【英文标准名称】:StandardTestMethodforNondestructiveDetectionofLeaksinPackagesbyVacuumDecayMethod
【原文标准名称】:用真空衰变法的包装紧密性无损检验的标准试验方法
【标准号】:ASTMF2338-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F02.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:衰变;检漏;非破坏性的;包装件;运输;真空的
【英文主题词】:absolutepressuretransducer;barrierperformance;block;criteriaparameters;differentialpressuretransducer;flexiblepackaging;foodpackages;holeleaks;holes;leaks;mask;medicalpackages;non-destructivetesting;packageintegritymonitoring;packageintegritytest;permeablepackaging;pharmaceuticalpackages;porousbarrier;porousbarriermaterial;porouspackaging;pressurechangeleaktesting;pressuretransducer;sealintegritymonitoring;sealintegritytest;sealleaks;semi-rigidthermoformedtrays;sterileintegritytest;vacuumdecayleaktesting;vacuumleaktesting;volumetricairflowmeter
【摘要】:Leaksinmedicaldevice,pharmaceuticalandfoodpackagesmayresultintheingressofunwantedgases(mostcommonlyoxygen),harmfulmicrobiologicalorparticulatecontaminants.Packageleaksmayappearasimperfectionsinthepackagecomponentsthemselvesoratthesealjuncturebetweenmatedcomponents.Theabilitytodetectleaksisnecessarytoensureconsistencyandintegrityofpackages.Afterinitialset-upandcalibration,theoperationsofindividualtestsmaybesemi-automatic,automaticormanual.Thetestmethodpermitsthenon-destructivedetectionofleaksnotvisiblydetectable.Thetestmethoddoesnotrequiretheintroductionofanyextraneousmaterialsorsubstances,suchasdyesorgases.However,itisimportanttophysicallymaskorblockoffanyporousbarriersurfaceofthepackageduringthetesttopreventarapidlossofchambervacuumresultingprimarilyfromgasmigrationthroughtheporoussurface.Leakdetectionisbasedsolelyontheabilitytodetectthechangeinpressureinsidethetestchamberasaresultofairegressfromtheproperlymaskedpackagewhenchallengedwithvacuumconditions.Thistestisausefulresearchtoolforoptimizationofpackagesealingparametersandforcomparativeevaluationofvariouspackagesandmaterials.Thistestmethodisalsoapplicabletoproductionsettingsasitisrapid,non-invasiveandnon-destructive,makingitusefulforeither100%on-linetestingortoperformtestsonastatisticalsamplingfromtheproductionoperation.Leaktestresultsthatexceedthepermissiblelimitsforthevacuumdecaytestareindicatedbyaudibleorvisualsignalresponses,orboth.1.1TestPackagesPackagesthatcanbenondestructivelyevaluatedbythistestmethodinclude:1.1.1Rigidandsemi-rigidnon-liddedtrays.1.1.2Traysorcupssealedwithporousbarrierliddingmaterial.1.1.3Rigid,nonporouspackages.1.1.4Flexible,nonporouspackages(see1.2.4).1.2LeaksDetected-Thistestmethodiscapableofdetectingpackageleaksusinganabsoluteordifferentialpressuretransducerleakdetector.Thesensitivityofatestisafunctionofthesensitivityofthetransducer,thepackagedesign,thedesignofthepackagetestfixture,andcriticaltestparametersoftimeandpressure.Typesandsizesofleaksthatmaybedetectedforvariouspackagesystems,aswellastestsensitivitiesaredescribedbelow.Thesedataarebasedonprecisionandbiasconfirmationstudies.1.2.1TraysorCups(Non-lidded)-Holeorcrackdefectsinthewallofthetray/cupofatleast50mindiametercanbedetectedataTargetVacuumof4104Pa(400mbar)usinganabsolutepressuretransducertestinstrument.1.2.2TraysSealedwithPorousBarrierLiddingMaterial-Holeorcrackdefectsinthewallofthetray/cupofatleast100mindiametercanbedetected.Channeldefectsinthesealarea(madeusingwiresof125mindiameter)canbedetected.Severesealbondingdefectsinbothcontinuousadhesiveanddotmatrixadhesivepackagesystemscanbedetected.Slightlyincompletedotmatrixadhesivebondingdefectscanalsobedetected.AllporousbarrierliddingmaterialpackagesweretestedataTargetVacuumof4104Pa(400mbar)usinganabsolutepressuretransducertestinstrument.Usingacalibratedvolumetricairflowmeter,thesensitivityofthetestforporousliddedpackagesisshowntobeapproximately10-2Pam3s-1.1.2.3Rigid,NonporousPackages-Holedefectsofatleast5mindiametercanbedetected.Allrigid,nonporouspackagesweretestedatatargetvacuumof5104Pa(500mbar)usingadifferentialpressuretransducertestinstrument.Usingacalibratedvolumetricairflowmeter,thesensitivityofthetestforrigid,nonporouspackagesisshowntobeapproxima......
【中国标准分类号】:A82
【国际标准分类号】:55_180_40;55_180_40
【页数】:9P.;A4
【正文语种】: