ASTM F2095-07e1

Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates

SIGNIFICANCE AND USE
These test methods provide a rapid, simple to apply method to detect small leaks in flexible package seals or walls at the leak rate level of greater than 1 × 10−4 sccs, thus providing a measure of package integrity. Porous barrier film packages made non-porous with an impermeable film forming coating may demonstrate lateral leakage through the barrier material. Verification of leakage differences from background leakage must be included in validation methods. The use of calibrated hole sizes or orifices may be appropriate to determine leakage sensitivity or barrier integrity for these materials.
While theoretical leak rate sensitivity can be established by calculation, the test measurement is in pressure units and the measuring instrument must be calibrated, certified, and verified with these units.
The pressure decay method of leak testing is a physical measure of package integrity. When testing medical packaging which must conform to ISO 11607–1: 2006 standards, it may necessary to verify the results of the pressure decay test method with other sterile package integrity test methods.
Test Method A allows packages to be pressurized without restraint. In Test Method A the pouch, tray, or other type package will contain a volume of air defined by its mechanical configuration and its ability to resist internal pressure applied. This test method requires that the package reach a stable volume configuration (stop stretching) to make a measurement.
Test Method B allows the use of rigid restraining plates against the walls of the package to limit its volume and stabilize the package volume.
SCOPE
1.1 These test methods cover the measurement of leaks in nonporous film, foil, or laminate flexible pouches and foil-sealed trays, which may be empty or enclose solid product. If product is enclosed, seals or surfaces cannot be in contact with water, oils, or other liquid.
1.2 These test methods will detect leaks at a rate of 1 × 10−4 sccs (standard cubic centimetres per second) or greater, in flexible packages. The limitation of leak rate is dependent on package volume as tested.
1.3 The following test methods are included:
1.3.1 Test Method A—Pressure Decay Leak Test for Flexible Packages Without Restraining Plates
1.3.2 Test Method B—Pressure Decay Leak Test for Flexible Packages With Restraining Plates
1.4 These test methods are destructive in that they require entry into the package to supply an internal pressure of gas, typically air or nitrogen, although other gases may be used. The entry connection into the flexible package must be leak-tight.
1.5 For porous packages, see 9.3.
1.6 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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2007
• ICS: 19.060 - Mechanical testing
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.40 - Package Integrity

Relations

• Replaces: ASTM F2095-07 - Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
• Effective Date: 01-Oct-2007
• Referred By: ASTM E3336-22 - Standard Test Method for Physical Integrity Testing of Single-Use Systems
• Effective Date: 01-Oct-2007
• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 01-Oct-2007

Standards Content (Sample)

