ASTM F1140 F1140M-2013 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages《可伸缩包装的抗内部增压损坏用标准试验方法》.pdf

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1、Designation: F1140 07 (Reapproved 2012)F1140/F1140M 13Standard Test Methods forInternal Pressurization Failure Resistance of UnrestrainedPackages1This standard is issued under the fixed designation F1140;F1140/F1140M; the number immediately following the designation indicatesthe year of original ado

2、ption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of lastreapproval. A superscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 These test methods explain the procedure for determining the ability of

3、 packages to withstand internal pressurization.1.2 The burst test increasingly pressurizes the package until the package fails.1.3 The creep test maintains a specified pressure for a specified time or until the package fails.1.4 The values stated in either SI units or inch-pound units are to be rega

4、rded separately as standard. The values stated in eachsystem may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from thetwo systems may result in non-conformance with the standard.1.5 This standard does not purport to address all of the sa

5、fety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D1898E171 Practice for Sampling o

6、f PlasticsConditioning and Testing Flexible Barrier Packaging (Withdrawn 1998)D4332F17 Practice for Conditioning Containers, Packages, or Packaging Components for TestingTerminology Relating toFlexible Barrier PackagingF88 Test Method for Seal Strength of Flexible Barrier Materials3. Terminology3.1

7、DefinitionsFor definitions and terms used in this test method, refer to Terminology F17 for standardized terminology forflexible barrier packaging.3.2 Definitions of Terms Specific to This Standard:3.1.1 flexibleindicates a material of the proper flexural strength and thickness to permit a turn back

8、 at an appropriate 180angle. In order to fulfill all terms of the definition, at least one of the sealed materials must be flexible.3.2.1 package failurerefers to rupture of seal or material.3.2.2 restrainta mechanism that prevents package movement during inflation.4. Summary of Test Method4.1 Test

9、Method A (Burst Test)Packages are tested in an apparatus that internally pressurizes the package until the packagefails. The pneumatic supply and pressurization equipment need the capability to maintain an increasing pressure until the packagebursts. The test measure is the maximum pressure detected

10、 before the package fails.4.2 Test Method B1 (Creep Test)Packages are tested in apparatus that internally pressurizes the package to a specified pressureand maintains that internal package pressure for a specific time. The test measure is pass/fail.1 These test methods are under the jurisdiction of

11、ASTM Committee F02 on Flexible Barrier Packaging and are the direct responsibility of Subcommittee F02.20 onPhysical Properties.Current edition approved Nov. 1, 2012April 1, 2013. Published November 2012June 2013. Originally approved in 1988. Last previous edition approved in 20072012 asF1140 07.F11

12、40 DOI: 10.1520/F1140-07R12. 07 (2012). DOI: 10.1520/F1140_F1140M-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM

13、website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult p

14、rior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.3 Test Method B2 (Creep to Failure)Pac

15、kages are creep-tested and held until the package fails. Test setup is similar to thatof the Creep Test except the pressure setting will need to be higher to ensure the package fails in a reasonable amount of time (thatis, about 15 s). The test measure is the time until failure.5. Significance and U

16、se5.1 These test methods provide a rapid means of evaluating tendencies for package failure when the package is exposed to apressure differential. Pressure differentials may occur during processes such as sterilization and transportation.5.2 These test methods are frequently used to quickly evaluate

17、 packages during the manufacturing process and at various stagesof the packages life cycle.5.3 If correlations between pieces of test equipment are to be made, it is important that all parameters of the test method beexactly the same. Typical parameters may include, but are not limited to, package s

18、ize, material, seal configuration, test equipment,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 correlation with actual package seal strength as typically measured using

19、TestMethod F88 (or equivalent).6. Apparatus6.1 Packages are tested under unrestrained conditions as follows:6.1.1 Open Package Tester, used to test flexible packages with one opened side.6.1.2 Closed Package Tester, internally pressurizes the completely sealed package through a puncture.6.2 The test

20、 apparatus for both open and closed package testing shall include the following:6.2.1 Means of Measuring the Pressure Inside the Package,6.2.2 Timer, and6.2.3 Pressure Regulator, intended to maintain steady or increasing pressure in the package.NOTE 1If the pressure regulator cannot provide the nece

21、ssary 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 an adequate determination of representative performance. Practice D1898provides guidance to test specimen selection. Testing of specimens with visual defect

22、s or other deviations from normality may ormay not be appropriate, depending on the purpose of investigation. Indiscriminate elimination of defects can bias results.8. Conditioning8.1 Standard Test ConditionsCondition packages and conduct testing in accordance with Practice D4332E171.8.2 If the test

23、 methods are conducted in other than standard test conditions, record the temperature and relative humidity at thetime of the test method.9. Procedure9.1 Test Method A (Burst Test)Place the package in the apparatus and increase the internal pressure until a failure occurs.9.1.1 Open Package Test:9.1

24、.1.1 Package PreparationThe package may be tested with or without the product enclosed. Record the package testpreparation.9.1.1.2 Place the package in the test apparatus, and set the specified parameters. The open package tester must be adjusted suchthat the tester does not restrain the package fro

25、m forming its normal unrestricted height at the time of the burst.NOTE 2The package is typically positioned in one of the positions shown 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 Begin the test

26、 method by starting the inflation process. The rate of pressurization may affect the test results and mustnot 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 position and type of failure (material o

