Search results for: sterility and safety in pharmaceutical development
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 18549

Search results for: sterility and safety in pharmaceutical development

18429 Modeling and Implementation of a Hierarchical Safety Controller for Human Machine Collaboration

Authors: Damtew Samson Zerihun

Abstract:

This paper primarily describes the concept of a hierarchical safety control (HSC) in discrete manufacturing to up-hold productivity with human intervention and machine failures using a systematic approach, through increasing the system availability and using additional knowledge on machines so as to improve the human machine collaboration (HMC). It also highlights the implemented PLC safety algorithm, in applying this generic concept to a concrete pro-duction line using a lab demonstrator called FATIE (Factory Automation Test and Integration Environment). Furthermore, the paper describes a model and provide a systematic representation of human-machine collabora-tion in discrete manufacturing and to this end, the Hierarchical Safety Control concept is proposed. This offers a ge-neric description of human-machine collaboration based on Finite State Machines (FSM) that can be applied to vari-ous discrete manufacturing lines instead of using ad-hoc solutions for each line. With its reusability, flexibility, and extendibility, the Hierarchical Safety Control scheme allows upholding productivity while maintaining safety with reduced engineering effort compared to existing solutions. The approach to the solution begins with a successful partitioning of different zones around the Integrated Manufacturing System (IMS), which are defined by operator tasks and the risk assessment, used to describe the location of the human operator and thus to identify the related po-tential hazards and trigger the corresponding safety functions to mitigate it. This includes selective reduced speed zones and stop zones, and in addition with the hierarchical safety control scheme and advanced safety functions such as safe standstill and safe reduced speed are used to achieve the main goals in improving the safe Human Ma-chine Collaboration and increasing the productivity. In a sample scenarios, It is shown that an increase of productivity in the order of 2.5% is already possible with a hi-erarchical safety control, which consequently under a given assumptions, a total sum of 213 € could be saved for each intervention, compared to a protective stop reaction. Thereby the loss is reduced by 22.8%, if occasional haz-ard can be refined in a hierarchical way. Furthermore, production downtime due to temporary unavailability of safety devices can be avoided with safety failover that can save millions per year. Moreover, the paper highlights the proof of the development, implementation and application of the concept on the lab demonstrator (FATIE), where it is realized on the new safety PLCs, Drive Units, HMI as well as Safety devices in addition to the main components of the IMS.

Keywords: discrete automation, hierarchical safety controller, human machine collaboration, programmable logical controller

Procedia PDF Downloads 346
18428 Enhancing Civil Aviation Safety and Security: A Comprehensive Approach

Authors: J. Waldon

Abstract:

The civil aviation industry plays a crucial role in global transportation, connecting people and goods across the world. Ensuring the safety and security of passengers, crew, and aircraft is of paramount importance. This paper aims to address the aspect of training and human factors, amongst others, necessary for enhancing civil aviation safety and security. In this context, we are focusing on the level of attention exhibited in the checking of luggage and travel credentials, with the aim to identify areas of improvement and avoid compromising security and safety at the Nsimalen Airport Yaoundé, Cameroon. We found that there is a lack of proper awareness among both travelers and some staff on the safety and security of goods and passengers. We suggest that improved training and handling, and sensitization in the form of legible billboards are important. Thus, we recommend refresher courses like this one for staff to keep abreast with the fast-changing security landscape in air transport as well as proper sensitization, including health-related issues. In conclusion, we established that the human factors, as well as the frequency of training and refresher courses, have a positive outlook on safety and security in air transport.

Keywords: safety, security, passengers, cargo

Procedia PDF Downloads 39
18427 Establishment and Evaluation of Information System for Chemotherapy Care

Authors: Yi-Ting Liu, Pei-Ying Wen

Abstract:

In order to improve the overall safety of chemotherapy, safety-protecting net was established for the whole process from prescribing by physicians, transcribing by nurses, dispensing by pharmacists to administering by nurses. The information system was used to check and monitor whole process of administration and related sheets were computerized to simplify the paper work.

Keywords: chemotherapy, bar code medication administration, medication safety

Procedia PDF Downloads 257
18426 Urban Sustainable Development with Flood Crisis Management Approach

Authors: Ali Liaghat, Navid Tavanpour, Nima Tavanpour

Abstract:

