scholarly journals Recommendations for Expounding Evaluation of Biological (Specific) Activity of Biotechnological Products in Product Specification Files

2018 ◽  
Vol 18 (3) ◽  
pp. 168-174
Author(s):  
O. V. Golovinskaya ◽  
S. L. Lysikova ◽  
Yu. N. Lebedeva ◽  
N. A. Alpatova ◽  
A. A. Movsesyants ◽  
...  
Keyword(s):  
Laboratory Testing ◽  
Specific Activity ◽  
General Structure ◽  
Quality Parameters ◽  
Test Methods ◽  
Test Method ◽  
Additional Information ◽  
Biotechnological Products ◽  
Specific Safety ◽  
Product Specification

Biotechnological products, like all other medicinal products, have to comply with efficacy, safety and quality requirements. Quality evaluation of medicines includes assessment of test methods used to control medicinal product quality (described in product specification files provided by the manufacturer), laboratory testing of samples using these methods, as well as assessment of the registration dossier materials, including materials on test method validation included into the product specification files. One of the most important quality parameters of biotechnological products is biological activity, i.e. specific ability of a product to induce a desired biological effect. The article presents the results of a detailed analysis of methods used for determination of biological (specific) activity that are described in product specification files of various biotechnological products. The aim of the study was to demonstrate the importance of proper presentation of methods used for assessment of biological (specific) activity of biotechnological products and familiarise specialists engaged in elaboration of product specification files with the principles of presenting data in the «Biological (specific) safety» section. The analysis of documentation helped summarise the most common mistakes and omissions, formulate general recommendations concerning the description of methods, develop a general structure of the «Biological (specific) safety» section with detailed guidance on what to include in each of the subsections. Rationalisation of information presented in this part of the product specification files will help reduce the number of expert body’s requests for additional information/documents and will help ensure that laboratory testing is performed at a high professional level and within a prescribed period of time.

scholarly journals Elaboration of Pharmacopoeial Quality Standards for Bacteriophage Products

2019 ◽  
Vol 19 (4) ◽  
pp. 233-241
Author(s):  
T. M. Kargina ◽  
E. I. Sakanyan ◽  
D. S. Davydov ◽  
R. L. Parfenyuk
Keyword(s):  
Russian Federation ◽  
Specific Activity ◽  
Quality Standards ◽  
Storage Conditions ◽  
Quality Parameters ◽  
Test Methods ◽  
Bacterial Strains ◽  
Test Procedures ◽  
Intestinal Infections ◽  
The Russian Federation

Bacteriophages are novel safe and efficacious medicinal products that are used for treatment of intestinal infections and purulent inflammations. The fact that virulent phages can be adapted to fight antibiotic-resistant bacterial strains makes this group of medicines a promising means of treatment of infections associated with medical interventions. The elaboration of quality standards for bacteriophage products will enable alignment of the quality requirements and test methods. There are no monographs on bacteriophage products in pharmacopoeias of other countries, therefore, the development of general chapters on groups of test methods used in bacteriophage quality control and monographs on bacteriophages for the State Pharmacopoeia of the Russian Federation (Ph. Rus.) was a very relevant and timely initiative. The aim of the study was to elaborate pharmacopoeial quality standards for bacteriophages approved in the Russian Federation for therapeutic and prophylactic indications. The authors of the study analysed product specification files and master production records for bacteriophages produced in the Russian Federation. They determined common GMP-compliant production steps, the selection criteria for bacteriophage strains and bacteria production strains, and cultivation and storage conditions. The authors standardised bacteriophage quality parameters and brought the test methods in line with the test procedures described in the Ph. Rus., 14th ed. The study summarised test methods used for identification of bacteriophages and determination of their specific activity. The main results of the study were included into the general monograph «Bacteriophages» and individual monographs on bacteriophage products that were included into the current edition of the Ph. Rus. Further studies and elaboration of new quality standards for mono- and multicomponent bacteriophage products, and the use of such products in clinical practice will improve prophylaxis and treatment of various infectious diseases.

