1、Designation: F2054 07 (Reapproved 2012)F2054/F2054M 13Standard Test Method forBurst Testing of Flexible Package Seals Using Internal AirPressurization Within Restraining Plates1This standard is issued under the fixed designation F2054;F2054/F2054M; the number immediately following the designation in
2、dicatesthe year of original adoption 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 cover the procedure f
3、or determining the minimum burst strength of a seal placed around the perimeterof a flexible package as it is internally pressurized and enclosed within restraining plates.1.2 The test methods described herein are functionally similar toTest Methods F1140 with the exception of the use of restraining
4、plates. Test Methods F1140 describes methods of burst testing that do not include the use of restraining plates and are suitable todetermine a packages general ability to withstand pressurization stresses. UnderTest Methods F1140 the stresses are not distributeduniformly to all areas of the package
5、seal. Under unrestrained conditions the stress on the package is highest at the middle of thepouch where it inflates to the packages maximum diameter; therefore, Test Methods F1140 may not reliably detect the weakestarea of the seal.1.3 The burst test internally and increasingly pressurizes a packag
6、e until an area of the package seal around the perimeter“bursts” open in response to pressurization. By placing the package within restraining plates during pressurization, the dimensionalstability of the package is maintained in a manner that results in stresses applied more uniformly along the per
7、imeter of thepackage, where seals are normally placed. This allows the test to have a higher probability of detecting the weakest area of theseal and provide a measurement of the pressure required to “burst” open the package.1.4 This test only applies to flexible packages with seals placed around th
8、e perimeter of a flexible package (often referred toas a pouch). In particular it is intended as applicable to packages with seals that have a peelable seal feature (peeled open by enduser to remove contents of package).1.4.1 Porous barrier materials failure to reach adequate pressure to burst the p
9、ackage seals may be due to insufficient volumeflow. See Appendix X4 for information.1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in eachsystem may not be exact equivalents; therefore, each system shall be used independently
10、 of the other. Combining values from thetwo systems may result in non-conformance with the standard.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and heal
11、th practices and determine the applicability of regulatorylimitations prior to use. Particular caution is advised where users of this procedure may be required to design and fabricaterestraining plate fixtures. Reference Appendix X3 for further information regarding calculation of stress factors and
12、 structuraldesign considerations.2. Referenced Documents2.1 ASTM Standards:2D1898E171 Practice for Sampling of PlasticsConditioning and Testing Flexible Barrier Packaging (Withdrawn 1998)D4332 Practice for Conditioning Containers, Packages, or Packaging Components for TestingE691 Practice for Conduc
13、ting an Interlaboratory Study to Determine the Precision of a Test MethodF17 Terminology Relating to Flexible Barrier PackagingF88 Test Method for Seal Strength of Flexible Barrier Materials1 This test method is under the jurisdiction of ASTM Committee F02 on Flexible Barrier Packaging and is the di
14、rect responsibility of Subcommittee F02.20 on PhysicalProperties.Current edition approved Nov. 1, 2012April 1, 2013. Published November 2012June 2013. Originally approved in 2000. Last previous edition approved in 20072012 asF2054 07.F2054 07 (2012). DOI: 10.1520/F2054-07R12.10.1520/F2054_F2054M-13.
