Technoeconomic evaluation of multiple MSMPR crystalliser configurations for continuous cyclosporine crystallisation

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Abstract

Continuous crystallisation using Mixed Suspension-Mixed Product Removal (MSMPR) crystallisers has been demonstrated as a feasible method for implementing continuous separations in pharmaceutical manufacturing processes. This work conducts a steady-state process modelling and
simulation study of the continuous cooling crystallisation of cyclosporine, comparing processes with and without solids recycle for their technoeconomic viability. The model describes population balance equations, crystallisation kinetics and process mass balances to compare attainable crystallisation and
plantwide yields of different process configurations. Total cost components using established economic analysis methodologies are compared for varying numbers of crystallisers, operating temperatures, total crystalliser cascade residence times and API feed concentrations. Economic analyses and the calculation of normalised cost components with respect to total crystalliser volumes identify the process without recycle as the most economically viable option, achieving the lowest total costs and low E-factors for pharmaceutical processes. The sensitivity of total costs to the selected total residence times for economic analyses highlights the need for rigorous comparison methodologies.
This work identifies the need for technoeconomic optimisation studies of continuous crystallisation processes to establish the optimal design of manufacturing campaigns prior to further development.
Original languageEnglish
Pages (from-to)1571
Number of pages1587
JournalOrganic Process Research and Development
Volume21
Issue number10
Publication statusPublished - 21 Oct 2017

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