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Single Use Wave Bioreactor

The system adopts the design concept of distributed control system,which can meet the process requirements of multi-level scale up.Users can configure flexibly.

We can provide a complete single-use production process solution.

The system adopts intelligent sensors and PID control strategies to meet the precise regulation of dissolved oxygen and pH for different products and different process stages.

The data is saved in the database,which meets the basic requirements of computerized management and data integrity in FDA 21PART 11.

The system provides functions such as multi-level user management,operation records, electronic signatures,formula management,and data reports;

The DCS(distributed control system)design increases the system compactness and realizes digital interconnection and data sharing.

Specification

Single Use Wave Bioreactor

Performance WAVE Mixing tank Spinner Flask/Shake Flask
Comparison
Mixed mode Wavy Immersion stirring Swinging vortex type
Shear force Extremely low High Low
Oxygen transfer area High Middle Low
Oxygen transmission mode Surface wave type oxygen transfer Bubbling oxygen transfer Surface oxygen transfer
Oxygen transmission effect High Middle Low
Dissolved oxygen level High Middle Low
Gas flow meter High precision mass flowmeter Cheap rotameter,low accuracy NA
Cell density(cell/mL) High density,generally >106-7 T CELL perfusion 1~2x107
Insect cell perfusion >108
106-7 Low density,generally1055-6
Cross contamination risk NA High High
Infection probability Low Middle High
Cluture parameter control Automatic feedback regulation pH,DO,Temp, CO₂% Automatic feedback regulation pH,
DO,Temp, CO₂%
NA
Weighing perfusion Integrated weighing and automatic filling NA NA
Working volume Flexible,10-100% Inflexible,50-100% Inflexible,10-30%
Foam Positive pressure,not easy to produce foam Large amount of foam will be 
generated,and a defoamer is required
Less foam
Operation Easy A lot of experience needed Difficult to scale up applicable
Microcarrier technology applicable applicable NA
Micro carrier ball It can be performed directly in the Wave without a digestion reactor The operation is complicated and needs
to be transferred to the digestion reactor.
/
Training environment Ordinary Clean room Clean room
mobility Yes Fixed Yes
Comparison of process scale-up production
Scale up mode 00mL-100L requires only one WAVE,
or multiple 100L WAVES for parallel scale up
Three to four seed tanks are required
for step by step to above 1000L.
Large amount of spinner
flasks/shake flasks
Scale up Easy,fine tune parameters High risk,need to explore again Difficult to scale up
Equipment cost Low High Low
Computer real-time monitoring Yes Yes No
Multi variety R&D and
production platform
Sterile closed piped platform
enables quick change of cell
bags for easy authentication.
Difficult to clean and certificate,
and cross contamination among varieties
Difficulties in
managing certification
Equipment maintenance cost Low High Low
Cost of new workshop 1(Class 10000 trolley room) 10(Class 100 medium workshop) 4(Class 10000 workshop)
Expansion and utilization
of existing workshops
No reconstruction required Redesign and build Extension
Workshop construction Short cycle and low cost Long cycle and high cost Long cycle and high cost
Production cycle Short Long Short
Fixed stainless steel pipe connection No Yes No
Production flexibility High Low Low
Auxiliary production cycle Short Long Long
Plant utilization rate High Low Low
SIP steam No Much No
WFI dosage Very little Much Middle
Cleaning and maintenance cost Extremely low Very high High
Consumables Cell bags(Cell bags of the same cells can be reused) Mixing energy consumption,
pipe sealing,valve gasket,
cleaning solution,WFl,SIP steam
Cell flasks,cleaning
solutions,WFI and
extensive manual work

 

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