JPS58134840A - Radiation sterilizing and packing method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a radiation sterilization packaging method, and more particularly to a radiation sterilization packaging method for substances unstable to the oxidizing action of oxygen in the air.

In recent years, it has been frequently used to sterilize medical products such as food-related products because it can be carried out at low temperatures and has strong penetrating power. In general, radiation sterilization treatment is because bacteria are highly resistant to radiation in anoxic conditions, and the killing effect is significantly reduced.

The packaging method used is to place the items to be sterilized in a bag that is made entirely of paper or paper on one side and plastic on the other, completely sealed, and subjected to radiation sterilization in the presence of air. Distribution to the market is about to take place. However, in this radiation sterilization packaging method, a part of the bag is made of paper, so it is difficult to use IC during the distribution process in the market.
This has the disadvantage that the paper is damaged and bacteria can easily enter from the damaged area. Furthermore, since a portion is made of paper, it is convenient because it can be sterilized in the presence of oxygen in the air, but it has the disadvantage that substances that are unstable to the oxidizing effects of oxygen in the air cannot be stored for a long period of time. In addition, the fRc material to be sterilized, such as a differential stick such as polyethylene or polystyrene, is placed in the bag, and the bag is filled with air, water is added, or oxygen is added, the bag is completely sealed, and then radiation sterilization is performed.

After processing, it is also distributed on the market.

However, this packaging method has the disadvantage that substances that are unstable to the oxidizing effects of oxygen cannot be stored for a long period of time because air, moisture, and oxygen remain in the 9 bags forever.

In view of the above-mentioned circumstances, the present inventors have conducted various studies to provide an ideal radiation sterilization packaging method, and as a result, they have arrived at the present invention.

That is, the present invention is a packaging method for radiation sterilization of substances unstable to the oxidizing action of oxygen in the air, and more specifically, the packaging method is open on one side and closed with a breathable material on the other side, and The object to be sterilized is stored in a container made of a material with low oxygen permeability, and after the opening is sealed, radiation sterilization is performed, and after the treatment, an inert gas is introduced into the container through a breathable material. Alternatively, it is a radiation sterilization packaging method characterized by sealing the inside of the container, which does not contain breathable material, after deoxidizing the inside of the container by enclosing an oxygen absorber across a breathable material. .

According to the present invention, the storage stability of sterilized products is very good because they can be stored or distributed in the market under an inert gas atmosphere or deoxidized atmosphere while retaining their sterilization effect, and are not subject to oxidation effects. It is.

According to the packaging method of the present invention, since the container is made of a material with low oxygen permeability, there is no need to worry about container breakage, long-term sterilization effect and long-term storage stability are maintained, and the container is easy to operate even when the container is small. It is economically very advantageous.

To perform radiation sterilization packaging using the method of the present invention, first, the object to be sterilized is placed in a container that is open on one side, closed with a breathable material on the other side, and whose sides are made of a material with low oxygen permeability. After storing and sealing the opening, radiation sterilization is performed.

The material with low oxygen permeability constituting the container used in the present invention is one with an oxygen permeability of 1000 ac/m・24 hre.
ATM or less, preferably 120 cc/d・24
For example, films, sheets, etc., which are less than or equal to hr ” atm.

Refers to things that have the shape of plates, tubes, pipes, etc.
Materials constituting such a material with low oxygen permeability include:
For example, polyvinyl V-Core S/''i resin, polyvinylidene chloride resin, polyamide resin, polyester resin, and lyolefin resin.

Examples include metal foil, and a suitable material is, for example, honed polyvinyl V alcohol V film.

Stretched polyvinyl V-apor V tube, ethylene polyvinyl V-alcohol film, ethylene polyvinyl p-cor V
Thug, biaxially oriented polyvinyl V-coat V-film, polyvinyl chloride denim film.

Vinylidene chloride tube, polyvinylidene chloride coated vinylon film, cellophane, polyvinylidene chloride coated cellophane, polyvinylidene chloride coated abrasive nylon film, polyvinylidene chloride coated polyester
Films, stretched polypropylene films coated with polyvinylidene chloride, polyethylene films coated with polycyclized vinylidene.

