Optimization of Biopharmaceutical Facility Layout Design Based on Lean Project Management to Enhance Operational Efficiency and Regulatory Compliance

Abstract

This study explores the integration of lean project management principles into the spatial design of biopharmaceutical manufacturing facilities. The aim is to enhance operational efficiency while meeting stringent regulatory standards. The research identifies key inefficiencies in traditional facility layouts, including excessive material transfer, poor cleanroom zoning, and lack of flow alignment. It introduces lean
methodologies such as value stream mapping, spaghetti diagram analysis, and visual control strategies to optimize layout planning. These
tools enable the rationalization of production zones, the elimination of cross-contamination risks, and the alignment of spatial configuration
with Good Manufacturing Practice (GMP) requirements. The results demonstrate that lean-aligned facility designs significantly improve production efficiency, reduce operating costs, and increase audit readiness. The study concludes with recommendations for early-stage facility
planning and suggests future directions involving digital modeling and simulation techniques to further enhance lean integration.