PDA-TR61--在线蒸汽灭菌(SIP)工艺=中英文对照

BethesdaTowers4350EastWestHighwaySuite200Bethesda,MD20814USATel:1(301)656-5900Fax:[phone]E-mail:[e-mail]::CopyingandDistributionProhibited.致蒲公英论坛蒲友：本书（TR61SIP）翻译工作由蒲公英制药技术论坛提供原文并发起主持。对各位的利用业余时间进行翻译工作表示至真至诚的感谢！！在此特别感谢以下参与翻译工作人员！翻译及校对人员名单序号章节页码认领情况认领人完成情况11.0-2.01-6已认领观沧海已完成23.07-10已认领张正言已完成34.011-18已认领开羽已完成45.019-25已认领wj1914已完成56.026-36已认领一沙一叶已完成67.037-39已认领weiguizhang0326已完成78.0-8.340-44已认领334352444已完成88.445-47已认领wmx2046已完成98.5-8.5.747-48已认领wj1914已完成108.5.8-8.5.1249-51已认领molly已完成校对人员：玻璃杯、wangjin1023PDATechnicalReportNo.61:SteaminPlaceTaskForceMembersAuthorsKevinTrupp(TaskForceChair),RetiredDaveAdams,BaxterHealthcareCorporationKeithE.Bader,HydeEngineeringandConsultingMichaelN.Blackton,ImCloneSystems,Inc.KeithA.Bowen,Centocor,Inc.GarthCorkill,PallLifeSciencesTimP.Cirbo,EliLillyandCompanyJoseA.Goin,Ph.D.,GenentechLeesaD.McBurnie,MeissnerFiltrationProducts,Inc.LanceL.Morien,Centocor-GlobalBiologicsSupplyChainMichaelP.Mulcare,BiogenIdecAntonPonomarenko,BayerHealthcareTonyVanHoose,SanofiPasteurEdwardK.White,BaxterHealthcareCorporationRandyWilkins,MilliporeCorporationContributorsMartinKern,HermesPharmaVictorG.Maqueda,Sr.(nocompanyaffiliation)KeithShuttleworth,KeithShuttleworth&AssociatesNigelWood,GlaxoSmithKlineTheSteaminPlaceTaskForcewouldliketodedicatethistechnicalreportinmemoryofLanceMorien.ThecontentandviewsexpressedinthisTechnicalReportaretheresultofaconsensusachievedbytheauthorizingTaskForceandarenotnecessarilyviewsoftheorganizationstheyrepresent.LicensedtoJiang,Binjun/PharmaceuticalEngineering:CopyingandDistributionProhibited.SteamInPlaceTechnicalReportNo.61ISBN:978-0-939459-53-7©2013ParenteralDrugAssociation,Inc.Allrightsreserved.BethesdaTowers4350EastWestHighwaySuite200Bethesda,MD20814USATel:1(301)656-5900Fax:[phone]E-mail:[e-mail]::CopyingandDistributionProhibited.1.0INTRODUCTION...................................................11.1Scope................................................................12.0GLOSSARYOFTERMS.........................................33.0STEAMINPLACESCIENCEANDTECHNOLOGY73.1SIPApplications................................................73.2MechanismsofLethality...................................84.0SYSTEMDESIGN...............................................114.1PlanningforDesignofSIPCycle.....................114.2EquipmentDesignConsiderations..................114.3SIPSystemControlandMonitoring................164.3.1Automation..............................................164.3.2ControllingtheSIPCycle..........................174.3.3SIPforPortableVessels...........................174.3.4Semi-ManualandManualSIPOperations185.0CYCLEDEVELOPMENTCONSIDERATIONS.......195.1UseofRiskManagementduringDevelopment205.1.1RiskAssessment.....................................205.1.2RiskMitigation.........................................215.1.3CycleDevelopmentData..........................215.1.4Testing.....................................................215.2CycleParameterDetermination......................215.3FilterCycleDevelopmentConsiderations.......245.3.1WetFilters...............................................245.3.2FilterIntegrityTests.................................245.4TemperatureMapping.....................................256.0PERFORMANCEQUALIFICATION......................266.1UseofRiskManagementduringQualification266.1.1System/EquipmentQualification..............266.1.2CycleQualification...................................276.2PhysicalQualification......................................276.2.1Sanitizationvs.Sterilization.....................276.2.2TemperatureMapping..............................286.3BiologicalQualification....................................296.3.1MicrobialChallenge.................................306.3.2UseandPlacementofBiologicalIndicators.................................316.4QualificationAcceptanceCriteria....................346.5ValidationApproaches....................................356.5.1FamilyValidation......................................366.5.2MatrixValidation......................................367.0ONGOINGPROCESSCONTROL..........................377.1UseofRiskManagementforOngoingProcessControl...............................................377.2RoutineMonitoring.........................................377.2.1OperationalParameters............................377.2.2FilterTesting............................................387.3ChangeControl/Revalidation...........................387.4PeriodicRequalification/Revalidation..............387.5PreventativeMaintenanceStrategy................397.6CalibrationStrategy........................................398.0APPENDICES......................................................408.1AppendixA:RiskAssessmentofSteaminPlaceProcesses...............................408.1.1Introduction..............................................408.2RiskAssessmentTools..........