The Effect of Cleanroom Design and Manufacturing Systems on the Microbiological Contamination of Aseptically Filled Products

1985 ◽  
Vol 28 (3) ◽  
pp. 25-27
Author(s):  
William Frieben
Keyword(s):  
Pharmaceutical Industry ◽  
Manufacturing Systems ◽  
Cost Effective ◽  
Pharmaceutical Products ◽  
Microbiological Contamination ◽  
Small Particles ◽  
Manufactured Products ◽  
Design And Manufacturing ◽  
Microelectronics Industry

Although cleanroom technology is employed in both the microelectronics and the pharmaceutical industry, the objectives of the two industries are different. The microelectronics industry is concerned about very small particles (i.e. < 0.3μm) in the manufacturing environment and often spends large amounts of money to control pariculate matter in the environment. The pharmaceutical industry, on the other hand, directs its efforts toward minimizing the risk of microbiological contamination. While the cleanroom extremes employed by the microelectronics industry certainly would not harm the quality of pharmaceutical products, they may not be the most cost-effective methods to minimize microbiological contamination. This paper explores various types of manufacturing constraints that can be employed to improve the sterility assurance of aseptically manufactured products.

scholarly journals International trade between Hungary and Russia within the development of the pharmaceutical industry

2022 ◽  
Vol 7 (4) ◽  
pp. 79-92
Author(s):  
R. R. Asmyatullin ◽  
I. A. Aydrus ◽  
Nagy Szabolcs
Keyword(s):  
Pharmaceutical Industry ◽  
Global Economy ◽  
Pharmaceutical Products ◽  
Pharmaceutical Market ◽  
Economic Potential ◽  
Trade Relations ◽  
Manufactured Products ◽  
Innovative Products ◽  
Political Differences ◽  
The Eu

The global pharmaceutical market is one of the most innovative and dynamically developing sectors of the global economy. In addition, this industry can be considered highly profitable. Its role has especially increased in the context during the coronavirus pandemic. This article examines trade relations between Russia and Hungary in the pharmaceutical sector. For the Hungarian economy, the pharmaceutical industry is one of the traditional and most innovative sectors of the economy: about 86% of the manufactured products are exported. Hungary is among the top 20 largest exporting and importing countries of pharmaceutical products. The main partners of Hungary are the EU countries. Russia remains an important partner of Hungary in the export of pharmaceutical products, however, it we should note the downward trend of the Russian share in Hungarian exports, due to the sanctions policy on the part of the EU. After the imposition of sanctions in 2014, the growth rate of the Russian pharmaceutical market slowed down, which also negatively affected the volume of trade cooperation with European partners. Russia has traditionally been a major importer in the global pharmaceutical market. An important problem is the reduction of drug import dependence and the expansion of exports. For Russia, this will be possible thanks to the development of unique innovative products. Hungary is an attractive country for the development and expansion of Russia's trade relations in the global pharmaceutical market. For both countries, the pharmaceutical industry is strategically important. The situation with the coronavirus pandemic has shown that political differences can be leveled. Hungary became the first European country to conclude a contract with Russia for the supply of Sputnik V coronavirus vaccine. Thus, there is a high economic potential to make up for the lost pharmaceutical relationship between the two countries.

scholarly journals Blockchain Technology Factor for Improve Good Distribution Practice in the Pharmaceutical Industry

2020 ◽  
Vol 8 (6) ◽  
pp. 2174-2180
Keyword(s):  
Pharmaceutical Industry ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Drug Distribution ◽  
Pharmaceutical Products ◽  
Related Literature ◽  
Blockchain Technology ◽  
Distribution Process ◽  
The Many

