Continuous Pharmaceutical Manufacturing (CPM) is a promising new paradigm to produce active pharmaceutical ingredients (APIs), allowing reduced equipment dimensions, lower waste production and energy consumption, and safer operation in comparison to the industrially dominant batch methods. Rufinamide is an antiepileptic agent whose demonstrated continuous flow synthesis (featuring three reactions in flow) circumvents the accumulation of toxic and explosive organoazide intermediates. To ascertain the feasibility and viability of this continuous synthetic route, systematic process modelling and costing is required. This paper presents a technoeconomic analysis of the upstream continuous flow synthesis of rufinamide via steady-state process modelling and plantwide simulation. Reaction kinetics and Arrhenius parameters are estimated from previously published experimental data, and plug flow reactor (PFR) volumes are calculated towards rigorous plant costing. Continuous reactor and separator units have been designed, and the CPM flowsheet is compared vs. the batch production method, with respect to technical efficiency and profitability. Plantwide costing via an established economic analysis methodology has been pursued to enable a detailed comparison of cost items towards process scale-up, as well as motivate the need for further systematic optimisation.

连续药物制造（CPM）是生产活性药物成分（API）的有希望的新范例，与工业上占主导地位的批处理方法相比，它可以减小设备尺寸，降低废物产生和能耗，并且操作更安全。Rufinamide是一种抗癫痫药，其连续流动合成（具有三个流动反应）可以避免有毒和易爆的有机叠氮化物中间体的积聚。为了确定这种连续合成路线的可行性和可行性，需要系统的过程建模和成本核算。本文通过稳态过程建模和全厂范围的模拟，对鲁芬酰胺的上游连续流动合成进行了技术经济分析。反应动力学和Arrhenius参数是根据以前发布的实验数据估算的，而塞流反应器（PFR）的体积是按严格的工厂成本计算的。设计了连续反应器和分离器单元，并将CPM流程图与分批生产方法进行了比较，以提高技术效率和获利能力。为了建立成本比较详细的过程，并通过成熟的经济分析方法进行了全厂成本核算，并激发了对进一步系统优化的需求。关于技术效率和盈利能力。为了建立成本比较详细的过程，并通过成熟的经济分析方法进行了全厂成本核算，并激发了对进一步系统优化的需求。关于技术效率和盈利能力。为了建立成本比较详细的过程，并通过成熟的经济分析方法进行了全厂成本核算，并激发了对进一步系统优化的需求。