Razvoj in validacija metod čiščenja laboratorijske steklovine za odstranjevanje vanilina v pogojih dobre proizvodne prakse

Božič, Anže (avtor), Ilaš, Janez (mentor), Andrenšek, Samo (komentor)

Cleaning of laboratory glassware is one of the most basic, but at the same time also one of the most important processes, that takes place in every analytical laboratory. Adequacy of cleaning and equipment, which is used in the cleaning process, therefore have to be checked on a regular basis. Because of that it is essential, that the used testing procedure is as easy and as fast as possible. The purpose of this thesis was to develop a routine procedure and analytical methods for determination of adequacy of cleaning. Because of the property of its crystals to form an even thin layer all over the surface of laboratory glassware, vanillin was chosen as a testing substance. GC, HPLC and UV-VIS spectrophotometry methods were developed for vanillin detection. To confirm the identity of vanillin, its GC-MS spectrum was recorded as well. All experimental work was done under good manufacturing practice conditions and followed all its guidelines. We tried to develop analytical procedures in such way, that the same solutions could be used in validation of all three analytical methods. Methanol was chosen as a solvent. All methods were successfully validated according to ICH guidelines. Due to the longer retention time of vanillin and higher baseline noise, GC method was found to be the worst of them. HPLC and UV-VIS methods gave comparable results. HPLC method was used to test the adequacy of our washing machine. We found out that the chosen sampling procedure with the dissolution of any residues of vanillin is suitable for testing the adequacy of washing machine performance and with that for testing the laboratory glassware cleaning on a daily basis.

• Jezik: Slovenski jezik
• Ključne besede: vanillin, good manufacturing practice, GC, HPLC, UV-VIS
• Vrsta gradiva: Magistrsko delo/naloga
• Organizacija: FFA - Fakulteta za farmacijo
• Leto izida: 2020
• PID: 20.500.12556/RUL-118662
• Datum objave v RUL: 29.08.2020

BOŽIČ, Anže, 2020, Razvoj in validacija metod čiščenja laboratorijske steklovine za odstranjevanje vanilina v  pogojih dobre proizvodne prakse [na spletu]. Magistrsko delo. [Dostopano 1 maj 2025]. Pridobljeno s: https://repozitorij.uni-lj.si/IzpisGradiva.php?lang=slv&id=118662

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Development and validation of vanillin cleaning methods from laboratory glassware under good manufacturing practice conditions

Izvleček

Čiščenje laboratorijske steklovine je eden izmed najosnovnejših in hkrati najpomembnejših procesov, ki potekajo v vsakem analitskem laboratoriju. Ustreznost čiščenja in delovanja opreme, ki jo pri tem uporabljamo, je zato potrebno redno preverjati. Zaradi tega je smiselno, da je uporabljeni postopek za preverjanje ustreznosti čiščenja kar se da enostaven in hiter. V okviru tega dela smo tako želeli razviti postopek vzorčenja in analizne metode, s katerimi bi lahko ustreznost čiščenja preverjali rutinsko. Za testno spojino je bil predvsem zaradi možnosti razporeditve njegovih kristalov po celotni površini steklovine izbran vanilin, razvite pa so bile metode za njegovo detekcijo s HPLC, GC in UV-VIS spektofotometrijo. Za potrditev istovetnosti vrha vanilina je bil posnet tudi GC-MS spekter. Eksperimentalno delo je potekalo v okolju dobre proizvodne prakse, pri čemer smo sledili vsem smernicam, ki jih ta predpisuje. Pri razvoju analiznih postopkov smo stremeli k temu, da bi lahko pri validiranju vseh metod uporabili iste raztopine. Kot topilo pri pripravi raztopin smo zato izbrali metanol. Vse metode smo nato uspešno validirali po ICH smernicah in pri tem ugotovili, da je GC metoda zaradi daljšega retencijskega časa vanilina in večjega šuma najslabša izmed uporabljenih metod, HPLC in UV-VIS metodi pa sta med seboj primerljivi. Za uporabo pri preverjanju ustreznosti delovanja pomivalnega stroja smo izbrali HPLC metodo. Pri tem smo ugotovili, da je izbrani način vzorčenja z raztapljanjem morebitnih po pomivanju prisotnih ostankov vanilina v metanolu primeren za preverjanje ustreznosti delovanja pomivalnega stroja in s tem za rutinski test čiščenja laboratorijske steklovine.

• Ključne besede: vanilin, dobra proizvodna praksa, GC, HPLC, UV-VIS