1.What are the chemical & Microbial tests have to be done during Phase I, II & III starting from the Source Water and all purification process steps to Purified Water.
2.In Phase III also, we have to do the all Chemical & Microbial tests to samples from all purification process steps starting from Source water to Purified water?
Yes,
Q : What are the chemical & Microbial tests have to be done during Phase I, II & III starting from the Source Water and all purification process steps to Purified Water.
Ans: Its depends on your specification whether you have IP or BP or USP or Ph Eur or In-house what so ever it may be you have to perform the all the tests mentioned in your specification. And at the same time your specification should be as per latest pharmacopoeia. all the purification steps should be analyzed to get the degree of contamination.
Q :In Phase III also, we have to do the all Chemical & Microbial tests to samples from all purification process steps starting from Source water to Purified water?
Ans : Yes, in phase III also all the Chemical & Microbial tests should perform,
the difference between Phase I, II, III are Sampling schedule (Time gap between sampling to sampling of same sampling point).
still any quries feel free to contact : mandla_naidu@yahoo.co.in
Is it necessary to validate the potable water system also and perform chemical and microbial testing for the same?
If this potable water is feed water to the purified water system, then it is a part of validation.
In phase I: Sampling should be done for daily for 2 - 4 weeks from all sampling points (Including Generation Points)
- To define Alert & Action Limits
- To develop SOPs
In Phase II: Sampling should be done for daily for 2-4 weeks (may exculde some non critical generation points)
- To verify the phase I results
- Water can use for production, but no batch should leave the factory till this phase is completed
In Phase III: for 1 year
Generation points may exculde or frequency should define in longer intervals
Usage points should sampled to cover all points in a week.
- To verify the seasonal variation
- To verify the reliable performance of the system
- Potable water is the source of water to generate the purified water. Hence potable water should analyse.