1、Designation: F2054 07 (Reapproved 2012)Standard Test Method forBurst Testing of Flexible Package Seals Using Internal AirPressurization Within Restraining Plates1This standard is issued under the fixed designation F2054; the number immediately following the designation indicates the year oforiginal
2、adoption or, in the case of revision, 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 cover the procedure for determiningthe minimum bu
3、rst strength of 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 F1140 with the exception of the use ofrestraining plates. Test Methods F1140 des
4、cribes methods 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 F1140the stresses are not distributed uniformly to all areas of thepackage seal. Under unrestrained conditi
5、ons the stress on thepackage is highest at the middle of the pouch where it inflatesto the packages maximum diameter; therefore, Test MethodsF1140 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 sea
6、l around the 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 ar
7、e normally 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 (ofte
8、nreferred to 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 insufficientvo
9、lume flow. 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 regulato
10、ry limitations 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 Document
11、s2.1 ASTM Standards:2D1898 Practice for Sampling of Plastics (Withdrawn 1998)3D4332 Practice for Conditioning Containers, Packages, orPackaging Components for TestingE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF88 Test Method for Seal Strength of F
12、lexible BarrierMaterialsF1140 Test Methods for Internal Pressurization Failure Re-sistance of Unrestrained PackagesF1327 Terminology Relating to Barrier Materials for Medi-cal Packaging (Withdrawn 2007)33. Terminology3.1 DefinitionsFor definitions and terms used in this testmethod, see Terminology F
13、1327.3.2 Definitions 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 co
14、nfigured to contact and limit the packagesexpandable surface area as the package is pressurized.1This test method is under the jurisdiction ofASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.20 onPhysical Properties.Current edition approved Nov. 1,
15、 2012. Published November 2012. Originallyapproved in 2000. Last previous edition approved in 2007 as F2054 07. DOI:10.1520/F2054-07R12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume in
16、formation, 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 States14. Summary of Test Method4.
17、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 atone or more areas of the seal. The pneumatic supply andpressurization equipment need the capability to maintain anincreasi
18、ng pressure until the seal area fails. (For porous barriermaterial, see Appendix X4.) During pressurization, 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
19、 beunrestricted. A sensor inside the package detects the internalpressure at the point at which the package 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
20、Configuration An open packageconfiguration is used where there is a seal placed around threesides of the 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 Pack
21、age Configuration A closed packageconfiguration is used where there is a seal placed around allfour sides 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 use
22、d.5. Significance and Use5.1 This test provides a rapid means of evaluating tenden-cies for package seal 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
23、the burst strength of apackage, where the burst will normally occur in one or moreareas of the seal. An indicator 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
24、 uniformity. This testmethod also cannot provide an evaluation of overall packageintegrity or the burst strength 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
25、 the package seal, oropening functionality, if so required.5.2 This test frequently is used to quickly evaluate 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 tha
26、t all parameters of the test beequivalent. Typical parameters can include, but are not limitedto the package 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 arti
27、cle, rigidity of restraining plates, anddistance between restraining plates. See Appendix X2 forfurther information.FIG. 1 Restraining Plates, Open Package ConfigurationFIG. 2 Restraining Plates, Closed Package ConfigurationF2054 07 (2012)25.4 This test may not necessarily provide correlation withpa
28、ckage seal strength as typically measured using Test Meth-ods F1140 or F88 (or equivalents).6. Apparatus6.1 Packages 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 (
29、nonsealed). The package is pressurized with aninflation nozzle and pressure sensing mechanism inserted intothe open 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
30、 packages with all four sides of the packagesealed. The closed package tester internally pressurizes thepackage utilizing 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 includ
31、e the following:6.2.1 An air supply and pressure regulating mechanism thatcan produce sufficient air flow to pressurize 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 tha
32、t an area of the package is stressed tofailure (burst);6.2.3 A means of measuring the internal pressure at thepoint 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
33、rigid to movement and flex, andcontact the expandable surface area of the package for theduration 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 pressuriza-tion nozzle and sensor that is inserted into the open end of thepackage, an
34、d a clamping mechanism that seals the open end ofthe package, as well as creates an air tight seal around thepressurization 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 ma
35、intaining an air tight seal aroundthose mechanisms.7. Sampling7.1 SamplingChoose the number of test specimens topermit an adequate determination of representative perfor-mance. Practice D1898 provides guidance to test specimenselection.8. Conditioning8.1 Standard Test ConditionsCondition and test pa
36、ckageunder standard laboratory atmosphere of 73.4 6 2F (23 61C) and 50 6 2 % relative humidity. Condition the packagesfor minimum of 72 h before performing testing. ReferencePractice D4332 for further information on standard condition-ing.8.2 Effects of environmental conditions other than the aboves
37、tandards have not been determined as they relate to the resultsof this test method and may depend on packaging materialsused. 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 th
38、e tem-perature and relative humidity at the time of test.9. Procedure9.1 Package PreparationThe package may be tested 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.
39、1 Insert the package in a manner in which the body ofthe package is enclosed between the restraining plates. Placethe 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 thaten
40、sures consistent placement for all packages tested. Ensureplate gap dimension is set to appropriate gap setting. 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 pa
41、ckage.9.2.3 Close the clamping mechanism to produce an air tightseal around the open end of the package including 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
42、required plategap dimension. See Appendix X1 for recommendations ondetermining appropriate plate gap dimension settings.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
43、 of entryand may be fixtured as an attachment to the restraining plates(see Fig. 2).9.4 Set the rate of pressurization 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), kilopas
44、cal kPa), or inches of water unitsof measure for most package test resolutions required.9.5 Begin test by initiating 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
45、 (burst) is detected by the sensingmechanism as a rapid decrease in pressure within the body ofthe package, and 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 we
46、ll as the pressure at which theF2054 07 (2012)3failure occurred. If the failure occurred in an area other than theseal the test 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 clos
47、ed package), apparatusused, test device machine settings chosen if operator adjustable(rate of pressurization and sensitivity 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 characteristi
48、cs ofpackage tested, that is, whether with or without packagecontents inside the package, seal type and configuration, etc.,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
49、 test values, and the units of measure thatthe sensing device is set to return as response values. Docu-mentation also may 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
