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Dissertation
Analysis of incidents in the pharmaceutical industry
Authors: --- ---
Year: 2023 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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The manufacturing industry is challenged everyday by hazards which could lead to devastating consequences. Specifically, the pharmaceutical industry is under the spotlight in term of hazard assessment due to the nature of work involved, materials handled and quality of products. In order to address the workplace safety of the pharmaceutical industry, an analysis on previous accidents was done in this paper to serve as benchmarks and potential learning lessons to avoid future recurrences. The purpose of this study is not only to analyze the accidents which shook the industry but also to find the underlying root causes which are often disregarded by process hazard analysis techniques or by investigation reports. To address these concepts, a broad literature review was conducted on all hazard types which could be manifested in the pharmaceutical industry, along with the listing of widely renown events which occurred across several locations and timelines. My research continues by addressing the main causes as reported by global agencies and databases responsible for workplace safety such as OSHA, eMARS, Fiercepharma and so on. The analysis part began when I raised the purpose of the root cause analysis as a powerful technique to list all possible causes of an accident especially when combined with the Ishikawa Diagram which I also generated for each of the 3 accidents presented. Statistically, the leading cause of workplace accidents is the lack of hazard awareness by employees based on the reports available in the OSHA database in the range of 2002 to 2022. Based on my further analysis, even though the reported causes of certain explosions were reported as dust accumulation, leaks or overheating, underlying causes can be directed towards human behaviors resulting from the lack of hazard training and routine inspections. The final part is a brief introduction to the revolutionary concepts of Industry 4.0, Maintenance 4.0 and Pharma 4.0 where I explained the use of Digital Twins in the chemical industry and the possibility of integrating this concept in the pharmaceutical manufacturing. The purpose is not only to predict the exact maintenance period of equipment which result in optimized process but also the safety of employees due to the simulation of chemical reactions by varying chemicals, process parameters and conditions. Further research can address the lack of reporting on pharmaceutical manufacturing accidents and a feasibility study and framework on the applicability of digital twins in the pharmaceutical sector to reduce the frequency of accidents by increasing human awareness of hazards through simulations and predictive maintenance.

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Dissertation
Thermodynamics and Kinetics involved in Vapour Cloud Explosions
Authors: --- ---
Year: 2018 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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A vapour cloud explosion simply defined as an explosion occurring outdoors is the most dangerous and destructive explosions in the chemical process industries Some examples of vapour cloud explosions are the Fixlborough and Buncefield disasters. A vapour cloud explosion can also be defined as a combustion process, which under appropriate conditions may develop a huge explosion intensity and blast overpressure enough to cause a great amount of damage to the surrounding area. The mechanism of how a vapour cloud explosion occurs and how the initial conditions affect its development and how it can be prevented or mitigated can be understood by studying the phenomenon of combustion from the thermodynamics, kinetics and mass transfer point of view. Thermodynamics describes the equilibrium state of a chemical process and helps in predicting the final temperature and final composition. The final temperature and composition of the system depends on the initial conditions like pressure, temperature and the initial composition of the mixture. When it comes to combustion and vapour cloud explosions it helps in the prediction of the adiabatic flame temperature. The adiabatic flame temperature plays a huge role in the value of the flame speed which the combustion mixture can obtain and this flame speed in the most instances determines whether the flame will propagate or be extinguished or whether an explosion will actually occur. Chemical kinetics helps in determining the rate of the reaction which plays a prominent part in determining the value of flame speed obtained as faster the reaction rate, higher the flame speed and hence higher the probability of an explosion occurring. The important use of chemical kinetics is the help it provides in the determination of the reaction mechanism and exactly how the products are formed from the reactants by the determination of the various elementary reactions. The topic of mass transfer and transport properties helps in understanding why explosions can only occur when the fuel and the oxidiser are sufficiently mixed and hence why premixed combustion can lead to explosions and not non-premixed combustion. It also explains why and how the addition of inerts and inhibitors can successfully mitigate and prevent an explosion from occurring. It also helps in understanding the role turbulence plays when it comes to the occurrence of an explosion. The second part of the thesis is about the simulations performed in the Software Cantera. In the first part of the simulation of Methane combustion is carried out in Cantera for various initial conditions using the GRI Mech 3.0 reaction mechanism and the value of the flame speed and adiabatic flame temperature for these different initial conditions are computed and this gives us an insight into how the various initial conditions affect the flame propagation and contribute to an uncontrolled combustion process and in turn a vapour cloud explosion and how for some conditions the flame ends up being extinguished. In the second part the GRI Mech 3.0 model, modified to include the combustion chemistry for Sodium containing compounds is used for simulations and the results are compared with those of available experiments from literature in order to evaluate the ability of this model and the software Cantera to predict flame propagation and inhibition characteristics of hydrocarbon flames in the presence of Sodium containing compounds as inhibitors.

