NIR spectroscope CUB-20

clinicalfor clinical research

The most sophisticated multipoint NIR-SRS (Spatially Resolved Spectroscopy) is embedded to allow prediction of the APIs (Active Pharmaceutical Ingredients) fractions in the tablets formulation. A close and strong collaboration between engineers, research centers, and universities has contributed to achieving extremely accurate content measurements. The versatile transportable unit is intended to run as a PAT non-destructive [ Key benefits Extremely versatile process development and PAT toolbox Fast & easy collection of spectra for chemometrics Help for process stability study, clinical batch testing, or validate new processes Simple to use thanks to 21 Part 11 compliant software guidance Easy cleaning, validation, and calibration The most sophisticated multipoint NIR-SRS (Spatially Resolved Spectroscopy) is embedded to allow prediction of the APIs (Active Pharmaceutical Ingredients) fractions in the tablets formulation. A close and strong collaboration between engineers, research centers, and universities has contributed to achieving extremely accurate content measurements. The versatile transportable unit is intended to run as a PAT non-destructive tool for a valuable process understanding: off-line: R&D activities, process development, process knowledge for scale-up, process stability studies, fast & easy collection of spectra for chemometrics, clinical batch testing, proving global batch quality for CMO, counterfeit product detection and sorting, batch recovery,… at-line: Allow stratified sampling method and improve the real-time decision, help to validate new manufacturing process (i.e. Continuous manufacturing) – Can serve multiple lines.