JPH05221461A - Packaging bag - Google Patents

Abstract

PURPOSE:To easily take out a sterile material from its double packaging bag. CONSTITUTION:In a double packaging bag consisting of an inner bag 8 for containing a sterile material 1 and an outer bag 9 for enclosing the inner bag therewith, the inner and outer bags are attached together at the place 6 of overlapping and sealing and a tearing part 4 is provided on a part 10 of the inner bag projecting from the sealed part to unpack the inner and outer bags at the same time.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a sterilized double packaging bag containing items to be sterilized such as medical devices, medicines, foods, etc. When the double packaging bag is opened, an inner bag and an outer bag are simultaneously opened. The present invention provides a packaging bag provided with such an opening part.

[0002]

2. Description of the Related Art In light of the sterilization of packaging of medical devices, pharmaceuticals, foods, etc., it is doubled in order to improve the sterilization retention and prevent deterioration of the sterilized object due to oxidation. The packaging format may be adopted.

For example, in JP-A-58-134839 and JP-A-62-74364, medical devices are placed in a breathable bag and radiation sterilized in the air, and then the internal air is replaced with an inert gas. It has been disclosed a method of substituting with oxygen or encapsulating an oxygen scavenger inside and packaging with an oxygen impermeable material. According to this method, since the sterilization is performed in the air, the D value does not increase, and oxygen is removed after the sterilization, so that deterioration over time can be prevented.

[0004] It is also effective to prevent the deterioration with time by packaging the inside of the body under vacuum after radiation sterilization.

However, the product packaged by the above-mentioned method further contains a packaging bag containing medical equipment in a non-breathable bag, and when the product is opened for use in a hospital, the opening operation is performed twice. Had to be done, which was troublesome.

[0006]

DISCLOSURE OF THE INVENTION The present invention provides a packaging bag which solves the above-mentioned drawbacks and which can easily take out sterilized objects such as double-packaged sterilized medical devices such as γ-ray sterilized. To do.

[0007]

Means for Solving the Problems The inventors of the present invention have conducted extensive studies to achieve such an object, and as a result, by providing an opening portion on a part of an inner bag of a double packaging bag, The inventors have found that it is preferable to open the inner bag together with the bag, and arrived at the present invention.

[0008] That is, the present invention is a double packaging bag comprising an inner bag containing an item to be sterilized and an outer bag containing the inner bag, wherein at least the interior of the inner bag is sterilized. At least a part of the inner bag and at least a part of the peripheral part of the outer bag are overlapped and sealed in a state where a part of the peripheral part projects outward, and the inner bag projects to the outside of the multiple sealing part. The present invention provides a packaging bag, characterized in that an opening portion for opening the inner bag is provided at the peripheral edge portion of the packaging bag.

Further, the present invention provides a double packaging bag comprising an inner bag in which an item to be sterilized is housed and an outer bag in which the inner bag is housed, wherein at least the inside of the inner bag is sterilized, and a peripheral edge of the inner bag is provided. At least a part of the portion and at least a part of the peripheral portion of the outer bag are overlapped and sealed, and an opening portion for opening the inner bag together with the outer bag is provided in the multiple sealing portion. It provides a packaging bag.

According to the present invention, in the multiple seal portion, the melting point of the material on at least the outer surface side of the inner bag is lower than the melting point of the material on the inner surface side of the outer bag, and the multiple seal is heat-sealed. Including packaging bags that are

Further, in the above-mentioned present invention, the sterilized object is a medical device, and at least a part of the inner bag is made of a breathable member impermeable to bacteria, and the sterilized object is stored in the inner bag. It is radiation sterilized in a sealed state with non-permeability and breathability, and the outer bag contains an inner bag and keeps oxygen impermeability and sealed in a state where oxygen is substantially absent inside. Included are packaging bags.

Specific examples of the material to be sterilized in the present invention include blood treatment devices such as artificial kidneys, medical devices such as catheters and other medical devices, food products such as processed foods, and pharmaceutical products such as blood products. In particular, those that are susceptible to deterioration due to oxidation in the packaging bag during the storage period after sterilization are more suitable for the present invention, and drugs such as medicines, foods, and urokinase-immobilized catheters that are naturally susceptible to oxidation by oxygen in the air are used. In addition to the tools, examples thereof include medical tools such as a blood processing device using a cellulose ester that is easily oxidized by oxygen after being sterilized by γ-rays.

The medical device to which the present invention can be applied is effective when it is made of a polymer material, but it is not limited to one made entirely of a polymer material, but a part thereof is made of a polymer material. But it's okay. As the polymer material, any known material can be applied, and cellulose, cellulose acetate, polyvinyl alcohol, polymethyl-methacrylate, polyacrylonitrile, polycarbonate,
Examples thereof include polyester, polyamide, ethylene-vinyl alcohol copolymer, silicone rubber, polyethylene, polystyrene, polyvinyl chloride, polyurethane, ABS resin, polybutadiene, and polypropylene.

