Method for sterilizing blood purifier and blood purifier package

Patent metadata

Field	Value
Publication number	US-10137234-B2
Application number	US-201514722898-A
Country	US
Kind code	B2
Filing date	May 27, 2015
Priority date	Oct 15, 2004
Publication date	Nov 27, 2018
Grant date	Nov 27, 2018

Abstract

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.

First claim

The invention claimed is:

1. A method for sterilizing a blood purifier comprising substantially dried selectively permeable separation membranes as a main component, by exposing said blood purifier to a radioactive ray and/or an electron ray, characterized in that said selectively permeable separation membranes comprise a hydrophobic polymer containing a hydrophilic polymer, said hydrophobic polymer comprises a polysulfone-based polymer, and said 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, wherein the relative humidity (RH) in the inner atmosphere of the packaging bag at room temperature is not lower than 50% RH.

2. The method according to claim 1 , wherein the moisture content of the selectively permeable separation membrane is not higher than 2.5 mass %.

3. The method according to claim 1 , wherein the hydrophilic polymer is polyvinyl pyrrolidone.

4. The method according to claim 1 , wherein the selectively permeable separation membrane is a hollow fiber membrane.

5. The method according to claim 1 , wherein the oxygen permeability of the packaging bag is not higher than 1 cm 3 /(m 2 ·24 hr·atm) (20° C. and 90% RH).

6. The method according to claim 1 , wherein the water vapor permeability of the packaging bag is not higher than 5 g/(m 2 ·24 hr·atm) (40° C. and 90% RH).

7. A blood purifier package comprising a blood purifier packed in a packaging material, characterized in that (i) said blood purifier comprising substantially dried selectively permeable separation membranes as a main component 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 exposure to a radioactive ray and/or an electron ray, (ii) said selectively permeable membranes comprise a hydrophobic polymer containing a hydrophilic polymer, wherein said hydrophobic polymer comprises a polysulfone-based polymer, and (iii) the relative humidity (RH) in the inner atmosphere of the packaging bag at room temperature is not lower than 50% RH.

8. The blood purifier package according to claim 7 , wherein the moisture content of the selectively permeable separation membrane is not higher than 2.5 mass %.

9. The blood purifier package according to claim 7 , wherein the hydrophilic polymer is polyvinyl pyrrolidone.

10. The blood purifier package according to claim 7 , wherein the oxygen permeability of the packaging bag is not higher than 1 cm 3 /(m 2 ·24 hr·atm) (20° C. and 90% RH).

11. The blood purifier package according to claim 7 , wherein the water vapor permeability of the packaging bag is not higher than 5 g/(m 2 ·24 hr·atm) (40° C. and 90% RH).

12. The blood purifier package according to claim 7 , wherein the selectively permeable separation membrane is a hollow fiber membrane.

Assignees

• Nipro Corp

Inventors

• Mabuchi Kimihiro
• Monden Noriko
• Kato Noriaki
• Hatakeyama Yuuki
• Sunohara Takashi
• Masuda Toshiaki

Classifications

• A61L2103/09

  Blood or products thereof · CPC title

• B01D65/022

  Membrane sterilisation · CPC title

• B01D2321/28

  by soaking or impregnating · CPC title

• A61L2/087 Primary

  Particle radiation, e.g. electron-beam, alpha or beta radiation · CPC title

• A61M1/168

  Sterilisation or cleaning before or after use · CPC title