Continuous production of monoclonal antibodies is gaining more and more importance. To ensure continuous flow through the entire process as well as viral safety, continuous viral clearance needs to be investigated as well. This study focuses on low pH viral inactivation inside a coiled flow inverter (CFI). Computational fluid dynamics (CFD) simulation is used to gain further insight into the inactivation process inside the apparatus. The influence of viruses in comparison to different tracer elements on the residence time distribution (RTD) behavior is investigated. Finally, the viral inactivation kinetics are implemented into the CFD simulation and real process conditions are simulated. These are compared to experimental results. To the authors' knowledge, this study represents the first successful simulation of continuous viral inactivation inside a CFI. It allows the detailed analysis of processes inside the apparatus and the prediction of experimental virus study results and will therefore contribute to the effective planning of future validation studies.

中文翻译：

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盘绕流逆变器内部连续低pH值病毒灭活的模拟。

连续生产单克隆抗体变得越来越重要。为了确保在整个过程中持续不断地流动以及病毒的安全性，还需要研究持续的病毒清除率。这项研究的重点是盘绕流逆变器（CFI）内的低pH值病毒灭活。计算流体动力学（CFD）模拟用于进一步了解设备内部的失活过程。研究了病毒与不同示踪剂元素相比对停留时间分布（RTD）行为的影响。最后，将病毒灭活动力学实现到CFD模拟中，并模拟实际过程条件。将这些与实验结果进行比较。据作者所知，这项研究代表了CFI内部连续病毒灭活的首次成功模拟。它允许对设备内部的过程进行详细分析，并预测实验性病毒研究结果，因此将有助于有效规划未来的验证研究。