A Digital Book, 2013 Edition
PHARMACEUTICAL PLANT VALIDATION
 

USP Purified Water Storage and Distribution Systems

SYSTEM DESCRIPTION
The USP Purified Water 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 sterile liquid filter, a UV sterilizer, a re-circulation loop, a re-circulation pump, a re-circulation water heater, 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 cold USP purified water that meets the specification of US Pharmacopeia. The system including the interior surface of the vessel, piping, valves, and any surface in potential contact with the product water is designed to be sanitized and/or sterilized with hot USP Purified Water.


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