ASTM F2054-07(2012)
(Test Method)Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
SIGNIFICANCE AND USE
5.1 This test provides a rapid means of evaluating tendencies for package seal failure when the package is exposed to a pressure differential. Pressure differentials may occur during such processes as sterilization and transportation. This test method provides an indicator of the burst strength of a package, where the burst will normally occur in one or more areas of the seal. An indicator of the minimum burst strength may be of importance to the package manufacturer and end user in ensuring adequate package integrity. This test method cannot provide a measure of package seal uniformity. This test method also cannot provide an evaluation of overall package integrity or the burst strength of areas of the package that contact the surface of the restraining plates used. This test method should be combined with other methods of evaluating overall package integrity, uniformity of the package seal, or opening functionality, if so required.
5.2 This test frequently is used to quickly evaluate package seal strength during the manufacturing process and at various stages of the package's life cycle.
5.3 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 seal, rate of air flow into 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 provide correlation with package seal strength as typically measured using Test Methods F1140 or F88 (or equivalents).
SCOPE
1.1 These test methods cover the procedure for determining the minimum burst strength of a seal placed around the perimeter of a flexible package as it is internally pressurized and enclosed within restraining plates.
1.2 The test methods described herein are functionally similar to Test Methods F1140 with the exception of the use of restraining plates. Test Methods F1140 describes methods of burst testing that do not include the use of restraining plates and are suitable to determine a packages general ability to withstand pressurization stresses. Under Test Methods F1140 the stresses are not distributed uniformly to all areas of the package seal. Under unrestrained conditions the stress on the package is highest at the middle of the pouch where it inflates to the packages maximum diameter; therefore, Test Methods F1140 may not reliably detect the weakest area of the seal.
1.3 The burst test internally and increasingly pressurizes a package 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 dimensional stability of the package is maintained in a manner that results in stresses applied more uniformly along the perimeter of the package, where seals are normally placed. This allows the test to have a higher probability of detecting the weakest area of the seal 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 the perimeter of a flexible package (often referred to as a pouch). In particular it is intended as applicable to packages with seals that have a peelable seal feature (peeled open by end user to remove contents of package).
1.4.1 Porous barrier materials' failure to reach adequate pressure to burst the package seals may be due to insufficient volume flow. See Appendix X4 for information.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices ...
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Designation:F2054 −07(Reapproved 2012)
Standard Test Method for
Burst Testing of Flexible Package Seals Using Internal Air
Pressurization Within Restraining Plates
This standard is issued under the fixed designation F2054; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 These test methods cover the procedure for determining
responsibility of the user of this standard to establish appro-
the minimum burst strength of a seal placed around the
priate safety and health practices and determine the applica-
perimeter of a flexible package as it is internally pressurized
bility of regulatory limitations prior to use. Particular caution
and enclosed within restraining plates.
is advised where users of this procedure may be required to
1.2 The test methods described herein are functionally
design and fabricate restraining plate fixtures. Reference Ap-
similar toTest Methods F1140 with the exception of the use of
pendix X3 for further information regarding calculation of
restraining plates. Test Methods F1140 describes methods of
stress factors and structural design considerations.
burst testing that do not include the use of restraining plates
and are suitable to determine a packages general ability to
2. Referenced Documents
withstand pressurization stresses. Under Test Methods F1140
2.1 ASTM Standards:
the stresses are not distributed uniformly to all areas of the
D1898Practice for Sampling of Plastics (Withdrawn 1998)
package seal. Under unrestrained conditions the stress on the
D4332Practice for Conditioning Containers, Packages, or
package is highest at the middle of the pouch where it inflates
Packaging Components for Testing
to the packages maximum diameter; therefore, Test Methods
E691Practice for Conducting an Interlaboratory Study to
F1140 may not reliably detect the weakest area of the seal.
Determine the Precision of a Test Method
1.3 The burst test internally and increasingly pressurizes a
F88Test Method for Seal Strength of Flexible Barrier
package until an area of the package seal around the perimeter
Materials
“bursts” open in response to pressurization. By placing the
F1140Test Methods for Internal Pressurization Failure Re-
package within restraining plates during pressurization, the
sistance of Unrestrained Packages
dimensional stability of the package is maintained in a manner
F1327Terminology Relating to Barrier Materials for Medi-
that results in stresses applied more uniformly along the
cal Packaging (Withdrawn 2007)
perimeter of the package, where seals are normally placed.
Thisallowsthetesttohaveahigherprobabilityofdetectingthe
3. Terminology
weakest area of the seal and provide a measurement of the
3.1 Definitions—For definitions and terms used in this test
pressure required to “burst” open the package.
method, see Terminology F1327.
