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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
Article in English | 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.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Quality Control / Corrosion / Needles Type of study: Prognostic study Country/Region as subject: South America / Brazil Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2019 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Rio de Janeiro/BR / Fundação Oswaldo Cruz/BR

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Full text: Available Index: LILACS (Americas) Main subject: Quality Control / Corrosion / Needles Type of study: Prognostic study Country/Region as subject: South America / Brazil Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2019 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Rio de Janeiro/BR / Fundação Oswaldo Cruz/BR