Abstract for: A novel flowsheet model of continuous API manufacturing process and its applications for dynamic optimization and control
Advanced continuous manufacturing (CM) is emerging as a preferred platform to produce active pharmaceutical ingredients (APIs). A digital twin is needed for quick design, adaptation, optimization, and control of CM process. In this work, a digital twin for continuous APIs manufacturing process using modular components has been developed and its applications have been demonstrated for dynamic optimization and control system design. The process flowsheet model is the heart of 'digital twin' and consists of mathematical representation of three modules with the options of adding more as needed. The first module is for feeding and dispensing. It consists of a refill unit, feed tank, pump, mixing, and preheater. The second module is for performing the chemical reactions required to produce the target APIs. This module consists of tubular reactors placed inside a heating and cooling jacket. The third module is focused on separation of API from impurities. A continuous chromatographic model is currently used for separation purposes that can be easily replaced with any other type of separation techniques such as continuous crystallization. Currently, the developed model library consists of 32 units across 10 types that has been used to generate the integrated flowsheet model. The model has been validated using experimental data.