Bioreactors

SYSTEM DESCRIPTION
The Bioreactor, a packaged system, consists of a 316L stainless steel vessel jacketed for heat transfer with the following associated equipment: an agitator, an aseptic lubricating system for the agitator mechanical seal, a sterile air filter, a vent condenser, a sterile vent filter, chemical injection pumps that are provided by the package system users, a bioreactor broth transfer pump, and a control and instrumentation system for monitoring and adjustment of the system pressure, temperature, broth level, pH and dissolved oxygen concentration. It is designed to provide an environment of suspension culture for efficient cell propagation with continuous pH, DO and foam control. 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.