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?
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.