High Shear Wet Granulation

The high shear wet granulation process

This typical pharmaceutical production process is a fast process, which is known for producing very dense granules resulting in a slow release of the API in the body. The process consists of three phases a) dry mixing, b) liquid addition and c) massing or granulation.

Why use NIR technology to monitor HSWG?

NIR spectroscopy is the only analyzer technology which provides deep insight about the physical and chemical properties during the process at very high measurement speed. It can detect changes in the particle size of excipients or API during the mixing phase and detect the end point based on the homogeneity in this phase, variation in particle growth throughout the process. Free and bound moisture can be monitored, since they have different effects on the NIR spectra. The monitoring of the dissolution of sugars during the granulation could be followed as well.

Why Diode array technology

Diode array spectrometers are much faster than other available technologies. In our optimized SentroPAT diode array systems a typical integration time is only approx. 10 ms giving an overall measurement interval of 1 sec or less. But even further, a diode array NIR detects all wavelengths of the spectrum simultaneously. This is totally different to all other NIR technologies including FT-NIR. When sample presentation is not constant during the process, (typical in the case of smaller granulators,) every single spectrum looks smooth. Only the baseline might be at different heights. Fast variations in a scanning spectrometer would make the spectrum unusable or show only noise. Similar effects reduce the data quality in FT-NIR systems.