ABSTRACT

Water is the most widely used ingredient in pharmaceutical manufacturing and the main component required for equipment and system cleaning. Therefore, special attention is given to this material in this chapter. Control of its microbial quality is difcult due to its source: municipal and nonmunicipal water systems, which is the major exogenous source of microbial contamination of pharmaceutical waters. It is estimated that there are 70 different types of bacteria in wastewater [1]. Several different types of microbes cross water-treatment barriers and are found in pharmaceutical waters. Most microbial contaminants are Gram-negative bacteria that pose the additional risk of endotoxin contamination of waters used for parenteral production.