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The importance of corrosion resistance test of cannulas in the quality control of hypodermic needles
Feitoza-Silva, Michele; Carvalho, Carolina Mesquita de; Bittencourt, Lívia Bretas; Leandro, Katia Christina; Gemal, André Luis.
  • Feitoza-Silva, Michele; Fundação Oswaldo Cruz. National Institute for Quality Control in Health. Chemistry Department. Rio de Janeiro. BR
  • Carvalho, Carolina Mesquita de; Fundação Oswaldo Cruz. National Institute for Quality Control in Health. Chemistry Department. Rio de Janeiro. BR
  • Bittencourt, Lívia Bretas; Fundação Oswaldo Cruz. National Institute for Quality Control in Health. Chemistry Department. Rio de Janeiro. BR
  • Leandro, Katia Christina; Fundação Oswaldo Cruz. National Institute for Quality Control in Health. Chemistry Department. Rio de Janeiro. BR
  • Gemal, André Luis; Federal University of Rio de Janeiro. Chemistry Institute. Rio de Janeiro. BR
Braz. J. Pharm. Sci. (Online) ; 55: e18148, 2019. tab, graf, ilus
Artículo en Inglés | LILACS | ID: biblio-1039038
ABSTRACT
According to Anvisa risk rating, hypodermic needles offer medium risk to the user's health. This study discussed the importance of the corrosion resistance test in tubes of hypodermic needles, in the product quality control. A review of cannulas of hypodermic needles was carried out according to ISO 96262003 and 92591997 ABNT NBR. For the results evaluation, a scale which classifies the extent of corrosion was adjusted. 174 samples of PNI needles from 17 States and 9 different record holders were analyzed. According to the methodology of ISO 96262003, 100% of the samples were considered satisfactory. However, in accordance with the methodology of ISO 92591997, 97.1% of the samples were rejected. Irregularities can lead to impairment of product quality, resulting in risks to the consumer's health. Since 2011 the product has undergone certification, so it is necessary to reflect on the importance of corrosion resistance testing and mandatory certification for health monitoring.
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Texto completo: Disponible Índice: LILACS (Américas) Asunto principal: Control de Calidad / Corrosión / Agujas Tipo de estudio: Estudio pronóstico País/Región como asunto: America del Sur / Brasil Idioma: Inglés Revista: Braz. J. Pharm. Sci. (Online) Asunto de la revista: Farmacologia / Terapˆutica / Toxicologia Año: 2019 Tipo del documento: Artículo País de afiliación: Brasil Institución/País de afiliación: Federal University of Rio de Janeiro/BR / Fundação Oswaldo Cruz/BR

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Texto completo: Disponible Índice: LILACS (Américas) Asunto principal: Control de Calidad / Corrosión / Agujas Tipo de estudio: Estudio pronóstico País/Región como asunto: America del Sur / Brasil Idioma: Inglés Revista: Braz. J. Pharm. Sci. (Online) Asunto de la revista: Farmacologia / Terapˆutica / Toxicologia Año: 2019 Tipo del documento: Artículo País de afiliación: Brasil Institución/País de afiliación: Federal University of Rio de Janeiro/BR / Fundação Oswaldo Cruz/BR