Search results for: sterility and safety in pharmaceutical development

Authors: Geremew Geidare Kailo, Igor Gáspár, András Koris, Ivana Pajčin, Flóra Vitális, Vanja Vlajkov

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Three-dimension (3D) printing, a very popular additive manufacturing technology, has recently undergone rapid growth and replaced the use of conventional technology from prototyping to producing end-user parts and products. The 3D Printing technology involves a digital manufacturing machine that produces three-dimensional objects according to designs created by the user via 3D modeling or computer-aided design/manufacturing (CAD/CAM) software. The most popular 3D printing system is Fused Deposition Modeling (FDM) or also called Fused Filament Fabrication (FFF). A 3D-printed object is considered food safe if it can have direct contact with the food without any toxic effects, even after cleaning, storing, and reusing the object. This work analyzes the processing timeline of the filament (material for 3D printing) from unboxing to the extrusion through the nozzle. It is an important task to analyze the growth of bacteria on the 3D printed surface and in gaps between the layers. By default, the 3D-printed object is not food safe after longer usage and direct contact with food (even though they use food-safe filaments), but there are solutions for this problem. The aim of this work was to evaluate the 3D-printed object from different perspectives of food safety. Firstly, testing antimicrobial 3D printing filaments from a food safety aspect since the 3D Printed object in the food industry may have direct contact with the food. Therefore, the main purpose of the work is to reduce the microbial load on the surface of a 3D-printed part. Coating with epoxy resin was investigated, too, to see its effect on mechanical strength, thermal resistance, surface smoothness and food safety (cleanability). Another aim of this study was to test new temperature-resistant filaments and the effect of high temperature on 3D printed materials to see if they can be cleaned with boiling or similar hi-temp treatment. This work proved that all three mentioned methods could improve the food safety of the 3D printed object, but the size of this effect variates. The best result we got was with coating with epoxy resin, and the object was cleanable like any other injection molded plastic object with a smooth surface. Very good results we got by boiling the objects, and it is good to see that nowadays, more and more special filaments have a food-safe certificate and can withstand boiling temperatures too. Using antibacterial filaments reduced bacterial colonies to 1/5, but the biggest advantage of this method is that it doesn’t require any post-processing. The object is ready out of the 3D printer. Acknowledgements: The research was supported by the Hungarian and Serbian bilateral scientific and technological cooperation project funded by the Hungarian National Office for Research, Development and Innovation (NKFI, 2019-2.1.11-TÉT-2020-00249) and the Ministry of Education, Science and Technological Development of the Republic of Serbia. The authors acknowledge the Hungarian University of Agriculture and Life Sciences’s Doctoral School of Food Science for the support in this study

Keywords: food safety, 3D printing, filaments, microbial, temperature

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Authors: M. Brockes, S. Beck, A. Sigaroudi, C. Brockes

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Over the last years, telemedicine and telemonitoring have become a popular way of treatment, especially in other chronic diseases. Therefore this type of treatment methodology was also implemented in interstitial lung disease (ILD) patients. In January 2024, a new service for patients with interstitial lung disease (ILD) treated with Nintedanib was established, which contains daily telemonitoring (home spirometry, pulse oximetry, and daily level of activity), daily evaluation of parameters as well as a telemedical availability answered by doctors and telemedical specialists throughout 365 days per year. The main motivational points of this service are the early detection of first signs of exacerbations and/or other symptoms/complications as well as easier access to healthcare professionals. The evaluation of the patient’s quality of life and the subjective feeling of safetyness was measured through patient reported experience measurements (PREMs) and patient reported outcome measurements (PROMs). Patients were introduced to the telemedical and telemonitoring service six-months ago. Within this period, every sixty days, the questionnaires were conducted by the scientific employees. Due to the unlimited time frame of the long-term service the evaluation is not completed. The first analysis of patient reported experience measurements (PREMs) and patient reported outcome measurements (PROMs) have shown an increased positive effect on the patients' quality of life as well as an increased positive effect on the subjective feeling of safety at home, plus a reduction and avoidance of secondary damages (e.g., exacerbations, deterioration of typical interstitial lung disease ILD symptoms and pharmaceutical side effects). The first results have shown a tendency that the telemedical treatment combined with telemonitoring at home and the encouragement of patients to actively participate in their healthcare has a positive effect on the patient’s overall well-being and could be implemented as a complementation of the traditional standard of care.

Keywords: avoidance of secondary damages, interstitial lung disease, telemedicine and telemonitoring, subjective feeling of safety

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Authors: Hyeon-Kyo Lim, Tong-Il Jang, Yong-Hee Lee

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For an operator in a nuclear power plant, human error is one of the most dreaded factors that may result in unexpected accidents. The possibility of human errors may be low, but the risk of them would be unimaginably enormous. Thus, for accident prevention, it is quite indispensable to analyze the influence of any factors which may raise the possibility of human errors. During the past decades, not a few research results showed that performance of human operators may vary over time due to lots of factors. Among them, stress is known to be an indirect factor that may cause human errors and result in mental illness. Until now, not a few assessment tools have been developed to assess stress level of human workers. However, it still is questionable to utilize them for human performance anticipation which is related with human error possibility, because they were mainly developed from the viewpoint of mental health rather than industrial safety. Stress level of a person may go up or down with work time. In that sense, if they would be applicable in the safety aspect, they should be able to assess the variation resulted from work time at least. Therefore, this study aimed to compare their applicability for safety purpose. More than 10 kinds of work stress tools were analyzed with reference to assessment items, assessment and analysis methods, and follow-up measures which are known to close related factors with work stress. The results showed that most tools mainly focused their weights on some common organizational factors such as demands, supports, and relationships, in sequence. Their weights were broadly similar. However, they failed to recommend practical solutions. Instead, they merely advised to set up overall counterplans in PDCA cycle or risk management activities which would be far from practical human error prevention. Thus, it was concluded that application of stress assessment tools mainly developed for mental health seemed to be impractical for safety purpose with respect to human performance anticipation, and that development of a new assessment tools would be inevitable if anyone wants to assess stress level in the aspect of human performance variation and accident prevention. As a consequence, as practical counterplans, this study proposed a new scheme for assessment of work stress level of a human operator that may vary over work time which is closely related with the possibility of human errors.