1.4 This test only applies to flexible packages with seals
3.2 Definitions of Terms Specific to This Standard:
placed around the perimeter of a flexible package (often
3.2.1 flexible package or pouch, n—refers to a package in
referredtoasapouch).Inparticularitisintendedasapplicable
which at least one of the sealed materials is of a flexible
to packages with seals that have a peelable seal feature (peeled
structure (that is, paper, polyethylene, and so forth).
open by end user to remove contents of package).
1.4.1 Porous barrier materials’ failure to reach adequate 3.2.2 restraining plates, n—refers to plates that are rigid in
pressure to burst the package seals may be due to insufficient nature and configured to contact and limit the packages
volume flow. See Appendix X4 for information. expandable surface area as the package is pressurized.
1 2
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Barrier Packaging and is the direct responsibility of Subcommittee F02.20 on contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Physical Properties. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Nov. 1, 2012. Published November 2012. Originally the ASTM website.
approved in 2000. Last previous edition approved in 2007 as F2054–07. DOI: The last approved version of this historical standard is referenced on
10.1520/F2054-07R12. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2054−07 (2012)
4. Summary of Test Method
4.1 Packages are tested in an apparatus that internally
pressurizes the package until an area of the package ruptures
(burst). For most applications the rupture (burst) will occur at
one or more areas of the seal. The pneumatic supply and
pressurization equipment need the capability to maintain an
increasing pressure until the seal area fails. (For porous barrier
material, see Appendix X4.) During pressurization, the pack-
age shall be enclosed between two rigid and parallel plates
(restraining plates) that limit the expansion and dimensional
distortionofthepackagebutallowthesealperimeterareatobe
unrestricted. A sensor inside the package detects the internal
pressure at the point at which the package ruptures (burst).
Dependentontheapplication,twoconfigurationsofrestraining
plates are indicated for use with this test 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
FIG. 2Restraining Plates, Closed Package Configuration
sidesofthepackageperimeterandthefourthsideisopen.This
configuration is generally used in the original package manu-
facture. See Fig. 1 for an illustration of the configuration used.
method also cannot provide an evaluation of overall package
4.1.2 Closed Package Configuration —A closed package
integrity or the burst strength of areas of the package that
configuration is used where there is a seal placed around all
contact the surface of the restraining plates used. This test
four sides of the package. This configuration generally is used
method should be combined with other methods of evaluating
in operations where the purpose is to test the seal in it’s
overall package integrity, uniformity of the package seal, or
finished, fully-sealed state. See Fig. 2 for an illustration of the
opening functionality, if so required.
configuration used.
5.2 This test frequently is used to quickly evaluate package
5. Significance and Use seal strength during the manufacturing process and at various
stages of the package’s life cycle.
5.1 This test provides a rapid means of evaluating tenden-
cies for package seal failure when the package is exposed to a 5.3 If correlations between pieces of test equipment are to
pressure differential. Pressure differentials may occur during be made it is important that all parameters of the test be
equivalent. Typical parameters can include, but are not limited
such processes as sterilization and transportation. This test
method provides an indicator of the burst strength of a to the package size, material, type and configuration of seal,
package, where the burst will normally occur in one or more rate of air flow into the package, pressure detection sensing
areas of the seal. An indicator of the minimum burst strength mechanism and sensitivity (machine response to pressure
may be of importance to the package manufacturer and end drop), position of test article, rigidity of restraining plates, and
user in ensuring adequate package integrity. This test method distance between restraining plates. See Appendix X2 for
cannot provide a measure of package seal uniformity.This test further information.
FIG. 1Restraining Plates, Open Package Configuration
F2054−07 (2012)
5.4 This test may not necessarily provide correlation with for minimum of 72 h before performing testing. Reference
package seal strength as typically measured using Test Meth- Practice D4332 for further information on standard condition-
ods F1140 or F88 (or equivalents). ing.
8.2 Effectsofenvironmentalconditionsotherthantheabove
6. Apparatus
standardshavenotbeendeterminedastheyrelatetotheresults
6.1 Packages are tested under conditions described as fol- of this test method and may depend on packaging materials
used.Wherecomparisonsorcorrelation’softestresultsmaybe
lows:
a requirement, and the test is conducted in other than standard
6.1.1 Open-Package Tester—Open-package test fixtures are
test conditions, record the conditioning factors and the tem-
used to test flexible packages with one of the four sides of the
perature and relative humidity at the time of test.
package open (nonsealed). The package is pressurized with an
inflation nozzle and pressure sensing mechanism inserted into
9. Procedure
the open end of the package. The open end then is sealed by a
clamping mechanism for the duration of the test (see Fig. 1).
9.1 Package Preparation—Thepackagemaybetestedwith,
6.1.2 Closed-Package Tester—Closed-package test fixtures
if the package can fit within the restraining plates, or without
are used to test packages with all four sides of the package
product enclosed inside the package. Record the package test
sealed. The closed package tester internally pressurizes the
preparation, if applicable.
package utilizing a pressure nozzle and sensing mechanism
9.2 Open-Package Test:
that is connected through a puncture in the package (see Fig.
