SOP NUMBER: SOP VERSION: EFFECTIVE DATE: SOP TITLE

STANDARD OPERATING PROCEDURE

e

SOP NUMBER:

6.1005

EFFECTIVE DATE:

19/08/2002 03:15:00 PM

SOP VERSION:

2.0

Originated By:

Reviewed By: John Toner

Reviewed By: Tony Carter

SOP TITLE:

PHARMACEUTICAL PLANT EFFLUENT ANDSURFACE WATER SYSTEMS MAINTENANCE ANDMONITORING

SIGNATURE INFORMATION

SIGNATURE DEPARTMENT DATE

Vicky Bow Environmental Health & 19/07/2002 10:50:14 amSafety

MaintenanceEngineering

06/08/2002 04:36: 14 pm

Environmental Health & 06/08/2002 06: 14:35 pmSafety

SOP STATUS: EffectiveFXFECTTVE DATE 19/~8/70~7 fN.15dX-I PM r$POP 1 nf4

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:01

t rSOP NUMBER: 6.1005SOP VERSION: 2.0SOP TITLE: PHARMACEUTICAL PLANT EFFLUENT AND SURFACE WATER SYSTEMSMAINTENANCE AND MONITORING

NO. REVISION DETAILS EFFECTIVEDATE

ORIGINAL

REV. ONE Total rewrite to reflect changes in monitoring of effluent andsurface water. Also reflects changes in balancing of effluent.Title change.

27.03.96

29.03.99

REV. TWO Official Copy List and Organisational Units effected amended.All references to Warner Lambert changed to Pfizer.The following sections were updated to reflect current practices:l Section 4 - Statement on cleaning of Simplex Strainers and

disposal route for the resulting waste.l Section 5 - Responsibilities for Firewater Retention System.l Section 6 - Requirements of internal and external contract

maintenance.l Sections 7.0 and 8.0 updated in line with amended EPA

Reporting and Monitoring requirements.l Appendices 2 and 3 updated and Appendix 4 removed in line

with changes to the associated PEMAC routinel Appendices 5-8 removed as format no longer relevant.

Original to be tiled in QA

Official Copy List:

EHS DepartmentMaintenance/Engineering Department

SOP STATUS: EffectiveF.FFFtCTIvE nATF..t 19/fH/7~~7 ~?~15~~~ PM *s‘ll= 3 nf 9

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:01

, SOPNUMBER:6.1005SOPVERSION: 2.0SOP TITLE: PHARMACEUTICAL PLANT EFFLUENT AND SURFACE WATER SYSTEMSMAINTENANCE AND MONITORING

1.0 PURPOSE:To outline the procedure for maintenance and monitoring of the Pharmaceutical PlantEftluent System and the Site Surface Water System, in accordance with the Company’sIntegrated Pollution Control (IPC) Licence.

2.0 SCOPE:Applies to the maintenance of:

l The pH balancing tank and associated dosing systeml All monitoring equipment related to this systeml AlI fiaI monitoring equipment for both effluent and surface water

Applies to all monitoring required as per IPC Licence.

\ Please reference Appendix 1 for layout of the Site Eilluent System.

0 3.0 ORGANISATIONAL UNITS AFFECTED:- Maintenance/Engineering Department- EHS Department

4.0 SAFETY:Maintenance:Please refer to the following Safety SOP’s:

l 6.0902, Moving Parts0 6.0903, Electrical Hazardsl 6.0904, Heat Hazardsl 6.0907, Compressed Airl 6.0917, Confined Space Entryl 6.0929, Safety, Health and Environmental Policy for Contractors on Sitel 6.0937, Chemical Hazards

Ail pumps must be switched off at the control panel in the pump house, prior to cleaningthe Simplex Strainer baskets. Safety gloves must be worn when emptying the strainers.

Dispose of waste from the strainers into biohazard bags and store in a yellow Sulu bin.Place this waste into an Eco-Safe Wheelie Bin in the -26°C Freezer at the end of the week.The EHS Department will arrange for the disposal of the contents of the Wheelie bins on aregular basis.

Cont. Caustic and Acid is used in the Dosing Plant. Refer to MSDS before handling.Ensure safety glasses and gloves are worn at all times if maintaining equipmentdosing hut.

in the

SOPSTATUS: Effectiveb‘~immnm nbm. I wnwmm wt.1 5-m PM

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:01

SOP NUMBER: 6.1005SOP VERSION: 2.0SOP TITLE: PHJUUVIACEUTICAL PLANT EFFLUENT AND SURFACE WATER SYSTEMSMAINTENANCE AND MONITORING

Monitoring:Care to be taken when taking samples; refer to manual handling SOP 6.0911.

