APPENDIX 1

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ENVIRONMENTAL STANDARD OPERATING PROCEDURES

Maintenance and Emptying of the bunded Areas in the Pharmaceutical Plant(6.1001)

Disposal of Municipal Waste at Pfizer (6.1004)

Pharmaceutical Plant Effluent and Surface Water Systems Maintenance andMonitoring (6.1005)

Spillage Control (6.1007)

Internal - External Environmental Complaint Procedure (6.1011)

Air Emissions Monitoring in the Pharmaceutical Plant (6.10 13)

Noise Monitoring at Pfizer (6.1020)

Disposal of Waste Bovine Material (6.1021)

Disposal of in Process and Finished Product Waste (6.1023)

Disposal of Maintenance and Project Related Waste (6.1024)

Waste Management Policy (6.1025)

Hazardous Deliveries - Loading and Un-Loading Procedure (6.1027)

Disposal of Laboratory Waste (QCG009)

CALIBRATION & MAINTENANCE STANDARD OPERATINGPROCEDURES

Calibration Programme (6.0361)

Operation of the Pemac Maintenance System (6.036

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STANDARD OPERATING PROCEDURE

SOPNUMBER: SOPvERsrON:6.1001 3.0

EFFECTIVEDATE:19/01/2005 08:OO:OOAM

SOPTITLE:hbUNTENANCE AND EMPTYING OF BUNDED AREASIN THE PHARMACEUTICALPLANT

Originated By:

Reviewed By:

Reviewed By:

Approved By Quality:

SIGNATURE INFORMATION

SIGNATURE

Vicky Bow

DEPARTMENT DATE

Environmental Health & 30/08/200403:56:01 pmSafety

John Toner

Tony Carter

Maintenance Engineering 07/09/2004 05:08:57 pm

Environmental Health & 13/09/2004 10:24:15 amSafety

Ann Whelan Quality Assurance 24/09/2004 1 I:4232 am

SOP STATUS: Effect iveTemplate Plug-In Version 2.2

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SOP NUMBER: 6 .1001SOP VERSION: 3.0SOP TITLE: MAlNTENANCE AND EMPTYING OF BUNDED AREAS IN THE! PHARMACEUTICALPLANT

N O . REVISION DETAILS EFFECTIVEDATE

ORIGINAL

Revision 1

Revision 2

Updated to include new bunded area, and to remove Chloroform andenclosed waste bunds. Changes made to disposal route of rainwater.Update circulation list.

Updated to reflect current practices, responsibil i t ies and additionalbunded areas on site.

03.04.96

1503.99

17.07.02

Bund Integrity Testing Programme and Rainfall AccumulationsProgramme included to comply with the updated corporate Groundand Surface Water Protection Guideline.Appendix 1 amended to include indicative features of likelycontaminants.Appendix 2 and Appendix 3 added to detail the requirements of theBund Integrity Testing Programme.Appendix 4 added to include an inventory of all storage tanks on-site.

Revision 3Official copy list deleted.

Appendix 2 updated to include a control for the measurement ofevaporation during the test period.

Original to be filed in QA

SOP STATUS: Effect iveEFFECTIVE DATE: 19/01/2005 O8:oo:OO AMTemplate Plug-In Version 2.2

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. .

SOP NUMBER: 6.1001SOP VERSION: 3.0SOP TITLE: MAINTENANCE AND EMPTYING OF BUNDED AREAS IN THE P HARMACEUTICALPL.ANT

1.0 -0SE

To outline the responsibility and procedure for the maintenance, emptying and integritytesting of all bunded areas on site.

2.0 SCOPE

This SOP covers the following bunds in the Pharmaceutical Plant:

(i) Heavy fuel oil tank bund.(ii) Diesel oil storage tank bund.(iii) Fuel oil pumps bund in Pump House.(iv) Chemical store bunds in Maintenance area.(v) Solvent store bunded area.(vi) Aqueous Protein Waste Bund in Elase staging area.(vii) Effluent pH Balancing Tank bund.(viii) Effluent caustic storage tank bund(ix) Effluent sulphuric acid storage tank bund

3.0 SAFETY

If chemical residues are suspected to be present in the bund liquid, then ensure you arefamiliar with the hazards and safety precautions of the chemical(s) (consult MSDS’s)before attempting to empty any bunds.

