NIR spectroscopy: The key to measurement and control
Solid dosage form manufacturing is one of the key pharmaceutical processes, and although the basic process has been around for generations, it is often not fully understood or controlled enough to yield highly reliable product quality batch after batch. Consequently, this process is often top of the priority list for process understanding, measurement and control activities by pharma companies, usually as part of their process analytical technology (PAT) initiatives in both R&D and the manufacturing parts of the business. This article offers an overview of the integrated application of a single measurement tool, near infrared (NIR) spectroscopy, across the breadth of the process and highlights the commercial & quality benefits that can be realised by exercising control.
About the Authors:
Dr Brian Davies is director, process analytical technology at Thermo Fisher Scientific based in Madison, Wisconsin. He is responsible for coordinating and leading Thermo’s activities in process analytical technology (PAT). Brian has an extensive background in product development, business development and technology management in the scientific instrument industry. Previously, he was with Glaxo Wellcome in the UK, involved in the early development of PAT through the adoption of NIR and automated analysis systems in manufacturing areas. He then moved onto a series of laboratory management and quality system positions, ending up managing their LIMS implementation across the UK . He can be contacted on email: brian.davies@thermofisher.com
Scot Ellis is product manager for near infrared analyser products with Thermo Fisher Scientific. He is responsible for market and product development of at-line and on-line analytical technologies for industrial applications based on molecular spectroscopy. He has over 10 years experience with applications, product development, and marketing of molecular spectroscopy products. He can be contacted on email: scot.ellis@thermofisher.com
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