On-line preparation of solutions for dialysis: practical aspects versus safety and regulations.
- Ingrid Ledebo
- Journal of the American Society of Nephrology…
In order to meet the sterility requirements imposed by the various regulatory bodies around the world, peritoneal dialysis solutions are terminally heat-sterilized at an acid pH. There is growing concern that both acid pH and the glucose degradation products formed during terminal heat sterilization adversely affect the quality of the therapy provided to the end-stage renal failure patient on peritoneal dialysis. Acid pH and glucose degradation products are thought to contribute to impaired host defense and hence to increased risk of infection, loss of ultrafiltration, and peritoneal fibrosis. On the other hand, peritoneal dialysis solutions prepared by aseptic processing are devoid of in vitro cytotoxicity and hence are considered more biocompatible than heat-sterilized solutions. With new technologies permitting aseptic processing to achieve sterility assurance levels approaching solutions manufactured by terminal heat sterilization, it is possible to produce solutions that are more biocompatible than heat-sterilized products without increasing the risk of microbial contamination.