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依据中华人民共和国国家标准GB/T16292-1996(以下简称国标),对医药工业洁净区(假设一个洁净区是由一个或多个洁净室组成)空气中悬浮粒子数的测试要求是:一个洁净室采样点数应不少于2点,总采样次数应不少于5次,并且计算该洁净室的95%置信上限(UCL)。在实际测试过程中,常会遇到室内环境不均匀、采样点少,致使UCL超标,而增加采样点UCL又能达到级别要求的情况,故笔者对悬浮粒子的计算方法进行了探讨。
According to the People’s Republic of China National Standard GB / T16292-1996 (hereinafter referred to as the national standard), the pharmaceutical industry clean area (assuming a clean area is composed of one or more clean rooms) the number of particles in the air test requirements are: a clean room The number of sampling points should be not less than 2, the total number of sampling should be not less than 5, and calculate the 95% confidence limit (UCL) for the clean room. In the actual testing process, we often encounter uneven indoor environment, sampling points, resulting in UCL exceeded, while increasing the sampling point UCL can reach the level of requirements, so I calculate the particle suspension were discussed.