《兽药生产质量管理规范(2020年修订)》洁净室受控环境关键 参数的理解

Understanding of key parameters of cleanroom controlled environment for Good manufacturing practices for veterinary (revised in 2020)

结合笔者参与《兽药生产质量管理规范(2020年修订)》编制及担任《兽药工业洁净厂房设计标准》主编的工作,对洁净室受控环境关键参数的指标确定、控制措施及最新的理念变化进行了阐述,重点介绍了动态级别、室内温湿度、气流流型、截面风速、送风量、自净时间及压差等指标的变化及理解要点。

Combined with the author’s working experience in the revision of Good manufacturing practices for veterinary(revised in 2020) and the chief editor of Design standard for clean workshop of veterinary pharmaceutical industry, expounds the indicator determination, control measures and the latest concept changes of the key parameters of the controlled environment in cleanrooms. Mainly focuses on the changes and understanding points of cleanliness of dynamic state, indoor temperature and humidity, air pattern, unidirectional airflow velocity, air supply volume, cleanliness recovery characteristics and differential pressure etc.