JP2019206386A - Aseptic transport container and connecting method of aseptic transport container - Google Patents

Abstract

SOLUTION: A cylindrical connection part 21 provided in an isolator 2 (a sterile room) is covered with a cover 22 made of a flexible material (a), a front opening part 11a of an aseptic transport container 4 is attached to the connection part 21 (b). An inner bag 12 (a partition body) and the cover 22 of the aseptic transfer container 4 are drawn into an internal space S2 of the isolator 2 (c), the cover 22 and the inner bag 12 are welded in a polymerized state (d). Further, the welded cover 22 and the welded part M of the inner bag 12 are cut at a substantially central part thereof (e), the coating C (a non-weldable part) provided on the inner bag 12 separates the inner bags 12 and allows the isolator 2 and the aseptic transfer container 4 to communicate with each other (f).EFFECT: The present invention provides a cheap and disposable aseptic transport container, and a connecting method of the aseptic transport container capable of a communication between an aseptic room and an aseptic transport container without decontamination.SELECTED DRAWING: Figure 3

Description

  The present invention relates to an aseptic transfer container and a method for connecting an aseptic transfer container, and more particularly, to a method for connecting an aseptic transfer container for transferring an article between an aseptic chamber and an aseptic transfer container while maintaining aseptic conditions, and the aseptic transfer container And a sterile transport container suitable for the connection method.

Conventionally, cell culturing work has been performed using an aseptic room such as an isolator whose interior is maintained in a sterile state, and instruments and containers for working in such an aseptic environment are aseptic for the aseptic room. It is necessary to transport while maintaining the state.
Therefore, various aseptic transport container connection methods for transferring articles between the sterile room and the sterile transport container while maintaining a sterile condition have been proposed. For example, a cylindrical connection at the tip of a plastic bag A method for connecting an aseptic transfer container is known in which an aseptic transfer container provided with a port is connected to a connection port provided in the sterilization chamber to transfer articles (Patent Document 1).

Japanese Patent No. 4744663

However, since the aseptic transport container used in the method for connecting the aseptic transport container must be provided with the connection port, it is difficult to make the aseptic transport container disposable.
Further, in the method for connecting the sterile transport container, when the sterile transport container is connected to the sterile room, the sterile chamber and the sterile transport container are communicated after decontaminating the portion that has been exposed to the outside. Therefore, there is a problem that the decontamination work is complicated.
In view of such a problem, the present invention provides an inexpensive and disposable aseptic transport container, and allows the sterile room and the sterile transport container to communicate with each other while maintaining aseptic conditions without decontaminating the connection portion. The present invention provides a method for connecting a possible sterile transport container.

That is, the aseptic transfer container according to the invention of claim 1 is an outer bag made of a flexible material having a front opening formed therein, a space in which the front opening is formed inside the outer bag, and a rear thereof. A partition made of a flexible material that partitions into a sealed space of
It is characterized in that a non-weldable portion is provided on the surface of the partition body on the side of the sealed space so that the surfaces on the side of the sealed space of the partition body are not welded to each other.
According to a third aspect of the present invention, there is provided a method for connecting an aseptic transport container, wherein the aseptic chamber whose interior is maintained in a sterile condition is connected to the sterile transport container whose interior is maintained in a sterile condition, while the sterile condition is maintained. A method for connecting an aseptic transfer container that allows the inside of an aseptic chamber and an aseptic transfer container to communicate with each other,
Provide a cylindrical connecting part protruding outside in the aseptic room,
The aseptic transfer container is partitioned into an outer bag made of a flexible material having a front opening formed therein, and a space in which the front opening is formed and a sealed space behind the outer bag. It consists of a partition made of a flexible material,
Covering the opening of the connection part from the outside with a cover made of a flexible material, and making the internal space of the sterile room sterile.
Attach the front opening of the sterile transport container to the connecting part so as to overlap the cover covering the opening,
Pull the partition of the sterile transport container and the cover into the interior space of the sterile room,
The inside of the cover that has been pulled back and folded, in a state where the partition body that has been pulled back and folded is polymerized, the cover and the partition body are welded with a predetermined width,
By cutting the welded portion between the welded cover and the partition, the sealed space of the sterile transport container is opened, and the internal space of the sterile chamber and the sealed space of the sterile transport container are communicated with each other. Yes.

