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Steam Sterilizer

Steam Sterilizer

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Published by j.k.kumar

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Published by: j.k.kumar on Oct 08, 2007
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06/26/2013

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Cipla
Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
CODE No.: OCP-022LOCATION: POWDER INJECTABLEAREA: COMPONENT STERILISATION AREAMAKE : METAL CHEM INDUSTRIESMACHINE SERIAL NO : 215PROTOCOL No. : EQ/OCP-022/01 
The purpose of this document is to qualify the Steam Sterilizer.This Document provides evidence that the equipment is functional and isInstalled according to design specifications, performs as designed and Complies with the Standard Operating Procedure and thus meetsThe cGMP obligations.
 
PROTOCOLCOMPILED BYPROTOCOLAPPROVED BYPROTOCOLAUTHORIZED BY
Production:Quality Control:Engineering:Safety:Quality Assurance:Unit Head:
Date:Date:Date:
Page 1 of 24
 
Cipla
Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYERCONTENTS1. Design qualification2. Checklist for equipment on receipt3. Installation qualification4. Operational qualification5. Performance qualification6. Equipment Hand over Certificate 
DESIGN QUALIFICATION1. Purpose :
The purpose of Design qualification is to ensure that all the critical aspects of Process/ Product requirements, cGMP and safety have been considered in designing SteamSterilizer and are properly documented.
Page 2 of 24
 
Cipla
Goa
QUALIFICATION OF STEAM STERILIZER CUM BUNG DRYER
2. Project requirements:
 To design a Steam Sterilizer which will be installed in component area of injectiondepartment to use for sterilization.
3. Critical variables to be met:
 
Critical variablesAcceptance CriteriaReferences1.0Process / Product Parameters
1.1. The system should beable to sterilize theload.Sterilization should assure the totaldestruction of microbial load(To be assured by supplier)Processrequirement1.2.OperationAuto / ManualShould be completely PLC operatedDouble Door Sterilizer Processrequirement1.3.Working capacity oAutoclaves.Volume : 1130 Litres.Working Pressure: 2.1 kg/cm
2
Processrequirement
2.0.Location Suitability
2.1.Availability of utilitiesat location.Utility connections should beavailable. cGMPrequirements2.2. Size of Autoclave.900 mm
×1050
mm
×
1200 mmProcessrequirement2.3.Room conditionShould be able to meet therequirement of Clean environmentcGMPrequirements2.4.Weight of Autoclave(in working condition).Should be less than the load bearingcapacity of the area. i.e. 1000 kg /sq.mProcessrequirement
DESIGN QUALIFICATIONCritical variablesAcceptance CriteriaReferences3.0Key Design Features
Page 3 of 24

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