15、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 website.This document is not an ASTM standard and is intended only to
16、 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 prior editions as appropriate. In all cases only the current versionof
17、 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 States1F1140 Test Methods for Internal Pressurization Failure Resistance of Unrestrained PackagesF1327 Terminology R
18、elating to Barrier Materials for Medical Packaging (Withdrawn 2007)33. Terminology3.1 DefinitionsFor definitions and terms used in this test method, see refer to Terminology F1327F17. for standardizedterminology for flexible barrier packaging.3.2 Definitions of Terms Specific to This Standard:3.2.1
19、flexible package or pouch, nrefers to a package in which at least one of the sealed materials is of a flexible structure(that is, paper, polyethylene, and so forth).3.2.1 restraining plates, nrefers to plates that are rigid in nature and configured to contact and limit the packages expandablesurface
20、 area as the package is pressurized.4. Summary of Test Method4.1 Packages are tested in an apparatus that internally pressurizes the package until an area of the package ruptures (burst). Formost applications the rupture (burst) will occur at one or more areas of the seal. The pneumatic supply and p
21、ressurizationequipment need the capability to maintain an increasing pressure until the seal area fails. (For porous barrier material, seeAppendix X4.) During pressurization, the package shall be enclosed between two rigid and parallel plates (restraining plates) thatlimit the expansion and dimensio
22、nal distortion of the package but allow the seal perimeter area to be unrestricted. A sensor insidethe package detects the internal pressure at the point at which the package ruptures (burst). Dependent on the application, twoconfigurations of restraining plates are indicated for use with this test
23、method. Generally, these are described as follows:4.1.1 Open Package Configuration An open package configuration is used where there is a seal placed around three sides ofthe package perimeter and the fourth side is open. This configuration is generally used in the original package manufacture. SeeF
24、ig. 1 for an illustration of the configuration used.4.1.2 Closed Package Configuration Aclosed package configuration is used where there is a seal placed around all four sidesof the package. This configuration generally is used in operations where the purpose is to test the seal in its finished, ful
25、ly-sealedstate. See Fig. 2 for an illustration of the configuration used.5. Significance and Use5.1 This test provides a rapid means of evaluating tendencies for package seal failure when the package is exposed to a pressuredifferential. Pressure differentials may occur during such processes as ster
26、ilization and transportation. This test method providesan indicator of the burst strength of a package, where the burst will normally occur in one or more areas of the seal. An indicatorof the minimum burst strength may be of importance to the package manufacturer and end user in ensuring adequate p
27、ackageintegrity.This test method cannot provide a measure of package seal uniformity.This test method also cannot provide an evaluationof overall package integrity or the burst strength of areas of the package that contact the surface of the restraining plates used. Thistest method should be combine
28、d with other methods of evaluating overall package integrity, uniformity of the package seal, oropening functionality, if so required.5.2 This test frequently is used to quickly evaluate package seal strength during the manufacturing process and at various stagesof the packages life cycle.FIG. 1 Res
29、training Plates, Open Package ConfigurationF2054/F2054M 1325.3 If correlations between pieces of test equipment are to be made it is important that all parameters of the test be equivalent.Typical parameters can include, but are not limited to the package size, material, type and configuration of se
30、al, rate of air flowinto the package, pressure detection sensing mechanism and sensitivity (machine response to pressure drop), position of test article,rigidity of restraining plates, and distance between restraining plates. See Appendix X2 for further information.5.4 This test may not necessarily
31、provide correlation with package seal strength as typically measured using Test MethodsF1140 or F88 (or equivalents).6. Apparatus6.1 Packages are tested under conditions described as follows:6.1.1 Open-Package TesterOpen-package test fixtures are used to test flexible packages with one of the four s
32、ides of thepackage open (nonsealed). The package is pressurized with an inflation nozzle and pressure sensing mechanism inserted into theopen end of the package. The open end then is sealed by a clamping mechanism for the duration of the test (see Fig. 1).6.1.2 Closed-Package TesterClosed-package te
33、st fixtures are used to test packages with all four sides of the package sealed.The closed package tester internally pressurizes the package utilizing a pressure nozzle and sensing mechanism that is connectedthrough a puncture in the package (see Fig. 2).6.2 The test apparatus for both open and clos
