Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Leak Test)

The Bubble Leak test, which follows the ASTM F2096 standard, is conducted by visually inspecting for bubble streams caused from a defect in the packaging/sterile barrier system – all while it is submerged under water and gently pressurized. This destructive testing method provides a practical way to examine packages for gross leaks, which may render the product non-sterile. This test method may apply to very large or long packages, which do not fit into any other package integrity test method apparatus.

The intensity of internal pressure for the package is determined by introducing a control defect created in a known location of the package. Pressure is gradually increased until the defect begins to show a constant stream of bubbles indicating a specific area of failure.

1. Scope

  • 1.1 This test method covers the detection of gross leaks in medical packaging. Method sensitivity is down to 250 μm.
  • 1.2 This test method is destructive in that it requires entry into the package to supply an internal air pressure.