Buffer Preparation and Hold Tanks

SYSTEM DESCRIPTION
The Buffer Preparation and Hold Tank consists of a 316L stainless steel vessel jacketed for heat transfer with the following associated equipment: an agitator, a sterile vent filter, a sterile liquid filter, a buffer solution transfer pump, and a control and instrumentation system for monitoring and adjustment of the system pressure, temperature, and fluid level and for monitoring pH and conductivity. It is designed to prepare, hold, and supply buffer solutions. 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.