The TANDEM from Bruker is a fully automatic on-line PAT tool that enables the collection of process data and controls the tablet compression process. The system provides both chemical and physical attributes of pharmaceutical tablets.
- Provides tablet physical properties (weight, diameter, thickness, hardness)
- Content uniformity analysis; simultaneous quantification of a number of components, such as moisture content and APIs
- Full validation with USP/EP protocols and IQ/OQ/PQ documentation
The regulatory authorities require the accurate analysis of finished pharmaceutical goods to verify the products’ physical attributes and content uniformity.
Traditionally, content uniformity analysis has been performed off-line with 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 been established to be a reliable, rapid and non-destructive alternative for routine tablet content uniformity testing along with moisture and excipient analysis.
The TANDEM is a leading technology that is available on the market for FDA-approved real-time release (RTR).
The TANDEM can 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 alert the user of a failing component.
Instrument performance is validated by clicking a button using Bruker’s Instrument Test Software along with the integrated Internal Validation Unit, assuring proper operation of the whole system. The instrument can be serviced rapidly and will be back in operation with minimum disruption of the manufacturing process.
Bruker offers seamless integration of the TANDEM to the tablet press, using the TabStatProTM software 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. Analysis parameters can be transferred in real-time using an OPC interface to the press control system and other process software platforms, such as the Siemens SIPAT™.
The TANDEM can be used in two different configurations:
TANDEM IIIA stand-alone mode:
- no connection to a tablet press
- no interface to a tablet press
- controlled by operators
- manual feed of the tablets into the system
- status and results are available as OPC outputs only
- detailed reports are available
TANDEM IIIA integrated, automatic mode:
- connected to a tablet press
- controlled by the tablet press
- interfaced to a tablet press via OPC (input/output)
- automatic feed of the tablets into the system
Complete instrument and software validation including:
- Full 21 CFR Part 11 compliance
- Full IQ/OQ/PQ support
- Full GMP compliance
Bruker - the PAT Leader
Bruker provides 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-MF FT-IR Spectrometer for Reaction Monitoring
- MATRIX-F Process FT-NIR Spectrometer
Automatic and accurate tablet positioning under the NIR transmission detector head for highest reproducibility.