JP5962430B2 - Method for carrying article into isolator and article container - Google Patents

Description

The present invention relates to a method for carrying an article into an isolator and an article container, and more specifically, a method for carrying an article into an isolator and an article that can quickly carry a decontaminated article into the isolator in an aseptic state. Concerning the container.

Conventionally, in the case of cell culture of human cells and tissues used for regenerative medicine, preparation for culturing, replacement of medium during culturing, and subculture work are necessary. Isolators are used in which the interior is kept sterile.
Isolators are completely isolated from the outside and the inside is maintained in a sterile condition. When carrying materials required for culturing operations into the isolator, a decontamination cabinet that can directly access the inside of the isolator is provided. The outer surface is decontaminated using a decontamination gas such as hydrogen peroxide vapor in a decontamination cabinet, and then carried into an isolator (Patent Document 1).

By the way, since the decontamination gas component for decontaminating materials is harmful to the human body, it is necessary to completely remove it so that there is no residue. However, depending on the type of material, there is a shape portion such as a tubular portion that is difficult for decontamination gas to enter, and there is a problem that it takes a long time to remove the decontamination gas component from such a portion.
Therefore, conventionally, as a method of carrying in the isolator without causing the decontamination gas to act directly on the material, the material is carried into the isolator while being contained in a bag. In this carrying-in method, the material is first put in a bag and sealed, and the inside of the bag is decontaminated in advance by irradiating the outside of the bag with radiation such as an electron beam or γ-ray, and the outer surface of the bag is decontaminated. After sterilizing with gas, it is carried into the isolator and taken out from the bag inside the isolator. According to this carrying-in method, since the inside of the material and the bag is decontaminated in advance, the inside of the isolator is not contaminated by opening. Moreover, in such a carrying-in method, the method of carrying in to an isolator in the state which carried out multiple packaging of the material with three types of bags of large, medium, and small is proposed (patent document 2).

JP 2005-278666 A JP 2008-239168 A

However, in the conventional delivery method, if the material is made of resin, there is a risk of discoloration or alteration due to irradiation of radiation. In particular, safety has been confirmed by tests defined by the Japanese Pharmacopoeia, such as pharmaceutical containers. If there is no impact, it could not be used. In addition, radiation sterilization has a large facility and is often not installed in a facility where culture work is performed.
Furthermore, depending on the material of the bag, the decontamination gas may permeate into the bag, and the decontamination gas component may act on the contained material, and the decontamination gas component is not sufficiently removed in the isolator. There was a risk of being released. For this reason, it takes time for aeration for removal, which hinders quick cell manipulation.

In view of the circumstances described above, the first present invention is a method for carrying an article into an isolator that is isolated from the outside and maintained in a sterile state,
A package that contains decontaminated articles and that is maintained in a sterile state inside is stored in an outer bag, and the outer bag is in a state in which required portions between the outer surface of the package and the inner surface of the outer bag are bonded by an adhesive means. Next, the outer surface of the outer bag is decontaminated and placed in a sterile isolator, and in the isolator, the outer bag and the package are cut at a required location bonded by the bonding means, and the The decontaminated article is taken out from the package through the opened opening.
The second aspect of the present invention is an article container for accommodating an article when the article is carried into an isolator that is isolated from the outside and maintained in an aseptic state.
The article container is composed of a package body that contains decontaminated articles and the inside is maintained in a sterile state, and an outer bag that houses the package body, and is disposed on the outer surface of the package body or the inner surface of the outer bag. Further, it is characterized in that an adhesive means for adhering a required portion of the outer surface of the package body and the inner surface of the outer bag in a state where the package body is housed in the outer bag is provided.

According to the present invention, the packaging body containing the decontaminated articles is accommodated in the outer bag, and the required portions of the outer surface of the packaging body and the inner surface of the outer bag are bonded together. The decontaminated article can be quickly taken out from the body.
Therefore, the decontaminated article can be quickly carried into the isolator.

The block diagram of the aseptic culture system which shows one Example of this invention. It is sectional drawing which shows the article | item container which concerns on this invention, FIG. 2 (a) is sectional drawing which shows a package, FIG.2 (b) is sectional drawing which shows the state which bonded the packaging body and the outer bag, FIG. c) is a sectional view showing a state in which the package and the outer bag are cut open. The top view of a package. Sectional drawing of the principal part of an outer bag.

  Hereinafter, the present invention will be described with reference to the illustrated embodiment. FIG. 1 shows an aseptic culture system. This aseptic culture system includes an isolator 1 in which an internal space is maintained in a sterile state, a pass box 5 connected to a carry-in port 1A of the isolator 1 and decontaminating an article container P containing materials 2 as articles, A sterilizer 6 that is provided separately from the isolator 1 and decontaminates the inner bag 3 and the material 2 as a package of the article container P, and the openings of the inner bag 3 and the outer bag 4 of the article container P. And a heat sealer 7 for sealing the part. The isolator 1 and the pass box 5 are connected to a decontamination device 11 for supplying a decontamination gas therein, and the isolator 1 is connected to an aseptic maintenance air conditioning means 12 for maintaining the interior at a positive pressure. .