Since the aseptic transport container according to the invention of claim 1 does not include a connection port for connecting to the aseptic chamber and is constituted by an outer bag and a partition body made of a flexible material, it is inexpensive. It is disposable.
According to the aseptic transport container connecting method according to the invention of claim 3 using the aseptic transport container, the outer bag of the aseptic transport container is attached to the connecting portion covered by the cover, so that the cover, the partition, During this period, a non-decontamination space that has been exposed to the outside is formed.
Thereafter, by welding the cover and the partition in a polymerized state, the non-decontamination space does not communicate with the interior space of the sterile room or the sterile transfer container even if the welded portion is cut.
Furthermore, since the surface of the sealed space side of the partition of the sterile transport container is not welded, the partition can be separated by cutting the welded portion, and the sterile room and the sterile transport container are in communication with each other in a sterile state. The article can be transferred while the aseptic condition is maintained by forming the opening.

Configuration diagram of cell culture system according to the present embodiment Configuration diagram of aseptic transfer container Diagram explaining how to use a sterile transport container The figure which shows the procedure which uses an aseptic conveyance container continuously

Hereinafter, the illustrated embodiment will be described. FIG. 1 illustrates a cell culture system 1 for culturing cells. An isolator 2 as an aseptic chamber whose interior is maintained in a sterile state, And an incubator 3 provided so as to be connectable.
In the cell culture system 1, a culture operation such as an operation of storing cells in the culture container or an operation of replacing the medium is performed inside the isolator 2, and the cells after the culture operation are stored in the culture container. After being transferred to the incubator 3 in a state, it is cultured in the incubator 3.
The inside of the isolator 2 is maintained in an aseptic environment, and a side surface is provided with a pass box 2a and a glove 2b. In the pass box 2a, a container containing cells and materials such as a tray and a pipette used in the isolator 2 In addition, it is possible to perform various operations inside the isolator 2 by decontaminating articles such as the above, and wearing the globe 2b by an operator.
The incubator 3 is maintained in a sterile environment and maintained at a predetermined temperature and humidity suitable for cell culture. While the cells are cultured, the incubator 3 is separated from the isolator 2, It can be stored in a place away from the isolator 2.
The isolator 2 and the incubator 3 are connected by connecting means, and for example, connecting means for contacting and separating the incubator 3 and the isolator 2 while maintaining aseptic conditions is used as described in Japanese Patent No. 4656485. be able to.
The details of the cell culture system 1 and the cell culturing work using the cell culture system 1 are well known in the art and will not be described in further detail.

And in the cell culture system 1 of a present Example, it shows in FIG. 3, FIG. 4 by connecting the aseptic conveyance container 4 shown in FIG. 2 to the isolator 2 separately from the carrying-in method of the articles | goods using the said pass box 2a. It is possible to transfer articles while maintaining sterility by using a method for connecting aseptic conveyance containers.
As shown in FIG. 2, the aseptic transport container 4 is constituted by an outer bag 11 having a front opening 11 a formed therein, and an inner bag 12 as a partition provided inside the outer bag 11. As materials constituting the outer bag 11 and the inner bag 12, flexible materials such as polyethylene and vinyl chloride are used.
The outer bag 11 is formed in a cylindrical shape in a state where the article is not accommodated, and a rear opening 11b is formed at the other end with respect to the front opening 11a, and the article is accommodated from the rear opening 11b. It is possible to do.
And after accommodating articles | goods, the said rear opening part 11b can be sealed by welding the vicinity of the said rear opening part 11b from the exterior of an outer bag.

The inner bag 12 is accommodated in the outer bag 11, and its opening is joined to the front opening 11a of the outer bag 11 in a state of being kept airtight by a method such as welding or adhesion.
With such a configuration, the inside of the outer bag 11 is partitioned into a space in which the front opening 11a is formed by the inner bag 12 and a sealed space S1 in which the article behind the housing is accommodated. It has become.
The surface of the inner bag 12 on the side of the sealed space S1 is formed with a coating C as a non-weldable part such that the surfaces of the inner bag 12 on the side of the sealed space S1 are not welded, and the surface on the side of the sealed space S1. They are not welded together.

