CS1000 ½“ Single-Use Tangential Flow Filtration System​

For Process Control and Ease of Use at Clinical and Production Scale

The CS1000 single-use tangential flow filtration systems (SUTFF) offers all of the controls and instrumentation for running fully automated UF|DF processes for feed volumes of 20 - 500 L (200 g to 2.5 kg) batches. The systems are compact, have hold-up volumes, and have the processing range to run cassette surface areas from 0.5 to 2.5 m².​

  • Designed for efficiency in single-use TFF applications

  • High level of operation-based automation

  • User-friendly and quick set-up time


This Product is Now Part of Sartorius Portfolio
Learn More About the Acquisition

Key System Features

  • Single-use TFF System with low hold-up volume and the capacity to run cassette surface areas from 0.5 to 2.5 m²

  • USP Class VI components and manufactured to ASME BPE* and FDA, cGMP standards
  • Easy set-up and installation of flow kits
  • Intuitive control system employing step editor software

  • Interactive P&ID-based user interface with dynamic flow path

  • Suitable for low shear applications

  • GAMP and GxP design

Request a Quote

The single-use TFF system offers a combination of hardware, control system and flow kits designed to work together perfectly. A smart system design ensures ease of use when running fully automated TFF process sequences with complete flow kits incorporating all critical sensor and instrumentation technologies.

  • The single-use TFF system facilitates automated processing of 20 - 500 L batch volumes of monoclonal antibodies, recombinant proteins and vaccines processes
  • The single-use sensors provide the means to fully monitor and control the process.


The automation concept is based on the Process Step
Editor (PSE), which allows the user to configure automated
process sequences (operations) in a very simple and user friendly
way. This is an intuitive control system that is ideally
suited for use in the single-use TFF system and has an operation
editor that allows easy generation and configuration of
end-user-specific processes.

  • Software complies with 21 CFR Part 11
  • The user can select the transition points that move the process from one step to the next (with an “and | or” logic) by selecting one or more process parameters such as conductivity, retentate volume, permeate volume or bag weight
  • Further flexibility is added as the system allows the configuration and use of loop and jump functions, making selective step repetitions feasible. Once selected by the operator, batch reports are automatically generated for each step at the end of a batch


Technical Specification

Membrane area

0.5 – 2.5 m²

Feed and retantate tubing ID

1“ (25.4 mm)

Permeate and product inlet |
diafiltration buffer tube ID

1/1“ (1.7 mm)

Recirculation pump

Quattroflow™ 1200SU,

4-Piston Diaphragm Pump

20 to 1000 L | h

Fed batch | buffer pump

Ismatec Flowmaster™ FMT300

Peristaltic pump, ISM Drive

6 – 600 L | h with 12.7 mm element

Control valve

Single-use diaphragm valve body with positioner

Recovery valve

Single-use diaphragm valve body

Recirculation bag

20 L, 50 L, 100 L tote or 50 L, 200 L mixer

Over pressure protection

Yes

Maximum pressure

4 barg for flow kits sections

Volume in feed and retentate lines

650 mL

Operating temperature range

4 – 40°C

System frame and cabinet materials of construction

304 stainless steel

Dimensions system (length × depth × height)

1800 × 800 × 1600 mm (nominal)

Weight of empty system

350 kg

Power

230 V, 1-phase 50 Hz


Component Specifications


CS1000

Recirculation pump

Flow range 20 to 1000 L/hour

Feed diafiltrate buffer pump6 – 600 L/hr with ½” 12.7 mm element

Pneumatic pinch valves

For use with ½ in. tubing

Control valve

Single-Use diaphragm valve body with positioner

Recovery valve

Single-use diaphragm valve body

Product contact materials for CS1000 SUTFF Systems


Process wetted components

Materials of construction

Tubing

Platinum cured silicone, reinforced in high pressure sections

Product recirculation pump CS1000 and CS4500 Diafiltration / fed batch pump CS4500

Machined polypropylene head, EPDM valves and O-rings, Santoprene♦ diaphragm Molded polyethylene head, polypropylene ports, EPDM valves and O-rings, Santoprene diaphragm

Connectors and fittings

Polypropylene

Single sensors:

  • Pressure, UV
  • Temperature
  • Flow
  • Conductivity



  • Polysulfone
  • Polysulfone with stainless sensor and silicon ring
  • PVDF with ruby bearing
  • Polysulfone with gold electrode


Multi sensor cell: temperature/ conductivity/pH/UV

PPSU (electrodes: SS 316 L, gaskets: EPDM, UV window: quartz)

Sanitary fittings

Polypropylene, gaskets silicone

TC gaskets

Silicone

Diaphragm valves

Body polypropylene, diaphragm TPE


Quality Standards

Sartorius maintains a pragmatic approach to quality of purchased and manufactured components. The system hardware is designed and built to well recognized industry standards, including but not limited to:​

  • Good automated manufacturing practice (GAMP) current version​

  • Code of Federal Regulations 21 – Good manufacturing practice for finished pharmaceuticals.​

  • 2004/108/EC​

  • Software complies with 21 CFR Part 11 for electronic records, signature and audit trail​

  • Code of Federal Regulations 21 – Good manufacturing practice for finished pharmaceuticals.​

  • The rules governing medicinal products in the European Community, Volume IV, and Good Manufacturing practice for medicinal products, Annex 11, computerized systems.​

Our manufacturing has implemented a quality management system according to DIN EN ISO9001: 2008, EN 729. The quality management system is certified by an independent third party



Single-Use Manifolds

  • Are assembled in a class 10000 clean room to ISO standards 9001:2008 and using validated assembly methods​

  • Components that are tested for biocompatibility and certified to USP <88>​

  • Components that are certified TSE/BSA free​

  • Are manufactures according to a validated assembly process​

  • Are supplied double bagged and irradiated at a minimum dose of 25 KGy​

  • Extractables data reports are available on request

Summary

The combination of single use technologies and automation provides many benefits in bioprocessing. Fully automated SUTFF systems make UF/DF a straightforward process with full control over the key parameters.​

The Allegro SUTFF systems provide control, flexibility and enable processing to be carried out under optimum conditions using fully automated process sequences.

Full process automation​Enables precise and consistent operation and control of key parameters​
Minimizes mundane operator interactions
Fully disposable flowpathsEasy system installation​
Reduces cleaning time, improves productivity and provides cost savings in manufacturing

Single-use sensors

Monitoring and control of key TFF process parameters
Enables automated control of processing to optimum conditions

Process step editor software

Flexibility to create recipes to suit individual processes
Monitors all process variables and provides data logging and batch reports

Allegro™ Fully Automated, Single-Use Tangential Flow Filtration Systems - For control, flexibility and ease of use in manufacturing

PDF | 2.9 MB

Allegro™ is a trademark of Pall Corporation used under non-exclusive and timely limited license.

Request a Quote