11 - Microbiological Management of Sterile Products

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1、MicrobiologicalManagementofSterileProductsModule11CopyrightMerckMillipore2011.1OverviewShowexamplesofasepticsamplingtechniquesandsamplinglocationsinthesterilesuiteUseofdisposabletechnologiesforin-processsamplinginsterilizingandredundantfiltrationprocessesAirsampleinclassifiedareasBiob

2、urdensamplingfromrawmaterialsandformulationsSterilitytestingoffinalproductOrganismspeciationanditsuseinmicrobiologicalcontrolCopyrightMerckMillipore2011.2MonitoringProgramsinMicrobiologyMicrobiologyIn-ProcessLaboratoryFinalProductRawEnvironmentalMaterialsMonitoringWaterSupportDataProd

3、uctReleaseCopyrightMerckMillipore2011.3SamplingADifficultProcessSamplingBatchQualification/Documentation•ProcedureParameter•Tools/Equipment•EnvironmentSampleNodirectmeasurementAnalysisDecisionsAdjustmentsSampleQualification/DocumentationParameter•Procedure•Tools/Equipment•EnvironmentC

4、opyrightMerckMillipore2011.4CommonsamplingmethodsCopyrightMerckMillipore2011.5SomeCurrentSamplingMethodsSteamonSampling-UsingGlassbottlesChallenges:CIP/SIPbetweensamplesHeat-uptankwallCondensationIssuesInconsistentNotRepresentativeLowSamplingFrequencyRequiresupto100minutesSlow(

5、Assembly)Advantages:Flexible,multiplesamples,compatibilityCopyrightMerckMillipore2011.6SomeCurrentSamplingMethodsUsingaSampleValveChallenges:DeadlegPre-flushNeededContaminationRiskDifficulttoSterilizeNotRepresentativeAdvantages:Flexible,multiplesamplesCopyrightMerckMillipore201

6、1.7AsepticSamplingDipandSwabTestersMAirTCompressedGasCopyrightMerckMillipore2011.8SetupStep1:AssemblesampleunitsandattachtotankStep2:PerformCIP/SIPCopyrightMerckMillipore2011.9BeginSamplingStep3:PressthetriggertosampleNeedlepuncturesthesiliconediaphragmReleasethetriggerwhensampling

7、iscompleteCopyrightMerckMillipore2011.10SealandSeparateStep4:Usingacrimpingtool,crimpthemetalpinchpipetosealandseparatethetubingCopyrightMerckMillipore2011.11ReadyforTestingStep5:ThedisposablebagisreadyfortransportandtestingCopyrightMerckMillipore2011.12SafeSamplingCopyrightMerckMil

8、lipor