Online Content Uniformity (CU) with NIR

Leading technology for FDA-approved real-time release
Online FT-NIR transmission spectroscopy
High precision measuring of physical tablet properties
Full validation with proven USP / EP compliant protocols

Automatic Content Uniformity Analysis (NIR)

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 offline by liquid chromatography. This time-consuming and operator-intensive process requires a manual collection of samples during a batch followed by laboratory Analysis.

Near-infrared (NIR) 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 IIIA combines Bruker’s MATRIX FT-NIR spectrometer with an AutoTest 4 tablet tester by Dr. SchleunigerR Pharmatron into one fully automated tablet testing system. Whether operated stand-alone or fully integrated with a tablet press, the system provides real-time information about a tablet’s content uniformity (CU) and physical properties such as weight, thickness, diameter/length and hardness. While collecting real-time process data helps you to improve your process understanding, the TANDEM IIIA also allows control of the tablet compression process and can be easily deployed as an integral part of your continuous manufacturing strategy using a standardized OPC protocol.

Real-time physical parameters

The AutoTest 4 is a key module of the TANDEM IIIA and has originally been designed for online testing in combination with a tablet press. Robust design, the ability to reliably handle even difficult-to-orient tablet shapes, and proven Dr. SchleunigerR hardness measuring technology have made it a favorite in compression rooms globally. As an integral part of the TANDEM IIIA, the unit separates tablets and measures weight and thickness before diverting samples to the TANDEM cube for NIR measuring. During NIR analysis, the AutoTest 4 continues to perform physical tests (weight, thickness, diameter/ length, hardness) of additional tablet samples in parallel.

For more Information on the AutoTest 4 Tablet Testing System, visit
the AutoTest 4 product page.

Real-time FT-NIR analysis

The TANDEM cube with integrated transmission FT-NIR automatically measures tablet samples that have been diverted from the AutoTest 4 module. Tablets are precisely oriented, automatically positioned under the NIR transmission detector head, measured, and collected in exactly the same sequence. While conventional spectrometers can’t be exposed to the demanding requirements of a production environment, the TANDEM cube is fully protected against dust and water (IP65). This ensures that the NIR components are safely contained inside the housing and that the unit can be easily cleaned –making even wash-down cleaning possible if required.

Seamless software integration

Operating the TANDEM IIIA is easy. Test runs can be started automatically by the tablet press via a standardized OPC protocol – without requiring any additional actions by the operator. Alternatively, TabStat™ Pro software is available to execute complete test plans with automatic sampling at predefined intervals if your tablet press does not support online NIR testing. Regardless from where tests are started, all NIR data analysis and evaluation is performed in the background using Bruker’s standard OPUS software. This implies that operators run the system from a single controller –and that NIR methods can be easily transferred from a standalone laboratory MATRIX FT-NIR to the TANDEM IIIA. Results, including complete spectra, can be sent to the tablet press or other process software platforms such as the Siemens SIPAT™.

Regulatory compliance

Comprehensive instrument and software validation documentation – based on years of experience – are readily available for the TANDEM IIIA.

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

Additionally, the TANDEM IIIA is designed to be easily maintained, e.g. exchange of the NIR light source. Permanent real-time diagnostics monitor the instrument and advise the user of a failing component. Instrument performance is validated at the click of a button using Bruker’s instrument test software in conjunction with the built-in internal validation unit – assuring correct operation of the entire System.