TANDEM II Fully Integrated On-line Pharmaceutical Tablet Characterization PAT Tool 0 pages

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.
Near-infrared spectroscopy has proven to be a rapid, cost-effective, convenient, and nondestructive
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.