Handle eflluent samples with care. Wear gloves at all times.

Any accidents/ near misses to be reported immediately to the FLM/ Supervisor and anaccident/near miss report completed as soon as possible.

5.0 RESPONSIBILITY:

It is the responsibility of the Maintenance/Engineering Manager to ensure that in housemaintenance is carried out as per this SOP.

It is the responsibility of the EHS Department to ensure that the external service contract iscarried out as per this SOP and that all monitoring is carried out as per the IPC Licence.

Firewater Retention SvstemIn the event of an activation of the firewater retention system the requirements of thedepartments responsible are detailed below:l It is the responsibility of the Maintenance/Engineering Department to inform the EHS

Department when the Fiiewater Retention System has been activated.l It is the responsibility of the EHS Department to investigate the activation and inform

Maintenance when the system can be reset.l It is the responsibiity of the Maintenance/Engineering Department to reset the system.l It is the responsibility of the EHS Department to ensure that any water in the Fiiewater

Retention tanks has been pH tested, at a minimum and is suitable of suitable quality fordischarge at a flow rate not in excess of IPC Licence Limits.

6.0 MAINTENANCE:

To be carried out by a designated member of the Maintenance/Engineering Department. Ifthis person is not available, then the Maintenance/Engineering Manager must eitherdesignate another person or inform the EHS Department.

Daily /Weekly (In House)

l Clean out the composite sampler and associated sample tubing on a weekly basis.l Visually check the dosing house for leaks on a weekly basis.l Clean and empty the simplex strainers on a twice-weekly basis.

WeeMy (External Service Contract)

The weekly service contract is detailed in Appendix 2, but is not limited to this list.

Six-Monthly (External Service Contract)The six monthly service contract is detailed in Appendix 3, but is not limited to this list.

All records in relation to the Weekly / Six-Monthly Maintenance Service Contract are filedin the EHS Department.

SOP STATUS: Effectivewmur~~m nhm. i4mmn7 wt.1 wn PM rl%,,P d nf a

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:01

. SOPNUMBER:6.1005SOPVERSION: 2.0SOP TITLE: PHARMACEUTICAL PLANT EFFLUENT AND SURFACE WATER SYSTEMSMAINTENANCE AND MONITORING

7.0 MONITORING:A designated member of the Maintenance/Engineering Department must collect thefollowing Surface Water/Effluent Samples. If this person is not available, then theMaintenance/Engineering Manager must either designate another person or inform theEHS Department.

l Weekly - A site surface water sample is collected on a weekly basis in a lOOOm1plastic bottle. This sample is sent by the EHS Department to an external laboratoryfor COD analysis.

l Monthly - Monthly eflluent samples are collected from the composite sampler in thefist week of each month. 2 x 1OOOml samples are collected in plastic bottles and 1 x500ml sample is collected in a pre-treated acid washed glass bottle. The eflluentsamples are sent by the EHS Department to an external laboratory for analysis of thefollowing parameters: BOD, COD, Suspended Solids, Sulphates, Detergents as MBASand Oils Fats and Greases.

l Annually - Annually an additional 1OOOml effluent sample must be collected in a plasticbottle. This sample is sent along with the monthly sample to an external laboratory forchlorides, phosphates, nitrates and ammonia analysis.

The EHS Department, may at their own discretion request testing of the Effluent/SurfaceWater for any other parameter deemed necessary.

Samples are stored at a temperature of < 4°C after collection and a sent for analysis as soonas possible.

A log of all Surface W~ter/EtIluent Samples sent for analysis is filed on the EHS Database.

The EHS Department will also record all chemical data on receipt of reports from theexternal laboratory and determine compliance with the IPC Licence. This data is grdphedand tabuldted and filed on the EHS database.

The EHS Department also monitor all aspects of the effluent system operation on a dailybasis via the BMS.

In particular the acid / caustic levels in the storage tanks. When the levels are at - 20% it isthe responsibility of the EHS Department to order additional supplies and oversee thedelivery ensuring that the external bunds at the dosing hut are uncovered to catch smallspills. If a large spill occurs, the operation is ceased and the Emergency Response for Spillsput into el3ect.

