Apparatus for extracorporeal blood or plasma treatment comprising a wet semi-permeable membrane and methods for making the same

A process for limiting risks of leakage and variations in a water permeability of a device for extracorporeal treatment of blood or plasma, said device being subjected to a temperature below 0° C., and comprising, a first compartment configured to circulate blood or plasma, and a second compartment configured to circulate spent liquid, said first and second compartments being separated by a semi-permeable membrane, said semi-permeable membrane being stored in a wet state, said process comprising the steps of:

• preparing a solution having one or more chemical compounds, said one or more chemical compounds improving the biocompatibility of the membrane;
• placing said solution in contact with a surface of the membrane, said surface being configured to be placed in contact with blood or plasma;
• mounting the membrane with improved biocompatibility in a housing;
• preparing an aqueous glycerol solution having a concentration of glycerol from 7% to 15% by weight and being free of chemical compounds that are toxic before or after a high-energy sterilization;
• placing the aqueous glycerol solution in contact with the semi-permeable membrane;
• purging the device of the aqueous glycerol solution;
• and
• sterilizing the device with higher energy sterilization.

A process for limiting risks of leakage and variations in a water permeability of a device for extracorporeal treatment of blood or plasma, said device being subjected to a temperature below 0° C., and comprising, a first compartment configured to circulate blood or plasma, and a second compartment configured to circulate spent liquid, said first and second compartments being separated by a semi-permeable membrane, said semi-permeable membrane being stored in a wet state, said process comprising the steps of:

• mounting the membrane in a housing;
• preparing a solution having one or more chemical compounds, said compounds improving a biocompatibility of the membrane;
• placing said solution in contact with a surface of the membrane, said surface being configured to be placed in contact with blood or plasma;
• preparing an aqueous glycerol solution having a concentration of glycerol from 7% to 15% by weight and being free of chemical compounds that are toxic before or after a high-energy sterilization;
• placing the aqueous glycerol solution in contact with the semi-permeable membrane;
• purging the device of the aqueous glycerol solution;
• and
• sterilizing the device with higher energy sterilization.