摘要
目的：探讨洁净室浮游粒子测点数的最低限度。方法：测点按ＦＳ２０９Ｄ的计算方法简化为查表法。在静态条件下测试，浮游粒子浓度的均值及其９５％置信上限均应符合规定，方可判定该室达到规定的洁净级别。结果：若按ＦＳ２０９Ｄ的规定最低测点数取２点，各测点的均值虽可达标，但２点ｔ值为６．３，故９５％置信上限往往超标，若增加１个测点则无此弊。结论：洁净室尤其是小于１０ｍ２的小洁净室浮游粒子最低限度测点数应修正为３点，以免评定失误。
OBJECTIVE:To measure the lowest limit of the floating particles in the clean room.METHODS:The measurement method of FS 209D was simplified into a reference table for checking.Under a static condition,the average value of the concentration of the floating particles was measured and 95% of the confidence upper limit should coincide with the stipulation in order to declare that the room has reached the grade of cleanliness as required.RESULTS:Two points were taken as the lowest measuring points in conformity with the specification of FS 209D.Though the average value of each measuring point can meet the requirement,the t value of the two points were 6.3.Hence 95% of the confidence upper limit exceeded the standard.If we added one more point for measurement,there would have no such defect.CONCLUSION:In the clean room that is less than 10 m 2,the lowest limit in the measurement of the floating particles should be remedied to 3 points in order to avoid any mistake.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1997年第3期170-172,共3页
Chinese Pharmaceutical Journal
关键词
洁净室
浮游粒子
最低测点数
clean room,floating particle,the lowest point for measurement
