Allegro™ CM150 Auto Single-Use Tangential Flow Filtration System

Optimized Small Scale SUTFF Processing

The Allegro™ CM150 Auto TMP control is a single-use tangential flow filtration (SUTFF) semi-automated system designed for pilot or small scale process ultrafiltration and diafiltration (UF/DF) applications at 2-20 L batch volumes.


This Product is Now Part of Sartorius Portfolio
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Key System Features

  • Isocratic or gradient set up options
  • System utilizes ⅜ in. (0.95 cm) ID and ½ in. (1.27 cm) ID manifolds
  • Utilizes new pinch valve block technology – easy manifold installation
  • No calibration of single-use sensors
  • CGMP compliant design and documentation
  • Compact system footprint with maneuverable HMI
  • Multimodal chromatography – sorbents and membrane chromatography
  • Intuitive Process Step Editor automation platform
  • Reliable, robust operation
  • Ethernet network capability
  • Full security access to configuration
  • Data and event logging
  • Audit trail


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Optimized small scale SUTFF processing

The Allegro CM150 Auto TMP control is a single-use tangential flow filtration (SUTFF) semi-automated system designed for pilot or small scale process ultrafiltration and diafiltration (UF/DF) applications at 2-20 L batch volumes.

The system layout is optimized for a low minimum recirculation loop, to ensure final target volumes can be achieved and provide excellent product recovery.

The programmable logic controller (PLC) based control system ensures easy operation and monitoring of UF applications, constant volume diafiltration, and provides real-time trending and data logging capabilities.

  • Designed for ease of use
  • Single-use sensors – Pressure, flow, conductivity, temperature, ultraviolet (UV)
  • Low feed / retentate volume ~100 mL
  • Excellent product recovery
  • 0.1 – 0.4 m2 cassette area


System Functionality

Scalability of performance is critical in developing tangential flow filtration (TFF) processes. The Allegro CM150 system is designed for use in small scale good manufacturing practice (GMP) manufacture and for process development activities, to generate scalable data. Continuity of single-use component choice and design approach across our system range provides reliable scale up from Allegro CM150 system to the larger scale Allegro SUTFF systems.

The system offers the flexibility needed for single-use processing. The base system can run with just pressure and flow sensors or utilize the additional optional sensors for conductivity, temperature and UV, depending on the process requirements. The base system accommodates this flexibility, and base systems can be upgraded later if additional features are needed for new projects.


Flexibility

  • Single-use sensors
    • Pressure: Feed and retentate
    • Flow: Retentate
    • Temperature: Feed (optional)
    • Conductivity: Permeate (optional)
    • UV: Permeate (optional)
  • Transmembrane pressure (TMP) control
    • Manual pinch valve
    • Automatic pinch valve
  • Tray for retentate biocontainer assemblies: 5 L and 10 L
    • Adjustable tray comes to lower position for easy installation of the biocontainer assembly, and is then moved to the upper position for processing
  • Accessory biocontainers and bespoke trolley

* Contact your sales representative for more detailed information



Control System

The Allegro CM150 offers automatic transmembrane pressure as well as retentate biocontainer weight control. The diafiltration pump can be set to automatically control the pump speed to maintain a constant mass in the retentate biocontainer according to the defined input weight.

Automated TMP Control Valve
The integration of a Transmembrane pressure (TMP) control valve offers the following benefits:

  1. Improved process control and reproducibility.
  2. Prevent high protein wall concentrations (polarization) or fouling.
  3. Minimized human error due to manual operation.

Automated Weight Control:
The diafiltration pump speed can automatically be controlled, to maintain a constant retentate biocontainer weight. This can be used for Diafiltration as well as for Product fed batch during concentration.

All process values are shown in the piping and installation diagram (P&ID) based operator interface. The main screen indicates all process signals as well as system/ component status.

The header bar clearly indicates the current user logged into the system, and provides the operator with navigation buttons to other areas of the control system.

A wireless link to a tablet, smartphone or PC enables remote viewing of the system screen and wireless transfer of data files.

The control software is designed for flexible and user friendly control of tangential flow filtration processes, providing the following key features:

  • P&ID based user interface with dynamic flow path
  • Retentate biocontainer weight controller
  • Transmembrane pressure controller
  • Full security access to configuration settings screens
  • Real-time trending
  • Data logging with data transfer in comma separated value (CSV) or line-delimited format
  • 3 level user login, user administration and password control

System Technical Specification

Membrane area

0.1- 0.4 m2, operating in typical crossflow range of 5 to 8 L/min/m2 Centramate T-series cassettes or equivalent;  SUTFF modules. For other suppliers cassettes please check recommended running conditions and torque settings

Tubing internal diameter (ID)   Feed and retentate tube: 3⁄8 in. (9.6 mm)
Permeate tube: ¼ in. (6.4 mm)
Retentate vessel

5 L or 10 L Allegro biocontainers, for larger process volumes system may be operated in fed batch mode.

Operating temperature

4 – 40 ºC

Operating pressure

4 barg for high pressure reinforced section on feed and retentate manifolds
1 barg permeate and medium pressure manifolds; 0 barg for biocontainers

Over pressure protection

Yes (on recirculation pump)

Minimum working volume

Minimum recirculation volume approximately: 105 mL (Estimated with 0.1 m2 membrane surface area installed). Volume in feed and retentate line: 98 mL

Non recoverable volume

Approximately: 10 mL (Hold-up volume will increase by ~ 10 mL / 0.1 m2 of installed membrane)

Process Wetted Components  

Materials of Construction

    Tubing 

Platinum cured silicone tube, reinforced

  Recirculation pump

Head: Polypropylene; Diaphragm: ethylene propylene diene monomer (EPDM)/ Polypropylene compound, Valves: EPDM

