Senior Scientific Liaison U.S. Pharmacopeia (USP) Rockville, Maryland
This presentation will briefly discuss the important role that material properties play in the design and the control of processing in a continuous manufacturing train, and the significance of their proper characterization. It will review the techniques used for physical properties characterization and associated standards (General Chapters), as well as identification of other technologies for the materials physical property characterization that are used in PCM and the need for developing new relevant USP standards. The presentation makes the case for the need for transparent public standards and highlights how the USP standard-setting structures and processes are used for the standardization of ingredients characterization techniques, represented in documentary standards and physical reference standards. A summary of material physical properties relevant to the PCM production lines is shown together with the associated techniques that are reported being used for the characterization of these properties, and whether the techniques are currently represented in USP-NF or not. A schematic illustration of how the out of defined specification material properties may cause potential processing failures in respective unit operations of a direct compression manufacturing train will be presented.
identify relevant physical properties of the material used in pharmaceutical continuous manufacturing (PCM) and the associated characterization techniques.
relate how the variability in the physical properties of materials could be a cause of concern and maay lead to manufacturing and/or product failure.
recognize the need of standardization and the use of scientifically sound public standards for the characterization techniques for physical properties of materials.