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The Use of Recipe-Driven Distributed Control System in Pharmaceutical Pilot Plant Operations

Matthew Casey1, Jeffrey Reinhardt1, and John Wasylyk2. (1) Process Research & Development, Bristol-Myers Squibb, Bldg 55/300, New Brunswick, NJ 08901, (2) Analytical Research & Development, Bristol-Myers Squibb, Bldg 50/211, New Brunswick, NJ 08901

Automation of traditionally manual processes through use of a recipe-driven distributed control system can increase the efficiency, reproducibility, and quality of pharmaceutical manufacturing operations. Applying the concepts of the ISA S88 standard has led to more effective experimentation in the laboratory, by forcing tests to better understand process ranges. On scale, these recipe controls facilitate the capture and review of process parameters for use in defining the operating design space. Instrumentation and recipe-driven control logic minimize operational inefficiencies and deviations while offering a high degree of reproducibility, as compared to conventional manual techniques. This approach has been utilized for a number of unit operations such as liquid-liquid extractions, constant volume solvent exchanges, and multi-stage product drying. These recipe-driven operations integrated with process analytical technologies (PAT) allow for in-line data monitoring while reducing operational cycle time. Additionally, following process completion, recipe-driven clean-in-place (CIP) operations ensure thorough cleanability, and rapid turnaround with minimal manpower requirements. This recipe-driven approach to process control in conjunction with highly automated equipment and enhanced data collection, has led to repeatable, more efficient processes.