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Scope

DESIG: F2228 02 ^TITLE: Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method ^SCOPE:

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.

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 units. Values in parentheses are for information only.

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.

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 Number Code 11.020 (Medical sciences and health care facilities in general); 19.100 (Non-destructive testing)

To find similar documents by ASTM Volume:

15.10 (Packaging; Flexible Barrier Packaging)

To find similar documents by classification:

11.020 (Medical sciences and health care facilities in general Including quality and environmental management in health care technology IT application in health care technology, see 35.240.80)

19.100 (Non-destructive testing Including testing equipment: industrial apparatus for X-ray and gamma radiography, penetrant flaw detectors, etc. Non-destructive testing of welded joints, see 25.160.40 Industrial radiographic films, see 37.040.25 Non-destructive testing of metals, see 77.040.20)

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