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Bruker’s LANCIR II is the next generation on-line process analytical technology (PAT) analyzer for pharmaceutical characterization and control. The analyzer is a self-contained, battery-operated near-infrared spectrometer that is dedicated for on-line blend uniformity monitoring. The analyzer provides real-time analysis on blending of powders for tablet production to ensure uniform consistency of active and excipients within a batch. In addition, the system can monitor components such as moisture to warn when these components are trending outside acceptable range, thus making it possible to validate every batch to determine parametric release. The analyzer is based on diode array near infrared spectroscopy, and can be mounted directly onto pilot and production scale blending equipments. It provides high sensitivity, with detection limits of >1% of pharmaceutical ingredients, including actives and excipients such as magnesium stearate. The system is protected against dust and water (NEMA4 IP65), allowing decontamination with water or recommended solvents. The propriety offers comprehensive validation solutions, including IQ/OQ/PQ documentation and the protocols for USP 1119 compliance.
Tim Studt Editor in Chief