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Advantages of Real-Time Blending Optimisation with NIR Technology for Improved Process

NIR Technology

Advantages of real-time blending optimisation with NIR technology for improved process understanding and cost reduction.

The use of NIR technology for real-time blending optimization has revolutionized the traditional laborious and time-consuming blend uniformity testing process. By continuously monitoring the blending process, NIR spectroscopy can determine the optimum end-point, leading to a reduction in effort, time, and cost while improving process understanding.

Interface of the MicroNIR PAT-W into the lid of a bin blender

MicroNIR PAT-W Instrument

What is the traditional method of blend uniformity testing in the pharmaceutical industry?

The traditional method of blend uniformity testing in the pharmaceutical industry involves stopping the blender after a given time and withdrawing 10 samples at predefined locations specified by the current International Conference on Harmonization (ICH) guidelines.

What are the disadvantages of the traditional blend uniformity testing method?

The disadvantages of the traditional blend uniformity testing method include the need to stop the blender for sample withdrawal, which makes continuous monitoring impossible, thief sampling causing perturbations in the blend process, labor-intensive and time-consuming laboratory characterization, operator exposure to API and solvents requiring extra safety measures, and the blend being exposed to the environment.

How does installing a near infrared (NIR) sensor online overcome the disadvantages of traditional blend uniformity testing?

Installing a NIR sensor online allows for continuous monitoring of the blending process in real time, without the need to stop the blender for sample withdrawal and further laboratory analysis. This eliminates thief sampling and reduces labor-intensive and time-consuming laboratory characterization.

What is the MicroNIR PAT-W, and how does it work?

The MicroNIR PAT-W is a near infrared (NIR) sensor that can be installed on a blender lid to monitor tumble blending continuously in real time. The MicroNIR PAT-W monitors blend uniformity throughout the blending cycle by plotting the standard deviation of the acquired spectra over time. This provides an easily interpreted numerical value that reflects the degree of uniformity of the mixture.

Spectra acquired during blending.

Moving Block Standard
Deviation of spectra plotted over time.

What is Moving Block Standard Deviation (MBSD), and how is it used to determine the endpoint of a blend?

MBSD is a data processing technique based on the calculation of standard deviation as an index of similarity. At the beginning of the blending cycle, the materials are well separated, and the spectral variability from one rotation to the next and the resulting block standard deviation are high. As the material becomes well blended, the MBSD decreases to a low, nearly constant level. Blending is complete when the calculated value falls below a user-defined threshold and remains consistent over a meaningful number of blender revolutions.

What are the benefits of using the MicroNIR PAT-W for blend uniformity testing?

The benefits of using the MicroNIR PAT-W for blend uniformity testing include enabling process monitoring from laboratory to production through a scalable path, acquiring actionable information within the process experimental domain, avoiding overprocessing, reducing blending time and increasing manufacturing productivity.

What are the advanced data analysis tools that can be applied for blend uniformity monitoring?

When complex blending dynamics need to be understood, more advanced data analysis tools such as narrowing the spectral region to the unique signatures of specific ingredients while simultaneously displaying the profile of multiple constituents or data reduction with PCA (Principal Component Analysis) prior to performing the MBSD computation can be applied.

What to do next?

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