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Integrity TestingSeal Integrity

"F2096 and F1929: Redundant or Complimentary Tests?"

This question is in regards to a tray and tyvek lid packaging. If package integrity is verified by performing ASTM F2096 Bubble Leak testing, would performing F1929 Dye Penetration testing be considered redundant?

Last Updated On February 5, 2015

Both F1929 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) and F2096 (Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)) are widely used to determine package integrity of sterile barrier systems. F1929 defines materials and a procedure that will detect and locate a leak equal or greater than a channel formed by a 50 mm (0.002 in.) wire in package edge seals formed between a transparent film and a porous sheet material, while F2096 covers the detection of gross leaks in packaging with a sensitivity down to 250 mm (0.010 in.) in tray and pouch packages. F2096 has specifically been tested in tray/lid package systems, while F1929 has not been tested in that configuration, although, with appropriate validation, it can certainly be applied in tray/lid configurations. F2096 further provides a test method that will detect gross leaks not only in package seals (as in F1929) but throughout the entire package. However, care must be taken to select an appropriate test pressure for each tray/lid/product configuration to ensure that excessive pressurization of the package does not rupture seals or cause misinterpretation of bubble patterns emanating from porous packaging. F1929, on the other hand, is significantly more sensitive than F2096, and will detect 50 mm channels in package seals with a confidence of 98-99%.

Selecting an appropriate test method, whether F1929, F2096, or any of the other package integrity tests available, depends largely on the requirements for the package. If channels in seals is the only integrity property being evaluated by this test and other requirements are being verified by secondary means, then performing both tests may, in fact, be redundant. However, if integrity breaches in the tray are a concern, and if detection of the smallest channels in the seals is desirable, then both tests may be performed, although not on the same package, since each test is destructive.