Designation:D7709−12(Reapproved2017)StandardTestMethodsforMeasuringWaterVaporTransmissionRate(WVTR)ofPharmaceuticalBottlesandBlisters1ThisstandardisissuedunderthefixeddesignationD7709;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thethreetestmethodsdescribedhereinareformea-surementofwatervaportransmissionrates(WVTRs)ofhigh-barriermultiple-unitcontainers(bottles),high-barriersingle-unitcontainers(blisters),andquasi-barriersingle-unitcontainersusedforpackagingpharmaceuticalproducts.Thecontainersaretestedclosedandsealed.Thesetestmethodscanbeusedforallconsumer-sizedprimarycontainersandbulkprimarycontainersofasizelimitedonlybythedimensionsoftheequipmentandtheweighingcapacityandsensitivityofthebalance.1.2Thesetestmethodsareintendedtobeofsufficientsensitivityandprecisiontoallowcleardiscriminationamongthelevelsofbarrierpackagescurrentlyavailableforpharma-ceuticalproducts.1.3Therearethreemethods:MethodAisforbottles,MethodBisforformedbarrierblisters,andMethodCisforformedquasi-barrierblisters.MethodsBandCcanbeadaptedforusewithflexiblepouches.1.4Thesetestmethodsusegravimetricmeasurementtodeterminetherateofweightgainasaresultofwatervaportransmissionintothepackageandsubsequentuptakebyadesiccantenclosedwithinthepackage.Thepackagesareexposedtoenvironmentstypicalofthoseusedforacceleratedstabilitytestingofdrugproductsinthepackage(typically40°C⁄75%relativehumidity[RH]).1.5Forthesemethods,balancesensitivity,amountofdesiccant,numberofblisterspertestunit,andweighingfrequencyweredevelopedinanexperimentbasedonTestMethodsE96/E96M.1.6TestMethodsE96/E96Mgivesspecificinstructionontheinteractionsamongweighingfrequency,numberofdatapointsnecessarytoestablishsteadystate,minimumweightgaininaweighingperiod,andbalancesensitivity.1.7Thetestmethodsinthisstandardweredevelopedspeci...