The distribution process is one of the processes that occur in all industries, including the pharmaceutical industry. The distribution of medicines in the pharmaceutical industry is the most important to provide quality pharmaceutical products to patients or consumers. With several problems that occur in the distribution of drugs in things that currently should be considered. This happens a lot due to the many drugs that disagree with the provisions or such illegal or false drugs. This research investigates the use of blockchain technology for drug distribution in Indonesia. This research uses a systematic literature review method with related literature. The results of this research found 54 blockchain factors that were used to improve nine aspects of good distribution practices and to ensure the good quality of medicines distributed to consumers

scholarly journals History and Background of the Implementation of Good Manufacturing Practice Standards in the Pharmaceutical Industry (Review)

2020 ◽  
Vol 6 (9) ◽  
pp. 182-191
Author(s):  
N. Toktonalieva ◽  
I. Toktonaliev
Keyword(s):  
Pharmaceutical Industry ◽  
Scientific Literature ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Pharmaceutical Market ◽  
High Quality ◽  
Practice Standards ◽  
International Good

The volume of the global pharmaceutical market in 2018 amounted to 1.2 trillion US dollars, and by 2020 the global pharmaceutical market has grown to 1.5 trillion dollars. Countries such as the United States, Japan, Germany, Switzerland and Great Britain took the leading positions in the pharmaceutical market, while the market share of the member states of the Eurasian Economic Union (EAEU) in the world community was 2.6%. Further growth of the global pharmaceutical market is predicted by 5% annually, which may contribute to the rapid production and distribution of low-quality pharmaceutical products. One of the main goals of the country is to provide the population with effective, high-quality and safe medicines drugs to protect their health, since consumers cannot assess the quality of medicines on their own. To accomplish this task in developed and developing countries, the state regularly checks and evaluates the quality, efficacy, safety, as well as the main pharmacological effects of drugs at all stages of production. In the production of drugs, it is necessary to comply with the rules of Good Manufacturing Practice. Good Manufacturing Practice is one of the indispensable elements of a modern control and authorization system in the field of pharmaceutical circulation, no less important than the Pharmacopoeia or other state drug standards. Materials and methods. The review article presents an analysis of published scientific works of the last 15 years. To search for reliable information, we used scientific literature data from available and open sources placed in scientific electronic databases: Cyberleninka, PubMed, E-library, Medline, J-stage, Hindawi using the keywords: Good Manufacturing Practice, GMP, pharmaceutical industry, quality of medicines. Results. When analyzing scientific literature sources, special attention is paid to the relevance of this problem, the prerequisites for the introduction of Good Manufacturing Practice standards in the pharmaceutical industry and world practice. Conclusion. Summarizing the scientific literature data, we came to the conclusion that it is necessary to comply with the basic requirements of the international Good Manufacturing Practice standard for the production of high-quality drugs, which has a positive effect on the health of consumers.

OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION

2013 ◽  
Vol 1 (1) ◽  
pp. 1-4
Author(s):  
Jitendra Kumar Badjatya
Keyword(s):  
Quality Of Life ◽  
Pharmaceutical Industry ◽  
Medical Devices ◽  
Legal Aspects ◽  
Pharmaceutical Products ◽  
Regulatory Agencies ◽  
Regulatory Requirements ◽  
Pharmaceutical Drug ◽  
Regulatory Affairs

Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrumcovering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulatedindustries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceuticalindustries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized variousindustries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a veryspecific meaning within the pharmaceutical industries.DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionalsare dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples.RA as profession is broader than registration of products, they advise companies both strategically and technically at thehighest level. Their role begins right from development of a product to making, marketing and post marketing.Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientificthinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are alsoplaced upon the claims which can be made for the product on labeling or in advertising.

