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
The Allegro CM150 Auto 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, and a dedicated kit offers the option to operate hollow fibers.
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.
- Single-use sensors
- Pressure: Feed and retentate
- Flow: Retentate
- Temperature: Feed (optional)
- Conductivity: Permeate (optional)
- UV: Permeate (optional)
- Centramate cassettes (T-series 0.1 to 0.4 m2)
- Cadence SUTFF modules 0.1 m2
- Optional kit to install hollow fiber can be provided upon specific request*
- 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
|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.|
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:
- Improved process control and reproducibility.
- Prevent high protein wall concentrations (polarization) or fouling.
- Minimized human error due to manual operation.
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:
System Technical Specification
|Membrane area||0.1- 0.4 m2, operating in typical crossflow range of 5 to 8 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|
|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
|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|
|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 StandardsPall 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
- 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
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.
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
Figures 3 and 4
Data for 10 L starting volume IgG processed on 0.4 m2 cassette area
|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)|
|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|
|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|
|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|
|7442-1057H||5 L Retentate Assembly|
|7442-1057K||10 L Retentate Assembly|
|7442-1057L||50 L Permeate Collection Biocontainer Assembly|
|7442-1057J||Sampling / Permeate Recirculation Manifold|
|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)|