scholarly journals Pharmaceutical Cleanroom Classification using ISO 14644-1 and the EU GGMP Annex 1 Part 2: Practical Application

2020 ◽  
Author(s):  
Tim Eaton
Keyword(s):  
Key Words ◽  
Test Method ◽  
Practical Application ◽  
Medicinal Products ◽  
The Eu ◽  
Classification Test

Classification of cleanrooms and clean zones associated with the manufacture of medicinal products has been assessed in two articles. The first article discussed the classification requirements and principles associated with ISO 14644-1 and Annex 1 of the EU GGMP, and a suitable classification test method for aseptic manufacturing was derived. This second article considers the practical application of the method for the classification of a pharmaceutical cleanroom, and isolator located within it. Key words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1

scholarly journals Pharmaceutical Cleanroom Classification using ISO 14644-1 and the EU GGMP Annex 1 Part 1: Testing rationale

2020 ◽  
Author(s):  
TIm Eaton
Keyword(s):  
Control System ◽  
Key Words ◽  
Test Method ◽  
Contamination Control ◽  
System A ◽  
Airborne Contamination ◽  
The Eu ◽  
Classification Test

Cleanroom classification is an essential part of the qualification activities in pharmaceutical cleanrooms that confirm the effectiveness of the cleanroom’s airborne contamination control system. A review of the classification requirements and principles associated with ISO 14644-1:2015 and the 2008 version of Annex 1 of the EU GGMP is contained in this first article, and a suitable classification test method derived for aseptic manufacturing. A second article will consider the application of the method by means of practical examples. ​ Key words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1

FEATURES OF OPHTHALMIC CARE FOR PATIENTS WITH COMPLICATED CATARACTS

2020 ◽  
pp. 84-89
Author(s):  
Inna Ivanovna Lapkina
Keyword(s):  
Health Care ◽  
Surgical Treatment ◽  
Postoperative Complications ◽  
Key Words ◽  
Outpatient Treatment ◽  
Practical Application ◽  
Unified Approach ◽  
Case Histories ◽  
High Prevalence

Today, around 50 million people worldwide suffer from cataracts, more than a half of them need surgical treatment. High prevalence of this pathology in Ukraine, the need to improve the provision of ophthalmic care to patients, and the reform of the health care system have made the research relevant. Concomitant diseases and special conditions of the eye increase the risk of intra− and postoperative complications, worsen the functional parameters of patients after surgery. In order to develop a unified approach to the treatment of complicated cataracts based on diagnostically related groups of patients, a retrospective analysis of case histories of patients with different variants of complications related to the condition of the lens itself, its ligament apparatus and other structures of the eye was conducted. In each case, the surgeon has to choose the appropriate modification of cataract phacoemulsification surgery. The study proposed the classification of cataract phacoemulsification modifications on the basis of the techniques and the sequence of operation stages, taking into account the classification of the degrees of turbidity of the lens, proposed by L. Buratto. It has been noted that in complicated cases, according to the indications of the patient, surgery may be performed on several modifications of cataract phacoemulsification. The developed classification made it possible to generalize the various variants of pathology and greatly facilitate the choice of tactics of surgical treatment in complicated cataracts. It can be used not only for practical application, but also for improving the qualification of trained professionals. The prospect of further research is to identify contraindications for outpatient treatment of the patients with complicated cataracts. Key words: cataract complication, classification of phacoemulsification modifications, diagnostically related groups.

EFFICACY OF ENDOSCOPIC HEMOCLIPS AND INTERMITTENT INTRAVENOUS PPI IN PEPTIC ULCER BLEEDING

2019 ◽  
pp. 40-44
Author(s):  
Van Huy Tran ◽  
Duy Lieu Dinh
Keyword(s):  
Peptic Ulcer ◽  
Key Words ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Ulcer Bleeding ◽  
Peptic Ulcer Bleeding ◽  
Forrest Classification

Background: Efficacy of continuous intravenous proton- pump inhibitors (IV PPI) and hemoclips alone was proved, but data about combination of an application of endoscopy clips and intermittent IV PPI in Vietnam was still limited. This study aimed to assess the efficacy of endoscopy hemoclip combined with intermittent IV PPI in the patients of peptic ulcer bleeding. Patients and methods: 34 patients diagnosed as peptic ulcer bleeding, having Forrest classification of Ia, Ib, IIa and IIb, were enrolled. Esomeprazole was administered as 80 mg IV bolus followed by intermittent IV injection of 40 mg/8h during 72h. Results: Immediate hemostasis was achieved in all 34 patients. Only 1 patient (2.9%) had early rebleeding. No severe complications was found in this study. Conclusion: Combination of endoscopy hemoclips and intermittent PPI showed effective, safe in patients of peptic ulcer bleeding. Key words: Peptic ulcer bleeding, intermittent PPI, endoscopy hemoclip

