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Establishing Standards and Methods for Qualification and Validation of New Particle Measurement Technologies



Srivalli Telikepalli, Dean C. Ripple, Kurt D. Benkstein, Kristen L. Steffens, Michael J. Carrier, Christopher B. Montgomery


Numerous particle sizing and counting methods exist for measuring particles in the submicrometer, subvisible, and visible size range. This article will briefly describe some key aspects that need to be considered for the most commonly used methods in order to obtain high quality data. Standards should be an integral part of qualifying or validating these methods. Some practical options of how standards can be implemented will be presented.
BioPharma Asia
Created November 11, 2019, Updated August 26, 2020