Allegro™ CM150 Single-Use Tangential Flow Filtration System product photo Primary L

Allegro™ CM150 Single-Use Tangential Flow Filtration System

Optimized small scale SUTFF processing

The Allegro CM150 single-use tangential flow filtration (SUTFF) system is easy to use and offers all the critical sensors for running ultrafiltration (UF) and diafiltration (DF) processes 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

The Allegro CM150 system is part of a broader range of SUTFF systems offered by Pall for processing 2 L to 2000 L batches. The system has the flexibility to run Cadence™ SUTFF modules or T-series Centramate™ cassettes with Omega™ or Delta membrane.

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.



All connections and key controls are easily accessible from the front of the system.

Flexibility

  • Single-use sensors
    • Pressure: Feed and retentate
    • Flow: Retentate
    • Temperature: Retentate (optional)
    • Conductivity: Retentate (optional)
    • UV: Permeate (optional)
  • Centramate cassettes (T-series 0.1 to 0.4 m2)
  • Cadence SUTFF modules 0.1 m2
  • Transmembrane pressure (TMP) control
    • Manual 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
Allegro manifolds and biocontainer assembly: the well-considered design and layout ensures easy installation whilst minimizing recirculation volumes.

Cadence CM holder. This can accommodate either Cadence 0.1 m2 SUTFF modules or T-series Centramate cassettes, with an appropriate Allegro manifold from the standard sets available.

Control System

The Allegro CM150 system offers essentially manual control of TFF processes, but has the capability to run constant volume diafiltration. 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.

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 (standard)
  • 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


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Description

Optimized small scale SUTFF processing

The Allegro CM150 single-use tangential flow filtration (SUTFF) system is easy to use and offers all the critical sensors for running ultrafiltration (UF) and diafiltration (DF) processes 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

The Allegro CM150 system is part of a broader range of SUTFF systems offered by Pall for processing 2 L to 2000 L batches. The system has the flexibility to run Cadence™ SUTFF modules or T-series Centramate™ cassettes with Omega™ or Delta membrane.

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.



All connections and key controls are easily accessible from the front of the system.

Flexibility

  • Single-use sensors
    • Pressure: Feed and retentate
    • Flow: Retentate
    • Temperature: Retentate (optional)
    • Conductivity: Retentate (optional)
    • UV: Permeate (optional)
  • Centramate cassettes (T-series 0.1 to 0.4 m2)
  • Cadence SUTFF modules 0.1 m2
  • Transmembrane pressure (TMP) control
    • Manual 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
Allegro manifolds and biocontainer assembly: the well-considered design and layout ensures easy installation whilst minimizing recirculation volumes.

Cadence CM holder. This can accommodate either Cadence 0.1 m2 SUTFF modules or T-series Centramate cassettes, with an appropriate Allegro manifold from the standard sets available.

Control System

The Allegro CM150 system offers essentially manual control of TFF processes, but has the capability to run constant volume diafiltration. 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.

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 (standard)
  • 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
Specifications

System Technical Specification

 
Membrane area 0.1- 0.4 m2, operating in typical crossflow range of 5 to 7 L/min/m2 Pall Centramate T-series cassettes or equivalent; Pall Cadence 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 Pall 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 Pall 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 Manual pinch valves Manual valve (allows control to ± 0.1 bar TMP at 0.8 bar TMP at 0.52 L/min with 0.1 m² membrane area)
Recovery valve Manual pinch valves 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
Mass measurement Load cell 0 to 30 kg (in situ readability 0.01 g)
 

Quality Standards

Pall 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
Performance

System Performance

The Allegro CM150 SUTFF system can process at typical crossflows of 5 to 7 L/min/m2, with 0.1 to 0.4 m2 cassette area. 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.

The data in figures 1 to 4 show the results from a x20 IgG concentration (starting concentration 10 g/L) and x5 diafiltration volumes with phosphate-buffered saline (PBS). The efficiency of the diafiltration was monitored by following the removal of 7% glucose added to the protein solution

The system showed good mixing, negligible foaming in the retentate biocontainer, and efficient diafiltration of the solution.

The system is fully drainable via the low point recovery valve.

Figure 1 and 2
Data for 5 L starting volume IgG processed on 0.1 m2 cassette area


Figure 1


Figure 2



Figures 3 and 4
Data for 10 L starting volume IgG processed on 0.4 m2 cassette area


Figure 3


Figure 4
Ordering Information

Base System

 
Part numbers SUTFF09-ZZ (Europe & Asia)
SUTFF10-ZZ (US)
Dimensions W x D x H 1015 x 764 x 1225 mm
System weight 110 kg
System components QF150 recirculation pump; WM313 peristaltic DF pump; Cadence CM Holder; 2 x 3⁄4 in. pinch valves; 1 x 3⁄4 in. manual TMP control valve
Software
Weigh scale
Pressure and flow transmitter
 

Additional Hardware

 
LGRTFFCMTRL Bespoke trolley, supplied with 1x 20 L tray and 1 x 50 L 3D tote
LGRTFFCMCONDKIT Add conductivity transmitter to base system
LGRTTFFCMUVKIT Add UV transmitter to base system
 

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)
 

 

 
Feed/Retentate/
Permeate Sets
Cassette Type Single-use Sensors in Manifold
744-69N Cadence SUTFF modules Pressure, flow
744-69P Cadence SUTFF modules Pressure, flow, temperature, conductivity
744-70H Centramate cassettes Pressure, flow
744-70J Centramate cassettes Pressure, flow, temperature, conductivity
7440-70W   UV assembly for permeate
744-70T FAT test set Contains all sensor options and 5 L retentate biocontainers
 
Application
Systems - Single-Use