首先:CNC区的定义:CNC是英文 “Controlled Not Classified”的首字母缩写,翻译成中文即“受控但未分级区域”。 参照ISPE的定义: Controlled Not Classified (CNC) An area without airborne particle limits, but with filtered ventilation. 更进一步的说明如下(ISPE Baseline Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition ...