Abstract

A COMPREHENSIVE REVIEW OF PILOT PLANT SCALE-UP TECHNIQUES IN PHARMACEUTICAL MANUFACTURING

Deepika Singaravelan*, Jemimah Sudhakaran, Kannabirran Vaikundam, Senthilkumar Krishnan

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Abstract

This review examines the critical aspects of pilot plant scale-up, emphasizing its role in bridging the gap between small-scale research and large-scale manufacturing. The transition from laboratory-scale to industrial-scale pharmaceutical manufacturing is pivotal in drug development. Pilot plants serve as hybrid facilities that integrate early development activities, clinical supply manufacture, technology evaluation, scale-up, and transfer to production areas. Key considerations include optimizing process parameters such as mixing time, drying techniques, granulation methods, and coating procedures to ensure product durability, reproducibility, and commercial viability. The data obtained from pilot plant studies are essential for designing efficient production processes, ensuring regulatory compliance, and minimizing risks during commercial manufacturing. Additionally, the review discusses the significance of SUPAC (Scale-Up and Post- Approval Changes) guidelines in maintaining product quality during scale-up and postapproval changes. The review concludes by highlighting the importance of pilot plant scaleup in the successful development of pharmaceutical dosage forms and its role in the regulatory framework.

Keywords: Pilot plant scale, personnel and space requirements, raw materials, SUPAC guidelines, Documentation, platform technology.