Design, Construction And Validation Of Purified Water System Of Pharmaceutical Industry

Key utility system in pharmaceutical industry plant are HVAC system and water system, and water system include city water system, purified water system and WFI(water for injection) system. Purified water are broadly used in pharmaceutical industry, and have direct impact on drug product quality. For regulatory(GMP regulatory) becomes more and more stringent, GMP inspection focuses more on water system. Water system validation is clearly declared in China GMP 1998 version. Then purified water system construction is covered by quality management from design stage. Based on current technology study, following a new purified water system construction process, this paper summarized key problems and approaches on how to handle them on purified water system construction. The study include brief design, process selection, detail design, equipment selection, process calculation, site construction and validation. Highlight of the design and construction is, found a good approach to solve the problem of hot water circulation and energy saving, realized no dead leg in system, realized hot water sanitization for generation unit and self circulation. The new purified water system construction realized not only eliminating chemical materials and microorganism from raw water and microorganism control but also water volume and accuracy control. International and local validation philosophy were built in the new purified system. New purified water system resolved problems of old system. Till now the new purified water system has been running for 30 days and produced purified water approximately 1000 cubic meter. Quality of water meet and exceed China , EU Phamarcopeia and USP specification. During design stage, technology of distribution unit of WFI system were used for the purified water system, so it can be a reference for water for injection system construction as well.