Keywords: human error, human performance, work stress, assessment tool, time-variant, accident prevention

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Authors: Tommaso Adamo, Gianpaolo Ghiani, Antonio Domenico Grieco, Emanuela Guerriero

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Batch production plants provide a wide range of scheduling problems. In pharmaceutical industries a batch process is usually described by a recipe, consisting of an ordering of tasks to produce the desired product. In this research work we focused on pharmaceutical production processes requiring the culture of a microorganism population (i.e. bacteria, yeasts or antibiotics). Several sources of uncertainty may influence the yield of the culture processes, including (i) low performance and quality of the cultured microorganism population or (ii) microbial contamination. For these reasons, robustness is a valuable property for the considered application context. In particular, a robust schedule will not collapse immediately when a cell of microorganisms has to be thrown away due to a microbial contamination. Indeed, a robust schedule should change locally in small proportions and the overall performance measure (i.e. makespan, lateness) should change a little if at all. In this research work we formulated a constraint programming optimization (COP) model for the robust planning of antibiotics production. We developed a discrete-time model with a multi-criteria objective, ordering the different criteria and performing a lexicographic optimization. A feasible solution of the proposed COP model is a schedule of a given set of tasks onto available resources. The schedule has to satisfy tasks precedence constraints, resource capacity constraints and time constraints. In particular time constraints model tasks duedates and resource availability time windows constraints. To improve the schedule robustness, we modeled the concept of (a, b) super-solutions, where (a, b) are input parameters of the COP model. An (a, b) super-solution is one in which if a variables (i.e. the completion times of a culture tasks) lose their values (i.e. cultures are contaminated), the solution can be repaired by assigning these variables values with a new values (i.e. the completion times of a backup culture tasks) and at most b other variables (i.e. delaying the completion of at most b other tasks). The efficiency and applicability of the proposed model is demonstrated by solving instances taken from Sanofi Aventis, a French pharmaceutical company. Computational results showed that the determined super-solutions are near-optimal.

Keywords: constraint programming, super-solutions, robust scheduling, batch process, pharmaceutical industries

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Authors: Jose A. Romero, Frank Otremba, Alejandro A. Lozano-Guzman

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Road safety is affected by many factors, involving the vehicle, the infrastructure, and the environment. Many efforts have been thus made to improve road safety through rational standards for the different systems involved in freight transportation. Cargo shifting and falling have been recognized as critical and contributive effects for road crashes. To avoid such situations, regional and international standards have been implemented, aiming to prevent such types of cargo-related accidents. In particular, there are specific compulsory standard requirements to maintain the cargo on the vehicle without shifting, when the vehicle performs an emergency braking maneuver. In this paper, a simulation is presented to analyze the effect of the vibration of the cargo on the braking distance of the vehicle. Such vibration can lead to a poor cargo restraining, and higher braking efficiency, as a result of the decoupling of the cargo mass from the vehicle mass. Such higher braking efficiency, on the order of 4.4%, further suggests a greater demand for the current braking standards.

Keywords: road safety, cargo securement, shifting cargo, vehicle dynamics, ABS

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Authors: Nick Woodier, Iain Moppett

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Background: It is estimated that one in ten patients admitted to hospital will suffer an adverse event in their care. While the majority of these will result in low harm, patients are being significantly harmed by the processes meant to help them. Healthcare, therefore, seeks to make improvements in patient safety by taking learning from other industries that are perceived to be more mature in their management of safety events. Of particular interest to healthcare are ‘near misses,’ those events that almost happened but for an intervention. Healthcare does not have any guidance as to how best to manage and learn from near misses to reduce the chances of harm to patients. The authors, as part of a larger study of near-miss management in healthcare, sought to learn from the UK nuclear sector to develop principles for how healthcare can identify, report, and learn from near misses to improve patient safety. The nuclear sector was chosen as an exemplar due to its status as an ultra-safe industry. Methods: A Grounded Theory (GT) methodology, augmented by a scoping review, was used. Data collection included interviews, scenario discussion, field notes, and the literature. The review protocol is accessible online. The GT aimed to develop theories about how nuclear manages near misses with a focus on defining them and clarifying how best to support reporting and analysis to extract learning. Near misses related to radiation release or exposure were focused on. Results: Eightnuclear interviews contributed to the GT across nuclear power, decommissioning, weapons, and propulsion. The scoping review identified 83 articles across a range of safety-critical industries, with only six focused on nuclear. The GT identified that nuclear has a particular focus on precursors and low-level events, with regulation supporting their management. Exploration of definitions led to the recognition of the importance of several interventions in a sequence of events, but that do not solely rely on humans as these cannot be assumed to be robust barriers. Regarding reporting and analysis, no consistent methods were identified, but for learning, the role of operating experience learning groups was identified as an exemplar. The safety culture across nuclear, however, was heard to vary, which undermined reporting of near misses and other safety events. Some parts of the industry described that their focus on near misses is new and that despite potential risks existing, progress to mitigate hazards is slow. Conclusions: Healthcare often sees ‘nuclear,’ as well as other ultra-safe industries such as ‘aviation,’ as homogenous. However, the findings here suggest significant differences in safety culture and maturity across various parts of the nuclear sector. Healthcare can take learning from some aspects of management of near misses in nuclear, such as how they are defined and how learning is shared through operating experience networks. However, healthcare also needs to recognise that variability exists across industries, and comparably, it may be more mature in some areas of safety.

