ASTM F2054-00(2005)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 2054 – 00 (Reapproved 2005)
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 design and fabricate restraining plate fixtures. Reference Ap-
pendix X3 for further information regarding calculation of
1.1 These test methods cover the procedure for determining
stress factors and structural design considerations.
the minimum burst strength of a seal placed around the
perimeter of a flexible package as it is internally pressurized
2. Referenced Documents
and enclosed within restraining plates.
2.1 ASTM Standards:
1.2 The test methods described herein are functionally
D 1898 Practice for Sampling of Plastics
similar toTest Methods F 1140 with the exception of the use of
D 4332 Practice for Conditioning Containers, Packages, or
restraining plates. Test Methods F 1140 describes methods of
Packaging Components for Testing
burst testing that do not include the use of restraining plates
E 691 Practice for Conducting an Interlaboratory Study to
and are suitable to determine a packages general ability to
Determine the Precision of a Test Method
withstand pressurization stresses. Under Test Methods F 1140
F88 Test Method for Seal Strength of Flexible Barrier
the stresses are not distributed uniformly to all areas of the
Materials
package seal. Under unrestrained conditions the stress on the
F 1140 Test Methods for Internal Pressurization Failure
package is highest at the middle of the pouch where it inflates
Resistance of Unrestrained Packages for Medical Applica-
to the packages maximum diameter; therefore, Test Methods
tions
F 1140 may not reliably detect the weakest area of the seal.
F 1327 TerminologyRelatingtoBarrierMaterialsforMedi-
1.3 The burst test internally and increasingly pressurizes a
cal Packaging
package until an area of the package seal around the perimeter
“bursts” open in response to pressurization. By placing the
3. Terminology
package within restraining plates during pressurization, the
3.1 Definitions—For definitions and terms used in this test
dimensional stability of the package is maintained in a manner
method, see Terminology F 1327.
that results in stresses applied more uniformly along the
3.2 Definitions of Terms Specific to This Standard:
perimeter of the package, where seals are normally placed.
3.2.1 flexible package or pouch, n—refers to a package in
Thisallowsthetesttohaveahigherprobabilityofdetectingthe
which at least one of the sealed materials is of a flexible
weakest area of the seal and provide a measurement of the
structure (that is, paper, polyethylene, and so forth).
pressure required to “burst” open the package.
3.2.2 restraining plates, n—refers to plates that are rigid in
1.4 This test only applies to flexible packages with seals
nature and configured to contact and limit the packages
placed around the perimeter of a flexible package (often
expandable surface area as the package is pressurized.
referred to as a pouch). In particular it is intended as applicable
to packages with seals that have a peelable seal feature (peeled
4. Summary of Test Method
open by end user to remove contents of package).
4.1 Packages are tested in an apparatus that internally
1.5 This standard does not purport to address all of the
pressurizes the package until an area of the package ruptures
safety concerns, if any, associated with its use. It is the
(burst). For most applications the rupture (burst) will occur at
responsibility of the user of this standard to establish appro-
one or more areas of the seal. The pneumatic supply and
priate safety and health practices and determine the applica-
pressurization equipment need the capability to maintain an
bility of regulatory limitations prior to use. Particular caution
increasing pressure until the seal area fails. During pressuriza-
is advised where users of this procedure may be required to
tion, the package shall be enclosed between two rigid and
1 2
This test method is under the jurisdiction ofASTM Committee F02 on Flexible 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 April 1, 2005. Published May 2005. Originally the ASTM website.
approved in 2000. Last previous edition approved in 2000 as F 2054 – 00. Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 2054 – 00 (2005)
FIG. 1 Restraining Plates, Open Package Configuration
parallel plates (restraining plates) that limit the expansion and
dimensional distortion of the package but allow the seal
perimeter area to be unrestricted. A sensor inside the package
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.
FIG. 2 Restraining Plates, Closed Package Configuration
5. Significance and Use
5.3 If correlations between pieces of test equipment are to
5.1 This test provides a rapid means of evaluating tenden- be made it is important that all parameters of the test be
cies for package seal failure when the package is exposed to a equivalent. Typical parameters can include, but are not limited
pressure differential. Pressure differentials may occur during
to the package size, material, type and configuration of seal,
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
F 2054 – 00 (2005)
the open end of the package. The open end then is sealed by a product enclosed inside the package. Record the package test
clamping mechanism for the duration of the test (see Fig. 1). preparation, if applicable.
6.1.2 Closed-Package Tester—Closed-package test fixtures 9.2 Open-Package Test:
are used to test packages with all four sides of the package 9.2.1 Insert the package in a manner in which the body of
sealed. The closed package tester internally pressurizes the the package is enclosed between the restraining plates. Place
package utilizing a pressure nozzle and sensing mechanism the package between the restraining plates in a manner which
that is connected through a puncture in the package (see Fig. minimizestheunrestrainedareasofthepackageduringthetest.