Wear appropriate personal protective equipment as indicated on the relevant MSDS.

Ensure that you minimise personal contact with the bund liquid during the operation.

Ensure that no leaks of bund contents occur between the bund and the collection vesselduring emptying.

Under no circumstances must any bund contents be allowed to enter surface water.

4.0 RESPONSIBILITY

It is the responsibility of the Maintenance/Engineering Manager or designees to ensurethat this procedure is adhered to.

SOP STATUS: EffectiveEFFECTIVE DATE: 19/01/2005 08:OO:OO AMTempIare Plug-In Version 2.2

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SOP NUMBER: 6.1001SOP VERSION: 3.0SOPTITLE: MAINTENANCEANDEMPTYINGOFBUNDEDAREASlNTHEPHAFWA CEUTICALPLANT

5.0 FROCEDUI~J~

5.1 All bunded areas are to be checked every 6 weeks by an engineeringrepresentative.

5.2 Visually check the bund integrity and check that the bund drain seal/cover is inplace.

5.3 Accumulated rubbish should be removed and disposed of in an Eco-Safe WheelieBin.

5.4 If there is any liquid in the bund then a visual check should initially be carried outto see if any contamination has taken place. A list of the likely contaminants ineach bund and indicating features of each of the contaminants is included inAppendix 1.

5.5 If there is no evidence of a spill/potential contamination, the liquid in the bundshould be pumped to the process drain.

5.6 If a spill is evident/suspected or potential contamination cannot be determined byvisual inspection alone, a sample of the liquid should be taken in a clean plasticcontainer and brought to the Environmental Officer.

5.7 The Environmental Officer will send the sample for laboratory analysis and willreview the results when obtained. These results will be filed in the EHS Dept.

5.8 If a spill/contamination is confirmed the contents of the bund should be pumpedinto 200L Drums and alternative disposa1 methods will be arranged by the EHSDept.

5.9 In the event of heavy rainfall periods, the external open bunds may requireemptying more frequently than the scheduled six - weekly basis, in order toprevent rainfall accumulations.

5.10 In addition to this the effluent caustic storage tank bund and the caustic storagetank bund must be emptied after bulk delivery of these chemicals. The EHS Dept.will advise when this is necessary.

5.11 At least once every three years a Bund Integrity Testing Programme for eachbunded structure on-site must be carried out. A checksheet for the inspection ofbunded areas is included in Appendix 2. This checksheet details the sequence ofevents in integrity testing each bund and includes a corresponding log (included inAppendix 3), that must be filled in while completing these tests. A report of thebund integrity testing programme is compiled by the Environmental Officer andfiled in the EHS Dept.

5.12 The checking & emptying of bunds is prompted by the PEMAC splant number MOOS/ STTK. CD

t@-&TGfz’to

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SOPNUMBER:6.1001SOPVERSION: 3.0SOPTITLE: h4AINTENANCE AND EMPTYING OF BUNDED AREAS IN THE PHARhUCEUTICALPL.ANT

APPENDIX 1

A LIST OF THE LIKELY CONTAMINANTS POTENTIALLY PRESENT INON-SITE BUNDED STRUCTURES

PHARMACEUTICAL PLANT

Bund

Heavy fuel oil tank bund.

Diesel oil storage tankbund.

Fuel oil pumps bund inPump House.

Chemical store bunds.

Likely Contaminants Indicative features Upon(if any) Visual Inspection

Fuel oil - only if fuel oilpresent in tank.

