Biopharmaceutical Process Module GMP 2
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1、Vessel and function

Total volume: 350L 250L

D:H : 1: 1; Working volume:70%-75%

Vessel:The main material is stainless steel 316L , the inner surface of the tank is polished Ra≤0.2um, the jacket is 304, and the insulation layer is 304.

Sandblasting/drawing matt treatment Ra≤0.8um for external surface. No dead angle in tank; Adopt large viewing angle observation sight glass for liquid level in the tank, top sight glass, two strip sight glasses at side, 12V safety sight light, with temperature, Liquid level interface, inoculation port, refilling port, CIP cleaning port and multiple spare ports, all welds are firm and neat and beautiful.


Vessel design pressure: 0.35Mpa  

Jacket design pressure: 0.35  Mpa,  

The optimized diversion design improves the exchange efficiency and the uniformity of the temperature in the tank, because stable and uniform temperature control is the basic condition for successful fermentation.

Motor: Frequency conversion drive, adopts German SEW frequency conversion motor. The separate design of the motor and the tank body greatly reduces the weight of the tank body, makes the operation easier and more convenient, and saves a lot of manpower.

Filter: It adopts the secondary filter of sterilization with the accuracy of 0.2μm 99.99% of Sartorius, automatic sterilization and automatic drying.

Tank pressure: Adopt pressure sensor (German Bode) for automatic tank pressure control and adjustment, digital display by pressure electrode.

Stirring form: 2 to 5 level 3 propellers, blade height is adjustable and the blade quantity can be increased or decreased

Temperature control: automatic heating and water cooling, Danish Grundfos circulating pump for temperature control, with air self-escape function and water cut-off, over-temperature protection function, with good heat exchange efficiency; intelligent module control ensures rapid temperature control. Energy saving has also been achieved.

Sterilization : in situ automatic sterilization;


Stirring speed:speed:20~300rpm stepless speed change; accuracy: ±1rpm; wide range, low noise, high temperature resistance, long life, constant torque;

Temperature control: PT100 electrode detection, display range: 0-150 ℃, cascade automatic control; electric heating, water cooling; Intelligent module control ensures the speed and accuracy of temperature control; control range: 0-130 ℃, Accuracy: ±0.1℃; Resolution: 0.1℃;

Tank pressure: German pressure sensor and pressure electrode digital display; automatic tank pressure adjustment, range: 0~0.25Map; accuracy: ± 0.01

Sterilization: sterilization temperature: 100-135°C, sterilization time 0-180min, sterilization temperature tolerance: ±0.5°C; automatic sterilization for filled tanks, empty tanks, filters

3.  control system

It will be integrated to 350L cell bioreactor control system.


Ⅱ.KNIKBIO-b control system


KNIKBIO-b control system




The KNIKBIO-B bio-fermentation control system is made up of the top machine, the 2017 version of the fermentation control software, the BIBIO - B/Siemens PLC, the sensors and the actuators.

The field controller is A programmable controller based on the s7-200 series of Siemens in Germany. It adopts multistage extension, and has sufficient A/D conversion channel, D/A conversion channel, and switch volume input and output. The on-site controls are manufactured by an industrial-grade Siemens interface, and the fermentation system will continue to operate without a superior machine. The design structure and selection enhance the reliability of the system, and it doesn't affect the fermentation of the system because it has been affected by the virus or the Windows operating system.

The software control system includes the acquisition of the field signal and the controller of the lower computer controller and the computer control of the upper computer and the network communication software. All the control aspects adopt intelligent PID control, control stability, high control precision, and have the parameter self-tuning control algorithm.


man-machine interface

The friendly man-machine interface can switch a variety of monitoring images; The operation state of multiple fermentation tanks can be monitored simultaneously on a display interface.


Detection and control

Can measure and control at the same time, stirring speed, tank temperature, sterilization temperature, pH value, the DO value, cell density, tank pressure, exhaust exhaust O2, CO2, inlet flow rate, etc. The project needs to be determined by the user.


Defoaming and rehydration

It has ultra - level alarm and automatic filling function, and has the function of hyperbubble alarm and automatic adding defoaming agent; Note: the defoaming function should be selected.



It has the software to set the peristaltic pump on a time rationing function; It is necessary to select the electronic scale function for the high precision timing quantitative filling function.


Association control

It has a link to the solution of oxygen and velocity, and the way to change the velocity is to improve the concentration of dissolved oxygen in the culture; The correlation between the filling and the pH; The correlation between the filling and the dissolved oxygen.



The filled tank and empty tank automatically control the sterilization, including the intake filter and the exhaust filter. It controls the sterilization temperature, sterilization time, the pressure, the pressure, and the speed of mixing. The sterilization is completed and then it enters the fermentation preparation state automatically.


Pressure protection test

It has the function of tank protection and pressure testing to realize the automatic detection of the gas and tightness of the tank.


Setting and calibration

The temperature, DO, pH, pressure and other sensors can be calibrated. The flow of each squirming pump can be calibrated manually.


Data display, record, and storage

The system has the function of real-time display, data record, data analysis, graph and batch report, output print, password management and alarm, etc. The history data and curve of various parameters can be kept for years (must have the upper computer to be realized). Important parameters are written to the database for data analysis at any time. Full Chinese interface, with detailed instructions.


PID control

Each parameter has PID control and regulatory process that shows, like seting values, real time values, PID Settings, upper and lower level values;


Overlimit alarm function

It can set temperature, rotating speed, pH value, DO value and other upper and lower limit and have overlimit alarm function.


Control switch

Speed, temperature, pH value, DO value, filling and so on can be set to automatic, manual and shutdown status;


Diagnosis and protection

The system has adaptive ability and self-diagnostic ability; Abnormal conditions can be set up according to the customer to do automatic alarm and protection operation.


Password protection function

Operation has password protection function, password is divided into passwords for operator and administrator ;



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