A statistical data analysis tool for the Morphologi G3 high sensitivity particle characterization system makes it quick and easy to investigate batch-to-batch variation in a powder feed or product. From the database of size and shape measurements, the data comparison tool rapidly identifies the parameters responsible for batch-to-batch variation. The results, in combination with process or product performance data, make it easy to identify those parameters that are ‘critical to quality’ and set appropriate criteria for QC. This tool is particularly relevant for the pharmaceutical industry, with its current focus on more effective specification setting, as encouraged by QbD.

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Malvern Instruments Inc.
10 Southville Road
Southborough, MA, 01772