JP2009189492A - Lyophilization container and manufacturing method of lyophilization container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a lyophilization container manufactured at low cost, hardly breaking and excellent in gas barrier property, thermal conductivity during lyophilization, and buckling strength when driving a lid, and not requiring classified disposal after use. <P>SOLUTION: The lyophilization container 10 comprising a container body 11 of plastic containing matter to be lyophilized and the lid 21 of plastic fitted in the container body 11 is characterized in that the container body 11 includes a side wall portion 14 formed of a molding 12 and a gas barrier film 13 and a bottom portion 16 covered with the gas barrier film 15 such that at least a part of the same may be constituted of only the gas barrier film 15, and in that the gas barrier film 22 is formed in the lid 21. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a freeze-dried container and a method for producing a freeze-dried container.

In general, medical drugs such as protein preparations and antibiotics are lyophilized to maintain the stability of active ingredients.
The freeze-dried product is accommodated in a freeze-drying container by the following operation. First, the freeze-dried stock solution is filled in the container body of the freeze-dried container. Next, the stopper is half-plugged into the container body, and the container body is placed on a shelf (heating / cooling shelf) having heating and cooling functions in the freeze-drying apparatus. Further, the container main body is cooled by the heating / cooling shelf, and the stock solution of the lyophilized product is frozen. Next, the stock solution of the lyophilized product is dried under reduced pressure while keeping the frozen state. Thereafter, nitrogen gas is supplied into the freeze-drying apparatus to return to atmospheric pressure, and the inside of the container body is replaced with gas, and then the stopper is completely plugged into the container body. In this way, the lyophilized product is stored in the lyophilization container.

  In order to take out the lyophilized product from such a lyophilized container, the injection needle is passed through the stopper of the lyophilized container, a predetermined solution for dissolving the lyophilized product is injected into the lyophilized container, and the lyophilized product is dissolved. Dissolve the lyophilizate with the solution. Thereafter, the lyophilized solution is aspirated with an injection needle. In this way, the freeze-dried solution is taken out of the freeze-dried container.

A glass container has been mainly used for the container body of such a freeze-dried container. Since the glass container is excellent in gas barrier properties, oxygen and moisture do not permeate into the container, and the freeze-dried product is not easily altered. However, there is a problem that the glass container is vulnerable to impact and easily damaged.
On the other hand, as an alternative to glass containers, freeze-dried containers using plastic containers have been commercialized. A plastic container has an advantage that it is less likely to break than a glass container. However, the plastic container is inferior in thermal conductivity as compared with the glass container, and there is a problem that it takes time to freeze-dry.

Therefore, in order to improve the thermal conductivity of the plastic container, Patent Document 1 discloses a freeze-dried container in which the container has a flat shape and the container wall of the container is thin. Patent Document 2 discloses a freeze-dried container in which the bottom of the container is thin, and a freeze-dried container in which an opening is provided in the bottom of the container and a thin film is attached to the opening. Yes.
Japanese Patent Laid-Open No. 10-236537 JP 10-155875 A

  However, since a plastic container is inferior to a gas container in comparison with a glass container, the plastic container of Patent Document 1 having a thin container wall may not be able to maintain the gas barrier property. Furthermore, the plastic container of Patent Document 1 having a thin container wall cannot provide sufficient buckling strength with a single container, and needs to be fixed and fixed to a dedicated receiving part. Moreover, although the plastic container of patent document 2 is set as multilayer extrusion molding using gas barrier resin, in multilayer extrusion molding, there is a possibility that the gas barrier resin layer may be broken, and there is a possibility that the gas barrier property cannot be maintained. is there.

