洁净区参数控制再测试周期

ECA新闻20150521：洁净区参数控制再测试周期  

2015-05-21

GMP News
21/05/2015

Time Intervals for the recurrent Controlof Clean Room Parameters

洁净区参数控制再测试周期

The VDI (Verein DeutscherIngenieure) published the standard 2083, part 2 final in April until thenonly available as draft. In principle, this standard summarises therequirements on clean rooms according to VDI 2083 part 1and 3 as well as DIN ENISO 14644-1 and -3 together and indicates the time intervals at whichcompliance with the requirements should be checked. What is meant by this arethe measurements from the first qualification (OQ) that have to be repeatedperiodically. These include among others the determination of the airflowvelocity, the volume flow rate and air change rate of rooms, filter leak tests,determination of filter pressure differential and pressure difference betweenrooms, air cleanliness classification as well as other tests such as noiselevel and illuminance.

VDI在4月份公布了2083标准第2部分的最终稿，之前只有草案。该标准基本上是根据 VDI2083第1和第3部分以及DIN EN ISO 14644-1和-3汇总了洁净区的要求，指出了符合这些要求的再测试周期。这表示自首次确认开始，需要周期性地进行测试。这包括气流速度、流量、房间换气次数、过滤器检漏、过滤器压差检测和房间之间的压差检查、空气洁净度以及其它如噪声水平和照度检测。

The VDI standard 2083 part2 can be bought at the publishing house Beuth Verlag inGerman and English language.

VDI标准2083第2部分可以在BEUTH VERLAG出版社买到德语和英语版本。

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