Vaccine bioreactor

automated

This system is fully closed and includes the following key elements: • Two identical manufacturing lines comprising bioreactors with the volumes of 20, 100, 500 and 3000 liters; • A system of connecting heat-insulated pipelines, the group of membrane valve that connect the referred bioreactors; • Stationary CIP/SIP systems for automated cleaning and sterilization of the bioreactors and connecting pipelines; • Nutrient medium preparation and transfer area; • Mobile containers with junction points to the CIP/SIP systems. The group of pneumatically controlled valves is used to ensure the integration of each bioreactor in the technological line.   In each valve is installed position sensor, and in each group of valves is installed vibration sensor for detection of the media presence. Such design of membrane valve group ensures sterile transport of substrate, product and CIP solutions. The automated control system can be divided into 3 parts: • Bioreactor and CIP/SIP system local automation unit; • Central cascade control system; • Computerized control system SCADA. ​ The best compliance to the GMP requirements for biopharmaceutical production is ensured by visualization and control software package (SCADA), developed in compliance with the requirements pf 21CFR Part11 (US FDA). In addition to basic control and visualization functions, in this case the SCADA software ensures complying with the requirements for electronic records, authorized system access sign-in and operator activity registration log. The JSC “Biotehniskais centrs” has developed its own russified software SCADA that allows creating an efficient biosynthesis process control system.