scholarly journals Implementation and validation of an in-house combined fluorescein/media-fill test to qualify radiopharmacy operators

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Cyril Fersing ◽  
Emmanuel Deshayes ◽  
Sarah Langlet ◽  
Laurence Calas ◽  
Vincent Lisowski ◽  
...  
Keyword(s):  
Quality Management System ◽  
Growth Promotion ◽  
Evaluation Criteria ◽  
Average Score ◽  
Test And Evaluation ◽  
Promising Tool ◽  
Post Evaluation ◽  
Evaluation Protocol ◽  
Growth Properties ◽  
General Chapter

Abstract Background The purpose of this work was to design, validate and implement a media-fill test combined with fluorescein (MFT-F) for the specific qualification and training of radiopharmacy operators, in accordance with United States Pharmacopeia General Chapter 797 and European Good Manufacturing Practices. MFT-F was embedded in the quality management system of our radiopharmacy unit. Its validation involved fluorescein concentration choice, media growth promotion test and evaluation protocol controls (with or without intentional aseptic mistakes). Each operator was evaluated following a three-part evaluation form. Evaluation criteria related to garbing and hygiene, fluorescent contamination and bacteriological contamination (pre- and post-evaluation environment controls and MFT-F samples). Combined MFT-F allowed the assessment of aseptic compounding skills and non-contamination of the working area through a single evaluation. It was also designed to fit the constraints of radiopharmacy common practice related to radiation protection equipment and to the small volumes handled. Results A 0.01% fluorescein concentration was chosen to prepare MFT-F. Addition of fluorescein in the culture medium did not jeopardize its growth properties according to growth promotion test. Eleven operators were evaluated and carried out 3 MFT-F over 3 successive days. Pre- and post-evaluation bacteriological controls of every session showed no CFU of microbiological contaminant above 5. All operators validated the garbing and hygiene evaluation, with an average score of 92.7%. All operators validated the fluorescent contamination evaluation, with an average score of 29.4 out of 30. None of the MFT-F samples showed any visible bacterial growth after incubation. Conclusions Combined MFT-F, as a part of a comprehensive sterile compounding training program, appeared as a convenient and promising tool to increase both the sterile compounding safety and awareness of radioactive contamination in radiopharmacy.

scholarly journals Comparison of Spectroscopic Techniques Combined with Chemometrics for Cocaine Powder Analysis

2020 ◽  
Vol 44 (8) ◽  
pp. 851-860
Author(s):  
Joy Eliaerts ◽  
Natalie Meert ◽  
Pierre Dardenne ◽  
Vincent Baeten ◽  
Juan-Antonio Fernandez Pierna ◽  
...  
Keyword(s):  
Gas Chromatography ◽  
Near Infrared ◽  
Evaluation Criteria ◽  
Classification Model ◽  
Support Vector ◽  
Spectroscopic Techniques ◽  
Data Set ◽  
Promising Tool ◽  
Powder Analysis ◽  
Mir Spectra

Abstract Spectroscopic techniques combined with chemometrics are a promising tool for analysis of seized drug powders. In this study, the performance of three spectroscopic techniques [Mid-InfraRed (MIR), Raman and Near-InfraRed (NIR)] was compared. In total, 364 seized powders were analyzed and consisted of 276 cocaine powders (with concentrations ranging from 4 to 99 w%) and 88 powders without cocaine. A classification model (using Support Vector Machines [SVM] discriminant analysis) and a quantification model (using SVM regression) were constructed with each spectral dataset in order to discriminate cocaine powders from other powders and quantify cocaine in powders classified as cocaine positive. The performances of the models were compared with gas chromatography coupled with mass spectrometry (GC–MS) and gas chromatography with flame-ionization detection (GC–FID). Different evaluation criteria were used: number of false negatives (FNs), number of false positives (FPs), accuracy, root mean square error of cross-validation (RMSECV) and determination coefficients (R2). Ten colored powders were excluded from the classification data set due to fluorescence background observed in Raman spectra. For the classification, the best accuracy (99.7%) was obtained with MIR spectra. With Raman and NIR spectra, the accuracy was 99.5% and 98.9%, respectively. For the quantification, the best results were obtained with NIR spectra. The cocaine content was determined with a RMSECV of 3.79% and a R2 of 0.97. The performance of MIR and Raman to predict cocaine concentrations was lower than NIR, with RMSECV of 6.76% and 6.79%, respectively and both with a R2 of 0.90. The three spectroscopic techniques can be applied for both classification and quantification of cocaine, but some differences in performance were detected. The best classification was obtained with MIR spectra. For quantification, however, the RMSECV of MIR and Raman was twice as high in comparison with NIR. Spectroscopic techniques combined with chemometrics can reduce the workload for confirmation analysis (e.g., chromatography based) and therefore save time and resources.

