1、Designation:F209611Standard Test Method forDetecting Gross Leaks in Packaging by InternalPressurization(Bubble Test)1This standard is issued under the fixed designation F2096;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year o
2、f 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 test method covers the detection of gross leaks inpackaging.Method sensitivity is down to 250 m(0.010 in.)with an 81
3、%probability(see Section 11).This test methodmay be used for tray and pouch packages.1.2 The sensitivity of this test method has not been evalu-ated for use with porous materials other than spunbondedpolyolefin or with nonporous packaging.1.3 This test method is destructive in that it requires entry
4、into the package to supply an internal air pressure1.4 The values stated in SI units are to be regarded as thestandard.The values given in parentheses are for informationonly.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibilit
5、y 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:2F17 Terminology Relating to Flexible Barrier Packaging3.Terminology3.1 DefinitionsGeneral terms relat
6、ing to barrier materialsfor medical packaging are found in Terminology F17.3.2 Definitions of Terms Specific to This Standard:3.2.1 breathing point pressure,npressure at which perme-ation of air through the porous material begins.34.Summary of Test Method4.1 The package is inflated underwater to a p
7、redeterminedpressure.The package is then observed for a steady stream ofair bubbles indicating a failure area.4.2 The sensitivity of this test method is dependent on thedifferential pressure and method of pressurization.Establish-ment of a test pressure for each package material/size is criticalfor
8、obtaining repeatable results(see Annex A1 for the proce-dure on establishing test pressure).Inadequate pressurizationof the package can significantly reduce the sensitivity of thistest method.Higher differential pressures will increase the testsensitivity.However,excessive pressurization of the pack
9、agemay rupture seals or cause misinterpretation of bubble patternsemanating from porous packaging.This may result in anerroneous conclusion regarding the presence or absence ofpackage defects.While not required,use of a bleed-off controlvalve in line with the pressure monitoring device,will aid inst
10、abilizing the test pressure,and help eliminate excessivepressurization of the package(see Fig.1).4.3 Two different test methods are presented for the testingof porous and nonporous packaging.The key differencebetween the test methods(as described in Annex A1)is inallowing time for the water to satur
11、ate the porous material.5.Significance and Use5.1 The internal pressurization test method provides a prac-tical way to examine packages for gross leaks.5.2 This test method is extremely useful in a test laboratoryenvironment where no common package material/size exists.5.3 This test method may apply
12、 to large or long packagesthat do not fit into any other package integrity test methodapparatus.1This 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 Dec.15,20
13、11.Published February 2012.Originallyapproved in 2001.Last previous edition approved in 2004 as F2096 04.DOI:10.1520/F2096-11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refe
14、r to the standards Document Summary page onthe ASTM website.3All porous packaging by definition will permit the passage of air.At a giveninternal pressure it will therefore exhibit an emanating stream of air bubblesdependent on the pore size.A stream of bubbles identified at a lower internalpressure
15、 than the breathing pressure point may indicate a defect in the packaging.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.4 This test method may be used as a means to evaluatepackage integrity.Package integrity is crucial to consumersaf
16、ety since heat sealed packages are designed to provide acontamination free or sterile environment,or both,to theproduct.5.5 This test method may be used to detect substrate holesand channels.6.Apparatus6.1 Pressure Delivery System,with pressure monitoringgage,and bleed-off control valve,capable of delivering air at apressure of 0-50 mbar(0-20 in.H2O).6.2 Device for Puncturing Package,device to allow inser-tion of air source and pressure monitoring device.6.3 Water Container,adequate to cover the