By the way, a rubber stopper is used as a stopper for a conventional freeze-drying container. However, the rubber stopper is expensive, which has been a cause of increasing the manufacturing cost of the freeze-dried container.
Further, the container body and the rubber stopper are caulked with an aluminum fastener so that the rubber stopper does not fall off from the container body after the stopper. Further, such a freeze-dried container needs to separate and discard the container body, the rubber stopper, and the aluminum fastener after use.
The present invention has been made in view of the above circumstances, is low in manufacturing cost, is not easily damaged, has excellent gas barrier properties, thermal conductivity during freeze-drying, and buckling strength at the time of plugging, and further after use. An object of the present invention is to provide a freeze-dried container that does not require separation and disposal and a manufacturing method thereof.

In order to achieve the above object, the present invention adopts the following configuration.
(1) A freeze-dried container comprising a plastic container main body in which a freeze-dried product is stored, and a plastic stopper fitted to the container main body,
The container body is composed of a side wall portion formed of a molded body and a gas barrier film, and a bottom portion covered with a gas barrier film so that at least a part thereof is composed only of the gas barrier film,
A freeze-dried container, wherein a gas barrier film is formed on the stopper.
(2) The freeze-drying container according to (1), wherein at least one of the gas barrier film on the side wall, the gas barrier film on the bottom, and the gas barrier film on the stopper is an aluminum foil laminated film.
(3) The freeze-drying container according to (1), wherein the gas barrier film on the side wall is a transparent film.

(4) The plug according to any one of (1) to (3), wherein the stopper is provided with a reseal layer that is in close contact with an injection needle that penetrates the stopper and prevents a gap from being generated in the stopper. Freeze-dried container.
(5) A method for producing a freeze-dried container comprising a plastic container main body in which a freeze-dried product is accommodated, and a plastic stopper fitted to the container main body,
Forming the side wall of the container body by welding a gas barrier film to a molded body molded from plastic,
A gas barrier film is welded to the lower end of the molded body to form the bottom of the container body,
A method for producing a freeze-dried container, wherein a gas barrier film is welded to the stopper formed from plastic.

  The freeze-dried container of the present invention is low in production cost, is not easily damaged, has excellent gas barrier properties, thermal conductivity during freeze-drying, and buckling strength during stoppering, and does not require separation after use. According to the method for producing a freeze-dried container of the present invention, the freeze-dried container of the present invention can be efficiently produced.

Hereinafter, the present invention will be described in detail with reference to the drawings.
As shown in FIG. 1, a freeze-dried container 10 according to an embodiment of the present invention includes a plastic container main body 11 in which a freeze-dried product is stored, and a plastic stopper 21 fitted in the container main body 11. Is provided.

  The container main body 11 includes a side wall portion 14 formed of a molded body 12 and a gas barrier film 13 and a bottom portion 16 whose bottom surface is covered with a gas barrier film 15 over the entire surface. In addition, an opening 17 is provided at the upper end of the container body 11 to fill a stock solution of lyophilized material. Here, the lower end surface of the molded body 12 is defined as a lower end 18, and a portion formed on the inner periphery of the lower end 18 and integrally molded with the molded body 12 is defined as a bottom molded portion 19.

The thickness of the molded body 12 is preferably 0.5 to 10 mm. By setting it to 0.5 mm or more, sufficient buckling strength of the container main body 11 is obtained, and the container main body 11 is not easily damaged by pressing during lyophilization stoppering. By setting it as 10 mm or less, transparency of the side wall part 14 can be made favorable, and the visibility of the freeze-dried material accommodated in the container becomes good. In this embodiment, the molded body 12 has a circular cross section as shown in FIG. 2, but may have other cross sectional shapes as long as the container body 11 can stand on its own.
Moreover, it is also preferable to provide a flange part (not shown) in the upper end part of the container main body 11 so that this flange part can be used as a welded part with a stopper described later.
Synthetic resins for forming the molded body 12 include polyolefin resins, cyclic polyolefin resins, polytetrafluoroethylene resins, polyethersulfone resins, polystyrene resins, polyester resins, polyamide resins, polyvinyl chloride resins. Etc. Among them, a polyolefin resin that has little influence on the lyophilized product and is excellent in discardability and recyclability is preferable. Moreover, since polyolefin resin is excellent in transparency, it is preferably used also when visibility is required for the side wall part 14. Examples of the polyolefin resin include polyethylene resin and polypropylene resin. Moreover, the molded object 12 may be made into the multilayer structure which consists of a several different resin layer.

