A Guide for Validation of Neutralizer Systems Used In Topical Antimicrobial Efficacy Evaluations

Authored by: Christopher M. Beausoleil

Handbook of Topical Antimicrobials

Print publication date:  September  2002
Online publication date:  September  2002

Print ISBN: 9780824707880
eBook ISBN: 9780203909256
Adobe ISBN:

10.1201/9780203909256.ch24

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Abstract

Many antimicrobial efficacy evaluations of topical antimicrobial products involve measurements of microbial population reductions at a specific time point after exposure to the product. To determine this accurately, the antimicrobial action of the product must be stopped at the time specified for sample, and it is for this action that neutralizer systems are employed. The validity of the neutralizer system must be established prior to performing the antimicrobial efficacy test. This concern for neutralizer validity has long been known, and a number of methods have been proposed for validating neutralizer systems [15]. Each of the methods focuses on two major concerns: (1) the neutralizer system must demonstrably neutralize the antimicrobial properties of the product, and (2) the neutralizer system must be proven nontoxic to the test microorganism(s). Few validation methods apply techniques of statistical analysis to the determination of their validity [5]. The purpose of this chapter is to incorporate statistical processes of analysis into a neutralizer validation system, as a means of providing more accurate and reliable outcomes.

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