1.0 Introduction
Validation of purified system involves stages like design qualification, installation qualification, operational qualification and performance qualification.
A three phase approach is used to achieve the objective of reliability and robustness of the system over extended periods.
Source water should be tested as part of routine monitoring and also be included in validation programme.
Source water should be in compliance with specifications and requirements of drinking water
1.1 Phase I – The incoming feed water should be monitored continuously or sampled daily to check its quality
A 2 weeks test period is spent on monitoring the system and during this period the system is operated continuously without any performance deviation or failure
1.1.1 Following considerations should be included:
Chemical and microbiological testing should be done according to a defined plan
Continuous monitoring or sampling the incoming feed water
Continuous monitoring or sample each step of purification process
Continuous monitoring or sample every usage point and other defined sample points
Develop suitable operating ranges
Develop procedures for operations, maintenance, cleaning and sanitizing and finalize them
Demonstrate the required quality and quantity of product water for production and delivery
Follow the standard operating procedures for maintenance, trouble shooting, operations and sanitization and refine them
Check the provisional alert levels
Develop the test failure procedures and refine them
1.2 Phase II
Phase II is a 2 weeks test period where intensive monitoring is done when SOPs are implemented after successful completion of Phase I.
Sampling procedure should be as in Phase I
Using the water for FPP manufacturing may be acceptable if the commissioning and phase I data depict water quality and is also approved by quality unit.
This approach should display consistency in the operation within the given ranges.
It should also show consistency in the production and delivery of required quality and quantity when operated according to SOPs
1.3 Phase III
This phase runs for a year after completion of phase II.
Using the water for FPP manufacturing may be acceptable when it demonstrates reliable performance for long period and also demonstrates that the seasonal variations are evaluated
Sampling locations, tests and frequencies should be reduced based on the established procedures to normal routine pattern during I and II phases
Validation of purified water system, performance qualification,chemical testing, microbiological testing, trouble shooting
