Hemodialysis patients are at risk of injury from chemical and microbiological contaminants in the dialysate. To avoid injury from these contaminants, the water and concentrates used to produce dialysate, as well as the dialysate itself, are required to meet well-established quality standards .
Compliance with these standards has largely eliminated acute adverse events resulting from dialysate contamination.
For this reason, the use of dialysate of much higher microbiological purity than is required has been recommended for routine hemodialysis. This "ultrapure" dialysate is commonly defined as :
1-Having a bacterial count less than 0.1 CFU/ ml and
2-An endotoxin content less than 0.03 EU/mL measured by the Limulus amebocyte lysate assay .
Use of ultrapure dialysate is required for High Flux dialysis and on-line hemodiafiltration , where dialysate is used to prepare the substitution solution.