An increase in population and prevalence of urbanity have led plan makers and decision makers put effort into sustainable development of cities at national and local levels. One of the important issues in urban development is compliance with safety issues in cities. Despite natural disasters and unexpected events such as floods, earthquakes, hurricanes, fires, etc., urban development should be regarded as an axiom, or else any form of construction and development is not safe, because it will greatly harm economic growth and development and pose an obstacle to achieving sustainable development, plus a loss to lives and finances of people. Therefore, in line with urban development, it is necessary to identify particular environmental and local issues as determinants and pay attention to them at the top of everything, in that we can call it a good action and factor in urban sustainable developments. Physical structure of each city represents how it has developed or its development shaped and what incidents, changes, natural disasters it has undergone over time. Since any form of development plan should be in accordance with the previous situations of cities, disregarding it, unfortunately, can escalate into uncontrolled urban development, non-resistant and unstable construction against earthquake or invasion of river areas, destruction of agricultural lands or vegetation, periodic floods over time. It has been viewed as serious threats to developing cities, and typically caused destruction of bed and other urban facilities as well as damages to lives and finances. In addition, uncontrolled development has caused cities to look ugly in terms of urban façade, and off and on such unplanned measures caused the country to face countless losses, and it not only vitiates expenses incurred, but it will also impose additional costs of reconstruction, i.e. it is unsustainable development. Thus, in this paper, in addition to a discussion about necessity for a profound attitude toward this subject and making long-term plans, programs for organizing river and its surrounding area, creating open and green urban spaces, retrofitting and flood preventing are presented for sustainable safety and development of cities along with a critique of successful countries.

Keywords: flood, sustainable development, urbanisation, urban management

Procedia PDF Downloads 246
18425 The Effect of Applying Surgical Safety Checklist on Surgical Team’s Knowledge and Performance in Operating Room

Authors: Soheir Weheida, Amal E. Shehata, Samira E. Aboalizm

Abstract:

The aim of this study was to examine the effect of surgical safety checklist on surgical team’s knowledge and performance in operating room. Subjects: A convenience sample 151 (48 head nurse, 45 nurse, 37 surgeon and 21 anesthesiologist) which available in operating room at two different hospitals was included in the study. Setting: The study was carried out at operating room in Menoufia University and Shebin Elkom Teaching Hospitals, Egypt. Tools: I: Surgical safety: Surgical team knowledge assessment structure interview schedule. II: WHO surgical safety observational Checklist. III: Post Surgery Culture Survey scale. Results: There was statistical significant improvement of knowledge mean score and performance about surgical safety especially in post and follow up than pre intervention, before patients entering the operating, before induction of anesthesia, skin incision and post skin closure and before patient leaves operating room, P values (P < 0.001). Improvement of communication post intervention than pre intervention between surgical team’s (4.74 ± 0.540). About two thirds (73.5 %) of studied sample strongly agreed on surgical safety in operating room. Conclusions: Implementation of surgical safety checklist has a positive effect on improving knowledge, performance and communication between surgical teams and these seems to have a positive effect on improve patient safety in the operating room.

Keywords: knowledge, operating room, performance, surgical safety checklist

Procedia PDF Downloads 307
18424 Developing a Driving Simulator with a Navigation System to Measure Driver Distraction, Workload, Driving Safety and Performance

Authors: Tamer E. Yared

Abstract:

The use of driving simulators has made laboratory testing easier. It has been proven to be valid for testing driving ability by many researchers. One benefit of using driving simulators is keeping the human subjects away from traffic hazards, which drivers usually face in a real driving environment while performing a driving experiment. In this study, a driving simulator was developed with a navigation system using a game development software (Unity 3D) and C-sharp codes to measure and evaluate driving performance, safety, and workload for different driving tasks. The driving simulator hardware included a gaming steering wheel and pedals as well as a monitor to view the driving tasks. Moreover, driver distraction was evaluated by utilizing an eye-tracking system working in conjunction with the driving simulator. Twenty subjects were recruited to evaluate driver distraction, workload, driving safety, and performance, as well as provide their feedback about the driving simulator. The subjects’ feedback was obtained by filling a survey after conducting several driving tasks. The main question of that survey was asking the subjects to compare driving on the driving simulator with real driving. Furthermore, other aspects of the driving simulator were evaluated by the subjects in the survey. The survey revealed that the recruited subjects gave an average score of 7.5 out of 10 to the driving simulator when compared to real driving, where the scores ranged between 6 and 8.5. This study is a preliminary effort that opens the door for more improvements to the driving simulator in terms of hardware and software development, which will contribute significantly to driving ability testing.

Keywords: driver distraction, driving performance, driving safety, driving simulator, driving workload, navigation system

Procedia PDF Downloads 138
18423 Safety Tolerance Zone for Driver-Vehicle-Environment Interactions under Challenging Conditions

Authors: Matjaž Šraml, Marko Renčelj, Tomaž Tollazzi, Chiara Gruden

Abstract:

