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.
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