ASTM F2096-01

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
• Technical Committee: F02 - Primary Barrier Packaging

Relations

• Replaced By: ASTM F2096-01e1 - 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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.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.
Designation: F 2096 – 01
Standard Test Method for
Detecting Gross Leaks in Porous Medical Packaging by
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. Scope pressure. The package is then observed for a steady stream of
air bubbles indicating a failure area.
1.1 This test method covers the detection of gross leaks in
4.2 The sensitivity of this test method is dependent on the
porous packages with one package side using Tyvek spun-
differential pressure and method of pressurization. Establish-
bonded polyolefin. Method sensitivity is down to 250 μm with
ment of a test pressure for each package material/size is critical
a 81 % probability (see Section 11). This test method may be
for obtaining repeatable results (see Annex A1 for the proce-
used for tray and pouch packages.
dure on establishing test pressure). Inadequate pressurization
1.2 This test method has not been evaluated for use with
of the package can significantly reduce the sensitivity of this
porous materials other than spunbonded polyolefin or with
test method. Higher differential pressures will increase the test
nonporous packaging.
sensitivity. However, excessive pressurization of the package
1.3 This test method is destructive in that it requires entry
may rupture seals or cause misinterpretation of bubble patterns
into the package to supply an internal air pressure
emanating from porous packaging. This may result in an
1.4 The values stated in SI units are to be regarded as the
erroneous conclusion regarding the presence or absence of
standard. The values given in parentheses are for information
package defects. While not required, use of a bleed-off control
only.
valve in line with the pressure monitoring device, will aid in
1.5 This standard does not purport to address all of the
stabilizing the test pressure, and help eliminate excessive
safety concerns, if any, associated with its use. It is the
pressurization of the package (see Fig. 1).
responsibility of the user of this standard to establish appro-
4.3 Two different test methods are presented for the testing
priate safety and health practices and determine the applica-
of porous and nonporous packaging. The key difference
bility of regulatory limitations prior to use.
between the test methods (as described in Annex A1) is in
2. Referenced Documents
allowing time for the water to saturate the porous material.
2.1 ASTM Standards:
5. Significance and Use
D 1898 Practice for Sampling of Plastics
5.1 The internal pressurization test method provides a prac-
F 1327 Terminology Relating to Barrier Materials for Medi-
3 tical way to examine packages for gross leaks, which may
cal Packaging
render the product non-sterile.
3. Terminology 5.2 This test method is extremely useful in a test laboratory
environment where no common package material/size exists.
3.1 Definitions—General terms relating to barrier materials
5.3 This test method may apply to very large or long
for medical packaging are found in Terminology F 1327.
packages, which do not fit into any other package integrity test
3.2 Definitions of Terms Specific to This Standard:
method apparatus.
3.2.1 breathing point pressure, n—pressure at which perme-
5.4 This test method may be used as a means to evaluate
ation of air through the porous material begins.
package integrity. Package integrity is crucial to consumer
4. Summary of Test Method
safety since heat sealed packages are designed to provide a
contamination free and sterile environment to the product.
4.1 The package is inflated underwater to a predetermined
6. Apparatus
This test method is under the jurisdiction of ASTM Committee F02 on Flexible
6.1 Pressure Delivery System, with pressure monitoring
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on
gage, and bleed-off control valve, capable of delivering air at a
Medical Packaging.
Current edition approved April 10, 2001. Published June 2001.
pressure of 0–50 mbar (0–20 in. H O).
Annual Book of ASTM Standards, Vol 08.01.
6.2 Device for Puncturing Package, (for example, small
Annual Book of ASTM Standards, Vol 15.09.
4 slotted screwdriver or other appropriate device) to allow
