TANDEMIIIA head

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; US 5923422

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