8.0 REPORTING:The following reports are prepared by the EHS Department and submitted to the EPA inaccordance with Condition 11 of the Company’s IPC Licence:

SOPSTATUS: EffectiveFFFlXTWF. nATl?: 19lOW7NI7 0?-154fI PM

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:01

SOPNUMBER:6.1005SOPVERSION: 2.0SOPTITLE:PHARMACEUTICALPLANTEFFLUENTANDSLJRFACEWATERSYSTEMSMAINTENANCEANDMONITORING

9.0

10.0

Twice Yearly Reports:

l Monitoring of Emissions to Sewer ReportThis report compiles the following data over a 6-month period:3 Total Daily Effluent Flow3 Max. Hourly Effluent Flow3 Max / Min Daily Effluent pH

(Should any Effluent pH value lie out of spec. with IPC Licence Liits, the duration oftime out of spec. must be also be detailed.)

3 Max Weekly Effluent Temperature3 Monthly Effluent Report Values for the parameters listed in Section 7 above.

l Monitoring of Emissions to Surface Water ReportThis report compiles the following data over a &month period:

3 Max / Min Daily Surface Water pH(Should any Surface Water pH value lie out of spec. with IPC Licence Limits, the durationof time out of spec. must be also be detailed.)3 Weekly Surfxe Water COD

Annual Reporting;

As part of the Annual Environmental Report (AER) submitted to the EPA, Mass EmissionsValues (in Kgs) must be included for all eftluent parameters monitored throughout the year.

ACTIONSONNOTINGOFVALUESOUTSIDEEMISSIONLIMITS:

The EHS Department must inform the Environmental Protection Agency by phone or faxof any event outside emission limits.

ACTIONONNOTINGMONITORINGEQUIPMENTOUTOFORDER:

The EHS Department must be notified immediately. Problem to be investigated and if noteasily resolved, standby equipment to be installed as soon as possible. EPA to be notifiedas above.

SOPSTATUS:EffectiveEFFECTTVF. K-BATE: 19/c18/7cIK’ t-R.1 =i.fW PM

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:01

28G-i. .0”

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:02

SOPNUMBER:6.1005SOP VERSION: 2.0SOP TITLE: PHARMACEUTICAL PLANT EFFLUENT AND SURFACE WATER SYSTEMSMAINTENANCE AND MONITORING

SEE: PEMACMOOS/EMS JOBNO. 1

Weekly Calibration & Maintenance of the Effluent & Surface Water System

l Calibration of the pH triple validation in the Pump Sump, Balance Tank, Final EffluentSump and the Surface Water Sump. Calibrate using buffers 4,7 and 10.

l Check operation ofeftluent pumps. Run in Hand and Auto. Check oil levels in pumps andtop up if required.

l Clean out eftluent sample cups in the effluent monitoring/sampling hut and checkoperation of the composite sampler.

l Check level transmitter in the Pump Sump and Balance Tank.l Check operation of tank mixer.

SOP STATUS: EffectiveEFFECTTVE DATE: 19/118/2X’P 0’3.1540 PM

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:02

* . SOPNUTHBER:6.1005SOP VERSION: 2.0SOP TITLE: PHARMACEUTICAL PLANT EFFXUENT AND SURFACE WATER SYSTEMSMAINTENANCE AND MONITORING

APPENDIX~:~IX-MONTHLYSERVICE CONTRACT

SEE: PEMAC MOOS/EMS JOB. No. 2

Six Monthly Pump Service

l Full Service on all three Pumps, to include the following:- Check non-return valves and change if required- Check diaphragms and oil lines. Clean if necessary.

l Calibrate temperature transmitters in the Pump Sump, Balance Tank and Eftluent Sump.l Check tank mixer in run & trip condition.l Carry out full electrical check on control panel in the pump house

This Six-Monthly Service is carried out in addition to the service parameters detailedAppendix 2: PEMAC MOOS/EMS Job Ol(Weekly calibration).

SOPSTATUS: EfTectiveFVlWCTlVW nATl?- 19/fK?/l)nn7 W4-15-NI PM

in

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:02

SOP TITLE: SPILLAGE CONTROLDepartment: EHSExt. No. : 2049100

TO: EHS DepartmentF r o m : Quality Assurance DepartmentDate: 09* August 2005Subject: Spillage Control SOP in route for approval

a To EHS Department,

This is to confirm that SOP No. 6.1007 ‘Spillage Control” is in route forapproval within the Quality Department.