Quality, Reliability and Maintenance (Q, R & M) Issues in Reconfigurable Manufacturing Systems (RMS)

2011 ◽  
Vol 110-116 ◽  
pp. 1442-1446 ◽  
Author(s):  
Dodla Srikanth ◽  
M. S. Kulkarni
Keyword(s):  
Manufacturing Systems ◽  
Production Capacity ◽  
Cost Effective ◽  
Life Cycles ◽  
Reconfigurable Manufacturing Systems ◽  
Reconfigurable Manufacturing ◽  
New Variety ◽  
Machine Reliability ◽  
Maintenance Plan

Reconfigurable Manufacturing Systems (RMS) have the potential to emerge as a cost effective solution that will help manufacturing organizations to stay competitive in an environment where product mix changes frequently and product life cycles are getting shorter. Reconfigurable Manufacturing Systems can achieve this as they are designed for quick changes in its configuration, as well as software and hardware components. This not only helps in accommodating production capacity but also production of new variety of products and introduction of new product within part family. However, the configurations have a significant impact on the productivity and reliability of the machines and the manufacturing system. In the present paper, the main objective is to present a framework consisting of Maintenance plan to be followed for the reconfigured machine, Reliability of the reconfigured machine, Quality of the product obtained. This framework can form as the basic idea and a link between maintenance, reliability and quality issues.

scholarly journals Significance of Personnel Hygiene Practices in Pharmaceutical Industry

2021 ◽  
Vol 9 (4) ◽  
pp. 1-5
Author(s):  
Anuradha Shenvi ◽  
Krishnananda Kamath K ◽  
E.V.S. Subrahmanyam ◽  
A R Shabaraya
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Product ◽  
Pharmaceutical Products ◽  
Vital Role ◽  
Hygiene Practices ◽  
Policies And Procedures ◽  
Hygiene Factors ◽  
Safe Product ◽  
Safe Working Condition

Personnel hygiene is very important in the pharmaceutical industry to prevent or reduce any kind of contamination which can affect the quality of medicinal products. When it comes to delivering highest quality standards of pharmaceutical products, key hygiene factors must to be upheld. Good personnel hygiene policies and practices are the foundation for successful product safety and purity. They are the backbone of a meaningful Good manufacturing Practices (GMP). Proper personnel training and sanitation are of prime importance. Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. All personnel should undergo medical check-up which may be a prerequisite for safe working condition. Personnel hygiene policies and procedures are to be followed by all personnel including management, visitors, production, sanitation and maintenance staff, for reducing the chance of product contamination. Personnel hygiene practices and procedures play a vital role in pharmaceutical industry in order to achieve a good quality and safe product.

scholarly journals Design and Manufacturing of a Turning Table for Polishing Tanks in Beer Industry

2020 ◽  
Vol 28 (46) ◽  
pp. 74-81
Author(s):  
Catalin Buciuman ◽  
Aurelian Adam ◽  
Laurentiu Galatan
Keyword(s):  
Surface Quality ◽  
Rotary Table ◽  
Polishing Process ◽  
Beer Industry ◽  
Manufactured Products ◽  
Design And Manufacturing ◽  
Design And Manufacture ◽  
Manufacturing Time ◽  
Made In

AbstractThe main objective of this paper was to design and manufacture a turning table for fixing conical and tori spherical heads used for tanks in beer industry, to polish the surfaces and to obtain better quality and roughness. The turning table is an indispensable fixture device in the polishing process for vessel heads, where the accuracy and the roughness of the surface is an important factor because it can influence the quality of the beer. If the surface is smooth, the microbes and bacteria cannot be deposited on the tanks’ surfaces and also a good quality of the tanks’ walls prevent contamination in the beer composition. The research were made in Inotec Company, Romania. The new proposed design for the turning table improved the actual technology and reduced the manufacturing time. The tests made on the obtained manufactured products using the rotary table showed that the surface quality was improved too.

