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 This test method covers 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 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with t...

General Information

Status
Published
Publication Date
30-Apr-2020
Drafting Committee
F02.20 - Physical Properties

Relations

Effective Date
01-May-2020
Effective Date
01-May-2020
Effective Date
01-Oct-2018
Effective Date
15-Aug-2018
Effective Date
01-Jun-2017
Effective Date
01-Aug-2013
Effective Date
01-May-2013
Effective Date
15-Apr-2013
Effective Date
01-Nov-2012
Effective Date
01-Nov-2012
Effective Date
01-Nov-2011
Effective Date
01-Oct-2008
Effective Date
01-Aug-2008
Effective Date
01-Sep-2007
Effective Date
01-Aug-2007

Overview

ASTM F2054/F2054M-13(2020), issued by ASTM International, specifies a standard test method for determining the minimum burst strength of package seals in flexible packaging using internal air pressurization within restraining plates. This method is a critical tool for packaging professionals, manufacturers, and quality assurance teams to assess package seal performance, especially in healthcare and other sensitive applications where package integrity is paramount.

Burst testing using internal air pressurization identifies the weakest area of a flexible package seal, helping to ensure that packaging will withstand the rigors of sterilization, handling, and transportation. The use of restraining plates during the test allows for more uniform distribution of stress along the seal perimeter, unlike unrestrained testing methods that may not locate the weakest point. This focus makes ASTM F2054/F2054M especially relevant for peelable pouch seals commonly used in medical and sterile product packaging.

Key Topics

  • Burst Strength Determination: Measures the pressure level at which a seal on a flexible package fails when subjected to internal pressurization, providing a direct indicator of minimum seal strength.
  • Restraint of Package: The use of restraining plates during the test maintains dimensional stability and ensures stresses are applied uniformly, increasing the likelihood of identifying seal weaknesses.
  • Applicable Package Types: The method is intended for flexible packages (pouches) with perimeter seals, particularly those featuring peelable seals for easy opening by end users.
  • Test Configurations: Both open-package and closed-package testing are supported, accommodating packages at different production or lifecycle stages.
  • Limitations: The method does not assess seal uniformity or overall package integrity and should be complemented with other evaluations (e.g., ASTM F88 for seal strength uniformity, overall integrity tests).
  • Test Repeatability and Reproducibility: Includes guidance for achieving consistent results across different laboratories and equipment, emphasizing careful control over parameters like plate gap, air flow rate, and specimen placement.
  • Handling Porous Materials: Notes considerations for packages made from porous barrier materials, which may require special handling to achieve adequate burst pressure.

Applications

  • Medical Packaging: Frequently used to assess the integrity of sterile medical device pouches, ensuring compliance with regulatory and safety standards.
  • Manufacturing Quality Control: Serves as a rapid production-line test to evaluate seal strength at various stages of package life or after critical processing steps.
  • Research & Development: Supports optimization of flexible packaging materials, sealant choices, and design by quantifying weakest-point burst strength.
  • Regulatory Compliance: Helps satisfy FDA, ISO, and other regulatory agency requirements for package validation and performance verification.
  • Transportation Stress Testing: Simulates pressure differentials experienced during shipping or air transport, providing critical data for packaging robustness.
  • Sterilization Compatibility: Verifies that packages can withstand pressure changes during sterilization processes, essential in healthcare product packaging.

Related Standards

  • ASTM F1140/F1140M: Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages - similar burst tests without restraining plates.
  • ASTM F88/F88M: Standard Test Method for Seal Strength of Flexible Barrier Materials - measures uniformity and maximum peel strength of seals.
  • ASTM E171: Practice for Conditioning and Testing Flexible Barrier Packaging - provides standard environmental conditioning protocols.
  • ASTM E691: Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method.
  • ASTM F17: Terminology Relating to Primary Barrier Packaging - defines terms used in flexible packaging and testing.

Keywords: flexible package burst testing, package seal strength, restraining plate test method, ASTM F2054, medical packaging integrity, package pressure testing, burst strength evaluation, flexible pouch testing


For further details, always refer to the full ASTM F2054/F2054M-13(2020) text and consult related standards to ensure comprehensive package testing and compliance across all applications.

