UniFuge® Product Family
UniFuge® Pilot Single-Use Centrifugation
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Product overview

Single-Use System

The UniFuge® Pilot uses a gamma-irradiated, single-use module to eliminate cleaning needs. It is designed for primary clarification of mammalian cell cultures (e.g., CHO cells), and harvesting (including washing and concentrating) stem cells and other types of cells for biotechnology and pharmaceutical applications.
  • Bowl capacity: 1.8 L
  • Flow rate from 1-4 L/min (higher flow rates may be achieved, based on application)
  • Small bench top footprint: 61 cm wide x 99 cm deep x 117 cm high (24” x 39” x 117”)
  • Easy to handle: Total weight ~ 291kg (640 lbs) - Easily movable with stainless steel casters leveling on skid with vibration isolators
  • Gamma-irradiated single-use modules
  • Scale processes up with the U2k® or down with the UFMini®
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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 stremalined 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 28 SLPM, 80-100 PSI, 5.5-6.9 Bar
Single-Use Modules
  • 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

Endorsements

See What People Are Saying About Our Equipment
keymarketslider1
“This one is perfect. This would reduce our harvest time significantly. I think it fits well into the needs for a Phase III trial.”

Cell Therapy Bioproduction Expert

keymarketslider4
“The UniFuge is scalable, easier to operate, and my process yield is better than using depth filters.”

Protein Separation Bioproduction Expert, CHO

testimonials3
“The UniFuge line is simpler and required less calibration than other solutions we have tried.”

Protein Separation Bioproduction Expert, CHO

testimonials4
“The UniFuge had the shortest processing time versus Ksep.”

Protein Separation Bioproduction Expert, CHO

keymarketslider5
“The UniFuge has higher g forces and flow rates [compared to competitive offerings].”

Viral Vector Bioproduction Expert, HEK

keymarketslider1
“The UniFuge was fairly simple to use and scaled nicely from the UFMini.”

Cell Therapies Bioproduction Expert

testimonials7
“The UniFuge line is easy to scale-up to the U2k or down to the UFMini.”

mAbs Bioproduction Expert