ASTM F2095-07(2021)

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

SIGNIFICANCE AND USE
5.1 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.  
5.2 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.  
5.3 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.  
5.4 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.  
5.5 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 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.  
1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 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.

General Information

• Status: Published
• Publication Date: 14-Jan-2021
• 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

• Refers: ASTM F17-20 - Standard Terminology Relating to Primary Barrier Packaging
• Effective Date: 01-May-2020

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: F2095 − 07 (Reapproved 2021)
Standard Test Methods for
Pressure Decay Leak Test for Flexible Packages With and
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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. Scope 2. Referenced Documents
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1.1 These test methods cover the measurement of leaks in
2.1 ASTM Standards:
nonporous film, foil, or laminate flexible pouches and foil-
D4332Practice for Conditioning Containers, Packages, or
sealed trays, which may be empty or enclose solid product. If
Packaging Components for Testing
product is enclosed, seals or surfaces cannot be in contact with
E177Practice for Use of the Terms Precision and Bias in
water, oils, or other liquid.
ASTM Test Methods
−4
E691Practice for Conducting an Interlaboratory Study to
1.2 Thesetestmethodswilldetectleaksatarateof1×10
Determine the Precision of a Test Method
sccs (standard cubic centimetres per second) or greater, in
F17Terminology Relating to Primary Barrier Packaging
flexible packages. The limitation of leak rate is dependent on
package volume as tested.
2.2 Other Document:
ANSI/AAMI/ISO11607–1:2006Packaging for Terminally
1.3 The following test methods are included:
Sterilized Medical Devices—Part 1: Requirements for
1.3.1 Test Method A—PressureDecayLeakTestforFlexible
Materials, Sterile Barrier Systems, and Packaging Sys-
Packages Without Restraining Plates
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tems
1.3.2 Test Method B—PressureDecayLeakTestforFlexible
Packages With Restraining Plates
3. Terminology
1.4 These test methods are destructive in that they require
3.1 Definitions of Terms Specific to This Standard:
entry into the package to supply an internal pressure of gas,
typicallyairornitrogen,althoughothergasesmaybeused.The 3.1.1 integrity, n—the unimpaired physical condition of the
entry connection into the flexible package must be leak-tight. package. This implies that there are no leaks in the seals or
body materials.
1.5 For porous packages, see 9.3.
3.1.2 leak, n—see Terminology F17.
1.6 The values stated in SI units are to be regarded as
standard. The values given in parentheses after SI units are
3.1.3 nonporous, adj—types of materials that are not pur-
providedforinformationonlyandarenotconsideredstandard.
posely designed to transfer gases through their matrix.
1.7 This standard does not purport to address all of the
3.1.4 restraining plates, n—plates of rigid material, for
safety concerns, if any, associated with its use. It is the
example, aluminum, that are used to restrict the movement of
responsibility of the user of this standard to establish appro-
the package during inflation.
priate safety, health, and environmental practices and deter-
3.1.5 seal, n—see Terminology F17.
mine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accor-
3.1.6 standard cubic centimetre per second (sccs), n—the
dance with internationally recognized principles on standard-
flow rate of a gas (air) at standard conditions of 20°C (68°F)
ization established in the Decision on Principles for the
and 101.3 kPa (14.7 psig) (1 atmosphere or 760 mm Hg).
Development of International Standards, Guides and Recom-
3.1.6.1 Discussion—Conditions may be varied depending
mendations issued by the World Trade Organization Technical
on the source of data.Always check the definition being used.
Barriers to Trade (TBT) Committee.
1 2
These test methods are under the jurisdiction of ASTM Committee F02 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
PrimaryBarrierPackagingandarethedirectresponsibilityofSubcommitteeF02.40 contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
on Package Integrity. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Jan. 15, 2021. Published February 2021. Originally the ASTM website.
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approved in 2001. Last previous edition approved in 2013 as F2095–07 (2013). Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
DOI: 10.1520/F2095-07R21. 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 (2021)
4. Summary of Test Method 5.3 The pressure decay method of leak testing is a physical
measure of packag
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