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 casettes and system is essential to maintain flux and minimize the risk of cross contamination in a multi-product facility.
The filtration system provides a platform onto which five single-use manifolds are attached. The five manifolds – feed, retentate, permeate, retentate biocontainer, and recovery – are supplied gamma irradiated and ready to install on the system. The single-use flowpaths 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, and facilitates fully automated process sequences. Components in the single-use flowpaths have been selected to achieve the performance requirements of the system. Components and materials are used which meet the flow and pressure requirements of typical TFF processes, achieve scalability of performance, have full specification and certification, and have easy attachment and connectivity.
The system is fully automated, with a disposable flow path comprising high quality components in five easy to install manifold sets. The 1/2 in. ID system has a recirculation pump capacity of 1000 l/hour, and can typically run 0.5 to 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 biocontainer, and operated in fed batch mode. Cassettes are placed between single-use distribution plates, which are components of the feed and retentate flow paths. The cassette assembly is torqued between two stainless steel plates (non-wetted parts), to ensure correct sealing.
Achema 2012 Hall 5.0 – D34