Abstract
ABSTRACTIntroduction:In hemodialysis, patients are exposed to a large volume of water, which may lead to fatal risks if not meeting quality standards. This study aimed to validate an alternative method for monitoring microbiological quality of treated water and assess its applicability in dialysis and dialysate analysis, to allow corrective actions in real-time.Methods:Validation and applicability were analyzed by conventional and alternative methods. For validation, E. coli standard endotoxin was diluted with apyrogenic water in five concentrations. For the applicability analysis, treated water for dialysis was collected from different points in the treatment system (reverse osmosis, drainage canalization at the storage tank bottom, reuse, and loop), and dialysate was collected from four machines located in different rooms in the hemodialysis sector.Results:The validation results were in accordance with the Brazilian Pharmacopoeia acceptance criteria, except for the last two concentrations analyzed. In addition, the ruggedness criterion performed under the US Pharmacopoeia was in agreement with the results.Discussion:A limiting factor in the applicability analysis was the absence of the endotoxin maximum permitted level in dialysate by the Brazilian legislation. When comparing the analysis time, the alternative method was more time-consuming than the conventional one. This suggests that the alternative method is effective in the case of few analyses, that is, real-time analyses, favoring corrective actions promptly. On the other hand, it does not support the implementation of the alternative method in a laboratory routine due to the high demand for analyses.
Highlights
In hemodialysis, patients are exposed to a large volume of water, which may lead to fatal risks if not meeting quality standards
Patients with chronic renal disease can undergo renal replacement therapy, having as options peritoneal dialysis, hemodialysis, or renal transplantation depending on the disease stage and evolution.[1, 2]
In order to validate PTS®, the control standard endotoxin (CSE) from Escherichia coli was diluted with Limulus Amebocyte Lysate Test (LAL) reagent water at five concentrations (0.0625, 0.125, 0.25, 0.5, and 1.0 EU/mL), which were analyzed by the conventional and alternative methods
Summary
Patients are exposed to a large volume of water, which may lead to fatal risks if not meeting quality standards. This study aimed to validate an alternative method for monitoring microbiological quality of treated water and assess its applicability in dialysis and dialysate analysis, to allow corrective actions in real-time. Methods: Validation and applicability were analyzed by conventional and alternative methods. For the applicability analysis, treated water for dialysis was collected from different points in the treatment system (reverse osmosis, drainage canalization at the storage tank bottom, reuse, and loop), and dialysate was collected from four machines located in different rooms in the hemodialysis sector. When comparing the analysis time, the alternative method was more time-consuming than the conventional one. The lipopolysaccharide complex has a lipidic portion (lipid A), which confers toxicity during bacteria lysis, death, and during its multiplication.[7,8]
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