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

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.

Specifications

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
The Right Material for Upstream Process	Elastomers	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
	Hardware	Test protocols & report Hardware Hardware specification (HS) Wiring diagrams, Part lists I/O lists, Parameter lists Control panel
	Software	Functional Specification (FS) DCS & PLC software Visualization software
	Qualification	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