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Introduction into Process Analytical Technologies (PAT)
Tuesday, November 13
7:00 am – 8:15 am
Sunrise Session
ACPE #073-999-07-576-l04
Getting relevant information from multicomponent systems, such as pharmaceutical unit operations, is not a straightforward task. Consider a typical solid dosage form with numerous sequential processing steps. There are many possible pitfalls during processing that may critically affect the final product performance, e.g., active pharmaceutical ingredient or excipient may be stressed in aqueous environment or they may be stressed thermally during processing. Focusing analysis on the end product will not enable the early detection of problems or further the complex relations between them. Recently, the U.S. Food and Drug Administration (FDA) introduced a guidance to address this issue. Process analytical technology (PAT) is a system for developing and implementing new efficient tools for use during pharmaceutical development, manufacturing, and quality assurance while maintaining or improving the current level of product quality assurance. This session will introduce recent developments in utilization of PAT in manufacture of solid dosage forms.
Moderator
Jukka Rantanen, Ph.D.
University of Copenhagen, Denmark
Basics of Process Analysis
Jukka Rantanen, Ph.D.
University of Copenhagen, Denmark
Raman Spectroscopy: A Technique for Process Analysis
Alan Gift, Ph.D.
Indiana University, South Bend
Terahertz Radiation – A Novel Approach for Process Understanding
Axel Zeitler, Ph.D.
University of Cambridge