JP2010025370A - Freeze-dry container and method of manufacturing freeze-dried matter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a freeze-dry container capable of being used in manufacturing a freeze-dried matter by using a commonly-used freeze-dry device, dispensing with segregation disposal after use, and efficiently manufacturing the freeze-dried matter, and to provide a method of manufacturing the freeze-dried matter by using the freeze-dry container. <P>SOLUTION: In this freeze-dry container 10 comprising a plastic container body 11 which has an opening 17 at its top and in which the freeze-dried matter is charged from the opening 17, and a plastic tap 21 capping the opening 17, an edge 31 of the opening 17 and/or the tap 21 is provided with a sticking section 32 for bringing the edge 31 and the tap 21 to be closely kept into contact with each other by capping the opening 17 with the tap 21, and a welding section 33 welded to the tap 21 is disposed on the whole periphery of the edge 31 of the opening 17. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

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

In general, medical drugs such as protein preparations and antibiotics are freeze-dried and stored in freeze-dried containers in order to maintain the stability of active ingredients.
The freeze-dried product is stored 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 is dried under reduced pressure while being kept frozen. Thereafter, nitrogen gas is supplied into the freeze-drying apparatus to return the inside of the container body to atmospheric pressure, whereby the atmosphere in the container body is replaced with nitrogen gas. Then, after the stopper is completely plugged into the container body in the freeze-drying apparatus, the freeze-dried container containing the freeze-dried material is taken out from the freeze-drying apparatus. In the lyophilized product thus produced, the atmosphere in the lyophilized container is replaced with nitrogen gas, and it is difficult to cause denaturation due to oxidation, and the stability of the active ingredient is excellent.

  In order to take out the lyophilized product from the lyophilized container, a syringe needle is passed through the stopper of the lyophilized container, a predetermined solution for dissolving the lyophilized product is injected into the freeze-dried container, and the solution is frozen with the solution. Dissolve the dried product. 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.

  Conventionally, as such a freeze-dried container, a combination of a glass container, a rubber stopper, and an aluminum fastener that prevents the rubber stopper from falling off by crimping the glass container and the rubber stopper has been used. . However, in such a conventional freeze-dried container, it was necessary to separate and discard the glass container, the rubber stopper, and the fastener after use.

Therefore, Patent Document 1 discloses a method for producing a freeze-dried product using a freeze-dried container composed of a plastic container body and a plastic sealing material that plugs the opening of the container body. In Patent Document 1, a sealing material is welded to a container body in a freeze-drying apparatus, and a freeze-dried product accommodated in a freeze-drying container is manufactured. Thus, in the manufacturing method of the freeze-dried material of patent document 1, since the freeze-drying container in which the container main body and the sealing material were both made of plastic is used, it is not necessary to separate and discard the freeze-drying container after use.
JP-A-5-302616

However, in the method for producing a lyophilized product of Patent Document 1, it is necessary to use a special lyophilization apparatus provided with welding means, and a general lyophilization apparatus cannot be used.
The present invention has been made in view of the above circumstances, and can be used for producing a freeze-dried product using a general freeze-drying apparatus, and a freeze-drying container that does not require separate disposal after use, and the freezing An object of the present invention is to provide an efficient method for producing a freeze-dried product using a drying container.

In order to achieve the above object, the present invention adopts the following configuration.
(1) A plastic container having an opening used for packaging of a freeze-dried product, wherein the adhesive part temporarily seals the container by pressing the plastic container, and a weld part that seals the container by welding. And a freeze-dried container.
(2) A freeze-drying container comprising a plastic container body having an opening at the upper end and a plastic stopper plugged into the opening, the edge of the opening and / or the stopper being connected to the opening By sticking the stopper, there is provided an adhesive part that closely contacts the edge and the stopper, and a weld part that is welded to the stopper is provided over the entire periphery of the edge of the opening. The freeze-dried container as described in (1).
(3) The freeze-drying container according to (2), wherein the welded portion is provided on the inner peripheral side of the edge and the adhesive portion is provided on the outer peripheral side of the edge.
(4) The freeze-drying container according to (2) or (3), wherein a separation portion that separates the adhesive portion and the welding portion is provided over the entire periphery of the edge.
(5) The container has a bag shape having the opening at one end, and the adhesive portion is provided on one side or both sides of the inner surface of the container that is in close contact when the container is temporarily sealed (1) The freeze-dried container according to 1.
(6) A method for producing a freeze-dried product using the freeze-dried container according to any one of (2) to (4), wherein the container body is filled with a stock solution of the freeze-dried product, and the stock solution of the freeze-dried product Lyophilized, the stopper is driven into the opening, the stopper is brought into close contact with the container body, and then the container body and the stopper are welded. .
(7) A method for producing a freeze-dried product using the freeze-dried container according to (5), wherein the bag-shaped container is filled with a stock solution of the freeze-dried product, and the stock solution of the freeze-dried product is freeze-dried A method for producing a freeze-dried product, characterized in that the container is temporarily sealed by pressing the pressure-sensitive adhesive portion and then the welded portion is welded.

