We have started purified water system performance qualification for Generation, storage and distribution system. Phase III is going on. Now we have planned to extended the storage and distribution system. Whether we have to validate the whole system again or only storage and distribution system performance qualification is sufficient.
Technically your generation tank and distribution falls under one line of activity.
It is always wise to validate the whole system back.
Since you have extended those lines few issues will always pop up in the mind of auditor
1.Required speed and turbulence in the whole distribution line. That is pump capacity.–is this proper?
2.Passivation of the new extended line. With out stopping you cannot passivate. That means obviousley its a new start.
3.Number of new sampling points added in the line due to extension of distribution line. Trends must be found out.
I would revalidate whole distribution line rather than taking chances.
Thanks for the valuable information