Continuous processing in pharmaceutical manufacturing is a relatively new approach that has generated significant attention. While it has been used for decades in other industries, showing significant advantages, the pharmaceutical industry has been slow in its adoption of continuous processing, primarily due to regulatory uncertainty. This paper aims to help address these concerns by introducing methods for batch definition, raw material traceability, and sensor frequency determination. All of the methods are based on established engineering and mathematical principles, especially the residence time distribution (RTD). This paper introduces a risk-based approach to address content uniformity challenges of continuous manufacturing. All of the detailed methods are discussed using a direct compaction manufacturing line as the main example, but the techniques can easily be applied to other continuous manufacturing methods such as wet and dry granulation, hot melt extrusion, capsule filling, etc.

中文翻译：

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使用停留时间分布（RTD）解决连续制药过程中原材料的可追溯性。

制药生产中的连续加工是一种相对较新的方法，引起了广泛的关注。尽管它已在其他行业中使用了数十年，显示出显着的优势，但制药行业在采用连续加工方面一直进展缓慢，这主要是由于监管的不确定性。本文旨在通过介绍用于批次定义，原材料可追溯性和传感器频率确定的方法来帮助解决这些问题。所有这些方法均基于既定的工程和数学原理，尤其是停留时间分布（RTD）。本文介绍了一种基于风险的方法来解决连续制造中内容均匀性方面的挑战。以直接压实生产线为主要示例，讨论了所有详细方法，