纯蒸汽灭菌验证方案

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1、文件标题：CG-0.6型纯蒸汽灭菌柜再验证方案文件编码：针剂车间CG-0.6型纯蒸汽灭菌柜再验证方案编定人审核人批准人药业有限公司目录第18页共18页文件标题：CG-0.6型纯蒸汽灭菌柜再验证方案文件编码：1.概述··········································································································································32.再验证目的·····························

2、·····························································································33.引用标准·······························································································································34.验证组织职责··············································

3、·······································································45.进度计划·······························································································································56.验证实施的步骤和要求································································

4、·······························56.1预确认···································································································································56.2运行确认·········································································································

5、·····················56.3性能确认······························································································································5第18页共18页文件标题：CG-0.6型纯蒸汽灭菌柜再验证方案文件编码：7.异常情况处理程序················································································

6、·························58.拟定验证周期·····················································································································69.结果与评定··························································································································6

7、1、概述针剂车间CG-0.6型纯蒸汽灭菌柜是一种全自动的灭菌器。选用先进的微机可编程序控制器进行全程自动控制，密封门的开关锁紧实电动操作。是我公司注射剂车间的器具灭菌专用设备。该灭菌器于2004年安装，2005年通过GMP认证并于2010年通过了GMP再认证，现根据验证要求进行再验证。2、验证目的：2.1确认本设备能够正常运行符合安装要求，各项性能指标符合生产工艺要求。2.2提供必要的文件以证实本设备操作与所预期的完全一致。2.3确认本方案所制定的操作程序及验证方案,能有效地使本设备处于确认状态下,第18页共18页文件标题：CG-0.6型纯蒸汽灭菌柜再验证方

8、案文件编码：并能稳定地、恒常地达成其所预期的功能。3