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Dissertation
Review of the passive fire protection requirements in Belgium, The Netherlands and France
Authors: --- ---
Year: 2021 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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At European level, fire safety legislation falls entirely within the competence of the Member States (MS), unlike the Construction Products Regulation and the harmonised Eurocodes. The consequence of this European approach has led to the development of different perspectives regarding fire safety legislation that are being used by the MS. On the other hand, fire safety legislation in each MS is being composed in a different way. Besides national regulations, fire safety legislation may be shaped on other levels as well such as on regional level, by the mayor on municipal level or by the fire department. Due to the shared objective of obtaining an adequate level of safety in all MS, and given that serious fire accidents have occurred in the recent past, the decentralised approach to fire safety has been criticised. In terms of the fire safety of buildings, one can say that the EU does not provide a comprehensive approach. The lack of a framework to address fire safety legislation in a harmonised manner is recognised, as well as the need to do so equally in all Member States. Secondly, a growing need for harmonious cooperation between MS, and the joint resolution of fire safety problems in buildings is tangible. This raises the question as to whether or not there is an overlap of fire safety legislation between the various MS and how the differences and similarities are reflected. In this research, an attempt is made to shed light on these unanswered questions. A comparative study between Belgium, The Netherlands and France will reveal the similarities and differences between these countries with the aim of encouraging the harmonisation of fire safety legislation of buildings on European level. The emphasis of the aspects examined is placed on the passive fire protection requirements with specific attention to compartmentation, evacuation and building elements such as structural elements, walls, (interior) doors, ceilings and facades. Increased risk profiles will not be included in this research. Specifically, this concerns schools, hospitals, industries, and underground car parks. On the basis of an analysis of the national legislation of these three countries, a comprehensive table was established for each country containing all passive fire protection requirements of buildings. Subsequently, an overall table was drawn up covering all three countries. The results show that there are large differences in the harmonisation of national fire safety legislation, that each country has a different classification, that the fire resistance values (REI values) are not uniquely used in countries and that differences exist between a comparative table across the three countries. The overall table shows that the emphasis is different across countries on certain aspects. Finally, the recommendations give a direction as to how harmonisation of fire safety legislation in Europe can be promoted. Remarkably, the shortcomings of the prescriptive approach, such as the over-regulation of some aspects, and the complicated explanations of some articles, become apparent here as well.

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Dissertation
Incidents with Ethylene Oxide and Related Derivatives: Lessons Learned
Authors: --- ---
Year: 2021 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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The aim of this project is divided in two sections. First, to investigate past incidents related with EO and its derivatives in order to obtain a series of lessons learned that will help prevent future accidents and, secondly, to focus on the Tarragona 2020 accident and summarise the two independent investigation reports that were done and evaluate their different conclusions.

