ASTM F2096-02e1

Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

SCOPE
1.1 This test method covers the detection of gross leaks in medical packaging. Method sensitivity is down to 250 μm with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages.
1.2 The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefin or with nonporous packaging.
1.3 This test method is destructive in that it requires entry into the package to supply an internal air pressure
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.5 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: 09-Apr-2002
• ICS: 19.060 - Mechanical testing
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging

Relations

• Replaces: ASTM F2096-02 - Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• Effective Date: 10-Apr-2002
• Replaced By: ASTM F2096-04 - Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• Effective Date: 01-Apr-2004
• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 10-Apr-2002

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
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Designation: F 2096 – 02
Standard Test Method for
Detecting Gross Leaks in Medical Packaging by Internal
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Pressurization (Bubble Test)
This standard is issued under the fixed designation F 2096; 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.
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e NOTE—The captions for Figs. 1 and 2 were switched editorially in March 2004 in order to correct them.
1. Scope 4. Summary of Test Method
1.1 This test method covers the detection of gross leaks in 4.1 The package is inflated underwater to a predetermined
medical packaging. Method sensitivity is down to 250 μm with pressure. The package is then observed for a steady stream of
an 81 % probability (see Section 11). This test method may be air bubbles indicating a failure area.
used for tray and pouch packages. 4.2 The sensitivity of this test method is dependent on the
1.2 The sensitivity of this test method has not been evalu- differential pressure and method of pressurization. Establish-
ated for use with porous materials other than spunbonded ment of a test pressure for each package material/size is critical
polyolefin or with nonporous packaging. for obtaining repeatable results (see Annex A1 for the proce-
1.3 This test method is destructive in that it requires entry dure on establishing test pressure). Inadequate pressurization
into the package to supply an internal air pressure of the package can significantly reduce the sensitivity of this
1.4 The values stated in SI units are to be regarded as the test method. Higher differential pressures will increase the test
standard. The values given in parentheses are for information sensitivity. However, excessive pressurization of the package
only. may rupture seals or cause misinterpretation of bubble patterns
1.5 This standard does not purport to address all of the emanating from porous packaging. This may result in an
safety concerns, if any, associated with its use. It is the erroneous conclusion regarding the presence or absence of
responsibility of the user of this standard to establish appro- package defects. While not required, use of a bleed-off control
priate safety and health practices and determine the applica- valve in line with the pressure monitoring device, will aid in
bility of regulatory limitations prior to use. stabilizing the test pressure, and help eliminate excessive
pressurization of the package (see Fig. 1).
2. Referenced Documents
4.3 Two different test methods are presented for the testing
2.1 ASTM Standards:
of porous and nonporous packaging. The key difference
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D 1898 Practice for Sampling of Plastics between the test methods (as described in Annex A1) is in
F 1327 Terminology Relating to Barrier Materials for Medi-
allowing time for the water to saturate the porous material.
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cal Packaging
5. Significance and Use
3. Terminology
5.1 The internal pressurization test method provides a prac-
3.1 Definitions—General terms relating to barrier materials tical way to examine packages for gross leaks, which may
for medical packaging are found in Terminology F 1327. render the product non-sterile.
3.2 Definitions of Terms Specific to This Standard:
5.2 This test method is extremely useful in a test laboratory
3.2.1 breathing point pressure, n—pressure at which perme- environment where no common package material/size exists.
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ation of air through the porous material begins.
5.3 This test method may apply to very large or long
packages, which do not fit into any other package integrity test
method apparatus.
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This test method is under the jurisdiction of ASTM Committee F02 on Flexible
5.4 This test method may be used as a means to evaluate
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on
package integrity. Package integrity is crucial to consumer
Medical Packaging.
Current edition approved April 10, 2002. Published June 2002. Originally safety since heat sealed packages are designed to provide a
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published as F 2096 – 01. Last previous edition F 2096 – 01 .
contamination free and sterile environment to the product.
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Annual Book of ASTM Standards, Vol 08.01.
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Annual Book of ASTM Standards, Vol 15.09.
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All porous packaging by definition will permit the passage of air. At a given
internal pressure it will therefore exhibit an emanating stream of air bubbles
dependent on the pore size. A stream of bubbles identified at a lower internal
pressure than the breathing pressure point may indicate a defect in the packaging.
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