The freeze-dried container of the present invention can be used for production of a freeze-dried product using a general freeze-drying apparatus, and does not require separation after use.
According to the method for producing a lyophilized product of the present invention, the lyophilized product can be stored in the lyophilized container of the present invention, which does not require separation and disposal after use, using a general lyophilization apparatus. It can be done efficiently.

The freeze-dried container of the present invention is a container having an opening used for packaging of a freeze-dried product. The container is provided with an adhesive portion that temporarily seals the container by pressing and a welding portion that seals the container by welding.
The freeze-dried container in the present invention may be a container provided with a container body having an opening at the upper end and a stopper plugged into the opening, or may be a bag-like container having an opening at one end.

<First Embodiment>
Hereinafter, as a first embodiment example, a freeze-dried container provided with a container body having an opening at the upper end and a stopper to be plugged into the opening, and a method for producing a freeze-dried product using the freeze-dried container will be described. Will be described in detail.
(Freeze-dried container)
As shown in FIG. 1, the freeze-dried container 10 of the present embodiment has an opening 17 at the upper end, a plastic container body 11 in which a stock solution of freeze-dried material is accommodated from the opening 17, and a stopper is plugged into the opening. The container body 11 and the stopper 21 are connected by a hinge portion 25.

  As shown in FIG. 2, the container body 11 includes a side wall portion 14 formed of a molded body 12 and a gas barrier film 13, a bottom molding portion 19 molded on the inner periphery of the lower end of the molded body 12, and a bottom molding. The bottom part 16 which consists of the gas-barrier film 15 which touches the part 19 and covers the whole surface of the bottom part 16 and the flange-shaped edge 31 formed integrally with the molded body 12 and formed over the entire periphery of the opening 17 are provided.

  The stopper 21 includes a molded body 23 that comes into contact with the opening 17 when the stopper is plugged, and a gas barrier film 22 that covers the molded body 23 and imparts a gas barrier property to the stopper 21. A hole 26 for inserting an injection needle is formed at the center of the stopper portion 23. In this embodiment, one of the holes 26 is closed by the gas barrier film 22 and the other is closed by the reseal layer 27. The molded body 23 is formed with a guide 24 for positioning when the opening 17 is plugged.

  At the edge 31, the adhesive part 32 that makes the stopper 21 and the edge 31 adhere to each other by the stopper, the weld part 33 that is welded to the stopper 21, and the adhesive part 32 and the weld part 33 are separated from each other. A separation portion 34 is formed.

The adhesive part 32 is provided on the outer peripheral side of the edge 31, and an adhesive or an adhesive is applied over the entire periphery.
Examples of the material of the pressure-sensitive adhesive or adhesive include rubber-based, polydiene-based, acrylic-based, silicone-based, urethane-based, and ester-based materials.
Examples of the form of the pressure-sensitive adhesive or adhesive include solid, solution type, and emulsion type.
Examples of the curing method of the pressure-sensitive adhesive or adhesive include a thermosetting type, a light (UV) curable type, a polymerization reaction type, and a pressure-sensitive adhesive type.

The width of the adhesive part 32 is preferably approximately 0.2 to 5 mm. If it is 0.2 mm or more, the adhesiveness of the stopper 21 and the edge 31 can be sufficiently secured at the time of stoppering. If it is within 5 mm, the freeze-drying container 10 can be made compact without unnecessarily increasing the edge 31.
As for the thickness of the adhesive or adhesive agent apply | coated to the adhesion part 32, 5-500 micrometers is preferable. If thickness is 5 micrometers or more, the adhesiveness of the stopper 21 and the edge 31 can fully be ensured at the time of stoppering. If the thickness is 500 μm or less, the amount of the pressure-sensitive adhesive or adhesive used can be suppressed, and it is possible to minimize the excess pressure-sensitive adhesive or adhesive from protruding out of the pressure-sensitive adhesive portion 32 due to pressing at the time of plugging. it can.

