Drying Requires Functional Model

By Emil W. Ciurczak
PharmaManufacturing.com
A brief look at how PAT methods are being applied to better understand and characterize the pharmaceutical drying process.
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At Interphex 2008 in Philadelphia, David Radspinner, chairman of the ASTM E-5503 subcommittee on general pharmaceutical standards and marketing manager with Thermo Fisher Scientific, shared his views on Process Analytical Technologies (PAT) and Quality by Design (QbD).
In order for the industry to realize the full benefits of QbD and PAT, he said, it must change the way that it views its processes, even processes that seem as well established as drying. The key is moving from a “parametric” to a “functional” process description, which requires a different strategy on the regulatory, scientific and quality management sides.
This article will review cases that show how PAT, and methods including mass spectroscopy (MS), Near Infrared (NIR) spectroscopy, and differential scanning calorimetry (DSC), are being used to change the way that drug manufacturers describe the drying process and how they are using that information to better control and optimize that process. This is not meant to be an exhaustive or detailed analysis, but rather a summary.

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