Real-time Data Processing for In-line Monitoring of a Pharmaceutical Coating Process by Optical Coherence Tomography

Coating of tablets is a widely applied unit operation in the pharmaceutical industry. Thickness and uniformity of the coating layer are crucial for efficacy as well as for compliance. Not only due to different initiatives it is thus essential to monitor and control the coating process in-line. Optical coherence tomography (OCT) was already shown in previous works to be a suitable candidate for in-line monitoring of coating processes. However, to utilize the full potential of the OCT technology an automatic evaluation of the OCT measurements is essential. The automatic evaluation is currently implemented in MATLAB and includes several steps: (1) extraction of features of each A-scan, (2) classification of A-scan measurements based on their features, (3) detection of interfaces (air/coating and coating/tablet core), (4) correction of distortions due to the curvature of the bi-convex tablets and the oblique orientation of the tablets, and (5) determining the coating thickness. The algorithm is tested on OCT data acquired by moving the sensor head of the OCT system across a static tablet bed. The coating thickness variations of single tablets (i.e., intra-tablet coating variability) can additionally be analysed as OCT allows the measurement of the coating thickness on multiple displaced positions on one single tablet. Specifically, the information about those parameters emphasises the high capability of the OCT technology to improve process understanding and to assure a high product quality.