ASTM F2096-11(2019)

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: F2096 − 11 (Reapproved 2019)
Standard Test Method for
Detecting Gross Leaks in Packaging by Internal
Pressurization (Bubble Test)
This standard is issued under the fixed designation F2096; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 Definitions of Terms Specific to This Standard:
3.2.1 breathing point pressure, n—pressure at which perme-
1.1 This test method covers the detection of gross leaks in
ation of air through the porous material begins.
packaging. Method sensitivity is down to 250 µm (0.010 in.)
with an 81 % probability (see Section 11). This test method
4. Summary of Test Method
may be used for tray and pouch packages.
4.1 The package is inflated underwater to a predetermined
1.2 The sensitivity of this test method has not been evalu-
pressure. The package is then observed for a steady stream of
ated for use with porous materials other than spunbonded
air bubbles indicating a failure area.
polyolefin or with nonporous packaging.
4.2 The sensitivity of this test method is dependent on the
1.3 This test method is destructive in that it requires entry
differential pressure and method of pressurization. Establish-
into the package to supply an internal air pressure
ment of a test pressure for each package material/size is critical
1.4 The values stated in SI units are to be regarded as the
for obtaining repeatable results (see Annex A1 for the proce-
standard. The values given in parentheses are for information
dure on establishing test pressure). Inadequate pressurization
only.
of the package can significantly reduce the sensitivity of this
test method. Higher differential pressures will increase the test
1.5 This standard does not purport to address all of the
sensitivity. However, excessive pressurization of the package
safety concerns, if any, associated with its use. It is the
may rupture seals or cause misinterpretation of bubble patterns
responsibility of the user of this standard to establish appro-
emanating from porous packaging. This may result in an
priate safety, health, and environmental practices and deter-
erroneous conclusion regarding the presence or absence of
mine the applicability of regulatory limitations prior to use.
package defects. While not required, use of a bleed-off control
1.6 This international standard was developed in accor-
valve in line with the pressure monitoring device, will aid in
dance with internationally recognized principles on standard-
stabilizing the test pressure, and help eliminate excessive
ization established in the Decision on Principles for the
pressurization of the package (see Fig. 1).
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
4.3 Two different test methods are presented for the testing
Barriers to Trade (TBT) Committee.
of porous and nonporous packaging. The key difference
between the test methods (as described in Annex A1)isin
2. Referenced Documents
allowing time for the water to saturate the porous material.
2.1 ASTM Standards:
F17 Terminology Relating to Primary Barrier Packaging
5. Significance and Use
5.1 The internal pressurization test method provides a prac-
3. Terminology
tical way to examine packages for gross leaks.
3.1 Definitions—General terms relating to barrier materials
5.2 This test method is extremely useful in a test laboratory
for medical packaging are found in Terminology F17.
environment where no common package material/size exists.
5.3 This test method may apply to large or long packages
This test method is under the jurisdiction ofASTM Committee F02 on Primary
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
that do not fit into any other package integrity test method
Package Integrity.
apparatus.
Current edition approved Nov. 1, 2019. Published December 2019. Originally
approved in 2001. Last previous edition approved in 2011 as F2096–11. DOI:
10.1520/F2096-11R19.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or All porous packaging by definition will permit the passage of air. At a given
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM internal pressure it will therefore exhibit an emanating stream of air bubbles
Standards volume information, refer to the standard’s Document Summary page on dependent on the pore size. A stream of bubbles identified at a lower internal
the ASTM website. pressure than the breathing pressure point may indicate a defect in the packaging.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2096 − 11 (2019)
FIG. 1 Sample Test Apparatus
5.4 This test method may be used as a means to evaluate 8. Conditioning
package integrity. Package integrity is crucial to consumer
8.1 No special conditioning of the specimen is required.
safety since heat sealed packages are designed to provide a
9. Procedure
contamination free or sterile environment, or both, to the
NOTE2—TheestablishmentofatestpressureinaccordancewithAnnex
product.
