LAPSE:2024.1549
Published Article

LAPSE:2024.1549
Technoeconomic and Sustainability Analysis of Batch and Continuous Crystallization for Pharmaceutical Manufacturing
August 16, 2024. Originally submitted on July 9, 2024
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.
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.
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Suggested Citation
Rhim J, Nagy Z. Technoeconomic and Sustainability Analysis of Batch and Continuous Crystallization for Pharmaceutical Manufacturing. Systems and Control Transactions 3:359-366 (2024) https://doi.org/10.69997/sct.107722
Author Affiliations
Rhim J: Purdue University, Department of Aeronautics and Astronautics Engineering, West Lafayette, IN, USA; Purdue University, Department of Chemical Engineering, West Lafayette, IN, USA
Nagy Z: Purdue University, Department of Chemical Engineering, West Lafayette, IN, USA
Nagy Z: Purdue University, Department of Chemical Engineering, West Lafayette, IN, USA
Journal Name
Systems and Control Transactions
Volume
3
First Page
359
Last Page
366
Year
2024
Publication Date
2024-07-10
Version Comments
DOI Assigned
Other Meta
PII: 0359-0366-676165-SCT-3-2024, Publication Type: Journal Article
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LAPSE:2024.1549
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https://doi.org/10.69997/sct.107722
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