34、ed package testing shall include the following:6.2.1 An air supply and pressure regulating mechanism that can produce sufficient air flow to pressurize the package to the pointof package failure (burst); for porous barrier materials, see Appendix X4;6.2.2 Ameans of detecting a rapid pressure drop in
35、side the package that signals that an area of the package is stressed to failure(burst);6.2.3 Ameans of measuring the internal pressure at the point in which a rapid pressure drop occurs as the result of seal or otherpackage failure (burst);6.2.4 Two restraining plates that are configured similar to
36、 as shown in Fig. 1 or Fig. 2, is rigid to movement and flex, and contactthe expandable surface area of the package for the duration of the test.6.2.5 The following depending on type of test conducted.6.2.5.1 Open-package test fixtures shall have a pressurization nozzle and sensor that is inserted i
37、nto the open end of the package,and a clamping mechanism that seals the open end of the package, as well as creates an air tight seal around the pressurizationnozzle and sensor; and6.2.5.2 Closed-package test fixtures shall have a pressurization nozzle and sensor that inserts into a puncture of the
38、body of thesealed package while maintaining an air tight seal around those mechanisms.7. Sampling7.1 SamplingChoose the number of test specimens to permit an adequate determination of representative performance.Practice D1898 provides guidance to test specimen selection.FIG. 2 Restraining Plates, Cl
39、osed Package ConfigurationF2054/F2054M 1338. Conditioning8.1 Standard Test ConditionsCondition and test package under standard laboratory atmosphere of 73.4 6 2F (23 6 1C)and 50 6 2 % relative humidity. Condition the packages for a minimum of 72 h before performing testing.test. ReferencePracticeSpe
40、cification D4332E171 for further information on standard conditioning.8.2 Effects of environmental conditions other than the above standards have not been determined as they relate to the resultsof this test method and may depend on packaging materials used. Where comparisons or correlations of test
41、 results may be arequirement, and the test is conducted in other than standard test conditions, record the conditioning factors and the temperatureand relative humidity at the time of test.9. Procedure9.1 Package PreparationThe package may be tested with, if the package can fit within the restrainin
42、g plates, or withoutproduct enclosed inside the package. Record the package test preparation, if applicable.9.2 Open-Package Test:9.2.1 Insert the package in a manner in which the body of the package is enclosed between the restraining plates. Place thepackage between the restraining plates in a man
43、ner which minimizes the unrestrained areas of the package during the test. It isadvised to use some type of markings or fixturing that ensures consistent placement for all packages tested. Ensure plate gapdimension is set to appropriate gap setting. See Appendix X1 for recommendations on determining
44、 appropriate plate gap dimensionsettings.9.2.2 Insert or otherwise place the pressurization and sensor nozzle inside the open end of the package.9.2.3 Close the clamping mechanism to produce an air tight seal around the open end of the package including the area aroundthe pressurization and sensor n
45、ozzle.9.3 Closed-Package Test:9.3.1 Insert the body of the package within the restraining plates and close the plates, if applicable, to the required plate gapdimension. See Appendix X1 for recommendations on determining appropriate plate gap dimension settings.9.3.2 Carefully insert the pressurizat
46、ion and sensor nozzle entry device, and affix to the package so as to create an air tight seal.The center of the package is the preferred point of entry and may be fixtured as an attachment to the restraining plates (see Fig.2).9.4 Set the rate of pressurization and sensor sensitivity, if user selec
47、table. Set the pressure failure sensor readout, if userselectable, to the desired units of measure, usually set to readout in pascal (Pa), kilopascal kPa), or inches of water units of measurefor most package test resolutions required.9.5 Begin test by initiating inflation process. Continue pressuriz
48、ation until a failure occurs. A failure in this context is when anarea of the package ruptures (bursts) as the result of pressurization. The rupture (burst) is detected by the sensing mechanism asa rapid decrease in pressure within the body of the package, and the pressure reading device reports the
49、 pressure at the point intime just prior to the pressure drop.9.6 Visually examine the tested package and note the position and type of failure, as well as the pressure at which the failureoccurred. If the failure occurred in an area other than the seal the test may be voided depending on the purpose of the investigation.10. Report10.1 The report should include or have traceability to the following:10.1.1 Test performed (open or closed package), apparatus used, test device machine settings chosen if operator adjustable (rateof pressurization and sensitivity o