The isolator 1 is isolated from the external atmosphere and maintained in an aseptic state, and cell operations such as culture preparation and passage work are performed in the isolator 1.
The side wall of the isolator 1 is provided with a pair of gloves 13 for working inside, and the operator performs a required work in the isolator 1 by operating the glove 13 by inserting a hand from outside. Be able to. Further, the isolator 1 includes a cutter 14 for opening the inner bag 3 and the outer bag 4 of the article container P.
In the isolator 1, a sealing door 15 for opening and closing the carry-in port 1A is provided, and the connection port 5A of the pass box 5 is connected to the carry-in port 1A while maintaining airtightness. On the other hand, a sealing door 16 is provided at the entrance 5 </ b> B of the pass box 5.
In this embodiment, a pipette tip, a dish, a centrifuge tube, a sample tube, and the like are assumed as the material 2 accommodated in the inner bag 3.

As shown in FIG. 3, the inner bag 3 is made of a plastic bag having an opening 3D, and the material 2 is accommodated therein through the opening 3D. The opening 3D is welded and sealed by the heat sealer 7.
A double-sided tape 21 is attached in advance to the outer surface 3A of the inner bag 3 as an adhesive means. A gas introduction part 3B is provided on the outer surface 3A of the inner bag 3. This gas introduction part 3B has closed the whole area of the opening part 3C with the nonwoven fabric made from a high density polyethylene. This non-woven fabric allows the inflow of decontamination gas into the inner bag 3, but has the ability to prevent the invasion of bacteria and microorganisms. For example, Tyvek (registered trademark) of DuPont USA can be adopted. .
As shown in the cross section of the main part in FIG. 4, the outer bag 4 has a property that the polyethylene layer 4a on the outer surface side easily passes the decontamination gas, and the inner nylon layer 4b is It has the property of easily adsorbing decontamination gas. In this embodiment, a polyethylene layer 4c is further provided inside the nylon layer 4b, and the nylon layer 4b is sandwiched between the polyethylene layers 4a and 4c.

  The article container P is configured as described above, and an article is carried into the isolator 1 using the article container P as follows. First, after the material 2 is accommodated as an article in the inner bag 3 that is a package, the opening 3D is welded and sealed by the heat sealer 7. Next, the inner bag 3 is decontaminated by the decontamination gas by the sterilizer 6. The sterilizer 6 uses, for example, a general ethylene oxide gas, and the decontamination gas flows from the gas introduction part 3B, and the inside of the inner bag 3 and the material 2 are decontaminated. When taken out from the sterilizer 6, the outer surface of the inner bag 3 is contaminated, but the gas introduction part 3B allows inflow of decontamination gas, but prevents invasion of bacteria and microorganisms. The material 2 is maintained in a sterile state after decontamination. And it leaves in this state and removes a decontamination gas component.

Next, the inner bag 3 is accommodated in the outer bag 4 that is slightly larger than the inner bag 3, and the cover sheet of the double-sided tape 21 attached to the outer surface 3 </ b> A of the inner bag 3 is peeled off and bonded to the inner surface of the outer bag 4. Thereby, the inner bag 3 and the outer bag 4 are adhere | attached with the double-sided tape 21 as an adhesion | attachment means (refer FIG.2 (b)). And the opening part of the outer bag 4 is welded with the heat sealer 7, and the outer bag 4 is sealed.
A required portion of the inner bag 3 and the outer bag 4 bonded by the bonding means is a cutting portion that is opened to take out an article from the inner bag 3. As shown by a straight line in FIG. 3, the cut portion is within the range of the double-sided tape 21 as an adhesive means.

  Next, the article container P composed of the inner bag 3 and the outer bag 4 is decontaminated by the pass box 5 and then carried into the isolator 1. First, the inside of the isolator 1 is decontaminated in advance with a decontamination gas such as hydrogen peroxide vapor supplied from the decontamination apparatus 11, and is maintained in a sterilized state by the aseptic maintenance air-conditioning means 12. In this state, Opens the outer sealing door 16, carries the article container P into the pass box 5, and removes the article by decontamination gas such as hydrogen peroxide vapor supplied from the decontamination apparatus 11 into the pass box 5. The outer surface of the container P, that is, the entire outer surface 4A of the outer bag 4 is decontaminated. The outer bag 4 is provided with a nylon layer 4b having a property of easily adsorbing decontamination gas, so that the decontamination gas penetrates into the outer bag 4 and flows into the inner bag 3. Is prevented.