Sheen on surface of liquid

Diesel oil. Sheen on surface of liquid

Fuel oil. Sheen on surface of liquid

Noticeable Odour. pH test -Various chemicals. And compare to MSDS’s of

substances present.

pH E&lancing Tank bund Effluent Distinctive Odour/ Colour ofEffluent

Deep burial bund in Elasestaging area

Effluent caustic storagebund

Effluent sulphuric acidstorage bund

Protein waste

30% NaOH

50% HzSOz,

Odour/ Non-Liquid(aqueousmaterial)

pH test - High pH of >13

pH test - Low pH of 42

Solvent store bunded area SolventspH test - And compare toMSDS’s of substances present

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SoPNUMF!ER:6.1001SOPVERSION: 3.0SOPTTTLE: MAINTENANCE AND EMPTYiNG OF BUNDED AREAS IN THE PHARMA CELITICALPLANT

APPENDIX 2

BUND INTEGRITY TESTING PROGRAMME CHECKSHEET

(USEINCONJUNCTIONWITHAPPENDIX 3-BUNJIINTEGRITY TESTINGFROGRAMME LOG)

Bund Location:

Description

Allow liquid in the bund to stabilise for 24 hours. This allows forabsorption and autogenous healing to take place. Additional make-up Maintenancewater may need to be added to maintain water at the maximum level forthe commencement of the test period.

e test should be

water in the acco anying log and leave the water to stand for a further

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SOPNUMBER:SOPVERSION: 3.0SOP TITLE: MAINTENANCE AND EMPTYING OF BUNDED AREAS IN THE PHARMACEUTICAL PLANT

APPENDIX 3

BUND INTEGRITY TESTING PROGRAMME LOG

SOPSTATUS: EffectiveEFFECTIVEDATE:19/01/200508:00:00AMTemplate Plug-In Version 2.2

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SOP NUMBER: 6.1001SOP VERSION: 3.0SOP TITLE: MAINTENANCE AND EhWI’YING OF BUNDED AREAS IN THE PHARMACEUTICALPLANT

APPENDIX 4

STORAGE TANK INVENTORY

TANK NAME

CONTENTS

Asset Id 1213

Diesel Fuel Oil

INSTALLATION

SOP STATUS: EffectiveE3?FECTJS% DATE: 19/01/2005 08:OO:OO AMTemplate Plug-In Version 2.2

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STANDARD OPERATING PROCEDURE

-SOP NUMBER:6.1004

SIGNATURE INFORMATION

SIGNATURE DEPARTMENT DATE

Originated By: Vicky Bow Environmental Health & 10/09/2003 11:17:04 amSafety

Reviewed By: John Toner Maintenance Engineering X2/09/2003 12:08:54 pm

Reviewed By: Tony Carter Environmental Health & 12/09/2003 02: 1859 pmSafety

Approved By Quality: Ann Whelan Quality Assurance 12/09/2003 02:29: 18 pm

SOP STATUS: Effective page 1 of 7

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.

Tara HoganQuality Assurance DepartmentExt. No. 365

TO: ListFrom: Tara HoganDate: 5 December, 2003

Subject: SOP No. 6.1004 Version 3.0

SOP No. 6.1004 Version 3.0 is now effective in the SOP Document Management System@MS). Attached is the official QA DMS printout of the SOP.

0 Please ensure that only the Form(s) Appendix 1 and Appendix 2 on page(s) 6 and 7 of thisSOP is used for photocopying. Retain original form with the copy of the SOP. This willensure that the correct SOP No. and Version No. will appear on each photocopied form used.

IPlease note that previous copies of the form(s) i.e. non DMS printouts are to be destroyed.

Tara Hog&Q.A. Administration

CC. Offkkl QA DMS Printout SOP Master

Suite #lSuite #3Environmental Health & Safety

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Tara HoganQuality Assurance DepartmentExt. No. 365

To: ListFrom: Tara HoganDate: 5 December, 2003Subject: Form(s) SOP No. 6.1004 Version 3.0

SOP No. 6.1004 Version 3.0 is now effective in the SOP Document Management System@MS). Attached are official QA DMS printouts of the following form(s) from this SOP:

Form(s) - Appendix 1 and Appendix 2 page(s) 6 and 7

Please ensure all previous copies of the form(s). i.e. non DMS printouts are destroyed. Usethe attached form(s) as “masters” to photocopy from. This will ensure that the correct SOPNo. and Version No. wifl appear on each photocopied form used.

