PDA-TR13-01环境检测程序的基本要素

PDAEnvironmentalMonitoringTaskForceJeanneE.Moldenhauer,Chairperson,VectechPharmaceuticalConsultants,Inc.AijazAhmad,Genentech,Inc.SusanE.Arrigoni,Ortho-ClinicalDiagnosticsAnthonyM.Cundell,Ph.D.,Wyeth-AyerstPharmaceuticalsGaryE.Strayer,Merck&Company,Inc.JohnH.Ducote,ChironCorporationSusanF.Elder,GlaxoWellcome,Inc.MaryBethGrace,Genentech,Inc.DavidA.Ness,AbbottLaboratories,Inc.ThaddeusG.Pullano,Ph.D.,Wyeth-LederleVaccinesandPediatricsJamesF.Quebbeman,Parke-Davis&CompanyBeritReinmüller,RoyalInstituteofTechnologyMiriamRozo,Ortho-ClinicalDiagnosticsLydiaTroutman,Schering-PloughCorporationTechnicalReviewersRussellE.Madsen,PDARobertMello,RJMPharmaceuticalConsultantsKennethH.Muhvich,Ph.D.,TheValidationGroupGlennWright,EliLilly&CompanyAcknowledgementsFrancoDeVecchi,VPCI,forprovidinginformationrelatingtoHVACsystemsandenvironmentalmonitoring.AnneMarieDixon,CleanRoomManagementAssociates,Inc.,forprovidingtheISOinformationrequiredforthisdocument.PhyllisKarpiel,FujisawaHealthcare,Inc.,forprovidingthemajorityofthetyp-ingsupport.SteveYentes,Pfizer,Inc.,forprovidingtechnicalreviewofthedocument.ElizabethJoyce,JordanPharmaceuticals,Inc.,forprovidingtechnicalwritingreviewofthedocument.FundamentalsofanEnvironmentalMonitoringProgramTechnicalReportNo.13RevisedPDASeptember/October2001Vol.55,No.5,September/October2001,SupplementTR13,RevisediPDATECHNICALREPORTNO.13REVISEDFUNDAMENTALSOFANENVIRONMENTALMONITORINGPROGRAMTableofContents1.0INTRODUCTION...............................................................................12.0ENVIRONMENTALCLASSIFICATIONS............................................................13.0SURVEILLANCESUPPORT......................................................................63.1CleaningandSanitization/Disinfection............................................................63.2SampleSiteSelection.........................................................................63.3SamplingFrequency..........................................................................73.4AlertandActionLevels.......................................................................83.5DataManagement(DataCollection,Analysis,Approach,andInterpretation).............................93.5.1DataCollection........................................................................93.5.2DataAnalysis.........................................................................93.5.3DataApproach.........................................................................103.5.4DataInterpretation.....................................................................113.6CharacterizationofIsolates....................................................................113.7Investigations/CorrectiveActions................................................................113.8Documentation.............................................................................124.0SYSTEMSURVEILLANCE......................................................................144.1Introduction................................................................................144.1.1TerminalSterilization...................................................................144.1.2AsepticFilling.........................................................................144.1.3IsolationTechnology....................................................................144.2WaterMonitoring............................................................................144.3CompressedGasMonitoring...................................................................154.4AirMonitoring..............................................................................154.4.1Non-ViableMonitoring..................................................................164.4.2ViableMonitoring.....................................................................164.4.3SurfaceMonitoring....................................................................194.5PersonnelMonitoring.........................................................................214.5.1Description..........................................................................214.5.2Training/CertificationofPersonnelforAsepticManufacturingArea...............................214.5.3Retraining............................................................................214.6ProductorComponentBioburden...............................................................214.6.1DeterminationofProductorComponentBioburden............................................224.6.2ParametricReleaseandBioburden.........................................................224.6.3In-ProcessTesting.....................................................................234.7EnvironmentalMonitoringDuringRoutineSterilityTesting..........................................255.0VALIDATION/QUALIFICATIONOFENVIRONMENTALMONITORINGSYSTEMS.......................255.1Environment/HVACSystems...................................................................255.2Utilities................................................................