Better batch control through Rapid Reliable measurement of PSD during Pelletization
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 (CQA) for many pharmaceutical applications making control of end-point particle size a fundamental requirement that demands a:
• rapid objective PSD measurement method during processing to follow the particle growth curve
• accurate end-point determination
Eyecon2 , a direct imaging method with automated high-speed image analysis can be practically used during processing in an at-line mode to accurately predict the process end-point with fast objective PSD data, supported by particle images, to significantly improve process optimisation and control.
Sample Data and Images from Trial Batch showing progression of process
The approach can also be used for rotor based pelletization processes including Glatt systems including the proprietary Complex Perfect Spheres (CPS®) technology.
Dr. Mirko Nowak, Head of CPS Technology Development…’The CPS process has attracted increasing interest in recent years as many pharmaceutical companies implement life cycle product extension projects such as paediatric formulations where taste masking can be important. Glatt have always been interested in PAT technologies that can be used while processing to improve process understanding and control. We’ve been successfully using Eyecon during processing for some time to optimise formulation and process conditions and predict end-point in CPS pelletization. Now it has now become a part of the control strategy as it provides timely objective data on a CQA in real-time.’
For more information or to request a demonstration contact our team by clicking here