隔离器等设备验证

隔离器等设备验证主要包括以下内容：

1.SCOPE/范围 

2.PURPOSE/目的 

3.RESPONSIBILITY/职责 

4.REGULATION AND GUIDANCE 法规和指南 

5.GOOD DOCUMENTATION PRACTICE 文件管理规范 

6.EXECUTANT OF DOCUMENTS/ 文件执行人员 

7.TESTING LIST/ 测试清单 

8.GENERAL CONCLUSION/ 总体结论 

Attachment 1-Air velocity qualification 

 附件1—风速确认 

Attachment 2 - leak test of HEPA filters 

附件2—高效过滤器检漏测试 

Attachment 3- particle count qualification 

附件3—洁净度检测确认

Attachment 4-Air-flow pattern qualification 

附件4—气流流型确认

Attachment 5- Sterilization validation (Non-load) 

附件5—空载灭菌测试 

Attachment 6- Sterilization validation (Full-load) 

附件6—满载灭菌测试 

Attachment 7- microorganism test 

附件7—微生物测试 

咨询检测具体验证方案，请咨询安洁检测技术人员。