Regulatory authorities require the accurate analysis of finished pharmaceutical goods to confirm the products’ content uniformity and physical characteristics. Traditionally, content uniformity analysis has been performed offline by liquid chromatography. This time-consuming and operator-intensive process requires a manual collection of samples during a batch followed by laboratory Analysis.

Near-infrared (NIR) transmission spectroscopy has proven to be a reliable, rapid and non-destructive alternative for routine tablet content uniformity testing along with moisture and excipient analysis. The TANDEM IIIA combines Bruker’s MATRIX FT-NIR spectrometer with an AutoTest 4 tablet tester by Dr. SchleunigerR Pharmatron into one fully automated tablet testing system. Whether operated stand-alone or fully integrated with a tablet press, the system provides real-time information about a tablet’s content uniformity (CU) and physical properties such as weight, thickness, diameter/length and hardness. While collecting real-time process data helps you to improve your process understanding, the TANDEM IIIA also allows control of the tablet compression process and can be easily deployed as an integral part of your continuous manufacturing strategy using a standardized OPC protocol.

The AutoTest 4 is a key module of the TANDEM IIIA and has originally been designed for online testing in combination with a tablet press. Robust design, the ability to reliably handle even difficult-to-orient tablet shapes, and proven Dr. SchleunigerR hardness measuring technology have made it a favorite in compression rooms globally. As an integral part of the TANDEM IIIA, the unit separates tablets and measures weight and thickness before diverting samples to the TANDEM cube for NIR measuring. During NIR analysis, the AutoTest 4 continues to perform physical tests (weight, thickness, diameter/ length, hardness) of additional tablet samples in parallel.

For more Information on the AutoTest 4 Tablet Testing System, visit
the AutoTest 4 product page.

The TANDEM cube with integrated transmission FT-NIR automatically measures tablet samples that have been diverted from the AutoTest 4 module. Tablets are precisely oriented, automatically positioned under the NIR transmission detector head, measured, and collected in exactly the same sequence. While conventional spectrometers can’t be exposed to the demanding requirements of a production environment, the TANDEM cube is fully protected against dust and water (IP65). This ensures that the NIR components are safely contained inside the housing and that the unit can be easily cleaned –making even wash-down cleaning possible if required.