Analytical method validation of GC-FID for the simultaneous measurement of hydrocarbons (C2-C4) in their gas mixture / Validación de un método analítico GC-FID para la medida simultánea de hidrocarburos (C2-C4) en una mezcla gaseosa / Validação de uma metodologia analítica GC-FID para a medida simultánea de hidrocarbonetos (C2-C4) em uma mistura gasosa

An accurate gas chromatography coupled to a flame ionization detector (GC-FID) method was validated for the simultaneous analysis of light hydrocarbons (C2-C4) in their gas mixture. The validation parameters were evaluated based on the ISO/TEC 17025 definition including method selectivity, repeatability, accuracy, linearity, limit of detection (LOD), limit of quantitation (LOQ), and ruggedness. Under the optimum analytical conditions, the analysis of a gas mixture revealed that each target component was well-separated with high selectivity property. The method was also found to be precise and accurate. The method linearity was found to be high with good correlation coefficient values (R² ≥ 0.999) for all target components. It can be concluded that the GC-FID developed method is reliable and suitable for determination of light C2-C4 hydrocarbons in their gas mixture. The validated method was successfully applied to the estimation of light C2-C4 hydrocarbons in natural gas samples, showing high performance repeatability with relative standard deviation (RSD) less than 1.0% and good selectivity with no interference from other possible components.

Se validó una cromatrografía de gases precisa, acoplada con un detector de ionización de llama (GC-FID) para el análisis simultáneo de hidrocarburos ligeros (C2-C4) en su mezcla gaseosa. Los parámetros de validación se evaluaron con base en la definición de la ISO/ IEC 17025, que incluye selectividad del método, precisión y repetibilidad, exactitud, linealidad, limite de detección (LOD), limite de cuantificación (LOQ) y robustez. Bajo las condiciones analiticas óptimas, el análisis de la mezcla gaseosa mostró que cada analito de interés fue separado adecuadamente con alta selectividad. Se encontró también que el método fue preciso y exacto; la linealidad fue alta y con buen coeficiente de correlación lineal (R² ≥ 0.999) para todos los analitos. Se puede concluir que el método GC-FID es confiable y apropiado para la determinación de hidrocarburos ligeros C2-C 4 en una mezcla gaseosa. El método validado ha sido exitosamente aplicado a la valoración de hidrocarburos ligeros C2-C4 en muestras de gas natural, mostrando alta repetibilidad con desviación estándar relativa (RDS) menor al 1% y buena selectividad sin interferencias de otros posibles componentes.

Foi avaliada uma cromatografia gasosa precisa, equipada com um detector de ionização de chama (CG-FID) para a análise simultâneo de hidrocarbonetos ligeiros (C2-C4) em uma mistura gasosa. Os parâmetros de validação foram avaliados baseados na definição da ISO/IEC 17025, que inclui seletividade do método, precisão e repetibilidade, exatidão, linearidade, limite de detecção (LOD), limite de quantificação (LOQ) e robustez. Baixo as condições analiticas ótimas, a análise da mistura gasosa mostrou que cada analito foi separado adequadamente com alta seletividade. Também foi encontrado que o método foi preciso e exato; a linearidade foi alta e com bom coeficiente de correlação linear (R² ≥0.999) para todos os analitos. Pode-se concluir que o método GC-FID é confiável e apropriado para a determinação de hidrocarbonetos ligeiros C2-C4 em uma mistura gasosa. O método avaliado têm sido exitosamente aplicado à valoração de hidrocarbonetos ligeiros C2-C4 em amostras de gás natural mostrando alta repetibilidade com desvio-padrão relativo menor funcionais. ao 1% e boa seletividade sem interferências de outros possiveis componentes.

Evaluation of a fungal collection as certified reference material producer and as a biological resource center

Abstract Considering the absence of standards for culture collections and more specifically for biological resource centers in the world, in addition to the absence of certified biological material in Brazil, this study aimed to evaluate a Fungal Collection from Fiocruz, as a producer of certified reference material and as Biological Resource Center (BRC). For this evaluation, a checklist based on the requirements of ABNT ISO GUIA34:2012 correlated with the ABNT NBR ISO/IEC17025:2005, was designed and applied. Complementing the implementation of the checklist, an internal audit was performed. An evaluation of this Collection as a BRC was also conducted following the requirements of the NIT-DICLA-061, the Brazilian internal standard from Inmetro, based on ABNT NBR ISO/IEC 17025:2005, ABNT ISO GUIA 34:2012 and OECD Best Practice Guidelines for BRCs. This was the first time that the NIT DICLA-061 was applied in a culture collection during an internal audit. The assessments enabled the proposal for the adequacy of this Collection to assure the implementation of the management system for their future accreditation by Inmetro as a certified reference material producer as well as its future accreditation as a Biological Resource Center according to the NIT-DICLA-061.