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
´1
Designation: F2095 − 07
StandardTest Methods for
Pressure Decay Leak Test for Flexible Packages With and
1
Without Restraining Plates
This standard is issued under the fixed designation F2095; 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
´ NOTE—Added research report reference to Section 11 editorially in March 2008.
1. Scope Packaging Components for Testing
E177Practice for Use of the Terms Precision and Bias in
1.1 These test methods cover the measurement of leaks in
ASTM Test Methods
nonporous film, foil, or laminate flexible pouches and foil-
E691Practice for Conducting an Interlaboratory Study to
sealed trays, which may be empty or enclose solid product. If
Determine the Precision of a Test Method
product is enclosed, seals or surfaces cannot be in contact with
F17Terminology Relating to Flexible Barrier Packaging
water, oils, or other liquid.
2.2 Other Document:
−4
1.2 Thesetestmethodswilldetectleaksatarateof1×10
ANSI/AAMI/ISO11607–1:2006Packaging for Terminally
sccs (standard cubic centimetres per second) or greater, in
Sterilized Medical Devices—Part 1: Requirements for
flexible packages. The limitation of leak rate is dependent on
Materials, Sterile Barrier Systems, and Packaging Sys-
package volume as tested.
3
tems
1.3 The following test methods are included:
3. Terminology
1.3.1 Test Method A—PressureDecayLeakTestforFlexible
Packages Without Restraining Plates
3.1 Definitions of Terms Specific to This Standard:
1.3.2 Test Method B—PressureDecayLeakTestforFlexible
3.1.1 integrity—the unimpaired physical condition of the
Packages With Restraining Plates
package. This implies that there are no leaks in the seals or
body materials.
1.4 These test methods are destructive in that they require
entry into the package to supply an internal pressure of gas,
3.1.2 leak—See Terminology F17.
typicallyairornitrogen,althoughothergasesmaybeused.The
3.1.3 nonporous—types of materials that are not purposely
entry connection into the flexible package must be leak-tight.
designed to transfer gases through their matrix.
1.5 For porous packages, see 9.3.
3.1.4 restraining plates—plates of rigid material, for
1.6 This standard does not purport to address all of the
example, aluminum, that are used to restrict the movement of
safety concerns, if any, associated with its use. It is the the package during inflation.
responsibility of the user of this standard to establish appro-
3.1.5 seal—See Terminology F17.
priate safety and health practices and determine the applica-
3.1.6 standard cubic centimetre per second (sccs)—theflow
bility of regulatory limitations prior to use.
rate of a gas (air) at standard conditions of 20°C (68°F) and
101.3 kPa (14.7 psig) (1 atmosphere or 760 mm Hg).
2. Referenced Documents
3.1.6.1 Discussion—Conditions may be varied depending
2
2.1 ASTM Standards:
on the source of data.Always check the definition being used.
D4332Practice for Conditioning Containers, Packages, or
4. Summary of Test Method
4.1 Detection of leak paths in flexible packages that have
1
These test methods are under the jurisdiction of ASTM Committee F02 on
nonporous material surfaces and seals can be accomplished by
FlexibleBarrierPackagingandarethedirectresponsibilityofSubcommitteeF02.40
on Package Integrity. pressurization of the package to a fixed pressure, shutting off
Current edition approved Oct. 1, 2007. Published November 2007. Originally
the pressure and connecting a pressure transducer. Observed
approved in 2001. Last previous edition approved in 2001 as F2095–01. DOI:
changes in pressure indicate the presence of leakage paths in
10.1520/F2095-07E01.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2095 − 07
the package seals or pinholes in the surfaces.This leak may be 5.4 Test Method A allows packages to be pressurized
represented in decay pressure units or calculated leak rate without restraint. In Test Method A the pouch, tray, or other
units. To accomplish this technique, a leak-tight measuring type package will contain a volume of air defined by its
path must be available between the package interior volume me
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
e1
Designation:F2095–01 Designation:F2095–07
Standard Test Methods for
Pressure Decay Leak Test for Nonporous Flexible Packages
1
With and Without Restraining Plates
This standard is issued under the fixed designation F2095; 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 (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Added research report reference to Section 11 editorially in March 2008.
1. Scope
1.1 These test methods cover the measurement of leaks in nonporous film, foil, or laminate flexible pouches and foil-sealed
trays, which may be empty or enclose solid product. If product is enclosed, seals or surfaces cannot be in contact with water, oils,
or other liquid.
−4
1.2 Thesetestmethodswilldetectleaksatarateof1 310 sccs(standardcubiccentimetrespersecond)orgreater,inflexible
packages. The limitation of leak rate is dependent on package volume as tested.
1.3 The following test methods are included:
1.3.1 Test Method A— Pressure Decay Leak Test for Nonporous Flexible Packages Without Restraining Plates
1.3.2 Test Method B— Pressure Decay Leak Test for Nonporous Flexible Packages With Restraining Plates
1.4 Thesetestmethodsaredestructiveinthattheyrequireentryintothepackagetosupplyaninternalpressureofgas,typically
air or nitrogen, although other gases may be used. The entry connection into the flexible package must be leak-tight.
1.5
1.5 For porous packages, see 9.3.
1.6 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.
2. Referenced Documents
2.1 ASTM Standards:
2
D1898 Practice for Sampling of Plastics ASTM Standards:
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F17Terminology Relating to Flexible Barrier Packaging
F1327Terminology Relating to Barrier Materials for Medical Packaging Terminology Relating to Flexible Barrier Packaging
2.2 Other Document:
ANSI/AAMI/ISO 11607Packaging for Terminally Sterilized Medical DevicesANSI/AAMI/ISO11607–1:2006 Packaging for
3
TerminallySterilizedMedicalDevices—Part1:RequirementsforMaterials,SterileBarrierSystems,andPackagingSystems
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 integrity—the unimpaired physical condition of the package. This implies that there are no leaks in the seals or body
materials.
3.1.2 leak—See Terminology F1327—See Terminology F17.
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ThesetestmethodsareunderthejurisdictionofASTMCommitteeF02onFlexibleBarrierMaterialsandarethedirectresponsibilityofSubcommitteeF02.40onPackage
Integrity.
Current edition approved April 10, 2001. Published June 2001.
1
These test methods are under the jurisdiction of ASTM Committee F02 on Flexible Barrier Packaging and are the direct responsibility of Subcommittee F02.40 on
Package Integrity.
Current edition approved Oct. 1, 2007. Published November 2007. Originally approved in 2001. Last previous edition approved in 2001 as F2095–01.
2
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,[e-mail] Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2095–07
3.1.3 nonporous—types of materials that are not purposely designed to transfer gases through their matrix.
3.1.4 restraining plates—platesofrigidmaterial,forexample,aluminum,thatareusedtorestrictthemovementofthepackage
during inflation.
3.1.5 seal—See Terminology F17.
3.1.6 standard cubic centimetre per second (sccs)—the flow rate of a gas (air) at standard conditions of 20°C (68°F) and 101.3
kPa (14.7 psig) (1 atmosphere or 760 mm Hg).
3.1.6.1 Discussion—Conditions may be varied depending on the source of data. Always check the definition being use
...