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1、SterileProductPackageIntegrityTestingCurrentPractice,CommonMistakes,NewDevelopmentsByDanaMortonGuazzo,PhDRxPax,LLCBridgewater,NJ08807dguazzo@rxpax.comPDAMetroChapterMay17,2010SterileProductPackageIntegrityTestingCurrentPractice,CommonMistakes,NewDevelopmentsPart1Marketed
2、SterileProductsPackageintegrityrelatedrecallsPart2DyeIngressLeakTests“Bestpractices”?Part3BestPracticesLeakTestMethodsValidationConceptsPart4BestPracticesLeakTestMethodsProvenNondestructiveMethodsSummaryRxPax,LLC,PDAMetroChapter,May20112Part1MarketedSterileProductsPackag
3、eintegrityrelatedrecallsRecentPackageIntegrityRelatedRecallsòPRODUCTAMOCOMPLETEMulti-PurposeSolutionòRECALLINGFIRM/MANUFACTURERRecallingFirm:AbbottMedicalOpticsInc(AMO),SantaAna,CA,byletteronJuly28,2010Manufacturer:AdvancedMedicalOpticsManufacturingSpain,S.L.,Alcobendas(
4、Madrid),SpainòREASONAlimitednumberofthefliptopcapsusedduringproductionofthesesolutionsmayleakand,althoughunlikely,thesterilityoftheproductmaybecompromised.Productsthatarenon-sterilehavethepotentialtocauseeyeinfections,whichmaybesightthreateningòVOLUMEOFPRODUCTINCOMMERCE3
5、4,224unitsRxPax,LLC,PDAMetroChapter,May20114RecentPackageIntegrityRelatedRecallsòPRODUCTMidazolamInjection,USP,2mg/2mL(1mg/mL),10x2mLSingle-doseSterileCartridgeUnitwithLuerLockpercartonòRECALLINGFIRM/MANUFACTURERRecallingFirm:Hospira,Inc.,LakeForest,IL,byletterdatedJune2
6、9,2010Manufacturer:Hospira,Inc.,McPherson,KSòREASONQualityprocedureswereincompletepriortothereleaseoftheproductwhichcouldresultincrackedvialswhichcouldcompromisethesterilityoftheproductòVOLUMEOFPRODUCTINCOMMERCE840cartonsRxPax,LLC,PDAMetroChapter,May20115RecentPackageInt
7、egrityRelatedRecallsòPRODUCTEpinephrineinjection,USP,auto-injectoròRECALLINGFIRM/MANUFACTURERRecallingFirm:ShionogiPharma,Inc.,Atlanta,GA,byletteron/aboutOctober28,2010Manufacturers:Hospira,Inc.,McPherson,KS;CovidienLP,Deland,FL;PhillipsPlasticsCorp,PhillipsMedical,Menom
8、onie,WIòREASONPossibilityexistsasmallnumberofsheathscoveringtheneedlemayhavepinholesòVOLUMEOFPRODUCTINC