Road safety is a worldwide issue with numerous and heterogeneous factors influencing it. On the side, driver state – comprising distraction/inattention, fatigue, drowsiness, extreme emotions, and socio-cultural factors highly affect road safety. On the other side, the vehicle state has an important role in mitigating (or not) the road risk. Finally, the road environment is still one of the main determinants of road safety, defining driving task complexity. At the same time, thanks to technological development, a lot of detailed data is easily available, creating opportunities for the detection of driver state, vehicle characteristics and road conditions and, consequently, for the design of ad hoc interventions aimed at improving driver performance, increase awareness and mitigate road risks. This is the challenge faced by the i-DREAMS project. i-DREAMS, which stands for a smart Driver and Road Environment Assessment and Monitoring System, is a 3-year project funded by the European Union’s Horizon 2020 research and innovation program. It aims to set up a platform to define, develop, test and validate a ‘Safety Tolerance Zone’ to prevent drivers from getting too close to the boundaries of unsafe operation by mitigating risks in real-time and after the trip. After the definition and development of the Safety Tolerance Zone concept and the concretization of the same in an Advanced driver-assistance system (ADAS) platform, the system was tested firstly for 2 months in a driving simulator environment in 5 different countries. After that, naturalistic driving studies started for a 10-month period (comprising a 1-month pilot study, 3-month baseline study and 6 months study implementing interventions). Currently, the project team has approved a common evaluation approach, and it is developing the assessment of the usage and outcomes of the i-DREAMS system, which is turning positive insights. The i-DREAMS consortium consists of 13 partners, 7 engineering universities and research groups, 4 industry partners and 2 partners (European Transport Safety Council - ETSC - and POLIS cities and regions for transport innovation) closely linked to transport safety stakeholders, covering 8 different countries altogether.

Keywords: advanced driver assistant systems, driving simulator, safety tolerance zone, traffic safety

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18422 An Integrated Approach for Risk Management of Transportation of HAZMAT: Use of Quality Function Deployment and Risk Assessment

Authors: Guldana Zhigerbayeva, Ming Yang

Abstract:

Transportation of hazardous materials (HAZMAT) is inevitable in the process industries. The statistics show a significant number of accidents has occurred during the transportation of HAZMAT. This makes risk management of HAZMAT transportation an important topic. The tree-based methods including fault-trees, event-trees and cause-consequence analysis, and Bayesian network, have been applied to risk management of HAZMAT transportation. However, there is limited work on the development of a systematic approach. The existing approaches fail to build up the linkages between the regulatory requirements and the safety measures development. The analysis of historical data from the past accidents’ report databases would limit our focus on the specific incidents and their specific causes. Thus, we may overlook some essential elements in risk management, including regulatory compliance, field expert opinions, and suggestions. A systematic approach is needed to translate the regulatory requirements of HAZMAT transportation into specified safety measures (both technical and administrative) to support the risk management process. This study aims to first adapt the House of Quality (HoQ) to House of Safety (HoS) and proposes a new approach- Safety Function Deployment (SFD). The results of SFD will be used in a multi-criteria decision-support system to develop find an optimal route for HazMats transportation. The proposed approach will be demonstrated through a hypothetical transportation case in Kazakhstan.

Keywords: hazardous materials, risk assessment, risk management, quality function deployment

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18421 Inter-Departmental Survey to Check the Impact of Bio-Safety Training Sessions among Lab Employees

Authors: Noorulaine Maqsood, Saeed Khan

Abstract:

Background: Concern regarding incident reporting and bio-safety training in clinical laboratories in Pakistan has increased remarkably in the last few years due to rapid increase in diagnosis and research on infectious organisms. In order to ensure the safety of employees, this issue needs to be addressed immediately. Bio-safety training sessions and lectures are necessary for the protection of laboratory workers in order to ensure safe practices and minimize the count of incident reporting in the lab. Objective: To carry out an inter-departmental survey in lab regarding the awareness of bio-safety practices among lab employees before and after conducting bio-safety training sessions. Methodology: We conducted a 30 questions survey of laboratory workers in June 2013 (before training session) to gather information related to bio-safety awareness. Afterwards, we conducted another survey after training sessions and workshops related to bio-safety. Result: The survey regarding bio-safety level showed that before the training session 32% of the participants were aware of bio-safety level being used in their lab whereas after the session this percentage increased to 72%. 48% of the participants had information about the proper usage of PPE which increased to 76%. Awareness regarding proper management of hazardous waste increased from 32% to 64%. The incident reporting practice, sample handling and hand hygiene awareness was previously reported to be 40%, 65%, and 52% that increased to 80%, 85% and 88% respectively after the training session was completed. Conclusion: The first survey results showed lack of awareness that suggest nearly all senior scientists, faculty, medical technologist, lab attendant and housekeeping staff working in laboratories are required to have bio-safety training, and required inspection at least twice a year by a bio-safety officer and also required to renew their bio-safety training. After the training session, significant changes in awareness level and attitude of the participants regarding biosafety practices were observed. Therefore, such bio-safety sessions should be carried out regularly in clinical laboratories.

Keywords: biosafety practices, clinical laboratory, Pakistan, survey

Procedia PDF Downloads 395
18420 Highway Casualty Rate in Nigeria: Implication for Human Capital Development

Authors: Ali Maji

Abstract:

Highway development is an important factor for economic growth and development in both developed and developing countries. In Nigeria about two-third of transportation of goods and persons are done through highway network. It was this that made highway investment to enjoy position of relative high priority on the list of government expenditure programmes in Nigeria today. The paper noted that despite expansion of public investment in highway construction and maintenance of them, road traffic accident is increasing rate. This has acted as a drain of human capital which is a key to economic growth and development in Nigeria. In order to avoid this, the paper recommend introduction of Highway Safety Education (HSE) in Nigerian’s education system and investment in train transportation among other as a sure measure for curtailing highway accident.

