在无菌制剂的生产和质量监管中，污染控制策略是保障药品安全性和有效性的基石。自净控制作为污染控制策略体系中的核心能力之一，其重要性日益凸显。通过研究无菌制剂灌装区域自净控制的机制及其关键影响因素，高风险区域的自净控制要求，以及提高自净效率的策略和方法，可为无菌制剂生产企业提供可行的参考方案。

In the production and quality supervision of sterile preparations, contamination control strategies are the cornerstone of ensuring drug safety and efficacy. As one of the core capabilities in the pollution control strategy system, self-cleaning control is becoming increasingly important. This article study the mechanism and key influencing factors of self-cleaning control in aseptic preparation filling areas, the requirements for self-cleaning control in high-risk areas, and strategies and methods to improve self-cleaning efficiency, which can provide feasible reference solutions for aseptic preparation production enterprises.

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