Process control perspective for process analytical technology: Integration of chemical engineering practice into semiconductor and pharmaceutical industries

FDA's Process Analytical Technology ( PAT) initiative provides an unprecedented opportunity for chemical engineers to play significant roles in the pharmaceutical industry. In this article, the authors provide their perspectives on ( 1) the need for chemical engineering principles in pharmaceutical development for a thorough process understanding; ( 2) applications of chemical engineering principles to meet the challenges from the semiconductor and pharmaceutical industries; and ( 3) the integration of chemical engineering practice 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 is 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 performance and to improve product quality substantially. Further, a case study of brake system design is discussed with the concept of Dr. Taguchi's robust engineering design to illustrate how quality-by-design can be achieved through appropriate experimental design, in conjunction with the discussion on the concept of quality-by-design in pharmaceuticals. Third, a case study of freeze-dried sodium ethacrynate is presented to demonstrate the vital importance of controlling the processing factors to achieve the desired product stability. Finally, the problems of the current pharmaceutical manufacturing mode, the opportunities and engineering challenges during implementation of PAT in the pharmaceutical industry, and the role of chemical engineering in implementation of PAT is discussed in detail.