Fermentation bioreactor system Esco StirCradle™ -Pro

I. Specification Esco StirCradle™ -Pro large-scale cell culture machine

Intelligent control system:

• Fermentation bioreactor system Esco StirCradle™ -Pro uses SCADA system
• 15” color HMI touch screen with real time 3D view of fermentation/culturing process and user friendly display
• Real-time cultural trend chart data logging. Internal persistent write memory:
  • Up to 12.5 days: 1 data every 30 seconds
  • Up to 25 days: 1 data per minute
  • Up to 50 days: 1 data every 2 minutes
• Fast download via USB in .xls . format
• Optional documentation for compliance with 21 CFR Part 11
• Share remotely via ethernet port or wireless sharing device.

Advanced design of reactor and components:

• Over 70% of the working volume, the tank is designed to eliminate blind spots
• LED light for easy viewing inside the tank
• Many options for transplanting:
  • Advanced Short Quantitative Gateway Rapid Release
  • Bacterial port inoculation
  • Needle diaphragm injection
• Φ25 Standard configurable electrode ports for pH and DO
• All contact surfaces inside the tank are polished with a MP # 400 + EP machine and the outside of the tank with a mechanical MP # 300 + EP machine
• Condenser housing and tubes:
  • Inner material: SUS316
  • Outer pipe: SUS304
• Quick disassembly for cleaning to facilitate cleaning
• The safe design of the pipeline allows for simple disassembly and replacement without affecting the process
• The impeller is designed to effectively achieve a high bubble dispersion rate and kLa . value
• Connection clamp Sanitary clamp Applies to Pressure Sensor, Diaphragm Manometer Port, and Feed Port Preparation.

Built-in configurable pump:

• Four (4) built-in configurable peristaltic pumps for liquid replenishment Each pump can be set as Alkaline, Acid, Feed or Antifoam The pump can be calibrated and the flow can be set using the % speed

Disinfection in place (SIP):

• Automated SIP system for both reactor and culture media
• The SIP program has 5 steps: Heating 1, Heating 2, Sterilizing, Cooling 1 and Cooling 2
• Optional cleaning-in-place (CIP) system.

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

• The authentication package includes the following:
  • Document certificate
  • Production control panel
  • Welding Profile
  • Pressure test report
  • Operating manual
  • Device sketch diagram
  • P&ID chart
  • Power Loop Diagram
  • Ra test report
• Optional IQ/OQ/PQ document.

Other features of the Esco StirCradle™ -Pro fermentation reactor:

• Automated Disinfection in Place (SIP)
• Batch, batch, continuous batch, semi-continuous and high-density batch systems
• Enhanced resistance high torque transmission and rack (SUS304 + EP surface treatment).
• Online repeat sterilization Mechanical shaft seal Dry cartridge sample.
• Sterilizable quick release air duct (Anti-clogging High Dispersion Air Divider), which can be easily disassembled and cleaned.
• High sensitive speed sensor (1,000Hz) using PID Automatic Calculation Feedback Compensated output to Inverter stepless speed change (Rotation speed can be controlled at ±1 rpm).
• Coolant Type Y Filter, Steam Filter, Steam Pressure Reducing Valve, Air Double Side Prefilter Group, and Air Pressure
• Reducing Valve Group.
• Pipeline controller:
  • Sterilization control valve
  • Manifold pipe temperature control
• Sterile ventilation control manifold
  • Pipeline pressure manifolds of the intake control valve metering discharge tank (consisting of four groups/sets)
  • Transfer inoculation control manifold pipeline.
• In the event of a power failure, positive pressure is kept in the tank for more than 24 hours. Parameters can be controlled.

II. Outstanding advantages of fermentation bioreactor system Esco StirCradle™ -Pro

In situ sterilization screen (SIP):

• The SIP screen shows a real-time view of the sterilization process
• Displays the current step of the sterilization process
• Show valve open or close
• Displays current and set values for sterilization parameters: temperature, agitation, air, pressure and time 5-step sterilization process:
• Heating 1 - 100% steam in the heater
• Heating 2 - Steam in heating jacket and air filter
• Cooling 1 - Using air for cooling system down to 50 - 60oC
• Cooling 2 - Uses cold/tap water to completely cool the system
• Disinfection module for both reactor culture media.

Ergonomic display:

• Real-time dynamic display of the culture
• Displays set value and current value of all parameters, valve opening and closing and total volume of liquid added by each pump
• User can switch between automatic and manual control of parameters
• Show total culture time.

Feed settings screen:

• The user can set the flow rate for each pump. Once the flow rate for each pump is set, the flow rate of each pump can be controlled via speed percentage.
• The user can set the pump in one of the following ways:
• On/Off: User controls pump regardless of parameter value
• DO Stat: Pump is controlled by changes in DO value, depending on user-set criteria
• The pH Stat Pump is controlled by the change of the pH value, depending on the criteria set by the user.

Step control setting screen:

• User can set 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.
• The user can select the point on a step program at which the program will start
• 50-step parameter control designed to easily and automate user control of the culture/fermentation process.

Setup and sterilization screen:

• User can set parameter values ​​for sterilization cycle and culture process
• For the sterilization process, the user sets the end temperature for each sterilization step, stirring speed, pressure, airflow and total sterilization time.
• For the culture setting, the user can choose automatic or stepwise control over the parameters:
• Automatic: controlled by user set value (SV)
• Step: controlled by user step setting
• The user can set one of the following DO control modes they require:
• Excitement speed
• Ventilation Control
• Excitation rate -> Air -> O2
• Ventilation -> Excitation rate -> O2
• The user can specify one of the following settings for the peristaltic pump:
• No: no pumping action
• Acid: add acid
• Alkl: alkaline supplement
• AF: added antifoam
• Feed: supplement feed
• Foaming can be controlled with one of two options:
• Anti-foam – except anti-foam
• Defoam - use pressure.

III. Application of Esco StirCradle™ -Pro

• Pilot and scale production of microbial fermentation processes such as yeasts, bacteria and fungi (large-scale bioreactors for culturing bacteria)
• Pilot scale and production of cells such as insect cells and suspended mammalian cells (large-scale bioreactors for suspension culture)
• Pilot and scale production of biopharmaceuticals such as recombinant proteins, vaccines and monoclonal antibodies.

IV. Specifications fermentation bioreactor system Esco StirCradle™ -Pro