D
dcvanderbush
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
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