Technoeconomic and Sustainability Analysis of Batch and Continuous Crystallization for Pharmaceutical Manufacturing

Abstract

Continuous manufacturing in pharmaceutical industries has shown great promise to achieve process intensification. To better understand and justify such changes to the current status quo, a technoeconomic analysis of a continuous production must be conducted to serve as a predictive decision-making tool for manufacturers. This paper uses PharmaPy, a custom-made Python-based library developed for pharmaceutical flowsheet analysis, to simulate an annual production cycle for a given active pharmaceutical ingredient (API) of varying production volumes for a batch crystallization system and a continuous mixed suspension, mixed product removal (MSMPR) crystallizer. After each system is optimized, the generalized cost drivers, categorized as capital expenses (CAPEX) or operational expenses (OPEX), are compared. Then, a technoeconomic and sustainability cost analysis is done with the process mass intensity (PMI) as a green metric. The results indicate that while the batch system does have an overall lower cost and better PMI metric at smaller manufacturing scales in comparison with the continuous system, the latter system showed more potential for scaling-up for larger production volumes.