9.2.1 Insert the package in a manner in which the body of
2).
the package is enclosed between the restraining plates. Place
6.2 The test apparatus for both open and closed package
the package between the restraining plates in a manner which
testing shall include the following:
minimizestheunrestrainedareasofthepackageduringthetest.
6.2.1 An air supply and pressure regulating mechanism that
It is advised to use some type of markings or fixturing that
can produce sufficient air flow to pressurize the package to the
ensures consistent placement for all packages tested. Ensure
point of package failure (burst); for porous barrier materials,
plate gap dimension is set to appropriate gap setting. See
see Appendix X4;
AppendixX1forrecommendationsondeterminingappropriate
6.2.2 Ameans of detecting a rapid pressure drop inside the
plate gap dimension settings.
package that signals that an area of the package is stressed to
9.2.2 Insert or otherwise place the pressurization and sensor
failure (burst);
nozzle inside the open end of the package.
6.2.3 A means of measuring the internal pressure at the
9.2.3 Close the clamping mechanism to produce an air tight
pointinwhicharapidpressuredropoccursastheresultofseal
seal around the open end of the package including the area
or other package failure (burst);
around the pressurization and sensor nozzle.
6.2.4 Tworestrainingplatesthatareconfiguredsimilartoas
9.3 Closed-Package Test:
shown in Fig. 1 or Fig. 2, is rigid to movement and flex, and
9.3.1 Insert the body of the package within the restraining
contact the expandable surface area of the package for the
plates and close the plates, if applicable, to the required plate
duration of the test.
gap dimension. See Appendix X1 for recommendations on
6.2.5 The following depending on type of test conducted.
determining appropriate plate gap dimension settings.
6.2.5.1 Open-package test fixtures shall have a pressuriza-
9.3.2 Carefully insert the pressurization and sensor nozzle
tion nozzle and sensor that is inserted into the open end of the
entrydevice,andaffixtothepackagesoastocreateanairtight
package, and a clamping mechanism that seals the open end of
seal. The center of the package is the preferred point of entry
the package, as well as creates an air tight seal around the
and may be fixtured as an attachment to the restraining plates
pressurization nozzle and sensor; and
(see Fig. 2).
6.2.5.2 Closed-package test fixtures shall have a pressuriza-
tion nozzle and sensor that inserts into a puncture of the body 9.4 Set the rate of pressurization and sensor sensitivity, if
ofthesealedpackagewhilemaintaininganairtightsealaround
user selectable. Set the pressure failure sensor readout, if user
those mechanisms. selectable, to the desired units of measure, usually set to
readoutinpascal(Pa),kilopascalkPa),orinchesofwaterunits
7. Sampling of measure for most package test resolutions required.
7.1 Sampling—Choose the number of test specimens to 9.5 Begin test by initiating inflation process. Continue
permit an adequate determination of representative perfor- pressurization until a failure occurs.Afailure in this context is
mance. Practice D1898 provides guidance to test specimen when an area of the package ruptures (bursts) as the result of
selection. pressurization. The rupture (burst) is detected by the sensing
mechanism as a rapid decrease in pressure within the body of
the package, and the pressure reading device reports the
8. Conditioning
pressure at the point in time just prior to the pressure drop.
8.1 Standard Test Conditions—Condition and test package
under standard laboratory atmosphere of 73.4° 6 2°F (23° 6 9.6 Visually examine the tested package and note the
1°C) and 50 6 2% relative humidity. Condition the packages positionandtypeoffailure,aswellasthepressureatwhichthe
F2054−07 (2012)
TABLE 2 Summary of Interlaboratory Test Results by Package
failureoccurred.Ifthefailureoccurredinanareaotherthanthe
Set
seal the test may be voided depending on the purpose of the
Standard
investigation.
Deviation Within Lab Between Lab
of Lab to Repeatability Reproducibility
10. Report
Lab Standard Standard
Package Average Averages, Deviation, Deviation,
10.1 The report should include or have traceability to the
Set kPa kPa COV% kPa COV% kPa COV%
following:
A 14.78 0.7221 4.89 % 1.3931 9.43 % 1.5060 10.19 %
10.1.1 Test performed (open or closed package), apparatus
B 18.58 1.5550 8.37 % 1.8825 10.13 % 2.3660 12.73 %
C 17.73 1.1346 6.40 % 1.5945 8.99 % 1.8910 10.66 %
used,testdevicemachinesettingschosenifoperatoradjustable
D 15.73 0.8591 5.46 % 2.7499 17.48 % 2.7499 17.48 %
(rate of pressurization and sensitivity of pressure drop detec-
E 10.54 0.6198 5.88 % 0.8477 8.04 % 1.0153 9.63 %
tion sensor), gap distance between restraining plates, and
F 9.06 0.8294 9.16 % 0.5974 6.60 % 1.0045 11.09 %
blocking agent used (see Appendix X4). G
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