Gross Leak (Bubble) Detection
This test is conducted by submerging a lightly pressurized breathable package under water to visually inspect for streams of bubbles that identify a leak or defect in both porous and non-porous packaging systems.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.
The bubbles here have been colored blue to show how they help us detect a leak or defect in a sterile medical device package.
Bubble testing is a widely used qualitative method of determining defects or gross leaks in breathable sterile medical device packaging
Westpak continually upgrades and expands its equipment line-up. Therefore this list is a minimum of our capabilities:
(8) Bubble Leak tanks
Bubble Test Video