求助：FDA不同洁净级别压差12.5Pa出处

质量人小灰

如题，请各位帮忙答疑FDA对于不同洁净级别压差为不小于12.5pa有法规/指南出处么？同一洁净级别压差有没有要求？

眷念锁眉间

Guidance for Industry Sterile Drug Products Produced by Aseptic Processing —Current Good Manufacturing Practice
An essential part of contamination prevention is the adequate separation of areas of operation. To maintain air quality, it is important to achieve a proper airflow from areas of higher cleanliness to adjacent less clean areas. It is vital for rooms of higher air cleanliness to have a substantial positive pressure differential relative to adjacent rooms of lower air cleanliness. For example, a positive pressure differential of at least 10-15 Pascals (Pa)6 should be maintained between adjacent rooms of differing classification (with doors closed). When doors are open, outward airflow should be sufficient to minimize ingress of contamination, and it is critical that the time a door can remain ajar be strictly controlled (Ref. 4).
In some cases, the aseptic processing room and adjacent cleanrooms have the same classification. Maintaining a pressure differential (with doors closed) between the aseptic processing room and these adjacent rooms can provide beneficial separation. In any facility designed with an unclassified room adjacent to the aseptic processing room, a substantial overpressure (e.g., at least 12.5 Pa) from the aseptic processing room should be maintained at all times to prevent contamination. If this pressure differential drops below the minimum limit, it is important that the environmental quality of the aseptic processing room be restored and confirmed.

kc1711422001

同一级别5pa-20pa之间都可以 最好是在15pa

zhaosc8326

眷念锁眉间 发表于 2016-7-19 15:59
Guidance for Industry Sterile Drug Products Produced by Aseptic Processing —Current Good Manufactur ...

很好，谢谢

hhww14

一般压差表误差2Pa,不同级别要求10Pa，所以稳妥起见，选12.5，

质量人小灰

kc1711422001 发表于 2016-7-19 15:08
同一级别5pa-20pa之间都可以 最好是在15pa

同一级别15Pa有点大了吧

质量人小灰

眷念锁眉间 发表于 2016-7-19 15:59
Guidance for Industry Sterile Drug Products Produced by Aseptic Processing —Current Good Manufactur ...

谢谢，下了这个文件，又好好研究了一下

质量人小灰

hhww14 发表于 2016-7-20 08:24
一般压差表误差2Pa,不同级别要求10Pa，所以稳妥起见，选12.5，

非常谢谢！

逆时针_BeK6w

w15252829511 发表于 2016-7-20 17:44
非常谢谢！

一般压差计是指的什么压差计啊。误差都是2pa吗。

beiwei5du

眷念锁眉间 发表于 2016-7-19 15:59
Guidance for Industry Sterile Drug Products Produced by Aseptic Processing —Current Good Manufactur ...

这个是指洁净区和非洁净区的压差必须保证在至少12.5pa,但是对于不同洁净区的压差可以在10-15pa的范围内的呢。

davidcone

e.g.的意思是例如，只是举了个例子，例如至少12.5Pa。。。。。具体多少要看你自己的实际情况。比如你购置的压差计误差是正负3Pa，你还定12.5Pa，显然当负3时就很有可能出现不合格。