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Frequently Asked Questions

ASTM F2054/F2054M-13(2020) is a standard published by ASTM International. Its full title is "Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates". This standard covers: 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 This test method covers 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 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with t...

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 This test method covers 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 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with t...

ASTM F2054/F2054M-13(2020) is classified under the following ICS (International Classification for Standards) categories: 55.040 - Packaging materials and accessories. The ICS classification helps identify the subject area and facilitates finding related standards.

ASTM F2054/F2054M-13(2020) has the following relationships with other standards: It is inter standard links to ASTM F2054/F2054M-13, ASTM F17-20, ASTM F17-18a, ASTM F17-18, ASTM F17-17, ASTM F17-13a, ASTM E691-13, ASTM F17-13, ASTM F17-12, ASTM F1140-07(2012), ASTM E691-11, ASTM E691-08, ASTM F17-08, ASTM F17-07a, ASTM F1140-07. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

ASTM F2054/F2054M-13(2020) is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F2054/F2054M −13 (Reapproved 2020)
Standard Test Method for
Burst Testing of Flexible Package Seals Using Internal Air
Pressurization Within Restraining Plates
ThisstandardisissuedunderthefixeddesignationF2054/F2054M;thenumberimmediatelyfollowingthedesignationindicatestheyear
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 1.4.1 Porous barrier materials’ failure to reach adequate
pressure to burst the package seals may be due to insufficient
1.1 This test method covers the procedure for determining
volume flow. See Appendix X4 for information.
the minimum burst strength of a seal placed around the
1.5 The values stated in either SI units or inch-pound units
perimeter of a flexible package as it is internally pressurized
are to be regarded separately as standard. The values stated in
and enclosed within restraining plates.
each system are not necessarily exact equivalents; therefore, to
1.2 The test methods described herein are functionally
ensure conformance with the standard, each system shall be
similar toTest Methods F1140 with the exception of the use of
used independently of the other, and values from the two
restraining plates. Test Methods F1140 describes methods of
systems shall not be combined.
burst testing that do not include the use of restraining plates
1.6 This standard does not purport to address all of the
and are suitable to determine a packages general ability to
safety concerns, if any, associated with its use. It is the
withstand pressurization stresses. Under Test Methods F1140
responsibility of the user of this standard to establish appro-
the stresses are not distributed uniformly to all areas of the
priate safety, health, and environmental practices and deter-
package seal. Under unrestrained conditions the stress on the
mine the applicability of regulatory limitations prior to use.
package is highest at the middle of the pouch where it inflates
Particularcautionisadvisedwhereusersofthisproceduremay
to the packages maximum diameter; therefore, Test Methods
be required to design and fabricate restraining plate fixtures.
F1140 may not reliably detect the weakest area of the seal.
Reference Appendix X3 for further information regarding
1.3 The burst test internally and increasingly pressurizes a
calculation of stress factors and structural design consider-
package until an area of the package seal around the perimeter
ations.
“bursts” open in response to pressurization. By placing the
1.7 This international standard was developed in accor-
package within restraining plates during pressurization, the
dance with internationally recognized principles on standard-
dimensional stability of the package is maintained in a manner
ization established in the Decision on Principles for the
that results in stresses applied more uniformly along the
Development of International Standards, Guides and Recom-
perimeter of the package, where seals are normally placed.
mendations issued by the World Trade Organization Technical
Thisallowsthetesttohaveahigherprobabilityofdetectingthe
Barriers to Trade (TBT) Committee.
weakest area of the seal and provide a measurement of the
2. Referenced Documents
pressure required to “burst” open the package.