The gas barrier film 13 is a film having an oxygen barrier property and a water vapor barrier property. The oxygen transmission rate as the oxygen barrier property of the index of the gas barrier film 13 ^is preferably 0~0.5ml / m 2 / 24hrs / MPa , it is 0~0.1ml / m 2 / 24hrs / MPa Is more preferable. Water vapor permeation amount of the water vapor barrier property of the index of the gas barrier film 13 is preferably 0~1.0g ^/ m 2 ^/ 24hrs, more preferably 0~0.5g ^/ m 2 ^/ 24hrs.
As a specific example of the gas barrier film 13, silica, aluminum, alumina or the like is vapor-deposited on a film made of a metal foil film of 5 to 100 μm made of a metal such as copper, aluminum or magnesium, a polyester resin, a polyamide resin or the like. Vapor-deposited barrier film, metal foil laminated film in which a metal foil having a thickness of about 5 to 100 μm is sandwiched between PET resin and polypropylene resin, a K-coated film in which a film such as PET or cellophane is coated with polyvinylidene chloride (PVDC), Examples thereof include a coated barrier film in which an organic and / or inorganic barrier material having a barrier property is coated on a film made of polyester or polyamide. In addition, films using polyvinyl alcohol resin (PVA), ethylene / vinyl alcohol copolymer (EVOH), PVDC, metaxylylenediamine polyamide resin (MXD) as raw materials for films, and these raw materials are used. In addition, a laminated film obtained by laminating the above-described film and the above-described other gas barrier film by a dry laminating method or the like, and a coextruded barrier film obtained by laminating these raw materials and a polyolefin resin or the like by coextrusion are also included.

The gas barrier film 13 is preferably a transparent film such as a coextrusion barrier film, a vapor deposition barrier film, or a coat barrier film when the container body 11 needs to be visible. The gas barrier film 13 having transparency can be combined with the above-described transparency 12 to form a side wall 14 having transparency, and the visibility of the lyophilized product accommodated in the container is visible. Becomes better.
The gas barrier film 13 is preferably a metal foil or a metal foil laminated film that is particularly excellent in gas barrier properties when particularly excellent gas barrier properties are required. In addition, thermal conductivity can also be improved more because the gas-barrier film 13 is a metal foil or a metal foil laminated film. As a metal used for these metal foil or metal foil laminated film, aluminum and magnesium are preferable.

  The gas barrier film 13 may be a commercially available product. For example, “GL film” manufactured by Toppan Printing Co., Ltd., “IB film” manufactured by Dai Nippon Printing Co., Ltd., “Tech Barrier” manufactured by Mitsubishi Plastics Co., Ltd., “Eval film” “Clarista” manufactured by Kuraray Co., Ltd. “Saran UB” manufactured by Asahi Kasei Co., Ltd. “Hitron BX” manufactured by Tamapoli Co., Ltd. “Max Barrier” manufactured by Tosero Co., Ltd. “Besera” manufactured by Kureha Etc.

  Although the thickness of the gas barrier film 13 depends on the type of film, in the case of a film containing a resin as a main component, the thickness is preferably 10 to 100 μm and more preferably 20 to 80 μm. If it is 10 μm or more, sufficient gas barrier properties can be obtained. If it is 100 micrometers or less, the heat conductivity at the time of freeze-drying will be favorable.

