Fermenter
BRIEF INTRODUCTION
Standalone Positioning
Independently completes the sterilization and fermentation / cultivation process, fully meeting GMP requirements for standalone production.
Applicable Capacity & Specifications
Working Volume Range: 30 – 10,000 L (filling ratio 70–80%)
Production Capacity: Batch cycle 5–7 days
Process Flow
Manual Charging / Charging via Inlet Port → [Integrated Process of This Unit: In-situ Steam Sterilization → Parameter Setting → Automatic Fermentation & Cultivation] → Discharge
Key Performance Parameters
| Item | Specification | Remarks |
|---|---|---|
| Temperature Control Accuracy | ±0.2 °C | PID closed-loop control |
| Sterilization Temperature | 121 °C | In-situ SIP |
| Operating Pressure | 0.15 MPa | Design pressure: 0.3 MPa |
| Yield Rate | ≥99.9 % | Batch acceptance rate |
| Changeover Time | ≤30 min | Sanitary clamp / tool-free |
| Noise Level | ≤75 dB(A) | Measured at 1 m |
Construction & GMP Design
316L stainless steel vessel and frame, internal surface finish Ra ≤0.4 μm, external surface Ra ≤0.8 μm, with no hygienic dead zones.
Fully enclosed top cover with tempered glass sight window; all seals made of pharmaceutical-grade EPDM / PTFE.
Sanitary clamp connections, supporting online CIP/SIP, with cleaning coverage ≥99%.
Control System
Siemens S7-1200 / S7-1500 PLC + color touchscreen HMI, ≥50 recipes.
21 CFR Part 11 compliant: audit trail and USB/PDF batch record export.
Reserved OPC UA interface for integration with MES / LIMS.
Utility Requirements
| Item | Requirement | Interface Standard |
|---|---|---|
| Power Supply | AC 220 / 380 V, 50 Hz | Industrial plug |
| Purified Water | ≥0.3 MPa, ambient temperature | Sanitary clamp |
| Water for Injection (WFI) | ≥0.3 MPa, 70–80 °C | Sanitary clamp |
| Compressed Air | Oil-free & dry, 0.6–0.8 MPa | ISO 8573-1:2010 [1:3:2] |
| Steam | ≥0.3 MPa, saturated steam | Sanitary clamp |
BIOTECH-10BS
BIOTECH-100BS
BIOTECH-100JS
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