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.

中文翻译：

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用于先进连续生产活性药物成分 (API) 的 SMX 静态混合器的新型 CFD 模型

目的

对有效药物治疗的需求不断增长，特别是在新冠肺炎等健康挑战中，凸显了改进药物生产技术的紧迫性。本研究检验了苏尔寿 SMX 静态混合器在层流条件下连续制药重要药品（尤其是伊马替尼）的模拟。

方法

采用计算流体动力学 (CFD) 来评估 SMX 静态混合器的流体动力学和混合性能。重点是具有 SMX 元件的混合器中的混合效率和停留时间分布 (RTD)。我们改进了模型的可靠性，并探讨了摩擦系数和雷诺数之间的相关性。最终筛选设计 (DSD) 用于确定影响混合器动态的主要因素。

结果

我们在摩擦因数和雷诺数之间建立了一种新颖的相关性。研究表明，较低的流速会显着影响混合效率，不同的溶剂会导致混合延迟。 RTD 研究确定了总入口流量对分布的影响，较高的流量导致更明显的 RTD 分布并减少轴向混合。筛选分析强调了流量在决定混合效率和停留时间方面相对于其他因素的主导地位。

结论

通过精确的计算流体动力学（CFD）模拟，该研究证实了所开发模型的稳健性，并强调了摩擦因数和雷诺数之间的新颖相关性。深入了解了流量在决定混合器效率和停留时间分布中的关键作用，最终形成了完善静态混合器操作以优化药物制造的综合指南。