Re: Area recovery test of clean rooms
I have never encountered "Recovery Test" in qualifying
a clean room. I can see the COMPLEXITY of setting a
meaningful test involving room size, quantitative distribution
of particles inside the room, and the dynamic of clearing
the particles, but I cannot see the UTILITY of such a test,
since clean rooms do not involve in issues of generating large
amount of particles to be effectively cleared (unless probably
in powder handling rooms).
----- Original Message -----
To: "PharmSciTech" <PharmTech@www2.pharmweb.net>
Sent: Wednesday, September 01, 2004 3:14 AM
Subject: Area recovery test of clean rooms
> Dear Members ,
> I am repeating the question. Hope someone will guide me.
> Can somebody suggest regarding the type/amount of particulate
> contamination we need to generate and the time period of recovery of
> area . Does this have a correlation with the room air changes of room.
> We used to generate DOP / Edina oil smoke in the room and test the
> recovery every 10 minutes afterwards and have a validated time period
> of 20 minutes max.
> But we have class B clean rooms with both 40 & 60 air changes /hour,
> sometimes more than 100 air changes in some rooms like gowning
> etc.But we have observed not so significant difference in the
> recovery period.
> Do the members agree with the procedure we are following in our facility?
> Of course we do not have any specifications on the amount of
> contaminants . This we do with our experience.
> I will appreciate if members will suggest me some guidelines.
> Thanks in advance