Thereafter, the operator opens the sealing door 15 from the inside of the isolator 1 using the globe 13 and carries the article container P into the isolator 1 from the pass box 5. Instead of using the pass box 5, the article container P may be positioned in the isolator 1 before decontamination, and decontamination may be performed simultaneously with the decontamination in the isolator 1.
Thereafter, the operator cuts a required portion where the inner bag 3 and the outer bag 4 of the article container P are bonded by the cutter 14 previously carried into the isolator 1 (see FIG. 2C). Thereby, in the state which sealed the uncontaminated contaminated part 22 except the part mutually adhere | attached on the outer surface 3A of the inner bag 3, and the inner surface of the outer bag 4, ie, this contaminated part 22 is exposed in the isolator 1. The inner bag 3 can be cut open from the outside of the outer bag 4 without. The decontaminated material 2 can be taken out from the inner bag 3 through the opened opening 3E. The outer bag 4 is provided with polyethylene layers 4a and 4c sandwiching the nylon layer 4b, thereby preventing the decontamination gas component adsorbed by the nylon layer 4b from being easily released. Moreover, since the decontamination gas easily passes through the outer polyethylene layer 4a, the outer surface 4A of the outer bag 4 can be sufficiently decontaminated by the permeation of the decontamination gas.
In the present embodiment, the article container P is carried into the isolator 1 and the decontaminated material 2 is carried into the isolator 1 as described above.

In addition, in the said Example, although the double-sided tape 21 as an adhesion | attachment means was previously affixed on the outer surface 3A of the inner bag 3, you may make it affix the double-sided tape 21 on the inner surface of the outer bag 4, The inner bag 3 and the outer bag 4 may be bonded to each other with a double-sided tape having a required length separately prepared when the inner bag 3 is accommodated in the outer bag 4. Moreover, not only a double-sided tape but an adhesive may be applied to form an adhesive surface and covered with a cover sheet.
In addition, the layer of the property which the decontamination gas used for the outer bag 4 is easy to pass can employ | adopt materials, such as polypropylene, a polystyrene, a polyethylene terephthalate similarly low gas barrier property and water vapor | steam barrier property other than polyethylene. In addition, as a layer having a property of easily adsorbing the decontamination gas, activated carbon can be adopted in addition to nylon.
In addition, the package to be accommodated in the outer bag 4 is not limited to the one that accommodates and seals the article when it is carried into the isolator 1 as in the case of the inner bag 3 described as an example. A package in which the material 2 or the like as a product is packaged may be used. In this case, radiation sterilization may be performed in advance.

1. Isolator 2. Material (article)
3. Inner bag (packaging body) 3A Outer surface 3B Gas inlet 3E Opening 4 Outer bag 21 Double-sided tape (adhesive means)
P: Goods container

Claims (5)

A method for carrying an article into an isolator that is isolated from the outside and maintained in a sterile state,
A package that contains decontaminated articles and that is maintained in a sterile state inside is stored in an outer bag, and the outer bag is in a state in which required portions between the outer surface of the package and the inner surface of the outer bag are bonded by an adhesive means. Sealed and
Next, the outer surface of the outer bag is decontaminated and positioned in a sterile isolator, and the outer bag and the package body are cut at a required position bonded by the bonding means in the isolator, and the cut opening is opened. A method for carrying an article into an isolator, characterized in that the decontaminated article is taken out of the package through a package.   The outer bag has a multilayer structure in which a layer having a property of allowing decontamination gas to pass through is provided on the outer surface, and a layer having a property of easily adsorbing the decontamination gas is provided on the inner surface thereof. The method for carrying an article into an isolator according to claim 1, wherein decontamination is performed using a gas.   The package includes a gas introduction part that allows inflow of decontamination gas while preventing invasion of bacteria and microorganisms. The decontamination gas is allowed to flow from the gas introduction part, and the inside of the package is accommodated. The method for carrying an article into an isolator according to claim 1 or 2, wherein the article is decontaminated. An article container that accommodates an article when the article is carried into an isolator that is isolated from the outside and maintained in an aseptic state.
The article container is composed of a package body that contains decontaminated articles and the inside is maintained in a sterile state, and an outer bag that houses the package body, and is disposed on the outer surface of the package body or the inner surface of the outer bag. An article container comprising an adhesive means for bonding a required portion of the outer surface of the package and the inner surface of the outer bag in a state where the package is stored in the outer bag.   The package includes a gas introduction part that allows inflow of decontamination gas while preventing invasion of bacteria and microorganisms, and the outer bag is provided with a layer having a property of allowing the decontamination gas to pass through on the outer surface thereof. 5. The article container according to claim 4, wherein the article container has a multilayer structure in which a layer having a property of easily adsorbing a decontamination gas is provided.

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