Clean Room Operator 20141104.pptVIP

* Cleanroom Operator Qualification Operator’s Behavior Cleanroom Personnel 洁净室人员 Expectation预期 Highly trained and qualified operators are required for the cleanroom “Basic knowledge of Microbiology” is must Task oriented Healthy individual with good hygienic habits 洁净室的操作人员需要培训有素并且经过确认 有基础的微生物知识 面向任务 身体健康,有良好的卫生习惯 * Cleanroom Operator Qualification Operator’s Behavior Cleanroom Personnel 洁净室人员 Even the state of the art and highly sophisticated cleanroom can not ensure product sterility, if the cleanroom operators do not follow the protocols for aseptic techniques. 假如洁净室的操作工不按照无菌工艺的方案操作，那么即使是最先进的和完善的洁净室也不能保证产品的无菌。 A breach in an aseptic technique can be resulted in a sterility failure and cost thousands of $$$$ due to the product rejection. 违反无菌操作工艺可能会造成无菌操作的失败，并且由于产品报废而破费成千上万元。 * Cleanroom Operator Qualification Operator’s Behavior Formal Cleanroom Operator Qualification 穿洁净衣确认的正式培训 Media Fill Participation 培养基 Initial Qualification 初始确认 By filling 500 sterile MF units 500个无菌培养基 OR Full media Fill 全培养基 Requalification 再确认 Annual (testing same as initial qualification)每年（和初始检查一样） Participate in at least one successful MF 至少参加一个成功的培养基灌装 * Cleanroom Operator Qualification Operator’s Behavior What is Good Personal Hygiene? 什么是良好的个人卫生习惯 Bathe daily 每天洗澡 Shampoo hair daily 每日用洗发水洗头发 Wash hands after rest room use 上厕所后洗手 Wash hands before and after meals 饭前饭后洗手 Wear clean clothing 穿干净的衣服 Keep fingernails short and clean保持指甲短和干净 No nail polish or false nails 没有假指甲和指甲油 Good skin care 良好的皮肤护理 * Cleanroom Operator Qualification Operator’s Behavior Good Aseptic Techniques 良好无菌工艺 No touching of the gown 不要接触洁净服 Reduced number of entry and exit 限制进出的人口 Minimal talking, motion, and traffic flow减少说话，动作和交通流量 Frequent glove sanitization or change 经常消毒和更换手套 Use only sterile forceps – NO GLOVED HAND!使用无菌工具——要带手套 Use only sterile tools for contacting sterile equipment 使用无菌工具接触无菌设备 Change of gloves prior to any critical operation 在任何关键操作前更换手套 * Cleanroom