磁力搅拌配液罐系统验证方案(IQOPPQ)打印 - 副本

磁力搅拌配液罐配液系统验证方案

IQ/OQ/PQ确认

修订历史纪录

验证方案审批

目录

I.验证目的------------------------------------------------------------------------------------------------------4 II.概要------------------------------------------------------------------------------------------------------------4 II.1.验证概述----------------------------------------------------------------------------------------------------4 II.2.设备描述-------------------------------------------------------------------------------------------------4 II.2.1.其他参数描述----------------------------------------------------------------------------------------4 III.验证周期------------------------------------------------------------------------------------------------------5 IV.验证小组成员及部门职责-------------------------------------------------------------------------------5 IV.1.验证小组成员-------------------------------------------------------------------------------------------5 IV.2.部门职责----------------------------------------------------------------------------------------------5 IV.2.1.设备工程职责-------------------------------------------------------------------------------------5 IV.2.2.生产部门职责-------------------------------------------------------------------------------------5 IV.2.3.质量保证部门职责-------------------------------------------------------------------------------5 V.安装确认------------------------------------------------------------------------------------------------------6 V.1.验证目的---------------------------------------------------------------------------------------------------6 V.2.实施条件检查---------------------------------------------------------------------------------------------6 V.3.文件检查---------------------------------------------------------------------------------------------------6 V.4.设备仪表检查---------------------------------------------------------------------------------------------6 V.5.元材质检查------------------------------------------------------------------------------------------------7 V.6.公用工程检查---------------------------------------------------------------------------------------------7 V.7.安全实施检查---------------------------------------------------------------------------------------------7 V.8.安装确认放行---------------------------------------------------------------------------------------------8 VI.运行确认---------------------------------------------------------------------------------------------------8 VI.1.验证目的------------------------------------------------------------------------------------------------8 VI.2.执行器点动运行确认---------------------------------------------------------------------------------8 VI.3.负载运行------------------------------------------------------------------------------------------------8 VI.4.运行确认放行------------------------------------------------------------------------------------------8 VII.性能确认---------------------------------------------------------------------------------------------------8 VII.1.目的-------------------------------------------------------------------------------------------------------8 VII.2.混合均匀度测试----------------------------------------------------------------------------------------8 VII.3.地上衡校正----------------------------------------------------------------------------------------------9 VII.4.罐体死体积测试----------------------------------------------------------------------------------------9 VII.5.CIP性能测试------------------------------------------------------------------------------------------10 VII.6.模拟试验----------------------------------------------------------------------------------------------- 10 VII.7.性能确认放行----------------------------------------------------------------------------------------- 10 VIII.附录----------------------------------------------------------------------------------------------------- 11 VIII.1.附录清单----------------------------------------------------------------------------------------------- 20 I.验证目的：

通过对磁力搅拌配液罐系统的验证,确认购买设备的技术指标、型号、性能及设计符