20.500.12556/DKUM-40381 VALIDACIJA STERILIZACIJE - DOLOČITEV ROKA UPORABE STERILIZIRANEGA MATERIALA VALIDATION OF STERILIZATION - DETERMINATION OF STERILIZATION MATERIAL 'S USAGE TIME Namen diplomskega dela je bil z validacijo dokazati, da material (oprema), steriliziran po predpisanem postopku v parnem sterilizatorju - avtoklavu, ohrani sterilnost tudi po 30 dnevih hranjenja. V sklopu raziskav smo pripravili pakete z deli opreme, ki so nujno potrebni v proizvodnem procesu in jih vstavili v sterilizacijske posode poleg materiala (opreme), ki se uporablja v proizvodnem procesu. Te pakete smo nato izpostavili sterilizaciji s paro v avtoklavu. Po ohladitvi paketov na sobno tempeaturo smo izbrane dele steriliziranih paketov hranili v proizvodnih prostorih razreda čistosti D. Po 30 dnevih hranjenja smo na teh delih steriliziranih paketov določali sterilnost. Rezultati v diplomskem delu kažejo, da je ustrezno sterilizirane in zapakirane pakete materiala (opreme) možno hraniti 30 dni, ne da bi bila pri tem kakorkoli ogrožena njegova kvaliteta oz. sterilnost. The purpose of our work was validation of sterilization which demonstrate that material (equipment) sterilized according to the prescribed procedure in a steam steriliser - autoclave maintains the sterility even after 30 days of storage. In the context of this thesis, we have prepared packages with items of equipment that are necessary in the production process and inserted it into sterilization containers loaded with the material (equipment) used in the production process. These packets were exposed to steam sterilization in an autoclave and than stored in the production area with cleanliness grade D. After 30 days of storage sterilized packages were analyzed to determine sterility. The results in this thesis show that properly sterilized and packed material (equipment) can be stored for 30 days, without being in any way compromised its quality or sterility. validacija sterilizacija avtoklav biološki indikatorji distribucija temperature rok uporabe oprema validation sterilisation autoclave biological indicators temperature distribution shelf life equipment true true false [D. Salajko] Slovenski jezik Angleški jezik Diplomsko delo/naloga 2013-05-13 21:02:17 2013-05-22 15:07:14 2022-05-12 23:38:18 2021-04-20 03:37:56 2013 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 614.48:615.014.4(043.2) 17473302 URN:SI:UM:DK:ESZ0AMWP VS_Salajko_Damir_2013.pdf VS_Salajko_Damir_2013.pdf 1 B82BE47C064B55E06D35BE55099D4DF9 227837b4bd1d1da0178a8e2ef4ac1bbb03cebff524f7f73160a896b8969e7c1e f0111540-7c09-11eb-bb7a-00155d0001ca 20.500.12556/dkum/ce3ab988-4830-4dba-aaed-8f24f84fc4cf https://dk.um.si/Dokument.php?lang=slv&id=55224 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0