Fontalvo-Lascano, Maria Alejandra

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Engineering economic analysis methodology to facilitate the implementation of process analytical technology (PAT) in the pharmaceutical industry
(2021-11-30) Fontalvo-Lascano, Maria Alejandra; Méndez-Piñero, Mayra I.; College of Engineering; Romañach, Rodolfo J.; González-Barreto, David R.; Department of Industrial Engineering; Santana-Vargas, Alberto
Business cases are necessary tools used in different organizations to present new projects for management evaluation, especially capital investment projects. A solid business case will facilitate the organization, presentation, and justification of innovative strategies. This research developed an engineering economic analysis methodology to evaluate Process Analytical Technology (PAT) implementation projects in the pharmaceutical industry. The developed methodology allows evaluating different scenarios, varying costs, and benefits for a PAT proposed project and can be adapted to each company's cost structure and manufacturing processes. The definition of the methodology parameters, assumptions, constraints, and potential tax incentives was the result of the literature review and recommendations of pharmaceutical industry leaders and tax advisors. Through a case study the ease of using the methodology could be evidenced as well as the evaluation in real-time of the results and any change generated during the project's analysis and its effect on the project's economic evaluation methods.