RESUMEN
INTRODUCTION: Online hemodiafiltration is a technique of dialysis with many advantages, but its use is limited because of the lack of control of microbiological risks. This work conducts a risk analysis of the process for producing substitution liquid for online hemodiafiltration and validates this process from a microbiological point of view. MATERIAL AND METHOD: The risk analysis was carried out following the approach of analysing failure modes, their effects and their criticalities. It identified the "worst case" of the production process being studied. For the validation of this process, we used the limulus amoebocytes lysate assay for bacterial endotoxins and the membrane filtration test for sterility control. RESULTS: We identified 17 failure modes, 13 of which were acceptable. Failure modes that exceeded the acceptability threshold were defined as "worst cases". Sterility monitoring and endotoxin testing, conducted in the "worst case", verified the microbiological quality of the liquid produced to the required standards and subsequently validated the process used. DISCUSSION: This approach has resulted in the identification of as many failure modes as possible. Validating in "worst case" is an extreme challenge to the process and its success provides a sufficient basis to conclude that the technique is safe and, therefore, to validate the process. CONCLUSION: This work has enabled us to validate our production process in extreme cases to promote safer use of the technique.
