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StirCradle™-Pro Large Scale Stirred Tank Bioreactor

Stirred Tank Bioreactor Partner

The StirCradle-Pro is a fully stainless steel fermenter/bioreactor system designed with an automated 5-step cycle SIP system for both culture medium and reactor vessel. Esco VacciXcell offers a wide range of large scale bioreactors capacities from 20L up to 1000L. However, customized reactor sizes are available should the users require a customized bioreactor for large scale culture of cells.

StirCradle-Pro features various advanced design and assembly to facilitate the fermentation/culture process including reactor design that eliminates blind spots and increases oxygen retention rate, lifting system for easy cleaning of reactor vessel, and LED light for easy viewing within the culture tank.

Esco VacciXcell simplifies scale up from the laboratory to pilot and production scale by providing analysis data as reference for scale-up conditions. Apart from customized sizes, Esco VacciXcell also offers parametric programming and special vessel development to help speed up the experiment. Esco Vaccixcell offers complete documentation of system parts.

Features

  • Uses SCADA system
  • 15” Touch Screen Colored HMI with real-time 3D view of the fermentation/culture process and user-friendly display
  • Real-time culture trend chart data logging. Internal continuous recording storage:
    • Up to 12.5 days: 1 data every 30seconds
    • Up to 25 days: 1 data every minute
    • Up to 50 days: 1 data every 2 minutes
  • Quick download via USB in .xls format
  • Optional documentation for 21 CFR Part 11 compliance
  • Remote sharing via ethernet port or wireless sharing device
  • Above 70% working volume, tank designed to eliminate blind spots
  • LED light for easy viewing inside the tank
  • Multiple options for inoculation:
    • Quick Release Enhanced Short-Necked Dosing Port
    • Combustion Implant Bacteria Port
    • Diaphragm needle injection
  • Φ25 Standard Configurable Electrode Ports for pH and DO
  • All the contact surfaces inside the tank are polished by mechanical MP#400+EP and outside the tank by mechanical MP#300+EP
  • Shell and Tube Condenser:
    • Inside Material: SUS316
    • Outside Piping: SUS304
    • Sanitary Quick Disassembly to Facilitate Cleaning
  • Safe design of pipings allow simple disassembly and replacement without affecting the process
  • Impellers are designed to achieve high bubbles dispersion rate efficiency and kLa value
  • Sanitary Clamp Joint Clips Applied to Pressure Sensor, Diaphragm Type Manometer Port, and Prepare Feed Port.
  • Four (4) built-in configurable peristaltic pumps for fluid addition
  • Each pump can be set as either Alkali, Acid, Feed or Antifoam
  • Pump can be calibrated and flow can be set using speed%
  • Automated SIP system for both reactor vessel and culture medium
  • SIP program features 5 steps: Heating 1, Heating 2, Sterilization, Cooling 1, and Cooling 2
  • Optional Cleaning-in-Place (CIP) system

Esco VacciXcell provides a thorough validation and documentation package for StirCradle™-Pro

  • Validation Packages is inclusive of the following:
    • Material Certificate
    • Production Control Table
    • Welding Record
    • Pressure Testing Report
    • Operation Manual
    • Equipment Outline Chart
    • P&ID Chart
    •  
    • Electrical Loop Chart
    • Ra Testing Report
  • Optional IQ/OQ/PQ documentation
  • Automated Sterilization-In-Place (SIP)
  • Batch, fed-batch, continuously-batch, semi-continuous and high-density batch systems
  • Enhanced High Resistance Torque Bearing Transmission Unit and Transmission Bracket (SUS304+ Surface EP Processing).
  • Online Repeatable Sterilization Dry-Type Cartridge Pattern Mechanical Shaft Seal.
  • Sterilizable Quick Release Air Pipe (Anti-Clogging Highly Dispersed Air Sparger ), can be easily removed and cleaned.
  • High Sensitivity Speed Sensor (1,000Hz) using PID Automatic Calculation Feedback Compensated Output to Stepless Speed Change Inverter (Can Control Rotational Speed at ±1rpm ).
  • Cooling Water Y Type Filter, Steam Filter, Steam Pressure Reducing Valve, Air Duplex Preliminary Filtrate Group and Air Pressure Reducing Valve Group.
  • Pipe control unit:
    • Sterilization control valve
    • Temperature control piping manifolds
    • Sterile ventilation control piping manifolds
    • Exhaust tank pressure piping manifolds dosing the fed control valve (of four groups /sets)
    • Transfer transmission inoculation control manifolds pipeline.
  • In case of power outage, positive pressure is kept in the vessel for more than 24 hours. Parameters can be controlled

Applications

  • Pilot and production scale of fermentation processes of microorganisms such as yeast, bacteria, and fungi (large scale bioreactor for bacterial culture)
  • Pilot and production scale of cells such as insect cells and suspended mammalian cells (large scale bioreactor for suspension culture)
  • Pilot and production scale of the manufacturing of biopharmaceuticals such as recombinant proteins, vaccines, and monoclonal antibodies

Highlights

Sterilization in Place (SIP) Screen
Culture Screen
Feed Setting Screen
Step Control Setting Screen
Sterilization and Culture Setting Screen

Sterilization in Place (SIP) Screen

  • SIP screen shows real-time view of sterilization process:
    • Shows the current step of the sterilization process
    • Shows open or close valves
    • Shows the present and set values for sterilization parameters: temperature, agitation, air, pressure, and time
  • 5-step sterilization process:
    • Heating 1 – 100% steam in heating jacket
    • Heating 2 – Steam in heating jacket and Air filter
    •  
    • Cooling 1 – Use of air for cool down system to 50 – 60oC
    • Cooling 2 – Use of chilled water/tap water to completely cool down system
  • Sterilization modules for both reactor vessel culture medium

