What revalidation is necessary if we change parts in a WFI loop ?

ifserav

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#1
Hi All
We are changing a valve and a tubbing in a validated loop, should we revalidate the entire two first phases of the validation?, in one case is only a plastic tube that take water from the loop to the tank, and the other point is a valve that we change from manual to automatic.
The first phase is to develop the parameter of the system, we sustain we have that and only sample one day the entire loop, and sample two weeks for second phase keeping product under risk.

Could you give me more ideas?

Thanks in advance

Sergio Avila
 
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