Tara Hog&Q.A. Administration

C.C. Official QA DMS Printout SOP Master

MaintenanceH RProjectsMaterials ManagementChemistryWarehouseMicrobiology

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.SOP NUMBER: 6.1004SOP VERSION: 3.0SOP TFIZE: DISPOSAL OF MUNICIPAL WASTE AT PFIZER

NO. REVISION DETAILS EFFECTIVEDATE

ORIGINAL

Revision 1

Revision 2

Changed title and categorisation of waste as per recent legislativechanges and increased the official copy list.

Updated to correct Revision No. on Pages 2 - 9. Changedresponsibilities, updated circulation list, changes to reflect position inGum Base, details re. docket handling and removed appendix no.3.

19/06/96

05.06.97

10.04.99

Revision 3 Revised to update the following:All references to Warner Lambert amended to Pfizer.All references to the Gum Base Plant removed,Updated official copy list

26.08.02

Reference to SOP 6.0901 in Section 4.0 removed as this SOP hasbeen discontinued.Section 4.0 updated to include reference to safety glasses, safetyshoes and SOP 6.025.Section 5.0 updated to detail additional recycling bins on site.Section 6.0 revised to reflect current practices.Appendices 3 and 4 removed as are in reference to the Gum BasePlant.

Revision 4 Revised as follows:

Title Change to Disposal of Municipal Waste at Pfizer.Section 5.0 replaced to include information on Pfizer WasteDesignations aad to detail the definition of Pfizer Non-SpecialWaste.Section 6.0 completely rewritten to update for currency. Allreferences to ‘a designated member of the Maintenance/EngineeringDepartment’ changed to ‘Waste Handlers’

Section 7.0 Records, added to &tail the new Waste ManagementPolicy SOP 6.1025

Official Copy List Deleted

Original to be filed in QA

SOP STATUS: EffectiveEFFIXTIVE DATE: 05/12/2003 11:45:00 AM

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SOP NUMBER: 6.1004SOP VERSION: 3.0SOP TITLE: DISPOSAL OF MUNICIPAL WASTE AT PFIZER

1.0 PURPOSE

To detail the requirements for the disposal of Municipal Wastes at PfEer, Dublin.

2.0 ORGINISATIONAL UNITS AFFECTED

This procedure applies to all areas where municipal wastes are generated.

3.0 RESPONSIBILITIES

It is the responsibility of Departmental Managers to ensure that:9 Containers for collection of general wastes are properly labelled.l Containers are removed to designated storage areas on a timely basis.l Designated storage areas used by the Department are left in a safe and suitable condition.

It is the responsibility of the EHS Department to ensure that all municipal waste streamsgenerated on-site are disposed of correctly in accordance with the site IPC Licence, relevantwaste legislation and the Pfizer Corporate Waste Management Guideline 19.

4 . 0 SAFFTY

Waste containers must be properly labelled to indicate the specific types of waste beingdisposed.

Wear personal protective equipment relevant to the type of waste you are handling and howwell it is packaged. Wear gloves, safety glasses and safety shoes as a minimum.

Ensure you use the correct manual handling technique - follow SOP 6.0911 at all times.

Report all accidents/near misses immediately to a Supervisor/Manager and compile anAccident/Near Miss Report as soon as possible, in accordance with SOP 6.0205.

5.0 PFIZER WASTE DESIGNATION

In line with the Pfizer Corporate EHS Waste Management Guideline 19, all municipal waste isclassified as ‘Non-Special Waste’.A definition for Pfizer Non-Special waste is detailed below:

Non-Special Waste is any wastestream comprising of no-hazardous constituents.A wastestream will also be considered non-special if the total wastestream volume is less than100 kg per year and it can be demonstrated that it does not contain any hazardous constituentsin concentrations of greater than 0.1 percent, that could adversely impact public health or theenvironment, if mismanaged.

