Clean Room Operator 20141104
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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.
无菌分nel observed reaching directly over open units awaiting filling.操作人员在封装时直接接触暴露的物体 Level of personnel activity (number of people)
子和胶塞
Proper wrap removal适当包装拆除 Minimal touching of objects减少接触物体 Avoidance of blockage between HEPA filters and critical articles 避免高效过滤器和关键部位的堵塞 No kneeling directly on the floor 不要直接跪在地板上 Change garments if torn – immediately 如果洁净服破损
张和纸制品 Cardboard 纸板
Specific writing tools 特别的书写工具 External medications 外用药
7
Cleanroom Operator Qualification Operator’s Behavior
Prohibited Actions 禁止行为 Horseplay 嬉戏 Fast movements 快速活动 Movements near critical surfaces 在关键表面活动 Interruption of airflow 阻断气流 Sitting on equipment 坐在设备上 Writing on equipment 在设备上写字 Removal of items from underneath cleanroom garments
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
1
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.
根据验证过的时间来灭菌的灭菌罐，设备，部件，洁净服和无菌产品处 理失败 地板，管道和设备上能观察到灰尘和污垢，墙上和门把上有污点 在分装间的灯具上看到死的昆虫
11
立即更换
6
Cleanroom Operator Qualification Operator’s Behavior Restricted Materials 限制的物料
Food, drink 食物，饮料 Tobacco 烟草 Cosmetics 化妆品 Jewelry 首饰 Regular paper and paper products 常规纸
在洁净服下移动物体
8
Cleanroom Operator Qualification Operator’s Behavior
QA Audit for Aseptic Behavior and risk associated with various steps QA对以下环节的风险和无菌行为进行审计 Movement of personnel 人的运动 Handling of sterilized items 无菌项目的处理 Product component handling 产品组成部分的处理 Equipment set-up 设备安装 Equipment dismantling 设备卸载 Line clearance 生产线清洁 Storage of items 储存条目 Loading of vials on a tray 负载药品托盘 Loading of stoppers 负载胶塞 Cleaning and disinfecting techniques 清洁和消毒工艺 Items dropped on the floor (not be picked up)物品掉到地板上
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。
2
Cleanroom Operator Qualification Operator’s Behavior
穿洁净衣确认的正式培训
Formal Cleanroom Operator Qualification
Media Fill Participation 培养基 Initial Qualification 初始确认
4
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
的培养基灌装
3
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
483’s
Failure to make aseptic connections under class 100 conditions. Failure to follow validated holding times for sterile tanks, equipment, components, gowns and sterile product. Dust & dirt were observed on floors, pipes and equipment. Smudges were noted on walls and around door handles. Dead insects were observed in overhead light fixtures in the filling room. 在100级洁净级别条件下建立无菌连接失败
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
检查一样）
Annual (testing same as initial qualification)每年（和初始 Participate in at least one successful MF 至少参加一个成功
（未被拣起）
Clearing of Jams- sterilized forceps, re-sanitized prior each use in critical area)
9
Cleanroom Operator Qualification Operator’s Behavior Current Compliance Issues – 483’s 目前483中存在的问 题 Personnel in the aseptic filling room routinely touch nonsterile objects without re-sanitizing their hands.
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
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
5
Cleanroom Operator Qualification Operator’s Behavior
Good Aseptic Techniques 良好无菌工艺 Slow and deliberate movements 缓慢的运动 No reaching over open vials or stoppers 不接触暴露的瓶
人员活动的水平（人员数量）
Aseptic techniques not used 未使用无菌工艺 Sequence of Gowning 穿戴洁净服的顺序 Glove sanitization practices 手套消毒程序
10
Cleanroom Operator Qualification Operator’s Behavior
A breach in an aseptic technique can be resulted in a sterility failure and cost thousands of $$$$ due to the product rejection.
无菌分nel observed reaching directly over open units awaiting filling.操作人员在封装时直接接触暴露的物体 Level of personnel activity (number of people)
子和胶塞
Proper wrap removal适当包装拆除 Minimal touching of objects减少接触物体 Avoidance of blockage between HEPA filters and critical articles 避免高效过滤器和关键部位的堵塞 No kneeling directly on the floor 不要直接跪在地板上 Change garments if torn – immediately 如果洁净服破损
张和纸制品 Cardboard 纸板
Specific writing tools 特别的书写工具 External medications 外用药
7
Cleanroom Operator Qualification Operator’s Behavior
Prohibited Actions 禁止行为 Horseplay 嬉戏 Fast movements 快速活动 Movements near critical surfaces 在关键表面活动 Interruption of airflow 阻断气流 Sitting on equipment 坐在设备上 Writing on equipment 在设备上写字 Removal of items from underneath cleanroom garments
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
1
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.
根据验证过的时间来灭菌的灭菌罐，设备，部件，洁净服和无菌产品处 理失败 地板，管道和设备上能观察到灰尘和污垢，墙上和门把上有污点 在分装间的灯具上看到死的昆虫
11
立即更换
6
Cleanroom Operator Qualification Operator’s Behavior Restricted Materials 限制的物料
Food, drink 食物，饮料 Tobacco 烟草 Cosmetics 化妆品 Jewelry 首饰 Regular paper and paper products 常规纸
在洁净服下移动物体
8
Cleanroom Operator Qualification Operator’s Behavior
QA Audit for Aseptic Behavior and risk associated with various steps QA对以下环节的风险和无菌行为进行审计 Movement of personnel 人的运动 Handling of sterilized items 无菌项目的处理 Product component handling 产品组成部分的处理 Equipment set-up 设备安装 Equipment dismantling 设备卸载 Line clearance 生产线清洁 Storage of items 储存条目 Loading of vials on a tray 负载药品托盘 Loading of stoppers 负载胶塞 Cleaning and disinfecting techniques 清洁和消毒工艺 Items dropped on the floor (not be picked up)物品掉到地板上
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。
2
Cleanroom Operator Qualification Operator’s Behavior
穿洁净衣确认的正式培训
Formal Cleanroom Operator Qualification
Media Fill Participation 培养基 Initial Qualification 初始确认
4
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
的培养基灌装
3
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
483’s
Failure to make aseptic connections under class 100 conditions. Failure to follow validated holding times for sterile tanks, equipment, components, gowns and sterile product. Dust & dirt were observed on floors, pipes and equipment. Smudges were noted on walls and around door handles. Dead insects were observed in overhead light fixtures in the filling room. 在100级洁净级别条件下建立无菌连接失败
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
检查一样）
Annual (testing same as initial qualification)每年（和初始 Participate in at least one successful MF 至少参加一个成功
（未被拣起）
Clearing of Jams- sterilized forceps, re-sanitized prior each use in critical area)
9
Cleanroom Operator Qualification Operator’s Behavior Current Compliance Issues – 483’s 目前483中存在的问 题 Personnel in the aseptic filling room routinely touch nonsterile objects without re-sanitizing their hands.
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
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
5
Cleanroom Operator Qualification Operator’s Behavior
Good Aseptic Techniques 良好无菌工艺 Slow and deliberate movements 缓慢的运动 No reaching over open vials or stoppers 不接触暴露的瓶
人员活动的水平（人员数量）
Aseptic techniques not used 未使用无菌工艺 Sequence of Gowning 穿戴洁净服的顺序 Glove sanitization practices 手套消毒程序
10
Cleanroom Operator Qualification Operator’s Behavior