VALIDATION OF THE TECHNOLOGICAL PROCESS OF PRODUCTION OF THE DRUG "GLUCONIL®, COATED TABLETS, 1000 MG"

2021 ◽  
pp. 77-83
Author(s):  
А.Ю. БРАТАШОВА ◽  
З.Б. САКИПОВА ◽  
А.У. ТУЛЕГЕНОВА
Keyword(s):  
Production Process ◽  
Medicinal Product ◽  
Quality Indicators ◽  
Technological Process ◽  
Dosage Form ◽  
Optimal Parameters ◽  
Critical Stage ◽  
Safety And Efficacy ◽  
Rational Scheme

Проведена валидация технологического процесса препарата «Глюконил®, таблетки, покрытые оболочкой, 1000 мг». Для каждой критической стадии процесса определены оптимальные параметры технологического процесса, установлен перечень контролируемых показателей качества, влияющих на безопасность и эффективность лекарственного препарата, и критерии их приемлемости, разработана рациональная схема отбора образцов, обеспечивающая их репрезентативность. Результаты, полученные при производстве трех промышленных валидационных серий, доказывают постоянство и надежность процесса производства лекарственного препарата от серии к серии и для каждой единицы дозированной лекарственной формы. The technological process of the preparation «Gluconil®, coated tablets, 1000 mg» was validated. For each critical stage of the process, the optimal parameters of the technological process are determined, a list of controlled quality indicators affecting the safety and efficacy of the medicinal product, and the criteria for their acceptability are established, a rational scheme for sampling is developed, ensuring their representativeness. The results obtained in the production of three industrial validation batches prove the consistency and reliability of the production process of the medicinal product from batch to batch and for each unit of the dosage form.

scholarly journals VALIDATION RESEARCHES OF THE PRODUCTION PROCESS OF THE GLUCOSE MEDICINE INFUSION SOLUTION

2020 ◽  
Vol 140 (6) ◽  
pp. 58-70
Author(s):  
О. О. Saliy ◽  
H. H. Kuryshko ◽  
A. S. Momotenko ◽  
T. A. Palchevska
Keyword(s):  
Data Collection ◽  
Production Process ◽  
Quality Indicators ◽  
Technological Process ◽  
Validation Studies ◽  
Glucose Solution ◽  
Raw Materials ◽  
Critical Parameters ◽  
Infusion Solution

The purpose of the work is to carry out validation researches of the technological process of production of glucose solution for infusions using the bracketing approach for batches of different volumes and  fullness the filling of containers. The object of the research is the manufacturing process for the manufacture of glucose infusion solution 50 mg / ml.  Data collection was carried out on the basis of series production protocols, protocols for analysis of of raw materials and supplies, intermediate and finished products, series packaging protocols, other protocol and registration documentation of the drug production process.  Validation studies were carried out at all stages of the technological process with the determination of critical parameters, confirming the quality of the product under the investigated parameters and the reproducibility of the results when the initial parameters were changed, such asy: preparation of raw materials, solution preparation, filtration of solution, filling and capping of vials, sterilization, inspection, packaging. The technological scheme for the production of the drug Glucose solution for infusion of 50 mg / ml was determined. Validation studies and data collection were carried out on 3 industrial series, determined by the bracketing method: 2000 l with a dosage of 200 ml of medicine per bottle (min. series size, min. dosage), 5000 l and a filling volume of 400 ml (min. series size for bottles of 400 ml), 10000 l with packaging in bottles of 500 ml (max. series size, max. dosage). The obtained research results indicate the reproducibility and normativity of the quality indicators of intermediate and finished products in accordance with the regulatory documentation and declared acceptance criteria for all investigated release forms of 200 ml, 400 ml and 500 ml in glass bottles. The results of validation examinations of the technological process for preparing a solution for glucose infusion solution of 50 mg / ml is representative of the intermediate parameters of drug production and are determined to be satisfactory to ensure stable quality indicators. The results of validation researches were obtained using a scientifically based approach to the selection of limit values, risk analysis and determination of critical parameters. The results of the study are of practical importance for organizing the validation of the technological process for the production of medicines with several dosages, volumes of production series, various sizes of container filling, in order to reduce the number of tests to save resources and time.

