004微生物检查室空气净化系统验证方案 (1)

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1、菌检室空气净化系统再验证方案菌检室空气净化系统再验证方案文件编号：VM/A-1-002-12-00起草：年月日审阅会签：批准：年月日第页共页菌检室空气净化系统再验证方案目录1.设备基本情况.........................................................32.验证目的.............................................................33.验证机构组成及职责.......................................

2、............33.1验证委员会组成......................................................33.2验证小组成员........................................................34职责................................................................35.验证......................................................

3、...........45.1运行确认............................................................45.1.1仪器、仪表校正....................................................45.1.2空调机组检查......................................................45.1.3洁净区建筑检查...............................................

4、.....45.1.4高效过滤器检漏....................................................45.1.5高效过滤器风速测定及风量换气次数计算...............................45.1.6房间静压差测定.....................................................55.1.7运行确认结果与评定.................................................55.1性能确定.......

5、......................................................55.2.1尘埃粒子数测定......................................................55.2.2沉降菌的测试.......................................................85.2.3性能确定测试周期.....................................................95.3检测项目及检测频率..

6、..................................................95.4异常情况处理程序.....................................................105.5验证结果与评定........................................................106.拟定日常监测程序及验证周期............................................10第页共页菌检室空气净化系统再验证方案7.附件..

7、................................................................10附件1验证方案修改申请及批准书............................................11附件2仪器仪表校验记录....................................................12附件3空调机组检查记录....................................................13附件4生产车间洁净室建材及

8、质量检查记录....................................14附件5HVAC系统高效过滤器风量及换气次数记录...............................15附件6洁净室压差监测