Keywords: accident rate, high way development, human capital, national development

Procedia PDF Downloads 255
18419 Real-Time Mine Safety System with the Internet of Things

Authors: Şakir Bingöl, Bayram İslamoğlu, Ebubekir Furkan Tepeli, Fatih Mehmet Karakule, Fatih Küçük, Merve Sena Arpacık, Mustafa Taha Kabar, Muhammet Metin Molak, Osman Emre Turan, Ömer Faruk Yesir, Sıla İnanır

Abstract:

This study introduces an IoT-based real-time safety system for mining, addressing global safety challenges. The wearable device, seamlessly integrated into miners' jackets, employs LoRa technology for communication and offers real-time monitoring of vital health and environmental data. Unique features include an LCD panel for immediate information display and sound-based location tracking for emergency response. The methodology involves sensor integration, data transmission, and ethical testing. Validation confirms the system's effectiveness in diverse mining scenarios. The study calls for ongoing research to adapt the system to different mining contexts, emphasizing its potential to significantly enhance safety standards in the industry.

Keywords: mining safety, internet of things, wearable technology, LoRa, RFID tracking, real-time safety system, safety alerts, safety measures

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18418 Assessment of Health and Safety Item on Construction Site in Ondo State

Authors: Ikumapayi Catherine Mayowa

Abstract:

The well-being of humans on a construction site is critical; abundant manpower had been lost through accidents which kill or make workers physically unfit to carry out construction activities, these, in turn, have multiple effects on the whole economy. Thus, it is necessary to put all safety items and regulations in place before construction activities can commence. This study was carried out in the Ondo state of Nigeria to investigate and analyze the state of health and safety of construction workers in the state. The study was done using first-hand observations, 50 construction project sites were visited in ten major towns of Ondo state, questionnaires were distributed, and the results were analyzed. The result shows that construction workers are being exposed to many construction site hazards due to lack of inadequate safety programs and lack of appropriate safety equipment for workers on site. From the data gotten from each site visited and the statistical analysis, it can be concluded that occurrences of an accident on construction sites depend significantly on the available safety facilities on the sites. The result of the regression statistics shows that the dependence of the frequency of occurrence of an accident on the availability of safety items on the site is 0.0362 which is less than 0.05 maximum significant level allowed. Therefore, a vital way of sustaining our building strategy is given a detail attention to the provision of adequate health and safety items on construction sites which will reduce the occurrence of accident, loss of manpower and death of skilled workers.

Keywords: construction sites, health, safety, welfare

Procedia PDF Downloads 300
18417 Aerodynamic Analysis of Vehicles

Authors: E. T. L. Cöuras Ford, V. A. C. Vale, J. U. L. Mendes

Abstract:

Two of the objective principal in the study of the aerodynamics of vehicles are the safety and the acting. Those objectives can be reached through the development of devices modify the drainage of air about of the vehicle and also through alterations in the way of the external surfaces. The front lowest profile of the vehicle, for instance, has great influence on the coefficient of aerodynamic penetration (Cx) and later on great part of the pressure distribution along the surface of the vehicle. The objective of this work was of analyzing the aerodynamic behavior that it happens on some types the trucks of vehicles, based on experimentation in aerodynamic tunnel, seeking to determine the aerodynamic efficiency of each one of them.

Keywords: aerodynamic, vehicles, wind tunnel, safety, acting

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18416 Analysis of Human Mental and Behavioral Models for Development of an Electroencephalography-Based Human Performance Management System

Authors: John Gaber, Youssef Ahmed, Hossam A. Gabbar, Jing Ren

Abstract:

Accidents at Nuclear Power Plants (NPPs) occur due to various factors, notable among them being poor safety management and poor safety culture. During abnormal situations, the likelihood of human error is many-fold higher due to the higher cognitive workload. The most common cause of human error and high cognitive workload is mental fatigue. Electroencephalography (EEG) is a method of gathering the electromagnetic waves emitted by a human brain. We propose a safety system by monitoring brainwaves for signs of mental fatigue using an EEG system. This requires an analysis of the mental model of the NPP operator, changes in brain wave power in response to certain stimuli, and the risk factors on mental fatigue and attention that NPP operators face when performing their tasks. We analyzed these factors and developed an EEG-based monitoring system, which aims to alert NPP operators when levels of mental fatigue and attention hinders their ability to maintain safety.

