(39c) The Use of Recipe-Driven Distributed Control System in Pharmaceutical Pilot Plant Operations
AIChE Annual Meeting
2008
2008 Annual Meeting
Pilot Plant Centennial Celebration - Sponsored by Group 12b, Pilot Plants
Instrumentation and Control - Sponsored by Group 12b, Pilot Plants
Monday, November 17, 2008 - 9:35am to 10:05am
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.