Bubble Leak Test
ASTM F2096 Standard Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization Packaging Compliance Labs provides ASTM F2096 testing as part of our medical package testing services. This testing method can be used for non-permeable and permeable materials, though there are different testing methods for each, as any porous materials receive a saturation period prior to testing. The ASTM F2096 standard is used to evaluate the integrity of packages designed to provide an uncontaminated environment.
Bubble leak testing is a whole-package integrity test. It is typically performed as part of a validation activity, such as sealer validation, or transit or shelf life simulations. The bubble leak test method has a sensitivity of 250 microns. It is performed by submerging the package in water and observing for a steady stream of bubbles, indicating a breach of the sterile barrier. Bubble leak testing is the most common approach to evaluating sterile barrier integrity for Tyvek(R) pouches or thermoformed trays.