A Digital Book, 2013 Edition
PHARMACEUTICAL PLANT VALIDATION
 

WFI Storage and Distribution Systems

SYSTEM DESCRIPTION
The WFI Storage and Distribution System consists of a 316L stainless steel vessel jacketed for heat transfer with the following associated equipment: a sterile vent filter, a re-circulation loop, a re-circulation pump, a re-circulation water heater, point of use coolers, and a control and instrumentation system for monitoring and adjustment of the system pressure, temperature, fluid level, and flow rates and for monitoring conductivity. It is designed to receive, store, and supply hot WFI that meets the specification of US Pharmacopeia. For cold WFI users, the hot WFI is cooled by the point of use coolers. The system including the interior surface of the vessel, piping, valves, and any surface in potential contact with product WFI is designed to be sanitized and/or sterilized with hot WFI.


PROTOCOL NAME UNIT PRICE  
DQ (Design Qualification) Protocol, WFI Storage and Distribution Systems (Sale!) US$ 100.00
IQ (Installation Qualification) Protocol, WFI Storage and Distribution Systems US$ 100.00
OQ (Operational Qualification) Protocol, WFI Storage and Distribution Systems US$ 100.00
PQ (Performance Qualification) Protocol, WFI Storage and Distribution Systems US$ 100.00
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