Keywords: culture, definitions, near miss, nuclear safety, patient safety

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Authors: Shabnum Shaheen, Nida Haroon, Farah Khan, Sumera Javad, Mehreen Jalal, Samina Sarwar

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Coffee Senna is pharmaceutically very important and used for multiple health disorders such as gastric pains, indigestion, snakebites, asthma and fever, tuberculosis and menstrual problems. However, its immense medicinal value and great demand lead to adulteration issue which could be injurious for users. Some times its adulterant Seena weed (Senna occidentalis L.) is used as its substitute which definitely not as effective as Coffee Senna. Hence, the present study was undertaken to provide some tools for systematic and pharmaceutical authentication of a shrubby plant Coffee Senna (Cassia occidentalis Linn.). These parameters included macro and micro morphological characters, anatomical and palynomorph characterization, solubility, fluorescence and phytochemical analysis. By the application of these parameters acquired results revealed that, these two plants are distinct from each other. The Coffee Seena was found to be an annual shrub with trilobed pollen, diacytic, paracytic and anisocytic stomata whereas the Seena weed stands out as an annual or perennial herb with spheroidal and circular pollen and paracytic type of stomata. The powdered drug of Coffee seena is dark grayish green whereas the powdered drug of Seena weed is light green in color. These findings are constructive in authentic identification of these plants.

Keywords: coffee senna, Senna weed, taxonomic evaluation, pharmaceutical markers

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Authors: Ma Chaoyang

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With the acceleration of urbanization, old communities are facing renewal problems such as an aging material environment, declining living quality, and insufficient resilience. The once glorious old communities have become the most vulnerable areas in the city. Through a re-understanding of the ‘disaster chain’ and resilient communities, it is believed that considering the construction of resilient communities during community renewal is of great significance for promoting the sustainable development of communities. This article proposes renewal strategies for old communities based on the concept of preventing the occurrence of disaster chains. After analyzing the main demand characteristics of old communities, it proposes a reflection on improving community spatial safety resilience based on the ‘broken chain’ concept. In the four stages of ‘pre-disaster, mid-disaster, and post-disaster’, it elaborates that considering the occurrence of disaster chain in community renewal is the main content of research on spatial safety resilience construction and clarifies that community resilience is the idea and principle of responding with the process of disaster chain. The study focuses on the four dimensions of ‘pre-disaster, mid-disaster, and post-disaster’. This can provide ideas and references for resilience construction in community updates.

Keywords: community updates, disaster chain concept, community resilience, space environment

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Authors: Tharwat Girgis Farag Girgis

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The link between development and human rights has long been the subject of scholarly debate. As a result, a number of principles have been adopted, from the right to development to the human rights-based development approach, to understand the dynamics between the two concepts. Despite the initiatives taken, the exact relationship between development and human rights remains unclear. However, the rapprochement between the two concepts and the need for development efforts regarding human rights have increased in recent years. On the other hand, the emergence of sustainable development as an acceptable method in development goals and policies makes this consensus even more unstable. The place of sustainable development in the legal debate on human rights and its role in promoting sustainable development programs require further research. Therefore, this article attempts to map the relationship between development and human rights, with particular emphasis on the place given to sustainable development principles in international human rights law. It will continue to investigate whether it recognizes sustainable development rights. The article will therefore give a positive answer to question mentioned here. The jurisprudence and interpretive guidelines of human rights institutions travel to confirm this hypothesis.

Keywords: sustainable development, human rights, the right to development, the human rights-based approach to development, environmental rights, economic development, social sustainability human rights protection, human rights violations, workers’ rights, justice, security

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Authors: Suraiya Abdul Rahman, Perasna M. Varma, Amrahi Buang, Zhari Ismail, Wan Rosalina W. Rosli, Ahmad Rashidi M. Tahir

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Background: Muslims has the obligation to ensure that everything they consume including medicines should be halal. With the growing demands for halal medicines in October 2012, Malaysia has launched the world's first Halal pharmaceutical standards called Malaysian Standard MS 2424:2012 Halal Pharmaceuticals-General Guidelines to serve as a basic requirement for halal pharmaceuticals in Malaysia. However, the biggest challenge faced by pharmaceutical companies to comply is finding the origin or source of the ingredients and determine their halal status. Aim: This study aims to determine the halal status of the antineoplastic and immunomodulating agents, and nutritional and dietary supplements by analysing the origin of their active pharmaceutical ingredients (API) and excipients to provide an insight on the common source and halal status of pharmaceutical ingredients and an indication on adjustment required in order to be halal compliance. Method: The ingredients of each product available in a government hospital in central of Malaysia and their sources were determined from the product package leaflets, information obtained from manufacturer, reliable websites and standard pharmaceutical references. The ingredients were categorised as halal, musbooh or haram based on the definition set in MS2424. Results: There were 162 medications included in the study where 123 (76%) were under the antineoplastic and immunomodulating agents group, while 39 (24%) were nutritional and dietary supplements. In terms of the medication halal status, the proportion of halal, musbooh and haram were 40.1% (n=65), 58.6% (n=95) and 1.2% (n=2) respectively. With regards to the API, there were 89 (52%) different active ingredient identified for antineoplastic and immunomodulating agents with the proportion of 89.9% (n=80) halal and 10.1% (n=9) were mushbooh. There were 83 (48%) active ingredient from the nutritional and dietary supplements group with proportion of halal and masbooh were 89.2% (n=74) and 10.8% (n=9) respectively. No haram APIs were identified in all therapeutic classes. There were a total of 176 excipients identified from the products ranges. It was found that majority of excipients are halal with the proportion of halal, masbooh and haram were at 82.4% (n=145), 17% (n=30) and 0.6% (n=1) respectively. With regards of the sources of the excipeints, most of masbooh excipients (76.7%, n = 23) were classified as masbooh because they have multiple possible origin which consist of animals, plant or others. The remaining 13.3% and 10% were classified as masbooh due to their ethanol and land animal origin respectively. The one haram excipient was gelatine of bovine-porcine origin. Masbooh ingredients found in this research were glycerol, tallow, lactose, polysorbate, dibasic sodium phosphate, stearic acid and magnesium stearate. Ethanol, gelatine, glycerol and magnesium stearate were the most common ingredients classified as mushbooh. Conclusion: This study shows that most API and excipients are halal. However the majority of the medicines in these products categories are mushbooh due to certain excipients only, which could be replaced with halal alternative excipients. This insight should encourage the pharmaceutical products manufacturers to go for halal certification to meet the increasing demand for Halal certified medications for the benefit of mankind.

