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

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.

Allegro™ CM150 Auto Single-Use Tangential Flow Filtration System - Data Sheet