A1 must be performed prior to initiating the test procedure. It is
5.5 This test method may be used to detect substrate holes
recommended that a sample test set-up be provided.
and channels.
9.1 Test Method A—Procedure for Nonporous Packaging:
9.1.1 Create a hole in the package using a puncturing device
6. Apparatus
for inserting the air source and pressure monitor into the
6.1 Pressure Delivery System, with pressure monitoring
control sample. Create the hole wherever it is most efficient to
gage, and bleed-off control valve, capable of delivering air at a
observe defects without obscuring any pre-existing defects or
pressure of 0-50 mbar (0-20 in. H O).
creating defects in the inner package during the puncturing
process. The hole size should allow insertion of the air source
6.2 Device for Puncturing Package, device to allow inser-
and pressure monitor with minimal air leakage. Use tape or a
tion of air source and pressure monitoring device.
rubber disk as a septum over the puncture site to seal the
6.3 Water Container, adequate to cover the test specimen
insertion site if necessary.
with approximately 25.4 mm (1 in.) of water.
9.1.2 Insert the air source and pressure monitor into the test
NOTE 1—It may be beneficial for observation of the test specimen and
specimen. Submerge the package approximately 1 in. under
for interpretation of results to perform the testing in a water container that
water. Start airflow into the package.
has at least one transparent side.
NOTE 3—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. slowlyinflatethepackagetoavalueequaltoorgreaterthanthe
F2096 − 11 (2019)
minimum test pressure as established in accordance with 9.2.6 Remove the package from the water and mark any
AnnexA1.Adjust the bleed-off valve and pressure regulator as observed area(s) of failure.
necessary to maintain constant pressure.
10. Report
9.1.4 Thoroughly inspect one side of the package facing
upwards for a constant stream of bubbles indicating a specific
10.1 Report the following information:
area of failure (seal channels, pinholes, cracks, tears, and so
10.1.1 Date and operator’s name or initials.
forth). Then repeat the process by rotating the package 180º so
10.1.2 Package type and any applicable traceable identifi-
the opposite side of the package is facing upwards. Inspection
cation numbers.
time will vary depending on package size.
10.1.3 Established defect size used to establish the test
9.1.5 Remove the package from water and mark any ob-
sensitivity, test pressure, and use of any blocking agent.
served area(s) of failure.
10.1.4 Number of test packages, number of packages that
passed, number of packages exhibiting leaks, and location of
9.2 Test Method B—Procedure for Porous Packaging:
each leak
9.2.1 Apply blocking agent to samples if required in accor-
10.1.5 Record the instrument used to create the opening of
dance with A1.1.2.4.
the package.
9.2.2 Create a hole in the package using a puncturing device
for inserting the air source and pressure monitor into the
11. Precision and Bias
control sample. Create the hole wherever it is most efficient to
observe defects without obscuring any pre-existing defects or
11.1 A round-robin study was conducted in 2000, which
creating defects in the inner package during the puncturing
included 5 laboratories, two package types, and two defect
process. The hole size should allow insertion of the air source
types. The defects consisted of a channel through the seal area
and pressure monitor with minimal air leakage. Use tape or a
on the pouch samples and a puncture through the porous
rubber disk as a septum over the puncture site to seal the
material,onboththetrayandpouchsamples.Alldefectsample
insertion site if necessary.
groups were created with a 125-µm (0.005 in.) and 250-µm
9.2.3 Insert the air source and pressure monitor into the
(0.010in.)wire.Thefirstpackagetypeconsistedofa4by6-in.
package.Submergethepackageapproximately25.4mm(1in.)
heat-sealed pouch, made from a combination clear film and
under water with the porous part of the package in the up
uncoated Tyvek. The second package type consisted ofa3by
position (if one side is porous) and hold for a minimum of 5 s.
5-in. thermoformed p
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