Voices: PAT Answers

Laser Diffraction as a PAT Tool for Spray Drying

An investigation into the capabilities of at- and in-line laser diffraction analysis for improved process monitoring and control.

By Paul Wan Sia Heng PhD, BSc (Pharm), Lai Wah Chan, PhD, BSc (Pharm), and Lay Hui Tan, PhD, BSc (Pharm), GEA-NUS Parmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore & Carl Sabin, Process Products Group, Mal
Jul 15, 2009

The FDA’s PAT initiative, in combination with Quality by Design (QbD), encourages the pharmaceutical industry to intensify its focus on efficiency in manufacturing. Conventional production relies heavily on off-line testing of both in-process materials and the end products. The FDA seeks to modernize practice by promoting a shift towards knowledge-based design and development, and the use of analytical tools that can continuously monitor critical processes. For some variables, timely and/or continuous measurements in the operational environment remain a significant technical hurdle, but for others, proven solutions are already commercially available. Particle size is one such variable.

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