Sartorius Stedim Biotech has inroduced FlexAct, a system for pre-configured single-use solutions to meet process requirements. FlexAct will enable biomanufacturers to utilise integrated single-use equipment for biomanufacturing steps in upstream and downstream processing.
FlexAct offers new possibilities for designing efficient and flexible production processes by using out of the box disposable unit operations. This new level of integration and standardisation makes it easy for anyone who still uses stainless steel equipment or individual disposable components to convert to single-use unit operations.
FlexAct is designed for preparation of buffers that are essential for stabilising target molecules and providing for their optimal production conditions. In biopharmaceutical processes, buffers, such as sodium phosphate, Tween and Tris, are particularly used in cultivation and fermentation as well as purification to maintain pH, salt content and other parameters of biologics within a desired range.
The FlexAct BP system is based on a multifunctional central operating module (COM), which accommodates pre-configured single-use assemblies and, moreover, a pump and a control unit. FlexAct BP addresses the entire development cycle and production capacity needs from 50 to 1,000 liters for buffer preparation.
The integration of monitoring and control features for pH, temperature, pump speed and fluid level control reflects for implementing process-relevant analytical tools. The integrated controls enable users to perform other tasks during the buffer preparation process without the need to supervise the system. In combination with a Flexel LevMixer system and multiple Palletanks, the multifunctional COM lets users install, operate and monitor a unit operation completely based on single-use components.
The FlexAct BP solution consists of a Flexel LevMixer system, a weighing platform, a multiple bag assembly with palletanks and the central operating module. Moreover, the COM takes up exceptionally little space. Its compact design enables users to easily maneuver it even in tight production spaces.
FlexAct provides ample room for accommodating extra equipment, such as a Sartocheck filter integrity test system. The standardised single-use components utilised in FlexAct harmonise and simplify validation and procurement.