The welding part 33 is provided on the inner peripheral side of the edge 31.
The width of the welded portion 33 is preferably approximately 0.2 to 10 mm. If it is 0.2 mm or more, welding with the stopper 21 can be sufficiently performed at the time of melting. If it is within 10 mm, the freeze-dried container 10 can be made compact without unnecessarily increasing the diameter of the edge 31.

In this embodiment, the separation portion 34 has a groove shape, and is provided between the adhesive portion 32 and the welding portion 33. The separation part 34 is formed for the purpose of preventing excess adhesive or adhesive protruding from the adhesive part 32 from reaching the welded part 33 side due to pressing at the time of plugging.
The width of the separation portion 34 is preferably about 0.1 to 5 mm. If it is 0.1 mm or more, it is possible to sufficiently prevent the excess pressure-sensitive adhesive or adhesive protruding from the pressure-sensitive adhesive portion 32 from reaching the welded portion 33 side by pressing at the time of plugging. If it is within 5 mm, the freeze-drying container 10 can be made compact without unnecessarily increasing the diameter of the edge 31.
As for the depth of the groove | channel of the separation part 34, about 0.1-10 mm is preferable in general. If it is 0.1 mm or more, it is possible to sufficiently prevent the excess pressure-sensitive adhesive or adhesive protruding from the pressure-sensitive adhesive portion 32 from reaching the welded portion 33 side at the time of stoppering. If it is within 10 mm, the formability of the container body 11 is improved without unnecessarily increasing the thickness of the edge 31.

The molded body 12 is provided to secure a storage space for the lyophilized product.
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 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 even by pressing during 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.

The gas barrier film 13 is a film having an oxygen barrier property and a water vapor barrier property, and is provided for imparting a gas barrier property to the container body 11. 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.

  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.

  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 polyvinylidene chloride (PVDC) is coated on a film such as PET or cellophane, 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 Co., Ltd. Etc.

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 formed 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 molded body 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.

  Similar to the gas barrier film 13, the gas barrier film 15 is a film having an oxygen barrier property and a water vapor barrier property, and is provided for imparting a gas barrier property to the container body 11. Specific examples of the gas barrier film 15, preferable oxygen transmission amount, preferable water vapor transmission amount, and preferable thickness are the same as those of the gas barrier film 13.

  The gas barrier film 15 is formed over the entire surface of the bottom portion 16 so as to contact the bottom portion molding portion 19. Thus, since the container main body 11 is made into the thin part which only the gas barrier film 15 consists of at least one part in the bottom part, it is excellent in thermal conductivity and can perform freeze-drying rapidly. In order to improve the thermal conductivity of the bottom portion 16, it is preferable that the bottom molding portion 19 is made as small as possible, and most of the bottom portion 16 is the gas barrier film 15, and the bottom molding portion 19 is eliminated and the gas barrier film 15 is removed. Only the bottom 16 may be used.

  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 applied to the joint part of both films. There is no possibility of generating a gap, and the gas barrier property of the container body 11 can be further improved.

  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. The preferred material and thickness of the protective layer are the same as those of the protective layer for protecting the gas barrier film 13.

  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 molded body 23 of the stopper 21 include the same resins as those of the molded body 12, and preferred resins are also the same.
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, and is provided for imparting a gas barrier property to the plug 21. Specific examples thereof, preferred oxygen permeation amount, preferred The water vapor transmission amount and the preferred thickness are the same as those of the gas barrier film 13 described above.
In addition, although the gas barrier film 22 of the stopper 21 is formed outside the molded body 23 in this embodiment, it may be formed inside the molded body 23. Moreover, you may form in the inner side and the outer side of the molded object 23. FIG.

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. The preferred material and thickness of the protective layer are the same as those of the protective layer for protecting the gas barrier film 13.
In the same manner as the adhesive layer preferably provided between the gas barrier film 13 and the molded body 12, the bonding of the gas barrier film 22 to the molded body 23 is strengthened between the gas barrier film 22 and the molded body 23. It is preferable that an adhesive layer (not shown) is provided. The material used for forming the adhesive layer and the preferred 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.

