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Module

Module

  • Depending on the requirements of respective process & culture, BAPS designed Fermenter / Bioreactor can be provided with the supply of Air, N2, O2 and CO2.
  • Individual MFCs having Individual gas line (except nitrogen line).  A flow meter with control valve also can be given with smart process automation.

  • Rota meter on bypass line to ensure uninterrupted gas supply in case of failure of MFC.
  • PRVs, NRVs & isolation valves on each gas line.

  • Individual or common 0.2 filter for sparger & overlay line with independent SIP / CIP options with design for qualification/validation.
  • CASACDE mode for control & maintaining p02 with selectable Air flow, agitation, back pressure and O2.
  • Removable ring sparger or sintered stainless steel 316L Micro sparger - 20 μm pore size.
  • Flexibility of changing sparger as per process requirements.

  • 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.


  • Empty vessel sterilization clean steam is directly introduced in vessel through spray balls, complete system is sterilized by taking out the steam from all auxiliary lines/valves & sterile boundaries. Temperature sensor & steam trap at coldest spot in the system drain.
  • Full vessel sterilization /FSIP with indirect heating by putting plant steam in jacket.
  • A variety of options can be given with open loop or Closed-loop pressurized water system with a circulation pumps.

  • Plate heat exchanger for cooling and a PIP stainless steel heat exchanger for heating for temperature control.
  • Temperature sensor, safety relief valve, pressure gauge, jacket drain facility with air inlet or a jacket drain.
  • Completely automated or semi-automatic system design options are possible.

  • 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.

Advantages:

  • 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.

Baffles:

  • 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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