论药品生产过程中的污染成因与防范

目的:为药品生产企业在药品生产过程中把握污染产生的原因和采取相应的防范措施提供参考。方法:对药品生产过程中污染传播媒介、传播方式、进入途径等进行分析,并分析其防范措施。结果与结论:常见污染形式主要有物理污染、化学污染和微生物污染;传播媒介主要有空气、水、表面、物料和人员;传播方式主要有直接污染、二次(多次污染)和交叉污染;进入途径主要有人流通道、物流通道和空调通道。防范污染应从药品生产的环境控制,员工、物料、空气通道的洁净控制等方面采取措施,严格按《药品生产质量管理规范》的要求组织生产。

On Causes and Prevention of Contamination during the Process of Pharmaceutical Production

OBJECTIVE： To provide reference for pharmaceutical manufacturers mastering the causes of contamination and carrying out relevant prevention measures during the process of pharmaceutical production. METHODS： The media and way of contamination spreading, route of entry during the process of pharmaceutical production were analyzed. Relevant prevention measures were also analyzed. RESULTS ＆ CONCLUSIONS： Common contamination includes physical contamination, chemical contamination and microbial contamination. The media of contamination spreading include air, water, surface, material and staff. The ways of contamination spreading are direct contamination, secondary （multiple） contamination and cross contamination. Routes of entry are people flow channel, logistics channel and air-conditioning channel. Contamination prevention should be conducted in respect of environment control of pharmaceutical production, sanitation control of staff, material and air channel, etc. Thus, pharmaceutical manufacturers must follow GMP requirements to carry out production.