JPH08280795A - Liquid processor - Google Patents

Abstract

PURPOSE: To prevent the adhesion of liquid at the outside walls of a liquid treating device and the inside of a package at the time of a sterilization treatment by hermetically plugging the dialyzate ports of this liquid treating device with gas permeable and liquid shieldable caps at the time of executing radiation sterilization. CONSTITUTION: A film protective agent is packed in a wet or half wet form into this liquid treating device. This liquid treating device is subjected to radiation sterilization in an inert gaseous atmosphere. Further, the dialyzate ports of the liquid treating device are hermetically plugged with the gas permeable and liquid shieldable caps. The liquid treating device and a deoxidizing agent are housed in a gas impermeable package bag and the liquid treating device is subjected to the radiation sterilization. Namely, the blood inlet and blood outlet of the liquid treating device packed internally with semipermeable membranes in the form of hollow yarn, coil, plate, etc., are hermetically plugged with ordinary gas shieldable material caps. Simultaneously, the dialyzate inlet and dialyzate outlet are hermetically plugged with gas permeable and liquid shieldable caps.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION The present invention relates to a liquid processor such as a blood processor or an ultrafilter filled with a membrane protective agent such as glycerin, water or physiological saline in a wet or semi-wet state under an inert gas atmosphere. This is a liquid processing device in which the cap of the dialysate port of the liquid processing device is improved upon radiation sterilization below.

[0002]

2. Description of the Related Art Conventionally, Japanese Patent Publication No. Sho 55-23620 is known as a method for sterilizing radiation by filling a liquid treatment device with water, physiological saline or the like, and the liquid treatment device is deteriorated by radiation sterilization. The purpose of preventing this has been achieved to some extent. In addition to the radiation sterilization of the liquid processor in the wet state, as a radiation sterilization of the liquid processor in the dry state, a method of radiation sterilizing the liquid processor in an inert gas atmosphere, that is, Japanese Patent Publication No. 10343/1993. Are known. And, as one of the means, as a method of performing radiation treatment in a state in which the oxygen inside the bag including the liquid treatment device is deoxygenated by further containing a deoxidizer in the liquid treatment device accommodated in the gas impermeable packaging bag. Japanese Patent Publication No. 5-50946 is known.

[0003]

SUMMARY OF THE INVENTION The present invention is a method of sterilizing a liquid processor by radiation in a wet state or a semi-wet state under an inert gas atmosphere. Conventionally, when performing radiation treatment on a liquid processor in an inert gas atmosphere, the dialysate inlet and the dialysate outlet of the liquid processor are opened to replace the inside of the liquid processor with an inert gas, or the liquid processor is used. Although the internal oxygen has been removed with a deoxidizer, when radiation sterilizing the liquid processor in an inert gas atmosphere in a wet or semi-wet state, glycerin is added near the dialysate inlet and dialysate outlet. However, there is a problem that physiological saline or water seeps out and adheres to the outer wall of the liquid processing device and the inside of the packaging bag, and adheres to the hand during operation of the liquid processing device. The present inventor has arrived at the present invention as a result of extensive studies in order to solve these problems.

[0004]

That is, according to the present invention, when a liquid treatment device having a film protective agent filled in a wet state or a semi-wet state is sterilized by radiation in an inert gas atmosphere, the liquid treatment device is It is a liquid processing device in which the dialysate mouth is sealed with a gas-permeable, liquid-blocking cap. Further, the present invention is the above liquid treatment device, wherein the liquid treatment device and the oxygen scavenger are housed in a gas impermeable packaging bag and sterilized by radiation.

The blood inlet and the blood outlet of a liquid processing device having a hollow fiber-shaped, coil-shaped, plate-shaped, etc. semi-permeable membrane filled inside are tightly sealed with a cap of a usual gas-blocking material, and a dialysate inlet and The mouth of the dialysate outlet is sealed with a cap of gas permeable, liquid barrier material. Examples of the gas-permeable and liquid-blocking material include silicone rubber, polyolefin rubber, porous fluorine resin and the like, and silicone rubber is particularly preferable. As the semipermeable membrane material of the liquid processor, there are used cellulose acetate, cellulose acetate saponified cellulose, cuprophane, polysulfone, polyethersulfone, polyurethane, ethylene / vinyl alcohol copolymer, polyacrylonitrile, polymethylmethacrylate. Examples include rate, polyvinyl alcohol, polypropylene and the like.