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Dissertation
Use of OpenFOAM for Numerical Research on Vapor Cloud Explosions
Authors: --- ---
Year: 2021 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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Battery Energy Storage Systems (BESS) are containers that can store large amounts of energy and are of paramount importance for the industry, with major applications in the transportation, telecommunication and grid energy storage fields. However, recent accident examples indicate the risk associated with the high energy density of BESS, such as the fire at the power plant of Drogenbos (Belgium) in 2017. Failure of BESS can be caused by thermal runaway, which is the release of a significant amount of heat, and can lead to a fire or even an explosion, under certain conditions. The conditions that exist during a battery explosion can be simplified and represented in a first stage as a hydrogen explosion in an enclosed space containing obstacles. In this master thesis, a CFD simulation for this case is conducted using the OpenFOAM software. During the computational simulation, all the elements of the problem formulation are interlinked forming a network of parameters and models that have to be selected and defined appropriately to guarantee the accuracy of the results. The process involves thermophysical properties and modelling of turbulence and combustion which are the first parameters to be specified. Regarding the numerical part, discretization and numerical methods together with a grid dependency study are examined. The investigated explosion characteristics are the temperature, the pressure and the flame velocities. Moreover, a comparison of turbulence models is conducted, namely k-ε, k-ω and k-ω SSTLM models. The interpretation of the results is based on validation procedures which include comparison with literature studies and values obtained from three ignition points in the domain. The results are proved to be stable with varying initial turbulent values and numerical methods, whereas they are sensitive when laminar flame models and ignition parameters change. The simulation reveals convergence problems with small variations in the thermophysical values of verb|janaf| equation and the numerical parameters, as the timestep. The fields of the temperature and laminar flame velocity resulted overestimated in reference to literature studies, but two out of three ignition points showed consistent numerical values. The turbulent flame front followed the same pattern for the different ignition points and the maximum values were in the suggested bibliographic interval. As for the generated overpressure, three mixtures with different equivalence ratio were investigated and presented similar profiles with values close to the reference ones. Finally, the comparison of the turbulence models showed that k-ε and k-ω SSTLM converge for the temperature, the pressure and the laminar flame velocity, while k-ω model exhibits higher values. As a conclusive statement, the OpenFOAM software is a promising tool with elevated accuracy and large applicability, however the learning curve is steep due to the limited documentation.

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Dissertation
Development of a practical, integrated guideline for industrial safety studies in different stages of hydrogen production, transport and delivery projects
Authors: --- ---
Year: 2020 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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The last few years have witnessed an important societal evolution on the topics of climatic urgency and city pollution. In this context of energy transition, a promising technology is the storage of energy in the form of hydrogen. There are, however, safety concerns. In order to expand hydrogen technologies at a large scale and in densely populated areas, it is crucial to demonstrate that hydrogen can be mastered with the highest level of safety. Tractebel ENGIE and its Industrial Risk & Safety Management department, being involved in an increasing number of hydrogen projects, are developing a strategy aiming at integrating safety in a consistent and systematic way. This thesis provides a practical tool for supporting hydrogen projects: a comprehensive health & safety approach, defining which safety studies and HSE activities must be performed at each stage of the project, as well as practical guidance on how to perform these studies. This guidance is based on an analysis of: (1) the specificities of hydrogen installations; (2) the properties and hazards associated with hydrogen; (3) return of experience from past accidents; (4) requirements from legislation; and (5) guidance from standards as well as industry’s best practices. Among others, a risk matrix is developed for risk workshops (HAZID, HAZOP); a comprehensive list of guidewords and practical examples of hazards is gathered to help performing HAZID studies; a methodology for calculating safety distances is set up; and hydrogen specific considerations for performing Quantitative Risk Assessment are given. The array of safety studies discussed in this document provides a comprehensive coverage of the hazards and risks, and would allow reaching the desired high level of safety.

