Aziz,
>From a compliance perspective, if your validation exercise indicates that the
process run did not meet all of the predefined acceptance criteria, the
exercise fails and you cannot consider the sterilization process validated.
This is independent of whatever prevailing regulations may exist. If you
threw in the BI in the validation protocol as an adjunct tool simply for
information purposes only, and your protocol is further relying on the
presumed regulation that recognizes the primacy of physical attributes, then
you could, with adequate, documented rationale, explain the BI discrepancy
and conclude that the validation exercise was acceptable assuming you met all
of the predefined (physical) acceptance criteria.
>From a scientific perspective, I expect to see a fundamental and unambiguous
relationship between purported physical forces and biological effects. If I
wear sunblock on a very hot day, a physical force (i.e., sunlight) can be
masked. If I do not wear sunblock, my skin color can darken depending on my
length of exposure and the intensity of the heat. So, you need to determine
whether or not your (discrepant) BI bulbs are masking a real physical effect.
I am not an expert in steam sterilization and I do not even know the term
"BI bulb." But, if I think of BIs as paper or aluminum carriers harboring
fairly resistant endospores, it is possible that the BIs may be superpotent
in either quantitative (count) or qualitative (resistance) terms. It is also
possible that your sterilization physical parameters are subpotent. In my
paradigm, a scary place to be, you may have a subpotent process and a
superpotent BI. The converse is also possible.
Richard Prince
rpaincorp@aol.com
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