Hereinafter, the connection method of the aseptic conveyance container using the said aseptic conveyance container 4 is demonstrated using FIG. 3, FIG. For the sake of explanation, the inner bag 12 and the following cover 22 constituting the aseptic transport container 4 are described as stretchable materials.
First, as shown in each drawing of FIG. 3, a cylindrical connection portion 21 is provided outside the isolator 2, and the internal space S <b> 2 of the isolator 2 communicates with the outside via the connection portion 21. It is like that.
FIG. 3A shows a process of covering the opening of the connecting part 21 from the outside with a cover 22 made of a flexible material and decontaminating the internal space S2 of the isolator 2 to make it sterile. ing.
The cover 22 is formed of a material such as polyethylene and vinyl chloride similar to the outer bag 11 and the inner bag 12 constituting the aseptic transport container 4 and is shown in the form of a film in the figure, but actually has a bag shape. doing.
Then, the cover 22 is brought into close contact with the outer periphery of the connection portion 21 so as to cover the opening of the connection portion 21 and is held on the connection portion 21 by a holding means 23 such as a rubber band from the outside of the cover 22. As a result, the internal space S2 of the isolator 2 and the outside are partitioned by the cover 22 in an airtight state.
Here, the holding means 23 may be in any form as long as the cover 22 and the outer bag 11 can be held in close contact with the outer peripheral surface of the connecting portion 21.
When the opening of the connection portion 21 is covered with the cover 22 in this manner, the internal space S2 of the isolator 2 is decontaminated using a conventionally known method, whereby the cover 22 on the side of the internal space S2 of the isolator 2 is decontaminated. The part will be decontaminated.

FIG. 3B shows a step of connecting the aseptic transport container 4 to the connecting portion 21. Here, articles are previously stored in the sealed space S1 of the sterile transfer container 4, and the sealed space S1 is maintained in a sterile state.
Here, as the operation of storing the article in the aseptic transfer container 4, when the article is first received from the rear opening 11 b of the outer bag 11, the rear opening 11 b is welded by a heat sealer, and then the aseptic transfer container 4. Radiation such as gamma rays and electron beams is irradiated from the outside to sterilize the sealed space S1 of the sterile transport container 4 and the article.
In this step, the front opening portion 11a of the aseptic transport container 4 is attached to the connection portion 21 so as to overlap the cover 22, and the holding means 23 holds the cover 22 from the outside of the outer bag 11. The holding means 23 different from the above is held together with the cover 22 on the outer peripheral surface of the connecting portion 21.
As a result, the non-excluded portion that has been exposed to the outside by the outer portion of the cover 22 and the inner portion of the inner bag 12 on the front opening 11a side of the inner bag 12 of the aseptic transport container 4 is thereby removed. A dye space P is formed.

FIG. 3C shows a step of drawing the inner bag 12 of the sterile transport container 4 and the cover 22 into the internal space S2 of the isolator 2 in a state where they are overlapped.
Specifically, when an operator wears the glove 2 b of the isolator 2, the cover 22 and the inner bag 12 are gripped from the inside of the isolator 2 through the connection portion 21 and passed through the connection portion 21. 2 into the internal space S2.
As a result, the cover 22 is folded by being drawn into the internal space S2 of the isolator 2, and the inner bag 12 is also folded by being drawn into the internal space S2 of the isolator 2.
At this time, since the non-decontamination space P formed between the cover 22 and the inner bag 12 is maintained in a sealed state, the internal space S2 of the isolator 2 and the sealed space S1 of the aseptic transport container 4 are maintained. There is no contamination.

