NIR Spectroscopy PAT Sensors

Continuous monitoring of a process’ critical quality attributes (CQAs) is a fundamental requirement of continuous processing in order to gain a sufficient understanding of the process and develop a data-driven control strategy. A suitable in-line Process Analytical Technology (PAT) sensor allows for real-time CQA readings as well as a real-time trend of the process’s stability.

The Benefits of using PAT Sensors To Measure CQAs

PAT sensors are used in the manufacturing process to measure certain quality parameters of a product, bypassing or greatly reducing the necessity for sampling for off-line analysis. This has many advantages over standard off-line analysis methods, including;

  • in-situ process measurements
  • instant data access
  • enabling quick decision making during product development and manufacturing

Real-time Analysis

While the time between sampling and off-line results varies depending on the test and analytical structures in place, many PAT systems can provide real-time measurement results, allowing control decisions to be made based not only on a process recipe but also on the true CQAs of the material at that point in time, allowing for a more dynamic process control.

           

Operator Efficiency

Additionally, the potential to develop an automated control with real-time release could reduce operator time when compared to testing samples at-line or off-line and manually adjusting the process within the specification.

           

Using NIR Spectroscopy Pat Sensor For Api Concentration Measurement

The tracking of the key component(s) in a powder blend is known as active pharmaceutical ingredient (API) concentration measurement. This is done to make sure that the correct amount of drug substance is introduced into the material during the blending process. NIR spectroscopy PAT sensors can be used to track the API concentration of the powder being outputted from a continuous blender.

NIR spectroscopy PAT sensor

InnoGlobal Technology’s Multieye2 is a multipoint near-infrared (NIR) spectrometer designed for real-time in-line process monitoring. It has a single sensor with up to four discrete channels that allows measurements from four probes within a process, removing the need for time-consuming alignment processes and channel-to-channel variance that numerous single point systems often have.

This multipoint near-infrared (NIR) spectrometer is ideal for use in;

  • advanced development and manufacturing to aid rapid identification
  • monitoring and control of critical quality attributes and critical process parameters as part of a process control strategy

Multieye2 can be used to monitor API/component concentration and can also be implemented in applications where blend uniformity, moisture content and ribbon density are of interest.

           

Case Study

In a study carried out by the University of Eastern Finland in their continuous processing lab in the School of Pharmacy, Kuopio, InnoGlobal Technology’s NIR spectroscopy PAT sensor, Multieye2, was used to track the API concentration of the powder being outputted by a continuous blender.

The objective of this study was to examine the ability of the NIR spectroscopy PAT sensor to accurately monitor the concentration of API being added to the product by the continuous blending system.

The powder blend contained two ingredients: the excipient, Prosolv EasyTab SP, and the API, paracetamol, which was being monitored. The powders were fed into the blender through separate feeders, and the paracetamol concentration was changed throughout the experiment.

Result

The experiment found that the NIR Spectrometer can be used successfully for monitoring of continuous blending operations by doing the following;

  • Measuring different levels (5%, 10%, 15% and 20%) of paracetamol concentration, as may be required for varying product SKUs
  • Detecting spikes of varying magnitude (2.5 g, 5 g, 10 g and 15 g) of paracetamol coming from the blender, allowing for real-time detection of changes in the process

           

Conclusion

So if you are looking to:

  • Capture the impact of your critical process parameters with real-time data analysis
  • Reduce testing time and increase quality
  • Enable quick decision making during product development and manufacturing

Then the Multieye2 NIR spectroscopy PAT sensor might just be what you’re looking for.

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