隔离器内部与周围区域之间的压差应为多少？

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建议

在设计用于无菌处理的隔离器时，隔离器内部和外部环境之间的压差必须为正值，同时执行关键操作以防止流动逆转。隔离器内部环境和背景环境之间的压差设定点通常应高于10 Pa，并且在运行期间始终保持并监视两者之间的正压差。

在采用传送带将组件移动通过隔离器的无菌设施中，通常在环境之间需要材料传送开口（例如，鼠洞口）。来自洁净隔离器的气流必须对鼠标孔施加正压。必须通过气流可视化研究证明正气流的方向。

隔离器内部和外部的压力均应进行连续监控，并以适当的限值发出警报，以指示偏离可接受的压差。

基本原理

隔离器依赖于物理分区，该分区通过将其与周围环境分开来提供无菌处理区域（A / ISO 5级）的保护。因此，隔离器的适当设计必须使隔离器能够实现将内部环境与外部环境隔离的意图，并在制造过程中保持隔离器内的无菌处理区域。关键的设计考虑因素包括隔离器内部与外部环境之间的适当压力差。需要一个正压来保持隔离器内的无菌环境，并防止周围环境的气体进入隔离器后空气质量降低。

参考

美国食品和药物管理局。行业指南：通过无菌加工生产的无菌药品-当前的良好生产规范；美国卫生与公共服务部：马里兰州罗克维尔，2004年。www.fda.gov/ ownloads / Drugs / GuidanceComplianceRegulatoryInformation / Guidances / UCM070342.pdf（2019年1月19日访问）。

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Smile1234567813

Guidance for Industry Sterile Drug Products Produced by Aseptic Processing —Current Good Manufacturing Practice
An essential part of contamination prevention is the adequate separation of areas of operation. To maintain air quality, it is important to achieve a proper airflow from areas of higher cleanliness to adjacent less clean areas. It is vital for rooms of higher air cleanliness to have a substantial positive pressure differential relative to adjacent rooms of lower air cleanliness. For example, a positive pressure differential of at least 10-15 Pascals (Pa)6 should be maintained between adjacent rooms of differing classification (with doors closed). When doors are open, outward airflow should be sufficient to minimize ingress of contamination, and it is critical that the time a door can remain ajar be strictly controlled (Ref. 4).
In some cases, the aseptic processing room and adjacent cleanrooms have the same classification. Maintaining a pressure differential (with doors closed) between the aseptic processing room and these adjacent rooms can provide beneficial separation. In any facility designed with an unclassified room adjacent to the aseptic processing room, a substantial overpressure (e.g., at least 12.5 Pa) from the aseptic processing room should be maintained at all times to prevent contamination. If this pressure differential drops below the minimum limit, it is important that the environmental quality of the aseptic processing room be restored and confirmed.


一般要求大于12.5pa，传感器波动以及精度问题。

皇皇者华

10版GMP和20版药典都对隔离器压差有要求。10版GMP《无菌制剂GMP实施指南》21.隔离技术要求：隔离器正常运行时需维持20～50Pa或以上的正压；20版《药典》第四部9206指无菌检查用隔离系统验证和应用导原则里对压差也做出了要求：静态条件下压差范围通常为20～50Pa，最高不超过100Pa。动态条件下，可由实验人员在进行模拟操作无菌检查和空气采样操作的同时记录舱体压差，正常操作时应始终维持正压。

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皇皇者华

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