Pro-single-use bioreactor adopts a bottom-stirring tank design, which can realize linear scale-up from 50L to 2,000L. Combined with 3D disposable cell culture bags independently developed and manufactured by Duoning, their bioreactors feature good biocompatibility, together with a flexible connection design, they can meet all requirements of complex upstream processes; their unique combination design of stirring and ventilation, not only reduce shear but also ensure excellent mass transfer and mixing performance, thus achieving good consistency during scaling-up. The Pro single-use bioreactors can be widely used in various stages from process development to GMP production of biopharmaceuticals.
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Pro Single-Use Bioreactor
- The cell culture bag features good biocompatibility, extremely low extractable and leachable, and ensures the safety of the product. All materials in contact with the product have passed the relevant validation requirements of CFDA for single-use systems and meet USP standards.
- The system is designed with Siemens PLC+ WinCC system, can be connected to SCADA data management system, all data can be recorded and exported, and supports audit trail, while complying with 21CFR Part 11 regulations.
- The system integrates an optical dissolved oxygen sensor with a DO resolution of 0.1% and control accuracy of ±2%, a pH resolution is 0.01 with a control accuracy of ±0.02; and a temperature resolution is 0.1°C with a control accuracy of ±0.5°C; the weighing accuracy is ±3‰ with pressure accuracy ±of 2%.
- The default configuration provides 3 channels of gas supply: macro-sparge bottom gas supply (0.05 vvm oxygen, 0.05 vvm air, 0.025 vvm carbon dioxide), micro-sparge bottom gas supply (0.025 vvm oxygen), overlay gas supply (0.05 vvm oxygen, 0.05 vvm air). All use Swiss Vogtlin or German Bürkert mass flowmeter.
- 2-way exhaust heating as standard (depending on the model of the culture bag); magnetic coupling stirring device with the inclined angle at the bottom, speed 0-300 rpm, temperature control ranges 20-50 ℃.
- Mettler-Toledo high precision load cell unit.
- The cell culture bag features good biocompatibility, extremely low extractable and leachable, and ensures the safety of the product. All materials in contact with the product have passed the relevant validation requirements of CFDA for single-use systems and meet USP standards.
- The system is designed with Siemens PLC+ WinCC system, can be connected to SCADA data management system, all data can be recorded and exported, and supports audit trail, while complying with 21CFR Part 11 regulations.
- The system integrates an optical dissolved oxygen sensor with a DO resolution of 0.1% and control accuracy of ±2%, a pH resolution is 0.01 with a control accuracy of ±0.02; and a temperature resolution is 0.1°C with a control accuracy of ±0.5°C; the weighing accuracy is ±3‰ with pressure accuracy ±of 2%.
- The default configuration provides 3 channels of gas supply: macro-sparge bottom gas supply (0.05 vvm oxygen, 0.05 vvm air, 0.025 vvm carbon dioxide), micro-sparge bottom gas supply (0.025 vvm oxygen), overlay gas supply (0.05 vvm oxygen, 0.05 vvm air). All use Swiss Vogtlin or German Bürkert mass flowmeter.
- 2-way exhaust heating as standard (depending on the model of the culture bag); magnetic coupling stirring device with the inclined angle at the bottom, speed 0-300 rpm, temperature control ranges 20-50 ℃.
- Mettler-Toledo high precision load cell unit.