ASTM_D_7709_-_12.pdf

Designation:D770912Standard Test Methods forMeasuring Water Vapor Transmission Rate(WVTR)ofPharmaceutical Bottles and Blisters1This standard is issued under the fixed designation D7709;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 The three test methods described herein are for mea-surement of water vapor transmission rates(WVTRs)ofhigh-barrier multiple-unit containers(bottles),high-barriersingle-unit containers(blisters),and quasi-barrier single-unitcontainers used for packaging pharmaceutical products.Thecontainers are tested closed and sealed.These test methods canbe used for all consumer-sized primary containers and bulkprimary containers of a size limited only by the dimensions ofthe equipment and the weighing capacity and sensitivity of thebalance.1.2 These test methods are intended to be of sufficientsensitivity and precision to allow clear discrimination amongthe levels of barrier packages currently available for pharma-ceutical products.1.3 There are three methods:Method A is for bottles,Method B is for formed barrier blisters,and Method C is forformed quasi-barrier blisters.Methods B and C can be adaptedfor use with flexible pouches.1.4 These test methods use gravimetric measurement todetermine the rate of weight gain as a result of water vaportransmission into the package and subsequent uptake by adesiccant enclosed within the package.The packages areexposed to environments typical of those used for acceleratedstability testing of drug products in the package(typically40C/75%relative humidity RH).1.5 For these methods,balance sensitivity,amount ofdesiccant,number of blisters per test unit,and weighingfrequency were developed in an experiment based on TestMethods E96/E96M.1.6 Test Methods E96/E96M gives specific instruction onthe interactions among weighing frequency,number of datapoints necessary to establish steady state,minimum weightgain in a weighing period,and balance sensitivity.1.7 The test methods in this standard were developedspecifically for pharmaceutical bottles and blisters as closedcontainer-closure systems.The experiment from which themethods were developed provided an inter-laboratory studyfrom which the precision and bias statement was written.Thepackages in the study were small bottles and blisters usedregularly for pharmaceutical solid oral dosage forms.1.8 In spite of the specific nature of their application,the testmethods in this standard should be suitable for other pharma-ceutical packages and most types and sizes of other consumerpackages.1.9 The values stated in SI units are to be regarded as thestandard.No other units of measurement are included in thisstandard.The units of measure for bottles are milligrams perbottle per day(mg/bottle-day)and for blisters,milligrams perblister cavity per day(mg/cavity-day).These units may be usedfor both standard and referee testing.1.10 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E96/E96M Test Methods for Water Vapor Transmission ofMaterials3.Terminology3.1 Definitions:3.1.1 barrier blister,nblister made from high-barriermaterial,formed and sealed so that the water vapor transmis-sion rate(WVTR)(when tested at 40C/75%RH)is less than1.0 mg/cavity-day.3.1.2 blister,nformed,lidded and sealed plastic dome thatcontains the solid oral product(usually one unit).1This test method is under the jurisdiction ofASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.10 onPermeation.Current edition approved May 1,2012.Published June 2012.Originallyapproved in 2011.Last previous edition approved in 2011 as D 7709 111.DOI:10.1520/D7709-12.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.2.1 DiscussionSynonymous with cavity.3.1.3 card,ncontiguous group of blisters formed andsealed with lid in place.3.1.3.1 DiscussionThe card is a production geometry thatis a convenient quantity for a dosage regimen.The number ofblisters per card commonly ranges from one to ten but may bemore.From a marketing and production point of view,the cardis the basic,irreducible number of blisters in a market orclinical trial package.The blister card may sometimes bereferred to as the container.3.1.4 cavity,nsee bl