The assessment of the state of the innovation sphere of Poland in relation to the world level shows that Poland has educational and scientific potential allowing to produce scientific ideas and developments but the level of their commercialization remains low. As a result, Poland lags in terms of such criteria for the development of innovation sphere as labor productivity and financial support for innovation activities. The methodological basis of the study is the theory of fuzzy sets and the matrix approach — in modeling the selection of strategies to stimulate innovative development of industrial enterprises. The construction of a matrix of strategies is based on the diagnosis of the total potential of industrial enterprises and the level of its implementation in the innovation sphere. Modeling of the selection of innovation development strategy for industrial entities based on the use of fuzzy set theory in assessing the level of investment attractiveness and innovation potential of enterprises is carried out. Based on the proposed methodological approach, the strategic directions of innovative development of three Polish industrial enterprises are substantiated.
вакцинопрофилактика является одним из наиболее развитых направлений противоэпидемической защиты. в рФ для специфической профилактики туляремии применяют туляремийную живую сухую вакцину, которая в 2011 г. приказом министерства здравоохранения и социального развития рФ (№ 51н от 31 января 2011 г.) включена в национальный календарь профилактических прививок по эпидемическим показаниям. в этой связи становится очевидным необходи-Биотехнология, иММунология
Introduction. The inevitable of post-registration variations due to the improvement of production processes and quality control related to the integration of the modern technological solutions, replacement of equipment, suppliers of raw, consumables and packaging materials, improvement of form release or composition, administrative changes, as well as obtaining new data on clinical efficacy and safety of immunobiological medicinal products (IMP) during post-marketing studies.Text. The purpose of this work is to analyze the post-registration changes in the life cycle of IMP «Сholera bivalent chemical Vaccine» produced by Russian State anti-plague Research Institute «Microbe», reflecting the harmonization of the documents of the registration dossier with the innovations of the Russian legislation, the optimization of production and quality control. First of all, the changes made to the registration documentation for IMP concerned the updating of the dossier in accordance with the adopted Federal laws and Resolutions of the government of the Russian Federation. The following changes related to the optimization of methods for controlling the limit content of impurities of substances used at different stages of antigen production. Also, the changes were associated with the improvement of consumer properties of the drug, namely the introduction of modern polymer packaging and several drug’s form release, convenient for use in practical health care institutions. The latest change of Pharmacopoeia enterprise article (PEA) R N001465/01-111119 regulates the application of identification means in the form of a two-dimensional bar code (QR-code) on the packaging of medicines, which is due to compliance with the requirements of article 67 «Information on medicines. The system of monitoring the movement of medicines» Federal law N 61 «Оn medicines circulation».Conclusion. Maintaining the required level of quality of IMP when changing production technology or control requires a comprehensive analysis of the proposed changes in order to make them in the documents of the registration dossier. At the same time harmonization of documents of the registration dossier with novelties of the Russian legislation is a necessary condition for implementation of production activity within the legal field.
The aim was to evaluate the effectiveness of using the “Sterius 60” microwave disinfection system (Russia) for decontamination of objects infected with PBA of groups I–IV emerging as a result of working with infected laboratory animals.Materials and methods. Effectiveness verification of disinfection of biological waste generated as a result of the life of laboratory animals by SHF radiation was carried out in the microwave system “Sterius 60”, recommended by the manufacturer for disinfection of epidemiologically hazardous and extremely dangerous medical waste, including biological ones (classes B and C), by volumetric SHF heating. Carcasses of uninfected laboratory animals (white mice, Guinea pigs, suckling rabbits), granulated feed and bedding material (wood shavings), which are objects directly in contact with biomodels, were used as vivarium waste to be decontaminated. The following microorganisms were utilized as model test ones: Bacillus subtilus VKM B-911, Bacillus stearothermophilus VKM B-718, Bacillus licheniformis G VKM B-1711-D, Alcaligenes faecalis 415, Yersinia pestis EV, Bacillus anthracis STI. Laboratory utensils (plastic Petri dishes, porcelain mortars and pestles) were used as a mock-up chamber filler for model test microorganisms.Results and discussion. As a result of the study, data were obtained indicating that the microwave system for disinfection of medical waste “Sterius 60” is ineffective for decontamination of biological waste in laboratories working with biomodels infected with PBA of groups I–II. The established standard mode of disinfection of this system was effective only for non-spore forms of microorganisms, pathogenicity groups III–IV. Therefore, in our opinion, it is advisable to use it for decontamination of laboratory utensils infected with PBA of groups III–IV, directly at sites of waste generation.
The aim of the work was to evaluate the efficiency of using the “Fhileas 75” hydrogen peroxide vapor generator for decontaminating the air ducts of the individually ventilated system, “Bio A.S.”, for housing of infected animals.Materials and methods. The hydrogen peroxide vapor generator “Fhileas 75” (France), a disinfectant manufactured by “FHILEASAFE” (7 % hydrogen peroxide solution and 0.15 % peracetic acid solution), separately ventilated system “Bio A.S.” (Germany) for the infected animal housing were applied in the work. Serratia marcescens 9 was used as test-culture.Results and discussion. The efficiency of using the hydrogen peroxide vapor generator “Fhileas 75” for decontamination of air ducts and internal surfaces of the rack of the individually ventilated system “Bio A.S.” on the test-culture S. marcescens 9 at 1·106 mc/ml concentration has been established (operation parameters of the individually ventilated system unit are as follows: air exchange rate – 60 changes per hour, air flow volume – 28 m3/hour, number of disinfection cycles – 5, disinfectant spraying time – 97 min, exposure time – 24 hours).
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