2.1 ASTM Standards:
1.4 This test only applies to flexible packages with seals
E171Practice for Conditioning and Testing Flexible Barrier
placed around the perimeter of a flexible package (often
Packaging
referredtoasapouch).Inparticularitisintendedasapplicable
E691Practice for Conducting an Interlaboratory Study to
to packages with seals that have a peelable seal feature (peeled
Determine the Precision of a Test Method
open by end user to remove contents of package).
F17Terminology Relating to Primary Barrier Packaging
F88Test Method for Seal Strength of Flexible Barrier
Materials
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onPrimary
Barrier Packaging and is the direct responsibility of Subcommittee F02.20 on
Physical Properties. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
CurrenteditionapprovedMay1,2020.PublishedJuly2020.Originallyapproved contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
in 2000. Last previous edition approved in 2013 as F2054–13. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F2054_F2054M-13R20. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2054/F2054M−13 (2020)
F1140Test Methods for Internal Pressurization Failure Re-
sistance of Unrestrained Packages
3. Terminology
3.1 Definitions—For definitions and terms used in this test
method, refer to Terminology F17 for standardized terminol-
ogy for flexible barrier packaging.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 restraining plates, n—refers to plates that are rigid in
nature and configured to contact and limit the packages
expandable surface area as the package is pressurized.
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
FIG. 2Restraining Plates, Closed Package Configuration
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
5. Significance and Use
distortionofthepackagebutallowthesealperimeterareatobe
unrestricted. A sensor inside the package detects the internal 5.1 This test provides a rapid means of evaluating tenden-
cies for package seal failure when the package is exposed to a
pressure at the point at which the package ruptures (burst).
Dependentontheapplication,twoconfigurationsofrestraining pressure differential. Pressure differentials may occur during
plates are indicated for use with this test method. Generally, such processes as sterilization and transportation. This test
these are described as follows: method provides an indicator of the burst strength of a
4.1.1 Open Package Configuration —An open package package, where the burst will normally occur in one or more
configuration is used where there is a seal placed around three areas of the seal. An indicator of the minimum burst strength
sidesofthepackageperimeterandthefourthsideisopen.This may be of importance to the package manufacturer and end
configuration is generally used in the original package manu- user in ensuring adequate package integrity. This test method
facture. See Fig. 1 for an illustration of the configuration used. cannot provide a measure of package seal uniformity.This test
4.1.2 Closed Package Configuration —A closed package method also cannot provide an evaluation of overall package
configuration is used where there is a seal placed around all integrity or the burst strength of areas of the package that
four sides of the package. This configuration generally is used contact the surface of the restraining plates used. This test
in operations where the purpose is to test the seal in it’s method should be combined with other methods of evaluating
finished, fully-sealed state. See Fig. 2 for an illustration of the overall package integrity, uniformity of the package seal, or
configuration used. opening functionality, if so required.
FIG. 1Restraining Plates, Open Package Configuration
F2054/F2054M−13 (2020)
5.2 This test frequently is used to quickly evaluate package 7. Sampling
seal strength during the manufacturing process and at various
7.1 Sampling—Choose the number of test specimens to
stages of the package’s life cycle.
permit an adequate determination of representative perfor-
5.3 If correlations between pieces of test equipment are to mance.
be made it is important that all parameters of the test be
equivalent. Typical parameters can include, but are not limited 8. Conditioning
to the package size, material, type and configuration of seal,
8.1 Standard Test Conditions—Conditionthepackagesfora
rate of air flow into the package, pressure detection sensing
minimum of 72 h before performing test. Reference Specifi-
mechanism and sensitivity (machine response to pressure
