20.500.12556/DKUM-39081 OPTIMIZACIJA STROJNEGA PRANJA OPREME V NAMENSKEM PENICILINSKEM OBRATU OPTIMIZATION THE PROGRAM OF WASHING MACHINE FOR EQUIPMENT IN PENICILLIN DEDICATED PRODUCTION PLANET V proizvodnem procesu farmacevtskih izdelkov je čiščenje proizvodne opreme skrbno nadzorovan delovni proces. Stroga regulatorna pravila veljajo še zlasti za področje čiščenja proizvodne opreme v penicilinskem obratu, kjer je zahtevana tudi uporaba namenske opreme. Penicilinski izdelki spadajo namreč med izdelke z visokim varnostnim tveganjem. Na podlagi večletnih izkušenj poznavanja procesa strojnega pranja opreme smo v okviru diplomske naloge izvedli optimizacijo strojnega pranja opreme v namenskem penicilinskem obratu. Izvedenih je bilo več testiranj v sklopu spremembe ciklov strojnega pranja ter analiza rizika spremembe procesa strojnega pranja. V sklopu naloge smo ovrednotili optimiziran način strojnega pranja za kontejner (vsebnik), ki velja za eno izmed specifičnih oprem v produkciji penicilinskih izdelkov in je tudi najpogosteje v neposrednem stiku z izdelkom. Na osnovi rezultatov kemijskih analiz, ki določajo nivo zaostanka aktivne učinkovine na opremi, smo potrdili optimiziran program strojnega pranja opreme. Optimiziran program pranja smo potrdili tudi na osnovi mikrobioloških analiz, ki potrjujejo odsotnost mikroorganizmov na opremi. Ugotovili smo, da s spremenjenim programom strojnega pranja vsebnika zadostimo zahtevanim predpisom očiščenosti enako kot pred spremembo programa (prisotnost amoksicilin trihidrata (pod 100 µm/bris) in prisotnosti števila celokupnih mikroorganizmov (pod 50/bris). Sprememba je zajemala spremembo temperature in časa pranja v posameznih fazah strojnega pranja ter spremembo časa ohlajanja opreme. Optimizacija strojnega pranja je pomembna tudi z vidika zmanjševanja stroškov na račun krajšega časa pranja, saj s tem prihranimo energijo, kontejner pa lahko tudi hitreje uporabimo. Na osnovi izvedenih analiz smo potrdili spremembo optimiziranega programa strojnega pranja opreme v obratu penicilinske proizvodnje. Rezultati predstavljajo osnovo za nadaljevanje optimizacije programa strojnega pranja tudi za drugo namensko proizvodno opremo. Cleaning of production equipment is highly controlled operation in the production process of pharmaceutical products. Strict regulatory rules are valid in particular in the field of cleaning manufacturing equipment in the penicillin plant where the use of dedicated equipment is required because the penicillin products belong among products with high security risks. On the basis of many years experience on the process of washing equipment and the testing performed in the frame of varying washing machine cycles and the analysis of the risk of changing washing process machine the optimization of the machine washing equipment in the penicillin dedicated production plant was established. The optimized program of the washing machine for the container which is considered to be one of the specific products available in the production of penicillin and is also the most frequently in the direct contact with the product, was evaluated in the context of the thesis. On the basis of the analytical results that determine the level of the active substance residue on the equipment and on the basis of the microbiological analyses confirming the absence of micro-organisms on the equipment, we proved that the program of washing machine for equipment was successfully optimized. It was found out that with the modified machine washing container program (by varying the temperature and the time of the individual phases for the machine washing) and by varying the time of cooling of the equipment we met the required cleaning regulations as they were set before the change of the program (the presence of amoxicillin trihydrate below 100 µm/swab, the presence of total micro-organisms under 50/swab). Optimization of the machine cycle is also important from the viewpoint of reducing costs at the expense of shorter washing time. In such a way the energy could be saved and the container you can also be used the faster. On the basis of analyses performed the change of the washing machine-optimized scrubbing equipment at the plant for penicillin production was proved. The results present the basis for the continuation of the of the washing machine program optimization for other dedicated production equipment. optimizacija validacija čiščenja zaostanek aktivne učinkovine strojno pranje opreme vsebnik optimization cleaning validation residue of the active substance process of washing equipment container true true false [L. Pušnik Verdnik] Slovenski jezik Angleški jezik Diplomsko delo 2012-11-26 20:12:15 2012-11-30 13:55:15 2022-05-04 14:02:20 2021-04-21 03:17:25 2012 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 577.182.22:542.058(043.2) 16719638 URN:SI:UM:DK:1TT92CQ7 VS_Pusnik_Verdnik_Lidija_2012.pdf VS_Pusnik_Verdnik_Lidija_2012.pdf 1 5659DDA79923501E448474ECC2BA6FDF dc7e8ddb9b0287439d6033939d17903a500a1e4b5d956c2f39859e4fb506df21 9ce32101-7c08-11eb-bb7a-00155d0001ca 20.500.12556/dkum/84960046-71a1-47c8-baa5-4ec30b7c8cb7 https://dk.um.si/Dokument.php?lang=slv&id=52576 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0