Cleanroom/Controlled Environment Modifications
Modifications to Cleanrooms/controlled environments
should be evaluated to ensure the existing validation
is still applicable. Addition of major components,
expansion of the room and addition of more personnel
and operations in the room can all affect the
performance of the room. At the very least Alert
and Action levels should be re-evaluated to ensure
realistic cleanliness standards are kept within
the room and sterilization validations do not
become compromised.
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