The use of Real-Time At-Line Particle Size Measurement on a Pelletization Process for Accurate End-Point Prediction

The direct pelletization process is a fast and flexible operation with the potential to produce high quality particles appropriate for sophisticated oral solid dose formulations where a narrow Particle Size Distribution (PSD) is required. Particle size is a critical quality attribute for many pharmaceutical applications making control of endpoint particle size a fundamental requirement. The Glatt proprietary Complex Perfect Spheres (CPS®) pelletization process is fast and therefore requires a rapid objective PSD measurement method during processing to follow the particle growth curve and accurately determine end-point. Traditional methods are too slow or subjective and therefore may be an unacceptable risk for use as an In-Process Control (IPC) in a control strategy. An at-line direct imaging method with automated high-speed image analysis can be practically used during processing to accurately predict the process end-point with fast objective PSD data, supported by particle images, to significantly improve process optimisation and control. The approach can also be used for other rotor based pelletization processes.

Download the full article here: 2018_Glatt_Innopharma_PAT_for_pellitization_process_development_and_IPC

Authors: Emmet Hogan (A), Mike Mulcahy (A), Dr. Ian Jones (B), Dr. Norbert Pöllinger (C), Mirko Nowak (C), Dr Orapin Rubino (D), Greg Jayne (D)
A: Innopharma Technology, Dublin, Ireland
B: Innopharma College of Applied Sciences, Dublin, Ireland
C: Glatt GmbH, Binzen, Germany
D: Glatt Air Techniques, Ramsey, NJ, USA