1、Designation: F 2095 07e1Standard Test Methods forPressure Decay Leak Test for Flexible Packages With andWithout Restraining Plates1This standard is issued under the fixed designation F 2095; the number immediately following the designation indicates the year oforiginal adoption or, in the case of re
2、vision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.e1NOTEAdded research report reference to Section 11 editorially in March 2008.1. Scope1.1 These test methods
3、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
4、 1 3 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 Flex-ible Packages Without Restraining Plates1.3.2 Tes
5、t Method BPressure Decay Leak Test for Flex-ible Packages 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 p
6、ackage 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-bi
7、lity of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 4332 Practice for Conditioning Containers, Packages, orPackaging Components for TestingE 177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE 691 Practice for Conducting an Interlaboratory S
8、tudy 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 Def
9、initions 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 thei
10、r matrix.3.1.4 restraining platesplates of rigid material, for ex-ample, aluminum, that are used to restrict the movement of thepackage 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) and1
11、01.3 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 accomplis
12、hed 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 calculate
13、d leak rateunits. To accomplish this technique, a leak-tight measuringpath must be available between the package interior volumeand the pressure transducer (see Fig. 1).1These test methods are under the jurisdiction of ASTM Committee F02 onFlexible Barrier Packaging and are the direct responsibility
14、 of Subcommittee F02.40on Package Integrity.Current edition approved Oct. 1, 2007. Published November 2007. Originallyapproved in 2001. Last previous edition approved in 2001 as F 2095 01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at service
15、astm.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.1Copyright ASTM International, 100 Barr Harbor
16、 Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.NOTE 1The 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 s
17、ensitivity 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 U
18、se5.1 These test methods provide a rapid, simple to applymethod to detect small leaks in flexible package seals or wallsat the leak rate level of greater than 1 3 104sccs, thusproviding a measure of package integrity. Porous barrier filmpackages made non-porous with an impermeable film formingcoatin
19、g may demonstrate lateral leakage through the barriermaterial. Verification of leakage differences from backgroundleakage must be included in validation methods. The use ofcalibrated hole sizes or orifices may be appropriate to deter-mine leakage sensitivity or barrier integrity for these materials.
20、5.2 While theoretical leak rate sensitivity can be establishedby calculation, the test measurement is in pressure units and themeasuring instrument must be calibrated, certified, and verifiedwith these units.FIG. 1 Leak-Tight Entry SystemFIG. 2 Restraining Fixture with Leak-Tight Entry SystemF209507
21、e125.3 The pressure decay method of leak testing is a physicalmeasure of package integrity. When testing medical packagingwhich must conform to ISO 116071: 2006 standards, it maynecessary to verify the results of the pressure decay test methodwith other sterile package integrity test methods.5.4 Tes
22、t Method A allows packages to be pressurizedwithout restraint. In Test Method A the pouch, tray, or othertype package will contain a volume of air defined by itsmechanical configuration and its ability to resist internalpressure applied. This test method requires that the packagereach a stable volum
23、e configuration (stop stretching) to make ameasurement.5.5 Test Method B allows the use of rigid restraining platesagainst the walls of the package to limit its volume andstabilize the package volume.6. Apparatus6.1 Test Method A:6.1.1 A measuring instrument that provides the following:6.1.1.1 A mea
24、ns to detect pressure changes with sufficientsensitivity to achieve theoretical leak rates in the packagespecification;6.1.1.2 Automatic timer controls to pressurize the packageto a preset pressure, hold the pressure for a set time, andprovide a time period during which pressure change data canbe ta
25、ken;6.1.1.3 A means to set pressure;6.1.1.4 A means of holding and displaying the pressurechange inside the package at the end of the test cycle;6.1.1.5 A means (optional) to set pressure decay limits for atest method and alert the operator if the limit is exceeded.6.1.2 Ameans to enter the package
26、in a leak tight manner sothat an inflation pressure can be applied to the package andchanges in internal pressure can be sensed.NOTE 2It is important to verify the leak integrity of the entry meansso that it does not contribute to the pressure changes sensed during testing.6.2 Test Method BUsing Res
27、training Plates:6.2.1 The measuring instrument shall have the characteris-tics described in 6.1.1.1-6.1.1.5.6.2.2 Parallel, rigid plates are required. An ability to adjustplate separation is desirable. The surface of the plates shouldprovide limited porosity in order to prevent blocking of pinholele
28、aks in the walls (see Fig. 2).NOTE 3Several techniques have been used to provide a means toprevent blocking or lowering of the leak rate in package material walls incontact with the plates. These techniques include the use of semi-porousplastic, scoring of plate surfaces and use of screen-type mater
29、ials.6.2.3 Ameans to enter the package in a leak-tight manner sothat an inflation pressure can be applied to the package andchanges in internal pressure can be sensed.NOTE 4It is important to verify the leak integrity of the entry meansso that it does not contribute to the pressure changes sensed du
30、ring testing.7. Sampling7.1 The sample size is chosen to permit an adequatedetermination of representative performance.7.2 Sample identification should be made prior to testing toallow the operator to refer to specific test samples, if necessary.Record information such that test results and anomalie
31、s areidentifiable back to the individual specimens.8. Conditioning8.1 Package samples should be conditioned to obtain thesame temperature conditions as exist for the test apparatus.Since measured pressure change is also a function of tempera-ture, then the samples must be at a stable temperature. Mo
32、sttesting will occur at standard laboratory conditions of 23 62C (73 6 4F) and 50 6 5 % relative humidity. Otherconditions should be recorded at the time of the test.NOTE 5As seen in the combined gas laws, the pressure change is afunction of temperature.Test packages and the test medium (air) should
33、 beat similar temperatures.9. Procedure9.1 Test Method ANo Restraining Plates:9.1.1 Package PreparationThe package may be testedwith or without the product enclosed. To maximize sensitivityof the test, the smallest internal volume of the package isdesired.9.1.2 Instrument Preparation (see Annex A1 f
34、or informa-tion on determining appropriate test parameters):9.1.2.1 Select and set the test pressure.9.1.2.2 Select and set the timers for charge (pressurization),settle (stabilization), and test (data taking period).9.1.2.3 Select and set pressure decay limits (if available).9.1.3 Attach the inflat
35、ion probe (supply and sensor) to theinstrument.9.1.4 Attach the leak-tight entry device and inflation probesensor to the package (see Fig. 1).9.1.5 Begin the test by activating the timer controls andvalves to inflate, hold, and measure the test pressure inside thepackage.9.1.6 Observe the pressure d
36、ecay at the end of the test timeperiod, and note if the pressure decay limit has been exceeded.NOTE 6Choice of times depends on package variables and leak raterequirements. For example, small changes in initial test pressure mayoccur from flexible package stretch, thus slightly increasing its volume
37、(decreasing its pressure) or from fixture contact or the expanding gasmedium. Increased stabilization time will allow these effects to becomestable before the test data period begins. Test times are selected based onrequired leakage rates or pressure decay criteria along with the packagevolume. See
38、Annex A1 for further discussion.9.2 Test Method BWith Restraining Plates:9.2.1 Package PreparationThe package may be testedwith or without the product enclosed. To maximize sensitivityof the test, the smallest internal volume of the package isdesired. To achieve the minimum volume, the smallest gapb
39、etween restraining plates is advisable.9.2.2 Instrument Preparation (see Annex A1 for informa-tion on determining appropriate test parameters):9.2.2.1 Select and set the test pressure.9.2.2.2 Select and set the timers for charge (pressurization),settle (stabilization), and test (data taking period).
40、9.2.2.3 Select and set pressure decay limits (if available).9.2.3 Attach the inflation probe (supply and sensor) to theinstrument.F209507e139.2.4 Attach the leak-tight entry device and inflation probesensor to the package (Fig. 1).9.2.5 Enclose the package and probe in the restrainingfixture.9.2.6 B
41、egin the test by activating the timer controls andvalves to inflate, hold, and measure the test pressure inside thepackage.9.2.7 Observe the pressure decay at the end of the test timeperiod and note if the pressure decay limit has been exceeded.NOTE 7Choice of times depends on package variables and
42、leak raterequirements. For example, small changes in initial test pressure mayoccur from flexible package stretch, thus slightly increasing its volume(decreasing its pressure) or from fixture contact or the expanding gasmedium. Increased stabilization time will allow these effects to becomestable be
43、fore the test data period begins. Test times are selected based onrequired leak rates or pressure decay criteria along with the packagevolume. See Annex A1 for further discussion.9.3 For porous packages, it is necessary to coat the porousmaterial with a coating that transforms the porous material in
44、toa non-porous material, as defined in ANSI/AAMI/ISO 11607-1,Annex C. Doing this will allow the evaluation ofthe packages seals and integrity of the non-porous side of thepackage. The selection of the coating and its use must notpenetrate completely through the porous web and potentiallyocclude any
45、defects in the seal area. The user must verify/validate that the coating is acceptable for this application.Evidence of suitability could be edge (cross-sectional) photo-graphs of the coated porous material or any other suitablemethod.410. Report (Test Methods A and B)10.1 Report the following infor
46、mation:10.1.1 Method used.10.1.2 Package type, size, materials, and lot numbers shouldbe traceable.10.1.3 Whether the package was tested empty or filled withproduct.10.1.4 The apparatus used and settings for test pressure,timers, and decay limits. Other optional apparatus settings maybe recorded suc
47、h as restraining plate gap.10.1.5 Date, time, location, and operators name.10.1.6 Conditioning parameters and environmental condi-tions at the time of test (if applicable).10.1.7 Package test number and pressure decay if pressuredecay limit was exceeded.11. Precision and Bias511.1 This interlaborato
48、ry study was conducted to evaluatethe precision of the pressure decay test method of leakdetection in identifying a known leak in various sealed,nonporous empty packages. Two variations of the test methodwere examined, with Test Method A allowing the pressurizedpackages to expand without restraint,
49、and Test Method Butilizing rigid restraining plates to limit package expansionunder pressurization. Each of five laboratories tested tenrandomly drawn test specimens from each of three materialsunder each of the two test methods, A and B. Materials werechosen to represent a range of products for which the testmethods are suitable. The design of the experiment was similarto that of Practice E 691.11.2 The precision information given as follows representspressure decay as measured in psig. The terms “repeatabilitylimit” and “reproducibility limit” are
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