Search results for: GMP Annex 1

Authors: Kelvin Datonye Bob-Manuel

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The shipping industry has begun to seriously look at ways of reducing fossil fuel consumption so that current reserves can last longer and operate their ships in a more environmentally friendly way. The concept of Green Shipping or Sustainable Shipping with the use of alternative fuels is now becoming an important issue for ship owners, shipping lines and ship builders globally. This paper provides a critical review of the performance of biodiesel and natural gas-fuelled diesel engines for shipboard application. The emission reduction technique included the use of either neat or emulsified rapeseed methyl ester (RME) for pilot ignition and the emission of NOx, CO2 and SOx were measured at engine speed range of 500 - 1500 r/min. The NOx concentrations were compared with the regulated IMO MARPOL73/78, Annex VI, Tiers I, II, III and United States Environmental Protection Agency (US-EPA) standard. All NOx emissions met Tier I and II levels and the EPA standard for the minimum specification of category 1 engines at higher speed but none met the MARPOL Tier III limit which is for designated Emission Control Areas (ECAs). No trace of soot and SOx emission were observed.

Keywords: dual-fuel, biodiesel, natural gas, NOx, SOx, MARPOL 73/78 Annex VI. USEPA Tier 3, EURO V &VI

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Authors: Doris Lacej, Eni Bushi

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Cleaning and disinfection procedures are essential for maintaining the cleanliness status of the pharmaceutical manufacturing environment particularly of the cleanrooms and sterile unit area. The Good Manufacturing Practice (GMP) Annex 1 recommendation highly requires the implementation of the standard and validated cleaning and disinfection protocols. However, environmental monitoring has shown that even a validated cleaning method with certified agents may result in the presence of atypical microorganisms’ colony that exceeds GMP limits for a specific cleanroom area. In response to this issue, this case study aims to arrive at the root cause of the microbial contamination observed in the sterile production environment in Profarma pharmaceutical industry in Albania through applying a problem-solving practical approach that ensures the appropriate sterility grade. The guidelines and literature emphasize the importance of several factors in the prevention of possible microbial contamination occurring in cleanrooms, grade A and C. These factors are integrated into a practical framework, to identify the root cause of the presence of Aspergillus Niger colony in the sterile production environment in Profarma pharmaceutical industry in Albania. In addition, the application of a semi-automatic disinfecting system such as H2O2 FOG into sterile grade A and grade C cleanrooms has been an effective solution in eliminating the atypical colony of Aspergillus Niger. Selecting the appropriate detergents and disinfectants at the right concentration, frequency, and combination; the presence of updated and standardized guidelines for cleaning and disinfection as well as continuous training of operators on these practices in accordance with the updated GMP guidelines are some of the identified factors that influence the success of achieving sterility grade. However, to ensure environmental sustainability it is important to be prepared for identifying the source of contamination and making the appropriate decision. The proposed case-based practical approach may help pharmaceutical companies to achieve sterile production and cleanliness environmental sustainability in challenging situations. Apart from the integration of valid agents and standardized cleaning and disinfection protocols according to GMP Annex 1, pharmaceutical companies must be careful and investigate the source and all the steps that can influence the results of an abnormal situation. Subsequently apart from identifying the root cause it is important to solve the problem with a successful alternative approach.

Keywords: cleanrooms, disinfectants, environmental monitoring, GMP Annex 1

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Authors: Mihail Simion Beldean-Galea, Virginia Coman, Florina Copaciu, Mihaela Vlassa, Radu Mihaiescu, Adina Croitoru, Viorel Arghius, Modest Gertsiuk, Mikola Gertsiuk

