ASTM F2054-00
(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
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 F 1140 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).
1.5 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 and determine the applicability of regulatory limitations prior to use. Particular caution is advised where users of this procedure may be required to design and fabricate restraining plate fixtures. Reference Appendix X3 for further information regarding calculation of stress factors and structural design considerations.
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Designation: F 2054 – 00
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 F 2054; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope pendix X3 for further information regarding calculation of
stress factors and structural design considerations.
1.1 These test methods cover the procedure for determining
the minimum burst strength of a seal placed around the
2. Referenced Documents
perimeter of a flexible package as it is internally pressurized
2.1 ASTM Standards:
and enclosed within restraining plates.
D 1898 Practice for Sampling of Plastics
1.2 The test methods described herein are functionally
D 4332 Practice for Conditioning Containers, Packages,
similar toTest Methods F 1140 with the exception of the use of
and Packaging Components for Testing
restraining plates. Test Methods F 1140 describes methods of
E 691 Practice for Conducting an Interlaboratory Study to
burst testing that do not include the use of restraining plates
Determine the Precision of a Test Method
and are suitable to determine a packages general ability to
F88 Test Method for Seal Strength of Flexible Barrier
withstand pressurization stresses. Under Test Methods F 1140
Materials
the stresses are not distributed uniformly to all areas of the
F 1140 Test Methods for Failure Resistance of Unrestrained
package seal. Under unrestrained conditions the stress on the
and Nonrigid Packages for Medical Applications
package is highest at the middle of the pouch where it inflates
F 1327 TerminologyRelatingtoBarrierMaterialsforMedi-
to the packages maximum diameter; therefore, Test Methods
cal Packaging
F 1140 may not reliably detect the weakest area of the seal.
1.3 The burst test internally and increasingly pressurizes a
3. Terminology
package until an area of the package seal around the perimeter
3.1 Definitions—For definitions and terms used in this test
“bursts” open in response to pressurization. By placing the
method, see Terminology F 1327.
package within restraining plates during pressurization, the
3.2 Definitions of Terms Specific to This Standard:
dimensional stability of the package is maintained in a manner
3.2.1 flexible package or pouch, n—refers to a package in
that results in stresses applied more uniformly along the
which at least one of the sealed materials is of a flexible
perimeter of the package, where seals are normally placed.
structure (that is, paper, polyethylene, etc.).
Thisallowsthetesttohaveahigherprobabilityofdetectingthe
3.2.2 restraining plates, n—refers to plates that are rigid in
weakest area of the seal and provide a measurement of the
nature and configured to contact and limit the packages
pressure required to “burst” open the package.
expandable surface area as the package is pressurized.
1.4 This test only applies to flexible packages with seals
placed around the perimeter of a flexible package (often
4. Summary of Test Method
referred to as a pouch). In particular it is intended as applicable
4.1 Packages are tested in an apparatus that internally
to packages with seals that have a peelable seal feature (peeled
pressurizes the package until an area of the package ruptures
open by end user to remove contents of package).
(burst). For most applications the rupture (burst) will occur at
1.5 This standard does not purport to address all of the
one or more areas of the seal. The pneumatic supply and
safety concerns, if any, associated with its use. It is the
pressurization equipment need the capability to maintain an
responsibility of the user of this standard to establish appro-
increasing pressure until the seal area fails. During pressuriza-
priate safety and health practices and determine the applica-
tion, the package shall be enclosed between two rigid and
bility of regulatory limitations prior to use. Particular caution
parallel plates (restraining plates) that limit the expansion and
is advised where users of this procedure may be required to
dimensional distortion of the package but allow the seal
design and fabricate restraining plate fixtures. Reference Ap-
perimeter area to be unrestricted. A sensor inside the package
This test method is under the jurisdiction ofASTM Committee F02 on Flexible
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on Discontinued. See 1998 Annual Book of ASTM Standards, Vol 08.01.
Medical Packaging. Annual Book of ASTM Standards, Vol 15.09.
