ASTM F2095-07(2013)

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 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: 31-Jul-2013
• ICS: 19.060 - Mechanical testing
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.40 - Package Integrity

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
Designation: F2095 − 07 (Reapproved 2013)
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 ASTM Test Methods
E691Practice for Conducting an Interlaboratory Study to
1.1 These test methods cover the measurement of leaks in
Determine the Precision of a Test Method
nonporous film, foil, or laminate flexible pouches and foil-
F17Terminology Relating to Flexible Barrier Packaging
sealed trays, which may be empty or enclose solid product. If
2.2 Other Document:
product is enclosed, seals or surfaces cannot be in contact with
ANSI/AAMI/ISO11607–1:2006Packaging for Terminally
water, oils, or other liquid.
Sterilized Medical Devices—Part 1: Requirements for
−4
1.2 Thesetestmethodswilldetectleaksatarateof1×10
Materials, Sterile Barrier Systems, and Packaging Sys-
sccs (standard cubic centimetres per second) or greater, in
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tems
flexible packages. The limitation of leak rate is dependent on
package volume as tested.
3. Terminology
1.3 The following test methods are included:
3.1 Definitions of Terms Specific to This Standard:
1.3.1 Test Method A—PressureDecayLeakTestforFlexible
3.1.1 integrity—the unimpaired physical condition of the
Packages Without Restraining Plates
package. This implies that there are no leaks in the seals or
1.3.2 Test Method B—PressureDecayLeakTestforFlexible
body materials.
Packages With Restraining Plates
3.1.2 leak—See Terminology F17.
1.4 These test methods are destructive in that they require
3.1.3 nonporous—types of materials that are not purposely
entry into the package to supply an internal pressure of gas,
designed to transfer gases through their matrix.
typicallyairornitrogen,althoughothergasesmaybeused.The
3.1.4 restraining plates—plates of rigid material, for
entry connection into the flexible package must be leak-tight.
example, aluminum, that are used to restrict the movement of
1.5 For porous packages, see 9.3.
the package during inflation.
1.6 This standard does not purport to address all of the
3.1.5 seal—See Terminology F17.
safety concerns, if any, associated with its use. It is the
3.1.6 standard cubic centimetre per second (sccs)—theflow
responsibility of the user of this standard to establish appro-
rate of a gas (air) at standard conditions of 20°C (68°F) and
priate safety and health practices and determine the applica-
101.3 kPa (14.7 psig) (1 atmosphere or 760 mm Hg).
bility of regulatory limitations prior to use.
3.1.6.1 Discussion—Conditions may be varied depending
2. Referenced Documents on the source of data.Always check the definition being used.
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2.1 ASTM Standards:
4. Summary of Test Method
D4332Practice for Conditioning Containers, Packages, or
4.1 Detection of leak paths in flexible packages that have
Packaging Components for Testing
nonporous material surfaces and seals can be accomplished by
E177Practice for Use of the Terms Precision and Bias in
pressurization of the package to a fixed pressure, shutting off
the pressure and connecting a pressure transducer. Observed
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These test methods are under the jurisdiction of ASTM Committee F02 on
changes in pressure indicate the presence of leakage paths in
FlexibleBarrierPackagingandarethedirectresponsibilityofSubcommitteeF02.40
the package seals or pinholes in the surfaces.This leak may be
on Package Integrity.
represented in decay pressure units or calculated leak rate
Current edition approved Aug. 1, 2013. Published September 2013. Originally
approved in 2001. Last previous edition approved in 2007 as F2095–07. DOI:
units. To accomplish this technique, a leak-tight measuring
10.1520/F2095-07R13.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
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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.
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F2095 − 07 (2013)
path must be available between the package interior volume pressure applied. This test method requires that the package
and the pressure transducer (see Fig. 1). reachastablevolumeconfiguration(stopstretching)tomakea
measurement.
NOTE 1—The coating used on porous barrier films will mask defect
...