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Sartoflow® Expert SU

Streamlined Single-Use TFF Platform for Process Development Through Pilot Manufacturing

Sartorius Stedim Biotech GmbH

Three unit operations in one fully automated single-use solution eliminates transfer risks

Seamless scalability from 1-20 L with gamma-irradiated closed-loop design reduces bioburden

Flexible process sequencing accommodates varied manufacturing strategies with cGMP compliance

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Automated solution combines mixing for ADC conjugation reactions, filtration and concentration steps

The Sartoflow^® Expert SU represents a paradigm shift in tangential flow filtration technology, delivering a fully automated single-use platform that integrates mixing, sterile-grade filtration, and ultrafiltration/diafiltration operations within a single closed-loop system. This innovative approach eliminates time-consuming and risk-prone transfer steps between unit operations, particularly beneficial for antibody-drug conjugate (ADC), monoclonal antibody, vaccine, mRNA, pDNA, and recombinant protein manufacturing processes.

The system operates across membrane areas from 0.14 to 1.4 m² with process volumes up to 20 L, supporting applications from process development through pilot-scale manufacturing. The platform features a double-jacketed 20 L 3D mixing bag with bottom impeller, sampling port, and conical bottom design for complete drainage, minimizing product loss. Temperature control operates from 10-40°C with integrated conductivity and optional pH monitoring capabilities.

Key technological advantages include a five-piston single-use diaphragm pump with integrated overpressure protection at 4 bar and pump capacity of 900 L/h. Peristaltic pumps enable precise media addition at rates up to 1,500 mL/min. The system accommodates both Sartocon^® Slice Self-Contained ECO and Sartocube^® Self-Contained ECO cassettes with Hydrosart^® or PES membranes.

Process control features comprehensive monitoring including transmembrane pressure, inlet/outlet pressure, flow rates for permeate and retentate streams, temperature monitoring for bags, level control, and external balance integration. UV measurement at 280 nm enables real-time monitoring of breakthrough in the permeate.

Single-use flow kits arrive gamma-irradiated and feature materials resistant to organic solvents, including Tuflux^® silicone tubing with platinum curing and reinforced configurations. All product-contact materials demonstrate chemical compatibility with organic solvents, supporting diverse applications including ADC conjugation. The closed-loop design eliminates cleaning validation requirements while maintaining sterility throughout operations.