cation E171 for further information on standard conditioning.
drop), position of test article, rigidity of restraining plates, and
8.2 Effectsofenvironmentalconditionsotherthantheabove
distance between restraining plates. See Appendix X2 for
standardshavenotbeendeterminedastheyrelatetotheresults
further information.
of this test method and may depend on packaging materials
5.4 This test may not necessarily provide correlation with
used.Wherecomparisonsorcorrelation’softestresultsmaybe
package seal strength as typically measured using Test Meth-
a requirement, and the test is conducted in other than standard
ods F1140 or F88 (or equivalents).
test conditions, record the conditioning factors and the tem-
perature and relative humidity at the time of test.
6. Apparatus
9. Procedure
6.1 Packages are tested under conditions described as fol-
lows:
9.1 Package Preparation—Thepackagemaybetestedwith,
6.1.1 Open-Package Tester—Open-package test fixtures are
if the package can fit within the restraining plates, or without
used to test flexible packages with one of the four sides of the
product enclosed inside the package. Record the package test
package open (nonsealed). The package is pressurized with an
preparation, if applicable.
inflation nozzle and pressure sensing mechanism inserted into
9.2 Open-Package Test:
the open end of the package. The open end then is sealed by a
9.2.1 Insert the package in a manner in which the body of
clamping mechanism for the duration of the test (see Fig. 1).
the package is enclosed between the restraining plates. Place
6.1.2 Closed-Package Tester—Closed-package test fixtures
the package between the restraining plates in a manner which
are used to test packages with all four sides of the package
minimizestheunrestrainedareasofthepackageduringthetest.
sealed. The closed package tester internally pressurizes the
It is advised to use some type of markings or fixturing that
package utilizing a pressure nozzle and sensing mechanism
ensures consistent placement for all packages tested. Ensure
that is connected through a puncture in the package (see Fig.
plate gap dimension is set to appropriate gap setting. See
2).
AppendixX1forrecommendationsondeterminingappropriate
6.2 The test apparatus for both open and closed package
plate gap dimension settings.
testing shall include the following:
9.2.2 Insert or otherwise place the pressurization and sensor
6.2.1 An air supply and pressure regulating mechanism that
nozzle inside the open end of the package.
can produce sufficient air flow to pressurize the package to the
9.2.3 Close the clamping mechanism to produce an air tight
point of package failure (burst); for porous barrier materials,
seal around the open end of the package including the area
see Appendix X4;
around the pressurization and sensor nozzle.
6.2.2 Ameans of detecting a rapid pressure drop inside the
9.3 Closed-Package Test:
package that signals that an area of the package is stressed to
9.3.1 Insert the body of the package within the restraining
failure (burst);
plates and close the plates, if applicable, to the required plate
6.2.3 A means of measuring the internal pressure at the
gap dimension. See Appendix X1 for recommendations on
pointinwhicharapidpressuredropoccursastheresultofseal
determining appropriate plate gap dimension settings.
or other package failure (burst);
9.3.2 Carefully insert the pressurization and sensor nozzle
6.2.4 Tworestrainingplatesthatareconfiguredsimilartoas
entrydevice,andaffixtothepackagesoastocreateanairtight
shown in Fig. 1 or Fig. 2, is rigid to movement and flex, and
seal. The center of the package is the preferred point of entry
contact the expandable surface area of the package for the
and may be fixtured as an attachment to the restraining plates
duration of the test.
(see Fig. 2).
6.2.5 The following depending on type of test conducted.
9.4 Set the rate of pressurization and sensor sensitivity, if
6.2.5.1 Open-package test fixtures shall have a pressuriza-
user selectable. Set the pressure failure sensor readout, if user
tion nozzle and sensor that is inserted into the open end of the
selectable, to the desired units of measure, usually set to
package, and a clamping mechanism that seals the open end of
readoutinpascal(Pa),kilopascalkPa),orinchesofwaterunits
the package, as well as creates an air tight seal around the
of measure for most package test resolutions required.
pressurization nozzle and sensor; and
6.2.5.2 Closed-package test fixtures shall have a pressuriza- 9.5 Begin test by initiating inflation process. Continue
