Modern Regulatory Requirements for Gas Fire Extinguishing to Improve the Safety of Facilities

2020 ◽  
pp. 55-60
Author(s):  
N.V. Smirnov ◽  
◽  
A.V. Kazakov ◽  
D.V. Bukhtoyarov ◽  
◽  
...  
Keyword(s):  
Experimental Studies ◽  
Combustion Time ◽  
Regulatory Requirements ◽  
Fire Extinguishing ◽  
Eurasian Economic Union ◽  
Flammable Liquids ◽  
Fire Experiment ◽  
Economic Union ◽  
Selection Of

To implement the technical regulations of the Eurasian Economic Union «On the requirements for fire safety and fire extinguishing equipment» (TR EAEU 043/2017), modern regulatory requirements were developed based on the advanced domestic and foreign research in order to increase the efficiency of using automatic gas fire extinguishing installations. The domestic methodology of experimental determination of the gas extinguishing concentration in the fire chamber has a number of advantages in comparison with the foreign analogues. It is established that it is necessary to take into account the conditions of fire experience for the selection of equipment for a fire extinguishing installation with FK-5-1-12 in the process of its design, in order to ensure more complete evaporation of the liquid phase of FK-5-1-12 after leaving the nozzles. An assumption was substantiated that allows setting the normative concentration of fire extinguishing gases at the level of heptane without conducting a fire experiment to extinguish fires of flammable liquids with a flash point of more than 61 оC. In this case, the concentration value can be taken 15 % less than according to the requirements of ISO 12854: 2009. Experimental studies on extinguishing smoldering materials with gases were conducted. It was established that nitrogen, CO2, freons 114B2 and 227ea at a concentration for extinguishing heptane eliminate not only flame combustion, but also smoldering if the free combustion time does not exceed 3 min. With free combustion for more than 6 minutes, reliable suppression of smoldering is achieved when the oxygen content in the volume of the fire chamber is up to 2.5 % vol. The results of the experiments were taken into account in the draft norms for the design of fire extinguishing installations. Additional requirements were developed for gas fire extinguishing containers and selector valves, which will make it possible to exclude the use of low-quality or obsolete products as part of gas fire extinguishing installations in the territory of the Eurasian Economic Union. The developed modern requirements are included in the drafts of new regulatory documents, which were publicly discussed, and are at the approval stage.

scholarly journals DETERMINATION OF DEFORMATION IN MESH COMPOSITE STRUCTURE UNDER THE ACTION OF COMPRESSIVE LOADS

2020 ◽  
Vol 17 (35) ◽  
pp. 599-608 ◽  
Author(s):  
Alexander A. OREKHOV ◽  
Yuri A. UTKIN ◽  
Polina F. PRONINA
Keyword(s):  
Composite Material ◽  
Carbon Fiber ◽  
Bearing Capacity ◽  
Polymer Composite ◽  
Experimental Studies ◽  
Polymer Composite Material ◽  
Lightweight Mesh ◽  
Carbon Filler ◽  
Selection Of

One of the significant innovative technologies is the creation of large-sized structures that work for a long time in space and meet stringent restrictions on overall mass characteristics. Among these structures, in the first place, is the section of bearing truss (BT). This article presents the results of experimental studies of sectors of load-bearing trusses of mesh design for compression. Recently, composite mesh cylindrical shells are used as spacecraft housings. The mesh shell is a supporting structure to which the instruments and mechanisms of the spacecraft are attached. The truss section is made of cross-linked polymer composite material with carbon fibers. The objective of the tests is to confirm the possibility of creating a lightweight mesh construction using a carbon fiber reinforced polymer composite material. To achieve this goal, the authors were assigned the following tasks: selection of carbon filler of polymer composite materials (PCM); selection of PCM binder; determination of the degree of carbon fiber reinforcement; choice of the number and orientation paths of spiral ribs, number of ring ribs and the sizes of individual ribs. As a result of the research, the calculated indicators for ensuring the bearing capacity and stiffness under the application of axial compressive load were obtained. At the same time, with the determination of bearing capacity, the deformation characteristics of the structure were twice determined in order to confirm their repeatability, as well as linear nature of the dependence of axial and radial deformations as a result of the applied load.