The freeze-dried container 10 of the present embodiment is temporarily sealed by pressing all of the freeze-dried containers 10 evenly with a single pressing machine, particularly when mass-producing freeze-dried products using a plurality of freeze-dried containers 10. From the viewpoint of facilitating, it is preferable that the freeze-drying container 10a is provided with an elastic layer 28 outside the gas barrier film 22 (FIG. 3).
That is, when the elastic layer 28 is not provided, it is difficult to apply force evenly to each freeze-drying container 10 when a plurality of freeze-drying containers 10 are pressed at a time with a single pressing machine during mass production. In some cases, the pressure may be insufficient and the adhesion of the adhesive portion 32 may be incomplete, or the pressure may be excessive and the freeze-dried container 10 may be damaged. However, in the freeze-drying container 10a provided with the elastic layer 28, the elastic layer 28 absorbs the force when excessive pressing is applied. Can be stably sealed temporarily.

  When the protective layer is provided in the freeze-drying container 10a, the elastic layer 28 may be provided inside the protective layer or may be provided outside. Further, the elastic layer 28 may be provided only in a portion corresponding to the adhesive portion 32 and / or the welded portion 33. For example, a hole equivalent to the hole 26 may be formed in a portion corresponding to the hole 26 of the elastic layer 28.

  Examples of the material of the elastic layer 28 include polyolefin resins such as polyethylene and polypropylene, polystyrene resins, polyester resins, polyurethane resins, thermoplastic elastomers, and rubbers such as polybutylene and polyisoprene. These may be mixed or combined, and may be a foam. Of these, the resin foam, thermoplastic elastomer, and rubber are preferable from the viewpoint of excellent absorption performance against excessive pressure.

  The thickness of the elastic layer 28 may be set to an appropriate value according to the elastic modulus of the elastic layer 28, preferably 0.3 to 10 mm, and more preferably 0.5 to 8 mm. If the thickness of the elastic layer 28 is 0.3 mm or more, sufficient absorbability of excessive pressure can be obtained, and the freeze-dried product can be easily mass-produced stably. Moreover, if the thickness of the elastic layer 28 is 10 mm or less, it becomes easy to insert the injection needle for injecting the solution into the freeze-dried container 10a and taking out the solution of the freeze-dried product.

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-dried container 10 having the hole 26 is shown. However, the present invention is not limited to this, and the stopper 26 is not limited to this, as long as the stopper is thin enough to penetrate the injection needle. Good.

The reseal layer 27 is provided in close contact with the injection needle penetrating the hole 26 so that no gap is generated in the stopper 21.
The reseal layer 27 may be provided so as to cover at least the hole 26. For example, as in this embodiment, it may be provided on the lower surface of the molded body 23, may be provided on the gas barrier film 22, or may be provided between the gas barrier film 22 and the molded body 23. Good. Furthermore, the gas barrier film 22 may be provided as a multilayer film.

  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.

One end of the hinge portion 25 is joined to the container body 11, and the other end is joined to the stopper 21, thereby connecting the container body 11 and the stopper 21. The hinge portion 25 can be bent so that the stopper 21 can be plugged into the opening 17.
Although the thickness of the hinge part 25 is suitably determined by the kind of resin which forms the hinge part 25, the magnitude | size of the freeze-drying container 10, etc., generally 10-5000 micrometers is preferable. If the thickness of the hinge portion 25 is 10 μm or more, the strength can be sufficient. If the thickness of the hinge part 25 is 5000 micrometers or less, the flexibility of the hinge part 25 will become enough.
The width of the hinge portion 25 is appropriately determined depending on the size of the freeze-drying container 10 or the like, but a diameter of approximately 0.2 mm to the edge 31 is preferable. If the width of the hinge part 25 is 0.2 mm or more, the connection between the container body 11 and the stopper 21 is stable, and the stoppering can be performed smoothly. If the width of the hinge portion 25 is equal to or smaller than the outer diameter of the edge, the size of the freeze-drying container is not unnecessarily increased.
In this embodiment, the hinge portion 25 is formed of the same resin as the molded body 12 and the molded body 23, and is formed integrally with the molded body 12 and the molded body 23. However, the present invention is not limited to this. The molded body 12 and / or the molded body 23 may be molded with a different resin, and may be molded separately from the molded body 12 and / or the molded body 23.

