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Fill-finish of parenteral formulations represents a crucial step in the pharmaceutical industry that necessitates careful monitoring of product stability down the line. Shear stress and interfacial stress are two elements that threaten product stability, the respective contributions of which are still up for debate. This article focuses on the analysis of shear stress in the sampling phase of the filling line. Specifically, Computational Fluid Dynamics (CFD) simulations were employed to determine the shear stress distribution experienced by a protein-based parenteral drug as it passes through sampling fittings of various shapes under laminar and turbulent regime conditions. Rather than seeking the specific mechanism triggering the destabilization of a product, an attempt was made to analyze the fluid dynamics within these fittings and offer further understanding of the resulting shear stress. In addition, information was collected on the product path within the fittings, which allowed the identification of equations suitable for describing the shear stress distribution. The proposed approaches made it possible to consider the actual flowrate subjected to a given shear stress at a given time. Finally, a comparison was drawn with respect to the fluid dynamics within classical straight tubing to outline differences. This study revealed that the shear stress experienced within the fittings was higher than that in the tubing. Moreover, significant differences were reported in the T-fitting case under turbulent conditions.

Parenteral products appear to be sensitive to process conditions in bioprocessing steps, such as interfacial stress and shear stress. The combination of these elements is widely believed and proven to influence product stability, but the defined roles of these players in the product damage process have not yet been identified. The present work addresses a current industrial problem, by focusing on the analysis of shear stress on protein-based therapeutics flowing in tubing by means of Computational Fluid Dynamics simulations. The purpose of this article is not to pinpoint the mechanism triggering the damage of the product, but it represents the first step towards wider experimental investigations and introduces a new strategy to quantify the average shear stress. The field of scale-down approaches, used to scale the commercial process down to the laboratory level, is also explored. Since quality control is critical in the pharmaceutical realm, it is essential that the scale-down approach preserves the same stress exposure as the commercial scale, which in the present work is considered to be that resulting from shear effects. Therefore, a new approach for scaling down the commercial process is proposed, which has been compared with traditional approaches and shown to provide greater representativeness between the two scales.

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Diplomska naloga opisuje načrtovanje mehanskega dela podajanja sveč ter izdelavo krmilnega programa na polnilni liniji podjetja Orodjarstvo Jelenko. V diplomski nalogi je podan opis danih zahtev ter idejna zasnova podajanja sveč. Mehanska zasnova podajanja je prikazana s pomočjo CAD modela, ki je modeliran s pomočjo programa Solid Works. Gibalni sistem je izveden s pomočjo pnevmatskih valjev, ki so krmiljeni s Siemensovim krmilnikom. Program za krmiljenje pnevmatskih valjev, motorjev ter senzorjev je napisan v programskem orodju Tia portal. Pnevmatski sistem je prikazan s pnevmatsko shemo. Izdelana simulacija delovanja pnevmatske sheme je predstavljena s programom Festo Fluidsim. The dissertation describes the design of the mechanical part of the candles feed as well as the production of a control program on the filling line of the tool company Jelenko. The diploma thesis provides a description of the given requirements and the conceptual design of the candles feed. The mechanical scheme of the feed is shown using a CAD model, modelled on the computer program Solid Works. The movement system is made using pneumatic cylinders controlled by the Siemens controller. The program for controlling pneumatic cylinders, motors and sensors is written with the software tool Tia Portal. The pneumatic system is shown with a pneumatic scheme, of which the simulated operation is displayed with the Festo Fluidsim program.

Diplomsko delo obravnava velikostno in modularno gradnjo v polnilni liniji. V uvodnem delu je predstavljena zgodovina delovnega okolja. Sledi predstavitev teorije s področja modularne in velikostne gradnje. Osrednji del diplomskega dela obsega načrtovanje in analizo modularnega gradnika podporne noge, ki je najpogostejši gradnik v večini polnilnih linij. Pri modeliranju je uporabljen program SolidWorks, za analizo modularnega gradnika pa programski orodji CreoParametric in CreoSimulate. Analizirana je trdnostna ustreznost, faktor varnosti pri predvideni maksimalni obremenitvi in možnost pocenitve gradnika. Analiziran modularni gradnik podporne noge je ustrezen za nadaljnjo velikostno gradnjo in je predimenzioniran. The diploma thesis deals with size and modular construction in a filling line. The introductory part, which presents the working environment history, is followed by theories concerning modular and size construction. The main part of the diploma thesis focuses on the planning and analysis of the modular element of a support leg, being the most common part in various filling lines. The SolidWorks program is used for modelling, whereas the software tools CreoParametric and CreoSimulate are helpful when analysing the modular element. Moreover, the thesis includes an analysis of strength specifications (suitability) as well as safety factors when operating at the estimated maximum capacity. Also mentioned is the possibility of reducing the price of the element. The analysed modular element of the support leg is suitable for further size construction and is predimensioned.

