ASTM_F_2228_-_13.pdf

Designation:F222813Standard Test Method forNon-Destructive Detection of Leaks in Packaging WhichIncorporates Porous Barrier Material by CO2Tracer GasMethod1This standard is issued under the fixed designation F2228;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 This non-destructive test method detects leaks in non-porous rigid thermoformed trays,as well as the seal betweenthe porous lid and the tray.The test method detects channelleaks in packages as small as 100 m(0.004 in.)diameter in theseal as well as 50 m(0.002 in.)diameter pinholes,orequivalently sized cracks in the tray,subject to trace gasconcentration in the package,package design and manufactur-ing tolerances.NOTE1This test method does not claim to challenge the porous(breathable)lidding material.Any defects that may exist in the porousportion of the package will not be detected by this test method.1.2 The values stated in SI units are to be regarded asstandard units.Values in parentheses are for information only.1.3 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:2D996 Terminology of Packaging and Distribution Environ-mentsF17 Terminology Relating to Flexible Barrier PackagingF1327 Terminology Relating to Barrier Materials for Medi-cal Packaging(Withdrawn 2007)33.Terminology3.1 General Term DefinitionsFor definitions used in thisstandard,see Terminologies D996,F17,and F1327.3.2 Definitions of Terms Specific to This Standard:3.2.1 basal flowtransverse transport of trace gas across theseal due to gas flow within the plane of the porous barriermaterial as well as flow between the porous barrier and thetemporary gasketing.This is an expected property of theporous barrier material and does not represent a leak.Experimentally,this flow may be thought of as noise,whichwill always be present,to some degree,during testing and mustbe accounted for.3.2.2 trace gasa compound selected solely for use toidentify leakage flow.4.Summary of Test Method4.1 This test method utilizes CO2sensing techniques in thedetection of a CO2trace gas to quantify leaks in medicalpackaging,which incorporates porous barrier material.Thistest method provides a qualitative(accept/reject)inspectionmethod to evaluate packages for pinhole,crack and channelleaks.Further information on the“Leak Test Theory”may befound in Annex A1.5.Significance and Use5.1 Harmful biological or particulate contaminants mayenter the package through incomplete seals or imperfectionssuch as pinholes or cracks in the trays.5.2 After initial instrument set-up and calibration,the op-erations of individual tests and test results do not need operatorinterpretation.The non-destructive nature of the test may beimportant when testing high value added products.5.3 Leak test results that exceed the permissible thresholdsetting are indicated by audible or visual signal responses,orboth,or by other means.5.4 This non-destructive test method may be performed ineither laboratory or production environments.This testing maybe undertaken on either a 100%or a statistical sampling basis.This test method,in single instrument use and current1This test method is under the jurisdiction ofASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.40 onPackage Integrity.Current edition approved Aug.1,2013.Published September 2013.Originallyapproved in 2002.Last previous edition approved in 2007 as F2228 02(2007).DOI:10.1520/F2228-13.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 implementation,may not be fast enough to work on a produc-tion packaging line,but is well suited for statistical testing aswell as package developmental design work.6.Apparatus6.1 Non-destructive Trace Gas Leak Detection ApparatusThe apparatus test fixture consists of three major elements andis shown in Fig.1.6.2 Sealing MembraneThe purpose of the sealing mem-brane is to seal off the tracer gas transmission,normal to theporous lid surface.However,the membrane does not com-pletely control the transmission of tracer gas basal flow in thetransverse direction.6.3 Control PackagesPackages with calibrated capillarychannel leaks as we