Abstract
This chapter considers pharmaceutical water systems, the supplied potable water and the purification process that generates purified water and water for injections. The chapter’s focus is with areas of microbiological concern pertaining to the design of water systems (where the chapter considers where contamination may arise) and with microbiological testing necessary to show whether the systems are in control or not. The testing of water systems is based on an examination of microbial counts and bacterial endotoxin. As well as established methods of testing, the chapter makes reference to rapid microbiological methods. Whichever methodology is used, it is important that data trends are studied, and this should be a central focus of the microbiologist.
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