Do I need to test "as built" for an expanded ISO Class 8 Clean Room ?

D

dcvanderbush

#1
All,

I am working on IQ, OQ, PQ documentation to re-commission our clean room following an expansion.

My question relates to the definition of "as built" as a state.

We have a qualified and operating clean room today, and following the expansion of this room, we will be moving some of our machinery within the confines of the same room.

Would we have to remove all machinery from the area to test in the "as built" state? It would make more sense to me for us to finish construction, move the equipment within the room, test for particulate levels, pressure differential, bio-burden, etc.; and then perform the testing in the operational state.


Thanks for any advice. If I need to clarify any information, let me know.

Dave
 
Elsmar Forum Sponsor
#3
Hi Dave

I cannot remember the exact requirements of ISO 14644 series but we had a similar issue where we installed a large piece of equipment prior to completing the cleanroom extension.
We did not do an as built validation as conditions are defined as ...installation is complete with all services connected and functioning but with no production equipment, materials of personnel present”

Instead we completed
1) an At Rest “… installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present” and
2) in operation validation

Ewan
 
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