The inside of the liquid treatment device is filled with a film protective agent in a wet or semi-wet form. Examples of the film protective agent include water, physiological saline, glycerin, etc. The inside of the liquid processing device is filled with a shape. To create an inert gas atmosphere inside the liquid processor, place the liquid processor in a gas impermeable packaging bag and replace the bag with an inert gas such as nitrogen gas, carbon dioxide gas, helium, or argon. The oxygen scavenger is housed in the gas impermeable packaging bag together with the liquid processor, and the oxygen scavenger adsorbs oxygen in the bag to create an inert gas atmosphere inside the bag. As the gas impermeable packaging bag for containing the liquid processing device, an unstretched or stretched film or sheet of polyvinylidene chloride, polyvinyl alcohol, polyamide, polyester or the like, or a film coated with these resins or See
Or a film or sheet obtained by laminating these films, or polyester / aluminum /
Examples thereof include a polyethylene laminated film or sheet, an aluminum foil, a metal foil such as an aluminum vapor deposition film, a metal vapor deposition film, or a laminate product thereof.

Further, as the oxygen scavenger, it is preferable to use one which does not generate other gas components during absorption of oxygen and does not lose the activity of the oxygen scavenger due to radiation irradiation. For example, it is preferable that the reaction rate is controlled by a catalyst containing an active metal as a main component. Examples of the active metal include iron, zinc, copper, tin and the like, and those having active iron oxide as a main component are particularly preferable. As such a deoxidizer, AGELESS (manufactured by Mitsubishi Gas Chemical Co., Inc.) can be mentioned. Since the dialysate port of the liquid processor is sealed with a gas-permeable stopcock, the adsorption of inert gas or oxygen of the oxygen scavenger is freely performed through the stopcock, and the inside of the liquid processor is replaced with the inert gas. It will be in a state of being. Especially in the case of the bag containing the liquid processor and the oxygen absorber,
Oxygen gradually released from the micropores of the semipermeable membrane is immediately adsorbed by the oxygen scavenger, so that the inside of the bag can be kept in an oxygen-free state for a long time. Moreover, since the stopcock has a liquid blocking property, physiological saline or glycerin filled in the liquid processor in a wet state or a semi-wet state seeps out during storage or radiation treatment outside the blood processor and becomes a liquid. If the liquid adheres to the outer wall of the processor or the inside of the packaging bag and touches the liquid processor, your hands will not get dirty. Radiation sterilization is particularly preferably sterilization by gamma ray irradiation.

[0008]

After the dialysate port of the liquid processor is sealed with the gas-permeable and liquid-blocking material cap, the liquid processor is housed in the gas-impermeable packaging bag together with the oxygen scavenger. Oxygen inside the liquid processor is adsorbed by the oxygen scavenger inside the bag through the cap of the gas permeable material of the liquid processor. Then, the inside of the liquid treatment device is filled with the inert gas to the inside of the membrane through hole.
Then, the sterilization process is completed by irradiating the liquid processor with gamma rays from the outside of the bag. Glycerin and physiological saline inside the liquid processor do not leak to the outside of the liquid processor because the cap has a liquid blocking property.

[0009]

【Example】

Example 1 The blood mouth of a hollow fiber hemodialyzer (membrane area: 1.9 m ² ) was sealed with a butyl rubber cap (thickness: 1.4 mm), and the dialysate mouth was sealed with a silicone rubber cap. The hemodialyzer was placed in a bag made of polyester / aluminum / polyethylene laminate sheet. An ageless was also stored in the bag. 1 day, 2 days, 3 days,
Seven days later, 14 days later, 21 days later, without opening the bag, stick a thin rubber on the dialysate port cap of the dialyzer, and use a microsyringe from above to sample the gas inside the dialyzer to measure the oxygen concentration. Was measured. Toray oxygen analyzer LF-700 was used for oxygen concentration analysis. Table 1 shows the results.

Example 2 Table 1 shows the results when the oxygen concentration of the dialyzer was measured by the same method as in Example 1 except that the thickness of the butyl rubber cap in Example 1 was 0.5 mm.

[0010]

[Table 1]

As is clear from Table 1, the oxygen inside the blood processor passes through the gas-permeable rubber stopper and is adsorbed by the oxygen scavenger inside the bag, and when the cap thickness is 1.4 mm, it takes 3 weeks. When it was 0.5 mm, the oxygen concentration inside the blood processor became 0 in 3 days.

[0012]

INDUSTRIAL APPLICABILITY When a wet or semi-wet liquid treatment device is subjected to radiation sterilization in an inert gas atmosphere, the use of the liquid treatment device of the present invention allows the membrane treatment agent to seep out from the inside of the liquid treatment device and cause liquid It does not adhere to the outer wall of the processor or the inside of the packaging bag, and your hands do not get dirty when opening the packaging bag or touching the liquid processing machine.

Claims (2)

[Claims] 1. When a liquid treatment device having a membrane protective agent filled in a wet state or a semi-wet state is sterilized by radiation in an inert gas atmosphere, the dialysate port of the liquid treatment device is gas permeable. A liquid processing device that is tightly sealed with a liquid blocking cap. 2. The liquid processor according to claim 1, wherein the liquid processor and the oxygen scavenger are housed in a gas impermeable packaging bag for radiation sterilization.