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

[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]

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]

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

Thank you for the link. Very good document (Procedural Standards For Certified Testing Of Cleanrooms - 2009 revision).

Just to append, the document linked to is by:

National Environmental Balancing Bureau (NEBB)
8575 Grovemont Circle
Gaithersburg, Maryland 20877
301-977-3698
International Certification, High Performance Building Systems | NEBB

 

[Dan33195]

Thank you!