The lyophilization container 10 described above is manufactured as follows, for example.
The molded body 12, the molded body 23, and the hinge portion 25 are molded by a molding method such as injection molding using the synthetic resin that forms the molded body 12 described above. A known injection molding machine can be used for each injection molding. The molded body 12, the molded body 23, and the hinge portion 25 are preferably integrally molded from the viewpoint of simplifying the manufacturing process. However, the present invention is not limited to this, and the molded body 12, the molded body 23, and the hinge portion are not limited thereto. The molded body 12 and the hinge portion 25 may be molded integrally, and the molded body 23 separately molded may be joined thereto, or the molded body 23 and the hinge 25 may be joined together. The part 25 may be integrally molded, and the molded body 12 separately molded may be joined thereto.

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. Among these welding methods, in-mold molding is preferably used.
The plug 21 is molded by welding the gas barrier film 22 to the molded body 23 by in-mold molding, high-frequency welding, hot plate welding, impulse welding, or the like. Among these welding methods, in-mold molding is preferably used.

  According to in-mold molding, for example, when the side wall portion 14 is molded, the gas barrier film 13 that has been cut into a predetermined dimension in advance is fixed at a predetermined position in the injection mold of the container body 11, The side wall part 14 can be shape | molded by pouring the synthetic resin used as the material of the molded object 12 to a type | mold. Therefore, the manufacturing process can be simplified by the method of welding the gas barrier film 13 after the molded body 12 is molded.

When the adhesive layer described above is provided between the molded body 12 and the gas barrier film 13, the surface of the gas barrier film 13 that contacts the molded body 12 and / or the surface of the molded body 12 that contacts the gas barrier film 13, What is necessary is just to weld, after apply | coating the adhesive agent and resin which form an contact bonding layer.
Similarly, when the adhesive layer described above is provided between the gas barrier film 22 and the molded body 23, the surface of the gas barrier film 22 that contacts the molded body 23 and / or the gas barrier film 22 of the molded body 23 is contacted. What is necessary is just to perform welding, after apply | coating the adhesive agent and resin which form an adhesive layer to a part.

The gas barrier film 15 at the bottom 16 is welded by in-mold molding, high frequency welding, hot plate welding, impulse welding, or the like.
In addition, it is also possible to perform in-mold molding of the gas barrier film 13 and the gas barrier film 15 integrated.

  When the adhesive layer described above is provided between the gas barrier film 15 and the bottom molding part 19, the gas barrier film 15 is in contact with the bottom molding part 19 and / or the gas barrier film 15 of the bottom molding part 19. The adhesive may be applied to the surface after applying an adhesive or resin for forming an adhesive layer.

  Next, application of a pressure-sensitive adhesive or adhesive to the pressure-sensitive adhesive portion 32, welding or adhesion of the reseal layer 27 to the molded body 23, and the like are performed. Examples of the welding method include high frequency welding, hot plate welding, and impulse welding. The adhesion is performed with an adhesive, an adhesive resin, or the like. When the elastic layer 28 is provided, it can be provided by welding or adhesion in the same manner as the reseal layer 27.

  The freeze-drying container 10 described above is provided with the adhesive portion 32 at the edge 31, but the present invention is not limited to this, and may be a freeze-dried container provided with an adhesive portion on the stopper. It may be a freeze-dried container provided with an adhesive portion on the main body.

  As shown in FIG. 2, the lyophilization container 10 has a grooved portion 34 as a groove. However, as shown in the lyophilization container 100 shown in FIG. 4, for example, the spacer 34 may be convex. Similarly to the separation portion 34 of the freeze-drying container 10, the separation portion 34 of the freeze-drying container 100 also causes excess adhesive or adhesive protruding from the adhesion portion 32 due to pressing at the time of stoppering to reach the welding portion 33. Can be prevented.

  Further, in the present invention, as in the freeze-drying container 110 shown in FIG. 5, a step may be formed between the adhesive portion 32 and the weld portion 33 in order to separate the adhesive portion 32 and the weld portion 33. . In the freeze-drying container 110, a step is formed between the adhesive portion 32 and the welding portion 33, so that excess adhesive or adhesive protruding from the adhesive portion 32 due to pressing at the time of plugging reaches the welding portion 33. Can be prevented. Note that the freeze-dried containers 10 and 100 provided with the separation portion 34 can more reliably prevent the adhesive from reaching the welded portion 33 than the freeze-dried container 110.

  Moreover, in this invention, as shown in FIG. 6, the freeze-drying container 120 by which the adhesion part 32 and the welding part 33 were formed in the flat edge 31 may be sufficient. Note that in the freeze-dried container 120, the pressure at the time of stoppering is greater than the possibility of the pressure-sensitive adhesive or adhesive of the adhesive portion 32 reaching the welded portion 33. It is preferable to adjust the application amount of the pressure-sensitive adhesive or the adhesive more strictly than in the other embodiments.

