环境监测-人员监测

Personnel Monitoring 
人员监测
Description 说明

Personnel are a primary source of contamination in an aseptic environment. It is therefore essential that all employees entering an aseptic environment be carefully selected and adequately trained so they can perform their required tasks in a well-disciplined manner. This training should include personal hygiene, an introduc-tion to microbiology, aseptic techniques, and gowning. After an individual has been trained, routine microbiological monitoring of garments and finger impressions should be completed to assess the ongoing practice of aseptic technique. 
在无菌环境中，工作人员是主要污染源。因此，若想高效地完成所要求的任务，就必须在进入无菌环境前对工作人员进行仔细的筛选并进行培训。培训应包括个人卫生、微生物学、无菌技术以及更衣。个人培训结束后，应完成工作人员服装和指纹的常规微生物监测，以评估无菌技术的实施。

Training/Certification of Personnel for Aseptic Manufacturing Area 
无菌生产区人员培训/证书
Training/certification of aseptic area personnel may include but is not limited to, the following subject areas: 
无菌区人员培训/证书可包含下列主题（但不限于此）：
a. Personal hygiene/habits 个人卫生/习惯
• Cleanliness of hair, skin, fingernails, and clothing 
保持头发、皮肤、指甲、服装的干净整洁
• No make-up, nail polish, sculptured fingernails, glue-on nails, gum, candy 
不化妆、不涂指甲油、不做指甲、不嚼口香糖、不吃糖
• No eating, drinking, chewing, or smoking 
不吃东西、不喝饮料、不咀嚼、不吸烟

b. Illness 疾病
• Report all colds, flu, infections, wounds, or sunburn 
报告一切感冒、流感、感染、创伤或灼伤
• Report all disease or chronic skin conditions 
报告所有疾病或慢性皮肤病情况

c. Clothing 服装
• Dedicated plant or area uniforms required 工厂或区域的专用制服
• No watches or protruding jewelry 不佩戴手表及显露在外的首饰
• Protective clothing required 要求的防护服

d. Introduction to microbiology 微生物学的介绍
• Common sources of microorganism types 微生物种类的常见来源

e. Introduction to aseptic techniques无菌技术介绍

f. Gowning practices着装规范
• Personnel are documented to properly gown (i.e., not add contamination) via gowning certification. 
人员需穿经认证的适当服装（即不会加大污染）
• Gowning certification may include additional sampling sites beyond those routinely monitored - the forehead, mask, neck area, back of head, garment zipper, arms, fingers. 
除了那些常规监测外，如：额头、面罩、颈部、背部、衣服拉链、手臂、手指等，更衣认证还包括其它取样点。
• Routine monitoring may include garment samples from both forearms, and finger impressions from both hands. Overall profiles may also be evaluated. 
常规监测包括两前臂的衣服样品和双手的指纹，亦可从整体进行评估。

g. Participation in media fills to demonstrate aseptic skill level. 
参与培养基灌装表明了无菌技术水平。

All training and certification activities should be documented and kept as part of the employee file. 
所有培训和证书都必须记录下来，并作为员工个人档案予以保存。

Retraining 再培训
Gowning Certification着装资格认证书
If samples from garment or finger impressions (dabs) exceed the alert/action level, the employee should be retrained on all appropriate procedures and re-certified before entry into the aseptic area is approved. 
一旦发现衣服或指纹（dabs）高于警戒线或行动水平，工作人员便无法进入无菌区。他们必须按所有适当的程序进行再培训，等再次认证后方可批准进入。

Routine Monitoring常规监测
If samples from garment or finger impressions exceed the action level, it may require that the employee should be retrained on appropriate procedures and re-sampled at the earliest possible time. If a trend of over alert/action level occurrences develops, further corrective action, which may include complete re-certification or reassignment to new duties outside the aseptic area, may be considered. 
如果衣服和指纹超过行动水平，这就需要工作人员按适当程序再次参加培训，并尽早重新采样。若其超过警戒线和行动水平呈上升趋势，就必须采取进一步的纠正措施，比如说进行完全的再验证，或在无菌区外重新分配任务。

Annual retraining and re-certification should occur for all employees required to work in an aseptic environment. In addition, all employees involved in aseptic manufacturing should participate in a process simulation test (media fill) at least annually. All retraining and re-certification activities should be documented and kept as part of the employee file. 
所有在无菌环境工作的人员每年都需再培训和再验证。此外，无菌生产区的全体成员每年至少要参加一次工艺模拟测试（培养基填充）。所有再培训和再验证活动都必须记录下来，并作为员工个人档案予以保存。

       文章来源：药品微生物检测

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