Problems Facing the Arab Pharmaceutical Industry: A Case Study from Yemen

2016 ◽  
Vol 2 (4) ◽  
pp. 234-241
Author(s):  
Mohammed Al-Shakka ◽  
Ebtesam Abood ◽  
Adel Al-Dhubhany ◽  
Sami Abdo Radman Aldubai ◽  
Khaled Said ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Low Income ◽  
Well Being ◽  
Pharmaceutical Products ◽  
Domestic Market ◽  
Raw Material ◽  
Political Crisis ◽  
Pharmaceutical Manufacturer ◽  
University Graduates ◽  
Pharmaceutical Drugs

Because of the almost-instant connection with the welfare and well-being of individuals, pharmaceutical industry stands prominently as a very important factor for the improvement and progress of a healthy productive nation. These days, pharmaceutical industry thrives as one of the largest and exponentially expanding global industries. Nonetheless, millions of people in low income developing countries, have to suffer from the fatal consequences of the inaccessibility and non-availability of essential drugs. This is also happening in Yemen, where the pharmaceutical manufacturers sector have to face up to many challenges. The Yemen Drug Company (YEDCO) was founded in 1964 by the Yemeni government as it collaborated with private investors. It was endorsed as a company with the expertise in the medicinal drug marketing. YEDCO started its work by taking in drugs from foreign companies and then locally marketing and distributing them. In 1982, YEDCO built the first medicinal factory for drugs in Sana’a. Since then, seven companies were set up to manufacture medicines in Yemen. The expanding population has led to the need to have more pharmaceutical products. It may be understandable that pharmaceutical manufacturer companies are also hit by the political crisis in the country. Inadequate amount of fuel and raw material as well as low security status were some of the underlying factors behind these ill-effects in Yemen. Imported drugs make up about nearly 90% % of the pharmaceutical market compared to 10% drugs from the domestic market. This situation has led to an additional burden being shouldered by the national economy, where Yemen spends about US$263 million annually on pharmaceutical drugs, in reference to the national Supreme Drugs Authority. Although there is a very quick growth in the population and drugs consumption, the pharmaceutical industry has not been very active, where global pharmaceutical products play their role dominantly on the domestic market. The pharmaceutical production necessitates skilled human resources like university graduates. By contrast, the government and the private sector should also motivate the pharmaceutical industry and make use of the local employment

Influence of mineral elements on the yield and quality of grain of the prospective line in winter tritikale

2020 ◽  
Author(s):  
I.N. Voronchikhina ◽  
◽  
A.G. Marenkova ◽  
V. S. Rubets ◽  
V. V. Pylnev
Keyword(s):  
Cost Effective ◽  
Mineral Elements ◽  
Early Spring ◽  
High Potential ◽  
Winter Triticale ◽  
Yield And Quality ◽  
Fertilizer System

The results of elements development of varietal agrotechnics of a new high-potential line 238h of winter triticale presented. It was identified that under the conditions of 2020 the most cost effective fertilizer system is an early spring application of NPK (S) (15-15-15 (10)) at a dose of 200kg/ha. The profitability level of this fertilizer was 88,9%.

Regulatory Issues in Pakistan Telecommunication

1998 ◽  
Vol 37 (4II) ◽  
pp. 873-882 ◽  
Author(s):  
Sarfaraz Khan Quershi
Keyword(s):  
National Economy ◽  
Cost Effective ◽  
Market Forces ◽  
Global Trends ◽  
Regulatory Issues ◽  
Competitive Price ◽  
Modern Services ◽  
A Company ◽  
Telecom Infrastructure

Growth in telecom infrastructure and provision of modern telecom services to consumers at a cost based tariff helps growth of national economy. Modern telecoms serve as the engine of growth of national economy. Following the global trends of liberalisation and deregulation in telecoms monopolies which have thus far been providing inefficient communication at a greedily high tariffs are falling apart. Mergers in telecoms are not for increasing the size of the monopoly but to provide more efficient and cost effective services to the consumers. In Pakistan the erstwhile T&T department played a needful role at its time. Conversion of the department into a corporation and then into a company were steps necessary for following the global trends. Need now is to continue this trend further, eliminate the monopolistic approach by allowing more players in the field thus permitting the market forces to decide the provision of better quality of modern services at competitive price.

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