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Taking into consideration the huge number of chemicals released into environment compartments a proper environmental risk assessment is difficult to predict due to the gap of legislation and improper toxicological assessment of chemicals compounds. In Romania as well as in many other countries from Europe, the chemical status of the water body is characterized taking into consideration the Water Framework Directive (WFD) and the substances listed in Annex X. This Annex includes 45 substances from different classes of organic compounds and heavy metals for which AA-EQS and MAC-EQS have been established. For other compounds which are not included in Annex X, different methodologies to prioritize chemicals for risk assessment and monitoring has been proposed. These methodologies take into account Predicted No-Effect Concentrations (PNECs) of different classes of chemicals compounds available from existing risk assessments or from read-across models for acute toxicity to the standard test organisms such as Daphnia magna and Selenastrum capricornutum. Our work presents the monitoring results of 30 priority substances including polyaromatic hydrocarbons, pesticides, halogenated compounds, plasticizers and heavy metals and other 34 substances from different classes of pesticides and pharmaceuticals which are not included on the list of priority substances, performed in the Upper Tisza River Watershed from Romania and Ukraine. The obtained monitoring data were used for the establishment of the list of more relevant pollutants in the studied area and to establish the potential river basin specific pollutants. For this purpose, two indicators such as the Frequency of exceedance and Extent of exceedance of Predicted no-Effect Concentration (PNEC) were evaluated. These two indicators are based on maximum environmental concentrations (MECs) of priority substances and for other pollutants is use statistically based averages of obtained measured concentration compared to the lowest PNEC thresholds. From the obtained results it can be concluded that polyaromatic hydrocarbon such as Fluoranthene, Benzo[a]pyrene, Benzo[b]fluorathene, benzo[k]fluoranthene, Benzo(g.h.i)perylene, Indeno(1.2.3-cd)-pyrene, heavy metals such as Cadmium, Lead and Nickel can be considered as river basin specific pollutants, their concentration exceeding the Annual Average EQS concentration. Other compounds such as estrone, estriol, 174-β estradiol, naproxen or some antibiotics (Penicillin G, Tetracycline or Ceftazidime) should be taken into account for a long monitoring, in some cases their concentration exceeding PNEC. Acknowledgements: This work is performed in the frame of NATO SfP Programme, Project no. 984440.

Keywords: prioritization, river basin specific pollutants, Tisza River, water framework directive

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Authors: Fahad Ahmed Qureshi

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There were abundant renowned financial markets in Pre-Islamic Arabs. Most of those were patterned and settled during pre-particularized sunshine. Those markets were classified either as vernacular markets helping the neighboring clans, or habitual markets that people sojourned to from all articulations of the Arabian Peninsula, such as Okaz near Mecca. Some of those markets had leading significance due to their geographical positions, such as Prime market of Eden, because of their entanglement in international trade i.e. with the markets of Sub-Continent, Abyssinia, Persia and China. Other markets such as Market of Yamamah annex its gist from being situated on the caravan crossroads. Islamic worldview and Islamic epistemology base of Financial Market’s realistic theory, pragmatic model and operative approach is moderately constrained in terms of its growth. The existent situation only parasol the form of accommodative-modification and splendid-methodologies, which due to depleted and decorous endeavor in explaining Islamic financial market theoretically. This is the demand of time that particular studies should be conduct to magnify the devours in developing theoretical framework for Islamic Financial Market.

Keywords: Islam, financial market, history, research, product development

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Authors: Nuo Xu, Kok Hun Goh, Jeyatharan Kumarasamy

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Pile load testing is significant during foundation construction due to its traditional role of design validation and routine quality control of the piling works. In order to verify whether piles can take loadings at specified settlements, piles will have to undergo working load test where the test load should normally up to 150% of the working load of a pile. Selection or sampling of piles for the working load test is done subject to the number specified in Singapore National Annex to Eurocode 7 SS EN 1997-1:2010. This paper presents an innovative way to rationalize the number of pile load test by adopting statistical analysis approach and looking at the coefficient of variance of pile elastic modulus using a case study at Singapore Tuas depot. Results are very promising and have shown that it is possible to reduce the number of working load test without influencing the reliability and confidence on the pile quality. Moving forward, it is suggested that more load test data from other geological formations to be examined to compare with the findings from this paper.