SOP STATUS: EffectiveEFFECTIVE DATE: 05/12/2003 11:45:00 AM

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SOP NUMBER: 6.1004SOP VERSION: 3 .OSOP TITLE: DISPOSAL, OF MUNICIPAL WASTE AT PFIZER

6.0 PROCEDURE

6.1 Municipal Waste CategoriesThe following municipal wastes are generated on-site:l Municipal Wastel Canteen Wastel Almninium Cansl Glass Wastel Paper for Recyclingl Magazine and Newspaper Recyclingl Printer Cartridges/Printer Toners

6.2 Municipal WasteMunicipal waste is collected at source in general waste bins located throughout the plant by thewaste handlers at regular intervals. This waste includes plastic, cardboard and otheruncontaminated packaging waste. Janitorial wastes and empty cleaning containers that havebeen rinsed are also categorised as municipaJ waste.

This waste is placed in the site compactor and collected by an external company upon requestfrom the waste handlers. This waste is disposed to landfill.

The waste handlers complete the attached Pharmaceutical Plant Compactor log in Appendix 1of this SOP each time the compactor is collected for disposaL

6.3 Canteen WasteCanteen waste is collected at source and transported to the designated canteen waste 1OOOLwheelie bins by the waste handlers at regular intervals throughout the day.

The canteen waste wheelie bins are emptied by a waste contractor company on a weekly basisand disposed to landfill.

The waste handlers complete the attached Pharmaceutical Plant Canteen Bin log in Appendix 2of this SOP each time the canteen wheelie bins are collected for disposal.

6.4 Aluminium Cans/Glass WasteRecycling bins for almninium cans and clear, green and brown glass are located in the mainpharmaceutical plant car park for the use of all personnel.

These bins are collected by an external waste contractor, upon request from the EHSDepartment and the resulting waste is sent to be recycled.

6.5 Paper for RecyclingWaste office paper is collected in designated recycling bins throughout the plant. These binsare emptied on a regular basis by the waste handlers and brought to the designated paperrecycling ZOOOL wheelie bin.

An external waste contractor collects the paper for recycling upon request from the EHSDepartment.

SOP STATUS: EffectiveEFFECTIVE DATE: 05/12/2003 11:45:00 AM

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.SOP NUMBER: 6.1004SOP VERSION: 3.0SOP TITLE: DISPOSAL OF MUNICIPAL WASTE AT PFIZER

6.6 Magazines and NewspapersA magazine and newspaper recycling bin is located opposite the pump house and adjacent tothe canteen and waste paper for wheelie bins. This recycling bin is for the use of all personnelon-site.

An external waste contractor collects the waste magazines and newspapers for recycling on aweekly basis.

6.7 Printer Cartridges/Printer TonersWaste printer cartridges and printer toners are collected in the designated recycling boxes inthe Post Room.

It is the responsibility of the Environmental Officer to schedule the collection of thesecartridges and toners by an external waste contractor. Printer cartridges and toners are sent tobe recycled.

7.0 REXORDS

All records associated with movement of municipal wastes off-site are detailed in the WasteManagement Policy SOP 6.1025.

SOP STATUS: EffectiveEFFECTIVE DATE: 05/12/2003 11:45:00 AM page 5 of 7

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SOP NUMBER: 6.1004SOP VERSION: 3.0SOP TITLE: DISPOSAL OF MUNICIPAL WASTE AT PFIZER

Appendix 1

Pharmaceutical Plant Compactor

SOP STATUS: EffectiveEFFECTIVE DATE: 05/12/2003 11:45:00 AMTcnlplnte Plug-111 Version 2.2

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Slop NUMBER: 6.1004SOP VERSION: 3.0SOP TITLE: DISPOSAL OF MUNICIPAL WASTE AT PFIZER

Appendix 2

Pharmaceutical Plant Canteen Bin

SOP STATUS: EffectiveEFFECTIVE DATE: 05/12/2003 11:45:00 AMTemplate Plug-In Version 2.2

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