  Each of the plugs 21 of the embodiment described above has the gas barrier film 22 and the molded body 23. However, the present invention is not limited to this. For example, as shown in FIG. The freeze-drying container 130 provided with 21 may be sufficient.

In the freeze-dried container 130, the thickness of the gas barrier film 22 is such that the injection needle can be penetrated, and no hole for insertion of the injection needle is formed in the stopper 21, but the injection needle can be inserted if necessary. Holes may be formed.
Moreover, in the freeze-drying container 130, the hinge part 25 is formed integrally with the gas barrier film 22, but not limited to this, the hinge part 25 may be integrated with the molded body 12. .

  All of the above-described exemplary embodiments have been freeze-dried containers having a hinge part. However, the present invention is not limited thereto, and a freeze-dried container having no hinge part may be used. As a freeze-dried container that does not have a hinge part, for example, as shown in FIG. 8, a part of the outer periphery of the stopper 21 that is schematically configured from the gas barrier film 22 is directly joined to the adhesive part 32 of the container body 11, An example is a freeze-dried container 140 in which the container body 11 and the stopper 21 are connected.

  In the above-described exemplary embodiments, the bottom portion covered with the gas barrier film 15 so that the side wall portion 14 is formed of the molded body 12 and the gas barrier film 13 and the gas barrier film 15 is at least partly formed. And a stopper 21 having a gas barrier film 22. The present invention is not limited to this, and as shown in FIG. 9, a freeze-drying container 50 in which the metal layer 52 is seamlessly formed on the entire container body 51 and the metal layer 52 is seamlessly formed on the entire stopper 61. It may be.

  The freeze-drying container 50 is schematically composed of a container body 51 and a stopper 61 having a metal layer 52, a synthetic resin inner layer 53 formed inside the metal layer 52, and a synthetic resin outer layer 54 formed outside the metal layer 52. It is configured. The freeze-dried container 50 is formed integrally by connecting a container body 51 and a stopper 61 with a hinge part 63.

The edge 71 provided in the opening 55 of the container body 51 is formed with an adhesive portion 72, a welded portion 73, and a separation portion 74, as in the above-described embodiment.
The plug 61 is formed with a guide 62 and a hole 67 closed with a gas barrier film 64 and a reseal layer 65, as in the above-described embodiment.

  The wall thickness of the container body 51 is preferably 20 to 1000 μm. If it is 20 micrometers or more, the intensity | strength of the container main body 51 is fully securable. If it is 1000 micrometers or less, the heat conductivity of the container main body 51 can fully be ensured, and freeze-drying can be performed smoothly.

The metal layer 52 functions as a gas barrier layer for the container body 51 and the stopper 61.
Examples of the material of the metal layer 52 include aluminum, iron, magnesium, copper, and the like. Among these, aluminum is preferable. Since aluminum is a relatively soft metal, it is particularly excellent in moldability and has the strength required for a freeze-dried container. Furthermore, aluminum has a low material cost among metals, is easily available, and has excellent thermal conductivity. The aluminum used in the present invention includes an aluminum alloy containing iron, copper, manganese, nickel, magnesium, zinc and the like.

  The thickness of the metal layer 52 is preferably 1 to 1000 μm, and more preferably 20 to 500 μm. If the thickness of the metal layer 52 is 1 μm or more, it can have a sufficient gas barrier property and the strength of the container body 51 can be made sufficient. If the thickness of the metal layer 52 is 1000 μm or less, the amount of metal used can be suppressed.

The synthetic resin inner layer 53 is provided in order to prevent the metal forming the metal layer 52 from reacting with the container (freeze-dried material) so as to prevent the metal layer 52 from contacting the container.
Synthetic resins for forming the synthetic resin inner layer 53 include polyolefin resins such as polyethylene resins, polypropylene resins, and cyclic polyolefin resins, polyester resins, acrylic resins, epoxy resins, urethane resins, vinyl chloride resins, and the like. Examples thereof include copolymers and mixed resins. Among these, polyolefin resins that have little influence on the lyophilized product are preferred. Further, the synthetic resin inner layer 53 may have a multilayer structure including a plurality of layers.

