Abstract
Background: Highly purified water is essential for the production of pharmaceuticals,
directly impacting the quality and safety of the final product.
Methods: In this work, we studied the physicochemical and microbiological quality of 1477 purified
water samples from 25 compounding pharmacies in Southeast Brazil. To the best of our
knowledge, this is the most comprehensive study on the quality of water purified in Brazil. It was
observed that 47.7% of the samples were purified by reverse osmosis, 39.9% by distillation and
12.4% by deionization. Of the total, 10.63% presented one or more non-compliances. Amongst the
three purification processes, the amount of non-compliance was found to be 8.9% for reverse osmosis,
10.9% for deionization, and 12.4% for distillation.
Results: It was therefore concluded that reverse osmosis is advantageous. However, even the advantageous
reverse osmosis process showed contamination by viable bacteria, total and faecal coliforms/
E. coli, and Pseudomonas aeruginosa.
Conclusion: Quantitative data showed that all purification processes significantly reduced the conductivity
and pH values of the input water. However, conductivity values above the limits and several
other non-compliances were found after purification by all processes, which points to the need
for additional studies on improvements in purification processes adopted by compounding pharmacies
in Brazil.
Keywords:
Purified water quality control, purified water, reverse osmosis, distillation, deionization, microbiological contamination.
[4]
Moura, J.P.; Monteiro, G.S.; Silva, J.N.; Pinto, F.A.; França, K.P. Applications of the Reverse Osmosis Process for the Use of Brackish Water from the Northeastern Semi-Arid Region; Águas Subterrâneas, 2008.
[5]
USP 42 - NF 37 The United States pharmacopeia and national formulary 2019 main edition plus supplements 1 and 2, 1. Auflage. In: Deutscher Apotheker Verlag; Stuttgart; , 2018.
[11]
dos Santos, N. V.; Moura, A. C.; Baptista, J. G. D.; Farache Filho, A. Brazil. Anvisa. RDC nº6Assessment of the quality of purified water used in pharmacies. 7, October 8,. J. Basic Applied Pharma. Sci., 2014.
[13]
Ferraz, C. C.; Silva, M. L. Assessment of Quality Control in Pharmacies with Manipulation in the City of Sorocaba - SP. University Studies Magazine - REU, 2009, 34.
[16]
Frischkorn, H. Reverse osmosis: Chemical cleaning of desalination membranes in Ceará. REVTEC, 2016, 30(1), 61-76. [https://ojs.unifor.br/tec/article/view/5277
[18]
Vieira, L. de J.; Valentini, A. Physicochemical Quality of Purified Water From Maipulation Pharmacies in the City of Campo Mourão; Revista Iniciare, 2017, p. 2.
[19]
World health organization. (WHO. Tech. Rep. Ser. (World Health Organ.), 2012, (970), 2012.
[23]
Pereira Filho, I.M.; Brunier, A.F. Quality management: Analysis of quality tools. In: Relação à Produtividade Do Segmento de Produtos Manipulados e Homeopáticos Da Farmácia de Manipulação Volta à Flora; Administra - Ação, 2013; p. 8.
[27]
Silva, G.S.; Tamaki, H.O.; Gonçalves, O.M. Implementation of Rational Water Use Programs on University Campuses. Ambient. Constr., 2006.