Introducing mechanistic models in Process Analytical Technology education.

The Process Analytical Technology (PAT) guidance of the Food and Drug Administration (FDA) is designed to move pharmaceutical production away from off-line product quality testing to ‘real-time release’ strategies supported by on-line measurement of critical process variables.A successful PAT implementation primarily requires in-depth process knowledge but also a number of tools and methods including on-line analysis, process monitoring, as well as process control. In order to achieve successful PAT implementation, the students and professionals already working in the pharmaceutical industry will need more skills particularly within the design, tuning and implementation of process control algorithms. Based on reported experiences in other engineering disciplines such as chemical and environmental engineering, we conclude that development of a benchmark (mechanistic) modeling platform for pharmaceutical manufacturing systems is needed. Supported by a team of experts from academia and industry, this benchmarking effort can deliver documented and validated models of selected casestudies from pharmaceutical industry. Such publicly available and expert validated models could significantly contribute to educating students and professionals with skills that are essential for implementing the PAT guidance in pharmaceutical manufacturing systems.

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