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1、Annex6.TRS902,2002SterilePharmaceuticalProductsSupplementaryTrainingModuleson GoodManufacturingPracticeSterileProductionObjectivesToreviewbasicGMPrequirementsinthemanufactureofsterilepharmaceuticalproductsToreviewairclassificationsforactivitiesrelatedto
2、themanufactureofsterileproductsToreviewthedifferenttypesofsterilizationmethodsToreviewqualityassuranceaspectsinthemanufactureandcontrolofsterileproductsToconsidercurrentissuesapplicableinyourcountrySterileProductionGMPRequirementsforSterileProductsAddit
3、ionalratherthanreplacementSpecificpointsrelatingtominimizingrisksofcontaminationmicrobiologicalparticulatematterpyrogenSterileProductionGeneralConsiderationsProductionincleanareasAppropriatestandardofcleanlinessFilteredairsuppliedAirlocksforentryPersonn
4、eland/orequipmentMaterialsSeparateareasforoperationscomponentpreparation(containersandclosures)productpreparation,filling,sterilization,etc.1.1–1-29.1–9.6SterileProductionPremisesDesignAvoidunnecessaryentryofsupervisorsandcontrolpersonnelOperationsobser
5、vedfromoutsideIncleanareas,allexposedsurfaces:Smooth,impervious,unbrokenMinimizesheddingandaccumulationofparticles,microorganismsPermitcleaninganddisinfectionNouncleanablerecesses,ledges,shelves,cupboards,equipmentSlidingdoorsundesirableFalseceilingssea
6、led9.6.SterileProductionPremisesIncleanareas,allexposedsurfaces(2):Properinstallationofpipesandducts,norecesses,nounsealedopeningsSinksanddrainsavoided,andexcludedinGradeAandBareasWhereinstalled,design,location,maintenanceEffectivecleanabletrapsAirbreak
7、spreventingbackflowFloorchannelsopenandeasilycleanable9.7–9.9SterileProductionPremisesChangingroomsDesignedasairlocksEffectiveflushingwithfilteredairSeparateroomsforentryandexitdesirableHandwashingfacilitiesInterlockingsystemfordoorsVisualand/oraudiblew
8、arningsystemUsefilteredairsupplytomaintainpressurecascadePressuredifferentialapproximately10to15PascalesZoneofgreatestrisk–immediateenvironment9.9–9.12SterileProductionPremisesPathogenic,highlytoxic,radioactivematerialsPressureca
