无菌系统验证培训

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1、AsepticLineValidationTraining无菌系统验证培训October27,2005StevenSunContentPurposeScopeDefinitionsEquipmentPerformanceValidationLineQualificationInstallation/OperationqualificationProcessValidationOperationalValidationPreparationPurposevalidationofanewasepticlineinstallation,validationofexistingasepticlin

2、esatnewcontractpackers,validationofexistingasepticlinesatexistingcontractpackersthatdidn’tperformthevalidationaccordingtoTCCCvalidationofanewdesignorsizeofbottleorclosureotherthanthoseusedintheoriginalorpreviouslinevalidation,Purposevalidationofamoremicrobiologicallysensitivehighacidbeveragethanth

3、eoneforwhichthelinehasbeenvalidated,yearlyrevalidationofanexistingasepticline,revalidationofanasepticlinefollowinganychangethatmayimpacttheasepticprocessScopeThisdocumentappliestoallasepticlines,whicharefillinghighacid(pH≤4.4)andlowacidbeveragesforTheCoca-ColaCompanyinPETorothertypesofplastic(e.g.

4、HDPE).DefinitionsBioburdenCommercialSterilityClass100airqualityHEPA,ULPAQualificationValidationVerificationDefinitionsLowAcidproductpH>4,4HighAcidproductpH<=4.4Logreduction=Log(InitialCount/Survivingcount).Onesurvivingcountoutofamillionislog6reduction.IngeneralLowacidproductlogreductionis1unit.igh

5、erthanHighacidproduct.UnderCommercialSterility–theconsumeracceptancerateisminimum1spoiledproductin10,000.[Nottobetakenasproductionstandard].Validationinvolvesvariouschallengingmicrobiologicalloadingteststomeasureupthelogreductionandproductionsimulationtestswithculturemediaandproducttoverifysterili

6、ty.DefinitionCIPSIPCOP/SOP.SterilezoneMicrobiologicalFailurerateSystemFailurerateCriteriaCIPcleaningrequirementsSterilezonecleaningrequirements(COP)Sterilezonesterilizationrequirements(SOP)SIPrequirementsPackagedecontaminationrequirementsBottle/closurerinsewaterWaterusedforproductchangeoverPressur

7、edifferentialmonitorandcontrolHEPA/ULPAfilterinstallationsPreparationLineEfficiencyOperationUtilityMaterialIndicateorganismsMaterialPreparationIndicatororganismGrowthmediumIncubationtemperature–timeScopeBacilluss