Keywords: antineoplastic and immunomodulation agents, halal pharmaceutical, MS2424, nutritional and dietary supplements

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Authors: Hussein Lujuo Mohamed

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Introduction: Public health has always been influenced by climate and weather. Changes in climate and climate variability, particularly changes in weather extremes affect the environment that provides people with clean air, food, water, shelter, and security. Tanzania is not an exception to the threats of climate change. The health sector is mostly affected due to emergence and proliferation of infectious diseases, thereby affecting health of the population and thus impacting achievement of sustainable development goals. Methodology: A desk review on documented issues pertaining to climate change and health in Tanzania was done using Google search engine. Keywords included climate change, link, health, climate initiatives. In cases where information was not available, documents from Ministry of Health, Vice Presidents Office-Environment, Local Government Authority, Ministry of Water, WHO, research, and training institutions were reviewed. Some of the reviewed documents from these institutions include policy brief papers, fieldwork activity reports, training manuals, and guidelines. Results: Six main climate resilience activities were identified in Tanzania. These were development and implementation of climate resilient water safety plans guidelines both for rural and urban water authorities, capacity building of rural and urban water authorities on implementation of climate-resilient water safety plans, and capacity strengthening of local environmental health practitioners on mainstreaming climate change and health into comprehensive council health plans. Others were vulnerability and adaptation assessment for the health sector, mainstreaming climate change in the National Health Policy, and development of risk communication strategy on climate. In addition information, education, and communication materials on climate change and to create awareness were developed aiming to sensitize and create awareness among communities on climate change issues and its effect on public health. Conclusion: Proper implementation of these interventions will help the country become resilient to many impacts of climate change in the health sector and become a good example for other least developed countries.

Keywords: climate, change, Tanzania, health

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Authors: Juliet Sorensen, Megan Schliep

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Introduction: After a multidisciplinary assessment of health and human rights issues in central Mali, a musical album was created in 2014 in Douentza, Mali to provide health information on female genital mutilation/cutting (FGM/C), malaria, HIV/AIDS, girls’ education, breastfeeding, and sanitation. The objective of this study was to assess the impact of this album. Methods: A mixed-methods assessment was conducted with 149 individuals across 10 villages in Douentza Cercle. Analyses focused on the association of radio listening habits, age, sex, ethnicity and education with a public health knowledge score. Results: Over 90% of respondents reported daily radio listening, many listening five or more hours per day. Potential risks of FGM/C cited by participants included death (59%), difficulty in childbirth (48%), sterility (34%), and fistula (33%); when asked about their level of control over FGM/C, 28% stated they would never cut their daughters. Being a listener for 1-5 hours per day was associated with a 11.5% higher score of 'public health knowledge' compared to those listening only a little or not at all (p < 0.01). Education (marginal versus no formal education) was associated with 7.6% increased score (p < 0.01). Conclusion: Radio appears to be a significant part of community members’ daily routines and may be a valuable medium for transmitting information, particularly for lower literacy individuals.

Keywords: female genital cutting, public health and social justice education, radio, Mali

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Authors: B. Zerouali, M. Kara, B. Hamaidi, H. Mahdjoub, S. Rouabhia

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In this paper, a safety analysis for crude oil tanks to prevent undesirable events that may cause catastrophic accidents. The estimation of the probability of damage to industrial systems is carried out through a series of steps, and in accordance with a specific methodology. In this context, this work involves developing an assessment tool and risk analysis at the level of crude oil tanks system, based primarily on identification of various potential causes of crude oil tanks fire and explosion by the use of Fault Tree Analysis (FTA), then improved risk modelling by Bayesian Networks (BNs). Bayesian approach in the evaluation of failure and quantification of risks is a dynamic analysis approach. For this reason, have been selected as an analytical tool in this study. Research concludes that the Bayesian networks have a distinct and effective method in the safety analysis because of the flexibility of its structure; it is suitable for a wide variety of accident scenarios.

