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Medical and Pharmaceutical Packaging, Primary Films and Flexible Packaging Materials Q&A

  •   Regarding air integrity tests on medical device packaging: Could you tell me if pinholes in the film that are smaller than holes in porous paper, thus keeping the sterile barrier intact, are acceptable?

    Answered September 15th, 2009 by Expert: Chris Heezen, Uncategorized

    The accepted wisdom regarding medical paper and Tyvek as a sterile barrier is that harmful microbes are prevented from entering the packs because they get caught up in the “tortuous pathways” created by the random nature of fibre orientation. It is also considered that a hole with a diameter less than 0.5 µm will prevent a microbe from passing through. Although the pore size in paper is often larger than this critical dimension, the pathways protect the sterile barrier and keep it intact.

    As extruded films do not have any form of resin or fibre orientation, they offer a short pathway that will not “capture” bacteria trying to pass through a possible pinhole. It is also likely that holes, where they do occur, will have a diameter greater than the critical size.

    Further research into this area was started at Michigan State University by Dr Laura Bix and Dr Jane Severin in 2003. I am not aware that any firm conclusions were reached, as elements such as pressure differential during transport were also being assessed, but in the interests of patient safety, I recommend zero tolerance on pinholes in film used to make a sterile barrier.

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