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TANDEM On-line тестер на таблети

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
  • 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).



IP 65 protection

TANDEM is protected against dust and water (IP65), allowing decontamination with water or recommended solvents. The mechanical construction of the TANDEM allows rapid and efficient cleaning. Dismantling and reassembling of component modules fitted on the system is fast and uncomplicated. The TANDEM performs well in the most severe production conditions and is ideally suited for installation in an isolator.

Software

Bruker provides seamless integration of the TANDEM to the tablet press, utilizing the TabStatProTM software along with Bruker’s OPUS data collection and evaluation software. Measurement cycles can be pre-configured for certain tablet products. The setup parameter and analysis results are stored in a database. With an OPC interface, analysis parameters can be transfered real-time to other process software platforms, such as the Siemens SIPATTM.

Validation

Complete instrument and software validation including:

  • Full 21 CFR Part 11 compliance
  • Full GMP compliance
  • Full IQ/OQ/PQ support

Hassle-free maintenance

TANDEM is designed to be easily maintained by the user, e.g. exchange of NIR light source or tablet holders on product change. Permanent online diagnostics monitor the instrument and advise the user of a failing component.

Instrument performance is validated at a click of a button using Bruker’s Instrument Test Software in conjunction with the built-in Internal Validation Unit, assuring proper operation of the entire system. The instrument can be serviced quickly and will be back in operation with a minimal disruption of the manufacturing process.

Bruker - the PAT Leader

Bruker offers the industry’s most comprehensive range of solutions based on vibrational spectroscopy for the FDA Process Analytical Technologies (PAT) initiative:

  • MPA At-line Method Development FT-NIR Spectrometer
  • MATRIX-F Process FT-NIR Spectrometer
  • MATRIX-MF FT-IR Spectrometer for Reaction Monitoring