Keywords: bayesian networks, crude oil tank, fault tree, prediction, safety

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Authors: Sarwar Beg, Gajanand Sharma, O. P. Katare, Bhupinder Singh

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The current studies entail development of self-nano emulsifying drug delivery systems (SNEDDS) of rosuvastatin, employing rational QbD-based approach for enhancing its oral bioavailability. SNEDDS were prepared using the blend of lipidic and emulsifying excipients, i.e., Peceol, Tween 80, and Transcutol HP. The prepared formulations evaluated for in vitro drug release, ex vivo permeation, in situ perfusion studies and in vivo pharmacokinetic studies in rats, which demonstrated 3-4 fold improvement in biopharmaceutical performance of the developed formulations. Cytotoxicity studies using MTT assay and histopathological studies in intestinal cells revealed the lack of cytotoxicity and thereby safety and efficacy of the developed formulations.

Keywords: SNEDDS, bioavailability, solubility, Quality by Design (QbD)

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Authors: Ebrahim Ghanbari, Mohammad Reza Nematollahi

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Integrating deterministic and probabilistic safety assessment (IDPSA) is one of the most commonly used issues in the field of safety analysis of power plant accident. It has also been recognized today that the role of human error in creating these accidents is not less than systemic errors, so the human interference and system errors in fault and event sequences are necessary. The integration of these analytical topics will be reflected in the frequency of core damage and also the study of the use of water resources in an accident such as the loss of all electrical power of the plant. In this regard, the SBO accident was simulated for the pressurized water reactor in the deterministic analysis issue, and by analyzing the operator's behavior in controlling the accident, the results of the combination of deterministic and probabilistic assessment were identified. The results showed that the best performance of the plant operator would reduce the risk of an accident by 10%, as well as a decrease of 6.82 liters/second of the water sources of the plant.

Keywords: IDPSA, human error, SBO, risk

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Authors: Luísa P. Cruz-Lopes, Artur Figueirinha, Isabel Brás, Bruno Esteves

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Portugal is an important wine and olive oil producer, activities which generate a high quantity of residues commonly called grape stalks and olive cake, respectively. In this work grape stalks and olive cake were used as lignocellulosic adsorbents for wastewater containing lead treatment. To attain a better knowledge of the factors that could influence the quality of the treated wastewater, a chemical characterization of the materials used in the treatment was done. To access the ecotoxicological safety of the treated wastewater, several tests were performed. The results of the toxicity test show that the samples leachate has a mild effect on the living models tested. The tests performed in lemna and bacteria were the most sensible to toxicity effects of the samples. The results obtained in this work evidenced the importance of use of simple and fast toxicity tests to predict impacts in the environment.

Keywords: chemical composition, lignocellulosic residues, ecotoxicological safety, wastewater

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Authors: Jakub Kraus, Vladimír Plos, Peter Vittek

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This article deals with a new approach to the airport emergency plans, which are the basic documents and manuals for dealing with events with impact on safety or security. The article describes the identified parts in which the current airport emergency plans do not fulfill their role and which should therefore be considered in the creation of corrective measures. All these issues have been identified at airports in the Czech Republic and confirmed at airports in neighboring countries.

Keywords: airport emergency plan, aviation safety, aviation security, comprehensive management system

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Authors: Walter Sebron, Hans Tschürtz, Peter Krebs

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The choice of applicable analysis methods in safety or systems engineering depends on the depth of knowledge about a system, and on the respective lifecycle phase. However, the analysis method chain still shows gaps as it should support system analysis during the lifecycle of a system from a rough concept in pre-project phase until end-of-life. This paper’s goal is to discuss an analysis method, the VISSE Shell Model Analysis (VISMA) method, which aims at closing the gap in the early system lifecycle phases, like the conceptual or pre-project phase, or the project start phase. It was originally developed to aid in the definition of the system boundary of electronic system parts, like e.g. a control unit for a pump motor. Furthermore, it can be also applied to non-electronic system parts. The VISMA method is a graphical sketch-like method that stratifies a system and its parts in inner and outer shells, like the layers of an onion. It analyses a system in a two-step approach, from the innermost to the outermost components followed by the reverse direction. To ensure a complete view of a system and its environment, the VISMA should be performed by (multifunctional) development teams. To introduce the method, a set of rules and guidelines has been defined in order to enable a proper shell build-up. In the first step, the innermost system, named system under consideration (SUC), is selected, which is the focus of the subsequent analysis. Then, its directly adjacent components, responsible for providing input to and receiving output from the SUC, are identified. These components are the content of the first shell around the SUC. Next, the input and output components to the components in the first shell are identified and form the second shell around the first one. Continuing this way, shell by shell is added with its respective parts until the border of the complete system (external border) is reached. Last, two external shells are added to complete the system view, the environment and the use case shell. This system view is also stored for future use. In the second step, the shells are examined in the reverse direction (outside to inside) in order to remove superfluous components or subsystems. Input chains to the SUC, as well as output chains from the SUC are described graphically via arrows, to highlight functional chains through the system. As a result, this method offers a clear and graphical description and overview of a system, its main parts and environment; however, the focus still remains on a specific SUC. It helps to identify the interfaces and interfacing components of the SUC, as well as important external interfaces of the overall system. It supports the identification of the first internal and external hazard causes and causal chains. Additionally, the method promotes a holistic picture and cross-functional understanding of a system, its contributing parts, internal relationships and possible dangers within a multidisciplinary development team.

