scholarly journals Metrological Traceability of Measurement Results in Pharmaceutical and Chemical Sciences: Selection and Use of Certified Reference Materials

Author(s):  
Raquel Nogueira
2019 ◽  
Vol 102 (6) ◽  
pp. 1695-1707
Author(s):  
Zhen Guo ◽  
Xianjiang Li ◽  
Hongmei Li

Abstract In the past decade, with the signing of the joint declaration by the International Bureau of Weights and Measures (BIPM), the International Organisation of Legal Metrology, the International Laboratory Accreditation Cooperation, and the International Organization for Standardization, and the issuing of new international standards such as ISO/IEC 17025 and ISO 13528, metrological traceability has become more and more important for the mutual recognition of measurement results. It is found that the important factors for ensuring the accuracy of results are not only relevant to calibrants but also to the analysis procedure. This paper focuses on the analysis of key factors that affect measurement results, such as analytical methods, reference materials (RMs), and proficiency testing of mycotoxins. The Capacity Building and Knowledge Transfer Programme for mycotoxins, led by the BIPM, which aims to establish a global measurement system traced to the Système International d’Unités (SI), is well illustrated. Furthermore, this paper suggests to stakeholders that great effort is needed to promote the effective use of certified RM resources that are traced to the SI and globally recognized by the International Committee for Weights and Measures to finally realize “one measurement, global recognition.”


2019 ◽  
Vol 14 (1-2) ◽  
pp. 25-32
Author(s):  
E. V. Kulyabina ◽  
O. N. Melkova ◽  
E. A. Guskova ◽  
T. V. Grebennikova

Introduction. The article considers the problems of metrological support of catalytic activity measurements. The paper gives certain characteristics of the State Primary Special Measurement Standard for the unit of catalytic activity – KATAL and examines the role of reference materials (RMs) in ensuring the metrological traceability of measurement results.Materials and methods. A method for measuring the concentration of the recombinant protective antigen of Bacillus anthracis and the recombinant GP-protein of the Ebola virus, which means in using «sandwich» enzyme-linked immunosorbent assay, was certified by FGUP «VNIIMS» as a measurement procedure. The following RMs tested by FGUP «VNIIMS» can be used for the development and production of appropriate control samples when performing measurements for comparisons: the RM for the mass concentration of the recombinant protective antigen of Bacillus anthracis in phosphate-saline solution, the RM for the mass concentration of the recombinant GP-protein of the Ebola virus, and the RM for the mass concentration of recombinant Clostridium Difficile toxin.Results. The paper presents the main reactions of the method for measuring the catalytic activity of catalysts for heterogeneous processes, which are also used to carry out exhaust gas cleaning processes.Discussion and conclusions. Thus, conditions have been created for building hierarchies of calibrations of in-demand objects established on the basis of the List of Critical Technologies of the Russian Federation, state programs for the development of industrial sectors.


2019 ◽  
Vol 102 (6) ◽  
pp. 1695-1707
Author(s):  
Zhen Guo ◽  
Xianjiang Li ◽  
Hongmei Li

In the past decade, with the signing of the joint declaration by the International Bureau of Weights and Measures (BIPM), the International Organisation of Legal Metrology, the International Laboratory Accreditation Cooperation, and the International Organization for Standardization, and the issuing of new international standards such as ISO/IEC 17025 and ISO 13528, metrological traceability has become more and more important for the mutual recognition of measurement results. It is found that the important factors for ensuring the accuracy of results are not only relevant to calibrants but also to the analysis procedure. This paper focuses on the analysis of key factors that affect measurement results, such as analytical methods, reference materials (RMs), and proficiency testing of mycotoxins. The Capacity Building and Knowledge Transfer Programme for mycotoxins, led by the BIPM, which aims to establish a global measurement system traced to the Système International d’Unités (SI), is well illustrated. Furthermore, this paper suggests to stakeholders that great effort is needed to promote the effective use of certified RM resources that are traced to the SI and globally recognized by the International Committee for Weights and Measures to finally realize “one measurement, global recognition.”


