Microbial preservative efficacy
assays (USP, CFTA, ASTM) are routinely performed on pharmaceutical,
cosmetic and industrial chemical products. Special emphasis
is placed on inoculum development and techniques applicable
to product inoculation with the aim of achieving OPTIMAL
uniformity in product organism mix. Minimizing ORGANISM PHASE
VARIATIONS and CURTAILING the possible formation of microbial
aggregates in the challenged PRODUCT contribute to the development
of more accurate organism response profiles.Improved recovery
media are utilized in order to maximize microbial recovery
rates throughout
the challenge period. These measures result in the
generation of highly reliable organism viablity profiles
which, in turn, are utilized to establish the overall preservative
response.
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Additionally, we have enhanced
the basic compendial protocols to include,as applicable,
short term count interval(s). This gives our sponsors
the extra information needed to make better product performance
evaluations. Because efficacy of preservation, for
the most part, is a predictive assay, i.e., performance is
extrapolated from reduction profiles generated with reference
organism strains, we have always encouraged testing actual
product isolates to augment the required compendial battery
or organisms. All preservative studies conducted at
Micra are fully validated to assure adequate neutralization
during the the designated recovery intervals.
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