical preparations.
Emissions to Sewer
Parameter Unit TLV 2011 2012
Volume M3 292,00 33,138 38,477
Suspended Solids Kg 14,600 133 77
BOD Kg 17,520 199 100
COD Kg 87,600 2,488 4,117
Total Nitrogen Kg 23,360 431 445
Total Phosphate Kg 5,840 96 123
Oils, fats & greases Kg 5,840 304 1,192
Sulphate (SO4) Kg 58,400 1,524 <192
Non-Compliance 1 0
No samples 52 52
Emissions to Air
Parameter Unit TLV 2011 2012
Particulates Kg 29.2 1.3 0
Nitrogen Oxides Kg 48,618 4,729 4993.2
Total Carbon Dioxide Kg N/A 3,147,000 3,566,000
Non-Compliance 0 0
No samples 1 1
Energy Consumption
Fuel Type Unit Sulphur Content 2011 2012
Diesel M3 3000 19
Natural Gas Nm3 1,759,145 19216
Biomass Kg 0 0
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2011-2012 Summary of Emissions (cont…)
Waste
Total quantity of waste produced (Tonnes) 2011 2012
Total quantity of waste produced disposed off-site 98 75
Total quantity of waste produced recovered off-site 207 288
Total quantity of non-hazardous waste produced (Tonnes) 2011
Total quantity of non- hazardous waste produced disposed off-site 88 27
Total quantity of non-hazardous waste produced recovered off-site 199 287
Total quantity of hazardous waste produced (Tonnes) 2011
Total quantity of hazardous waste produced disposed off-site 10 48
Total quantity of hazardous waste produced recovered off-site 8 2
Water Consumption Unit 2011 2012
Municipal water use M3 54,743 61,943
Environmental Complaints 2011 2012
Complaints received 0 0
Complaints requiring corrective action 0 0
Accreditation 2011 2012
EMAS None None
ISO 14001 Certification Certification Table 14: 2012 Summary Data Table.
Information on Non-Hazardous Waste Streams
EWC Code Description Quantity (Tonnes)
Method of Disposal/Recovery
Location of Disposal/Recovery
20 03 01
mixed municipal waste
29.0
D5 MRF Cork
15 01 06
mixed packaging
10.0
R12
Irish Lamps Recycling Ltd.,IRE/AG042/08,Woodstock Industrial
Estate,Kilkenny Road,Athy,County Kildare,Ireland
20 01 08
biodegradable kitchen and canteen waste
2.0
R3
Greenstar MRF Cork, W0136-2 Sarfieldcourt Glanmire, Co Cork
20 03 01
mixed municipal waste
101.0
R3
Greenstar MRF Cork, W0136-2 Sarfieldcourt Glanmire, Co Cork
Table 15: 2012 Non-Hazardous Waste Summary Data Table.
Information on Hazardous Waste Streams
EWC Code Description Quantity (Tonnes) Method of
Disposal/Recovery Location of Disposal/Recovery
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06 01 06 Other acids .035 D10 AVG, ,Abfall-Verwertungs-Gesellschaft Hamburg, Germany
07 05 13 Solid waste containing dangerous substances
19.736 D10 AVG, ,Abfall-Verwertungs-Gesellschaft Hamburg, Germany
08 01 11 Waste paint and varnish .251 D10 AVG, ,Abfall-Verwertungs-Gesellschaft Hamburg, Germany
12 08 99 Wastes not specified .18 D10 AVG, ,Abfall-Verwertungs-Gesellschaft Hamburg, Germany
16 05 07 Discarded inorganic chemical .176 D10 AVG, ,Abfall-Verwertungs-Gesellschaft Hamburg, Germany
07 05 01
aqueous washing liquids and mother liquors
21.697
D13
Indaver, Poldervlietweg ,Netherlands
07 05 04
other organic solvents, washing liquids and mother liquors
0.04
D13
Indaver Ireland,Licence 36-2,Tokka Quay Road,Dublin Port,Dublin 1 ,.,Ireland
07 05 04
other organic solvents, washing liquids and mother liquors
1.406
D15
Indaver,Poldervlietweg ,Netherlands
07 05 13
solid wastes containing dangerous substances
1.509
D15 Indaver Ireland,Licence 36-2,Tokka Quay Road,Dublin Port,Dublin 1 ,.,Ireland
18 01 03
wastes whose collection and disposal is subject to special requirements in
order to prevent infection
1.77
D15
Ecosafe Systems Ltd.,W0054-02,Allied Industrial Park,Kylemore Road,.,., Ireland
18 01 03
wastes whose collection and disposal is subject to special requirements in
order to prevent infection
.906 D9 Ecosafe Systems Ltd.,W0054-02,Allied Industrial Park,Kylemore Road,.,., Ireland
08 01 11
waste paint and varnish containing organic solvents or other dangerous
substances
0.306
R1
Indaver ,Poldervlietweg , 3,Netherlands
13 08 99
wastes not otherwise specified
0.137
R1
Indaver Ireland,Licence 36-2,Tokka Quay Road,Dublin Port,Dublin 1 ,.,Ireland
15 02 02
absorbents, filter materials (including oil filters not otherwise specified), wiping cloths, protective clothing
contaminated by dangerous substances
0.368
R1
Indaver, Poldervlietweg, Netherlands
Table 16: 2012 Hazardous Waste Summary Data Table.
