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Gross Leak Detection / Bubble Test

This test is conducted by submerging a lightly pressurized package under water to visually inspect for streams of bubbles that identify a leak or defect in both porous and non-porous packaging systems.

Bubble testing is a widely used qualitative method of determining defects or gross leaks in sterile medical device packaging.

Primary packages or Sterile Barrier Systems are subjected to this test to determine if their ability to maintain a sterile barrier has been compromised by tears, holes, or improper seals. Properly applied in a package validation test plan (within guidelines of ANSI/AAMI/ISO 11607) this method has significant advantages to methods such as microbial challenge when determining if a Sterile Barrier System has been compromised. This is the most common method used to determine the ability of a package to maintain a sterile barrier since it tests the entire Sterile Barrier System and not only the seal.

Typical Procedures/Protocols

ASTM F2096
ASTM E515
ISO 11607

WESTPAK Capabilities

(8) Bubble Leak tanks with state-of-the-art controls