Current edition approved Aug. 10, 2000. Published October 2000. Annual Book of ASTM Standards, Vol 14.02.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2054–00
FIG. 1 Restraining Plates, Open Package Configuration
detects the internal pressure at the point at which the package
ruptures (burst). Dependent on the application, two configura-
tions of restraining plates are indicated for use with this test
method. Generally, these are described as follows:
4.1.1 Open Package Configuration—An open package con-
figuration is used where there is a seal placed around three
sides of the package perimeter and the fourth side is open.This
configuration is generally used in the original package manu-
facture. See Fig. 1 for an illustration of the configuration used.
4.1.2 Closed Package Configuration—A closed package
configuration is used where there is a seal placed around all
four sides of the package. This configuration generally is used
in operations where the purpose is to test the seal in it’s
finished, fully-sealed state. See Fig. 2 for an illustration of the
configuration used.
5. Significance and Use
5.1 This test provides a rapid means of evaluating tenden-
FIG. 2 Restraining Plates, Closed Package Configuration
cies 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 rate of air flow into the package, pressure detection sensing
method provides an indicator of the burst strength of a
mechanism and sensitivity (machine response to pressure
package, where the burst will normally occur in one or more drop), position of test article, rigidity of restraining plates, and
areas of the seal. An indicator of the minimum burst strength
distance between restraining plates. See Appendix X2 for
may be of importance to the package manufacturer and end further information.
user in ensuring adequate package integrity. This test method
5.4 This test may not necessarily provide correlation with
cannot provide a measure of package seal uniformity. This test package seal strength as typically measured using Test Meth-
method also cannot provide an evaluation of overall package
ods F 1140 orF88 (or equivalents).
integrity or the burst strength of areas of the package that
6. Apparatus
contact the surface of the restraining plates used. This test
method should be combined with other methods of evaluating 6.1 Packages are tested under conditions described as fol-
overall package integrity, uniformity of the package seal, or lows:
opening functionality, if so required. 6.1.1 Open-Package Tester—Open-package test fixtures are
5.2 This test frequently is used to quickly evaluate package used to test flexible packages with one of the four sides of the
seal strength during the manufacturing process and at various package open (nonsealed). The package is pressurized with an
stages of the package’s life cycle. inflation nozzle and pressure sensing mechanism inserted into
5.3 If correlations between pieces of test equipment are to the open end of the package. The open end then is sealed by a
be made it is important that all parameters of the test be clamping mechanism for the duration of the test (see Fig. 1).
equivalent. Typical parameters can include, but are not limited 6.1.2 Closed-Package Tester—Closed-package test fixtures
to the package size, material, type and configuration of seal, are used to test packages with all four sides of the package
F2054–00
sealed. The closed package tester internally pressurizes the product enclosed inside the package. Record the package test
package utilizing a pressure nozzle and sensing mechanism preparation, if applicable.
that is connected through a puncture in the package (see Fig. 9.2 Open-Package Test:
2). 9.2.1 Insert the package in a manner in which the body of
6.2 The test apparatus for both open and closed package the package is enclosed between the restraining plates. Place
testing shall include the following: the package between the restraining plates in a manner which
6.2.1 An air supply and pressure regulating mechanism that minimizestheunrestrainedareasofthepackageduringthetest.
can produce sufficient air flow to pressurize the package to the It is advised to use some type of markings or fixturing that
point of package failure (burst); ensures consistent placement for all packages tested. Ensure
6.2.2 A means of detecting a rapid pressure drop inside the plate gap dimension is set to appropriate gap setting. See
package that signals that an area of the package is stressed to AppendixX1forrecommendationsondeterminingappropriate
failure (burst); plate gap dimension settings.