2). It is advised to use some type of markings or fixturing that
6.2 The test apparatus for both open and closed package ensures consistent placement for all packages tested. Ensure
testing shall include the following: plate gap dimension is set to appropriate gap setting. See
6.2.1 An air supply and pressure regulating mechanism that AppendixX1forrecommendationsondeterminingappropriate
can produce sufficient air flow to pressurize the package to the plate gap dimension settings.
point of package failure (burst); 9.2.2 Insert or otherwise place the pressurization and sensor
6.2.2 A means of detecting a rapid pressure drop inside the nozzle inside the open end of the package.
package that signals that an area of the package is stressed to 9.2.3 Close the clamping mechanism to produce an air tight
failure (burst); seal around the open end of the package including the area
6.2.3 A means of measuring the internal pressure at the around the pressurization and sensor nozzle.
point in which a rapid pressure drop occurs as the result of seal 9.3 Closed-Package Test:
or other package failure (burst); 9.3.1 Insert the body of the package within the restraining
6.2.4 Two restraining plates that are configured similar to as plates and close the plates, if applicable, to the required plate
shown in Fig. 1 or Fig. 2, is rigid to movement and flex, and gap dimension. See Appendix X1 for recommendations on
contact the expandable surface area of the package for the determining appropriate plate gap dimension settings.
duration of the test. 9.3.2 Carefully insert the pressurization and sensor nozzle
6.2.5 The following depending on type of test conducted. entrydevice,andaffixtothepackagesoastocreateanairtight
6.2.5.1 Open-package test fixtures shall have a pressuriza- seal. The center of the package is the preferred point of entry
tion nozzle and sensor that is inserted into the open end of the and may be fixtured as an attachment to the restraining plates
package, and a clamping mechanism that seals the open end of (see Fig. 2).
the package, as well as creates an air tight seal around the 9.4 Set the rate of pressurization and sensor sensitivity, if
pressurization nozzle and sensor; and user selectable. Set the pressure failure sensor readout, if user
6.2.5.2 Closed-package test fixtures shall have a pressuriza- selectable, to the desired units of measure, usually set to
tion nozzle and sensor that inserts into a puncture of the body readout in pascal (Pa), kilopascal kPa), or inches of water units
ofthesealedpackagewhilemaintaininganairtightsealaround of measure for most package test resolutions required.
those mechanisms. 9.5 Begin test by initiating inflation process. Continue
pressurization until a failure occurs.Afailure in this context is
when an area of the package ruptures (bursts) as the result of
7. Sampling
pressurization. The rupture (burst) is detected by the sensing
7.1 Sampling—Choose the number of test specimens to
mechanism as a rapid decrease in pressure within the body of
permit an adequate determination of representative perfor-
the package, and the pressure reading device reports the
mance. Practice D 1898 provides guidance to test specimen
pressure at the point in time just prior to the pressure drop.
selection.
9.6 Visually examine the tested package and note the
positionandtypeoffailure,aswellasthepressureatwhichthe
8. Conditioning
failureoccurred.Ifthefailureoccurredinanareaotherthanthe
8.1 Standard Test Conditions—Condition and test package
seal the test may be voided depending on the purpose of the
under standard laboratory atmosphere of 73.4°6 2°F (23° 6
investigation.
1°C) and 50 6 2 % relative humidity. Condition the packages
for minimum of 72 h before performing testing. Reference 10. Report
Practice D 4332 for further information on standard condition-
10.1 The report should include or have traceability to the
ing.
following:
8.2 Effectsofenvironmentalconditionsotherthantheabove
10.1.1 Test performed (open or closed package), apparatus
standards have not been determined as they relate to the results
used,testdevicemachinesettingschosenifoperatoradjustable
of this test method and may depend on packaging materials
(rate of pressurization and sensitivity of pressure drop detec-
used.Wherecomparisonsorcorrelation’softestresultsmaybe
tion sensor), and gap distance between restraining plates.
a requirement, and the test is conducted in other than standard
10.1.2 Packaging material types and other characteristics of
test conditions, record the conditioning factors and the tem-
package tested, that is, whether with or without package
perature and relative humidity at the time of test.
contents inside the package, seal type and configuration, etc.,
package lot number and source’s name.
9. Procedure
10.2 Include the date, time, location, and identification of
9.1 Package Preparation—Thepackagemaybetestedwith, the individual performing the test. The number of packages
if the package can fit within the restraining plates, or without tested, the individual test values, and the units of measure that
F 2054 – 00 (2005)
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
...