The medical device of the present invention has such a polymer material in at least a part thereof, and specific examples thereof include a hollow fiber hemodialyzer, a hemofilter, a plasma separator, and
A body fluid treatment device such as an adsorption type blood treatment device can be used. In addition, these may be manufactured by the method normally used.

Examples of the sterilization method of the object to be sterilized in the present invention include radiation sterilization of γ rays, EO gas sterilization, heat sterilization and the like. Specific examples of γ-ray sterilization and EO gas sterilization include:
One example is sterilization of a hollow fiber hemodialyzer using hollow fibers of cellulose ester. Specific examples of heat sterilization include sterilization of medicines and retort foods.

According to the present invention, the sterilized product is packaged in a double packaging form. As a specific example of the double packaging, the sterilized product is double packaged and then sterilized by sterilizing the whole. In addition to the one that strengthens the retention of the item to be sterilized, after sterilizing what is stored in the inner bag of the item to be sterilized, and storing them in the outer bag so that the atmosphere of the internal space is substantially oxygen-free,
Some are sealed in a vacuum.

The double wrapping of the present invention is characterized in that an opening portion suitable for opening the inner bag together with the outer bag is provided at least at the peripheral portion of the inner bag.

That is, as a concrete example of the double wrapping of the present invention, as shown in FIG. 1, a state in which a part 10 of an inner bag 8 in which a sterilized object 1 is housed and a peripheral edge 2 is sealed is projected. The peripheral portion 3 is housed in a sealed outer bag 9, and at least the inner surface of the outer bag and the outer surface of the inner bag are sealed in a portion 6 where the inner bag and the outer bag are overlapped. There is something. It is more desirable that the inner surface of the inner bag is also sealed at the overlapped portion 6.

Further, as a concrete example of the double packaging of the present invention, as shown in FIG.
The inner bag 18 with 2 sealed therein is housed in the outer bag 19 sealed with the peripheral portion 13, and both are sealed to each other at the portion 16 where the peripheral portions of the inner bag and the outer bag are overlapped. There is one that is in a standing state.

At the portion where the inner bag and the outer bag are overlapped and sealed in the double packaging of the present invention, the melting point of the thermoplastic resin constituting at least the outer surface side of the inner bag constitutes the inner surface side of the outer bag. It is desirable that the melting point be lower than the melting point of the thermoplastic resin. That is, by using such a combination, it is possible to surely perform the sheet sealing in the multiple sealing portion. Specific examples thereof include those in which the inner bag is made of a polyethylene sheet and the inner surface of the outer bag is made of polypropylene having a higher melting point than that of polyethylene.

FIG. 1 shows a specific example of the opening portion for opening the inner bag together with the outer bag in the double packaging according to the present invention.
2, there are V notches 4 provided on the peripheral edge of the protruding inner bag, and V notches provided on the overlapping portion 16 of the inner bag and the outer bag as shown in FIG. As another example of the unsealing part of the present invention, one in which two sheets constituting the inner bag are separated from each other in a part of the peripheral portion of the projecting part in FIG. In place of the V notch in Fig. 1, a continuous cut or a broken line-shaped cut is made in the peripheral portion.

As an example of this additional embodiment of the present invention, as shown in FIGS. 1 and 2, the articles to be sterilized 1 and 11 are medical devices such as a hollow fiber blood processor using a cellulose acetate hollow fiber membrane. At least a part of the inner bags 8,18 5,15
Is a bacterium impermeable breathable member, which is sterilized by γ-rays in a state in which the medical device is housed in an inner bag and is bacterium impermeable and breathable and sealed. The outer bags 9 and 19 have the inner bags 8 and 18 housed therein. As shown in FIG. 1, the air in the inner bag and in the gap between the inner bag and the outer bag is substantially replaced with nitrogen gas. , Or in a state close to a vacuum, the multiple seal part 6 is formed, or as shown in FIG. 2, the oxygen absorbent 17 is housed in the outer bag together to form the multiple seal part 16 so that the multiple inner seal bag 16 is formed. An example is one in which oxygen gas does not substantially exist in the gap between the inner and outer bags.

The inner bag used in the present invention, which is partially made of a non-breathable material which is impermeable to bacteria, is mainly composed of a non-breathable material, and the sterilized material is contained therein. It is not particularly limited as long as it can store a barrel medical device, and may have any shape such as a tubular shape, a tube shape, a box shape, and a bag shape. The material may be one that allows nitrogen or oxygen to permeate to some extent, but if possible, one that has a relatively low oxygen permeability is desirable.

Further, the bacterium-impermeable and breathable material used in the present invention means a material which allows gas to pass but does not allow microorganisms to pass, for example, paper, non-woven fabric, film, sheet, filter, membrane, porous body. It is preferable to have holes or voids having a diameter of 0.5 μm or less, and to have a surface that can be sealed with heat or an adhesive. Further, when the inner bag is housed in the outer bag, a part of the inner bag protrudes to the outside, and an opening portion is provided at this protruding portion.

