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This test method covers the detection of gross leaks in medical packaging. It may be used for tray and pouch packages of medical devices.

The internal pressurization test method provides a practical way to examine packages for gross leaks, which may render the product non-sterile. What so call “Bubble” test method is extremely useful in a test laboratory environment where no common package material/size exists. Gross Leak “Bubble” 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.

While detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) the package is inflated underwater to a predetermined pressure. The package is then observed for a steady stream of air bubbles indicating a failure area.