Culture Screen

  • Real-time dynamic display of culture process
  • Shows the set value and present value of all parameters, open and closed valves, and total volume of liquid added by each pump
  • Users can switch between automatic and manual control of parameters
  • Shows the total culture time

Feed Setting Screen

  • Users can set the flow rates for each pump. Once flow rate for each pump is set, flow of each pump can be controlled via speed percentage.
  • Users can set the pump as one of the following:
    • On/Off: Users control pumping without depending on parameter values
    • DO Stat: Pumping is controlled by changes in DO value, depending on the criteria set by the user
    • pH Stat Pumping is controlled by changes in pH value, depending on the criteria set by the user

Step Control Setting Screen

  • Users can set a 50-step control program for temperature, agitation, pH, DO, aeration, and feeding
  • Up to 20 step programs can be saved for each parameter. Saved programs can be loaded, modified and deleted.
  • Users can select the point on a step program at which the program will begin
  • The 50-step parameter control is designed to ease and automate user control of the culture/fermentation process

Sterilization and Culture Setting Screen

  • Users can set the parameter values for the sterilization cycle and culture process
  • For the sterilization process, users set the end temperatures for each sterilization step, agitation speed, pressure, airflow, and total time of sterilization.
  • For culture settings, users can choose to have automatic or step control of the parameters:
    • Automatic: controlled by the set value (SV) of the user
    • Step: controlled by the step setting of the user
  • Users can set one of the following DO control modes they require:
    • Agitation speed
    • Vent Control
    • Agitation speed -> Air -> O2
    • Vent -> Agitation speed -> O2
  • Users can designate one of the following settings for the peristaltic pumps:
    • None: no pump action
    • Acid: acid addition
    • Alkl: alkali addition
    • AF: antifoam addition
    • Feed: feed addition
  • Foaming can be controlled using one of the two options:
    • Antifoam –addition of antifoam
    • Defoam – use of pressure
Frequently Asked Questions
Airflow rate control is achieved by mass flow controller (MFC).
Foaming can be controlled in 2-ways: (1) using antifoam as surfactants, and (2) putting pressure on top to prevent foaming. Using antifoam should be done in consideration with sensitivity of the cells. Natural surfactants can also be considered as they are often non-toxic.
StirCradle-Pro is a bioreactor for large scale culture of cells designed with an impeller system for balancing and mixing of microorganisms to achieve a homogenous concentration inside the bioreactor.
Microbial and suspension cell lines can also be cultured in large scale stirred tank bioreactors.
StirCradle-Pro is applicable as a large scale bioreactor for bacterial culture and suspension culture in batch, fed-batch, continuously-batch, semi-continuous, and high-density modes.
Setpoints for control parameters vary between cell lines, strains, and microorganisms. Hence, these need to be optimized for the particular process.
Dual impeller configuration is usually recommended for large scale bioreactors. Studies can be performed to determine the best configuration via kLa values.
No, comb type foam breaker is not applicable for the agitator of StirCradle-Pro.

Product Specification

StirCradle™-Pro

GENERAL SPECIFICATION
Features Unit StirCradle™-Pro 20 StirCradle™-Pro 30 StirCradle™-Pro 50 StirCradle™-Pro 100 StirCradle™-Pro 200 StirCradle™-Pro 500 StirCradle™-Pro 1000
Nominal Volume L 20 30 50 100 200 500 1000
Total Volume L 25 34 56 126 220 620 1120
Working Volume L 15 20 35 75 150 400 750
Tank Inner Diameter (D) mm 260 260 310 400 480 680 830
Tank Depth mm 450 620 730 980 1200 1650 2000
Mixing Blade Diameter NA D/3 D/2.5 D/3 D/2.5 D/3 D/2.5 D/3 D/2.5 D/3 D/2.5 D/3 D/2.5 D/3 D/2.5
mm 87 104 87 104 103 124 133 160 160 192 227 272 277 332
Agitation Speed rpm 80-1000 80-1000 80-800 60-600 60-600 60-550 40-400 30-300
Precision rpm ±1
Blade tip maximum speed m/s 3.6 4.4 3.6 4.4 4.4 5.2 4.2 5 5 5 5.9 5.7 5.8 5.2
pH Range NA 0-14
Precision NA ±0.01
Temperature Precision °C ±0.01
Heating NA Hot water tank
Cooling NA Tap or Chilled water tank
Dissolved Oxygen Range % 0 - 200
Precision % Display: ±0.1 | Control: ±0.2-0.5
Noise Level dBA <100
Air flow (0.3 kg/cm2 culture) wm 2.3 2.3 2 2 2.1 2 2.2
Total electricity demand 220 V, 3Φ A 7 8 10 20 35 60 100
Steam demand (2 kg/cm2-G 133°C kg/hr 15 20 30 60 130 250 300
Air Demand (2 kg/cm2-G 1/min 36 48 75 159 333 848 36
Cooling Water Demand (2 kg/cm2-G 20°C m3/hr 0.3 0.4 0.5 0.8 1.5 2.5 4
Continue Caliber Stream A 8 10 10 15 25 25 25
Air A 8 10 10 15 20 25 40
Water A 8 10 10 15 20 25 25
Fermenter Sterilization Sterilization-in-Place (SIP)