Evaluation of the Quality of Water Samples Purified by Compounding Pharmacies in Brazil

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.