ABSTRACT
The literature contains an ample discussion of the several facets of pharmaceutical water requirements: regulatory constraints; system designs; operational protocols; the microbiological imperatives, biofilms, sanitizations and bioburden analyses; and the various aspects of the validation exercise including that of the individual purification units (1, 2). A duplication of such efforts is not intended in this chapter. Indeed, it is assumed that the reader will have some fair knowledge of the principles and operations involved in water treatments such as softening, filtration, total organic carbon (TOC) ionexchange, reverse osmosis, and so forth. The intention of this writing is to suggest new outlooks for designing pharmaceutical water purification systems, particularly based on practices in other applications.
