ASTM_F_2095_-_07_2013.pdf

Designation:F209507(Reapproved 2013)Standard Test Methods forPressure Decay Leak Test for Flexible Packages With andWithout Restraining Plates1This standard is issued under the fixed designation F2095;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 These test methods cover the measurement of leaks innonporous film,foil,or laminate flexible pouches and foil-sealed trays,which may be empty or enclose solid product.Ifproduct is enclosed,seals or surfaces cannot be in contact withwater,oils,or other liquid.1.2 These test methods will detect leaks at a rate of 1 104sccs(standard cubic centimetres per second)or greater,inflexible packages.The limitation of leak rate is dependent onpackage volume as tested.1.3 The following test methods are included:1.3.1 Test Method APressure Decay Leak Test for FlexiblePackages Without Restraining Plates1.3.2 Test Method BPressure Decay Leak Test for FlexiblePackages With Restraining Plates1.4 These test methods are destructive in that they requireentry into the package to supply an internal pressure of gas,typically air or nitrogen,although other gases may be used.Theentry connection into the flexible package must be leak-tight.1.5 For porous packages,see 9.3.1.6 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:2D4332 Practice for Conditioning Containers,Packages,orPackaging Components for TestingE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF17 Terminology Relating to Flexible Barrier Packaging2.2 Other Document:ANSI/AAMI/ISO 116071:2006 Packaging for TerminallySterilized Medical DevicesPart 1:Requirements forMaterials,Sterile Barrier Systems,and Packaging Sys-tems33.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 integritythe unimpaired physical condition of thepackage.This implies that there are no leaks in the seals orbody materials.3.1.2 leakSee Terminology F17.3.1.3 nonporoustypes of materials that are not purposelydesigned to transfer gases through their matrix.3.1.4 restraining platesplates of rigid material,forexample,aluminum,that are used to restrict the movement ofthe package during inflation.3.1.5 sealSee Terminology F17.3.1.6 standard cubic centimetre per second(sccs)the flowrate of a gas(air)at standard conditions of 20C(68F)and101.3 kPa(14.7 psig)(1 atmosphere or 760 mm Hg).3.1.6.1 DiscussionConditions may be varied dependingon the source of data.Always check the definition being used.4.Summary of Test Method4.1 Detection of leak paths in flexible packages that havenonporous material surfaces and seals can be accomplished bypressurization of the package to a fixed pressure,shutting offthe pressure and connecting a pressure transducer.Observedchanges in pressure indicate the presence of leakage paths inthe package seals or pinholes in the surfaces.This leak may berepresented in decay pressure units or calculated leak rateunits.To accomplish this technique,a leak-tight measuring1These test methods are under the jurisdiction of ASTM Committee F02 onFlexible Barrier Packaging and are the direct responsibility of Subcommittee F02.40on Package Integrity.Current edition approved Aug.1,2013.Published September 2013.Originallyapproved in 2001.Last previous edition approved in 2007 as F2095 07.DOI:10.1520/F2095-07R13.2For 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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 path must be available between the package interior volumeand the pressure transducer(see Fig.1).NOTE1The coating used on porous barrier films will mask defects(pin-holes)in/through the porous material but not defects in the seals.4.2 Restraining plates may be used to limit the volume ofthe pressurized package.Because the sensitivity of these testmethods is dependent in part on the internal volume of thepackage,the effect of restraining plate use is to increase thesensitivity of the test(see Fig.2).See Appendix X1 for furtherdiscussion of the effects of restraining plates on these testmethods.5.Significance and Use5.1 These test methods provide a