It is preferable that a protective layer (not shown) for protecting the gas barrier film 13 is provided on the surface of the gas barrier film 13. Thereby, damage to the gas barrier layer of the gas barrier film 13 due to rubbing or the like can be prevented more reliably, and the gas barrier property can be maintained.
Examples of the resin that forms the protective layer include PET resin, polypropylene resin, and polyethylene resin. The thickness of the protective layer is preferably 5 to 100 μm.
It is preferable that an adhesive layer (not shown) that strengthens the bonding between the gas barrier film 13 and the molded body 12 is formed between the gas barrier film 13 and the molded body 12. Thereby, a physical stimulus generated due to a difference in expansion rate and shrinkage rate between the gas barrier film 13 and the molded body 12 based on a temperature change during freeze-drying, or a chemical stimulus from the contents that can permeate the molded body 12 For example, the gas barrier film 13 can be prevented from being peeled off from the molded body 12, and good gas barrier properties can be maintained. The adhesive layer is made of a synthetic resin such as polyethylene resin or polypropylene resin, or a known adhesive or adhesive resin that can be bonded to the resin of the head 23. The thickness of the adhesive layer is preferably 5 to 100 μm. Examples of the adhesive include urethane adhesives, epoxy adhesives, ester adhesives, and the like. Examples of the adhesive resin include a modified polyethylene resin and a modified polypropylene resin.

More specifically, the bottom portion 16 is formed of a gas barrier film 15 and a bottom portion molding portion 19 provided continuously to the lower end 18. The gas barrier film 15 is formed over the entire bottom portion 16 so as to contact the lower end 18 and the bottom molding portion 19.
In order to improve the thermal conductivity of the bottom portion 16, it is preferable to make the bottom molding portion 19 as small as possible as shown in FIG. 1 and to make most of the bottom portion 16 a gas barrier film 15, and to eliminate the bottom molding portion 19. Alternatively, the bottom 16 may be the gas barrier film 15 alone. In this embodiment, the bottom molding portion 19 is formed in an annular shape having a certain width on the inner periphery of the molded body 12, as shown in FIG. It may be the bottom molding part 19 and may be formed in an annular shape having a certain width on the outer periphery.
Further, the gas barrier film 15 may be slightly wider than the entire surface of the bottom portion 16, and the widened portion may be attached to the vicinity of the bottom portion of the side wall portion 14. That is, the gas barrier film 15 may have a cup shape. Thus, a part of the gas barrier film 13 on the side wall part 14 and a part of the gas barrier film 15 on the bottom part 16 are overlapped to cover the container main body 11, so that the gas barrier is not formed at the joint part of both films. There is no gap, and the gas barrier property of the container body 11 is improved.

The gas barrier film 15 is a film having an oxygen barrier property and a water vapor barrier property, similar to the gas barrier film 13 described above, and specific examples thereof, a preferable oxygen permeation amount serving as an index of the oxygen barrier property, and a water vapor barrier property. The same applies to the preferable water vapor transmission amount as an index. A metal foil laminated film is preferred when the freeze-drying container 10 requires particularly excellent gas barrier properties. Further, by using a metal foil or a metal foil laminated film for the gas barrier film 15, the thermal conductivity can be further improved.
Although the thickness of the gas barrier film 15 depends on the film to be used, in the case of a film containing a resin as a main component, it is preferably 10 to 100 μm, more preferably 20 to 80 μm. If it is 10 μm or more, sufficient gas barrier properties can be obtained. If it is 100 micrometers or less, the heat conductivity at the time of freeze-drying will be favorable.

As with the gas barrier film 13, a protective layer that protects the gas barrier film 15 is preferably provided on the surface of the gas barrier film 15. Thereby, damage to the gas barrier layer of the gas barrier film 15 due to rubbing or the like can be prevented, and the gas barrier property can be maintained.
Examples of the resin that forms the protective layer include PET resin, polypropylene resin, and polyethylene resin. The thickness of the protective layer is preferably 5 to 100 μm.
In the same manner as the adhesive layer preferably provided between the gas barrier film 13 and the molded body 12, the bonding between the gas barrier film 15 and the bottom molded portion 19 is firmly formed between the gas barrier film 15 and the bottom molded portion 19. It is preferable that an adhesive layer (not shown) is provided. The material used for forming the adhesive layer and the preferable thickness of the adhesive layer are the same as those of the adhesive layer preferably provided between the gas barrier film 13 and the molded body 12.

