TANDEM II
The TANDEM II is an advanced on-line PAT system for automatic content uniformity analysis. It provides both physical and chemical 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.
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Automatic content uniformity analysis (NIR)
The TANDEM II offers rapid, non-destructive near-infrared transmission spectoscropy (NIR) paired with physical testing.
- Provides physical tablet properties
(weight, thickness, diameter, hardness measuring with 10X tablet testing system) - Content uniformity analysis
Simultaneous quantitation of multiple components, such as actives and moisture - Leading NIR technology
Integrates the most advanced MATRIX FT-NIR technology from Bruker Optics - Full validation
with IQ/OQ/PQ documentation and USP/EP protocols - IP65 rated
Accurate tablet positioning
Automatic and accurate tablet positioning under the NIR transmission detector head for highest repeatability.
The measurement sequence can be configured. A sampling wheel stores up to 10 tablets for the NIR analysis and the assay.
Non-destructive analysis
NIR analysis of tablets is non-destructive and up to 30 analyzed tablet samples are stored for further evaluation with other off-line techniques.
Seamless integration
The TANDEM II 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.
