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ASTM International - ASTM F2228-13(2021)

Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO 2 Tracer Gas Method

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Organization: ASTM International
Publication Date: 15 January 2021
Status: active
Page Count: 5
ICS Code (Medical sciences and health care facilities in general): 11.020
ICS Code (Non-destructive testing): 19.100
significance And Use:

5.1 Harmful biological or particulate contaminants may enter the package through incomplete seals or imperfections such as pinholes or cracks in the trays.

5.2 After initial instrument... View More

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.

Document History

ASTM F2228-13(2021)
January 15, 2021
Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
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...
August 1, 2013
Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
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...
April 1, 2007
Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
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...
December 10, 2002
Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
DESIG: F2228 02 ^TITLE: Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO 2 Tracer Gas Method ^SCOPE: 1. Scope 1.1...
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