TYAML - Yet Another Multicolumn Layout for TYPO3

    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.

    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

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