chapter  9
12 Pages

Disinfectant Rotation in a Cleaning=Disinfection Program for Clean Rooms and Controlled Environments

WithScott V. W. Sutton

CONTENTS 9.1 Introduction ............................................................................................... 165 9.2 The Development of Resistance in Bacterial Populations ................. 168

9.2.1 Genetic Resistance ........................................................................ 168 9.2.2 Physiological Adaptation ............................................................ 169 9.2.3 Relevance........................................................................................ 170 9.2.4 On the Need for Clarity in Terms.............................................. 171

9.3 Summary .................................................................................................... 172 References ........................................................................................................... 173

An effective cleaning and disinfection program is an essential component for the successful manufacture of products in the pharmaceutical, personal products, and medical device industries. This cleaning and disinfection program is designed to minimize the cross contamination of chemicals between manufacturing runs and to maintain the microbial control of the facility. A major concern in this effort is the potential for microbial development of resistance to the agents used in this program. This concern has led to a regulatory expectation in some circles that manufacturers employ a program of disinfectant rotation in the cleaning and disinfection program to prevent the development of resistant strains of bacteria in their facilities. We examine the scientific underpinnings of this concern in this chapter.