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

Allegro™ Single-Use Tangential Flow Filtration System

For control, flexibility and ease of use in manufacturing

The Allegro CS1000 and CS4500 single-use tangential flow (SUTFF) systems offer all the control and instrumentation for running fully automated UF/DF processes from 500 to 2000 L batches. The approach to design offers systems that are compact, ensure low feed/retentate volumes, and have the flexibility to run cassette surface areas from 0.5 to 10 m2.
  • Intuitive control system employing step editor software
  • Easy set up and installation of manifolds
  • Good selection of single-use sensors

System Concept

Allegro 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.

Flexibility 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 bio-containers are available for retentate, product recovery and buffer / WFI. Weigh scales and mixer technologies can also be offered with these systems, to suit individual process requirements.

A review of specific process needs with our 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 totes and mixers. Or it might lead to the creation of a custom 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 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 Allegro SUTFF systems 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 resource allocation.

Control System

The automation concept is based on the Pall Process Step Editor (PPSE), which 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.


Main screen with indication of all process signals as well as system/ component status

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, biocontainer 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.

CS1000 cassette holder, with manual torque, 0.5 to 2.5 m2 T-series cassettes or Cadence™ single-use TFF modules

Key System Features

  • Interactive P&ID based user interface with dynamic flow path
  • Flow, TMP and bag weight controller
  • Phase based automation (one phase comprising up to 30 freely definable steps)
  • Easy to use phase editor
  • Full security access to configuration
  • Real-time trending
  • Graphic data analysis using the Pall Analytic Tool (PAT)
  • Data and event logging
  • Batch report generator (one page per step)
  • User administration
  • Audit Trail


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Description

For control, flexibility and ease of use in manufacturing

The Allegro CS1000 and CS4500 single-use tangential flow (SUTFF) systems offer all the control and instrumentation for running fully automated UF/DF processes from 500 to 2000 L batches. The approach to design offers systems that are compact, ensure low feed/retentate volumes, and have the flexibility to run cassette surface areas from 0.5 to 10 m2.
  • Intuitive control system employing step editor software
  • Easy set up and installation of manifolds
  • Good selection of single-use sensors

System Concept

Allegro 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.

Flexibility 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 bio-containers are available for retentate, product recovery and buffer / WFI. Weigh scales and mixer technologies can also be offered with these systems, to suit individual process requirements.

A review of specific process needs with our 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 totes and mixers. Or it might lead to the creation of a custom 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 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 Allegro SUTFF systems 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 resource allocation.

Control System

The automation concept is based on the Pall Process Step Editor (PPSE), which 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.


Main screen with indication of all process signals as well as system/ component status

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, biocontainer 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.

CS1000 cassette holder, with manual torque, 0.5 to 2.5 m2 T-series cassettes or Cadence™ single-use TFF modules

Key System Features

  • Interactive P&ID based user interface with dynamic flow path
  • Flow, TMP and bag weight controller
  • Phase based automation (one phase comprising up to 30 freely definable steps)
  • Easy to use phase editor
  • Full security access to configuration
  • Real-time trending
  • Graphic data analysis using the Pall Analytic Tool (PAT)
  • Data and event logging
  • Batch report generator (one page per step)
  • User administration
  • Audit Trail
Specifications

