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Scope

1.1 This non-destructive test method detects pinhole leaks in trays, as small as 50 m (0.002 in.) in diameter, or equivalently sized cracks, subject to trace gas concentration in the tray, tray design and manufacturing tolerances.

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.

Significance and Use

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

After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation.

Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.

This non-destructive test method may be performed in either laboratory or production environments and may be undertaken on either a 100 % or a statistical sampling basis. This test method, in single instrument use and current implementation, may not be fast enough to work on a production packaging line, but is well suited for statistical testing as well as package developmental design work.

Keywords

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