Model No. BIS-0001
Upstream Bioprocess System上游生物工艺系统
- Working volume
- 0.1–2,000 L
- Temperature range
- 15–45 °C, ±0.2 °C
生物工艺系统
Bioprocess Systems
生物工艺系统
Bioprocess Systems — Biotechnology Equipment
Bioprocess systems move a product from cell culture through recovery and purification under controlled, documented conditions. We configure upstream and downstream skids, single-use systems, perfusion setups and automated control layers. Most orders are engineered to a process description, so early discussion saves redesign later. Regulated buyers typically reference ICH Q7, Parts 11 and 211 of 21 CFR, and EU GMP Annexes 1 and 11.
5 models
Range code BIS
OEM available
Applicable standards
EU GMP Annex 1
EU GMP Annex 11
21 CFR Part 11
21 CFR Part 211
ICH Q7
ICH Q11
USP <1050>
USP <661>
IEC 61010-1
How to specify
- Send your process flow diagram and working volumes with the inquiry.
- Decide early between stainless, single-use or a hybrid approach.
- Ask what qualification documents are included with delivery.
Models in this range
5 models
Model No. BIS-0002
Downstream Bioprocess System下游生物工艺系统
- Flow rate
- Up to 1,500 cm/h (column dependent)
- Operating pressure
- Up to 0.5–1.0 MPa
Model No. BIS-0003
Single-Use Bioprocess System一次性使用生物工艺系统
- Bag volume
- 1–2,000 L
- Bag material
- Multi-layer polyethylene film
Model No. BIS-0004
Perfusion Bioprocess System灌流生物工艺系统
- Working volume
- 1–2,000 L
- Perfusion rate
- 0.5–5 vessel volumes per day
Model No. BIS-0005
Automated Bioprocess Control System生物工艺自动化控制系统
- Control hardware
- PLC or DCS with I/O modules
- Control loops
- Up to 32–128 analog loops