ASTM F2391-22
(Test Method)Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
SIGNIFICANCE AND USE
5.1 The vacuum, bubble test method, as described in Test Method D3078, and various other leak detection methods described elsewhere (Test Method D4991, Guide E432, Test Method E493, Test Method E498, Test Method E499, and Test Method E1603) have been successfully used widely in various industries and applications to determine that a given package is or is not a “leaker.” The sensitivity of any selected leak test method has to be considered to determine its applicability to a specific situation.
5.2 The procedures presented in this test method allow the user to carry out package and seal integrity testing with sufficient sensitivity to quantify seals in the previously defined moderate to fine seal ranges.
5.3 By employing seal-isolating leak testing fixtures, packages constructed of various materials can be tested in the full range of seal performance requirements. Design of these fixtures is beyond the scope of this method.
5.4 These seal/package integrity test procedures can be utilized as:
5.4.1 A design tool,
5.4.2 For tooling qualification,
5.4.3 Process setup,
5.4.4 Process validation tool,
5.4.5 Quality assurance monitoring, or
5.4.6 Research and development.
SCOPE
1.1 This test method includes several procedures that can be used for the measurement of overall package and seal barrier performance of a variety of package types and package forms, as well as seal/closure types. The basic elements of this method include:
1.1.1 Helium (employed as tracer gas),
1.1.2 Helium leak detector (mass spectrometer), and
1.1.3 Package/product-specific test fixtures.
1.1.4 Most applications of helium leak detection are destructive, in that helium needs to be injected into the package after the package has been sealed. The injection site then needs to be sealed/patched externally, which often destroys its saleability. Alternatively, if helium can be incorporated into the headspace before sealing, the method can be non-destructive because all that needs to be accomplished is to simply detect for helium escaping the sealed package.
1.2 Two procedures are described; however the supporting data in Section 14 only reflects Procedure B (Vacuum Mode). The alternative, Sniffer Mode, has proven to be a valuable procedure for many applications, but may have more variability due to exactly the manner that the operator conducts the test such as whether the package is squeezed, effect of multiple small leaks compared to fewer large leaks, background helium concentration, package permeability and speed at which the scan is conducted. Further testing to quantify this procedure’s variability is anticipated, but not included in this version.
1.2.1 Procedure A: Sniffer Mode—the package is scanned externally for helium escaping into the atmosphere or fixture.
1.2.2 Procedure B: Vacuum Mode—the helium containing package is placed in a closed fixture. After drawing a vacuum, helium escaping into the closed fixture (capture volume) is detected. Typically, the fixtures are custom made for the specific package under test.
1.3 The sensitivity of the method can range from the detection of:
1.3.1 Large leaks—10-2 Pa·m 3/s to 10-5 Pa·m3/s (10–1 cc/sec/atm to 10-4 cc/sec/atm).
1.3.2 Moderate leaks—10-5 Pa·m 3/s to 10-7 Pa·m3/s (10-4 cc/sec/atm to 10-6 cc/sec/atm).
1.3.3 Fine leaks—10-7 Pa·m 3/s to 10-9 Pa·m3/s (10-6 cc/sec/atm to 10-8 cc/sec/atm).
1.3.4 Ultra-Fine leak—10-9 Pa·m 3/s to 10-11 Pa·m3/s (10-8 cc/sec/atm to 10-10 cc/sec/atm).
Note 1: Conversion from cc/sec/atm to Pa·m3/s is achieved by multiplying by 0.1.
1.4 The terms large, moderate, fine and ultra-fine are relative terms only and do not imply the acceptability of any leak rate. The individual application dictates the level of integrity needed. For many packaging applications, only “large leaks” are considered unacceptable and the ability to detect smaller leaks is immaterial. All leak rates referred...
