IUBio

Urgent need of 'Expert Opinion'

Eric Penrose jamers at sympatico.ca
Sun Jan 31 00:06:23 EST 1999


The company I work for has to make a regulatory submission immediately, and
need a 3rd party expert to provide a letter regarding survival factors of
selected bioburden in a pharmaceutical product.  The business will pay a
reasonable fee for such a letter which we will include in the submission.
The expert microbiologist we are seeking should have some experience in the
field of preservative effectiveness, or the impact of disinfectants for
example.  The pharmaceutical product has a normal pH in the range of 4.5 at
release, which decreases over time, it contains bisulfite as an oxygen
scavenger (not claimed as an inhibitory agent).  We have done a series of
'reverse-inoculation' using 10 - 100 organisms of several Staphylococcus
species, mostly common skin flora biotypes, and they are typically not
recoverable alive after a mere 1 to 2 days.

If anyone is qualified to make an expert opinion for this urgent regulatory
submission on this matter, please email me for additional details at
jamers at sympatico.ca

Eric Penrose R.M.






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