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ASTM F 2391 : 2005 : R2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
Available format(s)

Hardcopy , PDF

Superseded date

03-12-2022

Language(s)

English

Published date

27-04-2016

CONTAINED IN VOL. 15.09, 2016 Defines 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.

1.1This 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:

1.1.1Helium (employed as tracer gas),

1.1.2Helium leak detector (mass spectrometer), and

1.1.3Package/product-specific test fixtures.

1.1.4Most 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.

1.2Two 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.

1.2.1Procedure A: Sniffer Mode—the package is scanned externally for helium escaping into the atmosphere or fixture.

1.2.2Procedure 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.

1.3The sensitivity of the method can range from the detection of:

1.3.1Large leaks—10-2 Pa·m 3/s to 10-5 Pa·m3/s (10–1 cc/sec/atm to 10-4 cc/sec/atm).

1.3.2Moderate leaks—10-5 Pa·m 3/s to 10-7 Pa·m3/s (10-4 cc/sec/atm to 10-6 cc/sec/atm).

1.3.3Fine leaks—10-7 Pa·m 3/s to 10-9 Pa·m3/s (10-6 cc/sec/atm to 10-8 cc/sec/atm).

1.3.4Ultra-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.

1.4The 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.

1.5The method may have applicability to any package type:

1.5.1Flexible,

1.5.2Semi-rigid, or

1.5.3Rigid.

1.6The 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.

1.7The method is not applicable to breathable or porous packaging.

1.8The results obtained can be qualitative, semi-quantitative or quantitative depending on the procedure used.

1.9Test fixture design is not within the scope of this method except to note that different designs will be needed for different applications (which have different package types and package integrity requirements). Furthermore, the fixture selection and design will be based on where the testing is to be conducted within the manufacturing process (in other words, quality control versus research).

1.10This 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 and health practices and determine the applicability of regulatory limitations prior to use.

Committee
F 02
DocumentType
Test Method
Pages
7
ProductNote
Reconfirmed 2016
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 2097 : 2020 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM E 3336 : 2022 Standard Test Method for Physical Integrity Testing of Single-Use Systems
ASTM F 2097 : 2016 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

ASTM D 3078 : 2002 : R2021 : EDT 1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM F 1327 : 2005 Standard Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007)
ASTM E 432 : 1991 : R2017 : EDT 1 Standard Guide for Selection of a Leak Testing Method
ASTM D 4991 : 1994 : R1999 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method
ASTM D 3078 : 1994 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM E 1603 : 1999 Standard Test Methods for Leakage Measurement Using the Mass Spectrometer Leak Detector or Residual Gas Analyzer in the Hood Mode
ASTM E 432 : 1991 : R2022 Standard Guide for Selection of a Leak Testing Method
ASTM D 3078 : 2002 : R2013 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM E 691 : 2020 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 996 : 2016 : REDLINE Standard Terminology of Packaging and Distribution Environments
ASTM E 493 : 2006 Standard Test Methods for Leaks Using the Mass Spectrometer Leak Detector in the Inside-Out Testing Mode
ASTM E 691 : 2019 : EDT 1 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2022 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2009 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 4991 : 2007 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method
ASTM D 3078 : 2002 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D 4991 : 2007 : R2015 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method
ASTM E 691 : 2021 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 3078 : 2002 : R2008 : EDT 1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D 3078 : 2002 : R2008 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D 996 : 2010 Standard Terminology of Packaging and Distribution Environments
ASTM F 1327 : 1998 Standard Terminology Relating to Barrier Materials for Medical Packaging

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