A Perspective on the Role of Digitalization Enablers in Sustainable Pharmaceutical Manufacturing

Abstract

Due to the steady rise in the implementation of Industry 4.0 concepts in chemical and (bio)pharmaceutical industries, an essential aspect of transitioning pharmaceutical production towards Sustainable Pharmaceutical Manufacturing (SPM) is the utilization of digitalization technologies. SPM involves the collaboration of a multitude of different process engineering and sustainability-oriented systems methodologies like Lifecycle Assessment and green metrics. Keeping this in mind, this paper aims to provide a concise review of critical areas of digitalization aspects to overcoming the hurdles towards sustainability of pharmaceutical processes: process analytical technologies (PATs), soft sensors and Digital Twins (DTs). These tools enable manufacturing under the Quality-by-Design (QbD) paradigm, prioritizing process and product understanding and yield to reduce the number of tests, resources, and costs in the long run. Modernization through DTs and PAT requires significant data exchange and a fully realized data management system. Successful integration of digitalization, I4.0, and lean manufacturing concepts have been found to be of substantial advantage for flexible supply chains and continuous manufacturing, higher efficiencies, and productivity with minimal waste production. The path to utilizing these tools to their full potential in the pharmaceutical industry is closely examined for application in specific processes and products in the future.