Hohl Roland, Scheibelhofer Otto, Stocker Elena, Behzadi Sharareh Salar, Haack Detlev, Koch Kai, Kerschhaggl Peter, Lochmann Dirk, Sacher Stephan, Zimmer Andreas
Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
Institute for Process and Particle Engineering, Graz University of Technology, Graz, Austria.
AAPS PharmSciTech. 2017 Jan 1;18(1):182-193. doi: 10.1208/s12249-016-0504-4. Epub 2016 Mar 2.
The aim of the present work was to develop a PAT strategy for the supervision of hot melt coating processes. Optical fibers were placed at various positions in the process chamber of a fluid bed device. Experiments were performed to determine the most suitable position for in-line process monitoring, taking into account such requirements as a good signal to noise ratio, the mitigation of dead zones, the ability to monitor the product over the entire process, and reproducibility. The experimental evidence suggested that the position at medium fluid bed height, looking towards the center, i.e., normal to particle movement, proved to be the most reliable position. In this study, the advantages of multipoint monitoring are shown, and an in-line-implementation was created. This enabled the real-time supervision of the process, including the fast detection of inhomogeneities and disturbances in the process chamber, and the compensation of sensor malfunction. In addition, a model for estimating the particle size distribution via NIR was successfully created. This ensures that the quality of the product and the endpoint of the coating process can be determined correctly.
本工作的目的是开发一种用于热熔包衣过程监控的过程分析技术（PAT）策略。将光纤放置在流化床设备的处理腔室的不同位置。进行实验以确定在线过程监测的最合适位置，同时考虑诸如良好的信噪比、减少死区、在整个过程中监测产品的能力以及可重复性等要求。实验证据表明，在流化床中等高度处，朝向中心，即垂直于颗粒运动方向的位置，被证明是最可靠的位置。在本研究中，展示了多点监测的优势，并创建了在线实施方案。这实现了对过程的实时监控，包括快速检测处理腔室中的不均匀性和干扰，以及补偿传感器故障。此外，成功创建了一种通过近红外光谱（NIR）估计粒度分布的模型。这确保了能够正确确定产品质量和包衣过程的终点。
