scholarly journals Validation of technological process of preparation hymoding cream with hyaluronic acid

2021 ◽  
pp. 27-35
Author(s):  
Т. Г. Ярних ◽  
Г. М. Мельник ◽  
О. А. Рухмакова
Keyword(s):  
Risk Assessment ◽  
Hyaluronic Acid ◽  
Technological Process ◽  
Critical Parameters ◽  
Documentary Evidence ◽  
Technological Parameters ◽  
Eligibility Criteria ◽  
Critical Control Points ◽  
Definition Of ◽  
The Impact

To date, in the mass production of medicines both in pharmaceutical companies and in pharmacies, more and more attention is paid to the practice of process validation. Validation is a key condition for the implementation of Good Manufacturing (GMP) and Pharmacy (GPP) practices, the standards of which are mandatory for medicines worldwide and in Ukraine. The aim of the work – validation of the technological process of preparation extemporaneous hymoding cream with hyaluronic acid in order to obtain documentary evidence of effective reproduction of the preparation of this medicine. The study design is based on research on the development of dosage form technology, analysis of the impact of critical manufacturing points and evaluation of their impact on the final quality of the cream, taking into account the requirements of GPP. The object of validation is the technological process of preparation hymoding cream with hyaluronic acid. The validation procedure was performed on 3 experimental batches of the medicine. In order to check and optimize the selected technological process of preparation hymoding cream in pharmacies, its validation was carried out. According to the calculated quantities of the components of the studied cream, as well as the identified critical parameters, three batches of the medicine of 100.00 g were developed. On the series of cream, the optimization of technological parameters, testing of critical parameters for all planned stages of production with the definition of eligibility criteria and validation scheme was carried out. Acceptance criteria for all critical parameters were determined during the optimization of technology on batches of the studied medicine. The general risk assessment was carried out at the stage of pharmaceutical development according to the procedure «identification – analysis – risk assessment» to determine the scheme of validation work on batches of the medicine. During the technological process, critical indicators were checked and appropriate forms were filled out. A study on the validation of the technological process of preparation hymoding cream with hyaluronic acid in pharmacies was performed. Documentary evidence of effective reproduction of the manufacture of this medicine has been obtained. A comprehensive analysis of the developed manufacturing process makes it possible to identify critical control points that minimize the occurrence of possible risks in the manufacture of the investigated medicine. According to the results of the research, it can be concluded that the developed cream with hyaluronic acid meets the requirements of State Pharmacopoeia of Ukraine in all quality indicators, which allows to recommend it for use in dermatology.

Colonizing Cane Toads cause population declines in native predators: reliable anecdotal information and management implications

1997 ◽  
Vol 3 (1) ◽  
pp. 65 ◽  
Author(s):  
Scott Burnett
Keyword(s):  
Risk Assessment ◽  
Habitat Management ◽  
Extinction Risk ◽  
Population Declines ◽  
Cane Toad ◽  
Research Attention ◽  
Predator Species ◽  
Continental Scale ◽  
Definition Of ◽  
The Impact

This paper presents compelling, anecdotal evidence of severe population declines in five predator species, Dasyurus hallucatus, Varanus gouldii, V. mertensi, V. panoptes, and V. timorensis similis, in almost immediate response to Cane Toad colonization of their habitat in three widely distributed areas of northern Queensland. Furthermore, risk assessment of all quoll and monitor taxa whose distributions overlap the potential distribution of the Cane Toad in Australia (Sutherst et al. 1996), indicates that at the continental scale, three of the four quoll taxa and eight of the 20 monitor species examined are at high risk of severe population declines following Cane Toad colonization. One quoll taxon and seven monitor species are at moderate risk and five monitor species are at low risk. The definition of the threat which Cane Toads pose to native predators has received very little research attention, and fundamental questions including; which predator species are most at risk (testing of the risk assessment hypotheses presented here), the extent of these risks (is there a need to manage Cane Toad impacts upon predators?), and the contexts of intraspecific variation in relative extinction risk (for example, interactions of extinction risk with predator and Cane Toad population demography, climate, landscape, and land use), need to be assessed. Assuming that Cane Toads are found to have an impact across a range of taxa and landscapes (which I propose to be likely), management of the impact of this species on predators can be approached from two not necessarily exclusive directions; management of Cane Toad populations and management of predator populations, through both population and habitat management. At this stage, however, management from either viewpoint is constrained by a lack of published information relevant to autecology and fine scale distribution of predators.