MPEG-7 TEXTURE DESCRIPTORS

2001 ◽  
Vol 01 (03) ◽  
pp. 547-563 ◽  
Author(s):  
PENG WU ◽  
YANGLIM CHOI ◽  
YONG MAN RO ◽  
CHEE SUN WON
Keyword(s):  
Similarity Search ◽  
Texture Classification ◽  
Evaluation Criteria ◽  
Image Search ◽  
Texture Descriptor ◽  
Comprehensive Overview ◽  
Test And Evaluation ◽  
Evaluation Phase ◽  
Competitive Test ◽  
Edge Histogram

A texture description is useful in many applications including similarity based image search and browsing. We present here three texture descriptors that are being considered for the final committee draft of the ISO/MPEG-7 standard. A comprehensive overview of the syntax and semantics of these texture descriptors is provided. The Homogeneous Texture Descriptor (HTD) and the Edge Histogram Descriptor (EHD) are useful in similarity search. The HTD characterizes homogeneous texture regions and is also useful in texture classification and recognition. The EHD is applicable when the underlying texture is not homogeneous and can also be used in sketch based retrieval. In addition, a compact descriptor that facilitates browsing applications is also defined. These descriptors are selected after a highly competitive test and evaluation phase within the MPEG group and we briefly summarize the evaluation criteria, the datasets used and the experimental results.

Test and Evaluation for Weapon Systems

2019 ◽  
pp. 98-110 ◽  
Author(s):  
Levent Eriskin ◽  
Murat M. Gunal
Keyword(s):  
Modeling And Simulation ◽  
Evaluation Criteria ◽  
Decision Makers ◽  
Value For Money ◽  
Weapon Systems ◽  
Defense Systems ◽  
Test And Evaluation ◽  
Systems Requirements

Defense systems are complex and expensive and decision makers acquiring these systems aspire better value for money. As part of a procurement decision, test and evaluation (T&E) is conducted to assess if the system is meeting desired requirements. This chapter reviews the concepts in T&E for weapon systems in the navy and presents the process for its implementation. The authors point out the role of modeling and simulation and how to use them to support T&E. The review reveals that developmental and operational T&E can examine weapon systems requirements before their deployment, T&E process can effectively be implemented in six steps, and mission/capacity requirements must be decomposed into predefined evaluation criteria.

scholarly journals Quality Management Systems in the Ambulant Sector: An Analytical Comparison of Different Quality Management Systems

2019 ◽  
Vol 16 (3) ◽  
pp. 444
Author(s):  
Marcus Gumpert ◽  
Jens-Peter Reese
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Family Physicians ◽  
Management Systems ◽  
Average Score ◽  
Family Practitioner ◽  
Quality Management Systems ◽  
Medical Practices ◽  
Quality Categories

Background: Since 1 January 2004, all physicians, psychotherapists, and medical care centers that are under contract to statutory healthcare in Germany are obliged, according to § 135a Section 2 of the Fifth Social Security Statute Book, to introduce an intra-institutional quality management system. Methods: A total of 24 medical practices were chosen through random sampling. In total, there were 12 family physicians and specialist practices each and eight practices each per quality management system. The analysis was carried out with the help of three specially developed questionnaires (physician, employee, and patient). A total of 26 quality categories with different questions were available in the three survey groups (physicians, employees, and patients). The Kruskal–Wallis test checked the extent to which the different scores between the quality management systems were significant and effective for specialists or family physicians. Results: ”Quality and Development in Practices (QEP)” had the highest average score. Due to a specific family practitioner specialism, “Quality management in Saxony medical practices (QisA)” followed with good average scores. The individual quality categories in the quality management systems, such as the “range of services” or “allocation of appointments”, received the highest average scores among the specialists. In contrast, categories such as “telephone enquiries” and “external cooperation and communication” received the highest average scores among the family physicians. Conclusion: Differences in the evaluation of quality management systems and medical groups (specialists/family physicians) were found in the study. The reasons for these differences could be found in the quality categories.

scholarly journals Effect of Native Trichoderma asperellum Isolate on Phosphate Solubilization and Growth of Pea

