Sius™ TFF Skid: 100% single-use

Sius™ TFF Skid: 100% single-use
Sius™ TFF Skid: 100% single-use Sius™ TFF Skid: 100% single-use
Brand: Novasep Novasep
Product Code: Sius TFF Skid
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One TFF platform from bench to commercial scale

 

The Sius™ TFF Skid is the first fully automated single-use TFF skid for cGMP TFF operations from development to commercial scale. In combination with the Sius™ cassettes , holders and a disposable flowpath, the skid completes our single-use TFF offering.

The Sius™ TFF Skid is compatible with Sius™ 2BMC and 4BMC holders, in a range of surface areas from 0.1 to 1.5 m² at 9L/min/m² recirculation flowrate, meaning that this sole equipment fits lab and pilot scales.

A turn-key solution for single-use TFF

The main components of the hardware system are:

  • Nanopanel PC: including control software (WinAC RTX) and visualization software (WinCC Flex)
  • Peristaltic recirculation pump
  • Peristaltic pump for diafiltration (filling, diafiltration, fed batch concentration)
  • Electrically actuated control valve
  • Flow, conductivity and pressure monitors
  • Cables for single-use sensor connections

SiusTM TFF Skid

2BMC Holder & Flowpath

4BMC Holder & Flowpath

Membrane surface area

0.1 - 0.5 m²

0.5 - 2 m²

Max. recirculation flowrate

9 L/min

15 L/min

Min. working volume

300 mL

450 mL

Fluid operating temperature

15 - 40°C (59 - 104°F)

Max. operating pressure

3 bar

Pneumatic utility

No

External tanks connections

Yes (M12 connectors)

Electrical voltage

115/230 V

Dimensions (H x W x D)

425 x 940 x 640 mm (16.7 x 37.0 x 25.2 in)

Weight

Approx. 100 kg (220.5 lbs)

A clever design for the flowpath 

The flowpath is fully single-use and is the only part of the skid in contact with the fluid. Delivered gamma-irradiated and ready-to-use, it consists of:

  • Tubing: platinum-cured silicone and Bioprene® peristaltic pump tubing (4 bar pressure rating)
  • Sensors: single-use flowmeters and pressure sensors
  • Connectors: Colder Products Company® MPC and MPX single-use quick connectors
  • Single-use Sius™ Filter Plate Insert (FPI): 2BMC or 4BMC
  • Single-use feed bag: 10 and 20 liters as standard products
  • Manual pinch valves

A device to perform integrity testing to verify installation is available as an option  to ensure safe operation.

 

2BMC Flowpath

4BMC Flowpath

Holder compatibility

2BMC

4BMC

Max. recirculation flowrate

9 L/min

15 L/min

Skid flexibility

  • Possibility to use external bags

Flowpath materials

Bag: polyethylene 
Tubing: platinum-cured silicone 
Sensors & connectors: polycarbonate, PVDF, polysulfone

Connections

Colder Products Company® MPC quick connectors

Colder Products Company® MPC and MPX quick connectors

Regulatory Information

FDA, USP Class VI, BSE/TSE free

Automation and Software 

The software has been designed to be user-friendly and easy-to-use. Thanks to the monitoring software, the skid is fully automated with the following automatic modes:
  • Filling
  • Batch concentration
  • Fed batch concentration
  • Diafiltration
  • Product recovery
  • Equilibration
  • Membrane flushing

All of our software is validated and compliant with 21CFR part 11.

Quality and Documentation Support 

The Sius™ flowpath design (manufacturing conditions and quality control) is adapted for cGMP use.

Quality control lot release includes 100% testing to verify that release specifications are met. The result is scalable process development and reproducible manufacturing. Sius™ flowpath materials are FDA and USP Class VI compliant, and BSE/TSE free. The SiusTM flowpaths are gamma-irradiated and individually packaged in a sealed foil-lined bag and outer cardboard carton.

Novasep experts provide you with a user guide and any data and documentation you need to meet cGMP guidelines and regulatory requirements.

 
 

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