  The thickness of the synthetic resin inner layer 53 is preferably 1 to 600 μm. If the thickness of the synthetic resin inner layer 53 is 1 μm or more, the metal layer 52 can be sufficiently protected from rubbing during handling. If the thickness of the synthetic resin inner layer 53 is 600 μm or less, the thermal conductivity of the container body 51 and the stopper 61 can be sufficiently secured.

  The synthetic resin outer layer 54 is provided in order to prevent the metal layer 52 from generating rust and scratches. Synthetic resins that form the synthetic resin outer layer 54 include polyolefin resins such as polyethylene resins, polypropylene resins, and cyclic polyolefin resins, polyester resins, acrylic resins, epoxy resins, urethane resins, vinyl chloride resins, and the like. Copolymers and mixed resins. Further, the synthetic resin outer layer 54 may have a multilayer structure including a plurality of layers.

  The thickness of the synthetic resin outer layer 54 is preferably 1 to 600 μm. If the thickness of the synthetic resin outer layer 54 is 1 μm or more, it is effective in preventing the rust of the metal layer 52, and it is possible to prevent the metal layer 52 from being damaged due to rubbing during handling. If the thickness of the synthetic resin outer layer 54 is 600 μm or less, the heat conductivity of the container body 51 and the stopper 61 can be sufficiently secured.

  The freeze-drying container 50 may be mainly made of plastic or metal in the mass of the freeze-drying container 50, and these may be a desired gas barrier property, moldability, waste after use. It is determined appropriately in view of the type of the above. When making the gas barrier property of the freeze-drying container 50 more reliable, it is advantageous that the metal is mainly used, and in view of moldability, it is advantageous that the plastic is mainly used.

  The freeze-drying container 50 is manufactured, for example, by deep-drawing a laminated sheet in which a synthetic resin (synthetic resin inner layer 53 and synthetic resin outer layer 54) is laminated on a metal sheet (metal layer 52). Deep draw molding is a widely used molding technique such as juice can production, and it is possible to produce molded articles quickly and in large quantities.

  In the freeze-drying container 50, the container body 51, the hinge part 63, and the stopper 61 are integrally formed. However, the present invention is not limited to this, and the container body 51, the hinge part 63, and the stopper 61 are individually formed and then joined. Alternatively, the container body 51 and the hinge part 63 may be formed integrally, and a separately formed plug 61 may be joined to the hinge part 63. After the plug 61 and the hinge part 63 are formed integrally, A separately molded container body 51 may be joined to the hinge part 63.

(Method for producing freeze-dried product)
Next, a method for producing a freeze-dried product using the freeze-dried container 10 of the present embodiment will be described with reference to FIGS.
First, as shown in FIG. 10, the lyophilized product stock solution A in a sterilized state is filled in the container body 11 of the lyophilized container 10, and a heating / cooling shelf 200 (with heating and cooling functions in the lyophilization apparatus). On the shelf provided). And the container main body 11 filled with the stock solution A of the freeze-dried material is cooled using the heating / cooling shelf 200, and the stock solution A of the freeze-dried material is subjected to a freezing treatment. Next, the stock solution A of the lyophilized product is dried under reduced pressure while being kept in a frozen state, thereby sublimating moisture and obtaining a lyophilized product. Next, nitrogen gas is supplied into the freeze-drying apparatus to return to atmospheric pressure, and the atmosphere in the container body 11 is replaced with nitrogen gas.

  Next, as shown in FIG. 11, the pressing machine 201 provided in the freeze-drying apparatus is pressed against the stopper 21, and the stopper 21 is plugged into the opening 17 of the container body 11 containing the freeze-dried product B. 21 and the edge 31 are brought into close contact with each other. Thereafter, the freeze-drying container 10 is taken out from the freeze-drying apparatus.

  Here, the close contact in the present invention means that when the stopper is plugged into the opening by a physical force, the time until the welding step described later is such that the nitrogen gas in the freeze-drying container does not leak out. The stopper and the edge are joined by the adhesive force of 32, and the freeze-dried container is temporarily sealed.

  As shown in FIG. 12, the freeze-drying container 10 taken out from the freeze-drying apparatus is placed in a high-frequency welding machine. Then, while pressing the stopper 21 with the pressing jig 203 provided in the high-frequency welding machine, the lyophilized container 10 is irradiated with a high frequency from the high-frequency generating coil 204 provided in the pressing jig 203. Thereby, the welding part 33 is heat-melted, the container main body 11 and the stopper 21 are welded, and the airtightness of the freeze-drying container 10 becomes more reliable. In this way, the freeze-dried product B is stored in the freeze-drying container 10. The container body 11 and the stopper 21 are not limited to high-frequency welding, but may be welded by means such as ultrasonic welding, laser welding, hot plate welding, and impulse welding.

