ASTM F2391-05
(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
The vacuum, bubble test method, as described in Test Method D 3078, and various other leak detection methods described elsewhere (Test Method D 4991, Guide E 432, Guide E 479, Test Method E 493, Test Method E 498, Test Method E 499, and Test Method E 1603) 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.
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 very fine seal ranges.
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.
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 procedures 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 Pam 3/s to 10-5 Pam3/s (10-1 cc/sec/atm to 10-4 cc/sec/atm).
1.3.2 Moderate leaks-10-5 Pam 3/s to 10-7 Pam3/s (10-4 cc/sec/atm to 10-6 cc/sec/atm).
1.3.3 Fine leaks-10-7 Pam 3/s to 10-9 Pam3/s (10-6 cc/sec/atm to 10-8 cc/sec/atm).
1.3.4 Ultra-Fine leak-10-9 Pam 3/s to 10-11 Pam3/s (10-8 cc/sec/atm to 10-10 cc/sec/atm).
Note 1—Conversion from cc/sec/atm to Pam3/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 c...
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2391–05
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 detected. Typically, the fixtures are custom made for the
specific package under test.
1.1 This test method includes several procedures that can be
1.3 The sensitivity of the method can range from the
used for the measurement of overall package and seal barrier
detection of:
performance of a variety of package types and package forms,
-2 3 -5 3 –1
1.3.1 Large leaks—10 Pa·m /s to 10 Pa·m /s (10 cc/
aswellasseal/closuretypes.Thebasicelementsofthismethod
-4
sec/atm to 10 cc/sec/atm).
include:
-5 3 -7 3 -4
1.3.2 Moderate leaks—10 Pa·m /s to 10 Pa·m /s (10
1.1.1 Helium (employed as tracer gas),
-6
cc/sec/atm to 10 cc/sec/atm).
1.1.2 Helium leak detector (mass spectrometer), and
-7 3 -9 3 -6
1.3.3 Fine leaks—10 Pa·m /s to 10 Pa·m /s (10 cc/sec/
1.1.3 Package/product-specific test fixtures.
-8
atm to 10 cc/sec/atm).
1.1.4 Most applications of helium leak detection are de-
-9 3 -11 3 -8
1.3.4 Ultra-Fine leak—10 Pa·m /s to 10 Pa·m /s (10
structive, in that helium needs to be injected into the package
-10
cc/sec/atm to 10 cc/sec/atm).
after the package has been sealed.The injection site then needs
3
to be sealed/patched externally, which often destroys its
NOTE 1—Conversion from cc/sec/atm to Pa·m /s is achieved by mul-
saleability.Alternatively, if helium can be incorporated into the
tiplying by 0.1.
headspace before sealing, the method can be non-destructive
1.4 The terms large, moderate, fine and ultra-fine are rela-
because all that needs to be accomplished is to simply detect
tive terms only and do not imply the acceptability of any leak
for helium escaping the sealed package.
rate. The individual application dictates the level of integrity
1.2 Two procedures are described; however the supporting
needed. For many packaging applications, only “large leaks”
data in Section 14 only reflects Procedure B (Vacuum Mode).
are considered unacceptable and the ability to detect smaller
The alternative, Sniffer Mode, has proven to be a valuable
leaks is immaterial.All leak rates referred to in this method are
procedure for many applications, but may have more variabil-
based on conversion of actual conditions (based on partial
ityduetoexactlythemannerthattheoperatorconductsthetest
pressure of helium) to one atmosphere pressure differential and
such as whether the package is squeezed, effect of multiple
standard temperature conditions.
small leaks compared to fewer large leaks, background helium
1.5 Themethodmayhaveapplicabilitytoanypackagetype:
concentration, package permeability and speed at which the
1.5.1 Flexible,
scan is conducted. Further testing to quantify this procedure’s
1.5.2 Semi-rigid, or
variability is anticipated, but not included in this version.
1.5.3 Rigid.
1.2.1 Procedure A: Sniffer Mode—the package is scanned
1.6 The sensitivities reported in the supporting data for this
externally for helium escaping into the atmosphere or fixture.
method pertain to the detectability of helium emanating from
1.2.2 Procedure B: Vacuum Mode— the helium containing
the sample and are not a function of the packaging form.
package is placed in a closed fixture.After drawing a vacuum,
1.7 The method is not applicable to breathable or porous
helium escaping into the closed fixture (capture volume) is
packaging.
1.8 The results obtained can be qualitative, semi-
quantitative or quantitative depending on the procedure used.
1
This test method is under the jurisdiction ofASTM Committee F02 on Flexible
1.9 Testfixturedesignisnotwithinthescopeofthismethod
Barrier Materials and is the direct responsibility of Subcommittee F02.40 on
excepttonotethatdifferentdesignswillbeneededfordifferent
Package Integrity.
applications (which have different package types and package
Current edition approved April 1, 2005. Published May 2005. DOI: 10.1520/
F2391-05. integrity requirements). Furthermore, the fixture selection and
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2391–05
design will be based on where the testing is to be conducted 3.2.2 breathable/porous packaging—Packages, in whole or
within the manufacturing process (in other words, quality in part, that intentionally allow gases/vapors to flow freely into
control versus research). and out of the package. (See also Terminology F1327)
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