NIR In-Line Monitoring for Drug Product Continuous Process: From Understanding t - Seguridad Mania.com - España y América Latina

During the past decade, continuous processing has steadily gained traction within pharmaceutical industry. The smaller footprint, the reduction or minimization of technology transfer and overall flexibility of these systems generate the economic drivers for change. The advancement of technology, such as integration of process equipment and process analytical technology (PAT) enables concentrated process understanding and effective process control for these systems. There are an increasing number of joint efforts from industries, academia and regulatory agencies in this area. Continuous manufacturing implementations for commercial products are beginning to emerge as companies begin to turned this vision into reality. Among all the process analyzers, NIR is still one of the most widely used platform PAT tools in continuous processes. Some critical aspects should be considered for NIR (or other common PAT tools) implementation in continuous processes.