For the most part, items which are terminally-sterilized by a validated
process (e.g., cobalt, EtO, whatever) are accepted by C. of A. (with
sterility assurance cert) and audit of vendor. This should include
gloves, syringes, etc., and certainly most purchased sterile components.
For some items, which perhaps might not be exposed to a full
sterilization cycle, a direct-inoculation sterility test can be done, but
you would need to establish your own policies on that (e.g., every
receipt, X times per year, audit only basis, etc.). And obviously,
anything which you re-process in your own facility (repacking, etc.)
would need to be evaluated as it is actually presented to your aseptic
M. Carroll ([log in to unmask])
On Thu, 17 May 2001 18:55:13 -0700 Patricia Parish
<[log in to unmask]> writes:
> We are now being asked to check all product contact components
> sterility. This includes syringes, gloves, and many other odd
> items. We
> are wondering how others are testing this type of component. Are
> simply validating the vendor using audits, or qualifying them
> sterility testing of random items? I've been asked to survey the
> Patricia Parish
> Berlex Biosciences
> Richmond, CA
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