scholarly journals Quantitative risk assessment of haemolytic uremic syndrome associated with beef consumption in Argentina

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0242317
Author(s):  
Victoria Brusa ◽  
Magdalena Costa ◽  
Nora L. Padola ◽  
Analía Etcheverría ◽  
Fernando Sampedro ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Hazard Analysis ◽  
Ground Beef ◽  
Quantitative Risk Assessment ◽  
Annual Number ◽  
Production Chain ◽  
Haemolytic Uremic Syndrome ◽  
Critical Control Points ◽  
Uremic Syndrome ◽  
The Impact

We developed a quantitative microbiological risk assessment (QMRA) of haemolytic uremic syndrome (HUS) associated with Shiga toxin-producing Escherichia coli (STEC)-contaminated beef (intact beef cuts, ground beef and commercial hamburgers) in children under 15 years of age from Argentina. The QMRA was used to characterize STEC prevalence and concentration levels in each product through the Argentinean beef supply chain, including cattle primary production, cattle transport, processing and storage in the abattoir, retail and home preparation, and consumption. Median HUS probability from beef cut, ground beef and commercial hamburger consumption was <10−15, 5.4x10-8 and 3.5x10-8, respectively. The expected average annual number of HUS cases was 0, 28 and 4, respectively. Risk of infection and HUS probability were sensitive to the type of abattoir, the application or not of Hazard Analysis and Critical Control Points (HACCP) for STEC (HACCP-STEC), stx prevalence in carcasses and trimmings, storage conditions from the abattoir to retailers and home, the joint consumption of salads and beef products, and cooking preference. The QMRA results showed that the probability of HUS was higher if beef cuts (1.7x) and ground beef (1.2x) were from carcasses provided by abattoirs not applying HACCP-STEC. Thus, the use of a single sanitary standard that included the application of HACCP-STEC in all Argentinean abattoirs would greatly reduce HUS incidence. The average number of annual HUS cases estimated by the QMRA (n = 32) would explain about 10.0% of cases in children under 15 years per year in Argentina. Since other routes of contamination can be involved, including those not related to food, further research on the beef production chain, other food chains, person-to-person transmission and outbreak studies should be conducted to reduce the impact of HUS on the child population of Argentina.

scholarly journals Improving the representation of aggregation in a two-moment microphysical scheme with statistics of multi-frequency Doppler radar observations

2021 ◽  
Vol 21 (22) ◽  
pp. 17133-17166
Author(s):  
Markus Karrer ◽  
Axel Seifert ◽  
Davide Ori ◽  
Stefan Kneifel
Keyword(s):  
Size Distribution ◽  
3D Model ◽  
Doppler Radar ◽  
Terminal Velocity ◽  
Critical Parameters ◽  
Distribution Width ◽  
Radar Observations ◽  
Functional Relationships ◽  
Definition Of ◽  
The Impact

Abstract. Aggregation is a key microphysical process for the formation of precipitable ice particles. Its theoretical description involves many parameters and dependencies among different variables that are either insufficiently understood or difficult to accurately represent in bulk microphysics schemes. Previous studies have demonstrated the valuable information content of multi-frequency Doppler radar observations to characterize aggregation with respect to environmental parameters such as temperature. Comparisons with model simulations can reveal discrepancies, but the main challenge is to identify the most critical parameters in the aggregation parameterization, which can then be improved by using the observations as constraints. In this study, we systematically investigate the sensitivity of physical variables, such as number and mass density, as well as the forward-simulated multi-frequency and Doppler radar observables, to different parameters in a two-moment microphysics scheme. Our approach includes modifying key aggregation parameters such as the sticking efficiency or the shape of the size distribution. We also revise and test the impact of changing functional relationships (e.g., the terminal velocity–size relation) and underlying assumptions (e.g., the definition of the aggregation kernel). We test the sensitivity of the various components first in a single-column “snowshaft” model, which allows fast and efficient identification of the parameter combination optimally matching the observations. We find that particle properties, definition of the aggregation kernel, and size distribution width prove to be most important, while the sticking efficiency and the cloud ice habit have less influence. The setting which optimally matches the observations is then implemented in a 3D model using the identical scheme setup. Rerunning the 3D model with the new scheme setup for a multi-week period revealed that the large overestimation of aggregate size and terminal velocity in the model could be substantially reduced. The method presented is expected to be applicable to constrain other ice microphysical processes or to evaluate and improve other schemes.

