ABSTRACT
The Brazilian Food, Drug and Sanitary Agency (ANVISA) published a Resolution (RDC 67) in 2007, repealing RDC 33 of 2000, which established a legally required monthly analysis of a number of microbiological and physicochemical variables in the purified water used in compounded pharmaceutical preparations, which were not specified in the preceding RDC. In view of the amendment, the aim of this study was to assess the quality of purified water used in compounding pharmacies in the region of Araraquara (SP, Brazil) and review the impact of the most recent regulation (RDC 67 of 2007) on this quality. In the study, 744 samples of purified water were collected from 30 pharmacies in the course of four years (2008 to 2011). The variables recorded were: presence of total coliforms and fecal coliforms/E. coli, pH, color, turbidity, total dissolved solids, fluoride and residual free chlorine. The methods used were pharmacopeial standards for water analysis, published by the Brazilian National Health Foundation (FUNASA) and the American Public Health Association (APHA). Among the samples, 78.90% were in compliance with the required standards. No sample contravened the rules for color and fecal coliforms/E. coli. However, 0.54%, 7.80%, 10.75%, 0.54% and 4.56% of the samples were unacceptable in terms of turbidity, fluorides, pH, free residual chlorine and total coliforms respectively. There was a variation in the number of irregular samples by comparing the years of 2008 and 2009 (20.26% and 26.71%, respectively) and the years of 2010 and 2011 (18.33% and 19.91%, respectively). Four years after the RDC n°. 67 of 2007, manipulation pharmacies are still adjusting to the rules, and it is important that ANVISA and others agencies continue monitoring to ensure the quality of purified water...
A RDC n° 67 de 2007, que revogou a RDC nº 33 de 2000, regulamentou análises mensais que avaliam parâmetros microbiológicos e físico-químicos em águas purificadas utilizadas em preparações magistrais, antes não especificados pela RDC n° 33 de 2000. Diante dessas alterações, o objetivo do trabalho foi avaliar a qualidade de águas utilizadas em farmácias de manipulação em Araraquara e região e verificar o impacto da legislação mais recente (RDC nº 67 de 2007) nessa qualidade. Foram analisadas 744 amostras de água purificada em 30 farmácias no decorrer de quatro anos (2008 a 2011). Os parâmetros avaliados foram: presença de coliformes totais e coliformes termotolerantes/E.coli, pH, cor, turbidez, sólidos totais dissolvidos, fluoreto e cloro residual livre. Os métodos utilizados seguiram padrões de farmacopeias, da FUNASA e da APHA. Dentre as amostras analisadas 78,90% estavam em conformidade com os padrões estabelecidos. Não foram encontradas amostras irregulares quanto aos parâmetros cor e coliformes termotolerantes/E. coli. No entanto, 0,54%, 7,80%, 10,75%, 0,54% e 4,56% das amostras estavam irregulares para turbidez, fluoretos, pH, cloro residual livre e coliformes totais, respectivamente. Foi observada uma variação do número de amostras irregulares ao compararmos os anos de 2008 e 2009 (20,26% e 26,71% respectivamente) com os anos de 2010 e 2011 (18,33% e 19,91% respectivamente). Quatro anos após a RDC n° 67 de 2007, as farmácias de manipulação ainda estão se adequando às normas e é importante que a ANVISA e outros órgãos continuem a fiscalização para garantir a qualidade da água purificada...
Subject(s)
Humans , Legislation, Pharmacy/standards , Chemical Phenomena , Water Quality , BrazilABSTRACT
Milk is an important nutritional source to man and water buffalo raw milk is used to produce mozzarella cheese. Products from unpasteurized milk have been associated with certain infectious diseases and can carry pathogenic mycobacteria. Nontuberculous mycobacteria (NTM) are emerging pathogens causing opportunistic infections in humans and animals. The objectives of this study were to demonstrate the presence of mycobacteria in water buffaloes' milk and to determine their role as possible sources of NTM infections. In this study, raw milk samples from dairy water buffaloes (Bubalus bubalis) (N = 23) were decontaminated by Petroff method and inoculated on to Löwenstein-Jensen and Stonebrink medium. After confirming positive colonies for acid fast bacilli (AFB) by Ziehl-Neelsen technique, the isolated mycobacteria were identified by PCR-Restriction Enzyme Analysis (PRA) and mycolic acids analysis by thin-layer chromatography (TLC). Mycobacterium simiae (2 isolates), Mycobacterium kansasii (2 isolates), Mycobacterium flavescens (2 isolates), Mycobacterium gordonae (3 isolates) and Mycobacterium lentiflavum (1 isolate) were identified by these techniques. The isolation of opportunistic pathogens such as M. kansasii, M. simiae and M. lentiflavum from raw milk represent a risk for the consumers of mozzarella cheese made by this milk.
