精品文档。I欢迎下载PCR厂房标准二零一三年五月精品文档。I欢迎下载目录1体外诊断试剂生产实施细则.....................................................11.1设施、设备与生产环境控制.................................................11.2体外诊断试剂生产用净化车间环境与控制要求.................................32洁净厂房设计规范.............................................................52.1总则....................................................................52.2空气洁净度等级..........................................................52.3总体设计................................................................62.3.1洁净厂房位置选择和总平面布置.........................................62.3.2工艺布置和设计综合协调...............................................62.3.3噪声控制.............................................................72.3.4微振控制.............................................................82.4建筑....................................................................92.4.1一般规定.............................................................92.4.2人员净化和物料净化设施...............................................92.4.3防火和疏散..........................................................102.4.4室内装修............................................................112.4.5装配式洁净室........................................................112.5空气净化...............................................................122.5.1一般要求............................................................122.5.2洁净室正压控制......................................................122.5.3气流组织和送风量....................................................132.5.4空气净化处理........................................................152.5.5采暖通风............................................................162.5.6风管和附件..........................................................172.6给水排水...............................................................172.6.1一般规范............................................................172.6.2给水................................................................182.6.3排水................................................................182.6.4消防设施............................................................18精品文档。II欢迎下载2.7工业气体管道...........................................................192.7.1通常规定............................................................192.7.2管道材料、阀门和附件................................................192.7.3管道连接和清洗......................................................202.7.4安全技术............................................................202.8电气...................................................................202.8.1配电................................................................202.8.2照明................................................................212.8.3控制、通信和防护....................................................212.9附录....................................................................222.9.1名词解释............................................................222.9.2洁净室空气洁净度的测试..............................................242.9.3洁净厂房生产的火灾危险性分类举例....................................262.9.4净化空气调节系统设计对施工的要求.....................................
