Abstract
Convective therapies have proved to be the most efficient method of ensuring adequate purification. Online cold sterilization of ultrapure dyalisate is a membrane-based filtration process using an ultra-filter with a dual action: one relates to the sieving property, the other to the adsorption capacity. Today there are five specifically and qualified CE online HDF machines commercially available. Online production of substitution fluid gives access to large amounts of sterile and non-pyrogenic fluid at a reduced cost and simplifies the technical aspects of HDF and HF. Cold sterilization process via ultra-filters has been accepted for online systems in several European countries but it is not fully approved by the Pharmacopoeia due to the fact that the reinjection fluid does not meet the requirements for infusion solutions. In June 2000 the French health authority published recommendations to ensure the security of the process where patients are treated with online HDF and HF.
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