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TANDEM: On-line Tablet Characterization PAT Tool

TANDEM: On-line Tablet Characterization PAT Tool
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TANDEM: On-line Tablet Characterization PAT Tool - 1

• TANDEM On-line Tablet Characterization PAT Tool TANDEM is a fully automatic on-line PAT tool that allows the collection of process data and the control of the tablet compression process. The system provides information about physical and chemical characteristics of pharmaceutical tablets. Delivers data about physical tablet properties (weight, thickness, diameter, hardness) Content uniformity analysis; simultaneous quantification of multiple components, such as API(s) and moisture content Full validation with IQ/OQ/PQ documentation and USP/EP protocols Improve your process understanding 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 nondestructive alternative for routine tablet content uniformity testing along with moisture and excipient analysis. TANDEM is an on-line pharmaceutical tablet characterization tool which incorporates the Sotax AT4 conventional tablet tester and Bruker's MATRIX FT-NIR spectrometer. Innovation with Integrity

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TANDEM: On-line Tablet Characterization PAT Tool - 2

Sotax Auto Test 4 The fully automatic tablet testing system sets a new standard for the measurement of weight, thickness, diameter and hardness. In contrast to other test equipment, the AT4 was designed specifically to meet the requirements of monitoring tablet quality during the production process. Automatic and accurate tablet positioning under the NIR transmission detector head for highest reproducibility. The measurement sequence can be configured to optimize tablet handling time and quality of spectra. After the non-destructive NIR analysis the tablets can be stored in a defined...

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