Bioreactor System

75L&600L&1200L&2400L&4500L Bioreactor System. 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.

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Email: info@rotech-group.com

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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.

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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;


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…


DEquipment 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.

Main Function Instruction

A.  316L stainless steel tank body with visible sight glass, 12-hole 316L stainless steel top cover, total 15 nozzles on the upper side, lower side and bottom of tank body for ventilation, feeding, electrode connection, sampling, stirring and drainage. Tank body equips with pressure gauge and tank pressure control system; inner surface of bioreactor is electrically polished: Ra<0.4μm.

B.  Controller of touch screen operation has the control loop of pH, DO, temperature, stirring and bubbles and so on and can provide parameter setting and control of pH, DO, temperature, stirring, bubble, feeding, ventilation, SIP, CIP of cell tank. Normal parameters are controlled by PID. Touch screen displays all the processing parameters, and displays the setting value and actual value by digital, curve and column diagram. Besides, reserved analog signal and digital signal joint, easy to add extension equipment according to needs.

C.  HMI controller can display the whole process flowchart of equipment and working state of valve, and displays 80 curve diagrams of 4 processing parameters at the same time. User can regulate value and time axis. Column can display setting value, test value and alarming value, and also display the controller status and output value of it.

D.  Adopt Siemens PLC, HMI: 12.1” color touch screen running Win CC, and has GAMP4 control system. Software module meets the requirement of S88.

F.  Equip with 4 peristaltic pumps (two of them are speed variable pump) for adding acid, alkali and feeding. Also it equips with 4 sealed feeding nozzles (four valve-unit design) which can be sterilized repeatedly and sealed sampling system (3 valve-units design), ensure the safety of feeding and sampling operations.

G.  Can communicate with computer via Ethernet connection and connect with internet, and can collect data from internet by software. Operation processing data and control can be realized in remote.

H.  PH control: use long-life pH electrode, control range: 0-14pH, accuracy: ±0.01pH; when deviating from set value, start the electromagnetic valve of mass Flowmeter of CO2 or activate the automatic alkali adding of peristaltic pump to control pH; pH electrode has a specially designed sleeve for the ion exchange between inner part of electrode and media. This design improves the test accuracy and lets the electrode has excellent performance: no cross-contamination (with inner pressure), accurate adjustment (need no repeat adjustment), long-time stable signal, no sensitive to waste, long use-life (each electrode has the serial no of long use-life) and double pH electrodes can test at the same time.

I.  Temperature control: Pt-100, range: 0-150, accuracy: ±0.1; control the media solution temperature by controlling the temperature of jacket circulation water by heating component and cooling water electromagnetic valve. Jacket is equipped with pressure gauge.

J.  DO control: low drift and long life DO electrode, range: 0-500%,±0.1%; DO can adopt cascade control, that is, control DO by the cascade of stirring rotating speed, ventilation or pure oxygen and nitrogen inlet. DO electrode with low drift based on the test pool principle consisting of small negative electrode and electrode membrane, adding a layer of strengthened silicon membrane with high osmosis, giving DO electrode with following features: low flow dependence, good reaction time, high mechanical strength, easy maintenance (continuous operation for several months needs no maintenance), long use life (each electrode has long life serial no.) and so on. It is made of material which meets FDA requirement with surface electrical polishing Ra<0.4μm, easy to clean. It has double DO electrodes, can test at the same time.

K.  The flow rate of air, Co2, O2 and N2 for deep ventilation is controlled by mass flowmeter; air and Co2 for top ventilation is controlled by mass flowmeter; the filters of all the inlet/out gases are equipped with integrity test nozzle.

L.  Stirring control: equip with bottom double mechanical sealing stirring motor, meets the one grade safety standard and CE requirement, rotating speed: 200rpm. Low cutting stirring blade, very suitable for the animal cell culture with microcarrier.

M.  Air outlet is equipped with electrical heater, reducing the relative humidity passing exhaust filter and ensuring the filtration effect.

N.  Equip with CIP spraying head and CIP pipeline can connect CIP equipment for CIP.

O.  Bioreactor equips with electrical cap lifting device.

P.  Include IQ and OQ validation document; electrical component meets the CE requirement, all the mechanical part meets the ASME BPE 2005 requirement.

R.  Equip with GMP software, realizing the monitoring of the reactor; password protection function, ensuring the stable and reliable data. Control parameters can be program setting and control by software, and display the data by diagram, table or digital forms and record data. And compare and analyze between different batches.


Documentation Support

1.  Implementation Schedule of Equipment Plan.

2.  PID Process Flowchart Diagram.

3.  System Configuration List.

4.  System Layout Diagram.

5.  Electrical Component List.

6.  Electrical Principle Diagram.

7.  FS Function Instruction.

8.  DQ Design Qualification.

9.  FAT Factory Acceptance Test.

10.  IQ Installation Qualification.

11.  OQ Operation Qualification.

12.  SAT Site Acceptance Test.

13.  Standard Operation Procedure.

14.  Welding Personnel Quality.

15.  Welding Record.

16.  Adjustment Certificate of Instrument and Appliance.

17.  Quality Certificate of Instrument and Appliance.

18.  Material Trace File.

19.  Standard Operation Procedure for Cleaning and Passivation.

20.  Surface Roughness Validation.

 

1.  Technical service: provide free consultation and suggestion, technical support and service by email/fax/telephone and lifetime technical support.

2.  Customized service: product development and design according to different customer's different requirements.

3.  After-sale service team: technical engineers available to service overseas if needed.

4.  Installation: we can arrange engineers to install machines in customer's factory.

5.  Maintenance: reply will be given within 48 hours once customer inform us any malfunction happened, we can also arrange engineers to customer's factory to main machines.

6.  Training: normal machine is properly adjusted before delivery, you will be able to use the machines immediately and you will be able to get free training advice towards our machine in our factory.

7.  Warranty: one year since the date of delivery.

There are multiple models of one type machine , we need to know more details about your products in order that we can recommend the most suitable machine for you. Our questions as below:

1.  What's your product ? please send one picture to us

2.  What's the dimension or specification of your product ?

3.  What's the filling volume of your product ?

4.  What's the production capacity of your required machines?

5.  If possible , please tell us your production process, we can select the approximate machine according to your requirements.

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