Applying Quality by Design to Digital Twin Supported Scale‐Up in Modular Plants

Modular Plants are highly flexible and scalable and thus have potential utility to support faster time-to-process. Digital Twins of these modules require FAIR data and prior knowledge from the different domains in process development to describe the equipment capabilities. These equipment-based Digital Twins can be combined with methods such as Quality by Design and Model-based Design of Experiments for reduced uncertainty in process transfer and robust process development.

Abstract

In the pharmaceutical and specialty chemical industries, faster time-to-process is a significant measure of success. Modular Plants made up of Process Equipment Assemblies are of significant interest due to high flexibility and good scalability. Additional benefit can be leveraged from equipment-based Digital Twins combined with methodologies such as Quality by Design (QbD). In 2024, a small survey, aimed at stakeholders in the modular plant community, was launched to address FAIR information in process development domains. Responses from professionals in multiple disciplines revealed critical gaps in information during the lifecycle of modular manufacturing systems. These insights informed the development of a Digital Twin-based workflow for scale-up in Modular Plants, incorporating principles of QbD. Key aspects of this workflow are illustrated for transfer of an esterification process from a 2-L to a 50-L reactor module.

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