1、Designation: F 2054 07Standard Test Method forBurst Testing of Flexible Package Seals Using Internal AirPressurization Within Restraining Plates1This standard is issued under the fixed designation F 2054; the number immediately following the designation indicates the year oforiginal adoption or, in
2、the case of revision, 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.1. Scope1.1 These test methods cover the procedure for determiningthe minimum burst strength of
3、 a seal placed around theperimeter of a flexible package as it is internally pressurizedand enclosed within restraining plates.1.2 The test methods described herein are functionallysimilar to Test Methods F 1140 with the exception of the use ofrestraining plates. Test Methods F 1140 describes method
4、s ofburst testing that do not include the use of restraining platesand are suitable to determine a packages general ability towithstand pressurization stresses. Under Test Methods F 1140the stresses are not distributed uniformly to all areas of thepackage seal. Under unrestrained conditions the stre
5、ss on thepackage is highest at the middle of the pouch where it inflatesto the packages maximum diameter; therefore, Test MethodsF 1140 may not reliably detect the weakest area of the seal.1.3 The burst test internally and increasingly pressurizes apackage until an area of the package seal around th
6、e perimeter“bursts” open in response to pressurization. By placing thepackage within restraining plates during pressurization, thedimensional stability of the package is maintained in a mannerthat results in stresses applied more uniformly along theperimeter of the package, where seals are normally
7、placed.This allows the test to have a higher probability of detecting theweakest area of the seal and provide a measurement of thepressure required to “burst” open the package.1.4 This test only applies to flexible packages with sealsplaced around the perimeter of a flexible package (oftenreferred t
8、o as a pouch). In particular it is intended as applicableto packages with seals that have a peelable seal feature (peeledopen by end user to remove contents of package).1.4.1 Porous barrier materials failure to reach adequatepressure to burst the package seals may be due to insufficientvolume flow.
9、See Appendix X4 for information.1.5 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-bility of regulatory limitati
10、ons prior to use. Particular cautionis advised where users of this procedure may be required todesign and fabricate restraining plate fixtures. Reference Ap-pendix X3 for further information regarding calculation ofstress factors and structural design considerations.2. Referenced Documents2.1 ASTM S
11、tandards:2D 1898 Practice for Sampling of Plastics3D 4332 Practice for Conditioning Containers, Packages, orPackaging Components for TestingE 691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF88 Test Method for Seal Strength of Flexible BarrierMaterialsF
12、 1140 Test Methods for Internal Pressurization FailureResistance of Unrestrained Packages for Medical Applica-tionsF 1327 Terminology Relating to Barrier Materials for Medi-cal Packaging33. Terminology3.1 DefinitionsFor definitions and terms used in this testmethod, see Terminology F 1327.3.2 Defini
13、tions of Terms Specific to This Standard:3.2.1 flexible package or pouch, nrefers to a package inwhich at least one of the sealed materials is of a flexiblestructure (that is, paper, polyethylene, and so forth).3.2.2 restraining plates, nrefers to plates that are rigid innature and configured to con
14、tact and limit the packagesexpandable surface area as the package is pressurized.4. Summary of Test Method4.1 Packages are tested in an apparatus that internallypressurizes the package until an area of the package ruptures(burst). For most applications the rupture (burst) will occur at1This test met
15、hod is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.20 onPhysical Properties.Current edition approved Aug. 1, 2007. Published August 2007. Originallyapproved in 2000. Last previous edition approved in 2005 as F 2054 00
16、 (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.1Copyright ASTM International, 100 Barr Ha
17、rbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.one or more areas of the seal. The pneumatic supply andpressurization equipment need the capability to maintain anincreasing pressure until the seal area fails. (For porous barriermaterial, see Appendix X4.) During pressurizati
18、on, the pack-age shall be enclosed between two rigid and parallel plates(restraining plates) that limit the expansion and dimensionaldistortion of the package but allow the seal perimeter area to beunrestricted. A sensor inside the package detects the internalpressure at the point at which the packa
