What is bubble leak testing?

The bubble leak test is used to determine the integrity of the package and the seal. The bubble leak test process involves visually inspecting for streams of bubbles coming from a defect while a sterile barrier system is gently pressurized and submerged under water.

Why do bubble leak testing?

  • Bubble leak testing is a whole package integrity test as it tests all of the package and not just the seals
  • Bubble leak testing is a method of determining defects (e.g. tears, holes or improper seals) or gross leaks in sterile medical device packaging

Guidance Documents / Standards:

  • ISO 11607
  • ASTM F2096 – Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

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