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In-line agglomeration degree estimation in fluidized bed pellet coating processes using visual imaging.
International Journal of Pharmaceutics 2018 July 31
Agglomeration of pellets in fluidized bed coating processes is an undesirable phenomenon that affects the yield and quality of the product. In scope of PAT guidance, we present a system that utilizes visual imaging for in-line monitoring of the agglomeration degree. Seven pilot-scale Wurster coating processes were executed under various process conditions, providing a wide spectrum of process outcomes. Images of pellets were acquired during the coating processes in a contactless manner through an observation window of the coating apparatus. Efficient image analysis methods were developed for automatic recognition of discrete pellets and agglomerates in the acquired images. In-line obtained agglomeration degree trends revealed the agglomeration dynamics in distinct phases of the coating processes. We compared the in-line estimated agglomeration degree in the end point of each process to the results obtained by the off-line sieve analysis reference method. A strong positive correlation was obtained (coefficient of determination R2 =0.99), confirming the feasibility of the approach. The in-line estimated agglomeration degree enables early detection of agglomeration and provides means for timely interventions to retain it in an acceptable range.
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