Connectors

Polysulfone, silicone

Fittings, distribution plates

Polypropylene

Pressure sensor, UV sensor

Polysulfone

Temperature sensor

Polysulfone with stainless steel sensor and silicone ring

Flow sensor

PVDF with ruby bearing

Conductivity sensor

Polysulfone with gold electrode

Sanitary fittings (tri-clamp)

Connector: Polypropylene
Gaskets: Silicone



System Hardware

Type

Specifications

Feed pump    

4-Piston diaphragm pump, single-use

Flow range 5 to 150 L/hour

Buffer pump    

Peristaltic pump

Flow range 0 to 54 L/hour (with 4.8 mm bore tubing)

Valves

Manual pinch valves

For use with 3⁄8 in. ID tubing

Control valve    

Automated pinch valve

Typical Control Range 0.5-2.0 ± 0.1 bar TMP, depending on process conditions.
 

Recovery valve    

Manual pinch valve

For use with ¼ in. ID tubing

Instrument

Type

Measuring Range/Accuracy

Flow measurement   

Single-use flow cell with turbine

30 - 1200 L/hour
Typically +/- 5% of range

Pressure measurement    

Single-use sensor with pressure sensitive chip

-0.48 to 5.2 bar
± 2% in the range
0 to 0.4 bar
± 3% in the range
0.41 to 2.0 bar
± 5% in the range
2.07 to 4.1 bar

Temperature measurement

Single-use temperature sensitive transistor 

0 to 70 °C ± 0.2 °C

Conductivity measurement 

Single-use sensor 

Range: 0.1 to 100 mS/cm 0.1 to 2 mS/cm ± 0.1 mS/cm 2 to 50 mS/cm ± 5% of reading; 50 to 100 mS/cm typically ± 5% of reading
 

UV

Single-use sensor    

0 – 2 AU ± 0.1 AU

Weight measurement  

Load cell    

0 to 30 kg (in situ readability 0.01 g)


Quality Standards

Sartorius maintains a stringent approach to quality of purchase and manufactured components. The system hardware is designed and built to well recognized industry standard, including but not limited to:

  • Good automated manufacturing practice (GAMP)
  • EMC 89/336/EEC
  • Software complies with CFR21 Part11 for electronic records



Single-Use Manifolds

  • Are assembled in dedicated class 10000 clean room to ISO standards 9001:2008 and using validated assembly methods
  • Have components tested for biocompatibility and certified to USP <88>
  • Components are certified TSE/BSA free
  • Are supplied double bagged and irradiated at a minimum dose of 25 KGy
  • Extractables data reports available on request


System Performance

The Allegro CM150 SUTFF system can process at typical crossflows of with 5 to 8 L/min/m2. It has a recirculation pump capacity of 150 L/Hour and can typically run 0.1 – 0.4 m2 cassettes (running at a crossflow of 5 L/min/m2). The system is supplied with retentate biocontainers to run 5-10 L batch volumes. Starting with larger volumes can be managed by running the system in a fed batch mode.

Part Number

Description

LGRTFF150EXC0T0

Allegro CM150 A SUTFF system with Permeate Cond. and Temp. sensors and Feed Temp sensor (EU-ASIA)

LGRTFF150WXC0T0

Allegro CM150 A SUTFF system with Permeate Cond. and Temp. sensors and Feed Temp sensor (US)

LGRTFF150EXCUT0

Allegro CM150 A SUTFF system with Permeate Cond.Temp. And UV sensors and Feed Temp sensor (EU-ASIA)

LGRTFF150WXCUT0

Allegro CM150 A SUTFF system with Permeate Cond.Temp. And UV sensors and Feed Temp sensor (US)

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Additional Hardware

LGRTFF150EX000T

Bespoke trolley, supplied with 1x 20 L tray and 1 x 50 L 3D tote, 1162 x 703 x 1175 mm (EU-ASIA)

LGRTFF150WX000T

Bespoke trolley, supplied with 1x 20 L tray and 1 x 50 L 3D tote, 1162 x 703 x 1175 mm (US)

Dimensions W x D x H

1083x822x1232mm (may vary according geographies

System Weight

Up to 140kg, depending upon configuration

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Services

LGRTFFF0150FAT/E

Customer witnessed FAT 1 day + 1 Manifold set

LGRSATD1Z1/E

SAT at customer site 1 day ZONE1

LGRSATD1Z2/E

SAT at customer site 1 day ZONE2

LGRTRND1Z1/E

Training at customer site 1 day ZONE1

LGRTRND1Z2/E

Training at customer site 1 day ZONE2

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Manifolds

Description

7442-1057A

Feed Manifold with pressure + temperature

7442-1057B

Feed Manifold with pressure

7442-1057C

Retentate Manifold with pressure and flow

7442-1057D

Permeate Manifold with distribution plate, conductivity and temperature

7442-1057E

Permeate Manifold with distribution plate

7442-1057F

Diafiltration Buffer Inlet

7442-1057J

UV Manifold

7442-1057H

5 L Retentate Assembly

7442-1057K

10 L Retentate Assembly

7442-1057L

50 L Permeate Collection Biocontainer Assembly

7442-1057J

Sampling / Permeate Recirculation Manifold

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Biocontainer Sets

744-69L

5 L retentate biocontainer assembly

744-69M

10 L retentate biocontainer assembly

7442-03030P

1 L product recovery biocontainer assembly

7442-0303G

5 L product recovery biocontainer assembly

7442-0318X

20 L Feed / collection biocontainer (for trolley)

7442-0318Z

50 L Feed / collection biocontainer (for trolley)

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

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