What should an ISO 14644 Clean Room PQ (Performance Qualification) look like?

D

Dan33195

What should a clean room performance qualification look like?

I am considering making a PQ consist of multiple "at rest" and "in operation" Non-viable and bioburden tests. Would this approach be recommended? Or would performing just operational tests be a more efficient approach?

Thanks!
 
Ninja

Ninja

Looking for Reality
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Howdy,

Are you familiar with this?
http://www.capitalmarva.org/wp-content/uploads/2013/04/CRProcStand.pdf

Consider whether "at rest" measurement has value to you...to many it has little value, but situations differ and you may find it valuable for your own condition.
"In Operation" is almost always the go-to number...that's the dirtiest your room is likely to get.

I do not work in a field where Bioburden is of concern, so I know little about any validation or requirements in that area.
 
Marc

Marc

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