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3 Management of the Activity
3.1 Schedule of Environmental Objectives and Targets Janssen Biologics determines its objectives, targets and Environmental Management Programmes based on a site philosophy of continuous improvement across all aspects of our business. They are determined in manner which is consistent with the site Environmental Policy and with consideration of the site Register of Environmental Aspects and other legal, corporate and social obligations. Janssen Biologics has set for itself 6 environmental objectives as follows:
1. Manage site operations in a manner which is consistent with achieving improved energy efficiencies and reductions in usage of natural resources. (Ref: OBJ 10)
2. Improve environmental performance and protect natural resources through the design and operation of plant processes in an environmentally responsible manner. (Ref: OBJ 6)
3. Reduce quantities of hazardous and non-hazardous waste generated on-site and optimise waste management operations in line with hierarchy of waste management. (Ref: OBJ 11)
4. Work with external suppliers, contractors and service providers in effecting positive impact on site indirect environmental aspects. (Ref: OBJ 4)
5. Ensure plant operation have no adverse impact on locality or those using local amenities
and endeavour to promote environmental awareness among all our stakeholders.(Ref: OBJ 2)
6. Maintain full compliance with all legislative, regulatory and corporate obligations though continually reviewing and improving all aspects of our EMS. (Ref: OBJ 8)
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3.2 Environmental Management Programme (EMP) EMP’s completed during 2012 and those proposed for 2013 are detailed below.
Ref Start Date Target Status
TAR 26 Jan 10 EMS to be certified to ISO 14001 standards. Closed
Timeframe Jan 2010- May 2012 Environmental Aspects All
Rationale
-IPPC licence requirements requires site to put in place an EMS. -Site objectives require continual improvements in EMS to deliver effective environmental improvements across all aspects of our business.
Responsibility Simon Garrett
Action Date Responsibility Comment
Develop and implement EMS auditing system.
ISO 14001 pre-audit assessment.
ISO 14001 certification audit.
Jan 10 Oct 10 May 12
JL JL JL
Complete (Jun 10) Complete (Oct 10) Scheduled- May 2012
Key Performance Indicator Successful ISO 14001 Certification
Comments/Progress/Achievements 11/04/11: EMS successfully certified to ISO 14001 during audit completed 5th -7th April 2011.
Project Investment/ Payback Time €5,000 Close Date/Comment Certification achieved
Ref Start Date Target Status
TAR 34 Oct 10 IPPC Licence test method to be to CEN/ISO standards. Closed
Timeframe Oct 2010- May 2012 Environmental Aspects All
Rationale
-IPPC licence audit finding requires all test methods applicable to IPPC licence to be certified to ISO /CEN standards. -Site objectives require continual improvements in EMS to deliver effective environmental improvements across all aspects of our business.
Responsibility John Lynch
Action Date Responsibility Comment
Review progress of target.
Confirm implementation
MD MD
Complete Complete
Key Performance Indicator Successful Implementation/ IPPC Acceptance of test methods. Comments/Progress/Achievements Complete Project Investment/ Payback Time €7,000 approx- No direct payback Close Date/Comment Complete- Reference: L:\Groups\EHS\IPPC Licence\PRTR
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Ref Start Date Target Status
TAR 22 Jan 11 25% Reduction in County Council supplied water. Closed
Timeframe Jan 11- Dec 2012 Environmental Aspects Use of natural resources
Rationale
-Condition 7 of the IPPC licence requires the site to identify opportunities for reduction of the quantities of water used on-site. -J&J EHS Standards require facilities to implement water conservation measures. -Site objectives require the identification of measures for reduction in use of natural resource.