tion nozzle and sensor that inserts into a puncture of the body pressurization until a failure occurs.Afailure in this context is
ofthesealedpackagewhilemaintaininganairtightsealaround when an area of the package ruptures (bursts) as the result of
those mechanisms. pressurization. The rupture (burst) is detected by the sensing
F2054/F2054M−13 (2020)
TABLE 1 Descriptions of Package Sets Tested in Round-Robin
mechanism as a rapid decrease in pressure within the body of
Study
the package, and the pressure reading device reports the
Number
pressure at the point in time just prior to the pressure drop.
of
Samples
9.6 Visually examine the tested package and note the
Package Package ID Dimensions and Material Tested Number
positionandtypeoffailure,aswellasthepressureatwhichthe
A
Set Configurations per Lab of Labs
failureoccurred.Ifthefailureoccurredinanareaotherthanthe
A 158.8 mm × 295.3 mm Spunbonded Olefin: PET/PE 10 10
seal the test may be voided depending on the purpose of the
B 139.7 mm × 231.8 mm Spunbonded Olefin: PET/PE 10 10
C 183.9 mm × 276.2 mm Spunbonded Olefin: PET/PE 10 10
investigation.
D 133.4 mm × 224.8 mm Spunbonded Olefin: PET/PE 10 10
E 171.5 mm × 301.6 mm Paper: PET/PE 10 10
10. Report
F 171.5 mm × 301.6 mm Paper: PET/PE 10 10
G 114.3 mm × 222.3 mm Paper: PET/PE 10 10
10.1 The report should include or have traceability to the
H 235.0 mm × 350.9 mm Paper: PET/PE 10 10
following:
A
All dimensions provided are nominal dimensions of width× length in millimeters,
10.1.1 Test performed (open or closed package), apparatus
measured as internal dimensions from seal to seal within the packages tested.All
used,testdevicemachinesettingschosenifoperatoradjustable
packagestestedaremedicalgradepeelablesealpoucheswith15degreechevron
style seal configuration. Materials listed are spunbonded olefin (1073B grade
(rate of pressurization and sensitivity of pressure drop detec-
Tyvek) or medical grade paper sealed to PET/PE (polyester/polyethylene) or
tion sensor), gap distance between restraining plates, and
PET/PP (polyester/polypropylene) laminated structures.
blocking agent used (see Appendix X4).
10.1.2 Packaging material types and other characteristics of
package tested, that is, whether with or without package
TABLE 2 Summary of Interlaboratory Test Results by Package
contents inside the package, seal type and configuration, etc., Set
package lot number and source’s name.
Standard
Deviation Within Lab Between Lab
10.2 Include the date, time, location, and identification of
of Lab to Repeatability Reproducibility
the individual performing the test. The number of packages Lab Standard Standard
Package Average Averages, Deviation, Deviation,
tested, the individual test values, and the units of measure that
Set kPa kPa COV% kPa COV% kPa COV%
the sensing device is set to return as response values. Docu-
A 14.78 0.7221 4.89 % 1.3931 9.43 % 1.5060 10.19 %
mentation also may include notations of failure mode, area of
B 18.58 1.5550 8.37 % 1.8825 10.13 % 2.3660 12.73 %
seal package failure, unusual test conditions and results. C 17.73 1.1346 6.40 % 1.5945 8.99 % 1.8910 10.66 %
D 15.73 0.8591 5.46 % 2.7499 17.48 % 2.7499 17.48 %
10.3 The conditioning parameters and environmental con-
E 10.54 0.6198 5.88 % 0.8477 8.04 % 1.0153 9.63 %
F 9.06 0.8294 9.16 % 0.5974 6.60 % 1.0045 11.09 %
ditions used at the time of test, if applicable.
G 12.17 1.2560 10.32 % 1.5828 13.01 % 1.9576 16.09 %
10.4 A summary including comments or conclusions, the H 8.84 0.4847 5.48 % 0.4197 4.75 % 0.6273 7.10 %
sample mean and standard deviation, should also be reported
where appropriate.
TABLE 3 Summary of Interlaboratory Test Results, Average COV
for all Materials
11. Precision and Bias
3 Coefficient of Variation Basis Average Value, %
11.1 Aresearchreport describesaroundrobinconductedin
Lab to lab averages 6.99
1999 in accordance with Practice E691, involving ten labora-
Within lab repeatability 9.80
tories testing four package sets for each of two material types.
Between lab reproducibility 11.87
Materials tested are listed in Table 1 and statistical results are
listed in Table 2 and Table 3.All samples were prepared at one
source and then distributed to each of the laboratories partici-
able to the materials used. In addition, the selection of test
pating in the study. Each laboratory performed ten replicate
tests for each package set. All testing was conducted using parameters (flow rate, plate gap height, pressure drop sensor
sensitivity, etc.) for an
...

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