Justification of design parameters of the fractional reaping conveyor and its devices for removal of beveled stems from under the wheels of the vehicle

2019 ◽  
Vol 1 (3) ◽  
pp. 1-10
Author(s):  
Mikhail M. Konstantinov ◽  
Ivan N. Glushkov ◽  
Sergey S. Pashinin ◽  
Igor I. Ognev ◽  
Tatyana V. Bedych
Keyword(s):  
Optimal Design ◽  
Technological Process ◽  
Design Parameters ◽  
Theoretical Studies ◽  
Optimal Parameters ◽  
Belt Conveyor ◽  
Grain Crops ◽  
Mode Of Operation ◽  
Optimal Values ◽  
Main Component

In this paper we consider the structural and technological process of the combine used in the process of separate harvesting of grain crops, as well as a number of its parameters. Among the main units of the combine, we allocate a conveyor and devices for removing beveled stems from under the wheels of the vehicle. The principle of operation of the conveyor at different phases of the Reaper and especially the removal of cut stems from under the wheels of the vehicle during operation of the Reaper. The results of theoretical studies on the establishment of the optimal design of the parameters of the belt conveyor are presented, the ranges of their optimal values are considered and determined. Studies on the establishment of optimal parameters of the screw divider in the Reaper, which is the main component of the device for removal of beveled stems, are presented. Taking into account the optimal design and mode of operation of the screw divider, the correct work is provided to remove the cut stems from under the wheels of the harvester.

МODERNIZATION TECHNOLOGY REPAIRING ACENTRIFUGAL WATER PUMP

2018 ◽  
pp. 48-51
Author(s):  
Sh.U. Yuldashev ◽  
D.T. Abdumuminova
Keyword(s):  
Production Process ◽  
Technological Process ◽  
Energy Efficient ◽  
Technical Support ◽  
Ultrasonic Processing ◽  
Water Pump ◽  
The Real ◽  
Technological Processes ◽  
Efficient Management ◽  
Pump Shaft

The article provides an overview of the principle of the pump D630-90, as well as methods for studying the real conditions of technical support to improve maintainability and optimize technological processes and systems. A technological process for the restoration of the shaft of a centrifugal water pump has been developed and an algorithm for managing it has been proposed, on the basis of which the system for energy-efficient management of the recovery area has been implemented. Also in the article some questions of use, metal-filled compound SK812, and also application of ultrasonic processing of a surface of a shaft of the centrifugal water pump of mark D630-90 are mentioned and considered. The developed technological process of pump shaft restoration showed that it is characterized by simplicity, it fits well into the production process of repair and can be widely used in repair shops.

Role and rationale of Kaala in the field of Ayurvedic Pharmaceutics - A Conceptual Approach

2017 ◽  
Vol 2 (4) ◽  
Author(s):  
Vrinda Bhat ◽  
Surekha S. Medikeri ◽  
Shobha G. Hiremath
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Preparation ◽  
Vital Role ◽  
Constant Factor ◽  
Conceptual Approach ◽  
Safety And Efficacy ◽  
Significant Aspect ◽  
Definition Of

Samskara is defined as a process of bringing about a desired modification or establishing a change of property in a drug or group of drugs. In the process of Aushadhi Nirmana, varied number of procedures (Samskaras) are adopted to inculcate the desired dosage form and efficacy to the medicine. Among all Samskaras, Kaala plays a vital role in Ayurvedic pharmaceutics. Kaala is a constant factor which follows incoherently in every step of Aushadhi Nirmana. Active principles of plants vary in every season and at different quarters of the day. After the collection of drugs for a pharmaceutical preparation, Kaala plays its role during Paka of various formulations. The definition of pharmaceutics does not end with mere production of a dosage form but also includes its safety and efficacy. Kaala has the potential to influence both these factors. Thus, our Acharyas have provided meticulous information on Ayurvedic pharmaceutics giving prime importance to a minute, yet very significant aspect called “Kaala”.

scholarly journals ESTIMATION OF STRUCTURAL SIMILARITY FOR CONTROL OF MICROELECTRONIC PRODUCTS

2019 ◽  
Vol 1 (7) ◽  
pp. 14-18
Author(s):  
Yu. A. Gusman ◽  
Yu. A. Pichugin ◽  
A. O. Smirnov
Keyword(s):  
Production Process ◽  
Technological Process ◽  
Good Reason ◽  
Structural Similarity ◽  
Fixed Number ◽  
Crystal Plate ◽  
Technological Scheme ◽  
Real Sample ◽  
Numerical Example

In this paper we consider the technological process of manufacturing micromechanical gyroscopes, the output of which is divided into cells of the crystal plate and each cell contains a fixed number of product elements. The estimation of structural similarity for measurements of technical characteristics of various devices is offered. A relatively large value of structural similarity assessment means that there is a dependence of the quality of the manufactured devices on the position on the crystal plate. This gives a good reason for further work to improve the quality of the process or to change the technological scheme as a whole. The article considers a numerical example based on a real sample of microelectronic products. The proposed method can be used both in the process of adjustment of the production process and in the rejection of products, when further configuration of the equipment is no longer possible.

scholarly journals Quality control of aluminium melt in production process

2016 ◽  
Vol 61 (Special Issue) ◽  
pp. S43-S47 ◽  
Author(s):  
M. Kotus ◽  
E. Jankajová ◽  
M. Petrík
Keyword(s):  
Quality Control ◽  
Chemical Composition ◽  
Production Process ◽  
Aluminium Alloy ◽  
Technological Process ◽  
Casting Alloy

The quality of aluminium alloy in the production process on the chemical composition basis was evaluated. The quality of casting alloy depends on the chemical composition of melt and on the technological process of production process. The basic elements such as Si, Cu, Fe, Mg and Al in melting were evaluated. The obtained data were compared with the guide data referred to in the standard for aluminium alloy.

Optimal Сontrol of Technological Process of Carburization of Automotive Gears

2016 ◽  
Vol 870 ◽  
pp. 647-653 ◽  
Author(s):  
M.Yu. Livshitc ◽  
E.A. Yakubovich
Keyword(s):  
Technological Process ◽  
Hierarchical Structure ◽  
Quality Criteria ◽  
Hardened Layer ◽  
Optimal Parameters ◽  
Carbon Distribution ◽  
Global Quality ◽  
The Hierarchical Structure ◽  
Technological Impact ◽  
The Relationship

This article presents the basis for and implementation of an approach to the development of the individualised gas carburization technology relying on optimisation of the process of carburizing surfaces of workpieces and taking into consideration working requirements. The approach is based on the hierarchical structure of carburization models, utilising the decomposition of global quality criteria and reflecting the relationship between the quality values of the hardened layer and the parameters of a technological impact on the workpiece. Taking the example of carburization of automobile gears, optimal parameters for the carburization technology are defined which minimise the duration of the process and maximise the precision of approximation to a given carbon distribution in the hardened layer within technical limitations.

Technological Principles for the Formation of Instrument Structures with Reproducible Parameters

2020 ◽  
Vol 22 (9) ◽  
pp. 489-492
Author(s):  
M.G. Mustafaev ◽  
◽  
G.A. Mustafaev ◽  
D.G. Mustafaeva ◽  
◽  
...  
Keyword(s):  
Production Process ◽  
Technological Process ◽  
Failure Mechanisms ◽  
Statistical Processing ◽  
Dielectric Strength ◽  
Design Stage ◽  
Statistical Relationships ◽  
Materials Used ◽  
The Stability ◽  
The Relationship

