对隔离装置进行气流方向与显形检查的要点  

Key Points of Airflow Direction and Visualization Inspection for Isolation Device

作　　者：韩源 Han Yuan(Austar Pharmaceutical Equipment(Shijiazhuang)Co.,Ltd,Hebei,Shijiazhuang 050011,China)

机构地区：[1]奥星制药设备(石家庄)有限公司,河北石家庄050011

出　　处：《化工与医药工程》2022年第4期21-25,共5页Chemical and Pharmaceutical Engineering

摘　　要：通过对隔离装置气流方向与显形检查的法规要求以及常见缺陷进行分析,阐述了气流显形检查的应用场合,从气流流型设计到显形检查实施的方法、测试仪器和烟雾源和数据完整性要求,进而实现气流显形检查的目的,即证明气流能充分地保护产品和操作,不会从低级别区域流入高级别区域,并将气流检查结果与无菌操作相关联,实现其作为一种控制污染的方法。By analyzing the regulatory requirements and common defects of airflow direction and visualization inspection of isolation Devices,the application of the air flow visualization inspection situation were described,from the airflow pattern design to visualization inspection implementation methods,test equipment and smoke source and data integrity requirements,thus the purpose of airflow visualization inspection was achieved,that is,to prove that the airflow can fully protect the products and operations,and will not flow from the low-level area to the high-level area.The results of air flow examination were associated with aseptic operation to realize it as a method of contamination control.

关 键 词：气流流型 气流显形检查 控制污染 

分 类 号：TQ460.6[化学工程—制药化工]