An evaluation of ECT sample height for small flute board grades and Box Manufacturer’s Certification compliance

TAPPI Journal ◽  
2009 ◽  
Vol 8 (6) ◽  
pp. 24-28
Author(s):  
CORY JAY WILSON ◽  
BENJAMIN FRANK
Keyword(s):  
Compressive Strength ◽  
Compressive Load ◽  
Test Sample ◽  
Test Methods ◽  
Test Method ◽  
Initial Development ◽  
Sample Height ◽  
Relationship Of ◽  
The Relationship ◽  
Corrugated Fiberboard

TAPPI test T811 is the specified method to ascertain ECT relative to box manufacturer’s certification compliance of corrugated fiberboard under Rule 41/ Alternate Item 222. T811 test sample heights were derived from typical board constructions at the time of the test method’s initial development. New, smaller flute sizes have since been developed, and the use of lighter weight boards has become more common. The T811 test method includes sample specifications for typical A-flute, B-flute, and C-flute singlewall (and doublewall and triplewall) structures, but not for newer thinner E-flute or F-flute structures. This research explores the relationship of ECT sample height to measured compressive load, in an effort to determine valid E-flute and F-flute ECT sample heights for use with the T811 method. Through this process, it identifies challenges present in our use of current ECT test methods as a measure of intrinsic compressive strength for smaller flute structures. The data does not support the use of TAPPI T 811 for ECT measurement for E and F flute structures, and demonstrates inconsistencies with current height specifi-cations for some lightweight B flute.

scholarly journals Comprehensive Parameters Identification and Dynamic Model Validation of Interior-Mount Line-Start Permanent Magnet Synchronous Motors

Machines ◽  
2019 ◽  
Vol 7 (1) ◽  
pp. 4 ◽  
Author(s):  
Luqman S. Maraaba ◽  
Zakariya M. Al-Hamouz ◽  
Abdulaziz S. Milhem ◽  
Ssennoga Twaha
Keyword(s):  
Mathematical Model ◽  
Permanent Magnet ◽  
High Efficiency ◽  
Experimental Tests ◽  
Induction Machines ◽  
Test Methods ◽  
Operating Conditions ◽  
Test Method ◽  
Permanent Magnet Synchronous Motors ◽  
Synchronous Motors

The application of line-start permanent magnet synchronous motors (LSPMSMs) is rapidly spreading due to their advantages of high efficiency, high operational power factor, being self-starting, rendering them as highly needed in many applications in recent years. Although there have been standard methods for the identification of parameters of synchronous and induction machines, most of them do not apply to LSPMSMs. This paper presents a study and analysis of different parameter identification methods for interior mount LSPMSM. Experimental tests have been performed in the laboratory on a 1-hp interior mount LSPMSM. The measurements have been validated by investigating the performance of the machine under different operating conditions using a developed qd0 mathematical model and an experimental setup. The dynamic and steady-state performance analyses have been performed using the determined parameters. It is found that the experimental results are close to the mathematical model results, confirming the accuracy of the studied test methods. Therefore, the output of this study will help in selecting the proper test method for LSPMSM.

scholarly journals Concept and Realization of a Novel Test Method Using a Dynamic Test Stand for Detecting Persons by Sensor Systems on Autonomous Agricultural Robotics

Sensors ◽  
2021 ◽  
Vol 21 (7) ◽  
pp. 2315
Author(s):  
Christian Meltebrink ◽  
Tom Ströer ◽  
Benjamin Wegmann ◽  
Cornelia Weltzien ◽  
Arno Ruckelshausen
Keyword(s):  
Environmental Conditions ◽  
Dynamic Test ◽  
Test Methods ◽  
Test Stand ◽  
Human Detection ◽  
Test Method ◽  
Sensor Systems ◽  
Functional Safety ◽  
Agricultural Robots ◽  
Agricultural Robotics

As an essential part for the development of autonomous agricultural robotics, the functional safety of autonomous agricultural machines is largely based on the functionality and robustness of non-contact sensor systems for human protection. This article presents a new step in the development of autonomous agricultural machine with a concept and the realization of a novel test method using a dynamic test stand on an agricultural farm in outdoor areas. With this test method, commercially available sensor systems are tested in a long-term test around the clock for 365 days a year and 24 h a day on a dynamic test stand in continuous outdoor use. A test over a longer period of time is needed to test as much as possible all occurring environmental conditions. This test is determined by the naturally occurring environmental conditions. This fact corresponds to the reality of unpredictable/determinable environmental conditions in the field and makes the test method and test stand so unique. The focus of the developed test methods is on creating own real environment detection areas (REDAs) for each sensor system, which can be used to compare and evaluate the autonomous human detection of the sensor systems for the functional safety of autonomous agricultural robots with a humanoid test target. Sensor manufacturers from industry and the automotive sector provide their sensor systems to have their sensors tested in cooperation with the TÜV.

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