FIG. 3D shows a step of welding the inner bag 12 and the cover 22 that are drawn back and folded in the inner space S2 of the isolator 2 with a predetermined width from the outside of the cover 22 in a superposed state. Is shown.
A heat sealer 24 is prepared in advance inside the isolator 2, and the heat sealer 24 is constituted by a pair of gripping members each provided with a heater (not shown), for example.
When a sheet made of polyethylene, vinyl chloride or the like is sandwiched by the gripping member of the heat sealer 24, the heater heats the polymerized sheet and welds the sheets together.
The heat sealer 24 is operated by an operator wearing the globe 2b and is welded by the heat sealer 24 in a state where the inner bag 12 and the cover 22 drawn into the internal space S2 of the isolator 2 are overlapped and folded. It has become.
Specifically, the two sheets constituting the folded inner bag 12 are laminated inside the two sheets constituting the folded cover 22, but the sheet constituting the cover 22 is laminated. The sheets constituting the inner bag 12 are welded, but the sheets constituting the inner bag 12 are not welded by the coating C formed on the inner bag 12.
As a result, when welding is actually performed, a ring-shaped welded portion M is formed by welding the cover 22 and the inner bag 12, thereby forming between the cover 22 and the inner bag 12. The non-decontamination space P is divided into two spaces by the welding portion M.
The width of the welded portion M by the heat sealer 24 is set to a width that can cut the substantially central portion of the welded portion M with scissors or the like in a subsequent process.

FIG. 3E shows a step of cutting the substantially central portion of the welded portion M.
Although not shown, a cutting means such as scissors is prepared inside the isolator 2, and an operator wearing the glove 2b cuts the substantially central portion of the welded portion M using the cutting means. ing.
As a result, the part located closer to the inner space S2 of the isolator 2 than the welded part in the cover 22 and the inner bag 12 is separated as the removed part, but the cut part is the welded part M. The non-decontamination space P formed between the cover 22 and the inner bag 12 constituting the removed portion and the remaining portion communicates with the internal space S2 of the isolator 2 and the internal space S2 of the sterile transport container 4. Absent.

FIG. 3F shows a process of transferring an article from the sterile transport container 4 to the isolator 2.
In the step of cutting the welded part M, when the removed part is removed, the sheets constituting the inner bag 12 are not welded by the coating C, so the surface of the inner bag 12 on the inner space S2 side is An opening that allows the internal space S2 of the isolator 2 and the internal space S2 of the sterile transport container 4 to communicate with each other can be formed.
Then, the operator can transfer the articles stored in the sterile transport container 4 to the isolator 2 through the opening formed inside the inner bag 12 and the connection portion 21.

Thus, according to the connection method of the aseptic transport container of the present embodiment, by using the aseptic transport container 4, it is possible to transfer articles while maintaining the aseptic condition with respect to the isolator 2. Yes.
Further, since the aseptic transport container 4 used in the present embodiment is not provided with a connection port, it can be composed of only a flexible material such as the outer bag 11 and the inner bag 12, so that the aseptic transport container 4 Can be manufactured at low cost and can be disposable after use.
In each of the above-described steps, the portion on the outside of the cover 22 exposed to the outside and the portion on the front opening 4a side of the inner bag 12 of the aseptic transfer container 4 are sealed as a non-decontamination space P. The maintained state is maintained, so that the isolator 2 and the aseptic transfer container 4 can be quickly communicated with each other while maintaining the aseptic state without decontaminating the portion exposed to the outside.

FIG. 4 shows a procedure for transferring an article a plurality of times using the sterile transport container 4. The used sterile transport container 4 from which the article has been taken out in the operation described in FIG. 3 is connected. The operation of transferring the article to the isolator 2 using the new sterile transport container 4 while being connected to the section 21 is shown.
Here, since the inner bag 12 of the used sterile transport container 4 is welded to the cover 22 by performing the operation described in FIG. 3, it is not possible to remove only the used sterile transport container 4. Further, when the cover 22 is removed, the internal space S2 of the isolator 2 communicates with the outside, and the aseptic state cannot be maintained.
Therefore, in the operation shown in FIG. 4, a new sterile transport container 4 can be connected while the used sterile transport container 4 remains connected, and articles can be carried in the aseptic transport container 4 while maintaining the sterile condition. It is what.

FIG. 4A shows a process of removing the outer bag 11 of the used sterile transport container 4 used in FIG. 3 from the connection portion 21.
Specifically, the holding means 23 that has been holding the outer bag 11 to the connecting portion 21 until then is removed, and the outer bag 11 may be detached from the connecting portion 21, whereby the cover 22 and the used aseptic can be removed. The non-decontamination space P formed between the inner bag 12 of the transport container 4 is opened to the outside.