Hydraulic characteristics and calculation of the innovative systems of surface runoff disposal

2021 ◽  
pp. 46-51
Author(s):  
Ю.В. Брянская ◽  
А.Э. Тен ◽  
Н.Т. Джумагулова ◽  
Г.Н. Громов
Keyword(s):  
Cross Sections ◽  
Surface Runoff ◽  
Experimental Studies ◽  
Drainage System ◽  
Anthropogenic Pollution ◽  
Hydraulic Characteristics ◽  
Regulatory Requirements ◽  
The Subject ◽  
Intensive Development ◽  
Selection Of

В условиях интенсивного развития новых отечественных и зарубежных технологий, материалов и оборудования, применяемых для защиты окружающей природной среды от загрязнений техногенного происхождения, особую актуальность приобретают разработки новых систем отвода и очистки поверхностных сточных вод. Эти системы позволяют использовать последние достижения отраслевой науки и оптимизировать алгоритм выполнения операций и практических приемов их гидравлического расчета. Примером является инновационная система отвода поверхностных сточных вод АСО Qmax, которая относится к открытой системе каналов (лотков) для сбора и отведения поверхностных сточных вод, формирующихся при выпадении атмосферных осадков. Однако широкому применению данного вида конструкций в России препятствует отсутствие методики их гидравлического расчета, в том числе таблиц для подбора сечений (диаметров) каналов, которая бы удовлетворяла требованиям российской нормативно-методической базы проектирования систем отведения поверхностных сточных вод. В этой связи предметом данной статьи явилась оценка гидравлических характеристик трубопроводов, каналов (лотков) системы водоотвода АСО Qmax. Приведены результаты теоретических и экспериментальных исследований гидравлических характеристик системы АСО Qmaxс учетом адаптации для российских условий и нормативных требований, а также обоснование рекомендуемых параметров для их использования. In the context of the intensive development of new domestic and foreign technologies, materials and equipment used to protect the environment from anthropogenic pollution, the development of advanced systems for surface runoff removal and treatment is of special actuality. These systems provide for using the latest achievements of the sectoral science and optimizing the algorithm for performing operations and practical methods for the hydraulic calculations. An example of the innovative surface runoff disposal system is ASO Qmax, that refers to an open system of channels for the collection and disposal of surface runoff formed during precipitation. However, the widespread use of these facilities in Russia is hampered by the lack of a method for the hydraulic calculations, including tables for the selection of cross-sections (diameters) of channels that meet the requirements of the Russian guidelines and regulations for the design of surface runoff disposal systems. In this regard, the subject of this paper is the estimation of the hydraulic characteristics of pipelines, channels of ASO Qmax drainage system. The results of theoretical and experimental studies of the hydraulic characteristics of ASO Qmax system with account of the adaptation for the Russian conditions and regulatory requirements, as well as the justification of the recommended parameters for their use are presented.

scholarly journals Rights and obligations of the broker and client in a brokerage contracts on the stock market in the EAEU member-states: doctrines, legislation, legal regulation and practice of implementation

2020 ◽  
pp. 1-24
Author(s):  
Renat Kanatovich Kanatov
Keyword(s):  
Stock Market ◽  
Legal Regulation ◽  
Comprehensive Analysis ◽  
Professional Activity ◽  
Member States ◽  
Conflict Of Interests ◽  
Eurasian Economic Union ◽  
Economic Union ◽  
Civil Codes

From the perspective of doctrines, legislation (such as civil codes), judicial and other practices, this article examines the rights and obligations of the broker and client in a nrokerage contracts in the countries of the Eurasian Economic Union. The author particularly explores certain obligations of the broker that invoke ambiguous interpretation: obligations of the broker on carrying out client’s assignment; on prevention of the conflict of interests in fulfilment of his professional activity in the stock market; on accounting of client’s funds on a special brokerage account, etc. The scientific novelty consists in comprehensive analysis of the selected circle of questions based on the material of EAEU member-states. The research results consists in determination of the theoretical and practical problems in execution of rights and obligations of the broker and his client on the stock market; formulation of recommendations on the improvement of legal regulation and harmonization of legislation of EAEU member-states in this regard.

