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Re: Area recovery test of clean rooms

Debashish,

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).

Simon Rusmin
Consultant

----- Original Message -----
From: <DebashishPanda@mjplmail.com>
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
>
>


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