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Dissertation
Verschillende interpretaties van de regelgeving voor risicoanalyses van elektrische installaties
Authors: --- ---
Year: 2018 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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Het welzijn van werknemers tijdens het uitvoeren van hun werk is een belangrijk aspect in elke onderneming. Toch gebeuren er op de werkplaats nog steeds veel arbeidsongevallen. Het aantal arbeidsongevallen waarbij elektriciteit aan de basis ligt, is over de jaren heen zelfs toegenomen. Om deze stijgende trend een halt toe te roepen, is de verplichting tot het uitvoeren van een risicoanalyse op elke elektrische installatie in het leven geroepen. Ondanks de regelgeving omtrent elektrische installaties en veiligheid zijn er nog steeds onduidelijkheden en gevaren verbonden aan elektrische installaties die zouden vermeden kunnen worden. In dit werk worden de verschillende interpretaties van de regelgeving rond elektrische installaties en risicoanalyses onderzocht. Dit onderzoek gebeurt aan de hand van een analyse van verscheidene risicoanalyses. Deze bestudeerde risicoanalyses zijn uitgevoerd door verschillende organisaties en personen met elk een eigen systematiek. Deze analyse geeft de sterke en zwakke punten van alle bestudeerde risicoanalyses weer, als ook de knelpunten van de bestaande risicoanalyses. Uit de analyse kunnen verplichtingen en aandachtspunten opgesteld worden, die kunnen bijdragen tot het opstellen van een kwaliteitsvolle risicoanalyse voor elektrische installaties.

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Dissertation
De vorming tot Preventieadviseur Niveau 1: De verwachtingen van het curriculum volgens de chemische en farmaceutische industrie in België.
Authors: --- ---
Year: 2022 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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Titel 4 van boek II van de codex ove welzijn op het werk beschrijft de voorwaarden op vlak van een vorming tot preventieadviseur. Dit heeft betrekking tot zowel het niveau, de toelatingsvoorwaarden en de inhoudelijke aspecten van de vorming. Met de nota van juni 2021 wil men deze voorwaarden aanpassen en een eengemaakte vorming tot preventieadviseur bekomen. De vrees is dat de invoer van dit nieuwe voorstel de veiligheid in Belgische bedrijven in het gedrang zal brengen. Deze thesis heeft als doel de noden vanuit de industrie te capteren aangaande de kennis en vaardigheden van preventieadviseurs. De focus ligt hierbij op de vorming tot niveau I met betrekking tot de chemische en farmaceutische sector. De mening van preventieadviseurs en managers uit de industrie is verzameld aan de hand van een vragenlijst. Op basis van de antwoorden zijn een aantal conclusies getrokken met betrekking tot het curriculum. Een opsplitsing in opleidingsniveau is op basis van de antwoorden noodzakelijk. Een eenmaking van de vorming zal vooral de kwaliteit van het hoogste niveau aantasten, wat grote gevolgen kan hebben voor de veiligheid in hoogrisicosectoren zoals de chemische en farmaceutische industrie. Voor die sectoren hoort het niveau van kandidaat-preventieadviseurs op masterniveau te liggen. Deze op een lager niveau dan een master organiseren heeft enkele negatieve gevolgen voor zowel het kennisniveau van nieuwe preventieadviseurs als de aantrekkingskracht van de vorming naar hogere profielen toe. Om de kwaliteit van de vorming te garanderen moeten ook de toelatingsvoorwaarden streng genoeg zijn. Met een vorming op masterniveau ligt deze toelatingsvoorwaarde logischerwijs op in het bezit zijn van een professionele bachelor- of masterdiploma, bij voorkeur in een technische richting. Een lager toelatingsniveau zal het tempo en de diepgang van de vorming drastisch aantasten. Op vlak van invulling van de vorming wijzen de resultaten erop dat de praktijkgerichtheid van de vorming beter kan. Een stage en opdrachten gelinkt aan de industrie inpassen in de vorming kan hier een oplossing bieden, al is het essentieel dat men bij de uitwerking ervan een goede balans tussen theorie en praktijkgerichtheid vindt. Verder lijkt er een draagvlak te bestaan voor een sectorale benadering van de opleiding. In dit model wordt een basisvorming met belangrijke algemene aspecten rond welijn aangevuld met sectorspecifieke modules.