27、r seal) and the pressure at which itoccurred.9.1.2 Closed Package Test:9.1.2.1 Package PreparationThe package may be tested with or without the product enclosed. Record the package testpreparation.9.1.2.2 Position the completely sealed package in the test apparatus and carefully insert the pressuriz

28、ation entry device (see Fig.2). The center of the package is the preferred point of entry. Location variations of the entry point may affect the results of thetest. Record the location of entry and perform all sample testing at this same location.NOTE 3It is important not to damage other package sur

29、faces when inserting the needle. If the package material tears easily, reinforce the point ofentry with tape or equivalent.F1140/F1140M 1329.1.2.3 Begin the test method by starting the inflation process. The rate of pressurization may affect the test results and mustnot exceed the response rate of t

30、he pressure indicator. Continue pressurization until a failure occurs.9.1.2.4 Visually examine the package and note the position and type of failure (material or seal) and the pressure at which itoccurred.9.1.3 If no failure is visible but equipment is indicating a burst, sensitivity settings may ne

31、ed to be adjusted, porosity of packagemay need to be limited (see Appendix X1), or this test method may not be appropriate.9.2 Test Method B1 (Creep Test)Place the package in the test apparatus, internally pressurize to the specified pressure, andmaintain that pressure for a specified time. The sugg

32、ested starting pressure for the creep test method may be expressed as aFIG. 1 Open Package Test PositionsF1140/F1140M 133percentage of the burst pressure for that package. A common starting point is 80 % of the burst value. Note however that thespecified creep pressure may be dependent on the materi

33、als or sealing mechanism and may be raised or lowered to allow testingto occur in an appropriate time range.Test Method B2 (Creep to Failure)Identical toTest Method B1 except the pressure is held until the package fails.The suggestedstarting pressure for the creep to failure test may be expressed as

34、 a percentage of the burst pressure for that package. A commonstarting point is 90 % of the burst value. Note however that the specified creep pressure may be dependent on the materials orsealing mechanism and may be raised or lowered to allow testing to occur in an appropriate time range. The time

35、to failure is thetest statistic.9.2.1 Open Package Test:9.2.1.1 Package PreparationThe package may be tested with or without the product enclosed. Record the package testpreparation.9.2.1.2 Place the package in the test apparatus and set the specified parameters. The open package tester must be adju

36、sted suchthat the tester does not restrain the package from forming its normal unrestrained height during the test. Package position isimportant, see Note 2.9.2.1.3 Begin the test method by starting the inflation process. The rate of pressurization may affect the test results and mustnot exceed the

37、response rate of the pressure indicator. Inflate the package to a specified pressure and hold for a specified 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 indicate

38、s a tendency to fail.9.2.1.5 This test method is complete when a specified time elapses or a failure occurs. Note the time elapsed and pressurereading. Visually examine the package and note the position and type of any failure (material or seal) and the pressure at whichit occurred.NOTE 4Failure of

39、a package to reach its intended test pressure may be a 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 tested with or without the product enclosed. Record the package testpreparation.9.2.2.2 Position the completel

40、y sealed package in the test apparatus and carefully insert the pressurization entry device (see Fig.2). The center of the package is the preferred point of entry. Location variations of the entry point may affect the results of thetest. Record the location of entry and perform all sample testing at

41、 this same location. See Note 3.9.2.2.3 Begin the test method by starting the inflation process. The rate of pressurization may affect the test results and mustnot exceed the response rate of the pressure indicator. Inflate the package to a specified pressure.9.2.2.3.1For the creep test method (B1),

42、 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 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 te

43、ndency to fail.FIG. 2 Closed Package Test Fixture with Package EngagedF1140/F1140M 1349.2.2.5 This test method is complete when a specified time elapses or a failure occurs. Note the time elapsed and pressurereading. Visually examine the package and note the position and type of any failure (materia

44、l or seal) and the pressure at whichit occurred. See Note 4.10. Report10.1 Report the following information:10.1.1 Test method performed (burst, creep, or creep to failure), apparatus used, machine setting chosen if operator adjustable,position of package, and blocking agent flow limiting method.10.

45、1.2 Material type(s) and other characteristics of package tested (with or without product), package lot number, and name ofsource.10.1.3 Date, time, location, and identification of the individual performing the test method.10.1.4 The number of packages tested, and the number of package failures for

46、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 pressure value and location at which failure occurred.10.1.6.2 Creep TestThe internal pressure at which the package was held and the hold time.10.1.6.3 Creep to Failure TestThe int

47、ernal pressure at which the package was held and the time until the package failed.10.1.7 A summary including comments or conclusions, or both, should also be reported.11. Precision and Bias11.1 Ten laboratories were supplied with test pouches in an open and closed state. The open-state samples were

48、 a three-sidedsealed pouch with a fourth side unsealed. The same pouch was used for the closed state samples, with the final side sealed.11.1.1 Test Method A, the aperture test, was evaluated by eight of the laboratories involved at four measurements per pouch.See Table 1.11.1.2 Test Method B, the p

49、ressurization/hold test was conducted at a test pressure of 9.96 kPa (40 in. H2O) for 30 s. Eight ofthe involved laboratories reported at four measurements per pouch. See Table 2.12. Keywords12.1 burst; closed package; creep; flexible packaging; inflation; 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 13.01Closed package 50.81 3.29 6.48 6.81