Keywords: brain imaging, EEG, power plant operator, psychology

Procedia PDF Downloads 70
18415 Development of the Integrated Quality Management System of Cooked Sausage Products

Authors: Liubov Lutsyshyn, Yaroslava Zhukova

Abstract:

Over the past twenty years, there has been a drastic change in the mode of nutrition in many countries which has been reflected in the development of new products, production techniques, and has also led to the expansion of sales markets for food products. Studies have shown that solution of the food safety problems is almost impossible without the active and systematic activity of organizations directly involved in the production, storage and sale of food products, as well as without management of end-to-end traceability and exchange of information. The aim of this research is development of the integrated system of the quality management and safety assurance based on the principles of HACCP, traceability and system approach with creation of an algorithm for the identification and monitoring of parameters of technological process of manufacture of cooked sausage products. Methodology of implementation of the integrated system based on the principles of HACCP, traceability and system approach during the manufacturing of cooked sausage products for effective provision for the defined properties of the finished product has been developed. As a result of the research evaluation technique and criteria of performance of the implementation and operation of the system of the quality management and safety assurance based on the principles of HACCP have been developed and substantiated. In the paper regularities of influence of the application of HACCP principles, traceability and system approach on parameters of quality and safety of the finished product have been revealed. In the study regularities in identification of critical control points have been determined. The algorithm of functioning of the integrated system of the quality management and safety assurance has also been described and key requirements for the development of software allowing the prediction of properties of finished product, as well as the timely correction of the technological process and traceability of manufacturing flows have been defined. Based on the obtained results typical scheme of the integrated system of the quality management and safety assurance based on HACCP principles with the elements of end-to-end traceability and system approach for manufacture of cooked sausage products has been developed. As a result of the studies quantitative criteria for evaluation of performance of the system of the quality management and safety assurance have been developed. A set of guidance documents for the implementation and evaluation of the integrated system based on the HACCP principles in meat processing plants have also been developed. On the basis of the research the effectiveness of application of continuous monitoring of the manufacturing process during the control on the identified critical control points have been revealed. The optimal number of critical control points in relation to the manufacture of cooked sausage products has been substantiated. The main results of the research have been appraised during 2013-2014 under the conditions of seven enterprises of the meat processing industry and have been implemented at JSC «Kyiv meat processing plant».

Keywords: cooked sausage products, HACCP, quality management, safety assurance

Procedia PDF Downloads 223
18414 A Framework for an Automated Decision Support System for Selecting Safety-Conscious Contractors

Authors: Rawan A. Abdelrazeq, Ahmed M. Khalafallah, Nabil A. Kartam

Abstract:

Selection of competent contractors for construction projects is usually accomplished through competitive bidding or negotiated contracting in which the contract bid price is the basic criterion for selection. The evaluation of contractor’s safety performance is still not a typical criterion in the selection process, despite the existence of various safety prequalification procedures. There is a critical need for practical and automated systems that enable owners and decision makers to evaluate contractor safety performance, among other important contractor selection criteria. These systems should ultimately favor safety-conscious contractors to be selected by the virtue of their past good safety records and current safety programs. This paper presents an exploratory sequential mixed-methods approach to develop a framework for an automated decision support system that evaluates contractor safety performance based on a multitude of indicators and metrics that have been identified through a comprehensive review of construction safety research, and a survey distributed to domain experts. The framework is developed in three phases: (1) determining the indicators that depict contractor current and past safety performance; (2) soliciting input from construction safety experts regarding the identified indicators, their metrics, and relative significance; and (3) designing a decision support system using relational database models to integrate the identified indicators and metrics into a system that assesses and rates the safety performance of contractors. The proposed automated system is expected to hold several advantages including: (1) reducing the likelihood of selecting contractors with poor safety records; (2) enhancing the odds of completing the project safely; and (3) encouraging contractors to exert more efforts to improve their safety performance and practices in order to increase their bid winning opportunities which can lead to significant safety improvements in the construction industry. This should prove useful to decision makers and researchers, alike, and should help improve the safety record of the construction industry.

Keywords: construction safety, contractor selection, decision support system, relational database

Procedia PDF Downloads 251
18413 Toward an Integrated Safe and Sustainable Food System: A General Overview

Authors: Erkan Rehber, Hasan Vural, Sule Turhan

Abstract:

It is a fact that food is a vital need of human beings. As a consumer, everyone has the right to access adequate and safe food. There are considerable development to establish quality standards and schemes to have safe foods and sustainable agriculture alternatives to protect natural resources and environment to reach this target. Recently, there is also a remarkable development in integration and combination of these efforts. Food Safety and Sustainable Agriculture Forum organized in 2014, Beijing shows that it is a global awareness more than being an individual view. Eventually, quality standards, assurance systems applied to conventional agriculture has to be applied to sustainable agriculture alternatives to have a holistic sustainable food chain from seed to fork. All actors of the whole food system from farmer to ultimate consumers, along with the state, have to work together meeting this big challenge.

