TANDEM IIIA

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

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).

TANDEM

TANDEM is an on-line pharmaceutical tablet characterization tool, which incorporates the Sotax AT4 conventional tablet tester and Bruker’s MATRIX FT-NIR spectrometer.

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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.

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 the press control system and other process software platforms, such as the Siemens SIPATTM.

Operation Modes

The TANDEM can be used in two different configurations:

TANDEM IIIA stand-alone mode:

  • no connection to a tablet press
  • manual feed of the tablets into the system
  • no interface to a tablet press
  • status and results are available as OPC outputs only
  • controlled by operators
  • detailed reports are available

TANDEM IIIA integrated, automatic mode:

  • connected to a tablet press
  • automatic feed of the tablets into the system
  • interfaced to a tablet press via OPC (input/output)
  • controlled by the tablet press

Validation

Complete instrument and software validation including:

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

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

Technologies used are protected by one or more of the following patents: US 7034944

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

Application Support

Bruker Optics is staffed by expert scientists and engineers who have an in-depth know-ledge of instrumentation and applications. Our product specialists are available to assist you with method development either remotely or in your lab.

 Moreover, Bruker Optics offers an array of ready-to-use calibrations which facilitate your entry into the world of NIR spectroscopy.

Service & Training

Bruker Optics spectrometers are designed to provide years of dependable trouble-free operation, but should a problem occur a network of Bruker companies and representatives throughout the world are ready to promptly respond to your needs. Professional installations and a high standard of post-delivery service are commitments Bruker Optics makes to each of its customers. Remote diagnostics in addition to a variety of service contract packages are available for comprehensive support.

 Apart from regular customer trainings, dedicated in-house seminars and local support can be arranged according to your needs.

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