Keywords: analysis methods, functional safety, hazard identification, system and safety engineering, system boundary definition, system safety

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Authors: Mohammed El Raey, Moustafa Osman Mohammed

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The spatial-ecological modeling is relating sustainable dispersions with social development. Sustainability with spatial-ecological model gives attention to urban environments in the design review management to comply with Earth’s System. Naturally exchange patterns of ecosystems have consistent and periodic cycles to preserve energy flows and materials in Earth’s System. The probabilistic risk assessment (PRA) technique is utilized to assess the safety of industrial complex. The other analytical approach is the Failure-Safe Mode and Effect Analysis (FMEA) for critical components. The plant safety parameters are identified for engineering topology as employed in assessment safety of industrial ecology. In particular, the most severe accidental release of hazardous gaseous is postulated, analyzed and assessment in industrial region. The IAEA- safety assessment procedure is used to account the duration and rate of discharge of liquid chlorine. The ecological model of plume dispersion width and concentration of chlorine gas in the downwind direction is determined using Gaussian Plume Model in urban and ruler areas and presented with SURFER®. The prediction of accident consequences is traced in risk contour concentration lines. The local greenhouse effect is predicted with relevant conclusions. The spatial-ecological model is also predicted the distribution schemes from the perspective of pollutants that considered multiple factors of multi-criteria analysis. The data extends input–output analysis to evaluate the spillover effect, and conducted Monte Carlo simulations and sensitivity analysis. Their unique structure is balanced within “equilibrium patterns”, such as the biosphere and collective a composite index of many distributed feedback flows. These dynamic structures are related to have their physical and chemical properties and enable a gradual and prolonged incremental pattern. While this spatial model structure argues from ecology, resource savings, static load design, financial and other pragmatic reasons, the outcomes are not decisive in artistic/ architectural perspective. The hypothesis is an attempt to unify analytic and analogical spatial structure for development urban environments using optimization software and applied as an example of integrated industrial structure where the process is based on engineering topology as optimization approach of systems ecology.

Keywords: spatial-ecological modeling, spatial structure orientation impact, composite structure, industrial ecology

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Authors: I. Ben Kaddour, S. Larbaoui

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Since their first synthesis in 1984, silicoaluminophosphates have proven their effectiveness as a good adsorbent and catalyst in several environmental and energy applications. In this work, the photocatalytic reaction of the photo-degradation of a pharmaceutical product in water was carried out in the presence of a series of materials based on titanium oxide, anatase phase, supported on the microporous framework of the SAPO4-5 at different levels, under ultraviolet light. These photo-catalysts were characterized by different physicochemical analysis methods in order to determine their structural, textural, and morphological properties, such as X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FTIR), microscopy scanning electronics (SEM), nitrogen adsorption measurements, UV-visible diffuse reflectance spectroscopy (UV-Vis-DRS). In this study, liquid chromatography coupled with spectroscopy of mass (LC-MS) was used to determine the nature of the intermediate products formed during the photocatalytic degradation of DCF.

Keywords: photocatalysis, titanium dioxide, SAPO-5, diclofenac

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Authors: Sung Uk Ryu, Byoung Gook Jeon, Sung-Jae Yi, Dong-Jin Euh

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In such passive safety injection systems in the nuclear power plant as Core Makeup Tank (CMT) and Hybrid Safety Injection Tank, various thermal-hydraulic phenomena including the direct contact condensation of steam and the thermal stratification of coolant occur. These phenomena are also closely related to the performance of the system. Depending on the condensation rate of the steam injected to the tank, the injection of the coolant and pressure equalizing timings of the tank are decided. The steam injected to the tank from the upper nozzle penetrates the coolant and induces a direct contact condensation. In the present study, the direct contact condensation of steam and the thermal mixing between the steam and coolant were examined by using the Particle Image Velocimetry (PIV) technique. Especially, by altering the size of the nozzle from which the steam is injected, the influence of steam injection velocity on the thermal mixing with coolant and condensation shall be comprehended, while also investigating the influence of condensation on the pressure variation inside the tank. Even though the amounts of steam inserted were the same in three different nozzle size conditions, it was found that the velocity of pressure rise becomes lower as the steam injection area decreases. Also, as the steam injection area increases, the thickness of the zone within which the coolant’s temperature decreases. Thereby, the amount of steam condensed by the direct contact condensation also decreases. The results derived from the present study can be utilized for the detailed design of a passive safety injection system, as well as for modeling the direct contact condensation triggered by the steam jet’s penetration into the coolant.

Keywords: passive safety injection systems, steam penetration, direct contact condensation, particle image velocimetry

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Authors: A. T. Siacara, A. T. Beck, M. M. Futai

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This paper shows how accurately and efficiently reliability analyses of geotechnical installations can be performed by directly coupling geotechnical software with a reliability solver. An earth slope is used as the study object. The limit equilibrium method of Morgenstern-Price is used to calculate factors of safety and find the critical slip surface. The deterministic software package Seep/W and Slope/W is coupled with the StRAnD reliability software. Reliability indexes of critical probabilistic surfaces are evaluated by the first-order reliability methods (FORM). By means of sensitivity analysis, the effective cohesion (c') is found to be the most relevant uncertain geotechnical parameter for slope equilibrium. The slope was tested using different geometries, taking into account unsaturated soil properties. Finally, a critical slip surface, identified in terms of minimum factor of safety, is shown here not to be the critical surface in terms of reliability index.

Keywords: slope, unsaturated, reliability, safety, seepage

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Authors: T. Penkova, A. Korobko, V. Nicheporchuk, L. Nozhenkova, A. Metus

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This paper presents an approach of on-line control of the state of technosphere and environment objects based on the integration of Data Warehouse, OLAP and Expert systems technologies. It looks at the structure and content of data warehouse that provides consolidation and storage of monitoring data. There is a description of OLAP-models that provide a multidimensional analysis of monitoring data and dynamic analysis of principal parameters of controlled objects. The authors suggest some criteria of emergency risk assessment using expert knowledge about danger levels. It is demonstrated now some of the proposed solutions could be adopted in territorial decision making support systems. Operational control allows authorities to detect threat, prevent natural and anthropogenic emergencies and ensure a comprehensive safety of territory.