FIG. 4 (b) shows that the used sterile transport container 4 together with the cover 22 is pulled through the connecting portion 21 into the internal space of the isolator 2 and turned over, and the front opening 11a of a new sterile transport container 4 is connected to the connecting portion. 21 shows a process of attaching to 21.
Here, in the procedure described in each drawing of FIG. 3, the cover 22 to which the inner bag 12 of the used sterile transport container 4 is welded is in a state welded by the welded portion M. A used cover bag U is constituted by the cover 22 and the used sterile transport container 4.
The operator draws the used cover bag U located outside from the inside of the isolator 2 through the connecting portion 21 into the internal space S2 of the isolator 2, and the used cover bag U thus drawn is inside. It is turned over in the space S2.
As a result, the portion that has been in contact with the aseptic environment that has been in communication with the isolator 2 until then is exposed in the internal space S2 of the isolator 2, and conversely, the portion that has been exposed to the outside is turned upside down. Therefore, the sterility of the isolator 2 is maintained.
In this state, as in FIG. 3B, the front opening 11a of the outer bag 11 of the new sterile transport container 4 is attached to the connecting portion 21 so as to overlap the cover 22, and further the outer bag 11 The cover 22 is held together with the cover 22 by holding means 23 different from the holding means for holding the cover 22 from the outside.
As a result, the space formed inside the used cover bag U located in the internal space S2 of the isolator 2 and the inner bag 12 of the new sterile transport container 4 have been exposed to the outside. A non-decontamination space P is formed.

FIG. 4C shows a process of superposing the inner bag 12 of the new sterile transport container 4 on the inside of the used cover bag U turned upside down.
The operator draws the inner bag 12 of the new sterile transport container 4 from the inner space S2 of the isolator 2 toward the inner space S2 of the isolator 2, and configures the new inner bag 12 to constitute the used cover bag U. Polymerize inside bag 12.

FIG. 4D shows a state in which the used cover bag U and the inner bag 12 are preliminarily placed in a state in which the folded back new inner bag 12 is polymerized inside the used cover bag U turned upside down. The process of welding with the width | variety of is shown.
In this step, the heat sealer 24 used in FIG. 3D can be used. In this step, the new inner bag 12 drawn into the isolator 2 by the operator and the inner bag of the used cover bag U are used. 12 is polymerized and welded in a folded state.
That is, the two sheets constituting the new folded inner bag 12 are laminated inside the two sheets constituting the inner bag 12 of the used cover bag U that has been folded. Therefore, the sheet constituting the inner bag 12 of the used cover bag U located on the outer side and the sheet constituting the new inner bag 12 located on the inner side have the coating C formed on opposite surfaces. Since it is not, it will be welded.
On the other hand, since the coating C is formed on the opposite surfaces of the sheets constituting the new inner bag 12, the sheets constituting the new inner bag 12 are not welded to each other. Yes.

4 (e) and 4 (f) show the step of cutting the substantially central portion of the welded portion M and the inner bag 12 of the new aseptic transfer container 4 separated from each other so that the internal space S2 of the isolator 2 and the new The steps of communicating with the sealed space S1 of the sterile transport container 4 are shown.
These steps are the same as those described in FIGS. 3E and 3F, and detailed description thereof is omitted.

  By performing the operation shown in FIG. 4, it is possible to transfer the article using the sterile transport container 4 to the isolator 2 a plurality of times, and at this time, the sterile transport container 4 is first attached to the isolator 2. As in the case of the connection, the isolator 2 and the new sterile transport container 4 can be communicated with each other while maintaining the sterile condition without performing decontamination.

The aseptic transport container 4 in the above embodiment has a configuration in which the inner bag 12 is provided inside the outer bag 11, but a film-like partition having elasticity is provided inside the outer bag 11. The sealed space S1 may be formed inside the outer bag 11 by a partition.
Even in such a configuration, the partition body can be welded in a state of being polymerized between the covers 22 by drawing the partition body into the internal space S2 of the isolator 2 as in the above embodiment.
If a non-weldable part is formed on the surface of the partition body on the sealed space S1 side, the isolator 2 and the sterile transfer container 4 can be communicated with each other while maintaining the sterile condition after the welded part M is cut.