scholarly journals Literature Monitoring for Pharmacovigilance

2019 ◽  
Vol 7 (1) ◽  
pp. 31-43
Author(s):  
A. G. Khudoshin ◽  
X. Xu ◽  
B. K. Romanov
Keyword(s):  
Good Practice ◽  
Search Strategies ◽  
Reference Database ◽  
High Recall ◽  
Eurasian Economic Union ◽  
Economic Union ◽  
Comparison Of The Results ◽  
Selection Of

Literature monitoring is a complicated aspect of pharmacovigilance. The guidelines on good practice of pharmacovigilance of the Eurasian Economic Union recommend the using of a biomedical reference database containing the maximum number of sources for the monitored drugs, which necessitates the selection of such a database. The aim of the paper is to compare the coverage and functionality of international databases of medical publications recommended for monitoring literature within pharmacovigilance in terms of coverage and functionality. The paper analyzes the coverage and presents the comparison of the results of the search in the databases Embase®, MEDLINE® and eLibrary for 35 drugs. It have been shown that the search in the Embase® database provides the maximum number of sources. In addition, the paper shows the applicability special PV Wizard functionality which facilitate the building of search strategies with high recall, sensitivity and compliance.

scholarly journals PROBLEMS OF MAKING QUALITY ASSURANCE DOCUMENTATION

2021 ◽  
Vol 93 (3) ◽  
pp. 5-13
Author(s):  
E. L. Alexandrova
Keyword(s):  
Quality Assurance ◽  
Quality Management System ◽  
Quality System ◽  
International Standards ◽  
Regulatory Requirements ◽  
Eurasian Economic Union ◽  
Pharmacy Organization ◽  
Pharmaceutical Quality System ◽  
Economic Union ◽  
The Republic

The article is devoted to the development of quality system documents for the pharmacy organization. The legislation of the Republic of Belarus, as well as the Eurasian Economic Union, requires the development and maintenance of the quality assurance system, the quality management system, the pharmaceutical quality system in a pharmacy organization, a distributor or manufacturer of medicinal products. The article presents the comparative analysis of regulatory requirements as well as approaches of the international standards ISO series to the construction of the quality systems and processes documentation. Such documents as the Quality Manual or its equivalent, Standard Operating Procedures (SOP) and Process Instructions are the most difficult to develop. The distribution of responsibility for processes within the organization is difficult to understand. On the example of RUE «BELPHARMATSIYA» it is shown how the processes in the pharmacy organization can be documented and responsibility for their implementation can be stated. The functioning of the quality system depends on the clarity of the documentation structure and its development and circulation organization. It is the responsibility of the organization authorities to maintain effective functioning of this system.

scholarly journals Approaches to Clinical Development of Combination Medicines in the Russian Federation and the Eurasian Economic Union in view of the Requirements of the Current Legislation

2019 ◽  
Vol 9 (1) ◽  
pp. 14-27
Author(s):  
A. V. Dobrovolskiy
Keyword(s):  
Russian Federation ◽  
Clinical Studies ◽  
Clinical Development ◽  
Drug Combinations ◽  
Sufficient Information ◽  
Regulatory Requirements ◽  
Eurasian Economic Union ◽  
Fixed Drug ◽  
The Russian Federation ◽  
Economic Union

In recent years, there has been an increasing interest in the development of combination medicines (fixed drug combinations) containing two or more active ingredients in a single dosage form. Therefore, there is an urgent need to develop an optimal programme of pre-authorisation clinical trials for combination medicines. The aim of the paper was to summarise modern science-based approaches to clinical development of combination medicines and identify possible ways of their practical implementation, taking into account the requirements of the current legislation. The author reviewed scientific publications devoted to creation of fixed drug combinations and analysed the regulatory documents defining regulatory requirements for pre-authorisation clinical studies of medicines in the Eurasian Economic Union, the Russian Federation, and other countries. Based on the results of the analysis the author described the general regulatory requirements for planning clinical studies of combination medicines for the purpose of their subsequent authorisation in the Russian Federation (via the national procedure) and the Eurasian Economic Union (via the centralized procedure). The pre-authorisation clinical development programme should be designed individually for each combination medicine. The selection of an optimal clinical trial strategy will make it possible to obtain sufficient information on the efficacy and safety of a combination medicine for its subsequent authorisation. 

