ASTM F 2227 Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method

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ASTM F 2227 Document Information:

Title
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method

ASTM International

Publication Date:
Dec 10, 2002

Scope:

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

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:

carbon dioxide (CO2) leak testing

flexible packaging

infrared CO2 sensor

medical package integrity test

nondestructive 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

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