Keywords: elastic modulus of pile under soil interaction, jurong formation, kentledge test, pile load test

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Authors: Mohammad Nazri Mustafa, Pedram Hatami Abdullah, M. Fakhrur Razi Ahmad Faizul

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With the issuance of Malaysian National Annex 2017 as a part of MS EN 1998-1:2015, the seismic mapping of Malaysian Peninsular including Sabah and Sarawak has undergone some changes in terms of the Peak Ground Acceleration (PGA) value. The revision to the PGA has raised a concern on the safety of oil and gas onshore structures as these structures were not designed to accommodate the new PGA values which are much higher than the previous values used in the original design. In view of the high numbers of structures and buildings to be re-assessed, a risk assessment methodology has been developed to prioritize and rank the assets in terms of their criticality against the new seismic loading. To-date such risk assessment method for oil and gas onshore structures is lacking, and it is the main intention of this technical paper to share the risk assessment methodology and risk elements scoring finalized via Delphi Method. The finalized methodology and the values used to rank the risk elements have been established based on years of relevant experience on the subject matter and based on a series of rigorous discussions with professionals in the industry. The risk scoring is mapped against the risk matrix (i.e., the LOF versus COF) and hence, the overall risk for the assets can be obtained. The overall risk can be used to prioritize and optimize integrity assessment, repair and strengthening work against the new seismic mapping of the country.

Keywords: methodology, PGA, risk, seismic

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Authors: Saiyeed Jakaria Baksh Imran

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The earth is being endangered by many of the climate related issues today. The most serious issue for the world today is the global warming. Increase in Greenhouse gas (GHG) emissions post-industrial revolution period is the prime reason for global warming. Shipping is the fifth largest GHG emitting sector worldwide. The key reason for this is because, over 90% of the world trade is conducted through ocean as the ocean alone covers 70% of the earth surface. While the countries continue to develop, trade and commerce continue to increase between them simultaneously. However, there is no sign of reduction in GHG emission from shipping because of many concerned issues. Firstly, there is technological barrier for which ships cannot just become environment friendly immediately. Secondly, there is no alternative fuel available as well. Thirdly, there is no proper mechanism to measure how much ships emit as emission from ships vary according to the size, engine type and loading capacity of ships. The International Maritime Organization (IMO) being the governing body of the international shipping has implemented MARPOL Annex VI. However, the policy alone is not enough unless there is a proper data available regarding ship emissions, which the IMO is yet to figure out. This paper will present a critical analysis of existing IMO policies such as the Energy Efficiency Design Index (EEDI), Ship Energy Efficiency Management Plan (SEEMP), Data Collection System (SEEMP) and the IMO’s Initial Strategy on Reduction of Greenhouse Gas emissions from shipping. Also, the challenges exist in implementing such policies have been presented in the paper.

Keywords: GHG, IMO, EEDI, SEEMP, DCS, greenhouse gas, decarbonization, shipping

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Authors: K. Ivandic, F. Dodigovic, D. Stuhec, S. Strelec

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A characteristic value of certain geotechnical parameter results from an engineering assessment. Its selection has to be based on technical principles and standards of engineering practice. It has been shown that the results of engineering assessment of different authors for the same problem and input data are significantly dispersed. A survey was conducted in which participants had to estimate the force that causes a 10 cm displacement at the top of a axially in-situ compressed pile. Fifty experts from all over the world took part in it. The lowest estimated force value was 42% and the highest was 133% of measured force resulting from a mentioned static pile load test. These extreme values result in significantly different technical solutions to the same engineering task. In case of selecting a characteristic value of a geotechnical parameter the importance of the influence of an engineering assessment can be reduced by using statistical methods. An informative annex of Eurocode 1 prescribes the method of selecting the characteristic values of material properties. This is followed by Eurocode 7 with certain specificities linked to selecting characteristic values of geotechnical parameters. The paper shows the procedure of selecting characteristic values of a geotechnical parameter by using a statistical method with different initial conditions. The aim of the paper is to quantify an engineering assessment in the example of determining a characteristic value of a specific geotechnical parameter. It is assumed that this assessment is a random variable and that its statistical features will be determined. For this purpose, a survey research was conducted among relevant experts from the field of geotechnical engineering. Conclusively, the results of the survey and the application of statistical method were compared.

