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  • ASTM
    F2228-13(2021) Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
    Edition: 2021
    $78.62
    Unlimited Users per year

Description of ASTM-F2228 2021

ASTM F2228-13-Reapproved2021

Active Standard: Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method




ASTM F2228

Scope

1.1 This non-destructive test method detects leaks in non-porous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as small as 100 μm (0.004 in.) diameter in the seal as well as 50 μm (0.002 in.) diameter pinholes, or equivalently sized cracks in the tray, subject to trace gas concentration in the package, package design and manufacturing tolerances.

Note 1: This test method does not claim to challenge the porous (breathable) lidding material. Any defects that may exist in the porous portion of the package will not be detected by this test method.

1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.

1.3 This 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.

1.4 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.


Keywords

basal flow; carbon dioxide (CO2) leak testing; flexible packaging; infrared CO2 sensor; medical packaging; non-destructive testing; package integrity monitoring; package integrity test; pass/fail criteria; pass/fail levels; permeable packaging; pinhole leaks; porous barrier; porous lids; porous packaging; rigid thermoformed trays; sealing membrane performance; seal integrity monitoring; seal integrity test; seal leaks; sterile integrity tests; trace gas leak testing;


ICS Code

ICS Number Code 11.020 (Medical sciences and health care facilities in general)


DOI: 10.1520/F2228-13R21

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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