Nipro Corporation

Toyo Boseki Kabushiki Kaisha

Kimihiro Mabuchi

Noriko Monden

Noriaki Kato

Toshiaki Masuda

Takashi Sunohara

Yuuki Hatakeyama

Katsuhiko Nose

Hiroshi Shibano

Noriyuki Tamamura

Katsuaki Kuze

Hideyuki Yokota

Hidehiko Sakurai

Shinya Koyama

Makoto Ohno

Isamu Yamamoto

Tohru Uenishi

Takahito Sagara

Makoto Ono

The invention provides a method for sterilizing a blood purifier, as well as a blood purifier package. The 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 is highly reliable in safety when employed for hemocatharsis therapy. The 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, 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.

Method for sterilizing blood purifier and blood purifier package

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.

Blood purifier and blood purifier package

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&#xb0; C.

Blood purifier package and process for manufacturing the same

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&#xb0; C.

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.

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.

The present invention provides a hollow fiber membrane where the membrane strength and pressure resistance to pressurization from the dialysate side is ensured, the retaining rate of water permeability after the repeated pressure load from outside is high, the resistance to the pressure from outside is excellent and the assembling property into module (low leakage rate at the adhered part) is satisfactory at the same time. The present invention also provides a method for manufacturing the same, and a blood purification module.

Hollow fiber membrane, method for manufacturing the same, and blood purification module

The present invention relates to a permselective separation membrane that can be used in blood purifying treatment. More particularly, the present invention relates to a polysulfone-based permselective separation membrane which has well-balanced separation properties, highly stable safety and performance, and also can be smoothly assembled into a module, and a method for producing the same.

Separation membrane with selective permeability and process for producing the same

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 %.

Polysulfone type selectively permeable hollow fiber membrane module and process for manufacturing the same

The present invention provides a polysulfone type hollow fiber membrane which is reliable in safety and stability of performance and is easily incorporated into a module, and thus can be suitably used in a highly water permeable blood purifier for use in a therapy of chronic renal failure. The present invention relates to a polysulfone type selectively permeable hollow fiber membrane comprising a polysulfone type resin and a hydrophilic polymer as main components, and characterized in that

Polysulfone-based hollow-fiber membrane with selective permeability

The present invention provides a highly water permeable hollow fiber membrane type blood purifier for medical use, which is excellent in safety and module-assembling ease and which has a high water permeability suitable for use in therapy of chronic renal failure. The present invention relates to a highly water-permeable hollow fiber type blood purifier comprising hydrophobic polymer hollow fiber membranes each of which contains a hydrophilic polymer, characterized in that the amount of the hydrophilic polymer eluted from the hollow fiber membrane is 10 ppm or less; in that the ratio of the hydrophilic polymer in the outer surface of the hollow fiber membrane is 25 to 50 mass %; in that the burst pressure of the hollow fiber membrane is 0.5 MPa or higher; and in that the coefficient of water permeability of the blood purifier is 150 ml/m/hr./mmHg or higher.

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Otsu, Japan

Kimihiro Mabuchi