20.500.12556/RUL-176189 Procesna analitska tehnologija v farmacevtski industriji Process analytical technology in pharmaceutical industry Diplomsko delo obravnava procesno analitsko tehnologijo (PAT) kot sodoben pristop za nadzor in optimizacijo proizvodnih procesov v farmacevtski industriji. V teoretičnem delu so predstavljeni temeljni koncepti in ključne komponente PAT ter opisane analitske tehnike, kot so spektroskopija, kromatografija, masna spektroskopija, mikroskopija in elektroforeza. Poseben poudarek je namenjen uporabi PAT pri proizvodnji aktivnih farmacevtskih sestavin (API) v skladu z zahtevami dobre proizvodne prakse (GMP). Na praktičnih primerih so prikazane aplikacije PAT pri reakcijah, kristalizaciji, sušenju in mletju, ki dokazujejo, da uvedba teh orodij omogoča sprotno spremljanje kritičnih procesnih parametrov, zmanjšuje variabilnost in napake ter skrajšuje čas sproščanja izdelkov na trg. Poleg tehničnih prednosti naloga izpostavlja tudi ekonomske vidike, saj se začetne investicije v PAT dolgoročno povrnejo z večjo učinkovitostjo, zmanjšanjem odpadkov in bolj trajnostnim delovanjem. V zaključku je poudarjeno, da PAT ni le tehnološka podpora, temveč strateško orodje za uresničevanje koncepta Quality by Design (QBD) ter za krepitev konkurenčnosti in zagotavljanje visoke kakovosti farmacevtskih izdelkov. The thesis discusses Process Analytical Technology (PAT) as a modern approach to monitoring and optimizing manufacturing processes in the pharmaceutical industry. The theoretical part presents the fundamental concepts and key components of PAT, as well as analytical techniques such as spectroscopy, chromatography, mass spectrometry, microscopy and electrophoresis. Special attention is given to the application of PAT in the production of active pharmaceutical ingredients (API) in compliance with Good Manufacturing Practice (GMP). Practical case studies demonstrate the use of PAT in reactions, crystallization, drying and milling, confirming that the implementation of these tools enables real-time monitoring of critical process parameters, reduces variability and errors and shortens product release times. In addition to technical advantages, the thesis also highlights the economic aspects, as initial investments in PAT are offset in the long term by increased efficiency, waste reduction, and more sustainable operations. The conclusion emphasizes that PAT is not merely a technological support, but a strategic took for implementing the Quality by Design (QbD) concept and for strengthening competitiveness while ensuring high-quality pharmaceutical products. procesna analitska tehnologija farmacevtska industrija API GMP Quality by Design process analytical technology pharmaceutical industry API GMP Quality by Design true false false Slovenski jezik Angleški jezik Diplomsko delo/naloga 2025-11-24 14:25:01 2025-11-24 14:25:09 2025-12-23 13:01:38 0000-00-00 00:00:00 2025 0 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 25402 262755075 Kuzner_Tanja_-_Analitska_procesna_tehnologija_v_farmacevtski_industriji.pdf Kuzner_Tanja_-_Analitska_procesna_tehnologija_v_farmacevtski_industriji.pdf 1 BAA13B07C3C07A7E0055FEDFF39874B5 ba884d19f6d27cfaedf95247289ed0c570b43bb5426fc7eec56b9496119395aa a34b04e9-c938-11f0-9328-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=222441 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0