Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality

2021 ◽  
Vol 55 (4) ◽  
pp. 143-164
Author(s):  
Gerald McDonnell ◽  
Hal Baseman ◽  
Lena Cordie-Bancroft
Keyword(s):  
Microbiological Quality ◽  
Drug Products ◽  
Cell Based Therapy ◽  
Product Innovations ◽  
Healthcare Product ◽  
Process Manufacturing ◽  
Regulatory Input ◽  
Different Parts ◽  
Or Applications

Abstract In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used for similar processes or applications internationally. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated healthcare product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled healthcare products internationally. The glossary is expected to continue to evolve, and further industry, academic, and regulatory input is encouraged.

scholarly journals Proliferative activity of mesenchymal stem cells from different parts of the placenta

2021 ◽  
Vol 7 (221) ◽  
pp. 76-80
Author(s):  
Yanina Isaykina ◽  
◽  
Elena Lyakh ◽  
Maria Novikova ◽  
Yulia Savich ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Amniotic Membrane ◽  
Population Doubling ◽  
Proliferative Potential ◽  
Self Renewal ◽  
Colony Forming Unit ◽  
Cell Based Therapy ◽  
Cumulative Population Doubling ◽  
Different Parts

The ability of mesenchymal stem cells (MSCs) isolated from the decidua, chorionic tissue and amniotic membrane of the placenta to the self-renewal and the proliferation was investigated. Our results revealed that the number of colony forming unit-fibroblast (CFU-F) and the growth rate of MSCs were higher in the decidua and chorionic tissue compared to the amniotic membrane. Decidua MSCs and chorionic MSCs possessed a similar powerful proliferative potential and increased in 1010- fold in cultures for 3 months, that is 103 times more then the amniotic MSCs. The cumulative population doubling (PD) of placenta-derived MSCs was significantly higher at all passages then PD of bone marrow derived MSCs. The decidua and chorionic tissue of the placenta are ideal MSCs sources for cell based therapy.

scholarly journals Microbiological Evaluation of some Oral Antacid Suspensions Sold in Delta State, Nigeria

2021 ◽  
Vol 25 (2) ◽  
pp. 283-285
Author(s):  
C.O. Anie ◽  
S.E. Okafo
Keyword(s):  
Microbial Contamination ◽  
Microbiological Quality ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Diffusion Method ◽  
Contamination Level ◽  
Microbial Quality ◽  
Drug Products ◽  
Bacteria And Fungi ◽  
Agar Well Diffusion Method

Pharmaceutical products (non-sterile) are faced with the challenges of not exceeding the minimum limit of microbial presence tolerated for the respective formulations. Antacid suspensions which are multi-dose drug products that are utilized in the neutralization of gastric acid. This drug with neutral pH makes them to be liable to microbial contamination. This study was conducted to evaluate antacid suspensions marketed in Delta State, Nigeria based on their microbial quality. Six different brands of antacid suspensions were collected from different Pharmacies in Delta state and were analysed microbiologically to isolate and quantify the implicated bacteria and fungi using conventional cultural and biochemical techniques. The microbiological evaluation of these samples was determined using the agar-well diffusion method. Five out of the six brands evaluated were found to be populated with a hugenumber of bacteria (2.5 x 102 to > 2.2 x 102 CFU/ml) and fungi (2 x 102 to 8 x 102 CFU/ml). Staphylococcus aureus was absent in any of the antacids brands studied. However, there were presence of objectionable microorganisms, Escherichia coli and Candida albicans in three of the six brands. The results of this study reveal the microbial contamination level of some of the antacid (suspensions)  marketed in Delta State which may be due to poor adherence to current good manufacturing practice by the manufacturers. Keywords: Antacid suspensions, Microorganisms, Microbiological quality, Brands.

A Computerized Prescription Writing Program for Doctors

1985 ◽  
Vol 24 (02) ◽  
pp. 101-105
Author(s):  
C. S. Brown ◽  
S. I. Allen ◽  
D. C. Songco
Keyword(s):  
Medical Record ◽  
Drug Prescriptions ◽  
Computer Assisted ◽  
Writing Program ◽  
Typing Skill ◽  
Drug Products ◽  
Default Options ◽  
Almost All ◽  
Prescription Writing ◽  
Drug Dosages

SummaryA computer-assisted system designed to write drug prescriptions and patient instructions has been in operation in a dermatologist’s office for two years. Almost all prescriptions are generated by the machine. Drug dosages, directions, and labeling phrases are retrieved from a diagnosis-oriented formulary of 300 drug products. A prescription template with preselected default options is displayed on a terminal screen where selection is made with the use of the video pointer. Typing skill is not required, as a detailed prescription can be produced from the use of only five function keys. Prescriptions and sets of relevant instructions for the patient are computer-printed. Therapy summaries for the medical record also are automatically composed and printed.

Microbiological quality of ready to hang enteral formulas

2005 ◽  
Vol 30 (03) ◽  
Author(s):  
J Kehr ◽  
B Morales ◽  
P Contreras ◽  
L Castillo ◽  
W Aranda
Keyword(s):  
Microbiological Quality ◽  
Enteral Formulas

Comprehensive Study of Blockchain Technology - Architecture, Consensus and Future Trends

2020 ◽  
pp. 319-325
Author(s):  
Shreya Joshi ◽  
Ms Bhavyaa ◽  
Suhani Gupta ◽  
Lalita Luthra
Keyword(s):  
Internet Of Things ◽  
Product Management ◽  
Future Trends ◽  
Deep Dive ◽  
Record Keeping ◽  
Blockchain Technology ◽  
Healthcare Product ◽  
Core Technology ◽  
Technical Challenges ◽  
Comprehensive Study

Blockchain is considered to be a disruptive core technology. Although many researchers have realized the importance of blockchain, but the research of it is still emerging. It is the record-keeping technology behind bitcoin and is one of the hottest and fastest growing skills in the IT sector today. It serves as an immutable ledger which allows transactions to take place in a decentralized man Blockchain-based applications are rising up, covering numerous fields including finance, healthcare, product management, Internet of Things (IoT), and many more. However, there are still some challenges of blockchain technology such as scalability and security problems which need to be overcome. This paper comprises of a comprehensive study of Blockchain technology. We have included here a deep dive into how blockchains work, its architecture, consensus and various applications. Furthermore, technical challenges are briefly listed.

