SOTAX TANDEM III Automatic Content Uniformity Analysis (NIR)

TANDEM III

The TANDEM III is an advanced on-line PAT system for automatic content uniformity analysis using rapid, non-destructive near-infrared transmission spectroscopy (NIR) paired with physical testing. It provides both chemical and physical characteristics of pharmaceutical tablets, allowing the collection of process data and control of the tablet compression process. Successful customer installations with FDA-approved real-time release (RTR) make the system the leading technology available on the market.

• Provides up to 5 physical tablet properties with tablet testing system
• (weight, thickness, diameter/length, hardness, content uniformity)
• Content uniformity analysis: Simultaneous quantitation of multiple components
• Integrates leading NIR technology from Bruker Optics
• Full validation with IQ/OQ/PQ documentation and USP/EP protocols

Automatic Content Uniformity Analysis (NIR)

Accurate Tablet Positioning

Automatic and accurate tablet positioning under the NIR transmission detector head for highest repeatability.

Non-destructive Analysis

NIR analysis of tablets is non-destructive and analyzed tablet samples are stored for further evaluation with other off-line techniques.

Seamless Integration

The TANDEM III can be integrated with a tablet press, utilizing TabStat Pro software along with Bruker’s OPUS data collection and evaluation software. Measurement cycles can be pre-configured and test results are stored in full compliance with 21 CFR, Part 11 requirements pertaining to electronic record keeping. With an OPC interface, analysis parameters can be transferred real-time to other process software platforms, such as Siemens SIPAT.