TANDEMIIIA head

On-line PAT Tool for Tablet Characterization

TANDEM is a fully automatic on-line PAT tool that allows the collection of process data and control the tablet compression process. The system provides both physical and chemical characteristics of pharmaceutical tablets.

  • Provides tablet physical properties (weight, thickness, diameter, hardness)
  • Content uniformity analysis; simultaneous quantification of multiple components, such as APIs and moisture content
  • Full validation with IQ/OQ/PQ documentation and USP/EP protocols

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The regulatory authorities require the accurate analysis of finished pharmaceutical goods to confirm the products’ content uniformity and physical characteristics.

Traditionally, content uniformity analysis has been performed off-line by liquid chromatography. This time-consuming and operator-intensive process requires a manual collection of sample tablets at regular intervals during a batch and a consecutive laboratory analysis. Near-infrared transmission spectroscopy has proven to be a reliable, rapid and non-destructive alternative for routine tablet content uniformity testing along with moisture and excipient analysis.

The TANDEM is the leading technology available on the market for FDA-approved real-time release (RTR).

TANDEM

TANDEM is an on-line pharmaceutical tablet characterization tool, which incorporates the Sotax AT4 conventional tablet tester and Bruker’s MATRIX FT-NIR spectrometer.