A Novel CFD Model of SMX Static Mixer Used in Advanced Continuous Manufacturing of Active Pharmaceutical Ingredients (API)

Purpose: The growing demand for effective pharmaceutical treatments, notably amidst health challenges like COVID, highlights the urgency for improved drug production techniques. This study examines the simulation of the Sulzer SMX static mixer in laminar conditions for the continuous pharmaceutical manufacturing of significant pharmaceuticals, notably imatinib. Methods: Computational fluid dynamics (CFD) were employed to assess the SMX static mixer’s hydrodynamics and mixing performance. Emphasis was on mixing efficiency and residence time distributions (RTD) in a mixer with SMX elements. We refined the model’s reliability and explored the correlation between friction factor and Reynolds number. The Definitive Screening Design (DSD) was used to determine major factors impacting mixer dynamics. Results: We established a novel correlation between friction factor and Reynolds number. The study reveal that lower flowrates significantly impact mixing efficiency, with different solvents inducing mixing delays. The RTD study identified the total inlet flowrate’s influence on distribution, with higher flowrates leading to more distinct RTD profiles and decreased axial mixing. The screening analysis highlighted flowrate’s dominance over other factors in determining mixing efficiency and residence time. Conclusions: Through precise computational fluid dynamics (CFD) simulations, the study affirms the robustness of the developed model and underscores the novel correlation between the friction factor and Reynolds number. Insights into flow rate’s pivotal role in dictating mixer efficiency and residence time distribution are discerned, culminating in a comprehensive guide for refining static mixer operations for optimized drug manufacturing.