This document discusses pilot plant scale-up techniques for pharmaceutical manufacturing. It defines a pilot plant and scale-up process. The key steps in scale-up involve conducting laboratory and smaller pilot studies, designing and constructing a pilot plant, evaluating results to make corrections, and deciding whether to proceed to full-scale production. General considerations for a pilot plant include personnel requirements, equipment, production rates, process evaluation, and ensuring product stability and uniformity. GMP must also be followed in areas like process validation and documentation.

1. PILOT PLANT SCALE- UP TECHNIQUE Prepared by:- Guided by:- Mr. Jiten B. Patel Mr. Senthil kumar R. M.pharm(1 st sem) M.pharm,MBA,P.G.D.H.M B.M.C.P.

6. STEPS IN SCALE UP

7. 08 June 2009 SRTM University, Nanded Define product economics based on projected market size and competitive selling and provide guidance for allowable manufacturing costs Conduct laboratory studies and scale-up planning at the same time Define key rate-controlling steps in the proposed process Conduct preliminary larger-than-laboratory studies with equipment to be used in rate-controlling step to aid in plant design

8. 08 June 2009 SRTM University, Nanded Design and construct a pilot plant including provisions for process and environmental controls, cleaning and sanitizing systems, packaging and waste handling systems, and meeting regulatory agency requirements Evaluate pilot plant results (product and process) including process Economics to make any corrections and a decision on whether or not to proceed with a full scale plant development