Upgrade of system required in 2013.
Responsibility Donncha Collins
Action Date Responsibility Comment
Capital approval for project.
Install grey water tank and capture rain water, WFI dump.
Jun 11 Dec 11
DC ND/KOM
Complete-Feb 11 Complete- Sep 11
Key Performance Indicator M3 Water/Kg product 2011 Vs 2010
Comments/Progress/Achievements
M3/year
2009: 52.2 Kg Product 2010: 68.4 Kg Product: 2011 96.4 Kg Product Total Water Usage 2009 = 88,268 m
3
Total Water Usage 2010 = 73,518 m3
Total Water Usage 2011 = 54,743 m3
Actual % Reduction 2010 versus 2009 = 16.7% decrease Actual % Reduction 2011 versus 2010 = 25.5% decrease Normalised 2009 = 1,691 m
3/Kg product
Normalised 2010 = 1,075 m3/Kg product
Normalised 2011 = 568 m3/Kg product
Project Investment/ Payback Time €160,000 investment, 3 year payback Close Date/Comment Target achieved
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Ref Start Date Target Status
TAR 30 Jan 11 25% Reduction in liquid nitrogen usage on-site. Open
Timeframe Jan 11- Dec 2012 Environmental Aspects Use of natural resources
Rationale - IPPC licence requires optimisation of raw material resource usage on-site. -Site objectives require reduction in usage of natural resources.
Responsibility Jim Kelly
Action Date Responsibility Comment
Install new LN2 freezer.
Sep 11
DC
In progress
Key Performance Indicator Kgs N2 usage/year
Comments/Progress/Achievements
Project complete in Nov 2011 so while indications of 5% reduction in usage for Dec 2011 total reduction target has been modified to 25%
Project Investment/ Payback Time Minimum investment Close Date/Comment In Progress
Ref Start Date Target Status
TAR 31 Jan 11 Review ATEX applicability to external flammable storage cabinets.
Closed
Timeframe Jan 11- Dec 11
Environmental Aspects Emissions to groundwater; emissions to surface water; use of hazardous substances; waste disposal; waste storage.
Rationale
-Observation in ISO14001 pre-certification audit. -Site objectives demand the continuous review of plant operations to ensure protection of natural resources.
Responsibility Simon Garrett
Action Date Responsibility Comment
Commission ATEX assessment for external flammable storage cabinets.
Complete review.
Implement findings of ATEX review.
Apr 11
Jun 11 Sep 11
SM
SM SM
Complete
Complete Complete
Key Performance Indicator Complete audit and implement findings.
Comments/Progress/Achievements 18/03: C&K have been on-site to review external hazardous waste storage areas and will issue a report.
Project Investment/ Payback Time Minimum investment Close Date/Comment Complete
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Ref Start Date Target Status
TAR 25 Jan 11 50% reduction in hazardous waste streams produced on-site. Open
Timeframe Jan 11- Dec 2013 Environmental Aspects Waste segregation; waste disposal; waste handling.
Rationale
Condition 2.2 of IPPC licence obliges site to review operations for opportunities to minimise wastes. Observation 1800/RMT/OBS/001 in ISO14001 pre-certification audit identified misplaced wastes in hazardous waste streams.
Responsibility Simon Garrett
Action Date Responsibility Comment
Install glass crushing and plastic shredding devices for compacting and washing contaminated waste containers.
Review integrity of hazardous waste streams in operations.
Review waste streams in operation and laboratories to identify materials suitable for crushing and shredding.
Apr 11
Jun 12
Jun 12
LN
JL
JL
Complete
In progress
In progress
Key Performance Indicator Kg hazardous waste/ kg production 2013 Vs 2010
Comments/Progress/Achievements 2010 Hazardous Waste Production: 20.5 mT 2011 Hazardous Waste Production: 17.0 mT Reduction 15% decrease
Project Investment/ Payback Time Minimum investment Close Date/Comment In Progress
Ref Start Date Target Status
TAR 35 Jan 11 Review Environmental Internal Audit programmes for effectiveness of structure and content
Closed
Timeframe Jan 2011- Dec 2013 Environmental Aspects All
Rationale
-ISO 14001 requirement for Internal Auditing protocol. -Site objectives require continual improvements in EMS to deliver effective environmental improvements across all aspects of our business.
