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WM3-120三辊蜜丸机确认方案
WM3-120三辊蜜丸机确认方案
目录
1. 确认目的 ····································································································· Page 3 of 2. 确认范围········································································································· Page 3 of 3. 职责················································································································ Page 3 of 4. 设备信息 ····································································································· Page of 15 5. 设计确认 ····································································································· Page of 15 6. 安装确认 ····································································································· Page of 15 7. 设备运行确认 ······················································································· Page 8 of 15 8. 工艺性能确认 ······························································································ Page 11 of 15 9. 风险分析 ····································································································· Page 14 of 15 10. 校正 ·········································································································· Page 14 of 15 11. 培训 ·········································································································· Page 15 of 15 12. 再确认周期 ································································································ Page 15 of 15 13. 附录 ············································································································ Page15 of 15
1. 确认目的
通过本次确认，证明WM3-120三辊蜜丸机、YUJ-300自动涂油机能符合口服固体制剂车间大蜜丸制丸岗位制丸的工艺需求。WM3-120三辊蜜丸机、YUJ-300自动涂油机的标准操作规程和设备预防性维修规程提供合理依据。
1.3. 为制定口服固体制剂车间大丸制丸岗位标准操作规程、岗位清场操作规程和设备清洁操作规程提供合理依据。
2. 确认范围
用于WM3-120三辊蜜丸机、YUJ-300自动涂油机设计确认用于WM3-120三辊蜜丸机、YUJ-300自动涂油机安装确认用于WM3-120三辊蜜丸机、YUJ-300自动涂油机运行确认
2.4. 适用于WM3-120三辊蜜丸机、YUJ-3
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