TANDEM II Fully Integrated On-line Pharmaceutical Tablet Characterization PAT Tool

 

 

CHICAGO, Illinois -- March 9, 2009 – At Pittcon® 2009, Bruker introduces the next generation on-line Pharmaceutical Process Analytical Technology (PAT) instruments.

 

The new TANDEM II is a fully automatic tablet testing system that sets new standards for on-line pharmaceutical process monitoring solutions. It combines FT-NIR spectroscopy for tablet content uniformity with physical tablet tests of weight, thickness, diameter and hardness.

 

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Near-infrared spectroscopy has proven to be a rapid, cost-effective, convenient, and non-destructive alternative for routine analysis of tablet content uniformity. It is recommended by the Food and Drug Administration’s Process Analytical Technology (PAT) initiative. The new TANDEM II incorporates near infrared transmission spectroscopy, providing simultaneous quantitation of multiple components, such as active(s) and moisture. NIR methods can be developed on the TANDEM or Bruker’s other laboratory FT-NIR spectrometers and directly transferred to the TANDEM II on-line system. The complete system was designed specifically to meet the requirements of monitoring tablet quality during the production process and is the only fully automatic on-line NIR PAT solution. It can be integrated with existing tablet pressing systems for automated analysis. The TANDEM provides real-time, in-process Stratified Sampling results recommended by the FDA and can measure over 300 tablets per batch. The analysis information can be used immediately to adjust production parameters to improve product uniformity.

 

The system is protected against dust and water (NEMA 4,IP65), allowing decontamination with water or recommended solvents. Bruker offers comprehensive validation solutions, including IQ/OQ/PQ documentation and USP/EP protocols for the TANDEM.

 

Bruker Optics is the global market leader for implementing PAT solutions to the Pharmaceutical Industry. The PAT solutions based on NIR, FTIR, Raman and TD-NMR have been successfully installed in the areas of API production, incoming material control, blending, drying, granulation, compression & final product assay.

 

For Further information:  Haydar Kustu
                                          Marketing Manager, Bruker Corporation
                                          Tel: +1 (978) 439-9899 ext 5134
                                          haydar.kustu(at)bruker.com