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【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】:ASTMF2338-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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】:
【英文主题词】:absolutepressuretransducer;barrierperformance;block;criteriaparameters;differentialpressuretransducer;flexiblepackaging;foodpackages;gaugepressuretransducer;holeleaks;holes;leaks;liquidleaks;mask;medicalpackages;non-destructive
【摘要】:Leaksinmedicaldevice,pharmaceutical,andfoodpackagesmayresultintheingressofunwantedgases(mostcommonlyoxygen),harmfulmicrobiological,orparticulatecontaminants.Packageleaksmayappearasimperfectionsinthepackagecomponentsthemselvesoratthesealjuncturebetweenmatedcomponents.Theabilitytodetectleaksisnecessarytoensureconsistencyandintegrityofpackages.Afterinitialset-upandcalibration,individualtestoperationmaybesemi-automatic,automatic,ormanual.Thetestmethodpermitsnon-destructivedetectionofleaksnotvisiblydetectable.Thetestmethoddoesnotrequiretheintroductionofanyextraneousmaterialsorsubstances,suchasdyesorgases.However,itisimportanttophysicallymaskorblockoffanypackageporousbarriersurfaceduringthetesttopreventrapidlossofchambervacuumresultingprimarilyfromgasmigrationthroughtheporoussurface.Leakdetectionisbasedsolelyontheabilitytodetectthechangeinpressureinsidethetestchamberresultingfromgasorvaporegressfromapackagechallengedwithvacuum.Thistestisausefulresearchtoolforoptimizingpackagesealingparametersandforcomparativelyevaluatingvariouspackagesandmaterials.Thistestmethodisalsoapplicabletoproductionsettingsasitisrapid,non-invasive,andnon-destructive,makingitusefulforeither100%on-linetestingortoperformtestsonastatisticalsamplingfromtheproductionoperation.Leaktestresultsthatexceedthepermissiblelimitsforthevacuumdecaytestareindicatedbyaudibleorvisualsignalresponses,orboth.1.1TestPackages8212;Packagesthatcanbenondestructivelyevaluatedbythistestmethodinclude:1.1.1Rigidandsemi-rigidnon-liddedtrays.1.1.2Traysorcupssealedwithporousbarrierliddingmaterial.1.1.3Rigid,nonporouspackages.1.1.4Flexible,nonporouspackages.1.2LeaksDetected8212;Thistestmethoddetectspackageleaksbymeasuringtheriseinpressure(vacuumloss)inanenclosedevacuatedtestchambercontainingthetestpackage.Vacuumlossresultsfromleakageoftestpackageheadspacegasesand/orvolatilizationoftestpackageliquidcontentslocatedinorneartheleak.Whentestingforleaksthatmaybepartiallyorcompletelypluggedwiththepackagex2019;sliquidcontents,thetestchamberisevacuatedtoapressurebelowtheliquidx2019;svaporizationpressure.Allmethodsrequireatestchambertocontainthetestpackageandaleakdetectionsystemdesignedwithoneormorepressuretransducers.Testmethodsensitivitiescitedbelowweredeterminedusingspecificproduct-packagesystemsselectedfortheprecisionandbiasstudiessummarizedinTable1.Table1alsolistsotherexamplesofrelevantproduct-packagesystemsthatcanbetestedforleakagebyvacuumdecay.1.2.1TraysorCups(Non-lidded)(AirLeakage)8212;Holeorcrackdefectsinthewallofthetray/cupofatleast50x03BC;mindiametercanbedetected.NonliddedtraysweretestedataTargetVacuumofx2013;4x00B7;E4Pa(x2013;400mbar).1.2.2TraysSealedwithPorousBarrierLiddingMaterial(HeadspaceGasLeakage)8212;Holeorcrackdefectsinthewallofthetray/cupofatleast100x03BC;mindiametercanbedetected.Channeldefectsinthesealarea(madeusingwiresof125