Bubble Leak Test

Meaning of Test

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 11607-1:2006) 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 not just the seal

Typical Range

The intensity of internal pressure is determined for each Sterile Barrier System by means of introducing a control defect of 125 or 250 microns created in a known location of the package. Test pressure is gradually increased until this defect begins to show a constant stream of bubbles indicating a specific area of failure. Test pressures of 0.5 psi are common for many flexible pouches and trays. Test parameters that must be addressed in the protocol include the test pressure and the size of the defect to be used to determine the minimum test pressure. The bubble leak test is not a package strength test, and is a destructive test since the sterile barrier is breached

Associated Standards

Leak detection through internal pressurization (Bubble Leak Testing) is most often referenced by ASTM F2096 - Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test).

What We Provide

Westpak provides thousands of Bubble Leak tests each year and has many Test Fixtures at our multiple locations to accommodate your next package validation.