20.500.12556/DKUM-91924 Validacija mikrobiološke metode preizkušanja kakovosti primarne ovojnine magistrsko delo Validation of microbiological method for quality control of primary packaging Embalaža zdravila je zelo pomembna pri njegovi proizvodnji. Pomaga zaščititi notranjost zdravila in ohraniti njegovo kakovost. Bistveno je, da je embalaža funkcionalna in izpolnjuje vse potrebne kriterije skozi celotno življenjsko dobo izdelka. Med transportom embalaža služi kot ščit, ki ščiti vsebino pred morebitnimi poškodbami zaradi mehanskega pritiska in okoljskih dejavnikov. Obstaja več različnih vrst embalaže za farmacevtski izdelek, ki so razvrščene kot primarna, sekundarna in terciarna. Uporabljena primarna ovojnina v proizvodnji zdravil ne sme sproščati toksikoloških pomembnih snovi v formulacijo zdravila, zato je pomembno, da je le-ta ustrezne mikrobiološke kakovosti. Mikrobiološka kontaminacija zdravil in bioloških zdravil namreč povzroča takojšnje škodljive učinke na zdravje, vključno z obolevnostjo in umrljivostjo ter dolgoročne škodljive učinke, kot so rak, avtoimunske in druge bolezni. Raven mikrobne kontaminacije v nesterilnih farmacevtskih produktih se lahko dopušča, saj se upoštevajo kriteriji sprejemljivosti, določenih v uradnih zbornikih kot so farmakopeje. Ustrezno mikrobiološko kakovost izdelka dokažemo z različnimi metodami, ki pa morajo biti ustrezno validirane pred njihovo uporabo. Validacija analitskih metod je ključni postopek v farmacevtski, biotehnološki in živilski industriji, ki zagotavlja kakovost in varnost izdelkov. Cilj validacije analitske metode je dokazati, da je metoda primerna za predvideni namen. V magistrski nalogi smo izvajali validacijo postopka za mikrobiološko preizkušanje kakovosti primarne ovojnine uporabljene za zaščito nesterilne aktivne učinkovine. Validacija postopka se je izvajala v farmacevtskem podjetju, v sklopu uvedbe nove primarne ovojnine. Sestavljena je iz štirih korakov (razvoj metode, izdaja validacijskega protokola, verifikacija metode in izdaja validacijskega poročila). Metodo smo uspešno validirali in se tako lahko uporablja pri zaščiti nesterilne aktivne učinkovine v obliki prahu. The packaging of a medicine is very important during its production. It helps to protect the inside parts of the medicine and maintain its quality. It is essential for the packaging to be functional and fulfil all the necessary criteria throughout the entire lifespan of the product. During transportation, the packaging serves as a shield, safeguarding the contents from potential damage caused by mechanical pressure and environmental factors. There are several different types of packaging for a pharmaceutical product, which are classified as primary, secondary, and tertiary. The packaging materials used in production of medicine must not release toxicologically relevant substances into the formulation, therefore, it is important that it is of appropriate microbiological quality. Microbial contamination of drugs and biologics causes immediate adverse effects on health, including morbidity and mortality, as well as long-term adverse impacts, such as cancer, auto-immune and other diseases. A level of microbial contamination in non-sterile pharmaceutical products may be tolerated since they follow the acceptance criteria established in official compendia, such as pharmacopeias. The appropriate microbiological quality of the product is proven by various methods, which must be properly validated before their use. Analytical method validation is a critical process in the pharmaceutical, biotechnology, and food industries to ensure the quality and safety of products. The objective of the validation of an analytical method is to demonstrate that it is suitable for its intended purpose. In this master thesis, the validation of the procedure for microbiological testing for quality control of the primary packaging material used to protect the non-sterile active ingredient was performed. The validation of the process was carried out in the pharmaceutical company, as part of the introduction of the new primary packaging. It consists of four steps (method development, validation protocol issuance, method verification, and validation report issuance). The method was successfully validated and can therefore be used to protect the non-sterile active ingredient in powder form. primarna ovojnina validacija analitskega postopka mikrobiološka kontaminacija farmacija primary packaging validation of analytical procedure microbiological contamination pharmacy true true false [L. Gruškovnjak] Slovenski jezik Angleški jezik Magistrsko delo/naloga 2025-02-28 16:04:39 2025-03-28 12:08:18 2025-04-08 03:09:41 0000-00-00 00:00:00 2025 0 Maribor 0 Maribor 1 spletni vir (1 datoteka PDF (VIII, 41 str.)) 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 579.6:615.014.8(043.2) 231664643 MAG_Gruskovnjak_Laura_2025.pdf MAG_Gruskovnjak_Laura_2025.pdf 1 443CDE3AA03384A15A4141117EC8D3EF da99bc8a8eb7d00706f3a2975c7a2a963025293fa091f0fc8e230d67ed11ab98 f59435bc-0bb5-11f0-af5a-00155d000105 https://dk.um.si/Dokument.php?lang=slv&id=189771 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0