Single Use Centrifuge For Cell And Gene Therapy:  UFMini

• Compact Size
  • Small footprint is perfect for early-stage process development, ​​process characterization and small volume commercial production.
• Confidently Scale Up
  • Accurately transferring operating protocols to the UniFuge® or U2k® is straightforward as you move from early-stage development to commercial manufacturing.
• Streamline Processes
  • Uses a sterile single-use module that is easy to install and replace after each run.
• Performance
  • Low-shear centrifugation allows for high-quality and high-recovery separation.
• Save Time
  • Easily incorporated into a fully-automated workflow and significantly reduces processing time.
• Efficiency
  • Software and automation minimize process upsets and errors.
• Minimize Contamination Risks
  • This single-use, closed system reduces contamination risks. It provides flexibility for multi-product facilities.
• Stop-N-Go
  • The UniFuge systems are designed to resume and recover from an interrupted process without product loss.
• Cell Washing
  • The UniFuge systems can hold materials in the bowl for washing and buffer exchanges.
• Reliable
  • Built in a state-of-the art US facility, following the highest standards of quality control.

Instrument

• Bowl capacity: 300mL

• Flow rate from 29-1000 mL/min

• Processing up to 1 L/min

• Variable speed up to 4,000 x g

• Designed for fluid transfer with temperatures in the range of 4-38 °C (39-100 °F)

• Optional data acquisition for SCADA System via Ethernet connection

• cGMP-compliant 21 CFR Part 11 data trail

• Low noise level (below 80 dB) during operation

• Instrument built in a state-of-the-art ISO 9001 US facility, following the highest standards of quality control.

• Fully-automated, intuitive software

• PLC color touchscreen

Single-use Modules

• Lightweight single-use module with integral tube set

• Predictable supply chain with multiple manufacturing facilities in the United States

• Gamma-irradiated

• Extractables data available

• SAL level 10-6

• Continuous discharge of supernatant and intermittent discharge of cell culture

• Modules can be tube-welded to single-use bioreactor connections. Customer-specified single-use connectors are available upon request.

How It Works

The UFMini is completely automated with flexible cycle parameters. The feed suspension is gently pumped to the separation zone of the single-use module and the cells centrifugally settle to the outer radius, while the clarified supernatant is continuously discharged. Once the user-programmed cycle timer has expired, the controller stops the rotor and discharges the cells. This cycle automatically repeats for a user-selectable number of cycles, based upon bioreactor volume.

Automation and General Specifications

• Allen Bradley® PLC

• Allen Bradley® HMI Touchscreen 22.9 cm (9”) - 16:9 aspect ratio

• Fluid connections on left front side of machine; utility connections on right side

• High cell density

• PCV up to 25%

Utility Requirements

• Power configuration: Single phase universal power supply 100 to 240 volts, 50/60 Hz, suitable for global use, including:

  • US: 120V/60 Hz, 6.3 A

  • Europe: 230V/50 Hz, 3.1 A

  • Japan: 100V/60 Hz/50 Hz, 7.5 A

• Pneumatic: Clean, dry air supply 4.5-6.6 bar (65-95 psi), 57 SLPM (2 SCFM)

Single-Use Module

• 300 mL single-use module with 6 mm (1/4”) ID and 9.5 mm (3/8”) OD Silicone tubing

• Continuous discharge of supernatant and intermittent discharge of cell culture

• Components compliant with physiochemical tests: USP <87> <88> Class VI, USP 661 (or ISO 10993) for plastic materials

• Center feed for low-shear operation

• Concentric tubes to introduce feed and remove supernatant

• Gamma-irradiated - SAL level 10-6