(451b) Impact of Material Properties and Process Parameters on Residence Time Distributions in Pilot Scale Continuous Powder Blending
- Conference: AIChE Annual Meeting
- Year: 2019
- Proceeding: 2019 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
Wednesday, November 13, 2019 - 8:19am-8:38am
This work investigates the effects of material properties and process parameters on the RTD of active in continuous powder blending at the pilot scale (10â20 kg/hr). Indomethacin is used as the model active pharmaceutical ingredient (API), while the bulk material consists of a combination of two commonly used tablet fillers (lactose and microcrystalline cellulose). Material properties in the powder blend are manipulated via flow rate adjustment of the individual components fed into the blender. Separately, blending process parameters investigated include blender speed, screw element configuration, and total throughput. The effects of changing to another API with similar flow properties and switching to a different batch of the same API are also evaluated. In all cases, the composition of the exiting blend is monitored in-line via near infrared spectroscopy and confirmed via off-line measurement. These measurements are used to assess the RTD of API associated with each set of conditions, which are then compared to elucidate the major factors influencing the flow rate and degree of dispersion of API in continuous powder blending at pilot scale.
Disclaimer: This work reflects the views of the authors and should not be construed to represent FDAâs views or policies.
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- FDA, Quality Considerations for Continuous Manufacturing - Guidance for Industry. 2019.