Keywords: integrated safe, food safety, sustainable food system, consumer

Procedia PDF Downloads 526
18412 General Principles of Accident Prevention in Built Environment Rehabilitation

Authors: Alfredo Soeiro

Abstract:

Rehabilitation in construction or built environment is a particular type of operations when concerning prevention of accidents. In fact, it is also a different type of task in construction itself. Therefore, due to the complex characteristics of construction rehabilitation tasks and due to the intrinsic difficulty of preventing accidents in construction, a major challenge faces the responsibility for implementing adequate safety levels in this type of safety management. This paper addresses a set of proposed generic measures to face the unknown characteristics of built environment in terms of stability, materials and actual performance of buildings or other constructions. It is also addressed the necessary adaptation of preventive guidelines to this type of delicate refurbishing and renovating of existing facilities. Training, observation and reflective approaches are necessary to perform this safety management in the rehabilitation of built environment.

Keywords: built environment, rehabilitation, construction safety, accident prevention, safety plan

Procedia PDF Downloads 178
18411 Comparative Evaluation of Pharmacologically Guided Approaches (PGA) to Determine Maximum Recommended Starting Dose (MRSD) of Monoclonal Antibodies for First Clinical Trial

Authors: Ibraheem Husain, Abul Kalam Najmi, Karishma Chester

Abstract:

First-in-human (FIH) studies are a critical step in clinical development of any molecule that has shown therapeutic promise in preclinical evaluations, since preclinical research and safety studies into clinical development is a crucial step for successful development of monoclonal antibodies for guidance in pharmaceutical industry for the treatment of human diseases. Therefore, comparison between USFDA and nine pharmacologically guided approaches (PGA) (simple allometry, maximum life span potential, brain weight, rule of exponent (ROE), two species methods and one species methods) were made to determine maximum recommended starting dose (MRSD) for first in human clinical trials using four drugs namely Denosumab, Bevacizumab, Anakinra and Omalizumab. In our study, the predicted pharmacokinetic (pk) parameters and the estimated first-in-human dose of antibodies were compared with the observed human values. The study indicated that the clearance and volume of distribution of antibodies can be predicted with reasonable accuracy in human and a good estimate of first human dose can be obtained from the predicted human clearance and volume of distribution. A pictorial method evaluation chart was also developed based on fold errors for simultaneous evaluation of various methods.

Keywords: clinical pharmacology (CPH), clinical research (CRE), clinical trials (CTR), maximum recommended starting dose (MRSD), clearance and volume of distribution

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18410 Producer’s Liability for Defective Medical Devices in Light of Council Directive 85/374/EEC

Authors: Vera Lúcia Raposo

Abstract:

Medical devices are products used for medical purposes and aimed to operate in the human body, sometimes even inside the human body. Therefore, they can become particularly risky products, and some of the injuries caused by medical devices can have serious effects on the person’s health or body, even leading to death. Because they fit in the category of 'products' as described in Article 2 of Council Directive 85/374/EEC of 25 July 1985, concerning liability for defective products, the liability of the manufacturer of medical devices follows the rules of strict liability as long as one of the defects covered by the directive is at stake. The directive is not concerned with the product’s efficiency, but instead with the product’s safety, although in what regards medical devices (the same being valid for drugs) the two concepts frequently go together, and a lack of efficiency can result in a lack of safety. In the particular case of medical devices, the most debatable defects are the ones related with erroneous or non-existing information and the so-called development defects. This paper analyses how directive 85/374/EEC applies to medical devices, which defects are covered by its regulation, and which criteria can be used to evaluate the product’s safety. Some issues are still to be clarified, even though the decisions from the European Court of Justice and from national courts are valuable tools to understand the scope of directive 85/374/EEC in what regards medical devices.

Keywords: medical devices, producer’s liability, product safety, strict liability

Procedia PDF Downloads 288
18409 The Cost and Benefit on the Investment in Safety and Health of the Enterprises in Thailand

Authors: Charawee Butbumrung

Abstract:

The purpose of this study is to evaluate the monetary worthiness of investment and the usefulness of risk estimation as a tool employed by a production section of an electronic factory. This study employed the case study of accidents occurring in production areas. Data is collected from interviews with six production of safety coordinators and collect the information from the relevant section. The study will present the ratio of benefits compared with the operation costs for investment. The result showed that it is worthwhile for investment with the safety measures. In addition, the organizations must be able to analyze the causes of accidents about the benefits of investing in protective working process. They also need to quickly provide the manual for the staff to learn how to protect themselves from accidents and how to use all of the safety equipment.

Keywords: cost and benefit, enterprises in Thailand, investment in safety and health, risk estimation

Procedia PDF Downloads 238
18408 Sustainable Food Systems and the Importance of Food Safety in Ensuring Sustainability

Authors: Özlem Turan, Şule Turhan

Abstract:

About 1 billion people in the world are suffering from hunger. Approximately 1.3 billion tons of produced food is wasted each year as well. While the waste of industrialized countries is 670 million tons per year, the waste per year in developing countries is estimated as 630 million tons. When evaluated in this respect, the importance of sustainability and food security can be seen clearly. Food safety is defined as taking the necessary measures and eliminating all risk arising from food. The goal of sustainable food security is, protection of consumer health, development of safe food and beverages trade nationally and internationally and to ensure reliable fair trade schemes. In this study, this study will focus on sustainable food systems and food security, by examining the food wastage and losses from environmental and economic point of views and the precautions that need to be taken will be discussed.

