受控不分级区域(cnc),可以使用一般舒适空调作为温度控制吗？

yhhtcwd

如题，国内医药厂房的普通区域通常都使用组合式空调机组作为环境温湿度控制的设备，麻烦问下各位大佬，能不能改为一般舒适空调，(如:吸顶空调)来调节？
国内外有没有相关的法规指南规定必须要用组合式空调机组？
不胜感激

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最佳答案

ISPE Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition 这个里面有提到，感觉这个还是看企业自己的管理水平，CNC需要有空气过滤系统，需要提供比普通的空调要更干净一点的空气，但是不用监测粒子和微生物，有的企业是按照D级来管理的（这两者有很多要求都是相同的），今天我也在学习这个内容，公司想开展微生物效价室，但是目前没有多余的洁净室可以用，只有一般空调的房间，很头疼。 Controlled Not Classified (CNC) ：An area without airborne particle limits, but with filtered ventilation. The “Controlled Not Classified” (CNC) designation is becoming increasingly popular for sterile product facilities. This designation appears to have originated in biologics facilities as a designation for spaces which are access controlled and cleaner than areas with general purpose HVAC, but for which either no claim of cleanliness classification is made or in which an owner may designate the cleanliness classification deemed appropriate (e.g., ISO 9). In some facilities, this designation is used as an equivalent to the EU and PIC/S Grade D (see Note 2). For CNC (Controlled, Not Classified) areas, requirements are Owner Determined (O/D) and are generally cleaner than ambient (outdoor) air, with no fixed limits. Some owners/companies prefer to set CNC limits equal to the limits for Grade D. CNC spaces should be described as having controlled access with a regular cleaning schedule, but they are not monitored for particulate or microbial growth

• 城危。
• 发表于2024-04-18
• 详细答案 >

成慧潫

用啥来控温，你自己说了算嘛
只要能满足你的使用要求，形式不限。

猫咪特工

CNC一般不作要求

涛哥

我们外包和一般区走廊都是 一般舒适空调

lootion12

自己的SOP规定就行，符合生产要求。

ch3b388968

CNC是需要有送风，但是温度其实没有要求。你CNC 28度也行

九五二七

只要你的吸顶空调送风带过滤装置  不带入杂物就可以

ouyang_xg

要考虑有新风的送入，这是人员健康的需要。

大CC

车间办公区 外包就是舒适性空调

城危。

ISPE Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition 这个里面有提到，感觉这个还是看企业自己的管理水平，CNC需要有空气过滤系统，需要提供比普通的空调要更干净一点的空气，但是不用监测粒子和微生物，有的企业是按照D级来管理的（这两者有很多要求都是相同的），今天我也在学习这个内容，公司想开展微生物效价室，但是目前没有多余的洁净室可以用，只有一般空调的房间，很头疼。
Controlled Not Classified (CNC) ：An area without airborne particle limits, but with filtered ventilation.
The “Controlled Not Classified” (CNC) designation is becoming increasingly popular for sterile product facilities. This designation appears to have originated in biologics facilities as a designation for spaces which are access controlled and cleaner than areas with general purpose HVAC, but for which either no claim of cleanliness classification is made or in which an owner may designate the cleanliness classification deemed appropriate (e.g., ISO 9). In some facilities, this designation is used as an equivalent to the EU and PIC/S Grade D (see Note 2).

For CNC (Controlled, Not Classified) areas, requirements are Owner Determined (O/D) and are generally cleaner than ambient (outdoor) air, with no fixed limits. Some owners/companies prefer to set CNC limits equal to the limits for Grade D.
CNC spaces should be described as having controlled access with a regular cleaning schedule, but they are not monitored for particulate or microbial growth

yhhtcwd

城危。 发表于 2024-4-18 14:51
ISPE Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition 这个里面有提到，感觉 ...

非常好，感谢