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Delamination and Breach of Sterile Barrier

Q.

Is delamination of the substrate considered to be a breach in sterile barrier? If not, what other methods are available to confirm the potential breach?

A.

During a qualification effort, delamination is generally considered a design failure, and a root cause / CAPA effort should be pursued to identify and correct the source of the delamination. In many cases, however, delamination does not result in a breach of the barrier.

Other methods to confirm breach of sterile barrier are: dye leak testing, gas leak testing, and bubble emission testing. See ASTM F2097, “Standard Guide for Design and Evaluation of Primary Packaging for Medical Products” for other applicable test methods.

Last updated on 2008-05-15 21:47:34 UTC
Keywords: package integrity, barrier, delamination, sterile barrier

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