关于CNC区域的定义

skywhitefox

药厂萌新，请教一下论坛的大神，CNC区域是怎么划分的？总更与洁净区之间的参观走廊，穿白大褂进入，空调设置的是一般空调，那这个区域算CNC区域，还是算K级区？

skywhitefox

infatuationty 发表于 2018-12-13 16:41
更衣前段区域，作为净化更衣的辅助区，需送入经过 HEPA 过滤器过滤的空
气、有一定的换气次数，有一定的压 ...

对，你说的这一段我知道是属于CNC区域的，但是对于更衣间之前与总更之后的走廊，不是很确定算不算CNC区域！

剑魔

更衣前段区域，作为净化更衣的辅助区，需送入经过 HEPA 过滤器过滤的空
气、有一定的换气次数，有一定的压力梯度，但属于不分级区。FDA 有一个专有名词是 CNC,
即 Controled Not Classified, 又称控制不分级区。

逍遥黑熊

我们算CNC过去，洁净非受控区~~~

智9d86f2d9

我们指的是“受控制的一般区”，我们CNC要求带发帽，换分体式工作服，穿工作鞋，除了公司配备的笔记本及手提电话，其他一律不许带进。

skywhitefox

智9d86f2d9 发表于 2018-12-13 16:19
我们指的是“受控制的一般区”，我们CNC要求带发帽，换分体式工作服，穿工作鞋，除了公司配备的笔记本及手 ...

所以说我们的参观走廊应该也是属于CNC区域，与一般空调或洁净空调送风没有关系，是吗？

智9d86f2d9

skywhitefox 发表于 2018-12-13 16:33
所以说我们的参观走廊应该也是属于CNC区域，与一般空调或洁净空调送风没有关系，是吗？

可以这么理解，完全不同于C/D的送风和回风，温湿度要求也不一样

skywhitefox

智9d86f2d9 发表于 2018-12-13 16:51
可以这么理解，完全不同于C/D的送风和回风，温湿度要求也不一样

好的，感谢指导与帮助！

青鱼乱

我们这里的CNC是一个独立的区域，在洁净区隔壁

successzhao

ISPE生物制药厂房设施定义：Controlled Not Classified (CNC): areas where HVAC systems are specifically designed to reduce airborne contaminants below the level of the ambient environment and both temperature and Relative Humidity (RH) are controlled more tightly than in the ambient environment. Claims for environmental control in these areas are related to the design of the system and installation qualification is common. No claim is made or qualified for the specific control of particulate. Typical systems will have heating, cooling and filtration meeting MERV 13 or better. These areas are sometimes referred to as “pharmaceutical” or “clean” areas within pharmaceutical facilities.
ISPE 空调系统指南：The US "CNC" has no equivalent to EU Grade D although the term Controlled Not Classified (CNC) has been used in the pharmaceutical industry and is discussed
in the ISPE Baseline® Guides for Sterile and Biopharmaceuticals (Reference 13, Appendix 12). A CNC space may meet ISO 8 at rest without the use of
HEPA filters if the airborne challenge is low. For further information on air filters, see Chapter 3 of this Guide. Therefore, a “CNC with monitoring” space could
look and perform similarly to a European Grade D space.

skywhitefox

successzhao 发表于 2018-12-14 17:19
ISPE生物制药厂房设施定义：Controlled Not Classified (CNC): areas where HVAC systems are specifically ...

感谢回复，大概明白了！