Динамические эффекты в решетчатых структурах, изготовленных с помощью аддитивных технологий

The influence of lattice structures on the propagation of elastic waves in these structures is analyzed. The statement of problem is formulated within the framework of linear elasticity under small strains. To solve this problem, the finite element method and the Fidesys CAEsystem were used. Different variants of plane lattice structures are modeled: the classical lattice and the lattice with uniformly curved strips across the plane: elevator and star-shaped lattices. The relation between the structure of lattice structures and the propagation of perturbations in these structures is analyzed. The dependence of wave velocity in curved lattice structures on the frequency of the emitted waves is analyzed. The applied conceptual model of the device for measuring the frequency of waves is developed.В статье исследовано влияние структуры решетчатых конструкций на распространение упругих волн в них. Постановка задачи сформулирована в рамках линейной теории упругости при малых деформациях. Для решения задачи использован метод конечных элементов, реализованный в пакете прочностного анализа Fidesys. Смоделированы различные варианты плоских решетчатых структур: классическая решетка с прямолинейными прутьями и решетки с равномерно изогнутыми прутьями: лифтовая и звёздчато-круговая решетки. Исследована зависимость между структурой решетчатых конструкций и распространением возмущений в них. Выполнен анализ зависимости скорости распространения волн в изогнутых решетчатых конструкциях от частоты. Предложена прикладная концептуальная модель прибора, измеряющего частоты волн

TOPICAL ISSUES OF TRAINING OF GMP INSPECTORS

The main requirements for a quality system of GMP-inspectorate in terms of inspectors’ appropriate training were described and analyzed. The existing international recommendations in this area were summarized. It was shown that the training of inspectors should be organized and carried out on such principles as systemacy, consistency, professionalism and performance of the international recommendations on training. The additional professional retraining program for GMP inspectors/auditors was developed, tested, and approved. The developed program can be used successfully for training of GMP-inspectors from regulatory authorities of the states that are members of Eurasian Economic Union. The program can be used successfully for training of GMP-inspectors from regulatory authorities of the states that are members of BRICS after some adaptation also

Evaluation of New Risk-based Regulatory Approach to Classification of GMP Deficiencies (Review)

Introduction. This paper is devoted to analysis of a new risk-based regulatory approach to the classification of deficiencies found by inspections of medicines manufacturers, which is undoubtedly relevant.Text. The article describes the new definitions for the deficiencies found in the medicinal products manufacturing, the proposed gradation of non-conformances distinguishes from the one that is currently used. The proposed innovation in regulatory activity is that a critical deficiency can consist of several related nonconformities, none of which can be critical on their own, but which together can constitute a critical nonconformity or system failure. The proposed approach to the classification of deficiencies, which is based on a risk assessment for the patient, is described. The main stages of the risk-based algorithm are characterized: a detailed assessment of the deficiency for its preliminary classification; assessment of risk increase or decrease factors, regardless of the initial classification; making a decision on the final classification, taking into account the factors of increasing, reducing risk or their absence. Block diagrams and illustrative examples are described, on the basis of which preliminary assignment of a revealed deficiency of one or another level of criticality is carried out. The factors of increasing or decreasing risk are considered. These factors are extrapolated to the category of deficiency and they can both increase the preliminary assigned category or decrease it, and can leave the preliminary classification unchanged.Conclusion. A new risk-oriented regulatory approach to the classification of non-conformances with the requirements of Good Manufacturing Practice, proposed by the Pharmaceutical Inspection Co-operation Scheme PIC / S, is described. An analysis of this approach and its characterization are made. The new approach is based on the systematic and methodological application of risk management tools, aimed at justifiably assigning a certain criticality category to a revealed deficiency. The implementation of the new approach allows to increase the objectivity and transparency of inspection procedures. Further detailed study and possible step-by-step implementation of this new approach is very important for regulators so for medicines manufacturers

Врахування ефекту обриву полоси, що прокатується, при моделюванні електроприводів двох суміжних клітей стана холодної прокатки

The simulation model of electric drives of two adjacent rolling mills is developed, which takes into account the possibility of rolled strip breaking. The model is designed to study electromechanical transition processes in these actuators at emergency operation.Разработана имитационная модель электроприводов двух смежных клетей, в которой учитывается возожность обрыва прокатываемой полосы. Модель предназначена для исследования электромеханических передных процессов указанных электроприводов при аварийных режимах.Розроблено імітаційну модель електроприводів двох суміжних клітей, в якій враховується можливість обриву смуги, що прокатується. Модель призначена для дослідження електромеханічних перехідних процесів вказаних електроприводів при аварійних режимах

Врахування ефекту обриву полоси, що прокатується, при моделюванні електроприводів двох суміжних клітей стана холодної прокатки

The simulation model of electric drives of two adjacent rolling mills is developed, which takes into account the possibility of rolled strip breaking. The model is designed to study electromechanical transition processes in these actuators at emergency operation.Разработана имитационная модель электроприводов двух смежных клетей, в которой учитывается возожность обрыва прокатываемой полосы. Модель предназначена для исследования электромеханических передных процессов указанных электроприводов при аварийных режимах.Розроблено імітаційну модель електроприводів двох суміжних клітей, в якій враховується можливість обриву смуги, що прокатується. Модель призначена для дослідження електромеханічних перехідних процесів вказаних електроприводів при аварійних режимах