Kontrola i validacija čuvanja hranjivih podloga za ispitivanje sterilnosti gotovih farmaceutskih proizvoda

master's thesis

• Title (english): Control and validation of storage of nutrient media for sterility testing of final pharmaceutical products
• Author: Kristina Zrinski
• Mentor: Anita Slavica (mentor)
• Mentor: Tatjana Turčinov (pomoć pri izradi, neposredni voditelj)
• Committee member: Jasna Novak (predsjednik povjerenstva)
• Committee member: Andreja Leboš-Pavunc (član povjerenstva)
• Committee member: Blaženka Kos (član povjerenstva)
• Granter: University 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 country: 2023-07-19, 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: kontrola; validacija; hranjive mikrobiološke podloge; sterilnost; test mikroorganizmi
• Keywords (english): control; validation; nutrient medium; sterility; test microorganisms
• Language: croatian
• URN:NBN: urn:nbn:hr:159:169983
• Study programme: Title: 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 resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2024-06-14 09:26:30