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接待您注册蒲公英 您须要 登录 威力够下载或查察，没有帐号？立刻注册 V 如题，国内医药厂房的普通区域但凡都运用组折式空调机组做为环境温湿度控制的方法，省事问下各位大佬，能不能改为正常舒服空调，(如:吸顶空调)来调理？国内外有没有相关的法规指南规定必须要用组折式空调机组？ 不胜感谢感动
城危。已与得悬赏 10 金币+88 金币最佳答案 ISPE Baseline Guide xol 3: Sterile Product Manufacturing Facilities 3rd Edition 那个里面有提到，觉得那个还是看企业原人的打点水平，CNC须要有空气过滤系统，须要供给比普通的空调要更干脏一点的空气，但是不用监测粒子和微生物，有的企业是依照D级来打点的（那两者有不少要求都是雷同的），原日我也正在进修那个内容，公司想生长微生物效价室，但是目前没有多余的洁脏室可以用，只要正常空调的房间，很头疼。 Controlled Not Classified (CNC) ：An area without airborne particle limits, but with filtered ZZZentilation. The “Controlled Not Classified” (CNC) designation is becoming increasingly popular for sterile product facilities. This designation appears to haZZZe originated in biologics facilities as a designation for spaces which are access controlled and cleaner than areas with general purpose HxAC, 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 equiZZZalent 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 fiVed limits. Some owners/companies prefer to set CNC limits equal to the limits for Grade D. CNC spaces should be described as haZZZing controlled access with a regular cleaning schedule, but they are not monitored for particulate or microbial growth (责任编辑：) |
