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ASTM F2096-11(2019)

(Test Method)

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

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

SIGNIFICANCE AND USE
5.1 The internal pressurization test method provides a practical way to examine packages for gross leaks.  
5.2 This test method is extremely useful in a test laboratory environment where no common package material/size exists.  
5.3 This test method may apply to large or long packages that do not fit into any other package integrity test method apparatus.  
5.4 This test method may be used as a means to evaluate package integrity. Package integrity is crucial to consumer safety since heat sealed packages are designed to provide a contamination free or sterile environment, or both, to the product.  
5.5 This test method may be used to detect substrate holes and channels.
SCOPE
1.1 This test method covers the detection of gross leaks in packaging. Method sensitivity is down to 250 μm (0.010 in.) 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 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.

General Information

Status
Published
Publication Date
31-Oct-2019
ICS
19.060 - Mechanical testing
55.040 - Packaging materials and accessories
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.40 - Package Integrity
Current Stage
Ref Project

Relations

Refers
ASTM F17-17 - Standard Terminology Relating to Primary Barrier Packaging
Effective Date
01-Jun-2017
Refers
ASTM F17-18 - Standard Terminology Relating to Primary Barrier Packaging
Effective Date
15-Aug-2018
Refers
ASTM F17-18a - Standard Terminology Relating to Primary Barrier Packaging
Effective Date
01-Oct-2018
Refers
ASTM F17-20 - Standard Terminology Relating to Primary Barrier Packaging
Effective Date
01-May-2020
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Nov-2019

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ASTM F2096-11(2019) - Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)ASTM F2096-11(2019) - Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
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ASTM F2096-11(2019) - Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
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Standards Content (Sample)

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
1
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
3
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
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.
1
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
...

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SCOPE
1.1 This practice covers the sampling of air for a variety of common pesticides and polychlorinated biphenyls (PCBs) and provides guidance on the selection of appropriate analytical measurement methods. Other compounds such as polychlorinated dibenzodioxins/furans, polybrominated biphenyls, polybrominated diphenyl ethers, polycyclic aromatic hydrocarbons, and polychlorinated naphthalenes may be efficiently collected from air by this practice, but guidance on their analytical determination is not covered by this practice.  
1.2 The sampling and analysis of PCBs in air can be more complicated than sampling PCBs in solid media (for example, soils, building materials) or liquids (for example, transformer fluids). PCBs in solid or liquid material are typically analyzed using Aroclor2 distillation groups in chromatograms. In contrast, recent research has shown that analysis of PCBs in air samples by GC-ECD has also been found to exhibit potential uncertainties due to changes in the PCB patterns, differences in responses in distillation groups, peak co-elutions and differences in response factors within a homolog group (1, 2).3 As such it is recommended that PCBs in air not be quantified using AroclorTM distillation groups. In addition, it is recommended that analysis of PCBs in air be done using GC-MS rather than GC-ECD. Any mention, to outdated practices for “Aroclor” and GC-ECD analysis of PCBs herein are retained solely for historical perspective.  
1.3 A complete listing of pesticides and other semivolatile organic chemicals for which this practice has been tested is shown in Table 1.  
1.4 This practice is based on the collection of chemicals from air onto polyurethane foam (PUF) or a combination of PUF and granular sorbent (for example, diphenyl oxide, styrene-divinylbenzene), or a granular sorbent alone.  
1.5 This practice is applicable to multicomponent atmospheres, 0.001 μg/m3 to 50 μg/m3 concentrations, and 4 h to 24 h sampling periods. The limit of detection will depend on the nature of the analyte and the length of the sampling period.  
1.6 The analytical method(s) recommended will depend on the specific chemical(s) sought, the concentration level, and the degree of specificity required.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. For specific hazards statements, see 10.24 and A1.1.  
1.9 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.

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