(314f) Powder Flow Analysis Using an Automated Milli-Scale Powder Flow Test

A novel milli-scale powder flow testing method has been developed that allows an understanding of the active pharmaceutical ingredient (API) powder flowability earlier in particle engineering or API development and with only 1 gram or less of material. The milli-scale flow test method requires as little as 50 mg of material per replicate, leverages automation technology, and provides a new tool that pragmatically evaluates powder flow characteristics. Results demonstrate discrimination between a broad range of materials. Least squares regression modeling calibrates the milli-scale mass flow rates to USP standardized powder property tests. The level of flow risk is determined by a comparison of the flow rates to the Hausner ratio. A case study will be presented showing the ability of the test to identify flow risks of numerous lots of API manufactured at different crystallization and milling conditions executed through development and optimization experiments.