scholarly journals Methodology for calculating the technological parameters of preventive deformation of the hardened parts of the "wall" type

2021 ◽  
Vol 25 (1) ◽  
pp. 8-16
Author(s):  
А. A. Makaruk ◽  
О. V. Samoylenko ◽  
Yu. N. Ivanov ◽  
N. S. Chashchin ◽  
N. V. Minaev
Keyword(s):  
Maximum Deviation ◽  
Technological Parameters ◽  
Principle Of Superposition ◽  
Acceptable Deviation ◽  
Deformation Hardening ◽  
Structural Parts ◽  
Definition Of ◽  
High Degree ◽  
The Impact ◽  
Blasting Method

The article aims to establish the effect of preventive deformation on the accuracy of aircraft parts made from the thermally hardened aluminium alloy 1933T2, after blasting hardening. Determination of the impact of preventive deformation was carried out by analysing structural parts of the "wall" type produced using various technological sequences. Sample 1 was produced using a standard manufacturing sequence: milling – blasting hardening – blasting correction. Sample 2 was produced as follows: milling – preventive deformation – hardening – blasting correction. The deformation of the samples was determined at checkpoints by deviations from flatness based on bending deflections. In sample 2, preventive deformation was performed on its ridges by a rolling device. The calculation of the technological parameters of the rolling device was conducted following the principle of superposition of individual operations, such as rolling and blasting hardening. The definition of the parameters of preventive deformation of sample 2 was based on the results ob tained for sample 1. It was established that, for both samples, the deviation from flatness after milling comprised 2.5 mm. The maximum deviation of sample 1 (without preventive deformation) after blasting hardening was 2.6 mm under a high degree of surface saturation. The maximum deviation of sample 2 (with preventive deformation) after blasting hardening did not exceed 0.4 mm, which corresponds to the acceptable deviation of such structural parts. Thus, the inclusion of the preventive deformation stage in the manufacturing process, with consideration of the deviations resulting from the milling stage, allows minimisation of deviations from the required form after blasting hardening. An analysis of the obtained re[1]sults confirmed that preventive deformation of structural parts reduces distortions after blasting hardening. Therefore, it is advisable to use the following manufacturing sequence: preventive deformation → hardening by a blasting method → correction by a blasting method.

INVESTIGATIONS OF TECHNOLOGICAL PARAMETERS IMPACT UPON QUALITY FORMATION IN SURFACE LAYER OF PARTS AT CENTRIFUGAL ROTARY PROCESSING

2021 ◽  
Vol 2021 (8) ◽  
pp. 4-13
Author(s):  
Mihail Tamarkin ◽  
Elina Tischenko ◽  
Van Nguen ◽  
Aleksey Mordovcev
Keyword(s):  
Surface Layer ◽  
High Speed ◽  
Metal Removal ◽  
Experimental Investigations ◽  
Technological Parameters ◽  
Motion Speed ◽  
Maximum Penetration ◽  
Definition Of ◽  
Surface Layer Quality ◽  
The Impact

In the paper there are carried out investigations on the definition of the basic technological parameters impact of centrifugal-rotary processing in abrasive environment upon formation of surface layer quality in the parts worked. There is used a finite element method of deformation modeling in granulated massive rotating under the impact of centrifugal forces with the use of the (Comsol Multiphysics) packet. On the basis of computer the high-speed shooting processing and theoretical investigations of the process dynamics there are defined distributions of pressures and granule motion speed in the working chamber. A specified model of abrasive granule encounter with the surface worked at the centrifugal rotary processing on the basis of the modern researches and analysis with the use of the Ansys software. The dependences are obtained for the definition of the maximum penetration depth of environment particles into the surface of the part worked, metal removal, surface roughness which adequacy is confirmed by the results of experimental investigations. There is developed a specified procedure for the computation of roughness height parameters of the surface worked and machining capacity. A specified procedure for the computation of metal removal from the surface worked of parts is offered. An algorithm for the optimization of an engineering process is developed. The investigation results are introduced into production.