Normative and technical regulation of production facilities in the context of the upcoming revision of Technical regulation “General requirements to fire safety”

2021 ◽  
Vol 30 (2) ◽  
pp. 5-14
Author(s):  
I. K. Bakirov ◽  
R. A. Valiullina
Keyword(s):  
Fire Safety ◽  
The Body ◽  
Federal Law ◽  
Technical Regulation ◽  
Safety Requirements ◽  
Fire Extinguishing ◽  
Eurasian Economic Union ◽  
Safety Regulations ◽  
Economic Union ◽  
Technical Regulations

Introduction. The text of draft amendments to Technical Regulation “General requirements to fire safety” was published on January 16, 2020. Draft amendments were developed with in the framework of the“regulatory guillotine”approach. The mission of the proposed amendments was to eliminate excessive and duplicative fire safety requirements, inter alia, requirements applicable to fire safety and fire extinguishing devices that had been established by Technical Regulation of the Eurasian Economic Union (EAEU)“Оn Requirements for fire safety and extinguishing devices” (TR EEU 043/2017). The purpose of this article is to substantiate the in expediency of, or, on the contrary, the need to make the proposed amendments to Federal Law No. 123-FZ of July 22, 2008 “Technical Regulation of Fire Safety Requirements”. The body (analytical part) of the work. The proposed amendments to the regulatory legal act titled “Technical Regulations on Fire Safety Requirements” were drafted within the framework of the “regulatory guillotine” approach. In the course of the comparative analysis of effective fire safety requirements and proposed amendments the co-authors came up with recommendations for their improvement. The co-authors of the article present arguments to substantiate the inexpediency of some particular amendments, but at the same time, they support the need to make other amendments to Federal Law No 123-FZ. The co-authors comment on the proposed draft document that has twenty-eight amendments.Conclusions. Fire safety regulations must represent a single consolidated document, rather than several “fragments” available in the Technical Regulations of the Eurasian Union, Technical Regulations of All-Russian Significance and Technical Regulations of Safety of Buildings and Structures.

EAEU: PRIORITY FOR THE DEVELOPMENT OF THE INDUSTRIAL COOPERATION OF THE STATES OF THE EURASIAN ECONOMIC UNION

2020 ◽  
Vol 1 (6) ◽  
pp. 140-145
Author(s):  
L. N. KRASAVINA ◽  
◽  
L. I. KHOMYAKOVA ◽  
Keyword(s):  
Industrial Development ◽  
Import Substitution ◽  
Industrial Policies ◽  
Industrial Cooperation ◽  
The Third ◽  
Eurasian Economic Union ◽  
Third Stage ◽  
Innovative Products ◽  
Economic Union ◽  
Selection Of

The article is devoted to the important problem of the industrial development in the countries of the Eurasian Economic Union in the context of the transition to the third stage of its development since mid-2014. In this regard, the authors analyzed the main directions of the industrial policies of member countries and their priority sectors. Criteria for the selection of industries are formulated in the Treaty on the EAEU, focused on the industrial policy and cooperation of the member countries of the Union and agreed upon with them by the document «Main Directions of Industrial Cooperation within the EAEU». On this basis, the article considers problems in this area and ways to solve them. The specifics of the policy of import substitution of export growth of manufacturing products and innovative products of member countries are revealed. The importance of annual monitoring of cooperation and the implementation of their projects is emphasized. The importance of creating discussion platforms on the EAEU common industry markets has been revealed.

scholarly journals COMPARISON OF REQUIREMENTS OF ANNEX 1 TO THE RULES OF GOOD MANUFACTURING PRACTICE OF THE EURASIAN ECONOMIC UNION AND REQUIREMENTS OF THE DRAFT ANNEX 1 GMP PIC/S

