Title:Evaluation of the Quality of Water Samples Purified by Compounding
Pharmacies in Brazil
Volume: 20
Issue: 1
Author(s): Lucas Prosperi Ferreira, Marcus Vinicius Martins Rubatino*, Magali Benjamin de Araújo and Rudy Bonfilio
Affiliation:
- Faculty of Pharmaceutical Sciences, Federal University of Alfenas, Alfenas, Brazil
Keywords:
Purified water quality control, purified water, reverse osmosis, distillation, deionization, microbiological contamination.
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.
