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Razvoj procesnega sistema za pranje na mestu delovanja v farmacevtski industriji
ID Benčina, Ignac (Author), ID Golobič, Iztok (Mentor) More about this mentor... This link opens in a new window, ID Zupančič, Matevž (Comentor)

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Abstract
V magistrski nalogi smo obravnavali procesni sistem za pranje na mestu v farmacevtski industriji in analizirali potrebne postopke dokumentiranja kvalifikacij posameznih faz pri razvoju tega sistema. Na osnovi podatkov pridobljenih iz literature, smo najprej predstavili teoretične osnove sistema, nekaj različnih izvedb tega sistema in pa teoretične osnove kvalifikacij in kvalifikacijske dokumentacije v farmacevtski industriji. Izdelali smo analizo kvalifikacijske dokumentacije, kjer smo se osredotočili na predstavitev posamezne faze kvalifikacijske dokumentacije in delovanja procesnega sistema za pranje na mestu delovanja. Na osnovi izvedenih testnih postopkov in ustreznih delovnih listov, smo opredelili ujemanje dokumentacije z dejanskim stanjem. Izvedli smo kvalifikacijo montaže za sedem testnih postopkov. Na osnovi izvedene analize, smo potrdili ustrezno izvedbo montaže sistema za pranje na mestu delovanja.

Language:Slovenian
Keywords:procesni sistemi, pranje na mestu delovanja, kvalifikacija opreme, kvalifikacija načrtovanja, kvalifikacija montaže, kvalifikacija delovanja, kvalifikacija po zagonu, farmacevtska proizvodnja
Work type:Master's thesis/paper
Typology:2.09 - Master's Thesis
Organization:FS - Faculty of Mechanical Engineering
Place of publishing:Ljubljana
Publisher:[I. Benčina]
Year:2020
Number of pages:XXI, 58 str.
PID:20.500.12556/RUL-114466 This link opens in a new window
UDC:628.288:615.658.5(043.2)
COBISS.SI-ID:17070619 This link opens in a new window
Publication date in RUL:29.02.2020
Views:1812
Downloads:233
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Secondary language

Language:English
Title:Development of the cleaning in place system in the pharmaceutical industry
Abstract:
The master’s thesis dealt with the cleaning in place system in the pharmaceutical industry and analyzed the necessary procedures for documenting the qualifications of the individual stages in the development of this system. Based on the information obtained from the literature, first, the theoretical basis of the system, some different implementations of the system, and the theoretical bases of qualifications and qualification documentation in the pharmaceutical industry were presented. An analysis of the qualification documentation was made, with focus on the presentation of each stage of the qualification documentation and operation of the cleaning in place system. On the basis of the performed test procedures and the relevant worksheets, the correspondence of the documentation with the actual situation was determined. Seven test procedures were performed for installation qualification. Based on the analyzes performed, the proper installation of cleaning in place system could be confirmed.

Keywords:process systems, clean in place, equipment qualification, design qualification, installation qualification, operational qualification, performance qualification, pharmaceutical production

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