Keywords: food, food safety, food systems, sustainability

Procedia PDF Downloads 355
18407 The Application of Enzymes on Pharmaceutical Products and Process Development

Authors: Reginald Anyanwu

Abstract:

Enzymes are biological molecules that significantly regulate the rate of almost all of the chemical reactions that take place within cells, and have been widely used for products’ innovations. They are vital for life and serve a wide range of important functions in the body, such as aiding in digestion and metabolism. The present study was aimed at finding out the extent to which biological molecules have been utilized by pharmaceutical, food and beverage, and biofuel industries in commercial and scale up applications. Taking into account the escalating business opportunities in this vertical, biotech firms have also been penetrating enzymes industry especially that of food. The aim of the study therefore was to find out how biocatalysis can be successfully deployed; how enzyme application can improve industrial processes. To achieve the purpose of the study, the researcher focused on the analytical tools that are critical for the scale up implementation of enzyme immobilization to ascertain the extent of increased product yield at minimum logistical burden and maximum market profitability on the environment and user. The researcher collected data from four pharmaceutical companies located at Anambra state and Imo state of Nigeria. Questionnaire items were distributed to these companies. The researcher equally made a personal observation on the applicability of these biological molecules on innovative Products since there is now shifting trends toward the consumption of healthy and quality food. In conclusion, it was discovered that enzymes have been widely used for products’ innovations but there are however variations on their applications. It was also found out that pivotal contenders of enzymes market have lately been making heavy investments in the development of innovative product solutions. It was recommended that the applications of enzymes on innovative products should be widely practiced.

Keywords: enzymes, pharmaceuticals, process development, quality food consumption, scale-up applications

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18406 Architectural Building Safety and Health Performance Model for Stratified Low-Cost Housing: Education and Management Tool for Building Managers

Authors: Zainal Abidin Akasah, Maizam Alias, Azuin Ramli

Abstract:

The safety and health performances aspects of a building are the most challenging aspect of facility management. It requires a deep understanding by the building managers on the factors that contribute to health and safety performances. This study attempted to develop an explanatory architectural safety performance model for stratified low-cost housing in Malaysia. The proposed Building Safety and Health Performance (BSHP) model was tested empirically through a survey on 308 construction practitioners using Partial Least Squares (PLS) and Structural Equation Modelling (SEM) tool. Statistical analysis results supports the conclusion that architecture, building services, external environment, management approaches and maintenance management have positive influence on safety and health performance of stratified low-cost housing in Malaysia. The findings provide valuable insights for construction industry to introduce BSHP model in the future where the model could be used as a guideline for training purposes of managers and better planning and implementation of building management.

Keywords: building management, stratified low-cost housing, safety, health model

Procedia PDF Downloads 527
18405 Embedded Hardware and Software Design of Omnidirectional Autonomous Robotic Platform Suitable for Advanced Driver Assistance Systems Testing with Focus on Modularity and Safety

Authors: Ondrej Lufinka, Jan Kaderabek, Juraj Prstek, Jiri Skala, Kamil Kosturik

Abstract:

This paper deals with the problem of using Autonomous Robotic Platforms (ARP) for the ADAS (Advanced Driver Assistance Systems) testing in automotive. There are different possibilities of the testing already in development, and lately, the autonomous robotic platforms are beginning to be used more and more widely. Autonomous Robotic Platform discussed in this paper explores the hardware and software design possibilities related to the field of embedded systems. The paper focuses on its chapters on the introduction of the problem in general; then, it describes the proposed prototype concept and its principles from the embedded HW and SW point of view. It talks about the key features that can be used for the innovation of these platforms (e.g., modularity, omnidirectional movement, common and non-traditional sensors used for localization, synchronization of more platforms and cars together, or safety mechanisms). In the end, the future possible development of the project is discussed as well.

Keywords: advanced driver assistance systems, ADAS, autonomous robotic platform, embedded systems, hardware, localization, modularity, multiple robots synchronization, omnidirectional movement, safety mechanisms, software

Procedia PDF Downloads 112
18404 Effect of Soil and Material Characteristics on Safety of Concrete Structures Including SSI

Authors: A. E. Kurtoglu, A. Cevik, M. Bilgehan

Abstract:

In this parametric study, effect of soil and material characteristics on safety of structures is investigated. The soil parameters such as shear strength, unit weight; geometrical parameters of the structure such as foundation depth and height of building; and material properties such as weight of concrete were selected as input parameters. A real accelerogram of 1989 El-Centro earthquake recorded by the USGS in Imperial Valley is used for this study. It is contained in the standard Strong Motion CD-ROM (SMC) format, which can be recognized and interpreted by FEM software used. The soil-structure interaction model subjected to above-mentioned earthquake was analyzed for 729 cases. Effect of input parameters on safety factor of the soil-structure system was then investigated and the interaction between the input and output parameters is presented in graphical form. Findings showed that all input parameters have significant effects on factor of safety results.

