摘要:
Objects of the invention are to provide a blood purifier package which shows a less increase in the amounts of extracts from the materials of its blood purifier, particularly of its selective permeable separation membranes, attributed to the deterioration of the same materials with time after exposure to a radioactive ray or an electron ray, and which is therefore highly reliable in safety in use for hemocatharsis, and to provide a process for manufacturing the same. The present invention relates to a blood purifier package obtained by packing a blood purifier which comprises selectively permeable separation membranes as a main component, and this blood purifier package is characterized in that the blood purifier is packed and sealed together with an oxygen scavenger in a packaging material capable of shutting out an external air and a water vapor, under a condition of a relative humidity of above 40% RH at 25° C.
摘要:
The invention relates to a hollow fiber membrane module comprising polysulfone type selectively permeable hollow fiber membranes which contain a polysulfone-based resin and a hydrophilic polymer as main components, wherein (A) the content of the hydrophilic polymer in the uppermost layer of the inner surface of the hollow fiber membrane is at least 1.1 times larger than the content of the hydrophilic polymer in the proximate layer of the inner surface of the membrane, and (B) the content of the hydrophilic polymer in the uppermost layer of the outer surface of the hollow fiber membrane is at least 1.1 times larger than the content of the hydrophilic polymer in the uppermost layer of the inner surface of the membrane. The hollow fiber membrane module is exposed to a radioactive ray, on condition that the oxygen concentration of an ambient atmosphere around the hollow fiber membrane is from 0.001 to 0.1%, and that the moisture content of the hollow fiber membrane to the weight thereof is from 0.2 to 7 mass %.
摘要:
The present invention provides a method for sterilizing a blood purifier, which method is effective to decrease the amounts of extracts from the blood purifier attributed to the deterioration of the selectively permeable separation membranes with time during and after exposure to a radioactive ray or an electron ray, and which method is highly reliable in safety when employed for hemocatharsis therapy. The present invention also provides a blood purifier package.The present invention relates to a method for sterilizing a blood purifier which comprises substantially dried selectively permeable separation membranes as a main component, by way of the exposure of the same blood purifier to a radioactive ray and/or an electron ray, and this method is characterized in that the blood purifier is sealed in a packaging bag, together with an oxygen scavenger and a humectant or together with an oxygen scavenger capable of releasing a moisture, and is then sterilized in such a sealed state by the above exposure.
摘要:
The present invention provides a blood purifier which shows a decreased amount of hydrogen peroxide extracted from its selectively permeable separation membranes, and thus is highly reliable in its safety in use for hemecatharysis. The present invention relates to a blood purifier which comprises selectively permeable separation membranes as a main component and which is characterized in that the amount of hydrogen peroxide which is extracted from the selectively permeable separation membrane removed from the blood purifier after 3 months or longer has passed since the sterilization of the blood purifier by exposure to a radioactive ray and/or an electron ray is not larger than 10 ppm.
摘要:
The invention provides a blood purifier which shows a decreased amount of hydrogen peroxide extracted from its selectively permeable separation membranes, and thus is highly reliable in its safety in use for hemecatharysis. The blood purifier comprises selectively permeable separation membranes as a main component and is characterized in that the amount of hydrogen peroxide which is extracted from the selectively permeable separation membrane removed from the blood purifier after 3 months or longer has passed since the sterilization of the blood purifier by exposure to a radioactive ray and/or an electron ray is not larger than 10 ppm.
摘要:
Objects of the present invention are to provide a blood purifier package which shows a less increase in the amounts of extracts from the materials of its blood purifier, particularly of its selective permeable separation membranes, attributed to the deterioration of the same materials with time after exposure to a radioactive ray or an electron ray, and which is therefore highly reliable in safety in use for hemocatharsis, and to provide a process for manufacturing the same. The present invention relates to a blood purifier package obtained by packing a blood purifier which comprises selectively permeable separation membranes as a main component, and this blood purifier package is characterized in that the blood purifier is packed and sealed together with an oxygen scavenger in a packaging material capable of shutting out an external air and a water vapor, under a condition of a relative humidity of above 40% RH at 25° C.
摘要:
Objects of the present invention are to provide a blood purifier package which shows a less increase in the amounts of extracts from the materials of its blood purifier, particularly of its selective permeable separation membranes, attributed to the deterioration of the same materials with time after exposure to a radioactive ray or an electron ray, and which is therefore highly reliable in safety in use for hemocatharsis, and to provide a process for manufacturing the same. The present invention relates to a blood purifier package obtained by packing a blood purifier which comprises selectively permeable separation membranes as a main component, and this blood purifier package is characterized in that the blood purifier is packed and sealed together with an oxygen scavenger in a packaging material capable of shutting out an external air and a water vapor, under a condition of a relative humidity of above 40% RH at 25° C.
摘要:
The present invention relates to a highly water-permeable hollow fiber membrane type blood purifier which comprises hydrophobic polymer hollow fiber membranes each containing a hydrophilic polymer, wherein the hollow fiber membrane has a hydrophilic polymer content of 25 to 50 mass % and a ratio of hole areas of 8 to 25% at its outer surface, and has a thickness non-uniformity degree of 0.6 or more, a thickness of 10 to 60 μm and a burst pressure of 0.5 to 2 MPa, and which is characterized in that the blood purifier has a water permeability of 150 to 2,000 ml/m2/hr/mmHg, and in that said blood purifier is exposed to radioactive rays on conditions that the oxygen concentration of an ambient atmosphere around the hollow fiber membranes is from 0.001% inclusive to 0.1% inclusive, and that the moisture content of the hollow fiber membrane to its weight is from 0.2 mass % inclusive to 7 mass % inclusive. The present invention also relates to a process for manufacturing the same-blood purifier.
摘要:
A dialyzer in which a nearly cylindrical case is provided therein with a hollow fiber bundle made of a plurality of hollow fiber membranes, a blood flow path formed by lumens of the hollow fiber membranes, a dialyzate flow path formed by a space between the inner wall of the case and the hollow fiber membranes and a cylindrical heat-shrinkable tube provided on the outside of the hollow fiber bundle and at least a part of which can be shrunk by heating, and a method for manufacturing the dialyzer.
摘要:
A packaged blood purification device including a hollow fiber blood-processing device having a bundle of hollow fibers and a cylindrical container holding the bundle of hollow fibers; and a gas-impermeable container for packaging the hollow fiber blood-processing device. The hollow fiber blood-processing device is sealed together with an oxygen absorber in the gas-impermeable container, and is sterilized with radiation. The blood-processing device is produced by a method including the steps of sealing a hollow fiber blood-processing device in said gas-impermeable container together with an oxygen absorber, and radiation sterilizing the blood-processing device held in the sealed gas-impermeable container.