An email will be forwarded when the SOP is ready for collection and has beenapproved and is effective.

Regards,

a Quality Assurance DepartmentPfizer Dublin

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:02

I. ,

Title: SPILLAGE CONTROL

Name: 6.1007 1 Status: Draft 1 Version: 4.1 1 Effective: N/A

N o . REVISION D ETAILS EFFECTIVE D ATE

Original 09/07/96Revision 1 Changed scope. 02.09.97

Changed responsibility to include relevant SOPS torefer to.Included procedure to be followed during normal /outside normal working hours.Included appendices detailing position of Spill Kits.

Revision 2 To update to include additional spill response stations 27.07.99and equipment to appendices, to include appendixdetailing PPE for specific products, to include detail onspecific actions required for dealing with spills, toupdate official copy list. To include requirement in theevent of chloroform spillage as per Corporate Health &Safety audit finding. To include requirement in theevent of an Ethanol spill

Revision 3 Updated Appendix 7 to include reference to UK- 10/l l/2000292,663 Fluconazole Prodrug.Added reviewed by section to Appendix 1Added titles to Spill Response Kit LocationsAppendices 2-5Minor text changes.

Revision 4 Updated for Azithromycin Dihydrate (bulk active) and 07/06/200 1Azithromycin for injection (SOOmg/vial) (lOOmg/mlWhen Reconstituted) and minor text changes.

Revision 5 Updated Appendix 7 to include Voriconazole for 30/l l/2001Parenteral Use (bulk active), Voriconazole for InfusionlOmg/ml when reconstituted, 200mg/Vial andSulphobutyl Ether P-Cyclodextrin Sodium (SBECD)and minor text changes.Remove reference to SOP 6.0901 ‘Hazard Awarenessand Reporting at Warner Lambert’ (Section 3.0) as thisSOP has been discontinued.

Revision 6 Complete rewrite for 3 year review.

Original to be filed in QA

Accessed By: Grainne MunnellyA c c e s s Date:09/Aug/2005 .

PageloflO

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:02


Name: 6.1007 ( Status: Draft 1 Version: 4.1 ( Effective: N/A

1.0 PURPOSE:

To outline the procedure for the control of spillages, in order to minimise the impact on theenvironment.

2.0 SCOPE:

This SOP applies to non permitted releases to the process or surface water drains thatl present an immediate danger to personnel or danger to the environment, andl occur on such a scale that the Spill Response Team or suitably trained personnel can

clean up the spill without the requirement of specialist or emergency services.

3.0 SAFETY:

3 . 1 Please refer to the following SOP’s for information on Safety Hazards

a6.0919 General Procedure for Storage and Handling of Hazardous Chemicals.6.0920 Precautions for Handling of Corrosive Substances.6.0921 Handling of Flammable Substances at Pfizer Ireland Pharmaceuticals.6.0922 Handling of Toxic and Harmful Substances.

3.2 Any accidents or near misses that occur should be reported to your FLMBupervisor andthe EHS Department immediately.

4.0 RESPONSIBILITIES:

4 . 1 It is the responsibility of the EHS Dept. to ensure that this procedure is adhered to.

4.2 It is the responsibility of the EHS Department to report any spills that contravene theconditions set down in the site IPC licence to both the EPA and the Sanitary Authority(Dun Laoghaire/Rathdown County Council) where necessary. Contact numbers forthese Regulatory Authorities are included in Appendix 1.

a 4.3 It is the responsibility of Security to inform a representative of EHS of any spills thatoccur outwith normal working hours.

4.4 It is the responsibility of the Departmental Managers to ensure that sufficient PPE isavailable to carry out spill clean ups in their areas of responsibility.

4.5 It is the responsibility of all site personnel to:(i) be aware of the correct disposal routes for the material they use, (Z&J SOP'.s6.1004; 6.102; 6.1023; 6.1024; QCGOO9)(ii) to exercise caution at all times to avoid spillages of substances;(iii) to be on the alert for spillages;(iv) to inform their FLMBupervisor and the EHS Department or Security immediately

on observing any evidence of spillage.(v) to attempt to contain or clean up the spill only if they have had training and if it is

safe to do so.

Accessed By: Grainne MunnellyAccess Date:09/AugJ2005

Page2oflO

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:02



4.6 It is the responsibility of EHS Self-assessment area owners (see SOP 6.0941) to ensurethe contents of spill kits in their respective areas are audited on a monthly basis toensure they contain a complete stock.

