Thermal Effusivity As A Process Analytical Technology (PAT) To Optimize Blend Uniformity: A Case Study In On-Line Monitoring Of A Pharmaceutical Blend In A Bin Blender

In October 2003, FDA released a draft guidance that introduced PAT to the pharmaceutical manufacturing industry [1]. PAT is a science based approach that focuses on the improvement of manufacturing efficiency and product quality. PAT tools perform real-time, on-line measurements of evolving quality parameters to ensure optimal processing conditions are maintained throughout the manufacturing process. PAT tools provide the means to gain new understanding and knowledge of the process critical control points and facilitate better control of process variation further upstream. The variability of inputs to the process may still exist, but knowledge of their existence and impact allows the process to be accommodating to these differences resulting in a more robust process and hence more consistent end product.

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