FT-NIR spectrometer / for the pharmaceutical industry
TANDEM On-line PAT Tool Bruker Optik GmbH

Characteristics

  • Type:

    FT-NIR

  • Applications:

    for the pharmaceutical industry

Description

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
IP65 Rated, suitable for cleaning in place (CIP)

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).

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