Fermenter_Stirred Tank Bioreactor StirCradle Pro

VacciXcell completes its bioprocessing solutions by providing a system for the fermentation of microorganisms and culture of suspension cells – StirCradle™ and StirCradle™-Pro. The StirCradle is the laboratory-scale autoclable system while the StirCradle-Pro is the SIP pilot/production scale system.

VacciXcell offers a wide range of fermenter sizes, starting from 5L laboratory scale all the way to 2000L production scale.

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. VacciXcell offers a wide range of standard reactor capacities from 20L up to 1000L; however, customized reactor sizes are available should the users require.

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.

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, VacciXcell also offers parametric programming and special vessel development to help speed up the experiment. Vaccixcell offers complete documentation of system parts.

Features

Smart Control System

• 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

Enhanced Design of Reactor Vessel and Components

• 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.

Built-in Configurable Pumps

• 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%

Sterilization-in-Place (SIP)

• 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

Validation and Documentation

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

Other Features

• 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
• Pilot and production scale of cells such as insect cells and suspended mammalian cells
• Pilot and production scale of the manufacturing of biopharmaceuticals such as recombinant proteins, vaccines, and monoclobal antibodies