Načrtovanje separacijskih alternativ za rekonstrukcijo procesa koncentriranja farmacevtske učinkovine : magistrsko delo

Goričanec, Rafael

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Title:	Načrtovanje separacijskih alternativ za rekonstrukcijo procesa koncentriranja farmacevtske učinkovine : magistrsko delo
Authors:	ID Goričanec, Rafael (Author) ID Bogataj, Miloš (Mentor) More about this mentor... ID Pečelin, Peter (Comentor)
Files:	MAG_Goricanec_Rafael_2026.pdf (4,54 MB, This file will be accessible after 18.02.2029) MD5: 269EC492C088E055E5033416B5203C96
Language:	Slovenian
Work type:	Master's thesis/paper
Typology:	2.09 - Master's Thesis
Organization:	FKKT - Faculty of Chemistry and Chemical Engineering
Abstract:	V magistrskem delu smo obravnavali rekonstrukcijo procesa koncentriranja aktivne farmacevtske učinkovine iz raztopine etilacetata z vsebnostjo vode. Obstoječi industrijski proces, ki vključuje destilacijsko kolono in tankoslojni izparilnik, predstavlja omejitev z vidika povečevanja proizvodne kapacitete in energijske učinkovitosti. Z uporabo programskega paketa Aspen Plus smo razvili simulacijski model obstoječega procesa in ga validirali z industrijskimi podatki. Rezultati so pokazali, da iz 5221,5 kg/h napajalne raztopine pridobimo 590,5 kg/h koncentrata z masno koncentracijo aktivne farmacevtske učinkovine 64,6 g/L ter 4631 kg/h regeneriranega topila. Analiza je pokazala, da je za obstoječi proces potrebnih približno 586 kW vročega in 654 kW mrzlega pogonskega sredstva. Pri tem moramo poudariti, da izparevanje poteka pri nizkih temperaturah, ugodnih z vidika termične stabilnosti učinkovine. V nadaljevanju smo analizirali dvostopenjsko izparevanje in razpenjanje kot alternativni rešitvi. Dvostopenjsko izparevanje omogoča enako proizvodno kapaciteto ob več kot 50 % nižji porabi vročega in mrzlega pogonskega sredstva, vendar povzroči večjo vsebnost vode v koncentratu. Razpenjanje napajalne raztopine omogoča do 10 % povečanje proizvodne kapacitete in zvišanje koncentracije učinkovine do 71,5 g/L. Magistrsko delo predstavlja uporabno osnovo za nadaljnjo optimizacijo procesa koncentriranja in podporo odločanju pri načrtovanju separacijskih procesov v farmacevtski industriji.
Keywords:	koncentriranje farmacevtske učinkovine, simulacija procesov, načrtovanje procesov, razpenjanje, izparevanje, destilacija
Place of publishing:	Maribor
Place of performance:	Maribor
Publisher:	[R. Goričanec]
Year of publishing:	2026
Number of pages:	1 spletni vir (1 datoteka PDF (IX, 45 str.))
PID:	20.500.12556/DKUM-96674
UDC:	66.011:66.063.94(043.2)
COBISS.SI-ID:	272739331
Publication date in DKUM:	05.03.2026
Views:	153
Downloads:	0
Metadata:
Categories:	KTFMB - FKKT
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Licences

License:	CC BY 4.0, Creative Commons Attribution 4.0 International

Link:	http://creativecommons.org/licenses/by/4.0/
Description:	This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.
Licensing start date:	22.01.2026

Secondary language

Language:	English
Title:	Design of separation alternatives for the reconstruction of the active pharmaceutical ingredient concentration process
Abstract:	In this master’s thesis, the reconstruction of an active pharmaceutical ingredient concentration process from an ethyl acetate solution containing water was investigated. The existing industrial process, which consists of a distillation column and a thin-film evaporator, represents a limitation in terms of increasing production capacity and improving energy efficiency. A simulation model of the existing process was developed using the Aspen Plus software package and validated against industrial data. The results showed that from 5221,5 kg/h of feed solution, 590,5 kg/h of concentrate with an active pharmaceutical ingredient concentration of 64,6 g/L is obtained, along with 4631 kg/h of regenerated solvent. Further analysis showed that the existing process requires approximately 586 kW of hot 654 kW of cold utility. It is important to note that evaporation takes place at relatively low temperatures, which is favorable in terms of the thermal stability of the active ingredient. Furthermore, two-stage evaporation and flash evaporation were analyzed as alternative solutions. Two-stage evaporation enables the same production capacity with more than 50 % lower consumption of hot and cold utilities, but results in a higher water content in the concentrate. Flash evaporation of the feed solution allows up to a 10 % increase in production capacity and an increase in the active ingredient concentration to values as high as 71,5 g/L. This master’s thesis provides a useful basis for further optimization of concentration processes and supports decision-making in the design of separation processes in the pharmaceutical industry.
Keywords:	concentration of active pharmaceutical ingredient, process simulation, process design, flash, evaporation, distillation

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