Wet granulation lines in pharmaceutical manufacturing facilities typically comprise a dryer that removes the excess moisture content after wet granulation. In this study, a semi-continuous dryer installed in the ConsiGma 25 wet granulation line was investigated. The goal was to highlight specific characteristics of this type of dryer, utilizing the available process data and the corresponding data obtained via material characterization. This paper addresses typical effects and issues associated with the dryer’s setup and operation (e.g., unexpected cell temperature profiles, the effects of air flow and temperature on the granule properties, variations in the granule moisture between the dryer cells). Since in many situations the liquid-to-solid ratio is based on the properties of granules after the granulation step, the selection of inlet air flow rate and the inlet air temperature of the dryer as well as the overall line throughput (affecting the cell fill level in the dryer) are of particular interest from a practical point of view. This paper discusses these issues and provides suggestions on how to address them when setting up the process. A novel approach for characterizing the fluidization inside the dryer by means of quantifying the “smoothness” of the temperature profile is proposed. The paper should be viewed as a hands-on guideline, which highlights possible pitfalls during the process setup and offers solutions.

制药设备中的湿法制粒生产线通常包括一个干燥器，用于在湿法制粒后去除多余的水分。在本研究中，对安装在 ConsiGma 25 湿法制粒生产线中的半连续干燥机进行了调查。目标是利用可用的过程数据和通过材料表征获得的相应数据，突出这种类型干燥机的特定特性。本文讨论了与干燥机设置和操作相关的典型影响和问题（例如，意外的单元温度曲线、气流和温度对颗粒特性的影响、干燥单元之间颗粒水分的变化）。由于在许多情况下，液固比取决于造粒步骤后颗粒的特性，从实际的角度来看，选择干燥器的入口空气流速和入口空气温度以及整个生产线吞吐量（影响干燥器中的细胞填充水平）特别重要。本文讨论了这些问题，并就如何在设置流程时解决这些问题提供了建议。提出了一种通过量化温度曲线的“平滑度”来表征干燥器内部流化的新方法。该论文应被视为实践指南，它突出了流程设置过程中可能存在的缺陷并提供了解决方案。本文讨论了这些问题，并就如何在设置流程时解决这些问题提供了建议。提出了一种通过量化温度曲线的“平滑度”来表征干燥器内部流化的新方法。该论文应被视为实践指南，它突出了流程设置过程中可能存在的缺陷并提供了解决方案。本文讨论了这些问题，并就如何在设置流程时解决这些问题提供了建议。提出了一种通过量化温度曲线的“平滑度”来表征干燥器内部流化的新方法。该论文应被视为实践指南，它突出了流程设置过程中可能存在的缺陷并提供了解决方案。