Chronic glomerulonephritis and pregnancy

2017 ◽  
pp. 84-87
Author(s):  
O.V. Islamova ◽  
Keyword(s):  
Pregnant Women ◽  
Key Words ◽  
Fetal Development ◽  
Postpartum Period ◽  
Chronic Pyelonephritis ◽  
Diagnosis And Treatment ◽  
Chronic Glomerulonephritis

The main data on general issues of epidemiology, etiology, pathogenesis and classification of chronic glomerulonephritis (CGN) in Ukraine were described in the article. The main information on the peculiarities of this clinic disease in pregnant women, on the course and complications of pregnancy, features of fetal development in pregnant women suffering from chronic pyelonephritis were highlighted. Separately, the questions devoted to the optimal tactics of diagnosis and treatment of CGN in pregnant women with characteristics of medicines and their groups applicable in this category of patients are disclosed. The rules for management of pregnancy, delivery and postpartum period are described. Key words: сhronic glomerulonephritis, pregnancy, treatment.

Social Media Handbuch

2021 ◽  
Keyword(s):  
Social Media ◽  
Data Processing ◽  
Business Models ◽  
Practical Application ◽  
Strategy Model ◽  
The Social ◽  
Platform Economy

The Social Media Handbook provides guidance on long-term developments in the ever-changing social media sector and explains fundamental interrelationships in this field. It describes a strategy model for the development of one’s own solutions, summarises the theories, methods and models of leading authors and shows their practical application, while also highlighting current developments and dealing with the topic of data processing in social media. An examination of the platform economy with its economic functions facilitates the classification of business models in social media. The book also shows how platforms and their algorithms can influence our actions and shape our opinions. With contributions by Prof. Karin Bjerregaard Schlüter, Andrea Braun, Franziska Geue, Tobias Knopf, Markus Korbien, Prof. Dr. Daniel Michelis, Stefan Pfaff, Thanh H. Pham, Tom Reichstein, Prof. Dr. Anna Riedel, Michael Sarbacher, Prof. Dr. Dr. Thomas Schildhauer, Prof. Dr. Hendrik Send, Dr. Stefan Stumpp, Prof. Dr. Sebastian Volkmann, Jan-Benedikt Weber, Julia Weißhaupt, Norman Wiebach und Prof. Dr. Christian Wissing.

Russia and EU Countries: Partnership for Modernization

2013 ◽  
pp. 54-61
Author(s):  
T. Romanova ◽  
E. Pavlova
Keyword(s):  
Rule Of Law ◽  
New Classification ◽  
Member States ◽  
The Rule Of Law ◽  
Normative Power ◽  
Eu Member States ◽  
The World ◽  
The Difference ◽  
The Eu

The article examines how the normative power, which the EU puts forward as an ideological basis of its actions in the world, manifests itself in the national partnerships for modernization between Russia and EU member states. The authors demonstrate the influence of the EU’s normativity on its approach to modernization as well as the difference in the positions of its member countries. It is concluded that there is no unity in the EU’s approach to democracy, human rights and the rule of law, and the new classification of EU member states, which is based on their readiness to act in accordance with the Union’s concept of normative power, is offered.

scholarly journals Corporate entrepreneurship - Distilling the concept

2015 ◽  
Vol 7 (1) ◽  
pp. 69 ◽  
Author(s):  
Colene Hind ◽  
Renier Steyn
Keyword(s):  
Key Words ◽  
Corporate Entrepreneurship ◽  
The Other ◽  
Strategic Renewal ◽  
Corporate Venturing ◽  
Body Of Knowledge ◽  
Core Elements ◽  
Conceptual Confusion ◽  
Level Of Agreement

<p><strong>Background:</strong> Corporate entrepreneurship (CE) is credited for many positive organisational outcomes, including systemic growth and increased revenue. Several terms associated with CE, including strategic renewal, corporate venturing and intrapreneurship are frequently used interchangeably and often confuse scholars, researchers and practitioners. The lack of clarity about the exact meaning of these terms is detrimental to the synergy in the current body of knowledge and the development of models involving these concepts. Objective: The aim of this paper was to describe CE as a unique concept, distinguishable from related concepts. Methodology: Several definitions of CE as well as the related terms were dissected, to identify core elements associated with each of them. The validity of these comprehensive definitions was tested by requesting 68 master’s degree students to classify the definitions. Inter-rater reliabilities were calculated in order to assess the level of agreement in the classification of the constructs. Results: The results indicate that CE is difficult to distinguish from strategic renewal and corporate venturing, but that intrapreneurship seems to be better defined and separate from the other constructs. Conclusion: These results emphasise the conceptual confusion that exists around CE and the need for further clarification of terminology.</p><p><strong>KEY WORDS</strong></p><p>Corporate entrepreneurship, strategic renewal, corporate venturing, intrapreneurship.</p>

scholarly journals Lusatian Folklore in the Slavic Research of the Italian Wolfango (Wolf) Giusti

