期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 546, 期 1-2, 页码 78-85出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ijpharm.2018.05.024
关键词
Agglomeration; Fluidized bed coating; Pellets; PAT; Visual imaging
资金
- Sensum, Computer Vision Systems
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 R-2 = 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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