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master's thesis
Kontrola i validacija čuvanja hranjivih podloga za ispitivanje sterilnosti gotovih farmaceutskih proizvoda
Zagreb: University of Zagreb, Faculty of Food Technology and Biotechnology, 2023. urn:nbn:hr:159:169983
Zrinski, Kristina
University of Zagreb
Faculty of Food Technology and Biotechnology
Department of Biochemical Engineering
Laboratory for Biochemical Engineering, Industrial Microbiology and Malting and Brewing Technology

Institutional repository: Repository of the Faculty of Food Technology and Biotechnology

Cite this document

Zrinski, K. (2023). Kontrola i validacija čuvanja hranjivih podloga za ispitivanje sterilnosti gotovih farmaceutskih proizvoda (Master's thesis). Zagreb: University of Zagreb, Faculty of Food Technology and Biotechnology. Retrieved from https://urn.nsk.hr/urn:nbn:hr:159:169983

Zrinski, Kristina. "Kontrola i validacija čuvanja hranjivih podloga za ispitivanje sterilnosti gotovih farmaceutskih proizvoda." Master's thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, 2023. https://urn.nsk.hr/urn:nbn:hr:159:169983

Zrinski, Kristina. "Kontrola i validacija čuvanja hranjivih podloga za ispitivanje sterilnosti gotovih farmaceutskih proizvoda." Master's thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, 2023. https://urn.nsk.hr/urn:nbn:hr:159:169983

Zrinski, K. (2023). 'Kontrola i validacija čuvanja hranjivih podloga za ispitivanje sterilnosti gotovih farmaceutskih proizvoda', Master's thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, accessed 07 August 2024, https://urn.nsk.hr/urn:nbn:hr:159:169983

Zrinski K. Kontrola i validacija čuvanja hranjivih podloga za ispitivanje sterilnosti gotovih farmaceutskih proizvoda [Master's thesis]. Zagreb: University of Zagreb, Faculty of Food Technology and Biotechnology; 2023 [cited 2024 August 07] Available at: https://urn.nsk.hr/urn:nbn:hr:159:169983

K. Zrinski, "Kontrola i validacija čuvanja hranjivih podloga za ispitivanje sterilnosti gotovih farmaceutskih proizvoda", Master's thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, Zagreb, 2023. Available at: https://urn.nsk.hr/urn:nbn:hr:159:169983

Metadata
TitleKontrola i validacija čuvanja hranjivih podloga za ispitivanje sterilnosti gotovih farmaceutskih proizvoda
Title (english)Control and validation of storage of nutrient media for sterility testing of final pharmaceutical products
AuthorKristina Zrinski
MentorAnita Slavica (mentor)
MentorTatjana Turčinov (pomoć pri izradi, neposredni voditelj)
Committee memberJasna Novak (predsjednik povjerenstva)
Committee memberAndreja Leboš-Pavunc (član povjerenstva)
Committee memberBlaženka Kos (član povjerenstva)
GranterUniversity of Zagreb
Faculty of Food Technology and Biotechnology
(Department of Biochemical Engineering)
(Laboratory for Biochemical Engineering, Industrial Microbiology and Malting and Brewing Technology)
Zagreb
Defense date and country2023-07-19, Croatia
Scientific / art field,
discipline and subdiscipline		BIOTECHNICAL SCIENCES
Biotechnology
Abstract
U ovome istraživanju načinjena je analiza po 10 LOT-ova dviju ready-to-use hranjivih podloga - Fluid Thioglycolate Medium (FTM) i Tryptic Soy Broth (TSB). Ove dvije ready-to-use podloge podržavaju rast test mikroorganizama, koji su najčešći kontaminanti ciljanih farmaceutskih proizvoda i to prema zahtjevima farmakopeje SAD-a i EU, ali i zahtjevima proizvodnih postrojenja PLIVA Hrvatska d.o.o. Zadovoljeni su svi kriteriji prihvatljivosti ovih dviju hranjivih podloga, koji su definirani planom validacije prema internom protokolu. Rok valjanosti hranjivih podloga potvrđen je ovom validacijom te se ove dvije podloge mogu koristiti u cjelokupnom razdoblju unutar propisanog roka valjanosti uz propisne uvjete čuvanja podloga. Dvije ispitivane hranjive podloge prošle su analizu hranjivosti, odgovaraju traženim zahtjevima te se mogu koristiti unutar Mikrobiološkog i biološkog laboratorija ove tvrtke za daljnje ispitivanje sterilnosti gotovih farmaceutskih proizvoda. Neželjene promjene ovih podloga, koje bi mogle utjecati na mogućnost identifikacije kontaminacije određenim vrstama mikroorganizama, nisu zamijećene ni u jednom od navedenih kritičnih parametara.
Abstract (english)
In this research analysis of 10 LOTs of two ready-to-use nutrient media - Fluid Thioglycolate Medium (FTM) and Tryptic Soy Broth (TSB) was accomplished. These two ready-to-use media support the growth of test microorganisms, which are the most common contaminants of targeted pharmaceutical products according to the requirements of the US Pharmacopoeia, the EU Pharmacopoeia, but also the requirements of PLIVA Hrvatska d.o.o. production facilities. All acceptance criteria of these two nutrient media, which were defined by the validation plan according to the internal protocol, were met. The shelf life of nutrient media is confirmed by this validation, and these two media can be used for the entire period within the prescribed validity period under the proper storage conditions. The two tested nutrient media have undergone nutrient analysis, meet the required requirements and can be used within the company's Microbiological and Biological Laboratory for further testing of the sterility of finished pharmaceutical products. Unwanted changes in these media, which could affect the possibility of identifying contamination by certain types of microorganisms, were not observed in any of the listed critical parameters.
Keywords
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:159:169983
Study programmeTitle: Bioprocess Engineering
Study programme type: university
Study level: graduate
Academic / professional title: magistar/magistra inženjer/inženjerka bioprocesnog inženjerstva (magistar/magistra inženjer/inženjerka bioprocesnog inženjerstva)
Type of resourceText
File originBorn digital
Access conditionsOpen access
Terms of useLicence Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) icon
Created on2024-06-14 09:26:30