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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: F2391 − 22
Standard Test Method for
Measuring Package and Seal Integrity Using Helium as the
1
Tracer Gas
This standard is issued under the fixed designation F2391; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.3 The sensitivity of the method can range from the
detection of:
1.1 Thistestmethodincludesseveralproceduresthatcanbe
-2 3 -5 3 –1
1.3.1 Large leaks—10 Pa·m /s to 10 Pa·m /s (10
used for the measurement of overall package and seal barrier
-4
cc/sec/atm to 10 cc/sec/atm).
performance of a variety of package types and package forms,
-5 3 -7 3 -4
1.3.2 Moderate leaks—10 Pa·m /s to 10 Pa·m /s (10
aswellasseal/closuretypes.Thebasicelementsofthismethod
-6
cc/sec/atm to 10 cc/sec/atm).
include:
-7 3 -9 3 -6
1.3.3 Fineleaks—10 Pa·m /sto10 Pa·m /s(10 cc/sec/
1.1.1 Helium (employed as tracer gas),
-8
atm to 10 cc/sec/atm).
1.1.2 Helium leak detector (mass spectrometer), and
-9 3 -11 3 -8
1.3.4 Ultra-Fine leak—10 Pa·m /s to 10 Pa·m /s (10
1.1.3 Package/product-specific test fixtures. -10
cc/sec/atm to 10 cc/sec/atm).
1.1.4 Most applications of helium leak detection are
3
NOTE 1—Conversion from cc/sec/atm to Pa·m /s is achieved by
destructive,inthatheliumneedstobeinjectedintothepackage
multiplying by 0.1.
afterthepackagehasbeensealed.Theinjectionsitethenneeds
1.4 The terms large, moderate, fine and ultra-fine are rela-
to be sealed/patched externally, which often destroys its
tive terms only and do not imply the acceptability of any leak
saleability.Alternatively,ifheliumcanbeincorporatedintothe
rate. The individual application dictates the level of integrity
headspace before sealing, the method can be non-destructive
needed. For many packaging applications, only “large leaks”
because all that needs to be accomplished is to simply detect
are considered unacceptable and the ability to detect smaller
for helium escaping the sealed package.
leaksisimmaterial.Allleakratesreferredtointhismethodare
1.2 Two procedures are described; however the supporting
based on conversion of actual conditions (based on partial
data in Section 14 only reflects Procedure B (Vacuum Mode).
pressureofhelium)tooneatmospherepressuredifferentialand
The alternative, Sniffer Mode, has proven to be a valuable
standard temperature conditions.
procedure for many applications, but may have more variabil-
1.5 Themethodmayhaveapplicabilitytoanypackagetype:
ityduetoexactlythemannerthattheoperatorconductsthetest
1.5.1 Flexible, semi-rigid, or rigid.
such as whether the package is squeezed, effect of multiple
1.5.2 Permeable or impermeable.
small leaks compared to fewer large leaks, background helium
concentration, package permeability and speed at which the 1.5.3 Packages comprised of both permeable and imperme-
able components, for example, formed aluminum blisters and
scan is conducted. Further testing to quantify this procedure’s
variability is anticipated, but not included in this version. other high barrier aluminum packaging, cartridges, and sy-
ringes.
1.2.1 Procedure A: Sniffer Mode—the package is scanned
externally for helium escaping into the atmosphere or fixture.
1.6 The sensitivities reported in the supporting data for this
1.2.2 Procedure B: Vacuum Mode—the helium containing
method pertain to the detectability of helium emanating from
package is placed in a closed fixture.After drawing a vacuum,
the sample and are not a function of the packaging form.
helium escaping into the closed fixture (capture volume) is
1.7 The method is not applicable to breathable or porous
detected. Typically, the fixtures are custom made for the
packaging.
specific package under test.
1.8 The results obtained can be qualitative, semi-
quantitative or quantitative depending on the procedure used.
1
1.9 Testfixturedesignisnotwithinthescopeofthismethod
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onPrimary
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
excepttonotethatdifferentdesignswillbeneededfordifferent
Package Integrity.
applications (which have different package types and package
Current edition approved Nov. 15, 2022. Published December 2022. Originally
integrity requirements). Furthermore, the fixture selection and
approved in 2005. Last previous edition approved in 2016 as F2391 – 05 (2016).
