20.500.12556/RUL-84125 Kvalifikacija sistema za pripravo laboratorijske vode Qualification of the system for production of clean water Prečiščena voda je osnovni nosilec vseh farmacevtskih postopkov in nekaterih izdelkov. Prečiščeno vodo se pridobiva iz naravnih virov preko različnih faz čiščenja. V smislu dobre proizvodnje prakse morajo biti vsi sistemi za proizvodnjo čiste vode kvalificirani oziroma dokazano ustrezni glede na zahteve regulativnega okolja, v katerem delujejo. Zato sem v svoji diplomski nalogi opravil kvalifikacijo sistema za proizvodnjo čiste vode. Končni produkt je kvalifikacijski protokol, s katerim se preverja ustrezno delovanje aparata glede na predpise za okolje, v katerih se uporablja. V okviru dela je nastalo pet dokumentov, v katerih je natančno opisan postopek izvajanja kvalifikacije sistema, da ustreza zahtevanemu standardu CSLI (ang. Clinical and Laboratory Standards Institute). Svojo diplomsko delo sem nadgradil s poglobljenim pregledom delovanja merilnika skupnega organskega ogljika (TOC, ang. total organic carbon), katerega uporaba se v zadnjih letih povečuje. Omenjeni merilik določa vrednost vsebnosti TOC v vodi posredno preko upornosti oksidirane vode. Na rezultat meritve tako močno vpliva kvaliteta konduktometra in pripadajoče sonde, točnost temperature izmerjene vode in njena kompenzacija. 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. Prečiščena voda kvalifikacija kvalifikacijski protokol TOC skupni organski ogljik foto oksidacija elektrodeionizacija Purified water qualification qualification protocol TOC total organic carbon photo oxidation electrodeionisation true false false Slovenski jezik Angleški jezik Diplomsko delo 2016-07-11 14:49:15 2016-07-11 14:49:18 2022-08-02 00:56:58 0000-00-00 00:00:00 2016 0 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 1970-01-01 33821 Dejak_Urban_-_Kvalifikacija_sistema_za_pripravo_laboratorijske_vode.pdf Dejak_Urban_-_Kvalifikacija_sistema_za_pripravo_laboratorijske_vode.pdf 1 F98EA2F251279E2ED732B5489756ABF6 243deebc18ec0220a5713f4cce03a48491167f475d20713fa719d844df7259fb dc877057-a1b0-11eb-a523-00155dcfd717 20.500.12556/rul/3884a12c-d7c4-46be-81ac-15b2c4b0d6b5 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=87162 Fakulteta za elektrotehniko 0 0 0