1、Designation: F 1140 07Standard Test Methods forInternal Pressurization Failure Resistance of UnrestrainedPackages1This standard is issued under the fixed designation F 1140; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year
2、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.1. Scope1.1 These test methods explain the procedure for determin-ing the ability of packages to withstand internal pressuriza
3、tion.1.2 The burst test increasingly pressurizes the package untilthe package fails.1.3 The creep test maintains a specified pressure for aspecified time or until the package fails.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresp
4、onsibility 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:2D 1898 Practice for Sampling of Plastics3D 4332 Practice for Conditioning Containers, Packa
5、ges, orPackaging Components for TestingF88 Test Method for Seal Strength of Flexible BarrierMaterials3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 flexibleindicates a material of the proper flexuralstrength and thickness to permit a turn back at an appropriate180 angle. In o
6、rder to fulfill all terms of the definition, at leastone of the sealed materials must be flexible.3.1.2 package failurerefers to rupture of seal or material.3.1.3 restrainta mechanism that prevents package move-ment during inflation.4. Summary of Test Method4.1 Test Method A (Burst Test)Packages are
7、 tested in anapparatus that internally pressurizes the package until thepackage fails. The pneumatic supply and pressurization equip-ment need the capability to maintain an increasing pressureuntil the package bursts. The test measure is the maximumpressure detected before the package fails.4.2 Test
8、 Method B1(Creep Test)Packages are tested inapparatus that internally pressurizes the package to a specifiedpressure and maintains that internal package pressure for aspecific time. The test measure is pass/fail.4.3 Test Method B2(Creep to Failure)Packages are creep-tested and held until the package
9、 fails. Test setup is similar tothat of the Creep Test except the pressure setting will need tobe higher to ensure the package fails in a reasonable amount oftime (that is, about 15 s). The test measure is the time untilfailure.5. Significance and Use5.1 These test methods provide a rapid means of e
10、valuatingtendencies for package failure when the package is exposed toa pressure differential. Pressure differentials may occur duringprocesses such as sterilization and transportation.5.2 These test methods are frequently used to quicklyevaluate packages during the manufacturing process and atvario
11、us stages of the packages life cycle.5.3 If correlations between pieces of test equipment are tobe made, it is important that all parameters of the test methodbe exactly the same. Typical parameters may include, but arenot limited to, package size, material, seal configuration, testequipment, rate o
12、f air flow into the package, sensitivity(machine response to pressure drop), and position of test article(see Fig. 1).5.4 These test methods do not necessarily provide correla-tion with actual package seal strength as typically measuredusing Test Method F88(or equivalent).6. Apparatus6.1 Packages ar
13、e tested under unrestrained conditions asfollows:6.1.1 Open Package Tester, used to test flexible packageswith one opened side.6.1.2 Closed Package Tester, internally pressurizes the com-pletely sealed package through a puncture.6.2 The test apparatus for both open and closed packagetesting shall in
14、clude the following:1These test methods are under the jurisdiction of ASTM Committee F02 onFlexible Barrier Packaging and are the direct responsibility of Subcommittee F02.20on Physical Properties.Current edition approved Aug. 1, 2007. Published August 2007. Originallyapproved in 1988. Last previous
15、 edition approved in 2005 as F 1140 00 (2005).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.3Withdrawn.1Cop
16、yright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6.2.1 Means of Measuring the Pressure Inside the Package,6.2.2 Timer, and6.2.3 Pressure Regulator, intended to maintain steady orincreasing pressure in the package.NOTE 1If the pressure reg
17、ulator cannot provide the necessary volume,the porosity of the sample may need to be limited. (See Appendix X1.)7. Sampling7.1 Choose the number of test specimens to permit anadequate determination of representative performance. PracticeD 1898 provides guidance to test specimen selection. Testingof
18、specimens with visual defects or other deviations fromnormality may or may not be appropriate, depending on thepurpose of investigation. Indiscriminate elimination of defectscan bias results.8. Conditioning8.1 Standard Test ConditionsCondition packages andconduct testing in accordance with Practice
19、D 4332.8.2 If the test methods are conducted in other than standardtest conditions, record the temperature and relative humidity atthe time of the test method.9. Procedure9.1 Test Method A (Burst Test)Place the package in theapparatus and increase the internal pressure until a failureoccurs.9.1.1 Op
20、en Package Test:9.1.1.1 Package PreparationThe package may be testedwith or without the product enclosed. Record the package testpreparation.9.1.1.2 Place the package in the test apparatus, and set thespecified parameters. The open package tester must be adjustedsuch that the tester does not restrai
21、n the package from formingits normal unrestricted height at the time of the burst.NOTE 2The package is typically positioned in one of the positionsshown in Fig. 1. Different positions may result in different test values and,therefore, the final report should specify which position was chosen.9.1.1.3
22、 Begin the test method by starting the inflationprocess. The rate of pressurization may affect the test resultsand must not exceed the response rate of the pressure indicator.Continue pressurization until a failure occurs.9.1.1.4 Visually examine the package, and note the positionand type of failure
23、 (material or seal) and the pressure at whichit occurred.9.1.2 Closed Package Test:9.1.2.1 Package PreparationThe package may be testedwith or without the product enclosed. Record the package testpreparation.9.1.2.2 Position the completely sealed package in the testapparatus and carefully insert the
24、 pressurization entry device(see Fig. 2). The center of the package is the preferred point ofentry. Location variations of the entry point may affect theresults of the test. Record the location of entry and perform allsample testing at this same location.NOTE 3It is important not to damage other pac
25、kage surfaces wheninserting the needle. If the package material tears easily, reinforce thepoint of entry with tape or equivalent.9.1.2.3 Begin the test method by starting the inflationprocess. The rate of pressurization may affect the test resultsFIG. 1 Open Package Test PositionsF1140072and must n
26、ot exceed the response rate of the pressure indicator.Continue pressurization until a failure occurs.9.1.2.4 Visually examine the package and note the positionand type of failure (material or seal) and the pressure at whichit occurred.9.1.3 If no failure is visible but equipment is indicating aburst
27、, sensitivity settings may need to be adjusted, porosity ofpackage may need to be limited (see Appendix X1), or this testmethod may not be appropriate.9.2 Test Method B1(Creep Test)Place the package in thetest apparatus, internally pressurize to the specified pressure,and maintain that pressure for
28、a specified time. The suggestedstarting pressure for the creep test method may be expressed asa percentage of the burst pressure for that package. A commonstarting point is 80 % of the burst value. Note however that thespecified creep pressure may be dependent on the materials orsealing mechanism an
29、d may be raised or lowered to allowtesting to occur in an appropriate time range.Test Method B2(Creep to Failure)Identical to Test MethodB1except the pressure is held until the package fails. Thesuggested starting pressure for the creep to failure test may beexpressed as a percentage of the burst pr
30、essure for thatpackage. A common starting point is 90 % of the burst value.Note however that the specified creep pressure may be depen-dent on the materials or sealing mechanism and may be raisedor lowered to allow testing to occur in an appropriate timerange. The time to failure is the test statist
31、ic.9.2.1 Open Package Test:9.2.1.1 Package PreparationThe package may be testedwith or without the product enclosed. Record the package testpreparation.9.2.1.2 Place the package in the test apparatus and set thespecified parameters. The open package tester must be adjustedsuch that the tester does n
32、ot restrain the package from formingits normal unrestrained height during the test. Package positionis important, see Note 2.9.2.1.3 Begin the test method by starting the inflationprocess. The rate of pressurization may affect the test resultsand must not exceed the response rate of the pressure ind
33、icator.Inflate the package to a specified pressure and hold for aspecified time, typically a value between 15 and 30 s.9.2.1.4 During the pressurization and hold cycle (9.2.1.3),observe the package to determine yielding of the seal or otherdeformation that indicates a tendency to fail.9.2.1.5 This t
34、est method is complete when a specified timeelapses or a failure occurs. Note the time elapsed and pressurereading. Visually examine the package and note the positionand type of any failure (material or seal) and the pressure atwhich it occurred.NOTE 4Failure of a package to reach its intended test