5.0 PROCEDURE

5 . 1 As soon as any person on site has knowledge of any non-permitted spilling, leaking,pouring, emptying/dumping to drain of any chemical substance or preparation, theperson shall immediately do the following to ensure their own safety before tackling thespill:(i) Seal off the area.(ii) Identify what they have seen, substance spilling, label information etc.(iii) Inform the EHS Department(iv) Remove ignition sources or isolate equipment which may be hazardous due to the

nature of the Spill.(v) Contact the Spill Response Team and Security.

5.2 The Spill Response Team should prepare for clean up of the spill in the followingmanner:(i) Ensure the correct PPE is available and is correctly worn(ii) Ensure adequate spill material is available(iii) Shut off spill/leak(iv) Contain the spill using the spill equipment available(v) Dispose of the spill equipment in the proper manner (Please contact the EHS

Department if unsure of the correct disposal procedure of spill related material)

5.3 PPE available

5.3.1

5.3.2

5.3.3

Please see attached Appendix 4 for a list of PPE to be worn during spill clean upoperations.

Appendix 2 and 3 details the location of spill response material on the Ground Floorand First Floor of the Pharmaceutical Building respectively. This material should beutilised to clean up spills.

Breathing apparatus (10 minute Escape Set) should be used for cleaning up spillsrelated to Chloroform and >2.5L Acid and Caustic from either the plant room or theeffluent dosing hut.

5.4 The type of spills which may occur throughout the plant are included below. Thesespills require reporting to the EHS Department.

Oils and coolants: Are not permitted to process drains. These are a potential spill inproduction and plant areas. Eg: Glycol.

Solvents (not including chloroform): Not permitted to process drains. These are apotential spill in the laboratories, waste storage areas, solvents storage area andproduction areas. They are also a potential spill externally.

Accessed By: Grainne MunnellyAccess Date:09/Aug/2005 N Page3oflO

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:02



Acids/ Bases: Permitted to process drain only if in diluted form and neutralised to Ph 7or if washed down with copious amounts of water. They form a potential spill in theLaboratories, Plant Room and Production Areas. Concentrated acids/ bases must becontained.

Chloroform: Not permitted to process drains. This is a potential spill in the laboratories,Chemical Storage Area, Waste Store and Elase Area. If a large spill occurs internally, i.e.> 2SL, then contact a member of staff trained in the use of the Breathing Apparatus(Escape Set) to deal with the spill. In the event of a spill cover the drains in the area, plugthe spill if possible and evacuate the area to allow vapours to evaporate. A warning signshould be posted to prevent any other person entering the area. All of these actions arerepresentative of the 10 min time restraint imposed by the use of an escape set.

Product: Elase may be washed to drain. Liquid drug products must be contained. Theseare potential spills all over the operational areas of the Plant. For pharmaceutical powderactives the spill must be cleaned up only using the proper PAPR and tyvec suits and only ifyou are trained.

Other: In general water soluble substances may be permitted to process drains but alwayscheck with the EHS Department if unsure.

5.5 Spill Equipment Available.

Please reference Appendices 2-3 for quick guide to spill kit locations.

5.5.1 Internal BuildingThe following spill kits are located in the Pharmaceutical Building and are equippedwith spill response material required for that area.

l SKA Attack Pack (Mobile Spill Kit) - These spill kits are located in theLaboratories, Suite 3 and in Elase.

l 200L Mobile Spill Kit - These spill kits are located in the plant room for HCW

Accessed By: Grainne MunnellyAccess Date:09/Aug/2005

e4oflO

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:02



l 27 Litre Attack Pack - This in the QCI Sampling Booth.

l Mercury Spill Kit - This spill kit is located in the Chemistry Laboratory.

a

l HEPA vacuums are located in the QC Inspection Dispensary and Sterile Suite 3area.

55.2 External to the BuildingThe following spill response equipment is located external to the PharmaceuticalBuilding

l 200L Mobile Spill Kit - These spill kits are located in the Oil Store and theEffluent Dosing Hut

l A 200L Spill Kit and Green Stuff absorbent is located in the Spill Response Hutsituated in the Waste Area.


NPage 5 of 10

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:03

.



