Exploring Model-Based Design for Conceptual Development of Smart Pharmaceutical Production Equipment
摘要
Thispaper examines the applicabilityof model-based design in the conceptual development of smart pharmaceutical production equipment, addressing the growing demand for highly flexible but low-volume machines required for on-demand and personalized medication. To meet the challenges of small-scale batch production, manufacturers must develop innovative concepts that either accelerate time-to-market for specialized machinery or leverage modular, reconfigurable equipment designs. An exploratory literature review was conducted to analyze the regulatory impact on the pharmaceutical sector and the role of model-based design theory in developing flexible machine concepts. Key regulatory frameworks, including Good Manufacturing Practice (GMP), Quality by Design (QbD), and Design Space (DS), were identified as critical to this discussion. Model-Driven Engineering (MDE) and Axiomatic Design (AD) emerged as prominent design methodologies in regulated industries. The research highlights the need to evaluate modular and smart pharmaceutical equipment concepts across the entire product lifecycle, from design and deployment to production, starting in the early design phases. Insights were further refined through feedback from ten industry experts, underscoring the advantages of model-based conceptual design for tackling these complex challenges. The main contribution of this work is the exploration of model-based design techniques to inform and advance the conceptual design of smart pharmaceutical equipment.