基于风险评估方法提高厂房空调系统验证工作效果的探索

The Exploration of Improving the Verification Effect of Plant Air Conditioning System Based on Risk Assessment Method

医药洁净室环境监测是制药工厂最关键的监测之一,如果其洁净度、微生物不能保证,不但会影响产品质量,还可能会导致长时间的生产中断,从而影响公司的产品供应,所以环境监测数据成为法规的重点关注领域。真实反映洁净区环境状况采样位置的确定成为一个关键要素。文章旨在以失效模式与影响分析(FMEA)、危害分析的关键控制点(HACCP)两种评估方法为基础,引入了六要素的打分原则,实现了对监测位置的定量评估,更具指导建议,并结合实例介绍了该方法的应用流程。

Pharmaceutical clean room environmental monitoring is one of the most critical monitoring of pharmaceutical factories,if its cleanliness,microorganisms can not be guaranteed,not only will affect the quality of the product,but also may lead to long-term production disruption,thereby affecting the company's product supply,so environmental monitoring data has become the focus of regulation.The determination of the sampling location of the environmental condition of the real reaction clean area becomes a key factor.Based on failure mode and impact analysis(FMEA)and Critical control point of hazard analysis(HACCP),this paper introduces the scoring principle of six elements to realize the quantitative evaluation of monitoring positions and provide more guidance and suggestions,and introduces the application process of this method with examples.