RO water system validation and qualification
Hi All
I work for a dietary supplement manufacturing company and we recently added a liquids product manufacturing line. Since we are now starting to use water as an ingredient, we had a water company come out and install a purified water system. My background is in microbiology and I have worked with purified water systems in the past but this is my first time qualifying one. The water is getting purified by RO. The installation company was not going to install any intermediate ports or valves throughout the system. Is that normal? Every other system I have worked with we took and tested water samples throughout the system. Should I only be testing the final water coming off the system?
Anyway, I asked them to install a port after the softeners, a port after the carbon tank, a port after the RO filters and a port after the UV lights because I though it was required to test those locations especially during validation. They reluctantly installed these sample ports except for the post UV because the pipes were already set. For micro testing, I applied the limit of "for information only" to all of the intermediate locations; I am monitoring them just to see how they are doing but not holding them to a specific micro standard. I am finding that the water just after the RO filters has the highest micro count in the whole system, around 10,000 CFU/ml. I think this is due to the fact that the system is built to shut off once our holding tank (with a circulation loop) is full and the RO unit is not going through an auto flush often enough. Our final water is meeting our micro count limit of <100 CFU/ml so I know my UV lights and final filter are working. We brought up the high results we are getting on the post RO filter water with the water installation company and their answer was that we should not have installed a sample port there!?
Was I wrong for having these ports installed? Should I only be testing the final water?
Water validation people, please weigh in
Thanks
Jackie