Ispitivanje mikrobiološke čistoće Urosal kapsula

master's thesis

• Title (english): Microbiological examination of Urosal capsules
• Author: Ivana Babec
• Mentor: Jagoda Šušković (mentor)
• Granter: University of Zagreb; Faculty of Food Technology and Biotechnology; (Department of Biochemical Engineering); (Laboratory for Antibiotic, Enzyme, Probiotic and Starter Cultures Technology); Zagreb
• Defense date and country: 2012-07-18, Croatia
• Scientific / art field, discipline and subdiscipline: BIOTECHNICAL SCIENCES; Biotechnology

Abstract

Sirovine prirodnog porijekla koje se koriste u proizvodnji farmaceutskih proizvoda mogu sadrţavati visoko mikrobno opterećenje, a mogu se dodatno opteretiti i tijekom proizvodnog procesa lijeka. Jedna od osnovnih zadaća farmaceutskog mikrobiološkog laboratorija je postizanje točnih i pouzdanih rezultata. U tu se svrhu prije same analize svi parametri odabranih metoda prilagođavaju fizikalnim, kemijskim i biološkim karakteristikama ispitivanog uzorka (razvoj i validacija metoda). Eksperimentalni dio ovog diplomskog rada obuhvaća razvoj i validaciju metoda za određivanje i ispitivanje mikrobiološke čistoće Urosal kapsula tvrtke Belupo d.d. Svi postupci provedeni su prema Europskoj farmakopeji (Ph. Eur.), poglavljima 2.6.12. i 2.6.13. Kriteriji mikrobiološke čistoće postavljeni se prema Ph. Eur. poglavlju 5.1.4. Svi dobiveni rezultati u skaldu su s odabranim kriterijima, metode za određivanje mikrobiološke čistoće Urosal kapsula uspješno su validirane, te su ocijenjene kao prikladne za rutinske analize.

Abstract (english)

Raw materials of natural origin which are using for pharmaceutical products may containing high microbial load and they can be an additional burden during the manufacturing process of the drug. One of the main tasks of pharmaceutical microbiology laboratory is to achieve accurate and reliable results. For this purpose, before the analysis, all of the parameters of the selected methods must be to adjust to the physical, chemical and biological characteristic of the testing sample (development and validation of the method). The experimental part of this thesis covers the testing and development and validation of methods for determining the purity and for microbiological testing of Urosal capsules Belupo. All of procedures were conducted according to the European Pharmacopoeia (Ph. Eur.), Chapters 2.6.12. and 2.6.13. Microbiological purity criteria are set by the Ph. Eur. Section 5.1.4. All of the results obtained in compliance with the eligibility criteria, microbiological purity methods for Urosal capsules are considered validated, and are appropriate for the porpose of routine analysis.

• Keywords: Urosal kapsule; mikrobiološka čistoća; Ph. Eur.; razvoj i validacija analitičkih metoda
• Keywords (english): Urosal capsules; microbiological purity; Ph. Eur.; Development and validation of the analytical methods
• Language: croatian
• URN:NBN: urn:nbn:hr:159:964879
• Study programme: Title: Biotechnology; specializations in: Biochemical Engineering; Course: Biochemical Engineering; Study programme type: university; Study level: graduate; Academic / professional title: diplomirani inženjer biotehnologije; smjer biokemijsko inženjerstvo (diplomirani inženjer biotehnologije; smjer biokemijsko inženjerstvo)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Access restricted to students and staff of home institution
• Created on: 2017-05-17 12:11:29