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BioP/工作服管理.md

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2 years ago
**GB 50457-2019** **《医药工业洁净厂房设计标准》5.1.16洁净工作服洗涤、干燥和整理应符合下列规定:**
1.洗衣间宜单独设置洁浄工作服的洗涤、干燥和整理室其空气洁净度级别不应低于D级;
2.不同空气洁净度级别的医药洁净室内使用的工作服,应分别清洗、整理;
3.A/B级医药洁净室内使用的工作服洗涤干燥后,宜在A级送风保护下整理,并及时灭菌。
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**GMP****检查-细则中关于洗衣房的检查清单**
l 洁净区所用工作服的清洗和处理方式应当能够保证其不携带有污染物,不会污染洁净区。应当按照相关操作规程进行工作服的清洗、灭菌,洗衣间最好单独设置
l 看无菌衣整理是否在保护下进行
l 看工作服清洗、灭菌记录
l 看无菌工作服的灭菌是否经过验证
l 看是否制定有洗衣的操作规程建议检查关键区域如B级、高产尘房间洗衣效果的确认
**其中关于生产工艺的要求包含如下:**
清洗设备要使用卫生隔离式洗衣机
烘干设备需要选用带有新风过滤功能的烘干机
洗涤烘干整理区域的净化等级
按照净化等级要求的洗涤,漂洗用水
洁净服洗涤专用洗涤级
综合以上来看洁净服的洗涤尤其是AB级洁净区域洁净服的洗涤绝不是传统认知中所理解的买一台普通洗衣机烘干机接上水电汽即可。