John M. Hyde; Peter K. Watler, Ph.D.; and Keith Bader, JM Hyde Consulting, Inc.

PAT for Pharmaceutical Cleaning

Since its introduction several years ago, the process analytical technologies (PAT) initiative of the U.S. Food and Drug Administration (FDA) has inspired significant reassessment of manufacturing practices in the pharmaceutical industry. Unlike other industries, pharmaceutical producers have been reluctant to adopt cutting edge process control technologies for fear of resistance from FDA and o...