Purified water Sytem- Revalidation


(Md.Asif Hussain) #1

Dear All,

What is the Revalidation frequency of purified water system,as a general industry standard… ?
How to conduct its revalidation and how many days it required for complete revalidation.
What are the test cases you will find to do,
if any deviation against you protocol, you observe how to handle it.?

Thanks


(lalpratap) #2

there is no revalidation frequency of purified water system as per standards.

however if we go through a change control for any replacement in the equipment revalidation is required through the protocol.


(Collins) #3

I agreen with your response


(Md.Asif Hussain) #4

Dear All,

Could you please provide the procedure of Stress study for :
1.Loop hold study:
2.Power failure:
3.No use low use:

Thanks


(lalpratap) #5

The system should be validated for the delay time after the power failure, based on the validation report the water loop shall be restarted after the power resumption.
if extended the time, deviation shall be raised followed by sanitation.

even no use or low use the distribution loop shall be run continuously by maintaining the velocity.


(Md.Asif Hussain) #6

Thank you Mr. lalpratap,So what will be the :
1.Sampling points–
2.Frequency of sampling–
3. how to evaluate chemical cleaning frequency ----

Thanks


(lalpratap) #7
  1. Sampling points shall be as given;- generation inlet, generation outlet , loop outlet, after UV, Loop return. remaining sample points will be the user points inside the production area.
  2. frequency of sampling : its defined critical points daily once like loop inlet , loop return , After UV and one of the user point. remaining sampling points frequency can be defined once in a week or 3 days once.
  3. chemical cleaning frequency is generally based on the output of the plant, if the output is less than 50%, chemical cleaning shall be performed. or during the quarterly PMP as per the schedule.

All the above mentioned answers should be driven through the validation.