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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.
Industry Application
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.
Frequently Asked Questions
How sensitive is bubble leak testing?
The bubble leak test method per ASTM F2096 can detect a breach in the sterile barrier system down to 250 microns.
How is bubble leak testing performed?
Bubble leak testing is performed by submerging a package into water and forcing air into the package. If a steady stream of bubbles is observed, that would indicate a breach of the sterile barrier.
