- Exhaust module designed with completely drainable Exhaust Condenser/Shell & tube HEX with chilled water Inlet/outlet, Pipe in pipe heater with steam inlet& condensate drain
- 0.2-micron filter with provision of independent SIP / CIP, it is designed to meet qualification & validation requirements.
- PID controlled back pressure control valve is provided with bypass arrangements.
- As per process requirements, system can be designed any Nos. of aseptic addition ports for Media, Inoculum, Antifoam, Acid, Alkali, Nutrient Feed and Inducer.
- Each aseptic addition port with 4 valve assembly or 6 valve assembly can be designed for sterilization in place.
- All possible designs can be given either with 2-way diaphragm valves, tandem valve, block valves or disposable colder valves.
- System can be provided with integrated variable speed or fixed speed peristaltic pumps for additive transfer.
- In case of Bioreactor, media sterilization can be provided with0.2-micron liquid filter for cell culture application, with provision of independent SIP / CIP, it is designed to meet qualification & validation requirements.
- Extremely important part in any process solutions & especially in Fermenter/Bioreactor. Agitation or Mixing is required for effective mass transfer of nutrients, gases, & temperature maintenance. The cell line dictates the choice if impeller & its RPM
- BioAspire can provide appropriate type of agitator & mounting as per process requirements & need of the cells.
Top mounted agitation:
- Mechanical agitators with dry seal or double mechanical wet seals.
- High shear resistant microbial cell culture: Rushton turbine impellers. Advanced BT-6 for effective mass transfer and power consideration.
- Shear sensitive culture :3-blade segment impellers are specifically designed for use in shear sensitive cell cultures. The impeller creates an axial flow to achieve homogenous and thorough mixing of the culture media.
- Removable and adjustable 3-blade segment impeller. Pitched at an angle and thus direct the liquid flow towards the base of the tank.
- Ineffective at breaking up bubbles and thus unsuitable for use in aeration of bacterial fermentations.
Bottom mounted agitation:
Bottom mounted mechanical or magnetic agitator and magnetic mixers.
- Bottom driven agitator requires less clearance
- Magnetic motor does not require any separate mechanical seal
- Segment impeller, axial mixing with low shear
- Absolutely tight/close system
- No influence on the integrity of the system
- Easy cleaning and sterilization
- Low shearing force &Careful mixing allows handling of sensitive products e.g. proteins, cells, blood fractions or factors.
- To break a vortex in terms of top mounted agitators, baffles are important
- Baffles ensure proper mass transfer.
- Fixed or removable baffles as an available options
- In case of a double mechanical seal, System can be provided with thermosyphon pot to generate & store sterile condensate. The seal is lubricated by pressurized sterile condensate. along with all required valves, temperature sensors and pressure switch.
- Unique design of a 0.02-micron sterile filter assembly provided to protect the seal in absence of pure steam.
- In situ sterilizable pH sensor from side wall port at minimum mixing level.
- Acid and alkali dosing bottles with aseptic design
- Acid & alkali dosing pumps integrated with the system.
- In case of Bioreactors CO2 supply with /without MFC
- Aseptic addition ports with provision for sterilization qualification & validation.
- Foam sensor from the top port.
- Antifoam dosing bottle with aseptic design
- Antifoam dosing pump integrated with the system
- Mechanical Foam Breaker if required.
- Smart process automation for aeration & agitation.
- A design for an aseptic sampling equipped with flushed sampling valve for manual sampling with inbuilt provision for independent SIP / CIP activities meeting the requirements of qualification & validation.
- Both the options of Multiple use /reusable autoclavable assembly or disposable bags with multiport & NA connection can be possible.
- An aseptic harvest and transfer with pneumatic or manual flushed harvest/bottom valve.
- Fully automatic OR semi-automatic harvest process sequence with independent SIP / CIP , activities meeting the requirements of qualification & validation.
Process automation features
- Smart Process automation/control logic designed by experts from hands on process experience.
- In-house designing of logic to program, interlocks, process alarms.
- Designed to meet process, user, GMP requirements.
- All possible options of PLC, HMI, SCADA automation architectures meeting user’s requirements, clean room layouts & budgets. Designed with advanced platforms.
- Precise control of CPPs.
- Real time comparison of batch parameters with reference Golden Batch.
- 21 CFR, Part 11 compatibility and integral features of Audit trails as per client’s regulatory needs.
- Smartly designed control panels with all possible options of communications.
- Advanced features of Web hosting for remote monitoring of the process.
- Remote assistance for online troubleshooting.
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