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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D996 Terminology of Packaging and Distribution Environments
F1327 Terminology Relating to Barrier Materials for Medical Packaging
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)
ASTM International is a member of CrossRef.
Citing ASTM Standards
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