Due to the presence of moisture and nutrients, brewery filling line surfaces are susceptible to unwanted microbial attachment. Knowledge of the attaching microbes will aid in designing hygienic control of the process. In this study the bacterial diversity present on brewery filling line surfaces was revealed by next generation sequencing. The two filling lines studied maintained their characteristic bacterial community throughout three sampling times (13-163 days). On the glass bottle line, γ-proteobacteria dominated (35-82% of all OTUs), whereas on the canning line α-, β- and γ-proteobacteria and actinobacteria were most common. The most frequently detected genera were Acinetobacter, Propinobacterium and Pseudomonas. The halophilic genus Halomonas was commonly detected, which might be due to its tolerance to alkaline foam cleaners. This study has revealed a detailed overall picture of the bacterial groups present on filling line surfaces. Further effort should be given to determine the efficacy of washing procedures on different bacterial groups.

V podjetju Vipoll smo zasnovali polnilno linijo za stekleno embalažo. Polnilna linija je zasnovana iz veliko različnih segmentov. Posebna pozornost je namenjena transporterjem embalaže. Po pregledu zasnove polnilne linije je ugotovljen del v katerem je potrebno zagotoviti dodatno možnost za zalogo embalaže. V ta del polnilne linije se je vključila bočna zalogovna miza s katero smo bistveno vplivali na kapaciteto polnilne linije. V zadnjem delu diplomskega dela je predstavljeno krmiljenje polnilne linije, kajti vsa polnilna linija je avtomatsko krmiljena. The company Vipoll has designed a filling line for glass containers consisting of various segments. Special attention was given to container conveyors. After checking the concept of the filling line, we determined the part where additional container supply is needed. Thus, a side buffer table was included greatly influencing the filling line capacity. The final part of the diploma thesis discusses the controlling of the filling line since the complete line is operated automatically.

Diplomsko delo Preračun transportne naprave opisuje načrtovanje in preračun členkastega transporterja. Na začetku diplomskega dela je uvod, v katerem so opisani namen, cilji in zahteve diplomskega dela. Temu sledi opis transportnih naprav. Glede na podane robne pogoje, ki so določeni od ostalih naprav, lahko izračunamo potrebno moč pogonskega motorja za transporter. Za konec diplomskega dela smo še modelirali transportno napravo s pomočjo programskega paketa Creo Parametric 2.0. Bistveno pri modeliranju je bilo sestavljanje pogonske enote in sestava vseh standardnih delov. Transporter je narejen tako, da prejema večje število steklenic in jih razvrsti v vrsto eno za drugo. Celotno diplomsko delo je bilo opravljeno v okviru praktičnega usposabljanja v podjetju ICS d.o.o. The diploma thesis Calculation of conveyor system, describes a designing and calculating the articulated conveyor. At the beginning of the thesis is the introduction, which describes the purpose, objectives and requirements of the thesis. This is followed by a description of the transport devices. According to the given boundary conditions, which are determined from other transport devices we can calculate the required power needed by the electric motor of the conveyor. At the end of the thesis, we have modeled the transport device using the software package Creo Parametric 2.0. It is essential for modeling the assembly of the drive unit and the composition of standard parts. Conveyor is designed to receive a greater number of bottles and placing them in series of one for the other. The entirte diploma thesis was conducted within the practical training at the company ICS d.o.o.

V diplomskem delu je predstavljena rekonstrukcija obstoječe transportne linije za transport PET steklenic. Namen rekonstrukcije transportne linije je ta, da se poveča akumulacijski prostor med polnilnim in etiketirnim strojem oziroma, da se poveča akumulacijski čas med polnilnim in etiketirnim strojem, ki je dandanes pomemben dejavnik v proizvodnem procesu. V uvodnih poglavjih so predstavljene vrste akumulacijskih transporterjev steklenic s katerimi dozežemo povečanje akumulacije, ter s tem tudi vrste verig. V osrednjem delu so prikazani preračuni obstoječega in rekonstrukcijskega stanja transportne linije. V zaključnem delu diplomskega dela je predstavljena ocena in vrednotenje uspešnosti učinkov. In this thesis is presented the reconstruction of the existing transport line for the transportation of PET bottles. The purpose of the reconstruction of the transport line is to increase the accumulation space between the filling and labeling machine or to increase the accumulation time between the filling and labeling machine, which is an important factor in the production process. In the introductory chapters are presented the types of accumulation transporters of bottles, with which we achieve an increase in accumulation, and with this also the types of chains. In the main part are presented the calculations of the existing and reconstruction state of the transport line. In the final part of the thesis is presented the rating and evaluation of the performance effects.