Keywords: decision making support systems, emergency risk assessment, natural and anthropogenic safety, on-line control, territory

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Authors: Elham Rezaee, Sayyed Abbas Tabatabai

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Dual inhibition of COX-2 and sEH enzymes represents one of the distinct pharmaceutical approaches for the treatment of inflammation, pain, cancers, and other diseases. The discovery of these inhibitors for treatment is a great deal of attention because of some advantages such as increased efficacy, a promising safety profile, ease of formulation, and better target engagement. In this research, based on the structure-activity relationship of COX-2 and sEH inhibitors, some amide derivatives with oxadiazole and dihydropyrimidinone rings against sEH and COX-2 enzymes were developed. The designed compounds showed high affinity to the active site of both enzymes in docking studies and were synthesized in good yield and characterized by IR, Mass, 1HNMR, and 13CNMR. All of the novel compounds exhibited considerable in-vitro sEH and COX-2 inhibitory activities in comparison with 12-(3-Adamantan-1-yl-ureido)- dodecanoic acid and celecoxib (a potent urea-based sEH inhibitor and selective nonsteroidal anti-inflammatory drug, respectively). Ethyl 6-methyl-4-(4-(4-(methylsulfonyl)benzamido)phenyl)-2-oxo-1,2,3,4-tetrahydropyrimidine-5-carboxylate was found to be the most selective COX-2 inhibitor (COX-2/COX-1 ratio: 683) with IC50 value of 2.1 nM targeting sEH enzyme.

Keywords: COX-2, dual inhibitors, sEH, synthesis

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Authors: Romany Wagih Farag Zaky

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The relationship between development and human rights has long been the subject of academic debate. To understand the dynamics between these two concepts, various principles are adopted, from the right to development to development-based human rights. Despite the initiatives taken, the relationship between development and human rights remains unclear. However, the overlap between these two views and the idea that efforts should be made in the field of human rights have increased in recent years. It is then evaluated whether the right to sustainable development is acceptable or not. The article concludes that the principles of sustainable development are directly or indirectly recognized in various human rights instruments, which is a good answer to the question posed above. This book therefore cites regional and international human rights agreements such as , as well as the jurisprudence and interpretative guidelines of human rights institutions, to prove this hypothesis.

Keywords: sustainable development, human rights, the right to development, the human rights-based approach to development, environmental rights, economic development, social sustainability human rights protection, human rights violations, workers’ rights, justice, security

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Authors: A. Stifi, S. Gentes

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Undoubtedly from construction's perspective, the use of explosives will remove a large facility such as a 40-storey building , that took almost 3 to 4 years for construction, in few minutes. Usually, the reconstruction or decommissioning, the last phase of life cycle of any facility, is considered to be the shortest. However, this is proved to be wrong in the case of nuclear power plant. Statistics says that in the last 30 years, the construction of a nuclear power plant took an average time of 6 years whereas it is estimated that decommissioning of such plants may take even a decade or more. This paper is all about the decommissioning phase of a nuclear power plant which needs to be given more attention and encouragement from the research institutes as well as the nuclear industry. Currently, there are 437 nuclear power reactors in operation and 70 reactors in construction. With around 139 nuclear facilities already been shut down and are in different decommissioning stages and approximately 347 nuclear reactors will be in decommissioning phase in the next 20 years (assuming the operation time of a reactor as 40 years), This fact raises the following two questions (1) How far is the nuclear and construction Industry ready to face the challenges of decommissioning project? (2) What is required for a safety and reliable decommissioning project delivery? The decommissioning of nuclear facilities across the global have severe time and budget overruns. Largely the decommissioning processes are being executed by the force of manual labour where the change in regulations is respectively observed. In term of research and development, some research projects and activities are being carried out in this area, but the requirement seems to be much more. The near future of decommissioning shall be better through a sustainable development strategy where all stakeholders agree to implement innovative technologies especially for dismantling and decontamination processes and to deliever a reliable and safety decommissioning. The scope of technology transfer from other industries shall be explored. For example, remotery operated robotic technologies used in automobile and production industry to reduce time and improve effecincy and saftey shall be tried here. However, the innovative technologies are highly requested but they are alone not enough, the implementation of creative and innovative management methodologies should be also investigated and applied. Lean Management with it main concept "elimination of waste within process", is a suitable example here. Thus, the cooperation between international organisations and related industries and the knowledge-sharing may serve as a key factor for the successful decommissioning projects.

Keywords: decommissioning of nuclear facilities, innovative technology, innovative management, sustainable development

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Authors: Ghazwan Al-Haji

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Most accidents occur in urban areas, and the most related casualties are vulnerable road users (pedestrians and cyclists). The traffic calming measures (TCMs) are widely used and considered to be successful in reducing speed and traffic volume. However, TCMs create unwanted effects include: noise, emissions, energy consumption, vehicle delays and emergency response time (ERT). Different vertical and horizontal TCMs have been already applied nationally (Sweden) and internationally with different impacts. It is a big challenge among traffic engineers, planners, and policy-makers to choose and priorities the best TCMs to be implemented. This study will assess the existing guidelines for TCMs in relation to safety and ERT with focus on data from Norrkoping city in Sweden. The expected results will save lives, time, and money on particularly Swedish Roads. The study will also review newly technologies and how they can improve safety and reduce ERT.

