4 - Use of PDA Technical Reports to Support Sterile r1

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1、UseofPDATechnicalReportstoSupportSterileandAsepticProcessingPracticesCopyrightMerckMillipore2011.1WhyPDAtechnicalreportsshouldbeincorporatedinsterileandasepticprocessdesignTechnicalReport26-SterilizingFiltrationofLiquids–Overview&keypointsTechnicalReport40-

2、SterilizingFiltrationofGases–Overview&keypointsCopyrightMerckMillipore2011.2WhyPDAtechnicalreportsshouldbeincorporatedinsterileandasepticprocessdesignPDAisaninternationalorganizationPDAtechnicalreportsgatherexpertsfromkeyorganisations,companies,vendors,andr

3、egulatoryagenciesPDAdocumentsarepublicregularlyupdatedNeutralandunbiasedcomprehensiveandincludeessentialinformationUsedasreferencedocumentsbyinspectorsExcellentvalueconsideringthewealthofinformationtheycontainCopyrightMerckMillipore2011.3PDATechnicalR

4、eport26SterilizingFiltrationofLiquidsCommentson2007RevisionCopyrightMerckMillipore2011.4ScopeoftheNewEditionPDA’soriginalTechnicalReportNo.26,SterilizingFiltrationofLiquids(1998)describestheuseandvalidationofsterilizingfiltration.2007Revisionis“intendedtopr

5、ovideasystematicapproachtoselectingandvalidatingthemostappropriatefilterforliquidsterilizingfiltrationapplications.”Therevisionoftheoriginalreportwasdevelopedinresponsetoenhancementsinfiltrationtechnologiesandrecentadditionalregulatoryrequirementswithinthep

6、harmaceuticalindustry.CopyrightMerckMillipore2011.5TaskForceMembersFilterusersfrompharmaandbiotech(BMS,Genera-Medix,Genentech,Merck,Novo,Pfizer,Sanofi,Schering-Plough)Representativesfromfiltermanufacturers(Cuno,GE,Gore,Meissner,Millipore,Sartorius)FDArepres

7、entativesPDArepresentativesIndependentconsultantsCopyrightMerckMillipore2011.6Comparisonof1998&2007TR26TableofContents1998Original2007Revision1.0Introduction1.0Introduction2.0Pharmaceuticalfiltration,2.0Pharmaceuticalfiltration,HistoricalHighlightsHistorica

8、lHighlights3.0Howfilterswork3.0Howfilterswork4.0Filterselectionandcharacterization4.0Filterselectionandcharacterization5.0Physicalandmechanicalcharacteristics5.0Filteruse,handlinganddesign6.0Sterilefil