The compact, modular fermenter system from Syntegon has been designed for development of Bio APIs at pilot scale within an wide range of cell types.
The range of options is based on three bioreactor sizes than can be selected with 500, 100 or 200 liter capacity. Each size can be configured as two versions in order to guarantee optimum height to diameter ration for all cell types and process controls. The mixer versions are correspondingly variable, whereby various agitators or gas-based distribution systems can be selected.
For process media feeding, there are up to four substrates that can be added via peristaltic pumps. The media containers are positioned on magnetic stirrers and ca be reconnected or cleaned without affecting ongoing fermentation. Other process media such as WFI, steam and CIP media are located in a separate supply skid.
The industrial design of the pilot fermenter means that the system can be used both in a laboratory environment and under production conditions because all components are designed for industrial use with the highest quality standards.
The PLC-based control system is equipped with a user-friendly HMI control panel and it is developed in accordance with GAMP guidelines. Process monitoring allow different process parameters such as pH value, oxygen level, carbon dioxide, optical density or filling level, etc.
The wall integration execution offers a positive separation of the technical area from the operating zone. This design reduces cleanroom space requirement and means that the process vessels can be changed quickly without having to modify the supply skid. If required a laminar flow unit can be installed.