The material having a low oxygen permeability used for the outer bag of the present invention has an oxygen permeability coefficient of 50 NCC / m ^2.
・ Hr · atm or less, preferably 10 NCC / m ² · H
r · atm or less, more preferably 5 NCC / m ² · H
For example, a film, a sheet, or the like having a thickness of r · atm or less. Examples of the material constituting such a material having low oxygen permeability include metal foil, polyvinylidene chloride resin, polyvinyl alcohol resin, polyamide resin, polyester resin, polyolefin resin, and a combination of two or more thereof. can give. The material having low oxygen permeability may have any thickness depending on the application, and may have any shape as long as it can cover the inner bag. However, a layer of a thermoplastic resin suitable for a sheet seal needs to be present on at least the inner surface of the peripheral portion of the outer bag.

As a preferred method for substantially removing oxygen in an oxygen-containing gas such as air existing in the space between the inner bag and the outer bag of the present invention, a seal after decompression treatment,
That is, there is a method of vacuum packaging. The pressure during depressurization in this case is not particularly limited as long as it is in a range that can easily prevent adverse effects on medical devices, but is preferably about 400 Torr or less, and more preferably 200 Torr or less. By evacuating this part to a vacuum, the volume of the packaged object to be sterilized is reduced, which is advantageous in the subsequent packaging and transportation.

The irradiation dose of γ-ray used for γ-ray sterilization in the present invention is usually appropriately selected within the range of about 15 to 50 KGy.

[0028]

INDUSTRIAL APPLICABILITY According to the present invention, since the double-wrapped inner bag can be opened by a simple operation, the object to be sterilized can be taken out very easily, which is an excellent practical effect.

Further, the present invention has the effect of improving the sealing property in the seal portion where the inner bag and the outer bag are superposed to ensure double packaging and also making it easy to open as described above. included.

Further, according to the present invention, particularly for an object to be sterilized, deterioration due to oxidation after radiation sterilization is apt to be a problem,
Those that have the effect of improving storage stability and facilitating opening are included.

[0031]

The present invention will be described in more detail with reference to the following examples, but the present invention is not limited thereto.

Hemodialysis prepared by loading a cellulose acetate hollow fiber bundle containing glycerin, etc., which has been preliminarily dipped in an aqueous glycerin solution containing a buffer, into a cylindrical container and forming tube plates at both ends. Figure 1
As shown in Fig. 4, after accommodating in a polyethylene inner bag 8 having a bacteria-impermeable and breathable part 5 made of a polypropylene non-woven fabric and completely sealing the peripheral portion 2, a γ of 20 KGY
The line was irradiated.

Then, the inner bag 8 was housed in an outer bag 9 made of a laminated film of aluminum (outside) and polypropylene (inside). At that time, the opened portion 4 of the inner bag was housed in a state of protruding outside the opening of the outer bag.

Thereafter, the inside of the outer bag is evacuated by a vacuum packaging machine for about 10 minutes.
The product was obtained by reducing the pressure to torr and further heat-sealing the opening of the outer bag in a state of being filled with N ₂ gas to about 400 torr to form the multiple sealing part 6 and packaging.

When the product is used, it is possible to open both the outer bag and the inner bag with a single opening operation by opening the inner bag 8 protruding from the outer bag 9 using the opening portion 4. It was

Both the eluate test and the sterility test of the dialysis membrane immediately after γ-ray irradiation and after storage for 6 months passed.

[Brief description of drawings]

FIG. 1 is an illustration of a specific schematic diagram of an interior bag of the present invention.

FIG. 2 is an illustration of a specific schematic diagram of the packaging bag of the present invention.

Claims (4)

[Claims] 1. A double packaging bag comprising an inner bag containing an item to be sterilized and an outer bag containing the inner bag, wherein at least the interior of the inner bag is sterilized. At least a part of the inner bag and at least a part of a peripheral portion of the outer bag are overlapped and sealed in a state where a part thereof protrudes to the outside, and a peripheral portion of the inner bag protrudes to the outside of the multiple sealing portion. A packaging bag, characterized in that an opening portion for opening the inner bag is provided in the packaging bag. 2. A double packaging bag comprising an inner bag containing an item to be sterilized and an outer bag containing the inner bag, wherein at least the interior of the inner bag is sterilized, and at least a peripheral portion of the inner bag is provided. A packaging bag, wherein a portion and at least a peripheral portion of the outer bag are overlapped and sealed, and an opening portion for opening the inner bag together with the outer bag is provided in the multiple sealing portion. 3. In the overlapped seal part, the melting point of the material on at least the outer surface side of the inner bag is lower than the melting point of the material on the inner surface side of the outer bag, and the multiple seals are heat-sealed. The packaging bag according to claim 1 or 2. 4. The sterilized object is a medical device, and at least a part of the inner bag is made of a gas impermeable member that is impermeable to bacteria, and the sterilized object is housed in the inner bag and is impermeable to bacteria and breathable. It has been sterilized by radiation in a sealed state by holding
The outer bag contains an inner bag and is sealed while maintaining oxygen impermeability in a substantially oxygen-free state inside.
Or the packaging bag of 2.