Examples of the resin that forms the stopper 21 include the same resin as that of the molded body 12, and the preferred resin is also the same. Moreover, it is preferable that the plug 21 is made of a resin having a rigidity different from that of the molded body 12 because the airtightness of the fitting portion is increased. Further, the plug 21 is a resin having a rigidity different from that of the molded body 12 and can be thermally bonded to the molded body 12, for example, a resin of the same type as the molded body 12, so that the airtightness of the fitting portion is increased. Since it becomes still higher, it is more preferable. Specifically, both the resin that forms the plug 21 and the molded body 12 is a polyethylene resin, and among the polyethylene resins, the plug 21 and the molded body 12 are respectively formed of resins having different rigidity, or the plug. For example, the plug 21 and the molded body 12 may be formed with the resin that forms the molded body 12 and the molded body 12 both being polypropylene resins and having different rigidity among the polypropylene resins.
As shown in FIG. 1, the stopper 21 includes a head 23 that plugs the opening 17 of the container body 11 with a stopper, and a leg that is continuously formed below the head 23 and is fitted into the opening 17 by the stopper. Part 24.

As shown in FIG. 1, the stopper 21 has a gas barrier film 22 formed inside thereof. In this embodiment, the gas barrier film 22 is formed inside the head 23, but may be formed outside the head 23. Further, it may be formed inside and outside the head 23.
The gas barrier film 22 is a film having an oxygen barrier property and a water vapor barrier property, similar to the gas barrier film 13 described above, and specific examples thereof, a preferable oxygen permeation amount serving as an index of the oxygen barrier property, and a water vapor barrier property. The same applies to the preferable water vapor transmission amount as an index. When particularly excellent gas barrier properties are required for the freeze-dried container 10, the gas barrier film 22 is preferably a metal foil or a metal foil laminated film.
Although the thickness of the gas barrier film 22 depends on the film to be used, in the case of a film containing a resin as a main component, it is generally preferably 10 to 100 μm, and more preferably 20 to 80 μm.

As with the gas barrier film 13, the gas barrier film 22 is preferably provided with a protective layer for protecting the gas barrier film 22. Thereby, damage to the gas barrier layer of the gas barrier film 22 due to rubbing or the like can be prevented, and the gas barrier property can be maintained.
Examples of the resin that forms the protective layer include PET resin, polypropylene resin, and polyethylene resin. The thickness of the protective layer is preferably 5 to 100 μm.
Between the gas barrier film 22 and the head portion 23, the bonding of the gas barrier film 22 to the head portion 23 is strengthened similarly to the adhesive layer preferably provided between the gas barrier film 13 and the molded body 12. It is preferable that an adhesive layer (not shown) is provided. The material used for forming the adhesive layer and the preferable thickness of the adhesive layer are the same as those of the adhesive layer preferably provided between the gas barrier film 13 and the molded body 12.

As shown in FIGS. 1 and 3, the head 23 is provided with a hole 26 in the top surface 25. The hole 26 is closed with the gas barrier film 22. The hole 26 is a hole into which an injection needle for injecting the solution into the freeze-dried container 10 and taking out the solution of the freeze-dried product is inserted.
The size of the hole 26 is larger than the diameter of the injection needle to be inserted, and a diameter of about 1 to 10 mm is preferable. In this embodiment, the freeze-drying container 10 having the hole 26 is shown. However, the present invention is not limited to this, and instead of not having the hole 26, the injection needle penetrates the thickness of the top surface 25. The stopper may be thinned as much as possible.

