Expert View: NIR technology in pharmaceutical environments
NIR technology has been used in the pharmaceutical industry for nearly two decades, but the major driver for its use over the last 10 years was recommendations made by the FDA and other regulating authorities.
The technology has been used in many kinds of applications; from raw material and product identification at the warehouse to evaluation of chemical and physical properties in pharma‑related materials and dosage forms. NIR spectroscopy can be easily adapted to different sampling geometries that use transmission, transflectance and reflectance measurements. The inherent capabilities of optical fibres can be used to separate the measuring point from the NIR spectrometer by up to 300 metres. These capabilities also open the door to multiplexing – several measuring points can be handled from a single instrument. The fact that the supplied software needs to be compliant with title 21 of the Code of Federal Regulations (CFR21, part 11) constitutes a major difference with other industries. This restricts data accessibility and functionality depending on the user roles; ensures data integrity; requires recording a history of user access and data changes, and clear indications if raw data was corrupted. Recent developments in NIR technology affect both the hardware and software sides. On the hardware side, there is a trend to miniaturise and simplify the instruments so that they become more reliable and robust. On the software side, software interfaces become more intuitive, along the lines of smartphone user interfaces, and massive data streams created by NIR spectroscopy need to be shared with colleagues working at different company sites. Software should thus be capable of collecting, archiving and granting access to this data on a global level. With its versatility, its clear technical and logistical advantages, its non-invasive nature, its ease of use, and bright future in development, it is easy to understand why NIR technology is the de facto standard in pharmaceutical environments.