Keywords: traffic calming measures, traffic safety, delay time, vulnerable road users

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Authors: Shittu Bisi Agnes

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Studies on households’ willingness to pay for environmental and general health safety in the advent of Ebola virus Diseases in Nigeria was carried out. This is aimed at revealing the means by which the virus was eventually eradicated in Nigeria as widely claimed in the media. This study therefore attempted to determine the environmental and general health condition in the State Of Osun, how socio-economic characteristics of the people affected willingness to pay. And also provide platform for the reduction of environmental and general health problems. Data were collected with the aid of well-structured questionnaire and administer 150 randomly selected people of study area, and oral interview was also utilized. Data collected were analyzed using both descriptive tools and inferential statistics vis-a-viz regression analysis. Findings showed 92.5% of respondents was aware of ebola virus diseases outbreak in Nigeria, 8.5% was unaware of any disease outbreak. And 65.7% of respondents was strongly willing to pay for environmental and general health safety 27.1% was fairly willing, 5.7% was indifferent and 1.7% was unwilling to pay. 5% rated the level of environmental and general health condition in the area has been good, 53.6% rated theirs has been fair, 33.6% as been poor. The average willingness to pay per household per month were #500.00, #250.00, #150.00 and #100.00 respectively for the four categories. It was recommended that policy instruments to increase peoples' income will accelerate eradication of environmental and general health problems, environmental health education in form of talk shop, workshop, lectures and seminars could be organized at the political ward levels, churches, mosque, and at schools. Environmental and general health safety related information could be disseminated through mass media, market women, and functional unions.

Keywords: ebola virus diseases (EVD), socio-economic, safety, pay, Osun

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Authors: Apisit Nawapanpong, Natthapat Boonjerm

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This project aims to analyze and identify the flight plan of low-altitude aviation in Thailand and other countries. The development of UAV technology has led the innovation and revolution in the aviation industry; this includes the development of new modes of passenger or freight transportation, and it has also affected other industries widely. At present, this technology is being developed rapidly and has been tested all over the world to make the most efficient for technology or innovation, and it is likely to grow more extensively. However, no flight plan for low-altitude operation has been published by the government organization; when compared with high-altitude aviation with manned aircraft, various unique factors are different, whether mission, operation, altitude range or airspace restrictions. In the study of the essential components of low-altitude operation measures to be practical and tangible, there were major problems, so the main consideration of this project is to analyze the components of low-altitude operations which are conducted up to the altitudes of 400 ft or 120 meters above ground level referring to the terrain, for example, air traffic management, classification of aircraft, basic necessity and safety, and control area. This research will focus on confirming the theory through qualitative and quantitative research combined with theoretical modeling and regulatory framework and by gaining insights from various positions in aviation industries, including aviation experts, government officials, air traffic controllers, pilots, and airline operators to identify the critical essential components of low-altitude flight operation. This project analyzes by using computer programs for science and statistics research to prove that the result is equivalent to the theory and be beneficial for regulating the flight plan for low-altitude operation by different essential components from this project and can be further developed for future studies and research in aviation industries.

Keywords: low-altitude aviation, UAV technology, flight plan, air traffic management, safety measures

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Authors: Magda Milleyde de Sousa Lima, Letícia Lima Aguiar, Marina Guerra Martins, Erika Veríssimo Dias Sousa, Lizandra Sampaio de Oliveira, Lívia Moreira Barros, Joselany Áfio Caetano

Abstract:

Patients with chronic kidney disease are vulnerable to episodes which make the safety of their health vulnerable, mainly due to the treatment process that exposes them to high rates of interventions during hemodialysis sessions. Some factors associated with health care contribute to the risk of death and complications. However, there are a small number of scientific studies evaluating the level of safety of hemodialysis clinics, and the sociodemographic characteristics of patients and professionals associated with this safety. Therefore, the present study aims to examine the level of patient safety in hemodialysis clinics in the Brazilian capital, to identify the sociodemographic and clinical factors of patients and nursing staff associated with the level of safety. This is an observational, descriptive and quantitative research conducted in three hemodialysis clinics placed in the city of Fortaleza-CE, Brazil, from September to November 2019. The sample was formed after a sample calculation for finite inhabitants of correlation with 200 chronic renal patients, 30 nursing technicians and seven nurses. Conventional sampling was used based on the inclusion criteria: being present at the hemodialysis session on the day the researcher performed the data collection and being 18 years of age or older. Participants who presented communication difficulties to listen to and/or answer the sociodemographic and clinical questionnaire were excluded. Two instruments were applied: sociodemographic and clinical characterization form and Chronic Renal Patient Safety Assessment Scale on Hemodialysis (EASPRCH). The data were analyzed using the Kruskal Walls Test for categorical variables and Spearman correlation coefficient for non-categorical variables, using the Statistical Package SPSS version 20.0. The present study respected the ethical and legal principles determined by resolution 466/2012 of the National Health Council, under the approval of the Ethics and Research Committee with an opinion number: 3,255,635. The results showed that a hemodialysis clinic presented unsafe care practices of 32 points in the EASPRCH (p=0.001). A statistical association was identified between the level of safety and the variables of the patients: level of education (p=0.018), family income (p=0.049), type of employment (p=0.012), venous access site (p=0.009), use of medication during the session (p=0.008) and time of hemodialysis (p=0.002). When evaluating the profile of nurses, a statistical association was evidenced between the level of safety with the variables: marital status (p=0.000), race (p=0.017), schooling (p= 0.000), income (p=0.013), age (p=0.000), clinic workload (p=0.000), time working with hemodialysis (p=0.000), time working in the clinic (p= 0.007) and clinic sizing (p=0.000). In order, the sociodemographic factors of nursing technicians associated with the level of patient safety were: race (p= 0.001) and weekly workload at (p=0.010). Therefore, it is concluded that there is a non-conformity in the level of patient safety in one of the clinics studied and, that sociodemographic and clinical factors of patients and health professionals corroborate the level of safety of the health unit.

Keywords: hemodialysis, nursing, patient safety, quality improvement

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