Are you keeping an eye on your products?

NGP asked Dr. Jörg-Peter Conzen, Vice President of Bruker Optics, why Near-Infrared (NIR) spectroscopy is a valuable tool for the pharmaceutical industry.

In today’s highly competitive business world, it is vital for pharmaceutical companies to consistently produce high-quality products at the lowest possible cost. This can be achieved if the production process is monitored and controlled by quick and reliable methods. The issue of QA/QC is especially important for the pharmaceutical industry, as impurities or wrong specifications for active ingredients in finished products can cause dangerous and sometimes even fatal consequences to consumers. Moreover, due to existing regulations, a lot of testing needs to be performed. The manufacture of high-quality pharmaceutical products requires at least two steps of quality analysis: identification of the incoming raw materials and quantitative analysis of active ingredients in finished products.

In both of these crucial steps, NIR spectroscopy has been proven to be an easy-to-use and powerful tool. The measurements can often be made non-invasively and non-destructively through glass vials or thin polymer films. High quality spectra can be collected within a few seconds. In contrast to time consuming methods like HPLC or wet chemical analysis, the NIR method produces no wastes, causes no pollution, and requires no chemical reagents. All of these above mentioned factors make NIR spectroscopy a quick, reliable and inexpensive analytical method for QA/QC work in the pharmaceutical industry.

Key applications
There are applications of NIR technology at nearly every stage along the supply chain. Due to the fact that any substance which contains -CH, -NH or -OH groups creates signals in the spectrum almost each material – API, auxiliary materials or fillers – can be monitored. Today, most instruments are used for raw material control in the QC lab or the warehouse. Other applications in the laboratory are final tablet checking, testing of placebos in blister packages for clinical studies, humidity measurements in lyophilisates or polymorphism studies. On the other hand more and more in-line applications are coming into focus now. Driven by FDA’s PAT (Process Analytical Technolgy) initiative, the current activities are set mostly on mixing and drying processes. Nonetheless, according to the vision of the PAT initiative, the monitoring of chemical and biological processes will be investigated as well.

Future application challenges
Modern quality control should not be limited to product testing after the respective process step (e.g. inside the laboratory), but rather accompany the whole process. By using fibre optic probes connected to the NIR spectrometer via light fibers, NIR spectra can be collected directly from both solid and liquid processes without any sample preparation. In this way, specific quality parameters can be controlled in real-time directly in the process and predicted for the final product prior to its release. By getting results within a few seconds it is guaranteed that statistically significant amounts of data are created. In many areas, NIR spectroscopy allows the direct control of the processes, leading to shorter cycle times, better product quality and the avoidance of out-of-spec batches.

Another aspect of the real-time analysis is the systematic observation of the individual system variables to achieve a better understanding of the process. It is important to notice that an important paradigm of the PAT initiative is not only about exchanging classical on-line or at-line methods by modern spectroscopic technologies – it goes further. The future challenges of applying NIR are to generate information from the process which, in addition to control issues, allows a detailed understanding of the ongoing processes and related mechanisms. This knowledge should then lead to further improvements of dedicated process steps, including risk minimisation.

Near infrared spectroscopy has become a widely used analysis tool in the pharmaceutical industry. In recent years, the FDA’s PAT initiative has been pushing hard to implement NIR for monitoring and control of processes to gain a closer understanding of the production processes.