19、ge ruptures (burst).Dependent on the application, two configurations of restrainingplates are indicated for use with this test method. Generally,these are described as follows:4.1.1 Open Package ConfigurationAn open package con-figuration is used where there is a seal placed around threesides of the
20、 package perimeter and the fourth side is open. Thisconfiguration is generally used in the original package manu-facture. See Fig. 1 for an illustration of the configuration used.4.1.2 Closed Package ConfigurationA closed packageconfiguration is used where there is a seal placed around allfour sides
21、 of the package. This configuration generally is usedin operations where the purpose is to test the seal in itsfinished, fully-sealed state. See Fig. 2 for an illustration of theconfiguration used.5. Significance and Use5.1 This test provides a rapid means of evaluating tenden-cies for package seal
22、failure when the package is exposed to apressure differential. Pressure differentials may occur duringsuch processes as sterilization and transportation. This testmethod provides an indicator of the burst strength of apackage, where the burst will normally occur in one or moreareas of the seal. An i
23、ndicator of the minimum burst strengthmay be of importance to the package manufacturer and enduser in ensuring adequate package integrity. This test methodcannot provide a measure of package seal uniformity. This testmethod also cannot provide an evaluation of overall packageintegrity or the burst s
24、trength of areas of the package thatcontact the surface of the restraining plates used. This testmethod should be combined with other methods of evaluatingoverall package integrity, uniformity of the package seal, oropening functionality, if so required.5.2 This test frequently is used to quickly ev
25、aluate packageseal strength during the manufacturing process and at variousstages 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 beequivalent. Typical parameters can include, but are not limitedto the pack
26、age size, material, type and configuration of seal,rate of air flow into the package, pressure detection sensingmechanism and sensitivity (machine response to pressuredrop), position of test article, rigidity of restraining plates, anddistance between restraining plates. See Appendix X2 forfurther i
27、nformation.5.4 This test may not necessarily provide correlation withpackage seal strength as typically measured using Test Meth-ods F 1140 or F88(or equivalents).FIG. 1 Restraining Plates, Open Package ConfigurationFIG. 2 Restraining Plates, Closed Package ConfigurationF20540726. Apparatus6.1 Packa
28、ges are tested under conditions described as fol-lows:6.1.1 Open-Package TesterOpen-package test fixtures areused to test flexible packages with one of the four sides of thepackage open (nonsealed). The package is pressurized with aninflation nozzle and pressure sensing mechanism inserted intothe op
29、en end of the package. The open end then is sealed by aclamping mechanism for the duration of the test (see Fig. 1).6.1.2 Closed-Package TesterClosed-package test fixturesare used to test packages with all four sides of the packagesealed. The closed package tester internally pressurizes thepackage u
30、tilizing a pressure nozzle and sensing mechanismthat is connected through a puncture in the package (see Fig.2).6.2 The test apparatus for both open and closed packagetesting shall include the following:6.2.1 An air supply and pressure regulating mechanism thatcan produce sufficient air flow to pres
31、surize the package to thepoint of package failure (burst); for porous barrier materials,see Appendix X4;6.2.2 A means of detecting a rapid pressure drop inside thepackage that signals that an area of the package is stressed tofailure (burst);6.2.3 A means of measuring the internal pressure at thepoi
32、nt in which a rapid pressure drop occurs as the result of sealor other package failure (burst);6.2.4 Two restraining plates that are configured similar to asshown in Fig. 1 or Fig. 2, is rigid to movement and flex, andcontact the expandable surface area of the package for theduration of the test.6.2
33、.5 The following depending on type of test conducted.6.2.5.1 Open-package test fixtures shall have a pressuriza-tion nozzle and sensor that is inserted into the open end of thepackage, and a clamping mechanism that seals the open end ofthe package, as well as creates an air tight seal around thepres
34、surization nozzle and sensor; and6.2.5.2 Closed-package test fixtures shall have a pressuriza-tion nozzle and sensor that inserts into a puncture of the bodyof the sealed package while maintaining an air tight seal aroundthose mechanisms.7. Sampling7.1 SamplingChoose the number of test specimens top
