Characterization of continuous convective powder mixing processes

The Process Analytical Technology (PAT) initiative has encouraged the development of new technology to improve upon the current manufacturing paradigm. As a result substantial attention has recently focused on continuous processing due to the ability to control disturbances online, avoiding the loss of processing materials and enabling effective process scale-up. In this paper, a pharmaceutical formulation is blended using a continuous flow “high shear” mixer utilizing different operating and design parameters. The mixing efficiency is characterized by extracting samples at the discharge of the blender, and analyzing them using Near Infrared Spectroscopy to determine compositional distribution. Operational conditions such as the inclination angle of the mixer and impeller rotation rate were investigated and showed to affect the mean residence time. The effects of mixer angle, agitation speed, number of blades, blade angle, number of passes through the mixer on the mixing performance of a powder continuous convective mixer are also examined and shown to affect mixing performance whereas the cohesive properties of the material did not significantly affect the mixing operation. Published by Elsevier B.V.