1、Designation: F1140 07 (Reapproved 2012)Standard Test Methods forInternal Pressurization Failure Resistance of UnrestrainedPackages1This standard is issued under the fixed designation F1140; the number immediately following the designation indicates the year oforiginal adoption or, in the case of rev
2、ision, 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 explain the procedure for determin-ing the ability of packages to withstand inte
3、rnal pressurization.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
4、. 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 Referenced Documents2.1 ASTM Standards:2D1898 Practice for Sampling of Plastics (Withdrawn 1998)3D4332 Practice for
5、Conditioning Containers, Packages, 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
6、 an appropriate180 angle. In order 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 Met
7、hod A (Burst Test)Packages are 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 bef
8、ore the package fails.4.2 Test 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-tes
9、ted and held until the package 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 meth
10、ods provide a rapid means of evaluatingtendencies 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 man
11、ufacturing process and atvarious 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 config
12、uration, testequipment, rate of 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 equivale
13、nt).6. Apparatus6.1 Packages are tested under unrestrained conditions asfollows: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 Nov. 1, 2012. Publ
14、ished November 2012. Originallyapproved in 1988. Last previous edition approved in 2007 as F1140 07. DOI:10.1520/F1140-07R12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information,
15、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 States16.1.1 Open Package Tester, used to tes
16、t 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 include the following:6.2.1 Means of Measuring the Pressure Inside the Package,6.2.2 Time
17、r, and6.2.3 Pressure Regulator, intended to maintain steady orincreasing pressure in the package.NOTE 1If the pressure regulator 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 anade
18、quate determination of representative performance. PracticeD1898 provides guidance to test specimen selection. Testing ofspecimens with visual defects or other deviations from normal-ity may or may not be appropriate, depending on the purposeof investigation. Indiscriminate elimination of defects ca
19、n biasresults.8. Conditioning8.1 Standard Test ConditionsCondition packages and con-duct testing in accordance with Practice D4332.8.2 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 T
20、est Method A (Burst Test)Place the package in theapparatus and increase the internal pressure until a failureoccurs.9.1.1 Open 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 te
21、st apparatus, and set thespecified parameters. The open package tester must be adjustedsuch that the tester does not restrain 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 po
22、sitions may result in different test values and,therefore, the final report should specify which position was chosen.9.1.1.3 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 indicator.C
23、ontinue pressurization until a failure occurs.9.1.1.4 Visually examine the package, and note the positionand type of failure (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. Rec
24、ord the package testpreparation.9.1.2.2 Position the completely sealed package in the testapparatus and 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. Re
25、cord the location of entry and perform allsample testing at this same location.NOTE 3It is important not to damage other package 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
26、inflationprocess. The rate of pressurization may affect the test resultsFIG. 1 Open Package Test PositionsF1140 07 (2012)2and must not 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
27、of failure (material or seal) and the pressure at whichit occurred.9.1.3 If no failure is visible but equipment is indicating aburst, 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 B
28、1(Creep Test)Place the package in thetest apparatus, internally pressurize to the specified pressure,and maintain that pressure for 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 poin
29、t is 80 % of the burst value. Note however that thespecified creep pressure may be dependent on the materials orsealing mechanism and 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 u
30、ntil the package fails. Thesuggested starting pressure for the creep to failure test may beexpressed as a percentage of the burst pressure 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
31、mechanism and may be raisedor lowered to allow testing to occur in an appropriate timerange. The time to failure is the test statistic.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 th
32、e package in the test apparatus and set thespecified parameters. The open package tester must be adjustedsuch that the tester does not 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 t
33、he 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 and hold for aspecified time, typically a value between 15 and 30 s.9.2.1.4 During the pressurization and hold cycle
34、(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 test method is complete when a specified timeelapses or a failure occurs. Note the time elapsed and pressurereading. Visually examine the package and note the positionan
35、d type of any failure (material or seal) and the pressure atwhich it occurred.NOTE 4Failure of a package to reach its intended test 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 wi
36、thout the product enclosed. Record the package testpreparation.9.2.2.2 Position the completely sealed package in the testapparatus and 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 af
37、fect theresults of the test. Record the location of entry and perform allsample testing at this same location. See Note 3.9.2.2.3 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 indica
38、tor.Inflate the package to a specified pressure.9.2.2.3.1For the creep test method (B1), hold for a specified time,typically a value between 15 and 30 s.9.2.2.3.2For the creep to failure test method (B2), hold until the packagefails.9.2.2.4 During the pressurization and hold cycle (9.2.1.3),observe
39、the package to determine yielding of the seal or otherdeformation that indicates a tendency to fail.9.2.2.5 This test 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 fail
40、ure (material or seal) and the pressure atwhich it occurred. See Note 4.10. Report10.1 Report the following information:10.1.1 Test method performed (burst, creep, or creep tofailure), apparatus used, machine setting chosen if operatoradjustable, position of package, and blocking agent flowlimiting
41、method.10.1.2 Material type(s) and other characteristics of packagetested (with or without product), package lot number, and nameof 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 fail
42、ures for each test method.10.1.5 Conditioning parameters used for the test method(s).FIG. 2 Closed Package Test Fixture with Package EngagedF1140 07 (2012)310.1.6 Results:10.1.6.1 Burst TestThe burst pressure value and locationat which failure occurred.10.1.6.2 Creep TestThe internal pressure at whi
43、ch 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 until 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
44、 with test pouches in anopen and closed state. The open-state samples were a three-sided sealed pouch with a fourth side unsealed. The samepouch 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 involve
45、d 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 kPa (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; fl
46、exible packaging; infla-tion; medical packaging; open packageTABLE 1 Precision SummaryTest Method A, Aperture Test, in. H2OAverageStandard Deviation,Within LaboratoriesSrCoefficient of Variance%Reproducibility,Between LaboratoriesSRCoefficient of Variance%Open package 49.11 3.67 7.47 6.39 13.01Close
47、d 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 1.70 13.40F1140 07 (2012)4APPENDIX(Nonmandatory Information)X1. TESTING PACKAGES WITH A LARGE POROUS AREAX1.1 The testing of the seals of packages with porousbar
48、rier materials may be limited due to the inability to providesufficient air volume. An example of this inability to providesufficient air volume may be encountered when the package isso large that air leaks through the porous barrier faster than itcan be applied. Because of this air leakage, inadequ
49、ate forcedue to lower pressure will not allow either the bursting of theseals or reaching the desired holding pressure level.X1.2 Industry has typically 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