APPENDIX~

REPRESENTATIVES OF REGULATORY AUTHORITIES TO BENOTIFIED BY THE EHS DEPARTMENT IN CASE OF AN ACCIDENTAL SPILLAGE

DUN LAOGAHAIRE /RATHDOWN COUNTY COUNCIL

Mr. Pat Ruddy,Water Pollution Inspector,Water and Drainage Section,Dun Laoghaire-Rathdown County Council,Enniskerry Road,Co. Dublin.Telephone: 2955063 Fax: 2959003

l ENVIFCONMJZNTALPROTECTIONAGENCYRegional Inspectorate,McCumiskey House,Richview,Clonskeagh Road,Dublin, 14.Telephone: 2680100 Fax: 2680199

Accessed By: Graiune Munnel lyAccess Date:09/Augf2005

Page 6 of 10

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:03

.LNV?d W3IUl33VCUWHd llOO?d ClNflOlIDSNOILV307 .LIx HSNOdSa TiIdS

2 XIaN3ddlpl

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:03

I


Name: 6.1007 1 Status: Draft ( Version: 4.1 1 Effective: N/AAPPENDIX 3

SPILL RESPONSE KIT LOCATION

FIRSTFLOORPHARMACEUTICAJ,PI.ANT

PFIZER IRCLANO PHARMACEUTICALSPOTTERY ROAD. DUN LAOGHAIRE.CO DllBLlN IRCLAND.TEL.Ol-2049100 fAXOI-2856108

___-~--._

__.- -.. .-----


Page 8 of 10

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:03

. .

Tit le : SPILLAGE CONTROL

n

Name: 6.1fiO7 1 Status: Draft 1 Version: 4.1 1 Effective: N/A

APPENDIX 4

PPE REQUIREMENTS

Hazardous Chemical Spill Clean Up

In addition to spill clean up material, i.e. Booms and wipes forLiquid spills or HEPA vacuum for powders:

Personal Protective equipment required is as follows:

Material Process PPE MandatoryBulk Chemicals:

Clean up large l Tyvec Protec Suit and over-&UARDCLASSII Powder spills bootsKetalar / Ketamine HCL . Half face negative pressureFibrinuclease Powder respiratory with visor or

PAPR.khZAFWCLASSII1 . Use HEPA filter vacuumUK-292,663 Fluconazole cleaner.Prodrug 0 Empty vacuum cleaner inAzithromycin Dihydrate single pass booth ONLY.Voriconazole for Parenteral 0Use

Do not raise dust or drysweep.

l

OTHERNote: Female colleagues who

Desoxyribonucleaseare either pregnant or

Sulphobutyl Etherplanning pregnancy must not

P-Cyclodextrin Sodiumbe exposed to Cerebyx ,UK-292,663 Fluconazole

(SBECD) Prodrug or Voriconazole inthe bulk Form.

Finished Products Clean up of Powder l Overall / Sterile Suitspills > 12 vial l Safety Shoes.

Hazard Class II Products breakage simultaneously . Boot-covers/SterilePurified thrombin Booties.Elase l Gloves.

l Goggles / Visor.l Surgical face mask.

Hazard Class IIIRespirator not required asSterile Suite air flow

ProductsKetaMKetanest S

satisfactorily eliminates

Azithromycin for injectionexposure.

500mg/vialDamp wipe powders withcloth / use HEPA vacuum

Voriconazole for Infusion200mg/vial Do not raise dust or dry

Accessed By: Grainne MunnellyA c c e s s Date:09/Aug/2005

Page9of 10

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:03


,n

Name: 6.lbb7 ) Status: Draft 1 Version: 4.1 ( Effective: N/A

APPENDIX 4(Continued)

PPE REQUIREMENTS

Hazardous Chemical Srrill Clean UP

In addition to spill clean up material, i.e. Booms and wipes forLiquid spills or HEPA vacuum for powders:

Personal Protective Equipment required is as follows:

Hazard Class II Products3ulk Purified Thrombinhuified ThrombinLiquid ThrombinElase

Overalls / Sterile Suit.

Booth-covers / Sterile

Hazard Class III ProductsKetalarCerebyxW-292,663 FluconazoleProdrugAzithromycin for injection500mghialVoriconazole for Infusion

Avoid skin contact with

Chloroform

Chloroform is anAnesthetic. It is toxic bv PVA Gloves (Polyvinyl


Page 10 of 10

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:16:08:03

Documents

SOP NUMBER: SOP VERSION: EFFECTIVE DATE: SOP TITLE