在线过程控制和过程分析技术.pdfVIP

On-line Process Control and Process Analytical Technology: Integration of Chemical Engineering Practice into Semiconductor and Pharmaceutical Industries 1 Huiquan Wu, Ph.D., Ajaz S. Hussain , Ph.D. Office of Pharmaceutical Science (OPS) Center of Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) Abstract: FDAs PAT Initiative provides an unprecedented opportunity for chemical engineers to play significant roles in the pharmaceutical industry. On-line process control, as an enabling process understanding tool and advanced quality control strategy, has been widely adopted in other industrial sectors. In the present manuscript, the authors will provide their perspectives on the need of chemical engineering principles in pharmaceutical development for a thorough process understanding. From the on-line process control perspective, we will discuss the following topics: (1) how can chemical engineering help meet the challenges from the semiconductor and pharmaceutical industries? (2) how can the chemical engineering practice be integrated into the semiconductor and pharmaceutical industries to achieve process understanding and the desired state of quality-by-design? A real-world case study from the semiconductor industry will be presented to demonstrate how a classic chemical engineering concept, mixing homogeneity, can be implemented by inducing forced flow to ensure an excellent Copper Electrochemical Plating Process (Cu ECP, a key process in Cu technology) performance. The concept of Dr.Taguchis robust engineering design will be briefly discussed with a case study of brake system design. This case study will illustrate how the quality-by-design can be achieved through a