What is Bubble Leak Testing?

Bubble leak testing is used to determine the integrity of the package and its 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 Perform Bubble Leak Testing?

  • Bubble leak testing is a complete package integrity test as it tests all of the package, 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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