UniFuge® Pilot

Small Footprint

The UniFuge has a small footprint.

Confidently Scale Up, Down or Out

The accurate transfer of operating protocols to the UFMini® or U2k® is streamlined as you move from early-stage development to commercial manufacturing and licensure.

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 U.S. facility, following the highest standards of quality control.

Instrument

• Bowl capacity: 1.8 L
• Flow rate from 1-4 L/min (higher flow rates may be achieved, based on application)
• Processing up to 4 L/min
• Variable speed from 300 to 4,000 x g
• Integrated trolley
• Designed for use at room temperatures (jackets available)
• 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 touch screen

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
• Compliant with ISO 11137 to SAL 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)
• Reduce HCP and other contaminants

How It Works

The UniFuge is completely automated with flexible cycle parameter entry. The feed suspension is gently pumped to the module and the cells settle to the outer radius while the clear supernatant is continuously discharged. Once the module has filled with cells, the controller stops the rotor and discharges the cells. This cycle is repeated until the bioreactor volume has been processed.

Automation and General Specifications

• Total skid weight of 291 kg (690 lbs)
• Allen-Bradley® PLC
• Maximum case pressure (for cooling) 6.9 bar (100 psi)
• Center feed for low shear operation
• Concentric tubes to introduce feed and remove supernatant
• PCV up to 25%

Utility Requirements

• Power configurations: 120/230 VAC, 50/60 Hz, 1 Ph, 10 A
• Optional: 120 VAC, 50/60 Hz, 1 Ph, 20 A
• Pneumatic: Clean, dry air supply 4.5-6.6 bar (65-95 PSI), 57 SLPM (2 SCFM)

Single-Use Module

• 1800 mL single-use modules with 12 mm (1/2”) ID x 19 mm (3/4”) OD Silicone tubing
• Continuous discharge of supernatant and intermittent discharge of cell culture
• Components compliant with physiochemical tests: intermittent discharge of cell culture: 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