Systems Technical Specification CS1000

 
Membrane area 0.5 – 2.5 m2 (dictated by specific process crossflow versus recirculation pump capacity)
Feed and retentate tubing ID ½ in. (12.7 mm)
Permeate and product inlet/diafiltration buffer Tube ID ½ in. (12.7 mm)
Recirculation pump Quattroflow♦ 1200SU,
4-Piston Diaphragm Pump
20 to 1000 L/hr
Fed batch/ Buffer pump Ismatec Flowmaster♦ FMT300 Peristaltic
pump, ISM Drive
6 – 600 L/hr with 12.7 mm element
Recirculation biocontainer 20 L, 50 L, 100 L tote or 50 L, 200 L mixer
Filter type Pall Centrasette™ cassettes or equivalent
Over pressure protection Yes
Maximum pressure 4 barg for reinforced manifold sections
1 barg for permeate and medium pressure manifold sections
0 barg for biocontainers
Volume in feed and retentate lines 650 mL
Non recoverable volume < 100 mL
Operating temperature range 4 – 40 ºC
System frame and cabinet materials of construction 304 stainless steel
Dimensions system with retentate 20 L tray (length x depth x height) 1800 x 800 x 1600 mm (nominal)
Dimensions system with retentate 100 L tote (length x depth x height) 1800 x 800 x 1955 mm (nominal)
Weight of empty system 350 Kg
Power 230 V, 1-phase 50 Hz; 120 V, 1-phase 60 Hz
 

Systems Technical Specification CS4500

 
  ¾ in. manifold assembly 1 in. manifold assembly
Membrane area 3.0 – 10 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
480 - 2000 L/h with
3-degree shaft
480 – 2940 L/h with
6-degree shaft
600 - 4500 L/h with
6-degree Pump Model
Fed batch/Buffer pump Quattroflow-1200SU, 4-Piston Diaphragm Pump 20 to 1000 L/hr  
Recirculation biocontainer 200 L tote or mixer 500 L tote or mixer
Filter type Pall Centrasette cassettes or equivalent
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 400 V, 3-phase 50 Hz
 
CS4500 cassette holder: central distribution plate, with or without auto torque. 3.0 to 10 m2: regular T-series cassettes

Component Specifications

 
  CS1000 CS4500
    ¾ in. manifold assembly 1 in. manifold assembly
Recirculation pump Flow range 20 to 1000 L/hour 480 - 2000 L/hr with 3-degree shaft
480 – 2940 L/h with 6-degree shaft
600 - 4500 L/hr with 6-degree shaft
Fed batch/ Buffer pump 6 – 600 L/hr with 12.7 mm element 20 to 700 L/hr
Pneumatic pinch valves For use with ½ in. tubing 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 Single-Use diaphragm valve body with positioner
Recovery valve Single-use diaphragm valve body Single-use diaphragm valve body
Retentate flow measurement 20 – 1200 L/hr +/-5% Configurable for a defined flow range (5% accuracy full scale)
Permeate flow measurement 20 – 1200 L/hr +/-5%  
Pressure measurement -0.48 – 5.2 bar; ± 2% from 0 – 0.41 bar; ± 3% from 0.41 – 2.07 bar; ± 5% from 2.07 – 4.14 bar
Temperature measurement 0 – 70 ºC 2 – 50 ºC
Conductivity High range 10 – 200 mS/cm
Low range 0 – 100 μS/cm)
Retentate: 0.0 to 150.0 mS/cm
Permeate: 0.0 to 100.0 μS/cm and 0.1 to 150.0 mS/cm
(reading switches between the two ranges)
± 2% of measured value ± 0.4 μS/cm
(dependent of process and ambient temperature being equal).
UV 0 – 2 AU +/- 0.1 AU 0 – 3 AU +/- 0.5%
pH n/a 0 – 12 pH units
Level sensor n/a Presence/Absence liquid on the product inlet line
Air flow n/a 0-12500 sccm +/-1%
Mass measurement 0 – 150 kg
+/- 20 g readability
Appropriate size load cell will be defined for each process
 

Product contact materials for Allegro CS1000 and CS4500 SUTFF Systems

 
Process wetted components Materials of construction
Tubing Platinum cured silicone, reinforced in high pressure sections
Product recirculation pump CS1000 and 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
Biocontainers LDPE
Distribution plate Polypropylene
 
Performance

Quality Standards

Pall maintains a stringent 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.
Pall has implemented a quality management system according to DIN EN ISO9001: 2008, EN 729. The Pall 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
  • Have components that are tested for biocompatibility and certified to USP <88>
  • Have 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
 
Application
Systems - Single-Use