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1、PDAJournalofPharmaceuticalScienceandTechnologyDRAFT13TechnicalMonographNo.1,2002RevisionIndustrialMoistHeatSterilizationInAutoclaves2003SupplementVolume57NumberXPDASteamSterilizationValidationTaskForceMembersJamesP.Agalloco,Agalloco&Associates,ChairmanJ
2、amesE.Akers,Ph.D.,AkersKennedy&AssociatesWilfAllinson,GlaxoSmithKlineBruceA.Bear,SterisLaboratoriesThomasJ.Berger,Ph.D.,AbbottLaboratoriesGöranBringert,KayeInstruments,Inc.Jean-LucClavelin,LillyFrancePhilDeSantis,Schering-PloughPeterDürr,F.Hoffmann-LaRo
3、cheAGWilliamR.Frieben,Ph.D.,Pharmacia&UpjohnJohnG.Grazal,AstraZenecaKlausHaberer,Ph.D.,ASIMNigelHalls,Ph.D.,NHCConsultingMartinA.Joyce,Ph.D.,Elkins-SinnLederleBernardKronenberg,BakronaBaselAG,EuropeanChairSteenLoevtrup,NovoNordiskA/STimothyF.Lord,EliLil
4、ly&Co.RussellE.Madsen,PDAVittorioMascherpa,Ph.D.,FedegariAutoclaviSpaDavidW.Maynard,Maynard&AssociatesJeanneE.Moldenhauer,Ph.D.,VectechJamesE.Owens,BaxterHealthcare(retired)HansJürgenReinhold,Ph.D.,ScheringAGFinlaySkinnerJohnT.Shirtz,AmericanPharmaceuti
5、calPartnersDieterWitthauer,Ph.D.,NovartisRichardT.Wood,Ph.D.,PfizerTechnicalReviewersJohnR.Gillis,Ph.D.,SGMBiotechRobertF.Morrissey,Ph.D.,Johnson&JohnsonIrvingPflug,Ph.D.,UniversityofMinnesotaDarioPistolesi,Ph.D.,FedegariAutoclaviSpaFDAParticipantsPeter
6、Cooney,Ph.D.KrisEvansRichardFriedmanJohnLevchuk,Ph.D.AdditionalContributorsFrankBing,AbbottLaboratoriesJohnGrillo,Ph.D.,AbbottLaboratoriesAnthonyPochiro,SterisCorporationJarmoSaari,LeirasOYKeithShuttleworth,KeithShuttleworthAssociatesCarloVoellmy,Ph.D.,
7、NovartisWilliamYoung,BaxterHealthcare1TechnicalMonographNo.1,2002Revision132IndustrialMoistHeatSterilizationinAutoclaves3CycleDevelopment,ValidationandRoutineOperation45TableofContents61.Preface...........................................................
8、....................................................................572.Scope..................................................................................................................................683.Introduction/KeyDe
