Hi,
I'm looking for a study that I can reference with respect to the
changes in d-value of an indicator organism in water compared to
different substances in water.
For instance, given the same bacteria (B.stearothermophilus)how does
the d-value comapre when sterilized in water as a carrier to a saline
solution, or sucrose, or a cyclodextrin? Does a lower pH, say 5.5
effect the d-value of a suspension? I know that concentrations of
these compounds in solution will have an effect, but I am looking for
ball park numbers, or even a general direction of the d-value. I
would be interested in hearing of unofficial tables, but would really
like to see something I could reference.
For those not in the industry, as part of developing a drug for
clinical trials and for distribution, the FDA requires that we assure
that the drug product is safe. One aspect of this is that, with
pararenterals, they must be sterile. In the process of proving that
we can dconsistently deliver sterile drugs, we purposely seed an
experemental lot of the drug product or a surrogte with bacteria. We
then use various methods of proving to the FDA that the bacteria are
killed. The FDA requires a SAL (sterility assurance level) of 10^6.
What I want is a table I can reference so that I can use water as the
carrier for the indicating organism, rather than the drug product.
Having scientific studies to show the change in d-value with respect
to these changes in solution components, would aid in this.
Thanks
Rob
