PW distribution system has been renovated through 01 new use point incorporation & relocation of two other existing use points. What will be the mode of requalification of the system ? Is it required to perform P-1, P-2 & P-3 phase up to 1 year ? Pls. suggest.
You have to demonstrate consistent operation of whole purified water system within the established ranges as follows after plan and execution of purified water system followed for the addition of user point and relocation of the user points to the existing loop system of purified water.
The above said activity shall be addressed through the change control and addendum validation report is for Initial Purified Water System Validation.
sampling schedule shall be carried out 14 days, by covering all the points for Physical, chemical, Microbial and TOC analysis.
In schedule ensure additional point (new point), relocation points and return loop points shall be covered daily for microbial and TOC analysis.
Note: During these 14 days water should be used for manufacturing.
After 14 days of validation compilation report shall be prepared and conclude. If all results were withing the specification limits, without any abnormalities then purified water can be used for manufacturing process and other usages and also recommended that it to continue the purified water system maintenance, treatment, sampling, testing and usage based up on the yearly / annual schedule and then evaluate the test results and other parameters once in a year.
Dear sir,
Good morning,
For my more uderstanding of the Note: During these 14 days should water be used for manufacturing ???
Sorry, it is a typo error. Water should not be used during the 14days…
Only that specific user point could not be used for normal usage during qualification.
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No, water should not be in total distribution loop…
Considering that the addition/relocation of points of use requires major intervention to the PW distribution system that could impact quality of all PW of that system (upon arrange of distribution loops); none of the points of use should be used until qualification concludes PW quality is met consistently in all points impacted of the system.
Almost every time you do a major intevention in a water system, even if it is a single point of use… all system gets impacted, since it is a single distribution system; unless you have means to demonstrate that sections of the PW system can be effectively secluded to avoid impacting the whole system, ubt typically it is one single distribution system.
I hope this helps
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