It is shown that increasing the role of control methods, identifying patterns and accuracy of performing technological operations, establishing the relationship between the characteristics of the technological process and the yield of suitable products, will ensure the reproducibility of technology and the formation of instrument structures with specified parameters. In the technological process of production, instrument structures are formed and constructive and technological foundations are implemented, on which the specified parameters are established in technological and final tests. Providing the specified parameters of device structures, depending on the production processes, is carried out on the basis of increasing the dielectric strength of oxide layers, improving the production process, and reducing the number of defects in oxide films. Improving the cleanliness during the production process allows you to reduce the level of defective structures. The inconsistency of the coefficients of thermal expansion of the materials used is the cause of failures of elements of integral electronics and a decrease in their reliability. Analysis of thermal effects and associated mechanical loads allows one to assess the optimality of the selected materials and to clarify the likely failure mechanisms. Knowledge of the failure mechanisms makes it possible to calculate the reliability of the device at the design stage, as well as to predict the reliability of the equipment being developed. The reproducibility of the technology is ensured by conducting a statistical analysis of the technological process, containing statistical processing, establishing statistical relationships between parameters, determining the regularities of the technological process, constructing regression models for the relationship between the yield of good products and modes of technological operations, and analyzing the stability of the technological process. The traceability of the relationship between the parameters of instrument structures and the technology of their manufacture allows to reduce the level of their defectiveness, statistical regulation, based on the measured values of the parameters, and determining their position relative to the regulation limits, ensures the accuracy of the production process.

Mathematical Substantiation of technological process of separation of forest seed HEAP

2015 ◽  
Vol 4 (1) ◽  
pp. 101-106
Author(s):  
Новиков ◽  
Artur Novikov
Keyword(s):  
Technological Process ◽  
Optimal Parameters ◽  
Seed Particles ◽  
Mathematical Justification ◽  
Logical Process

Оn the basis of the analysis of the interaction between the disk of the work-ing body of the separator with difficult allocated by the seed particles heap soft-wood given mathematical justification of the choice optimal parameters techno-logical process

scholarly journals Design of a roll crusher for sunflower stems and substantiation of the rational modes of its operation

2021 ◽  
Vol 6 (1 (114)) ◽  
pp. 28-37
Author(s):  
Viktor Sheichenko ◽  
Volodymyr Volskyi ◽  
Rostyslav Kotsiubanskyi ◽  
Viktor Dnes ◽  
Misha Shevchuk ◽  
...  
Keyword(s):  
Quality Indicators ◽  
Technological Process ◽  
Cutting Edge ◽  
Plant Residues ◽  
Causal Relationships ◽  
Additional Load ◽  
Total Level ◽  
Total Percentage ◽  
The Right ◽  
Roll Crusher

This paper reports a study of the technological process of grinding plant residues of sunflower and the causal relationships of factors that form the system of quality indicators. The necessary prerequisites for determining rational modes and parameters of the roll crusher have been devised. A prototype of the roll crusher was designed and fabricated, in which the cutting knives are arranged along the entire width of the grip in a staggered manner, with the possibility to change the angle of inclination to the axis of drum rotation in the range of 5...20°. It was established that in the case of the right-side arrangement of the cutting edge of knives, the highest total level of the percentage of crushed stems in the range of 101‒150 mm with an additional load weighing 800 kg exceeded by 1.58 times the corresponding indicators of the roll with an additional load of 600 kg. The largest overall value of the percentage of crushed stems in the range of 0‒200 mm when additionally loading the roll with 800 kg was 1.13 times higher than the corresponding indicators of the roll with an additional load of 600 kg. In the range of 0‒200 mm, with an additional load on the roll of 600 kg, at the left-side arrangement of the cutting edge of the knives of the roll, higher total percentage of crushed stems was observed compared to the right-side arrangement. At a speed of 7.45 km/h, 13.6 km/h, the cumulative value of the percentage of crushed stems exceeded the corresponding indicators at the right-side arrangement of knives by 1.09 times, at the speed of 18.6 km/h – by 1.04 times, at the speed of 22 km/h – by 1.04 times, respectively. It has been noted that at the left-side arrangement of the cutting edge of the knives of the roll, the percentage of crushed stems in the range of 51‒100 mm, with an additional load of 600 kg, exceeded the corresponding indicators with an additional load of 800 kg. At the speed of 10.08 km/h, it was exceeded by 1.9 times; at the speed of 13.6 km/h – by 1.44 times; at the speed of 18.6 km/h – by 1.96 times; at the speed of 22 km/h – by 1.99 times, respectively

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