2021 ◽  
Vol 24 (2) ◽  
pp. 121-124
Author(s):  
SMN Islam ◽  
MZH Chowdhury ◽  
NJ Mishu
Keyword(s):  
Phosphate Solubilization ◽  
Growth Promotion ◽  
Dry Weight ◽  
P Uptake ◽  
Shoot Biomass ◽  
Post Inoculation ◽  
Trichoderma Asperellum ◽  
Solution Ph ◽  
Promising Tool ◽  
Botanical Research

Application of phosphorus solubilizing microbes is a promising tool for enhancing P uptake in plant. The aim of this study was to evaluate the phosphate solubilization potential and growth promotion of pea (Pisum sativum L.) by native Trichoderma asperellum isolate G3. Phosphate solubilization by T. asperellum strain was assessed in National Botanical Research Institute’s Phosphate (NBRIP) broth medium. Pea plants were inoculated by Trichoderma strain and grown in pot in phosphate deficit condition. The fungal strain was able to solubilize phosphate (from 188.95±2.04 to 262.50±3.80 mgL-1) in broth at different time periods and decreased solution pH. The Trichoderma inoculated pea plant increased the root growth, shoot growth, leaf number, shoot biomass, root biomass, total dry weight, chlorophyll a, chlorophyll b and carotenoid by 23.9%, 33.3%, 33%, 37.1%, 32.7%, 28.4%, 24.5%, 17.4% and 14.7% respectively over control after 5 weeks of post inoculation. The results showed that the native T. asperellum isolate G3 has great potential in the phosphorus solubilization. Ann. Bangladesh Agric. (2020) 24(2) : 121-124

DEVELOPMENT OF A PROCESS GUIDE ALGORITHM QMS «PRESERVATION OF PRODUCT CONFORMITY» ON THE SMALL INNOVATIVE ENTERPRISE«MIKROVINODELIE, LLC»

2020 ◽  
Author(s):  
И.А. ИЛЬИНА ◽  
И.А. МАЧНЕВА ◽  
А.О. ЧУЙКО
Keyword(s):  
Quality Management ◽  
Quality Management System ◽  
Evaluation Criteria ◽  
Raw Material ◽  
Management Process ◽  
Output Data ◽  
Input And Output ◽  
Material Procurement ◽  
Distribution Matrix ◽  
Innovative Enterprise

Разработано руководство процесса СМК «Сохранение соответствия продукции» для малого виноградоперерабатывающего предприятия ООО МИП «Микровиноделие». Разработана структура руководства процессом, включающая выполнение рабочих операций в производственных подразделениях, связанных с приемкой, разгрузкой, хранением закупаемого сырья и материалов, организацией хранения, упаковки и поставки готовой продукции, обеспечением подъемно-транспортных и такелажных работ внутри предприятия. Представлен и описан алгоритм выполнения процесса; разработаны матрица распределения ответственности, контекстная диаграмма; определены требования к процессу, входные и выходные данные, ресурсы и критерии оценки данного процесса. The management of the Quality Management System process “Preserving Product Conformity” was developed for the small innovative enterprise “Mikrovinodelie, LLC”. The structure of the management process including maintenance in production units related to receiving, unloading, storage, raw material procurement, packaging and delivery of finished products, to ensure hoisting and lifting operations within the company. An algorithm for the execution of the process is presented and described; responsibility distribution matrix, context diagram developed; process requirements, input and output data, resources and evaluation criteria for this process are defined.

Test and Evaluation for Weapon Systems

2021 ◽  
pp. 287-299
Author(s):  
Levent Eriskin ◽  
Murat M. Gunal
Keyword(s):  
Modeling And Simulation ◽  
Evaluation Criteria ◽  
Decision Makers ◽  
Value For Money ◽  
Weapon Systems ◽  
Defense Systems ◽  
Test And Evaluation ◽  
Systems Requirements

Defense systems are complex and expensive and decision makers acquiring these systems aspire better value for money. As part of a procurement decision, test and evaluation (T&E) is conducted to assess if the system is meeting desired requirements. This chapter reviews the concepts in T&E for weapon systems in the navy and presents the process for its implementation. The authors point out the role of modeling and simulation and how to use them to support T&E. The review reveals that developmental and operational T&E can examine weapon systems requirements before their deployment, T&E process can effectively be implemented in six steps, and mission/capacity requirements must be decomposed into predefined evaluation criteria.

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