Bubble Leak Testing

Bubble leak testing per ASTM F2096 can be used for non-permeable and most permeable materials such as paper and Tyvek. The test method is destructive and is intended to determine sterile barrier integrity of an otherwise sealed package.

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Industry Application

Bubble leak testing is a whole-package integrity test. It is typically performed as part of a validation activity, such as a sealer validation, transit validation, or shelf life validation. ASTM F2096 bubble leak testing has a claimed sensitivity of approximately 250 microns. It is performed by submerging the package in water, inflating the package with air while it is underwater, and observing for a steady stream of bubbles emanating from the package, indicating a breach of the sterile barrier.