A systemic approach to development of process analytical technology (PAT) tools for monitoring the critical quality and performance attributes of the manufacturing process is of great importance in ensuring final product quality in the pharmaceutical industry. The aim of this study was to examine the possibilities for a visual inspection technique as a PAT tool for in-process and on-line monitoring of the coating process of pharmaceutical pellets. The in-process conditions of the Wurster coating system were studied and an experimental visual imaging system that mimics these conditions was set up. Image analysis methods were developed that allow the determination of pellets' coating thickness estimation from the images acquired during the coating process. The results of the proposed visual imaging method were evaluated through comparison with a reference method and a good agreement of the coating thickness estimations by the two methods was found.
COBISS.SI-ID: 8830804
Among the variety of available hyperspectral imaging systems, the line-scan technique stands out for its short acquisition time and good signal-to-noise ratio. However, due to imperfections in the camera lens and, in particular, optical components of the imaging spectrograph, the acquired images are spatially and spectrally distorted, which can significantly degrade the accuracy of the subsequent hyperspectral image analysis. In this work, we propose and evaluate an automated method for correction of spatial and spectral distortions introduced by a line-scan hyperspectral imaging system operating in the short wavelength infrared (SWIR) spectral range from 1000 nm to 2500 nm. The proposed method is based on non-rigid registration of the distorted and reference images corresponding to two passive calibration objects. The results of the validation show that the proposed method is accurate, efficient, and applicable for calibration of line-scan hyperspectral imaging systems. Moreover, the design of the method and of the calibration objects allows integration with systems operating in diffuse reflectance or transmittance modes.
COBISS.SI-ID: 9507924
The novel methods for calibration and deconvolution-based resolution and spatial coregistration enhancement of hyperspectral images provide the means to capture high fidelity near infrared hyperspectral images using cost-effective optics and low resolution InGaAs or HgCdTe sensor arrays. The novel calibration and hyperspectral image enhancement methods will enable the transfer of hyperspectral imaging technology that exploits the full near infrared spectral range up to 2500 nm, into state-of-the art industrial visual inspection systems, and create opportunities for new studies using the improved resolution in the extend spectral range.
COBISS.SI-ID: 10837332
Coating thickness is the most important attribute of coated pharmaceutical pellets as it directly affects release profiles and stability of the drug. Quality control of the coating process of pharmaceutical pellets is thus of utmost importance for assuring the desired end product characteristics. A visual imaging technique is presented and examined as a process analytic technology (PAT) tool for noninvasive continuous in-line and real time monitoring of coating thickness of pharmaceutical pellets during the coating process. Images of pellets were acquired during the coating process through an observation window of a Wurster coating apparatus. Image analysis methods were developed for fast and accurate determination of pelletsʼ coating thickness during a coating process. The accuracy of the results for pellet coating thickness growth obtained in real time was evaluated through comparison with an off-line reference method and a good agreement was found. Information about the inter-pellet coating uniformity was gained from further statistical analysis of the measured pellet size distributions. Accuracy and performance analysis of the proposed method showed that visual imaging is feasible as a PAT tool for in-line and real time monitoring of the coating process of pharmaceutical pellets.
COBISS.SI-ID: 3650417