Keywords: factor of safety, finite element method, safety of structures, soil structure interaction

Procedia PDF Downloads 475
18403 Lean Implementation Analysis on the Safety Performance of Construction Projects in the Philippines

Authors: Kim Lindsay F. Restua, Jeehan Kyra A. Rivero, Joneka Myles D. Taguba

Abstract:

Lean construction is defined as an approach in construction with the purpose of reducing waste in the process without compromising the value of the project. There are numerous lean construction tools that are applied in the construction process, which maximizes the efficiency of work and satisfaction of customers while minimizing waste. However, the complexity and differences of construction projects cause a rise in challenges on achieving the lean benefits construction can give, such as improvement in safety performance. The objective of this study is to determine the relationship between lean construction tools and their effects on safety performance. The relationship between construction tools applied in construction and safety performance is identified through Logistic Regression Analysis, and Correlation Analysis was conducted thereafter. Based on the findings, it was concluded that almost 60% of the factors listed in the study, which are different tools and effects of lean construction, were determined to have a significant relationship with the level of safety in construction projects.

Keywords: correlation analysis, lean construction tools, lean construction, logistic regression analysis, risk management, safety

Procedia PDF Downloads 147
18402 Safety Conditions Analysis of Scaffolding on Construction Sites

Authors: M. Pieńko, A. Robak, E. Błazik-Borowa, J. Szer

Abstract:

This paper presents the results of analysis of 100 full-scale scaffolding structures in terms of compliance with legal acts and safety of use. In 2016 and 2017, authors examined scaffolds in Poland located at buildings which were at construction or renovation stage. The basic elements affecting the safety of scaffolding use such as anchors, supports, platforms, guardrails and toe-boards have been taken into account. All of these elements were checked in each of considered scaffolding. Based on the analyzed scaffoldings, the most common errors concerning assembly process and use of scaffolding were collected. Legal acts on the scaffoldings are not always clear, and this causes many issues. In practice, people realize how dangerous the use of incomplete scaffolds is only when the accident occurs. Despite the fact that the scaffolding should ensure the safety of its users, most accidents on construction sites are caused by fall from a height.

Keywords: façade scaffolds, load capacity, practice, safety of people

Procedia PDF Downloads 379
18401 E-Pharmacy: An e-Commerce Approach for Buying Medicine Online in Saudi Arabia

Authors: Syed Asif Hassan, Tabrej Khan, Ibrahim Manssor Al Najar, Mohammed Nasser

Abstract:

The incredible accomplishment achieved by e-commerce in consumer durable area encouraged us to implement the online e-commerce model to tap the business benefits of electronic pharmacy in Saudi Arabia. The Kingdom of Saudi Arabia is famous for traditional herbal medicine. The rich heritage of traditional medicine has helped the mushrooming of regional pharmaceutical industries manufacturing drugs and other therapeutic against various diseases. However, the implementation of e-commerce in pharmacy has not been employed in the Kingdom of Saudi Arabia. The electronic pharmacy (E-Pharm) is an important sector that is flourishing across the globe and providing benefits of E-Pharm to the customers and suppliers all around the world. In this context, our web-based application of electronic pharmacy is the one of its kind in the Kingdom of Saudi Arabia. Surveys and personal interviews were used to identify key objectives of the proposed web-based portal. As per the findings of the surveys and personal interviews, following key objectives were identified: (a) The online platform will be used for ordering of prescription based medications for consumers. (b) The e-portal will provide space for pharmaceutical retailers who do not have an electronic platform to upload and sell their therapeutic products in an organized way. (c) The web portal will provide a tracking system to track the customer’s behavior like choice, offer, order, shipment, payment, etc. The web-based e-pharmacy portal will be developed using MySQL and PHP. The development of e-pharmacy web portal and e-prescription practices will not only improve the growth of electronic pharmacy but would also decrease the possibility of prescription alteration thus providing safety and improving the quality of service provided to the patient or consumers.

Keywords: e-commerce, E-Pharm, MySQL, PHP

Procedia PDF Downloads 369
18400 Patient Safety of Eating Ready-Made Meals at Government Hospitals

Authors: Hala Kama Ahmed Rashwan

Abstract:

Ensuring the patient safety especially at intensive care units and those exposed to hospital tools and equipment is one of the most important challenges facing healthcare today. Outbreak of food poisoning as a result of food-borne pathogens has been reported in many hospitals and care homes all over the world due to hospital meals. Patient safety of eating hospital meals is a fundamental principle of healthcare; it is new healthcare disciplines that assure the food raw materials, food storage, meals processing, and control of kitchen errors that often lead to adverse healthcare events. The aim of this article is to promote any hospital in attaining the hygienic practices and better quality system during processing of the ready-to- eat meals for intensive care units patients according to the WHO safety guidelines.

Keywords: hospitals, meals, safety, intensive care

Procedia PDF Downloads 476