CS4500 Single-use Tangential Flow Filtration System​

For Control, Flexibility and Ease of Use in Manufacturing

The Allegro CS4500 single-use tangential flow filtration (SUTFF) system offers all the control and instrumentation for running fully automated UF/DF processes from feed volumes of 500 to 2000 L (1 to 15 Kg) batches. The systems are compact, have low feed/retentate hold-up volumes, and the capacity to run cassette surface areas from 3 to 10 m2.​

  • Intuitive control system employing step editor software​

  • Easy set up and installation of manifolds

This Product is Now Part of Sartorius Portfolio
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Key System Features

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

  • Flow, TMP and bag weight controller​

  • Phase based automation (single phase comprising up to 30 freely definable steps)​

  • Easy to use phase/step editor​

  • Full security access to configuration​

  • Real-time trending​

  • Graphic data analysis using an imbedded visualisation analytic tool ​

  • Data and event logging​

  • Batch report generator (one page per step)​

  • User administration​

  • Audit Trail​


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System Concept

SUTFF systems offer a combination of hardware, control systems and SU assemblies designed 
to work perfectly together. Clever system design ensures ease of use in running fully automated TFF process sequences, 
with complex single-use assemblies, incorporating all of the critical sensor and instrumentation technologies.​

Processing range is a key requirement for single-use system design. These systems offer the end user a choice of 
single-use sensors for feed, retentate and permeate manifolds. A range of 2D and 3D Flexsafe bags are available for retentate, product recovery and buffer / WFI.
Load cell and Pro Mixer technologies can also be offered with these systems, to suit individual process requirements.​

A review of specific process needs with our Integrated Soutions Process Engineering team will ensure a solution is 
offered to meet exactly all of the process requirements. This might be achieved with one of our standard platform designs for SUTFF, 
along with standard Palletanks and mixers. 
Or it might lead to the creation of a custom engineered design. The custom designs will still retain the core components that we have 
validated for use in SUTFF processes. But we have the flexibility to integrate our systems with other plant equipment, plant control systems and offer systems designed for running other Crossflow / TFF formats such as hollow fibers.​

The use of validated components for running SUTFF processes is extremely important for success in design and ultimate system performance of our systems. 
Continuity of these components is maintained throughout our offering in SUTFF processing. ​

The CS 4500 SUTFF system facilitate the automated processing of 500 L to 2000 L batch volumes of monoclonal antibodies, recombinant proteins, vaccines and antibody-conjugate processes. The single- use sensors provide the means to monitor and control the process fully.​

The system design gives full consideration to ease of use in system set up and processing, 
while ensuring use of components and instruments that can achieve the performance requirements for TFF processes.​

Adopting SUTFF technologies can have many potential benefits in a process. Cost of Goods studies have shown significant savings in capital, materials, labor and facility operating costs 
when comparing SUTFF to regular processing with stainless steel TFF systems. A more flexible approach in manufacturing can lead to increased productivity and better equipment utilisation rate.​

Control System

The automation concept allows the user to configure automated process sequences (phases) in a very simple and user friendly way. This is a very intuitive control system ideal for use in the Allegro SUTFF systems, with a phase editor that allows easy generation and configuration of end user specific processes. The software complies with 21 CFR Part 11.​

The user can select the transition points which move the process from one step to the next. This can be done by selection of one or several process parameters (with an “AND” or “OR” logic) such as conductivity, retentate volume, permeate volume, Palletank weight.​

Further flexibility is added as the system allows the configuration and use of loop and jump functions thus making selective step repetitions feasible.​

Upon operator’s selection batch reports will be generated automatically at the end of a batch for each single step. The content of the batch report is predefined.​

Systems Technical Specification CS4500

¾ in. manifold assembly

1 in. manifold assembly

Membrane area

3.0 – 14 m2 (dictated by specific process crossflow versus recirculation pump capacity)

3.0 – 14 m2 (dictated by specific process crossflow versus recirculation pump capacity)

Feed and retentate tubing ID

¾ in. (19.05 mm)

1 in. (25.4 mm)

Permeate and product inlet/diafiltration buffer Tube ID

½ in. (12.7 mm)

½ in. (12.7 mm)

Recirculation pump

Quattroflow-5050SU 4-Piston Sanitary Diaphragm Pump

 Quattroflow-5050SU 4-Piston Sanitary Diaphragm Pump

480 - 2000 L/h with 3-degree shaf

600 - 4500 L/h with 6-degree Pump Model

480 – 2940 L/h with 6-degree shaft

Feed / diafiltrate buffer pump​

Quattroflow-1200SU, 4-Piston Diaphragm Pump 20 to 1000 L/hr

Quattroflow-1200SU, 4-Piston Diaphragm Pump 20 to 1000 L/hr

Recirculation tank

200 L Palletank or mixer500 L Palletank or mixer​

Over pressure protection

Yes

Maximum pressure

4 barg for manifold sections
0 barg for biocontainers

Volume in feed and retentate lines

1.9 L

2.5 L

Non recoverable volume

< 100 mL

Operating temperature range

4 – 40 ºC


The CS4500 has been designed to run both ¾ in. and 1 in. manifolds, using the same base hardware. The clamps on the pinch valves are specific to one size of tubing and these are easily changed out


System frame and cabinet materials of construction

304 stainless steel

Dimensions process skid (length x depth x height)

1920 x 1000 x 1718 mm (nominal)

Dimensions retentate trolley with 200 L tote (length x depth x height)

 747 x 975 x 1545 mm (nominal)

Dimensions retentate trolley with 500 L tote (length x depth x height)

955 x 1300 x 1600 mm (nominal)

Weight of empty system

420 Kg

Power

3-phase

Component Specifications


CS4500

¾ in. manifold assembly

1 in. manifold assembly

Recirculation pump

480 - 2000 L/hr with 3-degree shaft
480 – 2940 L/h with 6-degree shaft

600 - 4500 L/hr with 6-degree shaft

Feed diafiltrate buffer pump

20 to 700 L/hr

Pneumatic pinch valves

For use with 1 in. ID or ¾ in. ID tubing (feed and retentate)
For use with ½ in. ID tubing (permeate and product inlet/diafiltration buffer)

Control valve

Single-Use diaphragm valve body with positioner

Recovery valve

Single-use diaphragm valve body

Product contact materials for CS4500 SUTFF Systems


Process wetted components

Materials of construction

Tubing

Platinum cured silicone, reinforced in high pressure sections

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

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