Responsibility John Lynch
Action Date Responsibility Comment
Include Internal Audit protocol in EHS manual
Update Internal Templates to reflect ISO & MAARS requirements
Review completion and effectiveness status
Mar 11 Jul 11
Nov 11
LN LN
LN
Complete (Mar 11) Complete
Complete
Key Performance Indicator Effectiveness of Internal Auditing system
Comments/Progress/Achievements 18/03/11: IA protocol included in EHS Manual; IA programme has been reviewed and improved system put in place.
Project Investment/ Payback Time N/A Close Date/Comment Complete
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Ref Start Date Target Status
TAR 40 Mar 12 Achieve greater that 80% EHS training completion by Dec 2012 Open
Timeframe Mar 2012- Dec 2013 Environmental Aspects All
Rationale - Observation from ISO 14001 audit. - EHS regulatory audits.
Responsibility John Lynch
Action Date Responsibility Comment
Key Performance Indicator % training complete Comments/Progress/Achievements Project Investment/ Payback Time 0 Close Date/Comment In Progress
Ref Start Date Target Status
TAR 41 Mar 12 Adopt a Species Action Plan for Irish Hare Open
Timeframe Mar 2012- Dec 2013 Environmental Aspects All
Rationale
-J&J Biodiversity Program. - Site EHS objectives oblige us to ensure our operations have no impact on local amenities and the promotion of environmental awareness among our stakeholders.
Responsibility John Lynch
Action Date Responsibility Comment
Key Performance Indicator Programme in place Comments/Progress/Achievements Project Investment/ Payback Time 0 Close Date/Comment In Progress
AER 2012 Janssen Biologics
21
Ref Start Date Target Status
TAR 42 Mar 12 Hold an Environmental Information Day for site personal Closed
Timeframe Mar 2012- Dec 2013 Environmental Aspects All
Rationale - Improve environmental awareness on -site
Responsibility John Lynch
Action Date Responsibility Comment
Key Performance Indicator Information day takes place Comments/Progress/Achievements Project Investment/ Payback Time Close Date/Comment In Progress
Ref Start Date Target Status
TAR 43 Mar 12 Put Community Liaison Plan in place Open
Timeframe Mar 2012- June 2013 Environmental Aspects All
Rationale
- Site EMS -ISO 14001 -Communications Program
Responsibility John Lynch
Action Date Responsibility Comment
Key Performance Indicator Program in Place Comments/Progress/Achievements Project Investment/ Payback Time 0 Close Date/Comment In Progress
Ref Start Date Target Status
TAR 44 Mar 12 Complete Energy Audit of WWTP Open
Timeframe Mar 2012- Dec 2013 Environmental Aspects All
Rationale -J&J Energy Conservation Program. - Site EHS objectives
Responsibility John Lynch
Action Date Responsibility Comment
Key Performance Indicator Audit Complete Comments/Progress/Achievements Project Investment/ Payback Time 0 Close Date/Comment In Progress
AER 2012 Janssen Biologics
22
Ref Start Date Target Status
TAR 45 Mar 12 Complete Waste Audit of Facility Open
Timeframe Mar 2012- June 2013 Environmental Aspects All
Rationale -J&J Waste management - Site EHS objectives
Responsibility John Lynch
Action Date Responsibility Comment
Key Performance Indicator Audit Complete Comments/Progress/Achievements Project Investment/ Payback Time 0 Close Date/Comment In Progress
Ref Start Date Target Status
TAR 46 Mar 12 Set up Resource Sustainability Group Open
Timeframe Mar 2012- Dec2013 Environmental Aspects All
Rationale -J&J Guidelines - Site EHS objectives
Responsibility John Lynch
Action Date Responsibility Comment
Key Performance Indicator RS Group in operation Comments/Progress/Achievements Project Investment/ Payback Time 0 Close Date/Comment In Progress
4 Additional Requirements: Schedule D of IPPC licence specifies the following additional reports to be included in EMP:
Energy efficiency audit summary: An Energy Audit was carried out in 2008. Energy reduction targets are included in EMP. An Energy Audit is scheduled to be completed in 2013