A shortcut approach for decision-making and operational analysis of an integrated end-to-end continuous pharmaceutical process

In this work, a plant-wide model-based shortcut approach for decision-making and operational analysis of integrated end-to-end continuous pharmaceutical processes is developed and tested. The proposed hierarchical approach is implemented through a computer-aided framework. Using concepts of Layer of Protection Analysis (LOPA) combined with Net Present Value (NPV) are embedded in the framework from a modelbased point of view to comprehensively assess the overall benefits of a specific operational point. This in turn can be used to make an informed decision between competing operation alternatives. The application of the framework is demonstrated through a validated dynamic process model of an integrated end-to-end continuous pharmaceutical pilot plant. In this application, the implications of changing process operations from single pass operation to raw material recycling have been investigated.