All porous packaging by definition will permit the passage of air. At a given
insertion of air source and pressure monitoring device.
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
6.3 Water Container, adequate to cover the test specimen
pressure than the breathing pressure point may indicate a defect in the packaging.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 2096
TABLE 1 Percent Correct by Laboratory and Defect Type
Defect Type
Pouch Tray
No 125-μm 250-μm 125-μm 250-μm No 125-μm 250-μm Percent Correct
Laboratory
Defects Channel Channel Puncture Puncture Defects Puncture Puncture by Laboratory
1 100 100 90 60 80 100 40 90 82.50
2 100 70 90 50 60 90 10 100 71.25
3 80 20 80 60 80 90 60 80 68.75
4 100 70 90 0 0 100 60 100 65.00
5 80 20 100 0 30 100 20 90 55.00
Percent Correct
92 56 90 34 50 96 38 92
by Defect
FIG. 1 Sample Test Apparatus
with approximately one (1) in. of H O. one (1) in. Start airflow into the package.
NOTE 2—It may be helpful to use a fixture to keep the entire package
7. Sampling
submerged at the proper depth.
7.1 The number of test specimens shall be chosen to permit
9.1.3 Adjust the airflow and bleed-off valve as necessary to
an adequate determination of representative performance.
slowly inflate the package to a value equal to or greater than the
Practice D 1898 provides guidance for test speciman selection.
minimum test pressure as established in accordance with
8. Conditioning
Annex A1. Adjust the bleed-off valve and pressure regulator as
necessary to maintain constant pressure.
8.1 No special conditioning of the specimen is required.
9.1.4 Thoroughly inspect the package for a constant stream
9. Procedure
of bubbles indicating a specific area of failure (seal channels,
pinholes, cracks, tears, and so forth). Inspection time will vary
NOTE 1—The establishment of a test pressure in accordance with
Annex A1 must be performed prior to initiating the test procedure. depending on package size.
9.1.5 Remove the package from water and mark any ob-
9.1 Test Method A—Procedure for Nonporous Packaging:
served area(s) of failure.
9.1.1 Create a hole in the package using a puncturing device
9.2 Test Method B—Procedure for Porous Packaging:
(for example, small slotted screwdriver or other appropriate
9.2.1 Apply blocking agent to samples if required in accor-
device) for inserting the air source and pressure monitor into
dance with A1.1.2.4.
the control sample. Create the hole as close to the center of the
package as possible. The hole size should allow insertion of the 9.2.2 Create a hole in the package using a puncturing device
air source and pressure monitor with minimal air leakage. Use (for example, small slotted screwdriver or other appropriate
tape or a rubber disk as a septum over the puncture site to seal device) for inserting the air source and pressure monitor into
the insertion site if necessary. the control sample. Create the hole as close to the center of the
9.1.2 Insert the air source and pressure monitor into the test package as possible. The hole size should allow insertion of the
specimen. Submerge the package under water approximately air source and pressure monitor with minimal air leakage. Use
F 2096
tape or a rubber disk as a septum over the puncture site to seal 11. Precision and Bias
the insertion site if necessary.
11.1 A round-robin study was conducted in 2000, which
9.2.3 Insert the air source and pressure monitor into the
included 5 laboratories, two package types, and two defect
package. Submerge the package under water approximately 1
types. The defects consisted of a channel through the seal area
in. and hold for a minimum of 5 s. Start the airflow into the
on the pouch samples and a puncture through the porous
package.
material, on both the tray and pouch samples. All defect sample
NOTE 3—It may be helpful to use a fixture to keep the entire package
groups were created with a 125-μm (0.005 in.) and 250-μm
submerged at the proper depth.
(0.010 in.) wire. The first package type consisted ofa4by 6-in.
9.2.4 Adjust the airflow and bleed-off valve as necessary to
heat-sealed pouch, made from a combination clear film and
slowly inflate the package to a value equal to or greater than the
uncoated Tyvek. The second package type consisted ofa3by
minimum test pressure as established in accordance with
5-in. thermoformed polycarbonate tray, heat-sealed w
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