Description

PALL Allegro 3/4″ and 1″ Single Use TFF-Tangential Flow Filtration System-Fully Automated

The Allegro single-use TFF system is designed specifically for the incorporation of single-use components. It is not a disposable version of a traditional TFF system design because new concepts for ease-of-use in single-use processing have been used to achieve this unique design. This includes careful consideration of the layout and installation, allowing full access to components from one side of the system.

Key Attributes: Good engineering design provides reliability, control and ease-of-use

Full automation provides control and monitoring of key process parameters. Gamma-irradiated manifolds with pre-calibrated sensors ensure quick installation

System Concept Single-use technology is widely accepted in bioprocessing, with key benefits being the elimination of cross-contamination and cleaning and greater system flexibility. Tangential Flow Filtration (TFF) is more complex than many other unit operations for which single-use approaches have been adopted. In TFF, cleaning of the TFF cassettes and system is essential to maintain flux and minimize the risk of cross-contamination in a multi-product facility. The Allegro system provides a platform onto which five single-use manifolds are attached. The five manifolds – feed, retentate, permeate, retentate biocontainer and recovery – are provided gamma irradiated and ready to install on the system. The single-use flow paths have incorporated single-use sensors where possible. These sensors are manufactured to defined tolerances and minimize downtime in system set up. Integration of sensors in this system: Allows tracking of key process parameters Provides notification when processing is not within specification Enables automated control of processing to optimum conditions Facilitates fully automated process sequences Components in the single-use flow paths have been selected to achieve the performance requirements of the system. Use of components and materials which: Meet the flow and pressure requirements of typical TFF processes Achieve scalability of performance Have full specification and certification have easy attachment and connectivity

System Description The Allegro single-use TFF system has been designed for ultrafiltration and diafiltration (UF/DF) processes. Typical applications are concentration and diafiltration of proteins, recombinant molecules, potent biological and cytotoxic drugs, and vaccines. It is fully automated, with a disposable flow path comprising high quality components in five easy-to-install manifold sets. The 1⁄2in. ID (internal diameter) system has a recirculation pump capacity of 1000 L/hour, and can typically run 0.5 – 2.5 m2 cassettes (running at a crossflow of 5 L/min/m2). It can be fitted with a 20 L or 100 L retentate bio container and operated in fed batch mode. Cassettes are placed between single-use distribution plates, which are components of the feed and retentate flowpaths. The cassette assembly is torqued between two stainless steel plates (non wetted parts), to ensure correct sealing. Connections can easily be made to Allegro 2D and 3D containers for supply of WFI, diafiltration buffer and process fluid in fed batch operations. Product temperature control, either cooling or heating, is available using a heat exchange plate under the retentate biocontainer.

Key features: Pressure independent flow provided by a positive displacement diaphragm pump ensures that critical parameters do not vary during the concentration step Fully automated system for control and monitoring of keyprocess parameters Good accessibility for installing flowpaths and daily operationPre-irradiated manifold sets for feed/retentate/permeate/fedbatch/recovery Installation of manifold sets is intuitive, and typically takes 15 minutesFigure1CAD image showing manifolds, valves and pumps Designed for Ease-of-Use Single-use technology brings many benefits in bioprocessing and can make unit operations simpler to carry out. The fully automated single-use TFF system makes UF/DF astraight forward process with full control over the key parameters. Actuated valves Fully automated TMP and retentate flow control Pressure and flow sensors for monitoring½ in. ID high pressure silicone tubing Optional conductivity sensors on retentate and permeate Positive displacement diaphragm pumpFed batch and diafiltration buffer feed control User-configurable phases and recipes Can be run in automatic or manual mode All process signals and component status are shown on the main screen Pall analytical tool supplied for trending and calculation Data logging and batch reporting

Tangential Flow Filtration System