Keywords: characteristic values, engineering judgement, Eurocode 7, statistical methods

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Authors: Julien Acquadro, Sophie Noel, Frédéric Houze, Philippe Teste, Pascal Chretien, Clément Genet, Edouard Breniaux, Marie-Joël Menu, Florence Ansart, Marie Gressier

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This paper presents the study results of the electrical and tribological properties of nanocomposite hybrid sol-gel coatings developed for industrial applications on electrical connector housings. The electrical properties of coatings are provided by conductive fillers. The coatings presented in this study are formulated with different types of conductive carbon fillers, in this case carbon black and graphite particles. The coatings are deposited on a high-phosphorous nickel substrate by a dip-coating process. The authors have investigated the effects of the carbon black/graphite ratio on the coating's electrical and tribological properties. Electrical characterizations with a 4-probe method and AFM measurements as well as tribological tests by micro-friction shed light on the role of the black carbon/graphite ratio on the final properties of the sol-gel nanocomposite coatings. This study shows that the amount of carbon black mainly drives the coatings' electrical conduction property, while graphite's lubrication properties bring interest to reduce the values of friction coefficients (at a contact pressure of 800 MPa). In the industrial field of electrical connectors, such coatings aim at replacing cadmium and chromium (VI) protection, as recommended by REACH (Registration, Evaluation and Authorization of Chemicals) and RoHS (Restriction of Hazardous Substances in electrical and electronic equipment) regulations (Annex XVII of REACH).

Keywords: carbon conductive fillers, electrical conduction, sol-gel coatings, tribology

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Authors: Weichao Yu, Kai Wen, Weihe Huang, Yang Yang, Jing Gong

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Metal-loss corrosion is a major threat to the safety and integrity of gas pipelines as it may result in the burst failures which can cause severe consequences that may include enormous economic losses as well as the personnel casualties. Therefore, it is important to ensure the corroding pipeline integrity and efficiency, considering the value of wall thickness, which plays an important role in the failure probability of corroding pipeline. Actually, the wall thickness is controlled during pipe purchase stage. For example, the API_SPEC_5L standard regulates the allowable tolerance of the wall thickness from the specified value during the pipe purchase. The allowable wall thickness tolerance will be used to determine the wall thickness distribution characteristic such as the mean value, standard deviation and distribution. Taking the uncertainties of the input variables in the burst limit-state function into account, the reliability approach rather than the deterministic approach will be used to evaluate the failure probability. Moreover, the cost of pipe purchase will be influenced by the allowable wall thickness tolerance. More strict control of the wall thickness usually corresponds to a higher pipe purchase cost. Therefore changing the wall thickness tolerance will vary both the probability of a burst failure and the cost of the pipe. This paper describes an approach to optimize the wall thickness tolerance considering both the safety and economy of corroding pipelines. In this paper, the corrosion burst limit-state function in Annex O of CSAZ662-7 is employed to evaluate the failure probability using the Monte Carlo simulation technique. By changing the allowable wall thickness tolerance, the parameters of the wall thickness distribution in the limit-state function will be changed. Using the reliability approach, the corresponding variations in the burst failure probability will be shown. On the other hand, changing the wall thickness tolerance will lead to a change in cost in pipe purchase. Using the variation of the failure probability and pipe cost caused by changing wall thickness tolerance specification, the optimal allowable tolerance can be obtained, and used to define pipe purchase specifications.