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Dissertation
Chemical exposure assessment in an academic research laboratory: measurements and predictions
Authors: --- --- ---
Year: 2021 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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The European Working Conditions Survey of 2017 reports an increasing trend of occupational exposure to hazardous substances. This includes a 3% increase in handling or being in skin contact with hazardous chemicals. Academic researchers describe chemical research laboratories as dynamic and high risk indoor spaces in which large amounts of hazardous matter is consumed. Organic solvents are the traditional medium in which organic synthesis is practiced. Estimates show that over 80% of the organic waste in synthetic chemistry is attributed to the use of organic solvents and most synthetic chemistry researchers are exposed to those solvents on a daily basis. Systemic health effects associated with exposures to carbon based solvents are of high concern. The Belgian codex on well-being at work requires the performance of chemical exposure assessments to assess the acceptability of risks associated with occupational exposure to hazardous chemicals. In academic research laboratories, qualitative risk assessments are typically performed to minimize risks. As organic synthesis laboratories handle large amounts of organic solvents, one may question the suitability of qualitative risk analyses in the context of chemical exposure. The European Chemicals Agency suggests a tiered approach to quantitatively predict exposure concentrations for different exposure routes. In this master thesis, an exposure measurement survey is performed to examine if the currently applied qualitative risk assessment approach is suitable to ensure acceptable exposures to organic solvents in an academic research laboratory setting. Both dermal and inhalation exposure routes are considered. Moreover, the applicability of chemical exposure assessment tools suggested by ECHA is evaluated. The predictive quality of the tools is examined by comparing the tool estimates with the measured concentrations. Analysis of volatile organic compounds showed that researchers of the organic synthesis laboratory under study are in particular exposed to 2-methylpentane, ethanol, acetone, ethyl acetate, ethyl ether, methylene chloride and toluene. Highest inhalation and dermal exposure concentrations are measured for acetone. All daily inhalation exposures are acceptable and the individual substance exposure concentrations are in compliance with their associated regulatory occupational exposure limits according to the statistical test described in the NBN EN 689 standard. In relation to dermal exposure, One-way ANOVA shows that the middle finger and thumb of the right hand are significantly higher exposed to ethanol and the middle finger of the left hand is significantly higher exposed to acetone compared to the concentrations measured on the neck, arm and wrist. Inhalation and dermal exposure estimates are derived for acetone, ethyl ether and methylene chloride. Overall, the exposure estimates are less conservative. However, based on the measured concentrations, ART allows for a Bayesian update of the estimates. In addition, 8-hour TWA estimates of ART can consider up to four different exposure scenarios. This way, the tool can take into account the dynamic nature of the academic research environment. As a result, ART is suggested to complement the qualitative risk assessment approach of the organic synthesis laboratory.

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Dissertation
Analysis of casualties and effect distances in the Seveso industry
Authors: --- ---
Year: 2022 Publisher: Leuven KU Leuven. Faculteit Ingenieurswetenschappen

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The Seveso directive was introduced in 1976 to improve the safety in the industry with dangerous substances. Reports on incident investigation have been listed in a general database to learn from previous incidents. The origins of incident investigations was discussed in the first section. The specific role of safety barriers was explained using Bellamy’s bow-tie model. As an example, the explosion at a chemical plant in Tarragona was thoroughly investigated using the barrier-based systematic cause analysis technique. Since this is not the only fatal incident in the Seveso industry, an analysis of the implementation of the Seveso III directive was performed. From the implementation, all reports in the eMARS database since 2000 were exam- ined in detail in the second part. The content and the parameters of the database were explained. The database was separated into its three event types: ’Major Acci- dent’, ’Near miss’ and ’Other Event’. Each event type could then be further separated based on the Seveso status of the establishments where an accident occurred. Most attention is paid to the analysis of major accident reports as those account for 80% of all reports. Most major accidents occurred in the ’General chemicals manufacture’ industry, followed by the ’Petrochemical / oil refineries’ industry and the ’Processing of metal’ industry. The first two industries account for 50% of the fatalities in upper tier establishments. They also have the most ’Near Miss’ and ’Other Event’ reports and account for the majority of injuries and fatalities together with the ’Chemical installations’ industry. A few incidents with off-site effects were observed during the analysis and most are briefly mentioned. The on-site lethality of major accidents in the different industries was calculated as the number of injuries divided by the number fatalities, meaning that a higher percentage is related to a lower lethality. Surprisingly, the lethality for incidents in lower tier establishments was higher than for upper tier establishments.

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