Design Instruction
This system a standardized module system designed according to URS and GMP regulation and to the requirement of upstream and downstream processing equipment for biological reaction preparation. It is safe and reliable, easy to operate.
System adopts industrial integrated technology, using Siemens PLC, Siemens HMI and relevant industrial integrated control technology to simplify the complex operation and let the production to be more stable and efficient.
System Configuration
A. Bioreactor
Bioreactor with 400L working volume (total volume 500L) and diameter-height-ratio at 1:1.3, consisting of inner bladder (316L), jacket (304) and insulation layer (304). It has upper and lower seal heads and barrel flange abutting-joint structure. Design pressure for tank body is 4Bar, for jacket is 6Bar; material contacting part is 316L with inner surface roughness Ra≤0.4um. It meets the requirement of GB150 pressure vessel regulation, and provides qualification certificate by national organization.
Main Functional Configuration of Tank Body
1. Sight Glass Unit.
2. Pressure Differential Level Meter (LABOM, German).
3. Pressure Sensor (LABOM, German).
4. Pressure Gauge (BLD).
5. Rupture Disc (Huali).
6. Respirator (Millipore 0.22um PTFE).
7. CIP/SIP Nozzle (Spray Ball from Germany Neumo).
8. Water Inlet Nozzle.
9. Temperature Sensor (JUMO).
10.PH Meter (M.T).
11.DO Electrode.
12.Feeding Nozzle.
13.Sterile Sampling Valve (Rotech).
14.Bottom Valve (German, Gemu).
15.High-performance Mechanical Stirrer with Double Mechanical Sealing (Rotech) .
16.Inlet/Outlet of Jacket.
B. Pipeline System Part
Pipeline System part; Fluid inlet pipe, valve, material supplementary device, material transmit pipeline and auxiliary pipeline for CIP/SIP.
Functional Components for Pipeline System
1. Air Regulating Valve (Fersto).
2. Steam Trap (Spiraxsarco).
3. BPE Sanitary Pipeline (CSE).
4. Steam Pressure Regulating Valve (Spiraxsarco).
5. GMP Valve (Gemu PTFE+EPDM).
6. Pneumatic Diaphragm Valve (Gemu PTFE+EPDM).
7. Mass Flowmeter.
8. Proportioning Valve.
9. Exhaust Filter.
10.Inlet Filter.
11.Peristaltic Pump……
C．Electrical Control System
Electrical control system consists of Siemens PLC, I/O module, HMI, pneumatic control island, instrument and appliance, actuator, performance feedback, alarm, power line, signal transmission circuit and stainless steel electrical control cabinet and so on;
D．Equipment Frame
It consists of 304 stainless steel rectangular pipe, square pipe and auxiliary components in integrated welding, used for the supporting and orientation of whole system and guarantee of the integrity of equipment.
