Fermentation Tank Technical Parameters

1. Basic Parameters

Volume Range:

• o Lab Scale: 5–100 L (glass/stainless steel)
• o Pilot Scale: 100–5,000 L
• o Industrial Scale: 5,000–200,000 L (50 m³ standard common)

Design Pressure:

• o Vessel: -0.1~+0.35 MPa (vacuum to low pressure)
• o Jacket: 0.3~0.6 MPa (steam or circulating water)

Design Temperature:

• o Vessel: 0–150°C (sterilization requires 121°C)
• o Jacket: 5–150°C

Materials:

• o Main Body: 316L stainless steel (corrosion-resistant, polish Ra≤0.6μm)
• o Seals: Silicone/EPDM/PTFE (FDA compliant)
• o Sight Glass: Borosilicate glass (temperature and pressure resistant)

2.Agitation System

Impeller Types:

1. o Radial Flow: Rushton turbine (high shear, suitable for mycelia)
2. o Axial Flow: Pitched blade/propeller (low shear, suitable for mammalian cells)
3. o Combination: Multi-layer impellers (balances oxygen transfer and mixing)

Power Configuration:

Drive Seals:

1. o Mechanical Seal: Double-sided (sterilizable, life >5,000 h)
2. o Seal Fluid: Food-grade glycerin or synthetic oil

3.Aeration and Oxygen Transfer

Aeration System:

1. o Sparger: Ring pipe/microporous sintered (bubble diameter 0.5–2 mm)
2. o Airflow Control: Mass flow meter (accuracy ±1% FS)
3. o Sterile Filtration: 0.22 μm hydrophobic filter

Oxygen Transfer Capacity:

1. o kLa Range: 10–300 h⁻¹ (optimized by agitation and aeration)
2. o DO Probe: Polarographic/optical (high-temperature sterilization resistant)

4.Control System

Basic Monitoring Points:

1. o Temperature: PT100 (control accuracy ±0.5°C)
2. o pH: Gel electrode (automatic acid/base addition)
3. o DO: 0–100% air saturation
4. o Level: Weight/differential pressure/capacitive

Automation Functions:

1. o CIP/SIP: Fully automated cleaning and sterilization (temperature/pressure sequence control)
2. o Feed Control: Peristaltic/diaphragm pump (quantitative or feedback control)
3. o Data Logging: Complies with FDA 21 CFR Part 11

5.Hygienic Design

Surface Treatment:

1. o Internal Polish: Ra≤0.6 μm (mirror finish, prevents fouling)
2. o External Treatment: Matte or sandblasted (Ra=0.8–1.6 μm)

Connections:

1. o Quick Connections: DIN 11851/ISO 2852 standard
2. o Dead Leg-Free Design: All pipes sloped >3°

6.Validation Requirements

Factory Acceptance Test (FAT):

1. o Pressure Test: Hold at 1.5× design pressure for 30 min
2. o Leak Test: Helium leak check (leak rate <1×10⁻⁶ mbar·L/s)
3. o Vibration Test: Bearing vibration <4.5 mm/s

Site Validation (IQ/OQ/PQ):

1. o Installation Qualification: Pipe slope, instrument calibration
2. o Operational Qualification: Agitation power, oxygen transfer performance
3. o Performance Qualification: Blank medium sterilization test

7.Selection Guidelines

Cell Type:

1. o Microbial: High kLa, high power input
2. o Animal Cells: Low shear, microcarrier compatible
3. o Plant Cells: Low shear, high DO requirement

Process Needs:

1. o Batch/Fed-Batch: Consider feed and sampling ports
2. o Scale-Up: Maintain constant kLa or P/V