Abstract: A sterile container including at least one hollow fiber filter module, especially dialyzer, which is accommodated in a hermetically sealed holding volume of a primary package and includes a blood compartment delimited by a blood inlet opening and a blood outlet opening, wherein a plurality of hollow fiber filter modules is arranged in the primary package and the sterile barrier of the blood compartment of each hollow fiber filter module inside the primary package is implemented by caps which close the blood inlet opening and the blood outlet opening of each hollow fiber filter module. A method of manufacturing such sterile container is also disclosed.

Abstract: An apparatus for sterilizing a dialyzer for extracorporeal blood treatment includes a pulsed electric field generator arranged for generating a pulsed electric field penetrating the dialyzer received between a first electrode and a second electrode, when a pulsed electric voltage is applied between the first electrode and the second electrode of the generator. A method of sterilizing a dialyzer for extracorporeal blood treatment adapted to be executed using the apparatus incorporates, in a process for preparing or manufacturing the dialyzer, at least the steps of generating a pulsed electric field using a predetermined number of electric pulses of defined electric voltage, defined pulse duration and defined pulse-off time between the pulses, and applying the pulsed electric field to the dialyzer.

Abstract: Methods of combined sterilization and integrity testing of dialyzers such as hollow fiber dialyzers are disclosed. Sterilization and integrity testing may be performed by treating the dialyzer with a sterilization fluid for sterilizing at least the blood-side compartment of the dialyzer and for wetting the dialysis membrane of the dialyzer with the sterilization fluid, and carrying out an integrity testing of the dialysis membrane wetted with the sterilization fluid, wherein the sterilization fluid is selected from aqueous solutions containing peroxide and/or ozone, the peroxide being selected from peroxides which disintegrate into water, oxygen and/or volatile organic compounds, and from aqueous solutions containing chlorine, bromine and/or iodine.

Abstract: A sterile container including at least one hollow fiber filter module, especially dialyzer, which is accommodated in a hermetically sealed holding volume of a primary package and includes a blood compartment delimited by a blood inlet opening and a blood outlet opening, wherein a plurality of hollow fiber filter modules is arranged in the primary package and the sterile barrier of the blood compartment of each hollow fiber filter module inside the primary package is implemented by caps which close the blood inlet opening and the blood outlet opening of each hollow fiber filter module. A method of manufacturing such sterile container is also disclosed.

Abstract: An apparatus for sterilizing a dialyzer for extracorporeal blood treatment includes a pulsed electric field generator arranged for generating a pulsed electric field penetrating the dialyzer received between a first electrode and a second electrode, when a pulsed electric voltage is applied between the first electrode and the second electrode of the generator. A method of sterilizing a dialyzer for extracorporeal blood treatment adapted to be executed using the apparatus incorporates, in a process for preparing or manufacturing the dialyzer, at least the steps of generating a pulsed electric field using a predetermined number of electric pulses of defined electric voltage, defined pulse duration and defined pulse-off time between the pulses, and applying the pulsed electric field to the dialyzer.

Abstract: Methods of combined sterilization and integrity testing of dialyzers such as hollow fiber dialyzers are disclosed. Sterilization and integrity testing may be performed by treating the dialyzer with a sterilization fluid for sterilizing at least the blood-side compartment of the dialyzer and for wetting the dialysis membrane of the dialyzer with the sterilization fluid, and carrying out an integrity testing of the dialysis membrane wetted with the sterilization fluid, wherein the sterilization fluid is selected from aqueous solutions containing peroxide and/or ozone, the peroxide being selected from peroxides which disintegrate into water, oxygen and/or volatile organic compounds, and from aqueous solutions containing chlorine, bromine and/or iodine.