The Exploration of Improving the Verification Effect of Plant Air Conditioning System Based on Risk Assessment Method
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.
environmental monitoring and assessmentmicroorganismspecific location of the sampling point
万方数据
维普
