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ASTM F2391-05(2011)

(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 D3078, and various other leak detection methods described elsewhere (Test Method D4991, Guide E432, Guide E479, 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.
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:
A design tool,  
For tooling qualification,  
Process setup,  
Process validation tool,  
Quality assurance monitoring, or
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:

General Information

Status
Historical
Publication Date
31-Mar-2011
ICS
55.040 - Packaging materials and accessories
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.40 - Package Integrity
Current Stage
Ref Project

Relations

Replaces
ASTM F2391-05 - Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
Effective Date
01-Apr-2011
Referred By
ASTM E3336-22 - Standard Test Method for Physical Integrity Testing of Single-Use Systems
Effective Date
01-Apr-2011
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Apr-2011

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ASTM F2391-05(2011) - Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer GasASTM F2391-05(2011) - Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
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ASTM F2391-05(2011) - Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
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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(Reapproved 2011)
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
destructive,inthatheliumneedstobeinjectedintothepackage
NOTE 1—Conversion from cc/sec/atm to Pa·m /s is achieved by
multiplying by 0.1.
afterthepackagehasbeensealed.Theinjectionsitethenneeds
to be sealed/patched externally, which often destroys its
1.4 The terms large, moderate, fine and ultra-fine are rela-
saleability.Alternatively,ifheliumcanbeincorporatedintothe
tive terms only and do not imply the acceptability of any leak
headspace before sealing, the method can be non-destructive
rate. The individual application dictates the level of integrity
because all that needs to be accomplished is to simply detect
needed. For many packaging applications, only “large leaks”
for helium escaping the sealed package.
are considered unacceptable and the ability to detect smaller
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-
ityduetoexactlythemannerthattheoperatorconductsthetest
1.5 Themethodmayhaveapplicabilitytoanypackagetype:
such as whether the package is squeezed, effect of multiple
1.5.1 Flexible,
small leaks compared to fewer large leaks, background helium
1.5.2 Semi-rigid, or
concentration, package permeability and speed at which the
1.5.3 Rigid.
scan is conducted. Further testing to quantify this procedure’s
variability is anticipated, but not included in this version.
1.6 The sensitivities reported in the supporting data for this
1.2.1 Procedure A: Sniffer Mode—the package is scanned method pertain to the detectability of helium emanating from
externally for helium escaping into the atmosphere or fixture. the sample and are not a function of the packaging form.
1.2.2 Procedure B: Vacuum Mode—the helium containing
1.7 The method is not applicable to breathable or porous
package is placed in a closed fixture.After drawing a vacuum,
packaging.
helium escaping into the closed fixture (capture volume) is
1.8 The results obtained can be qualitative, semi-
detected. Typically, the fixtures are custom made for the
quantitative or quantitative depending on the procedure used.
specific package under test.
1.9 Testfixturedesignisnotwithinthescopeofthismethod
excepttonotethatdifferentdesignswillbeneededfordifferent
1
applications (which have different package types and package
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
integrity requirements). Furthermore, the fixture selection and
Package Integrity.
design will be based on where the testing is to be conducted
Current edition approved April 1, 2011. Published April 2011. Originally
within the manufacturing process (in other words, quality
approved in 2005. Last previous edition approved in 2005 as F2391 – 05. DOI:
10.1520/F2391-05R11. control versus research).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2391 − 05 (2011)
1.10 This standard does not purport to address all of the 3.2.3 fine leaks—For the purpose of this test method, leaks
-7 3
safety concerns
...

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SCOPE
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Standard Test Method for Abrasion Resistance of Flexible Packaging Films Using a Reciprocating Weighted Stylus

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1.1 This test method covers determination of the amount of residual solvents released from within a packaging material contained in a sealed vial under a given set of time and temperature conditions and is a recommended alternative for Test Method F151.  
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ASTM F34-13(2023)(Practice)
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5.1 Knowledge of extractives from flexible barrier materials may serve many useful purposes. A test cell constructed as described in this practice may be used for obtaining such data. Another test cell has been found equivalent to the one described in this practice. See the appendix for the source of the alternate cell.  
5.2 United States Federal Regulations 21CFR 176.170 (d)(3), 21CFR 177.1330 (e)(4), 21CFR 177.1360 (b), 21CFR 177.1670 (b), and 21CFR Appendix VI (b) cite this standard practice as the basis for determining the amount of extractables from the surface of a package or multilayer film or modified paper in contact with food. In some cases, it is the only practice defined for this purpose. No alternative detail is given in the regulations for conducting extractions.  
5.3 Test Method D4754 is not an equivalent to this test method. It is for two-sided extraction of films having the same material on both of the exposed surfaces of the film.
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1.1 This practice covers the construction of test cells which may be used for the extraction of components from flexible barrier materials by suitable extracting liquids, including foods and food simulating solvents.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
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ASTM F2391-22(Test Method)
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:  
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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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