BIO-S-F series stainless steel fermenter system

Provides fully automated stainless steel fermenters from laboratory to pilot to production scale, meeting the high-density fermentation needs of high-oxygen-consuming bacteria such as E. coli and Pichia pastoris. This product is suitable for the production of recombinant protein drugs, nucleic acid vaccines and other biopharmaceuticals.

Product Features

● The system adopts a 3D open frame structure design, which is compact and beautiful in appearance, easy to maintain and operate. The space occupancy rate is low, and there are very few work handovers, which helps to improve project execution efficiency and overall project controllability.

● Modular design, various functional modules can be added or reduced according to customer application needs, the configuration can be adjusted at any time, and it can easily adapt to constantly changing process requirements.

● The equipment is designed according to the BPE standard, and the material interfaces all use hygienic NA interfaces. The pipelines are installed at a reasonable inclined angle, and there is a drainage test before leaving the factory to ensure that there is no residue and avoid the risk of contamination.

● The tank body and all liquid-contacting metal parts are made of 316L stainless steel. The stainless steel parts that do not contact the culture medium are mirror-polished, and the stainless steel parts that contact the culture medium are electropolished, Ra < 0.4μm, which is easy to clean.

● Select pipelines and fittings that meet the ASME-BPE standard. Automatic welding is used, and each weld is inspected with a borescope. This ensures fluid flow under sterile conditions and the highest level of pipeline system cleanliness. It minimizes the risk of leakage from the source.

● High-quality electrodes are selected, with high control accuracy, good stability, and high consistency in process production.

● The system is equipped with multiple cold point temperature probes, and a drain valve is installed at the end. The sterilization temperature control design is reasonable, ensuring sufficient sterilization while saving the use of pure steam, making sterilization reliable and energy-saving.

● Fully automatic control of DO, pH, temperature, level, pressure, aeration, feeding, exhaust, defoaming, and speed.

● Cascade control: such as four-level cascade control of dissolved oxygen (correlating dissolved oxygen with air, oxygen, nitrogen, and stirring speed, and automatic sequencing can be achieved).

● Independent configuration of surface aeration/deep aeration, independent configuration of microbubble/small bubble/large bubble aeration, automatic proportional adjustment of AIR, CO2, O2, N2 (optional). The air mass flow sensor is matched with the exhaust regulating valve for dynamic flow continuous and precise aeration;

● Fully automatic CIP/SIP ensures perfect cleaning effect, ensures that the process parameters of each cleaning and sterilization are basically consistent, the cleaning results have good repeatability, effectively avoids cross-contamination between batches, and is conducive to verification. At the same time, fully automatic operation saves labor, reduces operational errors, is conducive to the rationalization of production plans, and improves product quality and production efficiency. Including fully automatic empty tank, full tank, single pipeline cleaning and sterilization, automatic pressure holding during sterilization, and automatic cooling after sterilization completion. The cleaning and sterilization process is fully automatically program-controlled, with one-button automated operation.

● AI artificial intelligence PID control: It can automatically identify various on-site scenarios such as changing setpoints, pure time delay, additional disturbances, unexpected power outages, etc., and simulate expert thinking to adjust the working state of PID, achieving accurate control without overshoot and undershoot in various different application scenarios. Achieve optimal control of parameters such as level, tank pressure, temperature, pH, and DO. Shorten process optimization time, especially suitable for the first operation or the launch of new projects.

● Redundant design of exhaust filters, allowing for online filter replacement and sterilization. An exhaust microbial inactivation device is installed to sterilize the exhaust gas to ensure biosafety. The sterilization temperature can be set, and the exhaust gas temperature has real-time and historical curves.

● Aseptic feeding: a four-valve group feeding system or aseptic push-valve feeding that can be sterilized online automatically.

● Automatic online sampling, online monitoring of nutrients, metabolites and cell growth (optional).

● Optional OD-600 sensor for online monitoring of bacterial concentration, and through a dedicated bacterial density module, online measurement and feedback feeding of bacterial density can be realized. Functional modules such as exhaust gas analysis and online glucose detection can be expanded.

● The program design refers to GAMP5 for optimization, improves the stability of the program, has corresponding document support, and ensures system traceability. Supports wireless remote control (mobile phone or tablet).

● Bioprocess big data analysis software (Ai-BIO) provides advanced process control and data analysis, supporting DOE