2020 ◽  
pp. 66-72
Author(s):  
Irina A. Piterskikh ◽  
Svetlana V. Vikhrova ◽  
Nina G. Kovaleva ◽  
Tatyana O. Barynskaya

Certified reference materials (CRM) composed of propyl (11383-2019) and isopropyl (11384-2019) alcohols solutions were created for validation of measurement procedures and control of measurement errors of measurement results of mass concentrations of toxic substances (alcohol) in biological objects (urine, blood) and water. Two ways of establishing the value of the certified characteristic – mass consentration of propanol-1 or propanol-2 have been studied. The results obtained by the preparation procedure and comparison with the standard are the same within the margin of error.


2020 ◽  
pp. 64-70
Author(s):  
Mariya Y. Medvedevskikh ◽  
Anna S. Sergeeva

The article raises the problem of ensuring metrological traceability of the measurement results of indicators of quality and nutritional value for food products and food raw materials: water (moisture), nitrogen (protein, crude protein), fat, ash and carbohydrates. The problem under consideration can be solved by applying reference materials of food composition, traceable to state primary measurement standards GET 173-2017 and GET 176-2019 and primary reference measurement procedures (PRMP), for attestation of measurement procedures and accuracy checking of measurement results. The article discusses the results of the PRMP development of mass fraction of fat, ash and carbohydrates in food products and food raw materials, as well as mass fraction of crude fat (oil content) in oil crops seeds and products based on them. The paper also presents metrological characteristics of reference materials of composition of dry dairy products, grain-milk dry porridges for nutrition of babies, grain dry porridges for nutrition of babies, egg powder, freeze-dried meat products, animal feed. The results of the work allow for building a chain of metrological traceability from GET 173-2017, GET 176-2019 and PRMP to routine measurement procedures, thereby ensuring the uniformity of measurements of nutritional value of food products.


2019 ◽  
Vol 15 (3) ◽  
pp. 5-13
Author(s):  
L. A. Konopelko ◽  
A. V. Kolobova ◽  
O. V. Fatina

Currently, in the Russian Federation, the metrological traceability of certified reference materials of the composition of gas mixtures in cylinders under pressure produced by manufacturers of certified reference materials is carried out in accordance with GOST 8.578-2014. Considering that certified reference materials of the composition of gas mixtures in cylinders under pressure are used for testing to approye the type of measuring instruments, verification, calibration, and graduation of gas-analytical measuring instruments used to control explosive gases and vapors, harmful components in the atmospheric air and the air of the working area, emissions from vehicles and enterprises, to control technological processes, the quality of hydrocarbon products, etc., the issue of ensuring the quality of seriously produced certified reference materials (about 100.000 cylinders with gas mixtures per year) is important. To ensure the quality of certified reference materials of gas mixtures in cylinders under pressure, mass-produced by manufacturers of certified reference materials, we offer the following actions:– manufacturers of certified reference materials’ passing of mandatory accreditation for compliance with the requirements of GOST ISO Guide 34–2014 and GOST ISO Guide 35–2015;– manufacturers of certified reference materials’ constant participation in the proficiency testing programs through interlaboratory tests;– actualizing and refining the existing set of standards defining the requirements for the entire life cycle of a certified reference material of a gas mixture in a cylinder under pressure;– improving the method of certification of a reference material by calculating the value of the expanded uncertainty of the reference material and the introducting a new coefficient «technological reserve».


Author(s):  
E. V. Borisenko ◽  
I. V. Buyanova

A serious barrier to the sale of products on the market is the trust in organizations that perform measurements during product testing, as well as calibration (verification) of the used measuring instruments. Confidence and recognition of measurement results at the international level is ensured through an accreditation mechanism. To ensure effective functioning at the international level, accreditation organizations enter into a multilateral agreement that provides for the use of common standards in the conduct of accreditation. One of the important requirements of these standards is the implementation and demonstration of metrological traceability, which is a tool for ensuring the uniformity of measurements.


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