CUB-20 – Non-destructive API’s fraction [%] prediction

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.
• on-line: Automated sampling at regular intervals. Allow more products to be tested in a short period (faster control strategy).
• in-line: Directly connected to an R&D, batch, or continuous manufacturing tablet press 

Each product is inspected by the multipoint NIR-SRS probe at a high-frequency frame rate, allowing several spectral acquisitions per product during its pass-through and allowing a very good RMSEP accuracy. Various extensive repeatability test campaigns and industrial case studies have shown that the predictions are within the predicted error boundaries.

This equipment is geared to provide you with this precise fraction prediction, and to remove 100% of non-compliant products from good products, allowing RTD (Real Time Decision). Using a dedicated chemometric model, the CUB-20 can also allow the prediction of the hardness in a non-destructive manner.  Samples can be sent to a classic 4-parameters tester (measuring weight, thickness, hardness, and diameter) to serve as the reference method for the indirect hardness predictions.

The unit has been developed with the utmost care to the mechanical design allowing fast and unexpansive format changes.

Data are processed and analyzed by high-speed processors and stored in a user-friendly “step by step” CFR21 acquisition software. Spectral data can easily be exported to a USB memory device, and process data can easily be exported to an upstream machine or software through OPC UA (e.g. connection to a SIPAT infrastructure or third-party process equipment). The utmost care has been taken to simplify the chemometric preparation work.

Pharma Technology – Q-Control systems are verified before delivery in a factory acceptance test (FAT). The results are part of the documentation package. Designed to comply with the European Union’s CE Guidelines, they are supplied with a manual, safety instructions, and wiring diagrams.  Our company can assist you with installation on-site and help you to develop chemometric models.