DOI: 10.1520/F2391-22. design will be based on where the testing is to be conducted
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700,
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2391 − 05 (Reapproved 2016) F2391 − 22
Standard Test Method for
Measuring Package and Seal Integrity Using Helium as the
1
Tracer Gas
This standard is issued under the fixed designation F2391; 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
1.1 This test method includes several procedures that can be used for the measurement of overall package and seal barrier
performance of a variety of package types and package forms, as well as seal/closure types. The basic elements of this method
include:
1.1.1 Helium (employed as tracer gas),
1.1.2 Helium leak detector (mass spectrometer), and
1.1.3 Package/product-specific test fixtures.
1.1.4 Most applications of helium leak detection are destructive, in that helium needs to be injected into the package after the
package has been sealed. The injection site then needs to be sealed/patched externally, which often destroys its saleability.
Alternatively, if helium can be incorporated into the headspace before sealing, the method can be non-destructive because all that
needs to be accomplished is to simply detect for helium escaping the sealed package.
1.2 Two procedures are described; however the supporting data in Section 14 only reflects Procedure B (Vacuum Mode). The
alternative, Sniffer Mode, has proven to be a valuable procedure for many applications, but may have more variability due to
exactly the manner that the operator conducts the test such as whether the package is squeezed, effect of multiple small leaks
compared to fewer large leaks, background helium concentration, package permeability and speed at which the scan is conducted.
Further testing to quantify this procedure’s variability is anticipated, but not included in this version.
1.2.1 Procedure A: Sniffer Mode—the package is scanned externally for helium escaping into the atmosphere or fixture.
1.2.2 Procedure B: Vacuum Mode—the helium containing package is placed in a closed fixture. After drawing a vacuum, helium
escaping into the closed fixture (capture volume) is detected. Typically, the fixtures are custom made for the specific package under
test.
1.3 The sensitivity of the method can range from the detection of:
-2 3 -5 3 –1 -4
1.3.1 Large leaks—10 Pa·m /s to 10 Pa·m /s (10 cc/sec/atm to 10 cc/sec/atm).
1
This test method is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
Package Integrity.
Current edition approved April 1, 2016Nov. 15, 2022. Published April 2016December 2022. Originally approved in 2005. Last previous edition approved in 20112016
as F2391 – 05(2011). 05 (2016). DOI: 10.1520/F2391-05R16.10.1520/F2391-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2391 − 22
-5 3 -7 3 -4 -6
1.3.2 Moderate leaks—10 Pa·m /s to 10 Pa·m /s (10 cc/sec/atm to 10 cc/sec/atm).
-7 3 -9 3 -6 -8
1.3.3 Fine leaks—10 Pa·m /s to 10 Pa·m /s (10 cc/sec/atm to 10 cc/sec/atm).
-9 3 -11 3 -8 -10
1.3.4 Ultra-Fine leak—10 Pa·m /s to 10 Pa·m /s (10 cc/sec/atm to 10 cc/sec/atm).
3
NOTE 1—Conversion from cc/sec/atm to Pa·m /s is achieved by multiplying by 0.1.
1.4 The terms large, moderate, fine and ultra-fine are relative terms only and do not imply the acceptability of any leak rate. The
individual application dictates the level of integrity needed. For many packaging applications, only “large leaks” are considered
unacceptable and the ability to detect smaller leaks is immaterial. All leak rates referred to in this method are based on conversion
of actual conditions (based on partial pressure of helium) to one atmosphere pressure differential and standard temperature
conditions.
1.5 The method may have applicability to any package type:
1.5.1 Flexible, semi-rigid, or rigid.
1.5.2 Semi-rigid,Permeable or impermeable.
1.5.3 Rigid.Packages comprised of both permeable and impermeable components, for example, formed aluminum blisters and
other high barrier aluminum packaging, cartridges, and syringes.
1.6 The sensitivities reported in the supporting data for this method pertain to the detectability of helium emanating from the
sample and are not a function of the packaging form.
1.7 The method is not appli
...
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