Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time Imaging
March 2nd 2015The pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature. This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.