ASTM F2228-02(2007)
Historical Standard: ASTM F2228-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO 2 Tracer Gas Method
SUPERSEDED (see Active link, below)
ASTM F2228
1. 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 m (0.004 in.) diameter in the seal as well as 50 m (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 1This 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 units. Values in parentheses are for information only.
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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
D996 Terminology of Packaging and Distribution Environments
F17 Terminology Relating to Flexible Barrier Packaging
F1327 Terminology Relating to Barrier Materials for Medical Packaging
Keywords
basal flow; carbon dioxide (CO 2 ) leak testing; flexible packaging; infrared CO 2 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); 19.100 (Non-destructive testing)
DOI: 10.1520/F2228-02R07
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