The leg portion 24 is provided with a notch 28. The notch 28 functions as a portion that connects the inside and outside of the freeze-dried container 10 that is half-plugged in the decompression drying of the stock solution of the freeze-dried product, and is for releasing air and moisture from the inside of the freeze-dried container 10.
The leg portion 24 is not limited to the shape of the notch 28, and may be any shape as long as it has a function of allowing the inside and outside of the freeze-drying container to communicate with each other in a half-plugged state and freeze-drying. There may be. Further, without providing the leg portion 24 on the stopper 21 side, a portion corresponding to the leg portion 24 of the stopper 21 is provided in the opening 17 on the container body 11 side, and the outer peripheral surface side of the portion and the leg portion are not provided. It is good also as a structure which the inner peripheral surface side of a stopper contacts and fits.
Further, when a flange portion (not shown) is provided at the upper end portion of the molded body 12, a flange portion (not shown) is also provided near the base of the leg portion 24, and these flange portions are welded to the container body 11 and the stopper 21. It is also preferable to use a part.
Further, when a flange portion is provided at the upper end portion of the molded body 12, the top surface of the plug is provided when the plug is plugged by providing the flange portion on the outer peripheral portion of the top surface and providing the leg portion 24 from directly below the top surface. All other parts may be buried in the container body.

In this embodiment example, the stopper 21 is provided with a reseal layer 27 that is in close contact with the injection needle that penetrates the stopper 21 when the lyophilized product is taken out so that no gap is formed in the stopper 21. With the reseal layer 27, when the lyophilized product is taken out, the sealed state in the container can be maintained even if the injection needle is penetrated. Thereby, it is possible to prevent foreign matters such as dust and germs contained in the outside air from entering the freeze-dried container 10 and to prevent the freeze-dried product and its solution from leaking to the outside.
The reseal layer 27 only needs to be provided so as to cover at least the hole 26. For example, as in this embodiment, the reseal layer 27 is provided in a state of being attached to the gas barrier film 22, or in the gas barrier film 22 May be provided in advance as a multilayer film, or may be provided on the top surface 25 side.

  Examples of the resin that forms the reseal layer 27 include resins having excellent adhesion, such as polyolefin resins such as polyethylene resins and polypropylene resins, and thermoplastic elastomers. Among these, a polyethylene resin is preferable, and a low-density polyethylene resin and a high-strength linear low-density polyethylene resin are particularly preferable. The thickness of the reseal layer 27 is preferably 50 to 500 μm.

In the freeze-drying container 10 of the present invention described above, since the stopper 21 is made of plastic, the manufacturing cost can be reduced as compared with conventionally used rubber stoppers.
In the freeze-drying container 10 of the present invention, since the container body 11 is made of plastic, it is strong against impact and hardly damaged.
In the freeze-dried container 10 of the present invention, since the container body 11 and the stopper 21 are both made of plastic, they are fitted and fixed in a physically airtight state after containing the freeze-dried material. be able to. Furthermore, in order to ensure completeness by airtightness, the container body 11 and the stopper 21 can be welded by high-frequency welding, ultrasonic welding, laser welding, hot plate welding, impulse welding, etc. Not necessary. Further, as described above, both the container body 11 and the stopper 21 are made of plastic. Therefore, there is no need to separate and discard after use.

Moreover, in the freeze-drying container 10 of the present invention, since at least a part of the bottom is a thin-walled portion made only of a gas barrier film, it has excellent thermal conductivity and can be quickly lyophilized.
Moreover, in the freeze-drying container 10 of the present invention, since the molded body 12 having sufficient buckling strength is formed on the side wall portion 14, the buckling strength at the time of stoppering is excellent, and it is special at the time of stoppering. Does not require a special receiver.
In the freeze-dried container 10 of the present invention, a gas barrier film made of a resin having a gas barrier property is used for forming the gas barrier layer of the container body 11 and the stopper 21. Therefore, a layer having gas barrier properties can be reliably formed on the container main body 11 and the stopper 21, and there is no risk of layer breakage due to multilayer extrusion molding.