Stretched nylon film, stretched nylon tube.

polyethylene terephthalate tube, polyethylene terephthalate tube, expanded polypropylene fibers,
Examples include AV Mihaku. The thickness of the material with low oxygen permeability may be any thickness depending on the application.

The breathable material used to close one end of the container used in the present invention is a material that allows gases to pass through but not microorganisms, such as paper, non-woven fabric, or film.5/
A porous body, etc., which preferably has pores or spaces with a diameter of 0.57 or less, and which can be V-&ed by itself or with defsticks, heat, adhesive, etc. means. Materials constituting such breathable materials include, for example, 7M loin, 7M loin, and 7M loin.
Looseesthetic V, polyamide, polyester A/, polycarbonate, polystyrene, polyethylene, 1N! Examples include lippropylene, fluororesin, V-licon resin, silica, and glass.

The shape of the container used in the present invention is not limited as long as the object to be sterilized can be stored in the container, and may be of any shape such as a bag, a tube, or a box. Furthermore, there are no particular limitations on the hardness or flexibility of the container.

The radiation used for sterilization in the present invention includes, for example, X-rays, electromagnetic radiation such as γ-rays, high-speed electron beams, β-rays,
Examples include particle radiation such as a-rays, neutrons, and protons, and the dose may be arbitrary depending on the object to be sterilized.

In the present invention, after sterilization, an inert gas is introduced into the container through a breathable material, or an oxygen absorber is sealed across the breathable material to deoxidize the inside of the container.
The object to be sterilized is stored in a deoxidized state by sealing the inside of the container, which does not contain breathable material. In this case, if storage stability is particularly desired, an inert gas is introduced into the container with an oxygen scavenger placed across one breathable material, and the container is filled with a Preferably, a method is employed in which, after removing trace amounts of oxygen, the container is sealed inside the container that does not contain any breathable material.

Examples of the inert gas used in the present invention include nitrogen, helium, argon, and carbon dioxide. The pressure of the inert gas is not specified, and the oxygen scavenger used in the present invention may be any oxygen absorbing agent, but the amount is sufficient to absorb the oxygen in the container. It is necessary to use

Preferred embodiments of the present invention will be described below based on the drawings.

Figure 1 ((a) is an explanatory diagram illustrating how to make a container used in the packaging method of the present invention; Figure 1 is a plan view of the container completed from 4C; (/→ is the first
Figure (- shows a cross-sectional view taken along the line A-A. As shown in Figure 1, two sheets of material 1 with low oxygen permeability are stacked together, and a breathable material 2 folded in half is sandwiched between two sheets of material 1 at one end of the sheet. A cylindrical container 6 is produced by completely sealing the side edge 5 of the breathable material with heat seal ν or an adhesive or the like with an IC breathable material 2 having a low oxygen permeability.

Figure 2 (Plant view of the container when the surface area of the air-permeable material 2 is widened with no treetops, Figure 2 (→ is B-B in Figure 2 ((a)
Although not shown in the drawing, the breathable material 2 may be folded multiple times to increase the surface area.

Figure 3 (4 is a plan view of the container when the material with low oxygen permeability is a tube-shaped material and the breathable material is thick);
B) shows a cross-sectional view taken along the line C--C of FIG.

As shown in FIG. 3, the breathable material 2 may be thick, that is, the filtration layer may have a long distance.

FIG. 4 is an explanatory diagram showing a state in which objects to be sterilized are stored in the container shown in FIG. Figure 6 (b) is an explanatory diagram showing the state in which an inert gas is filled into the container through a ventilating material. 7 (4° (b) is an explanatory diagram showing a state in which the inside of the container is sealed from the breathable material part, and Figure 8 shows a state in which the breathable material part is cut away. It is an explanatory diagram.

As shown in Fig. 4, the object to be sterilized 9 (schematically shown in the drawing) is stored in the container 6 through the opening 8, and the opening 8 is closed as shown in Fig. 5! /-A/1
0 or use adhesive to reduce radiation! After the treatment, fill the container with an inert gas through the breathable material 2 as shown in Figure 6 ((A), and seal the inside of the container from the breathable material 2 to ensure the sterilization effect. Either store it in a completely preserved state or distribute it to the market, or use an oxygen absorber 11 (for example, Ageless manufactured by Mitsubishi Gas Chemical Co., Ltd., 0 manufactured by Tokyo Norin Co., Ltd. -R-C, etc.), as shown in Figure 7, seal both edges of the breathable material with seams Iv12L to cut off contact with outside air and leave it for several days to deoxidize the air inside the container. After.

