re-validation ISO 7 clean room with microbial monitoring
Hello all,

we have just built and completed the validation for an ISO 7 clean room (with microbial limits as listed in Eudralex GMP Annex 1).

we validated the cleanroom according to the pre-approved layout and the equipment planned for use at the time.

Now we have a new project and would like to hear your opinion on what do you guys think is the threshold of re-validating the cleanroom, would added Tools and jigs require re-validation?
I think that a new blister machine is a must for validation, also pneumatic jigs that can potentially contaminate the area.

Thoughts?

Omri
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