Next, the manufacturing method of the freeze-drying container 10 of the example of 1 embodiment of this invention is demonstrated.
The molded body 12 constituting the side wall portion 14 of the container body 11 is molded by an extrusion molding method such as injection molding, blow molding, pipe molding or the like using the above-described synthetic resin. Of these, injection molding is preferably used. For injection molding, blow molding, and pipe molding, known injection molding machines and extrusion molding machines can be used, respectively.

As the gas barrier film 13, the above-described film having gas barrier properties is used. The side wall portion 14 is molded by welding the gas barrier film 13 to the molded body 12 by in-mold molding, high-frequency welding, hot plate welding, impulse welding, or the like. Of these, in-mold molding is preferably used.
In in-mold molding, a gas barrier film 13 cut in advance to a predetermined dimension is fixed at a predetermined position in an injection mold of the container body 11, and a synthetic resin that becomes a material of the molded body 12 is formed in the mold. The side wall portion 14 in which the gas barrier film 13 is welded to the molded body 12 can be molded.
Thus, by performing in-mold molding at the time of injection molding, the side wall part 14 can be manufactured by one molding, and after molding the molded body 12, the gas barrier film 13 is welded to form the side wall part 14. Compared to the above, the manufacturing process can be simplified.

  In addition, when providing the adhesive layer mentioned above between the molded object 12 and the gas barrier film 13, the surface which contacts the molded object 12 of the gas barrier film 13, and / or the surface which contacts the gas barrier film 13 of the molded object 12. Further, it is sufficient to apply an adhesive or a resin for forming the adhesive layer in advance and then perform extrusion molding.

The gas barrier film 15 at the bottom 16 is welded to the lower end 18 of the molded body 12 by in-mold molding, high-frequency welding, hot plate welding, impulse welding, or the like.
In this way, the container body 11 including the side wall portion 14 and the bottom portion 16 is manufactured.
Furthermore, it is possible to in-mold a gas barrier film 13 and a gas barrier film 15 that are integrated.
In addition, when providing the adhesive layer mentioned above between the gas barrier film 15 and the bottom molding part 19, the part which touches the bottom molding part 19 of the gas barrier film 15, and / or the gas barrier film 15 of the bottom molding part 19 is provided. The adhesive or resin for forming this adhesive layer may be applied in advance to the surface in contact with, and then the welding or in-mold molding may be performed.

The stopper 21 is molded using an injection molding method using the above-described synthetic resin. In addition, as a method of forming the gas barrier film 22 on the stopper 21, a welding method similar to the welding of the gas barrier film 13 to the molded body 12 described above can be used. Of these, in-mold molding is preferably used.
In addition, when providing the adhesive layer mentioned above between the gas barrier film 22 and the head 23, the surface which touches the head 23 of the gas barrier film 22, and / or the part which touches the gas barrier film 22 of the head 23 In addition, an adhesive or a resin for forming the adhesive layer may be applied in advance before injection molding.

Next, a procedure for storing the lyophilized product in the lyophilized container 10 according to the embodiment of the present invention will be described.
First, the container body 11 of the freeze-dried container 10 is filled with a stock solution of freeze-dried material that has been sterilized. Next, the container body 11 is half-plugged and placed on a shelf (heating / cooling shelf) having heating and cooling functions in the freeze-drying apparatus. As the freeze-drying apparatus, a known freeze-drying apparatus can be used. In addition, since the side wall part 14 has sufficient buckling strength, the container main body 11 can be arrange | positioned independently on a heating / cooling shelf, without using a special receiving part.
Next, the container body 11 filled with the freeze-dried stock solution is cooled using a heating and cooling shelf, and the freeze-dried stock solution is subjected to a freezing treatment. Here, since the container main body 11 is a thin-walled portion in which at least a part of the bottom portion 16 is formed of only the gas barrier film 15, the container main body 11 is excellent in thermal conductivity and can be quickly frozen.