scholarly journals RISK-ORIENTED APPROACH TO LABOR PROTECTION AT GRAIN PROCESS ENTERPRISES

2019 ◽  
Vol 19 (1) ◽  
pp. 4-10
Author(s):  
O. FESENKO ◽  
V. LYSYUK ◽  
Z. SAKHAROVA
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Working Conditions ◽  
Labor Protection ◽  
Security Measures ◽  
Operational Risks ◽  
Iso 31000 ◽  
Definition Of ◽  
The Impact ◽  
Oriented Approach

The article focuses on the introduction of a risk-oriented approach to labor protection at the enterprises of the grain processing industry. Such an approach is imperative in modern conditions in accordance with the Concept of reforming the system of labor protection management. This will involve the introduction of the proactive principle of “preventive actions” (prevention of hazardous events and situations) instead of the existing reactive principle of “corrective actions” (response to hazardous events and situations). A risk-oriented approach to occupational safety and health is the basis for the formation of a new national system for prevention of the operational risks. In the grain process enterprises, which have agreed their policy on labor protection with international standards, there has been an increase and improvement of the responsibility and competency of the ordinary employees and managers in the safety field, the risk of on-the-job injury has decreased. Improvement of the system of labor protection and risk management at enterprises should be carried out according to State Standard (DSTU) ISO 31000:2018 “Risk Management. Guidelines (ISO 31000:2018, IDT))”. The purpose of the standard is to reduce operational risks to an acceptable level. The main stages of the risk management process are presented. Identification of hazards, risk assessment, definition of security measures is a constituent and integral part of such a system. This is necessary to identify and understand the dangers that may arise in the course of an enterprise's activity, to assess the risk arising from a particular hazard, and to take measures to reduce the probability of occurrence of hazards. At the enterprises of the grain process industry, the identification of hazards consists in the definition of all objects, situations or actions (or their combination) that are inherent in an enterprise's activities and present a potential threat to the health and life of workers. At the same time, the different types of works and situations are considered in order to identify the dangers that are constantly present in normal working conditions, as well as the hazards, the impact of which is possible in case of deviation from normal working conditions and emergencies. Examples of possible hazardous factors at such enterprises are given. The adequacy of the existing security measures, the need for heir improvement or the introduction of other security measures are determined based on the results of the risk assessment.

scholarly journals Experimental research on vibrational digging-up of sugar beet

2018 ◽  
Vol 5 (1) ◽  
pp. 30-41
Author(s):  
V. Adamchuk ◽  
V. Bulgakov ◽  
I. Holovach ◽  
Ye. Ignatiev
Keyword(s):  
Sugar Beet ◽  
Technological Process ◽  
Experimental Research ◽  
Statistical Processing ◽  
Technological Parameters ◽  
A Value ◽  
Crop Root ◽  
The Impact ◽  
Experimental Researches

The technological process of vibrational digging-up of sugar beet has spread in many sugar beet-sowing coun- tries. The experience of using this process demonstrated its advantages compared against other ways of dig- ging-up, but there have been scarce experimental researches of the vibrational digging-up of sugar beet from soil which makes this topic urgent for sugar beet production. Aim. The experimental determination of rational parameters and modes of the vibrational digging-up working tool to ensure the required quality of conducting the technological process of digging sugar beet from soil. Methods. The methods of planning a multifactor ex- periment, fi eld studies, statistical processing, regression analysis of the experimental data with building graphic curves were applied. Results. A new model of a tool for vibrational digging-up of sugar beet from soil has been elaborated. The accepted program and method were used to conduct experimental research on the impact of the main construction and technological parameters of the vibrational digging-up working tool of the beet harvester on the quality indices of performing the technological process of harvesting sugar beet. The energy parameters of new vibrational digging-up working tools were studied in fi eld conditions via registering the values of tenzometric sensors in different modes of the device and different parameters and working modes of the vibrational digging-up tools. Conclusions. It was established that there is a value of the vibration frequency and running depth in soil of the vibrational digging-up working tool for each value of the translational veloc- ity of the vibrational digging-up machine which corresponds to minimal losses and damage to crop roots. It was also found that the degree of crop root damage depends on the conditions of performing the technological process of vibrational digging-up (soil solidity and humidity), and the weight of damaged crop roots increases with the increase in solidity and the decrease in humidity of soil.

