The importance of corrosion resistance test of cannulas in the quality control of hypodermic needles
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.
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
/
Teraputica
/
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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