Bubble Leak Testing
Bubble Leak Testing
Guidance Documents –
ISO 11607
ASTM F2096 - Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
What is it?
The bubble Leak test is used to determine the integrity of the package and the seal. The test process is described by visually inspecting for streams of bubbles from a defect while a Sterile Barrier System is gently pressurized and submerged under water.
Why do it?
- Bubble leak test in a whole package integrity test as it tests all of the package and not just the seals
- Method of determining defects (e.g. tears, holes or improper seals) or gross leaks in Sterile Medical Device Packaging.