Diplomsko delo obsega področje uporabe avtomatizacije v svetu polnjenja pijač. Predstavljena je polnilna linija za polnjenje steklenic.Sestavlja jo pralni stroj, polnilnik, zapiralnik, etiketirka in paketirnik.Vsi ti bloki so med seboj povezani s transportnimi traki.V delu smo se posebej posvetili izdelavi polnilno-zapiralnega bloka. Napisali smo program za krmiljenje stroja in izdelali čimbolj pregleden grafični vmesnik . The diploma thesis contains the scope of automation in the area of beverage filling. This work presents accordingly a beverage filling line. A washing machine is also a fundamental part of it as well as a palletizer, a sealing device, a labeler and a packer. All blocks are interlinked with the help of conveyor belts. At work, we addressed ourselves particularly to the production processes of a filling-closure-block. We wrote a program to work a machine like this and devised an clearly understandable graphic illustration.

Za doseganje optimalne proizvodnje, podjetja vlagajo sredstva v razvoj in nabavo sodobne opreme ter komponent. Zaradi nepravilne montaže, uporabe ali drugih, velikokrat čisto banalnih razlogov, pa lahko sicer zelo dobre komponente v danem postrojenju ne opravljajo svoje funkcije na nivoju, za katerega so bile konstruirane in izdelane. Tej problematiki je posvečeno tudi pričujoče diplomsko delo. Kratkemu uvodu in opisu obstoječega stanja, sledi opis problema in cilji naloge. V nadaljevanju je opisan obravnavan sistem in posamezne komponente. Poseben poudarek je na meritvah, ki so se izvajale ne terenu, saj so bili izsledki in ugotovitve odločujočega pomena za reševanje problematike in podajo rešitev, ki sledijo na koncu. In order to achieve optimal level of production, companies invest their funds in development and purchase of modern equipment and components. Due to improper installation, improper use or other often banal reasons, high quality components can also fail to fulfill their function in a given system on the level for which they were constructed and manufactured. This issue is addressed in the presented diploma thesis. First there is a short introduction and the description of the present state, followed by the description of the problem and the presentation of the diploma thesis goals. In continuation the discussed system and individual components are described. Strong emphasis is given on measurements that were carried out in the field as the results were of deciding importance for problem solving and solution suggestions, described at the end.

Industrija polnjenja pijač je ena najpomembnejših industrij sveta. V podjetju ICS, d. o. o., ki se že več kot dvajset let ukvarja predvsem z izdelavo polnilnih linij za plastenke in steklenice, smo se odločili, da zasnujemo sodobno polnilno linijo. Polnilna linija bo namenjena za polnjenje plastenk. Sestavlja jo pihalnik, izpiralnik, polnilnik, zapiralnik, etiketirka in paketirka. Ti osnovni bloki so med seboj povezani s transporterji. V delu smo se še posebej posvetili modeliranju izpiralno-polnilno-zapiralnega bloka, ki je najpomembnejši del polnilne linije. V okviru tega bloka smo na NC stroju izdelali tudi vodilo za zapiralne glave, ki smo ga doslej izdelovali ročno. Na ta način smo odpravili dosedanje težave v proizvodnem procesu. The bottling industry is one of the most important industries in the world. The company ICS, d. o. o., that has over twenty years of experience in mainly producing bottling lines for plastic and glass bottles, decided to design a modern bottling line. The bottling line will be used for filling plastic bottles. It consists of blowers, rinsing machines, closing machines, labeling machines and packaging machines. These main components are connected with conveyors. During the working process, we paid special attention to the designing of the rinsing-filling-closing component, which is the most important part of the bottling line. As a part of this component we also produced closing heads, with an NC machine, which were hand-made until now. This way we got rid of previous problems in the production process.

V diplomskem delu je realiziran projekt za avtomatizacijo transportnih trakov polnilne linije. Opisan je proces transporta steklenic po transportnih trakovih od začetka do konca polnilne linije. Predstavljeni so gradniki, ki so potrebni za delovanje celotnega avtomatiziranega sistema transportnih trakov polnilne linije. Narejena je rešitev postopka programiranja in vizualizacije transportnih trakov s programskim paketom B&R. This thesis is a realization of a plan for the automatisation of conveyor belts for the filling line. It includes the process description of the bottle transportation on conveyor belts from the beginning, until the end of the filling line. All the parts, which are necessary for the whole working of the automised conveyor belts system for the filling line, are presented. A solution for the programming process and the visualization of the conveyor belts is made with the programming package B&R.