Today’s competitive industrial environments require that manufacturers continuously strive to improve product quality and reduce manufacturing costs. As a result, new technologies are stirring up the spectroscopy market.
The FDA Process Analytical Technology (PAT) initiative is facilitating the introduction of new technologies to the manufacturing sector. The central point of PAT is to generate product-quality information in real-time. While process monitoring traditionally involves temperature, pressure, pH and other physical parameters, PAT focuses on the use of in-line testing using near infrared, Raman or other physiochemical techniques as a primary means of process monitoring. Using process analysers, uniformity, drying and mixing endpoints, and other targeted stages can be pinpointed to a high degree of accuracy, minimising sampling errors. Near-infrared (NIR) is one technique that has gained recognition as a means of analysis at the production level. Other techniques such as Raman and mid-infrared have also been successful.
NIR spectroscopy offers a practical alternative to time-consuming, wet chemical methods and liquid chromatography techniques. It is a non-destructive method requiring no sample preparation, making it quick and reliable for quantitative and qualitative analysis. It is ideal for rapid raw material identification and is also a powerful analysis tool capable of accurate multi-component quantitative analysis. Its ability to penetrate into and through solid samples makes it ideal for tablet content uniformity analysis. NIR is also ideal for process monitoring due to the availability of various fibre optic-based sampling techniques.
The Bruker Optics multi-purpose analyser is an ideal at-line system that eliminates samples transfer and the resulting time delays. It offers a complete solution for all pharmaceutical analysis sampling needs, including liquids, powders and tablets. Tandem, a development between Bruker Optics and Dr Schleuniger, is an integrated on-line tablet analyser. The system can be regularly coupled to a tablet press as well as samples across a batch, providing tablet potency, excipient content, weight, thickness, hardness and diameter data. Matrix-F is a rugged FT-NIR spectrometer ideally suited to on-line/in-line process monitoring of liquids and solids based on fibre optic probe technologies in both contact and non-contact modes, making it ideal for blending, granulation and drying processes.
Spectrometers for all applications
Bruker Optics Inc entered the infrared spectroscopy market in 1974 and subsequently gained a reputation for producing high-performance instruments and dedicated solutions for both research and analytical spectroscopy. Bruker Optics Inc is now a leading supplier of mid-infrared, NIR and Raman spectrometers and provides state-of-the-art instrumentation for multiple markets that include the pharmaceutical, life sciences, microanalysis, food and beverage, chemical, and oil and gas industries. It also produces advanced research applications in industrial, academic and government laboratories.
Bruker Optics offers a wide range of PAT-enabling solutions, which meet the pharmaceutical industry’s analytical requirements as well as the stringent validation and regulatory requirements (21 CFR Part 11 compliance, USP 1119 compliance, IQ/OQ/PQ, GMP compliance and so on). These products are supported by a comprehensive worldwide support organisation of field engineers and application scientists.