Keywords: allowable tolerance, corroding pipeline segment, operation cost, production cost, reliability approach

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Authors: Peyton M. Provenzano

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This paper draws primarily upon the framework of necropolitics and presents California as itself a former frontier, colony, and late-modern settler society. The convergence of these successive and overlapping regimes of state terror is actualized and traceable through an analysis of historical and contemporary police practices. At the behest of the Spanish Crown and with the assistance of the Spanish military, the Catholic Church led the original expedition to colonize California. The indigenous populations of California were subjected to brutal practices of confinement and enslavement at the missions. After the annex of California by the United States, the western-most territory became an infamous frontier where new settlers established vigilante militias to enact violence against indigenous populations to protect their newly stolen land. Early mining settlements sought to legitimize and fund vigilante violence by wielding the authority of rudimentary democratic structures. White settlers circulated petitions for funding to establish a volunteer company under California’s Militia Law for ‘protection’ against the local indigenous populations. The expansive carceral practices of Los Angelinos at the turn of the 19th century exemplify the way in which California solidified its regime of exclusion as a white settler society. Drawing on recent scholarship that queers the notion of biopower and names police as street-level sovereigns, the police murder of Kayla Moore is understood as the latest manifestation of a carceral regime of exclusion and genocide. Kayla Moore was an African American transgender woman living with a mental health disability that was murdered by Berkeley police responding to a mental health crisis call in 2013. The intersectionality of Kayla’s identity made her hyper-vulnerable to state-sanctioned violence. Kayla was a victim not only of the explicitly racial biopower of police, nor the regulatory state power of necropolitics but of the ‘asphyxia’ that was intended to invisibilize both her life and her murder.

Keywords: asphyxia, biopower, california, carceral state, genocide, necropolitics, police, police violence

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Authors: C. Mazilu, D. P. Georgescu, A. Apostu, R. Deju

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Cement mortars and concretes are some of the most used construction materials in the world, global cement production being expected to grow to approx. 5 billion tons, until 2030. But, cement is an energy intensive material, the cement industry being responsible for cca. 7% of the world's CO2 emissions. Also, natural aggregates represent non-renewable resources, exhaustible, which must be used efficiently. A way to reduce the negative impact on the environment is the use of additional hydraulically active materials, as a partial substitute for cement in mortars and concretes and/or the use of recycled concrete aggregates (RCA) for the recovery of construction waste, according to EU Directive 2018/851. One of the most effective active hydraulic admixtures is microsilica and more recently, with the technological development on a nanometric scale, nanosilica. Studies carried out in recent years have shown that the introduction of SiO2 nanoparticles into cement matrix improves the properties, even compared to microsilica. This is due to the very small size of the nanosilica particles (<100nm) and the very large specific surface, which helps to accelerate cement hydration and acts as a nucleating agent to generate even more calcium hydrosilicate which densifies and compacts the structure. The cementitious compositions containing recycled concrete aggregates (RCA) present, in generally, inferior properties compared to those obtained with natural aggregates. Depending on the degree of replacement of natural aggregate, decreases the workability of mortars and concretes with RAC, decrease mechanical resistances and increase drying shrinkage; all being determined, in particular, by the presence to the old mortar attached to the original aggregate from the RAC, which makes its porosity high and the mixture of components to require more water for preparation. The present study aims to use micro and nanosilica for increase the performance of some mortars and concretes obtained with RCA. The research focused on two types of cementitious systems: a special mortar composition used for encapsulating Low Level radioactive Waste (LLW); a composition of structural concrete, class C30/37, with the combination of exposure classes XC4+XF1 and settlement class S4. The mortar was made with 100% recycled aggregate, 0-5 mm sort and in the case of concrete, 30% recycled aggregate was used for 4-8 and 8-16 sorts, according to EN 206, Annex E. The recycled aggregate was obtained from a specially made concrete for this study, which after 28 days was crushed with the help of a Retsch jaw crusher and further separated by sieving on granulometric sorters. The partial replacement of cement was done progressively, in the case of the mortar composition, with microsilica (3, 6, 9, 12, 15% wt.), nanosilica (0.75, 1.5, 2.25% wt.), respectively mixtures of micro and nanosilica. The optimal combination of silica, from the point of view of mechanical resistance, was later used also in the case of the concrete composition. For the chosen cementitious compositions, the influence of micro and/or nanosilica on the properties in the fresh state (workability, rheological characteristics) and hardened state (mechanical resistance, water absorption, freeze-thaw resistance, etc.) is highlighted.

Keywords: cement, recycled concrete aggregates, micro/nanosilica, durability

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