Pankaj Doshi, Worldwide Research and Development, Pfizer Inc.
Continuous manufacturing is gaining traction in the pharmaceutical industry for its potential to enhance product quality, production flexibility and speed-up the drug production-to-shelf path. Continuous manufacturing offers several key benefits compared to batch production, including decreased downtimes, more compact footprints, and enhanced control over product quality. This study utilizes Discrete Element Method simulations to investigate the scaling up of powder mixing processes from a 6" Continuous Mixing Technology (CMT) to an 8" CMT. The primary objective is to enable higher throughput rates exceeding 50 kg/h, a challenge in 6” CMT. The goal was to develop a geometry like the original one but allow for higher throughput rates while keeping the mean residence time constant. Three distinct scale-up rules are examined: constant rpm, Froude Number, and tip velocity. The influence of the bottom impeller shape was investigated to increase the potential process space.
The simulations use previously validated DEM parameters. The simulations focus on critical parameters such as valve opening for process stability, number of continuous stirred tank reactors, and Mean Distance Traveled to assess mixing efficiency. By employing simulations, the study aims to gain insights into the dynamic behavior of powder mixing at an increased scale, providing valuable information for process optimization and design. The impeller design is chosen based on the similarity of the original process in the 6" CMT. The analysis results shed light on the effectiveness of each scaling approach in maintaining process stability. A comprehensive over of the scaled-up design space is shown.
