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Application Note: MicroNIR PAT for blend monitoring
18 January 2016 • Author(s): VIAVI
An example of Quality by Design in practice
The aim of Quality by Design (QbD) is to build quality into a product and process from the outset. The pharmaceutical and related industries utilise powder blending operations to make solid dose drugs, yet the phenomena of powder mixing is the least understood of all sciences.
The pharmaceutical industry is now being encouraged to implement QbD into all of its product submissions, thus providing a means for a manufacturer to show enhanced product knowledge and process understanding. To supplement QbD, Process Analytical Technology (PAT) is a must for better product/process understanding and the MicroNIRTM PAT Near Infrared (NIR) spectrometer, by Viavi Solutions is a compact, yet robust and powerful tool for monitoring dynamic blending operations.
This paper discusses how the MicroNIR PAT spectrometer was used to monitor the blend uniformity of a number of designed blends of commercially available coffee, sugar and creamer and to jointly assess the sensory preference of the blends in a way that is typical of the process used by a pharmaceutical company to better understand the powder blending operation in tablet manufacturing.
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