In continuous pharmaceutical manufacturing, the degree of back-mixing has two contrary effects on the propagation of disturbances through a process. Firstly, back-mixing results in the contamination of adjacent material by strong disturbances and additional losses. However, the available measuring frequency in the process must detect all disturbances causing OOS material. Consequently, back-mixing must also smoothen out all undetectable disturbances. Therefore, we introduce the minimal needed measuring frequency and the mean loss in yield as indicators for the degree of back-mixing. In a case study, we utilize a dry granulation line from the literature and those indicators to discuss a strategy for the usage of multiple diversion points, the impact of uncertainties in measuring the degree of back-mixing, and setting operational parameters in the tablet press. This way, we reveal opportunities for reducing discharged material due to back-mixed disturbances in a continuous manufacturing line.

在连续制药中，回混程度对整个过程中干扰的传播有两个相反的影响。首先，反向混合会由于强烈的干扰和额外的损失而导致相邻材料的污染。但是，过程中可用的测量频率必须检测所有引起OOS材料的干扰。因此，回混还必须消除所有无法检测到的干扰。因此，我们介绍了所需的最小测量频率和平均产量损失，作为回混程度的指标。在一个案例研究中，我们利用文献中的干法制粒生产线和这些指标来讨论使用多个分流点的策略，不确定性对测量反向混合程度的影响，并在压片机中设置操作参数。这样，我们揭示了减少由于连续生产线中的回混扰动而导致排放物料减少的机会。