Blood purifier package and process for manufacturing the same

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.

主权项

1. A blood purifier package comprising
(a) a blood purifier comprising selectively permeable separation membranes as a main component, wherein the moisture content of the selectively permeable separation membranes is not lower than 1.0 mass % and not larger than 2.1 mass %, wherein the selectively permeable separation membranes comprise a polysulfone-based polymer containing polyvinyl pyrrolidone, (b) an oxygen scavenger, and (c) a packaging material capable of shutting out external air and water vapor, which packaging material is sealed and defines a space containing an atmosphere, wherein the oxygen permeability of the packaging material is not larger than 1 cm3/(m2.24 hr.atm) (20° C and 90% RH), the water vapor permeability of the packaging material is not larger than 5 g/(m2.24 hr.atm) (40° C and 90% RH), the blood purifier and the oxygen scavenger are within the space defined by the sealed packaging material, the atmosphere in the space has a relative humidity of not less than 68% RH at 25° C, and the blood purifier has been sterilized by exposure of the blood purifier within the sealed packaging material to a radioactive ray, an electron ray, or both a radioactive ray and an electron ray, wherein the oxygen concentration within the sealed packaging material during sterilization is not higher than 5%.