ASTM F2096-01e1

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 m 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

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 F2096-01 - Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• Effective Date: 10-Apr-2002
• Replaced By: ASTM F2096-02 - Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• Effective Date: 10-Apr-2002
• 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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: F 2096 – 01
Standard Test Method for
Detecting Gross Leaks in Porous Medical Packaging by
1
Internal 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.
1
e NOTE—References to Figs. 1 and 2 were corrected editorially in November 2001.
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
porous packages with one package side using Tyvek spun- pressure. The package is then observed for a steady stream of
bonded polyolefin. Method sensitivity is down to 250 μm with air bubbles indicating a failure area.
a 81 % probability (see Section 11). This test method may be 4.2 The sensitivity of this test method is dependent on the
used for tray and pouch packages. differential pressure and method of pressurization. Establish-
1.2 This test method has not been evaluated for use with ment of a test pressure for each package material/size is critical
porous materials other than spunbonded polyolefin or with for obtaining repeatable results (see Annex A1 for the proce-
nonporous packaging. dure on establishing test pressure). Inadequate pressurization
1.3 This test method is destructive in that it requires entry of the package can significantly reduce the sensitivity of this
into the package to supply an internal air pressure test method. Higher differential pressures will increase the test
1.4 The values stated in SI units are to be regarded as the sensitivity. However, excessive pressurization of the package
standard. The values given in parentheses are for information may rupture seals or cause misinterpretation of bubble patterns
only. emanating from porous packaging. This may result in an
1.5 This standard does not purport to address all of the erroneous conclusion regarding the presence or absence of
safety concerns, if any, associated with its use. It is the package defects. While not required, use of a bleed-off control
responsibility of the user of this standard to establish appro- valve in line with the pressure monitoring device, will aid in
priate safety and health practices and determine the applica- stabilizing the test pressure, and help eliminate excessive
bility of regulatory limitations prior to use. pressurization of the package (see Fig. 1).
4.3 Two different test methods are presented for the testing
2. Referenced Documents
of porous and nonporous packaging. The key difference
2.1 ASTM Standards:
between the test methods (as described in Annex A1) is in
2
D 1898 Practice for Sampling of Plastics allowing time for the water to saturate the porous material.
F 1327 Terminology Relating to Barrier Materials for Medi-
3
5. Significance and Use
cal Packaging
5.1 The internal pressurization test method provides a prac-
3. Terminology
tical way to examine packages for gross leaks, which may
3.1 Definitions—General terms relating to barrier materials
render the product non-sterile.
for medical packaging are found in Terminology F 1327. 5.2 This test method is extremely useful in a test laboratory
3.2 Definitions of Terms Specific to This Standard:
environment where no common package material/size exists.
3.2.1 breathing point pressure, n—pressure at which perme- 5.3 This test method may apply to very large or long
4
ation of air through the porous material begins.
packages, which do not fit into any other package integrity test
method apparatus.
5.4 This test method may be used as a means to evaluate
1
This test method is under the jurisdiction of ASTM Committee F02 on Flexible
package integrity. Package integrity is crucial to consumer
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on
safety since heat sealed packages are designed to provide a
Medical Packaging.
Current edition approved April 10, 2001. Published June 2001.
contamination free and sterile environment to the product.
2
Annual Book of ASTM Standards, Vol 08.01.
3
Annual Book of ASTM Standards, Vol 15.09.
6. Apparatus
4
All porous packaging by definition will permit the passage of air. At a given
6.1 Pressure Delivery System, with pressure monitoring
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
gage, and bleed-off control valve, capable of delivering air at a
pressure than the breathing pressure point may indicate a defect in the packaging.
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