Uncertainty measurement in the homogenization and sample reduction in the physical classification of rice and beans / Incerteza de medição na homogeneização e redução de amostra na classificação física de arroz e feijão

ABSTRACT: The study aimed to i) quantify the measurement uncertainty in the physical tests of rice and beans for a hypothetical defect, ii) verify whether homogenization and sample reduction in the physical classification tests of rice and beans is effective to reduce the measurement uncertainty of the process and iii) determine whether the increase in size of beans sample increases accuracy and reduces measurement uncertainty in a significant way. Hypothetical defects in rice and beans with different damage levels were simulated according to the testing methodology determined by the Normative Ruling of each product. The homogenization and sample reduction in the physical classification of rice and beans are not effective, transferring to the final test result a high measurement uncertainty. The sample size indicated by the Normative Ruling did not allow an appropriate homogenization and should be increased.

RESUMO: O trabalho teve como objetivo i) quantificar a incerteza de medição nos ensaios físicos de arroz e feijão para um defeito hipotético; ii) verificar se a homogeneização e redução da amostra nos ensaios de classificação física de arroz e feijão são eficazes para reduzir a incerteza do processo; iii) analisar se o aumento do tamanho da amostra de grãos de feijão aumenta a precisão e reduz a incerteza de medição de forma considerável. Defeitos hipotéticos em arroz e feijão com diferentes níveis de danos foram simulados de acordo com a metodologia de ensaio da Instrução Normativa de cada produto. A homogeneização e redução da amostra na classificação física de arroz e feijão não são eficazes, transferindo para o resultado final do ensaio uma elevada incerteza de medição. O tamanho da amostra indicado pela instrução normativa não permite uma adequada homogeneização e deveria ser aumentado.

Quality Control of Radiation Dosimetry Service / 의학물리

We have developed standards based on international criterions for the quality control of dose tested by the measurement institutions of individual exposure doses through improving the reliability of data on the exposure dose of individuals working in radioactive environment and securing the accuracy and reliability of individual dose measurements. Laws related to radiation dose applied to domestic institutions refer to ANSI N13.11?1993, but currently , in U.S. and some other countries the measurement of radiation doses is based on ANSI N13.11?2001 that reduced test categories and tightened the standards. We made efforts to simplify the standards and to reduce the number of dosimeters required in experiment, and avoided preventing or hindering the use of future technologies not approved under the current law such as glass dosimeter and optical stimulation dosimeter. The Quality Management Manual of Radiation Dosimetry Service, Assessment Manual of Radiation Dosimetry Service Accreditation Program, and the Personnel Dosimetry Performance-Criteria for Testing are documents applicable in supervising laboratories.

Approaches to Improve the Core Competitive Power of Drug Clinical Trial Institutions / 中国药房

OBJECTIVE:To provide references for improving the quality of clinical trial of new drug (phase I-IV),guaranteeing participants' interests and enhancing the core competitive power of drug clinical trial institutions. METHODS: The advantages of both the guiding principle of Good Clinical Practice(GCP) and the quality standards of ISO/IEC17025:2005 were applied throughout the quality control process of clinical drug trial. RESULTS & CONCLUSIONS: To establish quality management and supervision system in China that is in line with the international norm and national condition by combining GCP principle with the quality standards of ISO/IEC17025 is conducive to the improvement of the quality of clinical drug trial and enhancement of the core competitive power of drug clinical trial institutions in China.

Research on Management of Apparatus in CDC Laboratory / 医疗卫生装备

According to management status of apparatus in Lianyungang CDC applied for national laboratory approval and the claim of ISO/IEC 17025:2005,the application of Lianyungang CDC laboratory apparatus is investigated for improving the mode of management in future.