Note that the aseptic transport container 4 used in each of the above examples has the coating C as the non-weldable part formed on the surface of the inner bag 12 on the side of the sealed space S1, but the aseptic product with the non-weldable part omitted. A transport container 4 can also be used.
In this case, a plate or sheet having approximately the same width as the welded portion M is previously stored in the sealed space S1 of the aseptic transfer container 4 and welded to the sealed space S1 side of the inner bag 12 on the surface of the plate or sheet. What is necessary is just to make it not weld between partitions, such as forming the coating C which does not carry out.
In the step of welding the inner bag 12 and the cover 22 shown in FIG. 3 (d), the plate or sheet is interposed between the sheets constituting the inner bag 12 in advance, If welding is performed, the partitions are not welded to each other as in the above embodiment, and a ring-shaped welded portion M is formed.
Moreover, although the said Example applies this invention to the cell culture system 1, it aims at connecting the aseptic conveyance container 4 to the aseptic room maintained aseptic conditions, and transferring an article | item. For example, the present invention can be applied to the pharmaceutical field.

DESCRIPTION OF SYMBOLS 1 Cell culture system 2 Isolator 3 Incubator 4 Aseptic conveyance container 11 Outer bag 11a Front opening part 12 Inner bag (partition body) 21 Connection part 22 Cover 23 Holding means 24 Heat sealer M Welding part P Non-decontamination space U Used cover bag S1 Sealed space S2 internal space

Claims (4)

An outer bag made of a flexible material with a front opening formed therein, and a flexible material that divides the inside of the outer bag into a space in which the front opening is formed and a sealed space behind the outer bag. And a partition made of
An aseptic conveyance container, wherein a non-weldable portion is provided on a surface of the partition body on the side of the sealed space so that surfaces of the partition body on the side of the sealed space are not welded to each other. The outer bag has a cylindrical shape with the front opening at one end and the rear opening at the other end,
The aseptic transfer container according to claim 1, wherein the sealed space is formed by sealing the rear opening in a state where an article is put in from the rear opening. Connection of a sterile transport container that connects the sterile chamber maintained in a sterile condition to the sterile chamber that is maintained in a sterile condition, and that communicates the interior of the sterile chamber with the sterile container while maintaining the sterile condition. A method,
Provide a cylindrical connecting part protruding outside in the aseptic room,
The aseptic transfer container is partitioned into an outer bag made of a flexible material having a front opening formed therein, and a space in which the front opening is formed and a sealed space behind the outer bag. It consists of a partition made of a flexible material,
Covering the opening of the connection part from the outside with a cover made of a flexible material, and making the internal space of the sterile room sterile.
Attach the front opening of the sterile transport container to the connecting part so as to overlap the cover covering the opening,
Pull the partition of the sterile transport container and the cover into the interior space of the sterile room,
The inside of the cover that has been pulled back and folded, in a state where the partition body that has been pulled back and folded is polymerized, the cover and the partition body are welded with a predetermined width,
By cutting the welded portion between the welded cover and the partition, the sealed space of the sterile transport container is opened, and the internal space of the sterile chamber and the sealed space of the sterile transport container are communicated with each other. To connect a sterile transport container. Remove the outer bag of the used sterile transport container from the above connection part,
The used cover bag consisting of the used aseptic transfer container and the cover welded to the partition body is pulled into the interior space of the sterilization chamber through the connecting portion and turned over.
Attach the front opening of a new sterile transport container to the connection,
Pull the new sterile transport container partition into the interior of the sterile room,
Inside the inside of the used cover bag turned upside down, the used cover bag and the partition body are welded with a predetermined width in a state in which the folded back part of the new sterile transport container is polymerized,
By cutting the welded cover bag and the welded portion of the partition, the sealed space of the new sterile transport container is opened, and the internal space of the sterile room and the sealed space of the new sterile transport container are The method for connecting sterile transport containers according to claim 3, wherein:

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