Background

American Institute of Chemical Engineers Delaware Valley Section	Background

May 10, 2005
Moving Beyond the Black Box: The Development of In-Line Measurements to Improve Pharmaceutical Process Understanding
Jim Zega

Join us on Tuesday May 10, 2005 to hear Dr. James Zega of Merck & Co. present a talk entitled “Moving Beyond the Black Box: The Development of In-Line Measurements to Improve Pharmaceutical Process Understanding.”

Historically, pharmaceutical process development relied on a black box approach. These black box approaches often use statistically designed experiments with machine operating parameters as variables. The operating variables, typically, are not directly related to the fundamental physical phenomena governing the processes. An alternative approach is to develop instrumentation and monitoring techniques or process analytical technologies (PAT) to provide more direct and physically meaningful measurements. Merck’s lab has developed a “toolbox” of these techniques for key pharmaceutical unit operations; including high shear wet granulation, roller compaction and column coating. The use of these techniques facilitates a deeper understanding of the fundamentals of pharmaceutical processes and provides a mean to reduce process development resources through more focused experimental designs

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