Knowledge of residence time is a critical aspect in developing control and material diversion strategies for continuous manufacturing processes in pharmaceutical manufacturing. Dry granulation is a promising continuous granulation technique as it is fast and economical. In this study, a step-change method to determine residence time in roll compaction/dry granulation is introduced. The factors roll speed and rotational speed of the impeller in the powder inlet unit of the compactor were evaluated using a central composite circumscribed statistical design of experiments in order to optimize the residence time. The fill volume in the compactor was varied exemplarily. It was found that high roll speed, low rotational speed of the impeller and low fill volume in the compactor are beneficial to generate fast transition through the compactor. The impact of roll speed increase was estimated. It can be concluded that despite fast residence time in the process, high roll speed and its subsequent high material throughput can generate a large amount of material that has to be discarded if material diversion is required.

停留时间的知识是为药品生产中的连续生产过程开发控制和材料转移策略的关键方面。干法制粒是一种有前途的连续制粒技术，因为它快速且经济。在这项研究中，介绍了一种确定辊压实/干法制粒中停留时间的分步变化方法。压实机粉末入口单元中叶轮的滚动速度和转速的影响因素采用中央复合外接实验设计进行评估，以优化停留时间。压实机中的填充量示例性地变化。已经发现，压实机中的高滚动速度，低叶轮转速和低填充量有利于产生通过压实机的快速过渡。估计了轧辊速度增加的影响。可以得出结论，尽管在该过程中停留时间很短，但是如果需要转移材料，高辊速及其随后的高物料通过量仍会产生大量必须丢弃的物料。