Pharmaceutical Water Systems
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Description
The factors that influence water system design are discussed in terms
of the different water sources and the impurities they contain. USP
chemical purity standards are described. The choices for removing
impurities are detailed and the considerations in making selections
among the alternatives are evaluated.
The several pretreatment and final treatment options are set forth
beginning with potable water preparation and leading to USP Purified
Water, Water for Injection and non-compendial waters. The control of
microbiological contamination and its consequences, such as bacterial
endotoxins, are addressed in the discussion of generation systems
and storage/distribution systems. Biofilm, water microbiology, proper
microbiological assaying and sanitization techniques are among the
topics covered.
Non-engineering aspects of water system validation are described:
specifically the regulatory background, the documentation, the unit
process operations and the microbiological requirements of the
validation exercise are emphasized. Future trends in water system
design and validation are indicated, with an emphasis upon the
selection of proper unit process, given a particular source water.