Advances in Instrumental Technology, Industry Guidance and Data Management Systems Enabling the Widespread Use of near Infrared Spectroscopy in the Pharmaceutical/Biopharmaceutical Sector

Abstract

Smaller, faster and more robust instrumentation combined with improved regulatory and industry guidance and advanced data management systems have all contributed to making the near infrared (NIR) spectroscopy technique a viable alternative to traditional in-process and final-release testing strategies in the pharmaceutical/biopharmaceutical industry. The NIR method cannot be used to replace all testing methods, but when it can be applied, it provides greater insights into the state of a process or product. It also provides real-or near-real-time quality information, allowing process operators, Quality Assurance personnel or Advanced Process Control systems to take a proactive, rather than reactive, approach to quality during the manufacturing process. This review summarises the developments in instrumentation, regulatory/industry guidance and information management systems that better enable the implementation of NIR technology into routine laboratory and process applications. A short review comparing the NIR and Raman techniques is provided, outlining the complementary nature of the two methods along with a discussion on how the two methodologies have experienced a similar evolution over the past 14 years.

The Current State of near Infrared Spectroscopy Application in the Pharmaceutical Industry

“…This edition starts with an overview of technological advances in NIR instrumentation, regulatory and industry guidance, and data-management systems over the past 14-year period. 11 This review also looks at some new areas of research and development in the industry related to the monitoring of bioprocesses with batch modelling techniques. It also discusses the role of NIR spectroscopy (and PAT) in continuous manufacturing operations.…”

Near‐infrared spectroscopy and data analysis for predicting milk powder quality attributes

“…2015); for determining particle size fractions, measuring compression strength and bulk density of pharma powders (Porfire et al . 2012; Swarbrick 2014); for measuring granulation size of particles (Lee et al . 2011); and for measuring film coating thickness on tablets (Märk et al .…”

“…Near-infrared spectroscopy has been used for real-time quality testing in the pharmaceutical industry. For example, NIR has been employed for the compositional analysis of active pharmaceutical ingredients (API) (Lin et al 2015); for determining particle size fractions, measuring compression strength and bulk density of pharma powders (Porfire et al 2012;Swarbrick 2014); for measuring granulation size of particles (Lee et al 2011); and for measuring film coating thickness on tablets (Märk et al 2010). Most of these reported studies followed guidelines provided by the United States Food and Drug Administration (FDA 2004).…”

Pharmaceutical Raw Material Identification Using Miniature Near-Infrared (MicroNIR) Spectroscopy and Supervised Pattern Recognition Using Support Vector Machine

“…Both techniques have found broad applications in pharmaceutical analysis, 4 , 5 but have their own advantages and disadvantages. 6 Raman spectroscopy has outstanding molecular selectivity, can be easily used in a non-contact fashion through common container materials, and is free of water interference from aqueous solutions. However, interference from fluorescent molecules can be a limitation, and the high energetic laser power may decompose sensitive samples.…”