6.2.3 A means of measuring the internal pressure at the 9.2.2 Insert or otherwise place the pressurization and sensor
point in which a rapid pressure drop occurs as the result of seal nozzle inside the open end of the package.
or other package failure (burst); 9.2.3 Close the clamping mechanism to produce an air tight
6.2.4 Two restraining plates that are configured similar to as seal around the open end of the package including the area
shown in Fig. 1 or Fig. 2, is rigid to movement and flex, and around the pressurization and sensor nozzle.
contact the expandable surface area of the package for the 9.3 Closed-Package Test:
duration of the test. 9.3.1 Insert the body of the package within the restraining
6.2.5 The following depending on type of test conducted. plates and close the plates, if applicable, to the required plate
6.2.5.1 Open-package test fixtures shall have a pressuriza- gap dimension. See Appendix X1 for recommendations on
tion nozzle and sensor that is inserted into the open end of the determining appropriate plate gap dimension settings.
package, and a clamping mechanism that seals the open end of 9.3.2 Carefully insert the pressurization and sensor nozzle
the package, as well as creates an air tight seal around the entry device, and affix to the package so as to create an air tight
pressurization nozzle and sensor; and seal. The center of the package is the preferred point of entry
6.2.5.2 Closed-package test fixtures shall have a pressuriza- and may be fixtured as an attachment to the restraining plates
tion nozzle and sensor that inserts into a puncture of the body (see Fig. 2).
ofthesealedpackagewhilemaintaininganairtightsealaround 9.4 Set the rate of pressurization and sensor sensitivity, if
those mechanisms. user selectable. Set the pressure failure sensor readout, if user
selectable, to the desired units of measure, usually set to
7. Sampling
readout in pascal (Pa), kilopascal kPa), or inches of water units
of measure for most package test resolutions required.
7.1 Sampling —Choose the number of test specimens to
permit an adequate determination of representative perfor- 9.5 Begin test by initiating inflation process. Continue
pressurization until a failure occurs.Afailure in this context is
mance. Practice D 1898 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
8. Conditioning
mechanism as a rapid decrease in pressure within the body of
the package, and the pressure reading device reports the
8.1 Standard Test Conditions—Condition and test package
pressure at the point in time just prior to the pressure drop.
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
for minimum of 72 h before performing testing. Reference
failureoccurred.Ifthefailureoccurredinanareaotherthanthe
Practice D 4332 for further information on standard condition-
seal the test may be voided depending on the purpose of the
ing.
investigation.
8.2 Effectsofenvironmentalconditionsotherthantheabove
standards have not been determined as they relate to the results
10. Report
of this test method and may depend on packaging materials
10.1 The report should include or have traceability to the
used.Wherecomparisonsorcorrelation’softestresultsmaybe
following:
a requirement, and the test is conducted in other than standard
10.1.1 Test performed (open or closed package), apparatus
test conditions, record the conditioning factors and the tem-
used, test device machine settings chosen if operator adjustable
perature and relative humidity at the time of test.
(rate of pressurization and sensitivity of pressure drop detec-
tion sensor), and gap distance between restraining plates.
9. Procedure
10.1.2 Packaging material types and other characteristics of
9.1 Package Preparation—Thepackagemaybetestedwith,
package tested, that is, whether with or without package
if the package can fit within the restraining plates, or without
contents inside the package, seal type and configuration, etc.,
package lot number and source’s name.
10.2 Include the date, time, location, and identification of
Test equipment found to be satisfactory for this purpose is available from
the individual performing the test. The number of packages
Carleton Corp., (Test-A-Pack System), Orchard Park, NY, and T.M. Electronics,
Worcester, MA. tested, the individual test values, and the units of measure that
F2054–00
TABLE 1 Descriptions of Package Sets Tested in Round-Robin TABLE 2 Summary of Interlaboratory Test Results by Package
Study Set
Number Standard
of Deviation Within Lab Between Lab
Samples of Lab to Repeatability Reproducibility
Package Package ID Dimensions and Material Tested Number Lab Standard Standard
A
Set Configurations per Lab of Labs Package Average Averages, Deviation, Deviation,
Set kPa kPa COV% kPa COV% kPa COV%
A 158.8 mm 3 295.3 mm Spunbonded Olefin: PET/PE 10 10
B 139.7 mm 3
...
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