VisioNIR LS

Application on FETTE FE35 tablet press.

The compacting process of tablets performed on a tablet press is essential for the efficacy of a drug. The content uniformity (CU), right compression force, the degree of humidity in the compound, particle size and other characteristics are critical parameters which are influenced or detectable in this processing step.

Close-up of VisioNIR system measuring head installed into FE35 tablet press

An in-line integrated Near Infrared (NIR) system can check for these physical-chemical characteristics to rule out deficiencies. The application is performed in a non-destructive way in real-time and to 100%. The application was developed together with Fette Compacting, Schwarzenbek, Germany.

The VisioNIR LS is a high speed Near Infrared spectrometer for the 100% Content Uniformity and hardness inspection. The reliable trend monitoring visualizes the CU/hardness prediction value of each individual tablet.  

Outliers can be removed from the product stream to ensure that no rogue tablet reaches the marketplace and the results of the in-line check of the CU can be used for the real time release

The VisioNIR LS can either be fully integrated into the tablet press or be provided as a stand-alone unit in a cabinet. The compact measuring head fits into all Fette tablet press types.  

There are no performance limits in terms of speed or throughput.  Each individual tablet is scanned in reflection mode directly after the compaction process and the resulting spectra are evaluated by the multivariate data analysis software “The Unscrambler”.

VisioNIR LS is the result of continuous development from customer requirements, process understanding and experience in the pharmaceutical production. As a result of the flexible hardware and intuitive operating software, VisioNIR LS is easy to retrofit and meets the pharmaceutical requirements.

VisioNIR LS is a high speed system. The diode array with transmission grid enables rapid and precise data acquisition. As a result of using diode array technology, no moving parts are in use and high scanning rates can be achieved to inspect individual products during the process.

Visiotec has an excellent team of NIR experts to support you with your application. Our long term experience in method calibration helps to find the best correlation between your process data and your critical quality attributes (CQA). We provide consultancy for the design of experiments (DOE), design space calculation and process calibration & validation.

Application examples

HMI visualization of acquired NIR spectra on Fette HMI
Close-up of a measuring head and mounting bracket

Functional Principle

Conceptual operating mode of system

The tungsten halogen illumination source provides NIR radiation from 700 – 2500 nm and the illumination light fiber transports the radiation to the measuring head. The measuring head focuses the NIR radiation onto the tablet and the reflected NIR radiation with spectral information is captured by the head and coupled into the collimation light fiber.  The collimated NIR radiation is transported to the diode array NIR spectrometer and the transmission grid splits the polychromatic NIR radiation into its single wavelengths. The single diodes are counting the number of photons regarding their wavelength range and the AD converter visualizes the NIR spectrum. The spectra will be evaluated in terms of CU or hardness in the evaluation PC with multivariate statistics. The results can be visualized on the trend monitoring screen.

Highlights

  • Sophisticated in-line technique
  • 100% inspection of individual tablets
  • Rapid and robust diode array technology
  • Integrated or stand alone solution
  • Compact design
  • Fiber optics technology
  • Multivariate evaluation
  • CU and hardness inspection
  • Rejection of rogue tablets
  • Real Time Release solution
  • Easy to retrofit into existing tablet presses
  • CFR Part 11 compliance

Downloads

Contact person

Christoph Lehmann

Head of Sales

Phone +49 7392 702-8712
Fax +49 7392 702-8539