U2k®

Product Overview

Single-Use System

The U2k® single-use centrifuge is the scaled-up version of our successful UniFuge Pilot product. It uses gamma-irradiated, single-use modules 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: up to 9 L
  • Flow rate up to 20L/min (5 times the flow rate of the UniFuge®.
  • Small footprint: 80 cm x 206 cm x 200 cm high (31” x 81” x 78”)
  • Easily movable with stainless steel casters leveling on skid with vibration isolators
  • Gamma-irradiated single-use modules
  • Scale processes down with the UniFuge® Pilot and UFMini®

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Small Footprint

The U2k has a small footprint.

High Capacity

Process hundreds of liters of product per hour.

Confidently Scale Down

Accurately transferring operating protocols to the UniFuge® Pilot or the UFMini® is straightforward.

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 by following the highest standards of quality control.

Instrument
  • Bowl capacity up to 9 L
  • Flow rate up to 20 L/min (5 times flow rate of the UniFuge®)
  • Variable speed from 300 to 4,000 x g
  • Designed for use at room temperature
  • Continuous operation and feed flow
  • Optional data acquisition for SCADA System
  • cGMP-compliant 21 CFR Part 11 data trail
  • Low noise level
  • 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 modules with integral tube set
  • Predictable supply chain with multiple manufacturing sites in the United States
  • Gamma-irradiated
  • Extractables data available
  • Compliant with ISO 11137 to SAL 10-6
  • Modules can be tube welded to single-use bioreactor connections (customer-specified single-use connectors are available upon request)
  • Reduce HCP and other contaiminants
How It Works

U2k modules can be tube welded to your single-use bioreactor connections (customer-specified single-use connectors available upon request). The U2k is completely automated with flexible cycle parameter entry via touch screen HMI. The feed suspension is gently pumped to the module and the cells settle to the outer radius, while the clear supernatant and concentrate are continuously discharged.

Automation and General Specifications
  • Total skid weight of 1050 kg (2300 lbs)
  • Allen-Bradley® or Siemens® PLC
  • Allen-Bradley or Siemens HMI Touchscreen 30.7 cm (12.1”)
  • Maximum case pressure (for cooling) 6.9 bar (100 psi)
  • Skid footprint 80 cm x 206 cm x 200 cm (31” x 81” x 78”)
  • Centripetal pump to evacuate cell paste
  • Center feed for low-shear operation
  • Concentric tubes to introduce feed and remove supernatant and concentrate
  • High cell density
  • PCV up to 25%
  • Acid Precipitated CHO application available
Utility Requirements
  • Power configuration: Three-phase voltage supply
    • US: 230V/60 Hz, 80A or 460V/60 Hz, 40A
    • Europe: 400V/50 Hz, 46A
    • Japan: 200V/60 Hz/50 Hz, 90A
    • Optional: Others as needed
  • Pneumatic: Clean dry air supply 6.2-8.3 bar (90-120 PSI) 100 SLPM (3.5 SCFM)
Single-Use Modules
  • 9000 mL single-use module with 19 mm (3/4”) ID and 25 mm (1”) 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 and concentrate

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