Highly Accurate Testing for Pharmaceuticals and Medical Packaging

The ASTM F2096 test (Detecting Gross Leaks in Packaging by Internal Pressurization) provides users with a practical way to examine their packages for gross leaks by visually inspecting bubble streams emitted from a package defect or leak. The FlexPak Internal Pressurization Assembly (FPIPA) can be combined with the standard FlexPak Leak Detector and used to perform ASTM F2096 to detect leaks, substrate holes, and channels, providing accurate and repeatable results. It is extremely useful in test laboratory environments where no common package or material size exists. The ASTM F2096 test is destructive, as it requires entry into the package to supply internal air pressure.

Sensitive Visual Testing

The ASTM F2096 test provides sensitivity down to 250 μm (0.010 in.) with an 81% probability. The FPIPA can detect micro leaks that would be undetectable by a standard Bubble Leak Test due to its high sensitivity and is therefore ideal for pharmaceutical and medical supplies packaging. Additionally, it can be used for heat-sealed, abnormally shaped, tray, and pouch packages. The transparent acrylic FlexPak water chamber allows for 360 degree viewing of the package, simplifying ASTM F2096 by eliminating the need for operator rotation of the package, reducing testing time. FPIPA can provide medical and pharmaceutical manufacturers with an accurate and straightforward seal integrity test to ensure packaging remains sterile across its lifespan, from manufacturer to consumer.

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