Analysis of Coliform and Colifecal Total Pollution Test on Various Types of Drinking Water Using the MPN (Most Probable Number) Method

2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Wanda Aulya ◽  
Fadhliani Fadhliani ◽  
Vivi Mardina
Keyword(s):  
Drinking Water ◽  
Fecal Coliform ◽  
Pathogenic Bacteria ◽  
Microbiological Quality ◽  
Coliform Bacteria ◽  
Most Probable Number ◽  
Inspection Method ◽  
Sample Number ◽  
Probable Number ◽  
Fecal Coliform Bacteria

Water is the main source for life and also the most severe substance caused by pollution. The mandatory parameters for determining microbiological quality of drinking water are total non-fecal Coliform bacteria and Coliform fecal (Escherichia coli). Coliform bacteria are a group of microorganisms commonly used as indicators, where these bacteria can be a signal to determine whether a water source has been contaminated by bacteria or not, while fecal Coliform bacteria are indicator bacteria polluting pathogenic bacteria originating from human feces and warm-blooded animals (mammals) . The water inspection method in this study uses the MPN (Most Probable Number) method which consists of 3 tests, namely, the presumption test, the affirmation test, and the reinforcement test. The results showed that of 15 drinking water samples 8 samples were tested positive for Coliform bacteria with the highest total bacterial value of sample number 1, 15 (210/100 ml), while 7 other samples were negative. From 8 positive Coliform samples only 1 sample was stated to be negative fecal Coliform bacteria and 7 other samples were positive for Coliform fecal bacteria with the highest total bacterial value of sample number 1 (210/100 ml).

Track 2.b Introduction: Design & Democracy

2019 ◽  
Vol 2 (1) ◽  
pp. 213
Author(s):  
Virginia TASSINARI ◽  
Ezio MANZINI ◽  
Maurizio TELI ◽  
Liesbeth HUYBRECHTS
Keyword(s):  
At Risk ◽  
Design Research ◽  
Core Theme ◽  
The Past ◽  
Noam Chomsky ◽  
Local Contexts ◽  
Democratic Discourse ◽  
Different Parts

The issue of design and democracy is an urgent and rather controversial one. Democracy has always been a core theme in design research, but in the past years it has shifted in meaning. The current discourse in design research that has been working in a participatory way on common issues in given local contexts, has developed an enhanced focus on rethinking democracy. This is the topic of some recent design conferences, such PDC2018, Nordes2017 and DRS2018, and of the DESIS Philosophy Talk #6 “Regenerating Democracy?” (www.desis-philosophytalks.org), from which this track originates. To reflect on the role and responsibility of designers in a time where democracy in its various forms is often put at risk seems an urgent matter to us. The concern for the ways in which the democratic discourse is put at risk in many different parts of the word is registered outside the design community (for instance by philosophers such as Noam Chomsky), as well as within (see for instance Manzini’s and Margolin’s call Design Stand Up (http://www.democracy-design.org). Therefore, the need to articulate a discussion on this difficult matter, and to find a common vocabulary we can share to talk about it. One of the difficulties encountered for instance when discussing this issue, is that the word “democracy” is understood in different ways, in relation to the traditions and contexts in which it is framed. Philosophically speaking, there are diverse discourses on democracy that currently inspire design researchers and theorists, such as Arendt, Dewey, Negri and Hardt, Schmitt, Mouffe, Rancière, Agamben, Rawls, Habermas, Latour, Gramsci, whose positions on this topic are very diverse. How can these authors guide us to further articulate this discussion? In which ways can these philosophers support and enrich design’s innovation discourses on design and democracy, and guide our thinking in addressing sensitive and yet timely questions, such as what design can do in what seems to be dark times for democracy, and whether design can possibly contribute to enrich the current democratic ecosystems, making them more strong and resilient?

In Quest of a Second Boom

2018 ◽  
Vol 11 (1-2) ◽  
pp. 257-278 ◽  
Author(s):  
Shirzad Azad
Keyword(s):  
Foreign Policy ◽  
Middle East ◽  
Crucial Role ◽  
Gulf Cooperation Council ◽  
East Region ◽  
Personal Motivation ◽  
Policy Measures ◽  
The Republic ◽  
Middle East Region ◽  
Different Parts

In spite of her troubled presidency at home and premature, ignominious exit from power, Park Geun-hye made serious attempts to bolster the main direction of the Republic of Korea’s (ROK) foreign policy toward the Middle East. A collaborative drive for accomplishing a new momentous boom was by and large a dominant and recurring theme in the Park government’s overall approach to the region. Park enjoyed both personal motivation as well as politico-economic justifications to push for such arduous yet potentially viable objective. Although the ROK’s yearning for a second boom in the Middle East was not ultimately accomplished under the Park presidency, nonetheless, the very aspiration played a crucial role in either rekindling or initiating policy measures in South Korea’s orientation toward different parts of a greater Middle East region, extending from the Gulf Cooperation Council (GCC) to Morocco.

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