Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
The internal pressurization test method provides a practical way to examine packages for gross leaks, which may render the product non-sterile.
This test method is extremely useful in a test laboratory environment where no common package material/size exists.
This test method may apply to very large or long packages, which do not fit into any other package integrity test method apparatus.
This test method may be used as a means to evaluate package integrity. Package integrity is crucial to consumer safety since heat sealed packages are designed to provide a contamination free and sterile environment to the product.
1.1 This test method covers the detection of gross leaks in medical packaging. Method sensitivity is down to 250 μm with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages.
1.2 The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefin or with nonporous packaging.
1.3 This test method is destructive in that it requires entry into the package to supply an internal air pressure
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.5 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.
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