35、ermit an adequate determination of representative perfor-mance. Practice D 1898 provides guidance to test specimenselection.8. Conditioning8.1 Standard Test ConditionsCondition and test packageunder standard laboratory atmosphere of 73.46 2F (23 61C) and 50 6 2 % relative humidity. Condition the pac
36、kagesfor minimum of 72 h before performing testing. ReferencePractice D 4332 for further information on standard condition-ing.8.2 Effects of environmental conditions other than the abovestandards have not been determined as they relate to the resultsof this test method and may depend on packaging m
37、aterialsused. Where comparisons or correlations of test results may bea requirement, and the test is conducted in other than standardtest conditions, record the conditioning factors and the tem-perature and relative humidity at the time of test.9. Procedure9.1 Package PreparationThe package may be t
38、ested with,if the package can fit within the restraining plates, or withoutproduct enclosed inside the package. Record the package testpreparation, if applicable.9.2 Open-Package Test:9.2.1 Insert the package in a manner in which the body ofthe package is enclosed between the restraining plates. Pla
39、cethe package between the restraining plates in a manner whichminimizes the unrestrained areas of the package during the test.It is advised to use some type of markings or fixturing thatensures consistent placement for all packages tested. Ensureplate gap dimension is set to appropriate gap setting.
40、 SeeAppendix X1 for recommendations on determining appropriateplate gap dimension settings.9.2.2 Insert or otherwise place the pressurization and sensornozzle inside the open end of the package.9.2.3 Close the clamping mechanism to produce an air tightseal around the open end of the package includin
41、g the areaaround the pressurization and sensor nozzle.9.3 Closed-Package Test:9.3.1 Insert the body of the package within the restrainingplates and close the plates, if applicable, to the required plategap dimension. See Appendix X1 for recommendations ondetermining appropriate plate gap dimension s
42、ettings.9.3.2 Carefully insert the pressurization and sensor nozzleentry device, and affix to the package so as to create an air tightseal. The center of the package is the preferred point of entryand may be fixtured as an attachment to the restraining plates(see Fig. 2).9.4 Set the rate of pressuri
43、zation and sensor sensitivity, ifuser selectable. Set the pressure failure sensor readout, if userselectable, to the desired units of measure, usually set toreadout in pascal (Pa), kilopascal kPa), or inches of water unitsof measure for most package test resolutions required.9.5 Begin test by initia
44、ting inflation process. Continuepressurization until a failure occurs. A failure in this context iswhen an area of the package ruptures (bursts) as the result ofpressurization. The rupture (burst) is detected by the sensingmechanism as a rapid decrease in pressure within the body ofthe package, and
45、the pressure reading device reports thepressure at the point in time just prior to the pressure drop.9.6 Visually examine the tested package and note theposition and type of failure, as well as the pressure at which thefailure occurred. If the failure occurred in an area other than theseal the test
46、may be voided depending on the purpose of theinvestigation.10. Report10.1 The report should include or have traceability to thefollowing:10.1.1 Test performed (open or closed package), apparatusused, test device machine settings chosen if operator adjustableF2054073(rate of pressurization and sensit
47、ivity of pressure drop detec-tion sensor), gap distance between restraining plates, andblocking agent used (see Appendix X4).10.1.2 Packaging material types and other characteristics ofpackage tested, that is, whether with or without packagecontents inside the package, seal type and configuration, e
48、tc.,package lot number and sources name.10.2 Include the date, time, location, and identification ofthe individual performing the test. The number of packagestested, the individual test values, and the units of measure thatthe sensing device is set to return as response values. Docu-mentation also m
49、ay include notations of failure mode, area ofseal package failure, unusual test conditions and results.10.3 The conditioning parameters and environmental con-ditions used at the time of test, if applicable.10.4 A summary including comments or conclusions, thesample mean and standard deviation, should also be reportedwhere appropriate.11. Precision and Bias11.1 Aresearch report4describes a round robin conducted in1999 in accordance with Practice E 691, involving ten labora-tories testing four package sets for each of two material types.Materials tested are listed in
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