质量部净化空调系统验证方案.doc

目 录 验证方案························································································································································2 1 概述···································································································································2 目的··································································································································3 职责··································································································································· 4 验证方案及记录···············································································································4.1文件资料的确认··········································································································· 4.2高效过滤器检漏确认···············································································2 4.3 运行确认······················································································································· 4.4 性能确认······························································································································································································································4 附件1：文件资料的确认记录洁净室高效过滤器安装检漏测试记录洁净室高效过滤器风速和换气次数测试记录洁净室尘埃粒子测试记录洁净室沉降菌的测试记录证明该系统GMP要求；4.1文件资料的确认 方法：采购设备前明确要求厂家提供完整的技术资料，设备到后对所附资料进行清理，缺少的资料及时向厂家索取，整理分类后存入设备档案。 标准：所有资料应能满足空调净化系统生产工艺要求和GMP的要求。 记录：见附件1 4.2 高效过滤器检漏确认 方法：应在洁净室净化空调系统进行全面清扫和系统连续试车12h以上后 m/s 式中： V1、 V2… Vn —各测点的风速，m/s； n—测点总数，个。 标准：高效过滤器的风速3.5m/s≤V≤6.8m/s。 记录：洁净室高效过滤器风速和换气次数测试记录见附件3。 4.3.2 洁净室的换气次数确认 方法：首先根据洁净室各风口通风面积和平均风速计算出各风口风量，再根据所在洁净室面积和高度一起推算出洁净室的换气次数。其中， 风口风量L=3600FV m3/h 式中： F—风口通风面积，m2； V—风口平均风速，m/s。 洁净室换气次数N＝ 次/h 式中： L1、L2…Ln—洁净室各送风口的风量m3/h；A—洁净室面积m2；H—洁净室高度m。 标准：十万级洁净室换气次数≥15次/h；万级洁净室换气次数≥25次/h。 记录：洁净室高效过滤器风速和换气次数测试记录见附件3。 4.3.3 洁净室（区）温度、湿度、噪音和照度的确认 方法：分别使用温湿度计、声级计和照度计，按照各仪器的使用说明，对洁净室（区）的温湿度、噪音和照度几项指标进行测试，并做好记录。对照标准分析结果，如不合格，应查找原因，解决后重新检测，直至合格。 标准：洁净室（区）温度：18～2