ASTM F 2391 : 2022
Current
The latest, up-to-date edition.
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
Hardcopy , PDF
English
30-11-2022
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
F 02
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| DocumentType |
Test Method
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| Pages |
7
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| PublisherName |
American Society for Testing and Materials
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| Status |
Current
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| Supersedes |
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, semi-rigid, or rigid.
1.5.2Permeable or impermeable.
1.5.3Packages comprised of both permeable and impermeable components, for example, formed aluminum blisters and other high barrier aluminum packaging, cartridges, and syringes.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.11This 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.
| ASTM E 3336 : 2022 | Standard Test Method for Physical Integrity Testing of Single-Use Systems |
| ASTM F 2097 : 2020 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| ASTM D 996 : 2023 | Standard Terminology of Packaging and Distribution Environments |
| ASTM D 996 : 2016 | Standard Terminology of Packaging and Distribution Environments |
| ASTM E 691 : 2023 | 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 D 4991 : 2007 : R2023 | Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method |
| ASTM D 4991 : 2007 : R2015 | Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method |
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