20.500.12556/RUL-182606 Brajica na farmacevtski embalaži Braille on pharmaceutical packaging Uveljavitev brajice na farmacevtski embalaži v Evropski uniji pomeni pomemben prispevek k večji samostojnosti slepih in slabovidnih oseb. Zahteva izhaja iz Direktive 2004/27/ES Evropskega parlamenta in Sveta, ki določa, da mora biti ime zdravila na zunanji ovojnini zapisano tudi v brajici, medtem ko zahteve in smernice za uporabo brajice na farmacevtski embalaži v Evropski uniji in Evropskem gospodarskem prostoru določa evropski standard CEN EN 15823. Ustrezna dimenzijska upodobitev brajevih pik je ključnega pomena za varno, samostojno in zanesljivo tipno prepoznavo zdravil. Kljub jasno opredeljenim zahtevam se v praksi pojavljajo odstopanja v velikosti in obliki brajevih pik, kar odpira vprašanje dejanske skladnosti embalaže s standardi in zanesljivosti tipne zaznave. Namen diplomskega dela je bil raziskati dimenzijsko ustreznost brajice na farmacevtski embalaži, preveriti njeno skladnost s standardom Marburg Large in ovrednotiti zanesljivost slikovne analize kot metode za presojo kakovosti brajevih pik v realnih pogojih uporabe. Cilji raziskave so bili: (1) analizirati večje število farmacevtskih embalaž z brajico, (2) izvesti sistematičen slikovni zajem brajevih pik, (3) izmeriti izbrane geometrijske parametre, s poudarkom na Feretovem premeru, (4) izračunati statistične kazalnike (povprečne vrednosti, standardni odklon in variacijski koeficient), (5) primerjati rezultate z zahtevami standarda Marburg Large in (6) identificirati vzorce z izrazitejšimi dimenzijskimi odstopanji. V raziskavo je bilo vključenih 70 farmacevtskih embalaž, pridobljenih iz realnega okolja uporabe. Slikovni zajem brajevih pik je bil izveden s stereomikroskopom Leica S9i, dimenzijska analiza pa v programu ImageJ. Feretov premer je bil uporabljen kot ključni parameter skladnosti, dopolnjen s kazalniki absolutne in relativne variabilnosti za presojo enakomernosti upodobitve brajevih pik znotraj posameznih vzorcev. Iz rezultatov je razvidno, da je 61,4 odstotka analiziranih vzorcev izpolnjevalo zahteve standarda Marburg Large, medtem ko je pri 38,6 odstotka vzorcev povprečna vrednost Feretovega premera presegala zgornjo mejo standarda. Ugotovljena sta bila trend približevanja dimenzij brajevih pik zgornji meji dovoljenega razpona in prisotnost variabilnosti pri posameznih vzorcih, zlasti pri embalažah z izrazitejšo obrabo ali specifičnimi površinskimi lastnostmi materiala. Iz analize je tudi razvidno, da numerična skladnost s standardom sama po sebi še ne omogoča zagotavljanja optimalne tipne zaznave brajice, saj nanjo poleg dimenzij vplivajo tudi oblika robov, površinske lastnosti in obraba materiala. Hkrati pa slikovna analiza ne zajame vseh tipno relevantnih značilnosti upodobitve. Diplomsko delo pripomore k boljšemu razumevanju kakovosti brajice na farmacevtski embalaži, poudarja pomen sistematičnega nadzora dimenzijske ustreznosti ter odpira vprašanja standardizacije in metod preverjanja kakovosti v praksi. The introduction of Braille on pharmaceutical packaging in the European Union is an important step towards increasing the independence of blind and visually impaired people. This requirement arises from Directive 2004/27/EC of the European Parli ment and of the Council, which states that the name of the medicinal product must also appear in Braille on the outer packaging. The requirements and guidelines for the use of Braille on pharmaceutical packaging in the European Union and the European Economic Area are defined by the European standard CEN EN 15823. Accurate dimensional representation of Braille dots is essential for the safe, independent, and reliable tactile identification of medicinal products. Despite clearly defined requirements, deviations in the size and shape of Braille dots occur in practice, raising questions about the actual compliance of packaging with standards and the reliability of tactile perception. The purpose of this bachelor’s thesis was to investigate the dimensional adequacy of Braille on pharmaceutical packaging, verify its compliance with the Marburg Large standard, and evaluate the reliability of image analysis as a method for assessing the quality of Braille dots under real conditions of use. The objectives of the study were: (1) to analyse a large number of pharmaceutical packages containing Braille, (2) to perform systematic image capture of Braille dots, (3) to measure selected geometric parameters, with emphasis on Feret’s diameter, (4) to calculate statistical indicators (mean values, standard deviation, and coefficient of variation), (5) to compare the results with the requirements of the Marburg Large standard, and (6) to identify samples with pronounced dimensional deviations. The study included 70 pharmaceutical packages obtained from a real usage environment. Image capture of Braille dots was carried out using a Leica S9i stereomicroscope, and dimensional analysis was performed using ImageJ software. Feret’s diameter was used as the key compliance parameter, complemented by indicators of absolute and relative variability to assess the uniformity of Braille dot representation within individual samples. The results showed that 61.4% of the analysed samples complied with the requirements of the Marburg Large standard, while in 38.6% of the samples the mean Feret diameter exceeded the standard's upper limit. A trend towards dimensions approaching the upper permissible limit was observed, along with variability within certain samples, particularly in packaging showing more pronounced wear or specific surface material properties. The analysis demonstrated that numerical compliance with the standard alone does not necessarily ensure optimal tactile perception of Braille, as tactile readability is influenced not only by dimensions but also by edge shape, surface properties, and material wear; moreover, image analysis does not capture all tactually relevant characteristics of the representation. The thesis contributes to a better understanding of the quality of Braille on pharmaceutical packaging, emphasises the importance of systematic control of dimensional adequacy, and raises questions regarding standardisation and methods of quality assessment in practice. brajica tisk brajice standardi brajice farmacevtska embalaža dimenzijska analiza brajice braille braille printing braille standards pharmaceutical packaging dimensional analysis of braille true false false Slovenski jezik Angleški jezik Diplomsko delo/naloga 2026-05-19 09:00:10 2026-05-19 09:00:43 2026-05-20 04:45:52 0000-00-00 00:00:00 2026 0 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 1970-01-01 113613 29076.pdf 29076.pdf 1 0FA98A148B458F2B15DDCA5293832878 53a02897505e1637883c4eb0a649f15ecc5738906b14f64fa218cbab413f84e3 2965db4b-5350-11f1-b0ab-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=234014 Naravoslovnotehniška fakulteta 0 0 0