2020 ◽  
Vol 2 (2) ◽  
pp. 8-19
Author(s):  
Anna V. Basevich ◽  
Irina E. Kaukhova ◽  
Artemy A. Kodash ◽  
Tatyana A. Bitkina ◽  
Elena M. Smirnova ◽  
...  
Keyword(s):  
International Organizations ◽  
Action Plan ◽  
Good Manufacturing Practice ◽  
Organizational Level ◽  
Pharmaceutical Companies ◽  
Current Version ◽  
Regulatory Requirements ◽  
Eurasian Economic Union ◽  
Organizational Work ◽  
Economic Union

This article provides an overview on draft GMP EC Annex 1 revision progress and, as a consequence, the GMP PIC/S. The role and position of Russia in the pharmaceutical market, its inclusion in international organizations involved in the regulation of the production and circulation of drugs has been indicated. The interconnection between economic integration processes, changes in international regulatory requirements and national legislation has been demonstrated. The article shows how changes in the laws governing the pharmaceutical industry entail changes in the organization of manufacturing or in the approach to the manufacturing process at the organizational level and/or lead to material expenses to eliminate incompliance. Keeping track of possible future changes in legislation allows to pre-build a plan for eliminating incompliance. When analyzing the changes in the Draft Appendix 1 regarding the current version of Appendix 1, it has been revealed that the documents have significant differences. To eliminate significant incompliances with a number of paragraphs of the draft Appendix 1, it is necessary to make changes not only in the operating procedures, but also in the planning solutions of production sites. Based on the results of the work carried out, it has been established that the introduction of the draft Annex 1 GMP PIC/S and its implementation in the GMP EAEU requirements will lead to incompliance at existing pharmaceutical enterprises, the elimination of which requires a lot of organizational work. Significant changes at the existing enterprise are required in accordance with 14 points of the draft. This article presents clauses 5.9, clause 5.21, clause 8.7, clause 8.16, clause 8.29, clause 9.17, clause 9.33 - this is due to that most of these requirements are absent in the current valid requirements of GMP EAEU and Russian GMP rules. The comparison made is an occasion for pharmaceutical companies to conduct internal audits for compliance with the requirements of the draft GMP PIC/S Annex 1 in order to preventively identify incompliances and develop an action plan to address them.

scholarly journals A template-based approach to the modification of binding properties of globular proteins I: Background and motivations.

2016 ◽  
Author(s):  
Imadol V Jeff-Eke
Keyword(s):  
Experimental Studies ◽  
Binding Properties ◽  
Partial Explanation ◽  
Selection Theory ◽  
Structures And Properties ◽  
Instruction Theory ◽  
Theoretical Considerations ◽  
Selection Of

Design and production of polypeptide/proteins with desired bind site properties involves utilization of the ligand of interest in selection of those bind sites that yield the desired properties from an assortment bind sites with different structures and properties. Thus, as opposed to an “instructive” role and therefore involvement in determination of these bind site properties, the ligand instead functions in selection of bind sites with preexisting properties. Although there is consensus over this role for ligands, this was not always the case. A debate over the role of cognate ligands dominated discourse during the early- to mid- 20th century. On one hand were proponents of an instructive role (as a direct template), and on the other hand were those in support of “selective” role. Haurowitz and Pauling proposed a role for ligand in determination of bind site properties, whereas Jerne and Burnet proposed selection. Experimental studies and theoretical considerations in immunology –by Nossal and Tonegawa– and in enzymology –by Anfinsen and Haber– provided results in support of the selection theory. Thus, an acceptance of selection- over instruction theory. However, both the uniqueness of antibody production and polyclonality draw questions to the applicability of such generalization of selection theory to other non-immune proteins. It is based on these notions that we advocate reconsideration of the instruction (direct template) theory as [at least] a partial explanation of origins of ligand binding properties of peptide molecules. Such reconsiderations are especially relevant when considering some of the current challenges regarding optimization of catalytic rates of artificially engineered enzymes. In such cases, the instruction theory may stand as part of a solution. In addition, this may create an avenue for optimization of: antibody-based therapeutics; and quantitative and qualitative immunoassays; for all of which binding interactions is a crucial determinant of affinity, specificity as well as sensitivity of agent.

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