Inactivation tank system

The inactivation tank system is a core equipment designed for biopharmaceuticals, vaccine production and biosafety. It is used to inactivate pathogenic microorganisms (such as viruses, bacteria), cell cultures or biologically active substances to ensure that they lose their infectivity or activity while retaining antigenicity or other functional characteristics. The system achieves a safe and efficient inactivation process by precisely controlling temperature, pressure, inactivator concentration and action time, in compliance with GMP, WHO biosafety regulations and FDA 21 CFR Part 610/1271 and other regulatory requirements.

1. Inactivation mechanism and process design

 Moist heat inactivation : Steam heating is used to destroy the protein structure of microorganisms, and the D value (Decimal Reduction Time) is calculated to ensure thorough inactivation (for example, 56°C/30min is required to inactivate the new coronavirus).

Chemical inactivation : The inactivator (such as β-propiolactone) covalently binds to the nucleic acid/protein, and the inactivation efficiency is controlled by the concentration-time integral (CT value).

2. Biosafety protection design

 Double-layer sealing structure : the tank body adopts flange seal + O-ring, and the valve uses diaphragm valve or bellows valve to eliminate the risk of leakage.

 Air tightness verification : Ensure the airtightness of the system through pressure decay test (such as pressure drop ≤1% after maintaining pressure for 30 minutes).

3. Thermodynamics and Fluid Optimization

 Jacket heating/cooling : Steam or cooling water is introduced into the tank interlayer, and the PID algorithm dynamically adjusts the temperature. The heating rate is controllable (such as 1°C/min).

 Turbulence suppression : The deflector design inside the tank reduces eddies and avoids local temperature/concentration gradients.

4. Automation and intelligent control

 PLC/SCADA system : preset inactivation procedures (such as gradient heating, staged inactivation), supporting one-button start and emergency shutdown.

5. Material and compatibility design

 Corrosion-resistant material : The part that contacts the inactivator is made of 316L stainless steel, Hastelloy, and PTFE to resist corrosion from formaldehyde, strong acids, and strong alkalis.

 Biocompatibility : The inner wall of the tank is electropolished (Ra≤0.5 μm) to avoid protein adsorption or residue.

6. Modularity and scalability

 Multi-tank parallel connection : supports multiple inactivation tanks in series/parallel operation to improve the efficiency of large-scale production (such as vaccine stock inactivation).

 Upstream and downstream integration : connected with the fermentation system and purification system through sterile pipelines to achieve continuous production.

1. Inactivation process control

Temperature-time coordinated control : During moist heat inactivation, precise control of temperature (50°C–121°C) and duration (minutes to hours) ensures complete inactivation of viruses/bacteria.

 Chemical inactivator addition : A high-precision metering pump quantitatively adds inactivators (such as β-propiolactone), with a concentration error of ≤±2%, and supports dynamic neutralization (such as sodium thiosulfate to terminate the reaction).

2. Mixing and homogeneity assurance

 Low-speed stirring : magnetic stirring or paddle stirring (speed 10–200 rpm) to ensure full contact between the inactivator and the material to avoid local uneven concentration.

 Circulation system : The internal circulation pump promotes liquid flow and is suitable for large-volume inactivation (such as hundreds of liters of fermentation liquid).

3. Online monitoring and security protection

 Key parameter monitoring : Real-time detection of temperature, pressure, pH value, and inactivator concentration. If the limit is exceeded, an alarm will be triggered and the process will be automatically terminated.

 Negative pressure control : The HEPA filter exhaust system maintains negative pressure in the tank (-10~-50 Pa) to prevent aerosol leakage.

4. Cleaning and Sterilization

 Online cleaning (CIP) : Multiple spray balls cover the tank and pipelines, and the cleaning liquid (NaOH, H2O2) is circulated for flushing, and the residual amount is ≤0.1%.

 Sterilization in Place (SIP) : Pass pure steam (121°C/30min) or chemical fumigation (VHP) to ensure the sterility of the tank.

5. Data integrity and traceability

 Electronic batch records : Automatically record inactivation process parameters (temperature curve, inactivator addition amount, operator), in compliance with ALCOA+ principles.

 Inactivation verification support : Integrate biological indicator (such as Bacillus subtilis spores) culture and detection interface to verify the effectiveness of inactivation.

· Vaccine production : virus inactivation (such as rabies vaccine, new coronavirus inactivated vaccine), bacterial toxin inactivation.

· Blood products : Inactivation of pathogens in plasma/serum (such as HIV, HBV).

· Cell therapy : Inactivation of CAR-T cell cultures (ensuring no residual live cells).

· Biosafety laboratory : inactivation of highly pathogenic microbial waste.