2020 ◽  
Vol 69 ◽  
pp. 36-44
Author(s):  
Yarema Kravets’ ◽  
Keyword(s):  
Key Words ◽  
Folk Songs ◽  
Folk Song ◽  
Way Of Life ◽  
Research Papers ◽  
Short Essay ◽  
Mood Classification ◽  
The Way ◽  
Literary Legacy

Purpose: The article is devoted to the Sorbian studies work of the Italian Slavic scholar of Lusatian origin Wolfango Giusti (1901-1980) “The Folk Lusatian Serbian Song” (1926), totally unknown in Ukrainian Slavic scholars’ circles. The author of a large number of Sorbian studies publications printed in the 1920s and 1930s in the pages of Italian Slavic editions, he became a true popularizer of Lusatian culture, and his works found a special reverberation in the research papers of authoritative Sorbian scholars. W. Giusti’s name as researcher and translator has recently been more frequently mentioned in Slavistic publications, his interest in Ukrainian poetry, esp. in the 1920s, is written about. The interest in W. Giusti’s literary legacy is linked, in particular, to his being interested in T. Shevchenko’s and M. Shashkevych’s lyrics. In the research under analysis, the Italian scholar stressed that “the soul of the Lusatian people has found its best and fullest expression in their folk song”. Also mentioned by W. Giusti were Ukrainian folk songs, rich in their multi-genre samples. Results: The paper presents a classification of the most characteristic folk songs, the classification coming to be basis-providing for the Italian scholar: W. Giusti relied on authoritative research papers, including those by the scholars K. Fiedler and B. Krawc. The Italian Slavicist acquaints us with songs of love between brother and sister, love songs about the way of life of the whole people, songs resonating with the motif of fidelity. Neither has the literary scholar bypassed the issue of the neighbouring peoples’ influence experienced by Lusatian culture, particularly that of a Germanic culture, providing some examples of a “spiritual analogy” with German folk songs. W. Giusti completed his short essay by promising to offer the reader, before long, “other genres of the extremely rich Lusatian folklore”. The promise came to be fulfilled as early as the next year, in the work published under the title “Folk Lusatian Serbian Songs”. Key words: Lusatian folklore, Wolfango Giusti, folk song, motif of fidelity/infidelity, dramatic mood, classification of songs, aspects of “Wendish” folklore, Germanic influence.

scholarly journals Can exports be used as an indicator of technological capabilities of countries?

Geografie ◽  
2015 ◽  
Vol 120 (3) ◽  
pp. 314-329 ◽  
Author(s):  
Jana Vlčková
Keyword(s):  
Emerging Economies ◽  
Value Added ◽  
The Philippines ◽  
Reliable Indicator ◽  
Technological Capabilities ◽  
The Past ◽  
Product Classification ◽  
Innovative Capabilities ◽  
The Eu

During the past 30 years, many emerging economies, especially China, have strengthened their technological and innovative capabilities. Have these countries started to threaten the position of traditional technological leaders? This paper examines whether technological capabilities of an economy can be evaluated based on the goods each economy exports (EXPY). Detailed product classification of exports to the EU in the period between 1984 and 2009 form the underlying data. Further, other data and studies are used to assess the reliability of EXPY. Results show that many emerging economies have significantly increased their technological sophistication; among them exports of Mexico, the Philippines and Malaysia are technologically the most sophisticated. These economies have significant share of foreign value added embodied in exports, though. Therefore, EXPY based on gross exports is not a reliable indicator of technological capabilities of countries and this indicator needs to be combined with other data.

scholarly journals Social and geographical essence of regional research of religious sphere

2014 ◽  
pp. 292-300
Keyword(s):  
Key Words ◽  
Social Geography ◽  
Human Geography ◽  
Regional Research ◽  
Distinctive Features ◽  
Geography Of Religion ◽  
Sacred Geography

The classification of human geographical subjects, their common and distinctive features has been noted. The place of geography of religion in the system of human geographical sciences has been traced. The object and subject of study of geography of religion has been identified. The regional investigations of sphere of religion have been analysed and approaches to its study have been systemized. Key words: geography of religion, sacred geography, religious sphere, social geography, human geography.

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