Sartoflow®4500 Single-Use Tangential Flow Filtration System​

For Process Control and Ease of Use at Production Scale

The Sartoflow®4500 single-use tangential flow filtration (SUTFF) system offers all of the controls and instrumentation for running fully automated UF | DF processes for batch volumes of 500 to 2000 L (1 to 15 kg). The system is compact, has low hold-up volume, and the capacity to run cassette surface areas from 3 to 10 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 3 to 10 m²
  • Easy set-up and installation of single-use assembly

  • 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


System Concept

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

  • The single-use TFF system facilitates automated processing of batch volumes from 500 to 2000 L of monoclonal antibodies, recombinant proteins and vaccines processes
  • The single-use sensors provide the means to fully monitor and control the process


Control System

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

3 to 10m²

Feed and retantate tubing ID

1“ (25.4 mm)

Permeate and product inlet |
diafiltration buffer tube ID

½“ (12.7 mm)

Recirculation pump

Quattroflow™ 5050SU

4-piston diaphragm pump

600 - 4500 L | h

Fed batch | buffer pump

Quattroflow™ 1200SU

4-piston diaphragm pump

20 to 1000 L | h

Control valve 

Single-use diaphragm valve body with positioner 

Recovery valve 

Single-use diaphragm valve body 

Recirculation bag

500L pallet tank or mixer

Over pressure protection

Yes

Maximum pressure

4 barg for flow kits sections

Volume in feed and retentate lines

2.5 L

Operating temperature range

4 – 40°C

System frame and cabinet materials of construction

304 stainless steel

Weight of empty system

420 kg

Pneumatic supply

90psi | 6 bar

System dimensions (length × depth × height)

US: 2050 × 1200 × 1750 mm (nominal)
EMEA | Asia: 1920 × 1000 × 1718 mm (nominal)

Power

EMEA | Asia: 400 V, 3-phase 50

US :
Main: 480VAC | 3P| 60Hz 11.1FLA
Control: 120VAC|1P|60Hz 4.6FLA
UPS Power (Onboard System)

Product Contact Materials for Sartoflow®4500

Components

Materials of Construction

Tubing

Platinum cured silicone, reinforced in high pressure sections

Product recirculation pump




Diafiltration | fed batch pump

Machined polypropylene head,
EPDM valves and O-rings,
Santoprene™ diaphragm


Molded polypropylene 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: 316 L, gaskets: EPDM, UV window: quartz)

Sanitary fittings

Polypropylene, gaskets silicone

TC gaskets

Silicone

Diaphragm valves

Body polypropylene, diaphragm TPE

Distribution plate

Polypropylene

*Santoprene™ is a trademark of Exxon Mobil Corporation

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:

  • 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​

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

The quality management system of the manufacturing is certified according to DIN EN ISO9001, EN 729. The quality management system is certified by an independent third party​


Single-Use Flow-Kits

  • Manufactured in a controlled environment (Class 7 in operation according to ISO 14644) under a quality system certified according to ISO 9001

  • Feature components tested for biocompatibility and certified according to USP<88>

  • Feature components certified as TSE | BSA-free

  • Manufactured according to a validated assembly process

  • Supplied double-bagged and irradiated with a minimum dose of 25 kGy

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 automation

Enables precise and consistent operation and control of key parameters
Minimizes operator contact

Fully disposable flowpaths

Easy system set up
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.

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