Food Safety Security: A new Concept for Enhancing Food Safety Measures

2012 ◽  
Vol 82 (3) ◽  
pp. 216-222 ◽  
Author(s):  
Venkatesh Iyengar ◽  
Ibrahim Elmadfa
Keyword(s):  
Food Safety ◽  
Hazard Analysis ◽  
Warning System ◽  
Shared Responsibility ◽  
Fine Tuning ◽  
Strategic Action ◽  
Surveillance Network ◽  
Measurement Systems ◽  
Critical Control Points ◽  
The Impact

The food safety security (FSS) concept is perceived as an early warning system for minimizing food safety (FS) breaches, and it functions in conjunction with existing FS measures. Essentially, the function of FS and FSS measures can be visualized in two parts: (i) the FS preventive measures as actions taken at the stem level, and (ii) the FSS interventions as actions taken at the root level, to enhance the impact of the implemented safety steps. In practice, along with FS, FSS also draws its support from (i) legislative directives and regulatory measures for enforcing verifiable, timely, and effective compliance; (ii) measurement systems in place for sustained quality assurance; and (iii) shared responsibility to ensure cohesion among all the stakeholders namely, policy makers, regulators, food producers, processors and distributors, and consumers. However, the functional framework of FSS differs from that of FS by way of: (i) retooling the vulnerable segments of the preventive features of existing FS measures; (ii) fine-tuning response systems to efficiently preempt the FS breaches; (iii) building a long-term nutrient and toxicant surveillance network based on validated measurement systems functioning in real time; (iv) focusing on crisp, clear, and correct communication that resonates among all the stakeholders; and (v) developing inter-disciplinary human resources to meet ever-increasing FS challenges. Important determinants of FSS include: (i) strengthening international dialogue for refining regulatory reforms and addressing emerging risks; (ii) developing innovative and strategic action points for intervention {in addition to Hazard Analysis and Critical Control Points (HACCP) procedures]; and (iii) introducing additional science-based tools such as metrology-based measurement systems.

PERTANGGUNGJAWABAN KERUGIAN NEGARA DALAM PENGELOLAAN KEUANGAN DAERAH

EDUKASI ◽  
2018 ◽  
Vol 16 (1) ◽  
Author(s):  
Hendra Karianga
Keyword(s):  
Financial Management ◽  
Criminal Liability ◽  
The State ◽  
Legal Proceedings ◽  
Regional Finance ◽  
Regional Budget ◽  
State Finance ◽  
Budget Policy ◽  
Definition Of ◽  
The Impact

Sources of revenue and expenditure of APBD (regional budget) can be allocated to finance the compulsory affairs and optional affairs in the form of programs and activities related to the improvement of public services, job creation, poverty alleviation, improvement of environmental quality, and regional economic growth. The implications of these policies is the need for funds to finance the implementation of the functions, that have become regional authority, is also increasing. In practice, regional financial management still poses a complicated issue because the regional head are reluctant to release pro-people regional budget policy, even implication of regional autonomy is likely to give birth to little kings in region causing losses to state finance and most end up in legal proceedings. This paper discusses the loss of state finance and forms of liability for losses to the state finance. The result of the study can be concluded firstly,  there are still many differences in giving meaning and definition of the loss of state finace and no standard definition of state losses, can cause difficulties. The difficulty there is in an effort to determine the amount of the state finance losses. The calculation of state/regions losses that occur today is simply assessing the suitability of the size of the budget and expenditure without considering profits earned by the community and the impact of the use of budget to the community. Secondly, the liability for losses to the state finance is the fulfillment of the consequences for a person to give or to do something in the regional financial management by giving birth to three forms of liability, namely the Criminal liability, Civil liability, and Administrative liability.Keywords: state finance losses, liability, regional finance.

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