Next, moisture is sublimated by drying under reduced pressure while keeping the stock solution of the lyophilized product in a frozen state. In this half-plugged state, moisture is released from the notch 28 to the outside of the freeze-drying container 10. Thereafter, nitrogen gas is supplied into the freeze-drying apparatus and returned to atmospheric pressure, whereby the inside of the freeze-drying container 10 is replaced with nitrogen gas. Thereafter, the stopper 21 is completely plugged, whereby the lyophilized product is accommodated in the freeze-dried container 10, and the container body 11 and the stopper 21 can maintain airtightness by physical fitting.
Furthermore, in order to ensure completeness by airtightness, the fitting portion between the container body 11 and the stopper 21 can be welded by high frequency welding, ultrasonic welding, laser welding, hot plate welding, or impulse welding.

Next, a procedure for taking out the lyophilized material stored in the lyophilization container 10 according to the embodiment of the present invention will be described.
First, an injection needle is inserted through the hole 26, the gas barrier film 22 is penetrated, and a predetermined solution for dissolving the lyophilized product is injected into the lyophilized container 10. Then, the freeze-dried product is dissolved with the solution. Next, the lyophilized solution is aspirated with an injection needle. In this manner, the lyophilized product is taken out from the lyophilization container 10 in the form of a lysis solution. Here, in the freeze-dried container 10, since the reseal layer 27 is provided on the stopper 21, the reseal layer 27 is in close contact with the injection needle, and there is a gap between the injection needle and the gas barrier film 22. It can be prevented from occurring. Thereby, it is possible to prevent foreign matters such as dust and bacteria from entering the freeze-dried container 10 and to prevent the freeze-dried product and the freeze-dried solution from leaking out of the freeze-dried container 10.
In addition, the freeze-dried product can be taken as it is without being dissolved again, or a tube having a plurality of channels is inserted from the hole 26, and it is transported out of the container as a fine powder freeze-dried product under an air flow. Is also possible.

  The freeze-dried container of the present invention is low in production cost, hardly breaks, has excellent gas barrier properties, has excellent buckling strength at the time of stoppering, has excellent thermal conductivity, and does not require separation after use. According to the method for producing a freeze-dried container of the present invention, this freeze-dried container can be produced efficiently.

It is a longitudinal cross-sectional view which shows the freeze-drying container of one example of embodiment of this invention. It is a top view of the container main body of the freeze-drying container of one embodiment of this invention. It is a top view of the stopper of the freeze-drying container of one embodiment of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Freeze-drying container 11 Container main body 12 Molded body 13, 15, 22 Gas barrier film 14 Side wall part 16 Bottom part 17 Opening 18 Lower end 21 Plug 23 Head part 24 Leg part 26 Hole 27 Reseal layer

Claims (5)

A freeze-dried container comprising a plastic container main body in which a freeze-dried product is accommodated, and a plastic stopper fitted to the container main body,
The container body is composed of a side wall portion formed of a molded body and a gas barrier film, and a bottom portion covered with a gas barrier film so that at least a part thereof is composed only of the gas barrier film,
A freeze-dried container, wherein a gas barrier film is formed on the stopper.   The freeze-drying container according to claim 1, wherein at least one of the gas barrier film on the side wall, the gas barrier film on the bottom, and the gas barrier film on the stopper is an aluminum foil laminated film.   The freeze-drying container according to claim 1, wherein the gas barrier film on the side wall is a transparent film.   The freeze-dried container according to any one of claims 1 to 3, wherein the stopper is provided with a reseal layer that is in close contact with an injection needle that penetrates the stopper and prevents a gap from being formed in the stopper. A method for producing a freeze-dried container comprising a plastic container main body in which a freeze-dried product is accommodated, and a plastic stopper fitted into the container main body,
Forming the side wall of the container body by welding a gas barrier film to a molded body molded from plastic,
A gas barrier film is welded to the lower end of the molded body to form the bottom of the container body,
A method for producing a freeze-dried container, wherein a gas barrier film is welded to the stopper formed from plastic.

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