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Procesna analitska tehnologija v farmacevtski industriji
ID Kužner, Tanja (Author), ID Žnidaršič Plazl, Polona (Mentor) More about this mentor... This link opens in a new window

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Abstract
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.

Language:Slovenian
Keywords:procesna analitska tehnologija, farmacevtska industrija, API, GMP, Quality by Design
Work type:Bachelor thesis/paper
Typology:2.11 - Undergraduate Thesis
Organization:FKKT - Faculty of Chemistry and Chemical Technology
Year:2025
PID:20.500.12556/RUL-176189 This link opens in a new window
COBISS.SI-ID:262755075 This link opens in a new window
Publication date in RUL:24.11.2025
Views:90
Downloads:16
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Secondary language

Language:English
Title:Process analytical technology in pharmaceutical industry
Abstract:
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.

Keywords:process analytical technology, pharmaceutical industry, API, GMP, Quality by Design

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