(762e) Characterization and Scalability of the Impulse Single-Use Mixing System

Single-Use mixing systems are increasingly accepted in the production of bio-pharmaceutical therapies because of their flexibility for multiproduct facilities, speed to market and reduced risk of cross-contamination. The imPULSE Single-Use Mixing Platform from ASI combines the benefits of single-use bags with an innovative patented mixing technology. The agitator or mixing head design is unique in comparison to traditional impellers with its hexagonal shaped disc and film flaps that open on the upstroke and close on the down stroke.  This achieves a vertical top to bottom mixing pattern without unwanted solid body rotation typical of traditional mixers.  This simplifies design by eliminating the need for baffles or off-set agitators to maximize power tranmission from the agitator to the liquid phase. The scalable geometric principles of the reciprocating mixing disc and vessel will be presented together with characterization using a combination of mixing studies and Computational Fluid Dynamic (CFD) methodologies. The results of these studies on the imPULSE systems throughout the entire platform of bench top to 5,000 Liter vessel sizes will be discussed.