Customized Bioreactor - Pilot and Production Scale Customized Reactor

Cat. No. Capacity Dimensions (WxDxH) Unit Price Quantity
BAF1486169-01 50L ~ 20000L Customized according to customer needs Each Inquiry

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Product Description
Product Description
The bioreactor is the heart of biopharmaceuticals process as it provides optimal growth environment for microorganisms and cells to synthesize products. A good fermenter/bioreactor design will help to improve product expression and higher quality at a lower cost.
In the field of fermenter/bioreactor, based on its comprehensive experience in the culture of microorganisms and cells, we will supply flexible customized proposal to meet customer need.
Volume 50L - 20000L
Height to diameter ratio Customize according to customer needs
Cultivate objects CHO cells
Cleaning/sterilization method In-place CIP/SIP
Tank material Stainless steel 316L Ra<0.4um EP
Stirring Magnetic stirring is installed at the bottom; 2-layer elephant ear or pitched blade blades; the height of the blades can be adjusted, and the assembly method is no dead angle assembly
Intake and exhaust The sterile filter with a stainless steel shell is equipped with a vent pipe and a gas distributor, and the maximum ventilation volume can reach 2wm
Temperature control The closed-cycle TCU system adopts indirect heat exchange between steam and cooling water, and achieves precise temperature control and air elimination through cascade PID.
pH Using smart PH electrode; associated control with alkali supplementation and CO2
Dissolved oxygen Use smart, optical DO electrode; associated control with stirring, ventilation, and oxygen
Defoaming Associated control of the defoamer supplement pump and defoamer electrode, automatic defoaming; provide timely and quantitative defoamer supplement program
Supplement Provide customized replenishment strategy
Control system Provide PLC and PCS7 two automatic control system architectures
Extended functions Reserved digital and analog input/output interfaces (no setting), which can be connected to external equipment (such as balance, turbidity, etc.)
Optional Viable cell count detection; online exhaust gas analysis; weighing\liquid level monitoring; refill balance measurement
Process and Engineering
General Design Criteria for Upstream Process Sterilization-in-place (SIP)
  • In general: sterilization at 121 °C, 20 min
  • Sterile gassing (Filter)
  • Sterile additions
Clean-in-Place (CIP)
  • No dead ends → piping design
  • High Surface quality → finish, choice of material
Process Safety
  • Closed System (Containment)
Safety for Personnel and Environment
  • Closed System for exhaust, drain, sampling (Containment)
The Right Material for Upstream Process Metallic Parts
  • Material 316 L (1.4404/1.4435) (Mo content approx. 2%)
  • High resistance to corrosion
  • Surface grinded to Ra ≤0.6 um or 0,4 um e-polished
  • Special means for protection of overheating during welding(ferrite formation)
  • 1.4539 (904 L), 1.4529, SMO, Duplex steel, Super Duplex with very high resistance possible
  • In general, material of choice: EPDM, PTFE may have mechanical drawbacks
  • FDA certificate
  • USP cl.VI becomes widely required
Basic Engineering User requirements
  • PFD diagram
  • Layout
  • Main dimensions
  • Automation concept
  • Specification
  • Document requirements (GAMP5, FDA, DATEX)
Detail Engineering Engineering
  • P & I-Diagram
  • Equipment
  • Pipe layout
  • 3D-Planing / Isometrics
  • Equipment datasheets and material purchasing
  • Qualification documents
  • Test protocols & report
  • Test protocols & report
  • Hardware Hardware specification (HS)
  • Wiring diagrams, Part lists
  • I/O lists, Parameter lists
  • Control panel
  • Functional Specification (FS)
  • DCS & PLC software
  • Visualization software
  • Batch software
  • SQL Database
  • Project Quality Plan PQP
  • Qualification Master Plan MQP
  • Design Qualification DQ
  • Installation Qualification IQ
  • Operational Qualification OQ
  • Performance Qualification PQ
Installation and commissioning Turnkey installation of process plants
  • Pipe installation
  • Electrical installation and calibration
  • Instrument air tubing
  • Commissioning
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