Sea A/13 is applied to the inside of the container from the breathable material 2, and the product is stored or distributed on the market in a state where the reduction effect is completely maintained. If necessary, after replacing and filling the air in the container with an inert gas through the breathable material 2 as shown in Figure 6 (shown in the top), further remove the oxygen in the container with an oxygen scavenger as shown in Figure 6 (n C). The final product is fully sealed, as shown in Figure 8.Also, the two sections of breathable material do not have to be separated if desired.

According to the method of the present invention explained with the above drawing, the catheter V on which urokinase is immobilized is sterilized by radiation,
When we investigated the decrease in Kurokinai activity when stored for a long period of time, we found that the activity retention rate of Kurokinai was 95g6 when stored at 25°C for 6 months, and Catheter V was in a sterile state. Biaxially oriented vinyl film was used as the material with low permeability, paper was used as the breathable material, and Co-60, 2,5Mrod was used for radiation sterilization.
Do it.

Argon gas was used as the inert gas, and Ageless, manufactured by Mitsubishi Gas Chemical Co., Ltd., was used as the oxygen absorber.

For comparison, when the catheter was stored in a conventional sterile bag with one side made of paper and one side made of plastic, the catheter was sterile, but the urokinase activity retention rate was 55%.
Met.

The activity of immobilized urokinase was measured in all valves.

Complete compilation of “Clinical Testing Law Summary” revised 27th edition (Metal Publishing)
Referring to U-100, the test was carried out as follows using a fibrin plate containing fibrinogen dissolved in water.

That is, the catheter M on which urokinase was immobilized was placed on a fibrin plate, and after being left at 37C for 24 hours, the area of the fibrin membrane divided into #I was taken as the activity titer. Then, the activity titer of the immobilized urokinase after storage for a predetermined period was divided by the activity titer immediately after sterilization, and the value was calculated and expressed as the residual activity rate.

The method of the present invention is effective for preserving substances that are unstable to the oxidizing effect of oxygen after radiation sterilization, and can be used for packaging in the medical field, food field, pharmaceutical and reagent fields, etc.

[Brief explanation of the drawing]

Figure 1 (b) is an explanatory diagram illustrating how to make a container used in the packaging method of the present invention;
-() The plan view of the completed container from C, @Figure 1 (/) is!
Figure 1 (A-Staff sectional view) Figure 2 (A) is a plan view of the container when the surface area of the breathable material is expanded (1). Figure 2 (B) is Figure 2 (40B- B-line sectional view, Figure 3 (
(a) The material with low linear oxygen permeability is in the form of a tube. A plan view of the container when the breathable material is thick, Figure 3 (C4 is a cross-sectional view taken along the line C-C of Figure 3 (4), Figure 4 shows the state in which objects to be sterilized are stored in the container shown in Figure 1). Fig. 5 is an explanatory drawing showing a state in which the opening of the container is V-rued, Fig. 6 is an explanatory drawing showing a state in which inert gas is filled into the container through a breathable material, Figure 6 is an explanatory diagram showing the state in which an oxygen absorber is sealed 1 m outside the container with a breathable material in between, and the oxygen absorber absorbs oxygen from the air inside the container. S/- on the inside of the container from the breathable material part
Explanatory diagram showing a pv closed state. FIG. 8 is an explanatory diagram showing a state in which the breathable material portion is cut away. 1... Material with low oxygen permeability, 2 - Breathable material, 6
-・Container, 9-・Object to be sterilized, 11-・Oxygen absorber Patent applicant Unitika Co., Ltd.

Claims (1)

[Claims] (1) The object to be sterilized is stored in a container with one side permanently open, the other side closed with a breathable material, and the sides made of a material with low oxygen permeability, and after the open opening is sealed, radiation sterilization is performed. Process. After the treatment, the inside of the container is deoxidized by introducing an inert gas into the container through a breathable material or by sealing an oxygen absorber across the breathable material. A radiation sterilization packaging method characterized by sealing on the inside.