Purified water is the main carrier of the pharmaceutical processes and products. Purified water is obtained from natural sources through various stages of purification. In terms of good manufacturing practice, all systems that produce clean water, should be qualified or proven relevant. In my thesis I have made a qualification of a system for production of clean water. The final product was a complete qualification protocol, which verifies the proper operations of the water cleaning system, according to the rules of the environment for which it applies. The resulting 5 documents in which it is precisely described whole process of how to perform a qualification of the system so that is proven to work in compliance of the required standard.
I have also upgraded my thesis with a thorough review of the operation of the TOC meter, the use of which in recent years it has become increasingly common. I came to the conclusion that the TOC meter indirectly determines the value of the content of TOC in the purified water through the resistance of the oxidized water. The final result can thereby be influenced by the quality of the conductivity meter and associated probes and the accuracy of the measured ultrapure water temperature and the compensation of it.
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