Razvoj modela za določanje vrednosti MSR postaj pri postopku kvalifikacije orodij

Susič, Tilen (avtor), Logar, Vito (mentor), Andonovski, Goran (komentor)

Diplomsko delo obravnava postopek kvalifikacije orodij na avtomatizirani pakirni liniji Uhlmann 1660, ki se uporablja v farmacevtski proizvodnji za pakiranje tablet v blistre in nadaljnje pakiranje blistrov v škatlice. Kvalifikacija orodij je izjemno pomembna, saj zagotavlja kakovostno in nemoteno proizvodnjo skladno s standardi dobre proizvodne prakse. V diplomskem delu je najprej predstavljena pakirna linija, ki je razdeljena na primarni in sekundarni del. Primarni del linije je namenjen izdelavi in polnjenju blistrov, sekundarni del pa pakiranju blistrov v škatlice skupaj z navodili. V nadaljevanju je opisan postopek kvalifikacije orodij, ki vključuje več zaporednih testov, ki so prav tako podrobneje opisani. Osrednji del diplomskega dela je namenjen postopku določanja vrednosti postaj MSR (ang. Master shift register). Parameter MSR določa oddaljenost mesta blistrov z napako od izločilne postaje in je ključen za pravilno izločanje neustreznih blistrov. Cilj diplomskega dela je bil razviti model, ki bo izračunal MSR-vrednosti za vsako postajo, za nove izdelke neznanih dimenzij na podlagi že znanih podatkov prej izvedenih kvalifikacij in dimenzij novega blistra. Za napoved MSR-vrednosti sta bila razvita dva modela. Prvi temelji na modelu križnega računa, kjer se uporabi en referenčni izdelek, drugi pa na modeliranju z več referenčnimi izdelki in izbiri ustreznega polinomskega modela s pomočjo križne validacije. Rezultati so pokazali, da oba pristopa dobro sledita dejanskim meritvam, pri čemer ima vsak model določene prednosti. Model križnega računa je v povprečju dosegel manjšo absolutno napako, model križne validacije pa je bil manj občutljiv na večja posamezna odstopanja. Razvita modela bosta pomagala inženirjem na liniji hitreje kvalificirati orodja novih dimenzij, saj bo skrajšal čas iskanja ustreznih nastavitev in zmanjšal število poskusnih zagonov. Vendar ne more v celoti nadomestiti praktičnega preverjanja na liniji, saj je treba končne vrednosti MSR-postaj še vedno potrditi z dejanskim delovanjem stroja in izvedbo predpisanih testov.

• Jezik: Slovenski jezik
• Ključne besede: kvalifikacija orodij, farmacevtska proizvodnja, pakirna linija, blister, glavni pomični register, križna validacija, avtomatizirana linija
• Vrsta gradiva: Diplomsko delo/naloga
• Tipologija: 2.11 - Diplomsko delo
• Organizacija: FE - Fakulteta za elektrotehniko
• Leto izida: 2026
• PID: 20.500.12556/RUL-183934
• COBISS.SI-ID: 283107587
• Datum objave v RUL: 22.06.2026

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Development of a model for determining the value of MSR stations in the tool qualification process

Izvleček

The thesis discusses the tool qualification procedure on the automated Uhlmann 1660 packaging line, which is used in pharmaceutical production for packaging tablets into blisters and subsequently packing the blisters into cartons. Tool qualification is extremely important, as it ensures high-quality and uninterrupted production in accordance with Good Manufacturing Practice standards. The thesis first presents the packaging line, which is divided into a primary and a secondary section. The primary section of the line is intended for forming and filling blisters, while the secondary section is used for packing blisters into cartons together with patient information leaflets. The thesis then describes the tool qualification procedure itself, which consists of several consecutive tests that are also described in more detail. The central part of the thesis is dedicated to improving the determination of MSR station values. The MSR parameter defines the distance between the location of a defective blister and the rejection station, and is crucial for the correct rejection of nonconforming blisters. The aim of the thesis was to develop a model that calculates MSR values for each station for new products with previously unknown dimensions, based on known data from previously performed qualifications and the dimensions of the new blister. Two models were developed to predict MSR values. The first is based on the rule-of-three calculation model, where one reference product is used. The second is based on modelling with several reference products and selecting the appropriate polynomial model using cross validation. The results showed that both approaches follow the actual measurements well, with each model having certain advantages. On average, the rule-of-three model achieved a lower absolute error, while the cross-validation model was less sensitive to larger individual deviations. The developed models will help engineers qualify tools for new product dimensions more quickly, as they will reduce the time required to find suitable settings and decrease the number of trial runs. However, they cannot completely replace practical verification on the line, since the final MSR station values must still be confirmed through the actual operation of the machine and the execution of the prescribed tests.

• Ključne besede: tool qualification, pharmaceutical production, packaging line, blister pack, Master Shift Register, cross-validation, automated line.