悬浮粒子浓度实验室检测能力的E_n值评价

Evaluation of the E_n Value for Laboratory Detection Capability of Airborne Particle Concentration

为了客观评价药品检验机构洁净室悬浮粒子浓度的检测能力,选择了三家药检机构进行比对分析.将这三家药检机构常用的悬浮粒子检测仪器集中于同一采样点,由同一测试人员操作,在《医药工业洁净室(区)悬浮粒子的测试方法》规定的条件下进行检测,并统计三台仪器的检测结果.计算各仪器测量的标准不确定度,并采用比值率E_n值对三台仪器的测量结果进行评价.结果显示,参加比对的三家药品检验实验室悬浮粒子浓度测量结果的E_n均小于1(越接近0越好),表明该三家实验室的检测结果均准确可靠,检测能力令人满意.

Three agencies were selected for comparative analysis to objectively evaluate the ability of detecting airborne particle in clean rooms of drug inspection agencies. Concentrate the airborne particle detection instruments commonly used by the three drug inspection agencies were placed on the same sample point, and were operated by same user, test under the conditions of ″Test method for airborne particles in clean room（zone） of the pharmaceutical industry″, and three instruments′ test results were counted. The standard uncertainty of each instrument′s test result was calculated and the ratio value Envalue was used to evaluate the test results of three instruments. The results showed that Enof the test results of the airborne particle in three drug inspection agencies participating in the comparison were all less than 1（the closer to 0 the better）, indicating that the test results of the three agencies were accurate and reliable, and the detection capability was proved satisfactory.