James K. Prescott, a Senior Consultant with Jenike & Johanson, will be discussing “Developing Robust Manufacturing Processes For Direct-Compression Operations” at the upcoming Interphex 2010 in New York City in April 20-22, 2010.
Direct compression tableting operations rely on obtaining a uniform blend of multiple components, and transferring that blend reliably from the blending operation to compression. Low dose products can be susceptible to segregation and sampling errors, while high dose products can be susceptible to erratic flow, weight variations, and feed rate limitations. Demonstrating that these manufacturing processes are robust, and establishing their design spaces, is essential to minimizing risk before heading into validation.
Process understanding can be gained via trial-and-error; however, if built on first-principle behaviors, uncertainty is significantly reduced. Discussions will include how to set design specifications and establish design spaces for materials and equipment, as related to powder storage, handling and transfer behaviors in manufacturing.
Visit http://interphex2010.conferencepath.com/program/ for more information.
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