Standardization of water purification in the central dialysis fluid delivery system: validation and parametric method

The central dialysis fluid delivery system (CDDS) has been mainly used for hemodialysis therapy in Japan. Validation and a parametric method are necessary for the quality control of dialysis fluid in CDDS. Validation is a concept for the assurance of system compatibility and product quality, and is defined as follows: the manufacturing and quality control methods including the system design and equipment of the manufacturing facility, manufacturing procedure and processes. Confirmed results must be kept within acceptable limits and they must be documented in a record. Important parameters for validating CDDS include: (1) setting the sterilized area; (2) decision of sterilization level; (3) confirmation of the maximum bio-burden; (4) performance of endotoxin retentive filter and reverse osmosis (RO) module, and (5) checkpoints of purity of dialysis water in the system. Taking the concept of validation and a parametric method in the management of CDDS into consideration enables the supply the purified dialysis fluid or the online prepared substitution fluid that meet the 2008 standards of the Japanese Society for Dialysis Therapy.