A Digital Book, 2013 Edition
PHARMACEUTICAL PLANT VALIDATION
 

Process Tanks

SYSTEM DESCRIPTION
The Process Tank consists of a 316L stainless steel vessel jacketed for heat transfer with the following associated equipment: an agitator, a sterile vent filter, a chemical injection pump, and a control and instrumentation system for monitoring and adjustment of the system pressure, temperature, fluid level, pH and conductivity. It is designed to receive, hold, and supply process solutions while acid, base and salt solutions can be added by a chemical injection pump. The system including the interior surface of the vessel, piping, valves, and any surface in potential contact with process streams is designed to be cleaned-in-place (CIP) and sterilized-in-place (SIP). The sterilization is performed to achieve a probability of nonsterility not greater than one in a million.


PROTOCOL NAME UNIT PRICE  
DQ (Design Qualification) Protocol, Process Tanks US$ 100.00
IQ (Installation Qualification) Protocol, Process Tanks US$ 100.00
OQ (Operational Qualification) Protocol, Process Tanks US$ 100.00
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