Hello
I’m writing performance qualification for newly installed purified water system. The system works on the principle of dual pass reverse osmosis. For the validation purposes the properties of the final product must be defined. According the european pharmacopoeia 5th edition “purified water” is water with following properties:
total viable aerobic count of 100 micro-organisms per millilitre;
total organic carbot 0.5 mg/l;
conductivity 4,3 uS/cm measured at 20 degrees Celsius;
nitrates maximum 0.2 ppm;
Heavy metals maximum 0.1 ppm.
The purified water system is equiped with calibrated conductometer with resolution 0.1 uS/cm. The water conductivity is measured in-line during the production process. Is it possible to use the readings of this conductometer for validation purposes or we must measure the conductivity off-line with another calibrated device.
We dont have TOC analyzer. Is it possible to use test for oxidisable substances instead TOC.
How long should be the phase of intensive sampling of the water (according some autors it is 4 to 6 months, according WHO guidelines 2-4 weeks).
[quote=petkov]Hello
I’m writing performance qualification for newly installed purified water system. The system works on the principle of dual pass reverse osmosis. For the validation purposes the properties of the final product must be defined. According the european pharmacopoeia 5th edition “purified water” is water with following properties:
total viable aerobic count of 100 micro-organisms per millilitre;
total organic carbot 0.5 mg/l;
conductivity 4,3 uS/cm measured at 20 degrees Celsius;
nitrates maximum 0.2 ppm;
Heavy metals maximum 0.1 ppm.
The purified water system is equiped with calibrated conductometer with resolution 0.1 uS/cm. The water conductivity is measured in-line during the production process. Is it possible to use the readings of this conductometer for validation purposes or we must measure the conductivity off-line with another calibrated device.
We dont have TOC analyzer. Is it possible to use test for oxidisable substances instead TOC.
How long should be the phase of intensive sampling of the water (according some autors it is 4 to 6 months, according WHO guidelines 2-4 weeks).[/quote]
I am doing water system PQ too and in our water system is equiped with on-line conductivitymeter too.
Now, I am in phase III and for TOC we testing water sample in all user points with TOC Analyzer. I think to test TOC we must use TOC Analyzer because conventional method is not recommended for testing TOC in water system PQ.