Authors
Nikolaeva O.
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Degree
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Postgraduate, Institute of Fine Chemical Technologies named after M. V. Lomonosov «Moscow Technological University» |
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E-mail
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polyakova@mitht.ru |
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Location
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Moscow |
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Articles
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The application of the system approach for building the information space for the development of the production of ready medicines
The authors consider the application of the system approach for building the information space for
the life cycle of the production of medicines. Visualization is provided by models in the IDEF0 notation.
This approach was designed to increase visibility and simplify the perception of complex technological
processes.
The QbD principle is based on the construction of the information shell, which is well-proven and
will be understood by a wide range of readers. To implement it on the basis of a system approach, the
Shuhart-Deming cycle is used, which allows obtaining all the necessary information about the general
concept of the technological processes being built.
The combination of the PDCA cycle and the system approach is given. The system approach opens
the possibility of designing and building a single information space, which is a necessity. The criterial
approach is analyzed and system management models are constructed in Melentiev’s notation.
The article provides reference materials in the form of tables and diagrams that are required to accompany
and explain the process of building individual units and subsystems of the unified information
space being developed.
Developed control systems are based on the initial training and further use of artificial intelligence
subsystems, which is necessary to significantly reduce the number of errors in calculations at all stages
of the formation and application of projected systems. Technologies, which in the modern world are
called artificial intelligence, have long and successfully been used in various fields of life of modern
society. Their implementation should be carried out strictly in stages with strict control. General provisions
and features of control subsystems are also specified in this article.
Read more...
Optimization of the management of continuous synthesis of active pharmaceutical ingredients (API)The article discusses the development of information and algorithmic support for a system for optimizing the control of the synthesis of continuous active pharmaceutical ingredients (APIs) by the example of continuous synthesis of diphenhydramine from chlorine/ bromodiphenylmethane on microreactors. The methodological basis of the proposed development is a systematic implementation of the Quality-by-Design (QbD) principle at the stage of development of continuous synthesis of APIs. Information modeling of the synthesis of diphenhydramine in flow-type devices (microreactors) was carried out. The scheme of an intelligent information support system for the synthesis of diphenhydramine (diphenhydramine) has been developed. The developed intelligent system includes a block for the preparation of managerial decisions, which is intended to formulate on-line recommendations to a researcher conducting synthesis of finished dosage forms (SFF). The main task that is solved using this unit is to predict the quality index of the synthesis process and at the same time determine the critical values of the synthesis, which allows the researcher not to go beyond the given limits. The basis of both the prediction model of the quality assessment indicator and the critical parameters of the process are the ideas of regression analysis. An algorithm for constructing multi-feedback regression equations is presented. The constructed regression equations make it possible to formulate the optimization problem at the second stage, for the solution of which one of the modifications of the coordinate search for the optimum was chosen - the Hook - Jeeves algorithm. A generalized block diagram is presented, which reflects in its most general form an algorithm for optimizing research planning in the continuous synthesis of diphenhydramine. Some results of studies of the continuous synthesis of diphenhydramine on the eduFLOSYS microreactor system are considered. Chlorobenzohydrol and bromobenzohydrol were used as starting components. Read more...
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