Method and system for producing sterile aqueous solutions.

摘要

A process is provided for purifying potable water to produce American Association for Advancement of Medical Instrumentation (AAMI) standard water for dialysis, United States Pharmacopeia Convention, Inc. USP XXII specifications water for injection or sterile water for injection. Potable water is passed through a plurality of treatment steps including a preliminary filtration step, a carbon adsorption module and a reverse osmosis module to produce water to the quality specified by AAMI for hemodialysis. An ion exchange filtration step is added to the steps stated above to produce USP XXII quality specifications for water for injection and a disposable sterilizing microfilter is further added to all the steps stated above to produce sterile water for injection. The process is designed such that the system is sanitized with hot water and subsequently flushed at a temperature and time that will control microbial population as specified by the user requirements without degrading the materials of construction in the treatment steps, for example at 80 DEG C for one hour. The sterile microfilter used for the production of sterile water is a disposable device changed periodically to maintain sterility of the final solution.