化学反应平衡谈一谈什么是CNC区域
北京大商场最近跟同事讨论洁净区的问题,涉及到一个术语CNC。对于CNC的理解部分同事还不清晰,故发帖阐述一下。
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”。
财务尽职调查报告参照ISPE的定义:
Controlled Not Classified (CNC)
An area without airborne particle limits, but with filtered ventilation.苏秦和张仪
更进一步的说明如下(h股etf
ISPE Baline Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition)
国际网络
):
Controlled Not Classified (CNC)
角质层薄的表现
A non-classified room environment where clod process and their immediate support systems may be located. CNC space is cleanable, access controlled and rved with filtered ventilation air; procedural controls and personnel garment upgrades may be applied at the Owner’s discretion. In the biopharmaceutical industry CNC is replacing the term “Gray Space”.兴味索然
可以看出,CNC区域的硬件有空气处理单元,为该区域提供过滤后的洁净空气;软件方面,要求进出控制、更衣、做清洁。
与传统的洁净区相比较,就是无需设定相关的尘埃粒子限度,也不需要进行监测。但是相关的清洁和控制是需要进行的。