35、pressure may bea result of insufficient volume delivery of air. See Appendix X1.9.2.2 Closed Package Test:9.2.2.1 Package PreparationThe package may be testedwith or without the product enclosed. Record the package testpreparation.9.2.2.2 Position the completely sealed package in the testapparatus a
36、nd carefully insert the pressurization entry device(see Fig. 2). The center of the package is the preferred point ofentry. Location variations of the entry point may affect theresults of the test. Record the location of entry and perform allsample testing at this same location. See Note 3.9.2.2.3 Be
37、gin the test method by starting the inflationprocess. The rate of pressurization may affect the test resultsand must not exceed the response rate of the pressure indicator.Inflate the package to a specified pressure.9.2.2.3.1 For the creep test method (B1), hold for a specifiedtime, typically a valu
38、e between 15 and 30 s.9.2.2.3.2 For the creep to failure test method (B2), hold untilthe package fails.9.2.2.4 During the pressurization and hold cycle (9.2.1.3),observe the package to determine yielding of the seal or otherdeformation that indicates a tendency to fail.9.2.2.5 This test method is co
39、mplete when a specified timeelapses or a failure occurs. Note the time elapsed and pressurereading. Visually examine the package and note the positionand type of any failure (material or seal) and the pressure atwhich it occurred. See Note 4.10. Report10.1 Report the following information:10.1.1 Tes
40、t method performed (burst, creep, or creep tofailure), apparatus used, machine setting chosen if operatoradjustable, position of package, and blocking agent flowlimiting method.10.1.2 Material type(s) and other characteristics of packagetested (with or without product), package lot number, and nameo
41、f source.10.1.3 Date, time, location, and identification of the indi-vidual performing the test method.10.1.4 The number of packages tested, and the number ofpackage failures for each test method.10.1.5 Conditioning parameters used for the test method(s).10.1.6 Results:10.1.6.1 Burst TestThe burst p
42、ressure value and locationat which failure occurred.FIG. 2 Closed Package Test Fixture with Package EngagedF114007310.1.6.2 Creep TestThe internal pressure at which thepackage was held and the hold time.10.1.6.3 Creep to Failure TestThe internal pressure atwhich the package was held and the time unt
43、il the packagefailed.10.1.7 A summary including comments or conclusions, orboth, should also be reported.11. Precision and Bias11.1 Ten laboratories were supplied with test pouches in anopen and closed state. The open-state samples were a three-sided sealed pouch with a fourth side unsealed. The sam
44、epouch was used for the closed state samples, with the final sidesealed.11.1.1 Test Method A, the aperture test, was evaluated byeight of the laboratories involved at four measurements perpouch. See Table 1.11.1.2 Test Method B, the pressurization/hold test wasconducted at a test pressure of 9.96 kP
45、a (40 in. H2O) for 30 s.Eight of the involved laboratories reported at four measure-ments per pouch. See Table 2.12. Keywords12.1 burst; closed package; creep; flexible packaging; infla-tion; medical packaging; open packageTABLE 1 Precision SummaryTest Method A, Aperture Test, in. H2OAverageStandard
46、 Deviation,Within LaboratoriesSrCoefficient of Variance%Reproducibility,Between LaboratoriesSRCoefficient of Variance%Open package 49.11 3.67 7.47 6.39 13.01Closed package 50.81 3.29 6.48 6.81 13.40Test Method A, Aperture Test, kPaOpen package 12.23 0.91 7.47 1.59 13.01Closed package 12.65 0.82 6.48
47、 1.70 13.40F1140074APPENDIX(Nonmandatory Information)X1. TESTING PACKAGES WITH A LARGE POROUS AREAX1.1 The testing of the seals of packages with porousbarrier materials may be limited due to the inability to providesufficient air volume. An example of this inability to providesufficient air volume m
48、ay be encountered when the package isso large that air leaks through the porous barrier faster than itcan be applied. Because of this air leakage, inadequate forcedue to lower pressure will not allow either the bursting of theseals or reaching the desired holding pressure level.X1.2 Industry has typ
49、ically responded to this effect bylimiting the porous barrier area. There are two major classifi-cations of barrier blocking agents, the first being labels or tape,and the second being non-solid agents that are spread acrossthe porous barrier material. Caution must be used with anymethod of blocking to ensure that the porous barrier area isconsistently and uniformly covered or coated. When usinglabels or tape as blocking agents, it is important that theblocking material does not reinforce the seal area being testedon the package. When using non-solid blocking
