Tests in PQ water system

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

For the physico-chemical tests of lab water system validation…
Is it necessary to measure TOC every day in the phase I for purifier water and water for injection?
Instead of using TOC, i can test oxidisable substances?

apart from TOC, pH, conductivity, are there other tests required?

For Microbiological contamination…
in PQ, is it necessary to measure the level of endotoxin at some point (frequency)?

in PQ, Is it necessary to measure the level of specified microorganisms (Escherichia coli, Pseudomonas aeruginosa, Candida albicans…) at same point? If so, which ones should be checked?

Sorry for so many questions.
Many thanks!

2

YES, you MUST perform TOC’s since oxidizable substances are no longer recognized. You MUST perform all compendial tests for ‘water for injection’ at each ‘point of use (POU)’ weekly (based on risk analysis). We had an online Anatel TOC/conductivity meter that performed measurements every 1 minute.

3

and endotoxin level?

4

Yes. If you are making parenterals. It is helpful if you have a heated water distribution loop so biomass cannot grow.

1 Like
5

Thanks, I have been proposed to me to check Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella spp and Escherichia coli in the phases of qualification, but I am not sure. it is necessary?

6

Yes. The microbiologist used a ‘very’ specific media which does not let anything else grow. A negative result is very helpful.

7

Thanks! :slight_smile: