验证方案(包装、包括报告)(英文)

XXXGroupCorp.MedicalPolymerproductsCo.,LTDPackinginspectprojectName:theartsandcraftsinspectionofpackingDocumentsserialNo:VP-002draftsmanexamineandapproveratifierSignDateCollectsigndept.CollectionsignDateCatalogue1.Purpose2.Contextofinspection3.Resultsanalysisandappraise4.Finalapproval5.Organizationofinspection6.Dutyanddividethework1.Inspectpurpose:ThedisposablePlasticBloodbagsmadebyusarepackedinnerpackagewithPVCandover-packagewithhightemperatureco-explasticbagswhicharemadefromPP-PETmaterial.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction(MDD93/42/EEC),AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:thegeneralrequirementsandinspectmethods,withregardtoourinnerpacking,wecarryouttheinspectionsinordertoapproveofmeasuringuptherequirementsofmedicaldeviceinstruction(MDD93/42/EEC).2.InspectcontentsThefirstpart:theinspectionofsinglepacking.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction(MDD93/42/EEC),AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:thegeneralrequirementsandinspectmethods,withregardtoourinnerpacking,wecarryouttheinspectionsasfollowing:1)PreliminarycontaminatedInspectionofsinglepacking:2)Non-ventilateinspectionofsinglepacking:3)Preventbacteriuminspectionofsinglepacking:4)Assistanceto-leakageinspectionofsinglepacking:5)Biologicalcompatibilityinspectionofsinglepacking:6)Toxicityinspectionofsinglepacking7)Labelsysteminspectionofsinglepacking1)PreliminarycontaminatedInspectionofsinglepacking:omnivorouslyholdingsamples10PCS(triplebags250mlwithlot20030218,20030219,20030220)aftersterilization,themethodsofinspectionrefertoEN1174-1/2/3:1996theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thefirstpart:essencerequirementslist,theappraiseofsterilizationofmedicaldevice-animalculecontaminatedappraise---thesecondpart:instructionofapplication,theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thethirdpart:theconfirmmethodinstructionofinspectiontechnical.2)Non-ventilateinspectionofsinglepacking:takeout5piecesaftersterilizationconvenientlywithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:thegeneralrequirementsandinspectmethods.3)Preventbacteriuminspectionofsinglepacking:takeout5piecesconvenientlyaftersterilizationwithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:thegeneralrequirementsandinspectmethods.4)Anti-leakageinspectionofsinglepacking:takeout5piecesconvenientlywithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.WhenfilledtonominalcapacitywithwaterasspecifiedinISO3696andsealed,theplasticcontainershallnotdevelopleaksunderconditionsofcentrifugationat5000gat37℃for10min.Theplasticcontaineristhensqueezedbetweentwoplatestoaninternalpressureequivalentto50kPaaboveatmosphericpressureat(23+5)℃for10min.Noleakageisallowedonvisualinspection.Note;whentheplasticcontainerisfilledwithanticoagulantsolution,leakagemaybedetectedbypressingtheplasticcontaineragainstsheetsofbluelitmuspaperandobservingthedevelopmentofpinkspotsonthepaper.ThedetailinformationreferstoISO3826:1993plasticcollapsiblecontainersforhumanbloodandbloodcomponents.5)Biologicalcompatibilityinspectionofsinglepacking:takeout5piecesconvenientlyaftersterilizationwithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.ThemethodsofexperimentsrefertoISO10993-1:1997biologicalappraiseofmedicaldevicethefirstpart:appraiseandtest.6)Toxicityinspectionofsinglepacking:takeout5piecesconvenientlyaftersterilizationwithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.ThemethodofexperimentsreferstoISO3826:1993plasticcollapsiblecontainersforhumanbloodandbloodcomponents.7)LabelsysteminspectionofsinglepackingTakeout5piecesconvenientlylabelstuckwithlot2003021811,2003021812,2003021813,inspectonebyoneaccordingtoEN980packageandsymbolofmedicalpolymerproductsincluding:(1)Generaldemandsa)Thesymbolindicatedonpackageshouldbeinstructtoshipments,storage,tearingopenandusageb)Thesymbolindicatedonpackageshouldbeclear,perspicuity,fastness,Itisforbiddentobrushofforslurintheprocessofsterilization,shipmentsandstorage.c)Thesymbolofparliamentarypackingshouldbetypedontheoutersurfacebutnotexceptforconsideringthatremovingcaninfluenceonthequalityinthepackage.(2)Thegeneralinformationonthesinglepackinga)Productsname.styleorspecificationb)Themanufacturename,addressandbrandsc)Productionlotordate:d)“non-sterilize”lettersand/thenon-sterilizesymbolofdrawing“destroyedafterusing”letters:e)Ifthesinglepackingisbroken,donotusetheproducts.“Packagebrokennottouse”mustbeindicated.f)Singleuseinstruction/symboldesign:g)Expirydate:Thesecondpart----over-packageinspection1.Inspectpurpose:.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction(MDD93/42/EEC),Accordingto