Validation and applicability of an alternative method for dialysis water and dialysate quality analysis

Abstract

Introduction: 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.

Physicochemical characterization of a lycopene-loaded mesoporous silica nanoparticle formulation

“…After de ning the best method, the system suitability was evaluated according to the FDA "Validation of chromatographic methods" guide. Then, in order to determine the e ciency and suitability of the method with the intended use a validation was conducted in accordance with Q2 (R1) from International Conference on Harmonization, as described in Table 1 (Carvalho et al, 2020a;FDA, 1994;International conference on harmonization, 2005).…”

“…On the other hand, the lowest concentration evaluated during the validation process, 25 µg/mL, was determined with accuracy and precision, but when lower concentrations were tested, precise results were not detected (FDA, 1994; International conference on harmonization, 2005). It is worth noting that experimental determinations are less reliable than calculated ones, since there is the operator variability in several steps, such as weighing and pipetting (Carvalho et al, 2020a;Vial and Jardy, 1999). In order to minimize operational errors in QL and DL experimental determination correction values were used.…”

Physicochemical characterization of a lycopene-loaded mesoporous silica nanoparticle formulation

“…On the other hand, experimentally, the lowest concentration evaluated during the validation process, 25 µg/mL, was determined with accuracy and precision, but when lower concentrations were tested, precise results were not detected [37,39]. It is worth noting that experimental determinations are less reliable than calculated ones, since there is the operator variability in several steps, such as weighing and pipetting [38,53].…”

“…After defining the best method, the system suitability was evaluated according to the FDA "Validation of chromatographic methods" guide. Then, in order to determine the efficiency and suitability of the method, a validation process was conducted in accordance with Q2 (R1) from International Conference on Harmonization, as described in Table 1 [37][38][39]. It is worth mentioning that the LYC used for the validation stage was purchased from APIChem Technology Co. and the one used as reference chemical from Sigma-Aldrich ® .…”

HPLC and thermal analysis, do they have a good correlation to quantify lycopene in mesoporous silica nanoparticles?

“…On the other hand, the lowest concentration evaluated during the validation process, 25 µg/mL, was determined with accuracy and precision, but when lower concentrations were tested, precise results were not detected (FDA 1994; International conference on harmonization 2005). It is worth noting that experimental determinations are less reliable than calculated ones, since there is the operator variability in several steps such as weighing and pipetting (Vial and Jardy 1999; Carvalho et al 2020a). In order to minimize operational errors in QL and DL experimental determination correction values are used.…”