According to the lyophilized product manufacturing method of the present embodiment, since the container body 11 and the stopper 21 of the freeze-dried container 10 are made of plastic, the container body 11 and the stopper 21 can be welded, and a conventional glass container is used. And aluminum fasteners required for freeze-dried containers using rubber stoppers can be omitted. Thereby, the lyophilized container 10 after use does not need to be disposed of separately.
In addition, according to the method for producing a lyophilized product of the present embodiment, the stopper and the edge are brought into close contact with each other, so that the nitrogen gas in the container can be removed even if the stoppered lyophilized container is taken out of the lyophilizer. Therefore, the stopper and the container main body can be welded outside the freeze-drying apparatus.
In addition, since the freeze-dried product manufacturing method of the present embodiment is less likely to be deformed by an external force of the freeze-dried container 10 than a bag-shaped freeze-dried container described later, the stored freeze-dried product is more stable. It is preferable in that it can be stored.
As described above, the method for producing a lyophilized product of the present invention is efficient because the lyophilized product can be stored in the lyophilized container of the present invention that does not require separation and disposal after use using a general lyophilizer. Lyophilized product can be produced.

In the manufacturing example described above, the pressure-sensitive adhesive (adhesive) that protrudes from the pressure-sensitive adhesive portion 32 due to pressing by the pressing machine 201 and the pressure jig 203 is received by the separation portion 34. Therefore, the pressure-sensitive adhesive does not reach the welding portion 33, and the protruding pressure-sensitive adhesive does not hinder the welding, so that the freeze-dried product can be manufactured more efficiently.
Furthermore, the freeze-drying container 10 used in the manufacturing example described above is provided with the adhesive portion 32 on the outer peripheral side of the edge 31 and the welded portion 33 on the inner peripheral side of the edge 31. With this configuration, the adhesive that protrudes from the adhesive portion 32 is blocked by the weld portion 33. Therefore, it is possible to minimize the possibility that the adhesive flows into the container body 11 and mixes with the lyophilized product. As a result, the freeze-dried product can be produced more efficiently.

(Removal of lyophilized product)
Next, a procedure for taking out the lyophilized material stored in the lyophilization container 10 of the present embodiment and disposal after use will be described.
First, an injection needle is inserted from the hole 26, the gas barrier film 22 and the reseal layer 27 are 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 way, the freeze-dried product is made into a solution and taken out from the freeze-drying container 10.

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. Occurrence can be prevented, and the sealed state in the container is maintained even if the injection needle is penetrated.
The removal of the lyophilized product from the lyophilized container 10 is not limited to using an injection needle, and may be taken as it is without dissolving the lyophilized product, or a tube having a plurality of channels from the hole 26 or the like. It may be inserted and transported to the outside of the freeze-dried container 10 as a fine powder freeze-dried product under air flow, and may be taken.

  After taking out the freeze-dried product in this way, the freeze-dried container 10 is discarded. Here, the freeze-dried container 10 of the present invention, as described above, can be discarded as plastic because the container body 11 and the stopper 21 are made of plastic, and does not require separation after use.

  In the case of the freeze-dried container 50, if the metal in the mass ratio is the main in the total mass of the container body 51 and the stopper 61, it can be discarded as a metal, or if the plastic is mainly in the mass ratio, it is discarded as a plastic. it can. Therefore, the lyophilization container 50 also does not need to be separated and discarded after use.

<Second Embodiment>
Next, as a second embodiment, a bag-like freeze-dried container having an opening at one end and a method for producing a freeze-dried product using the freeze-dried container will be described in detail with reference to the drawings.
(Freeze-dried container)
As shown in FIGS. 13A and 13B, the freeze-dried container 80 of the present embodiment has an opening 82 formed at one end of a bag-shaped container 81. In addition, the container 81 is provided with an adhesive part 83 that temporarily seals the container 81 and a welding part 84 that seals the container 81 by welding.

The container 81 is a bag-shaped container made of a gas barrier film having oxygen barrier properties and water vapor barrier properties. Thereby, the gas barrier property is imparted to the container 81.
The oxygen transmission rate as the oxygen barrier property of the index of the gas barrier films forming the container 81 ^is preferably 0~0.5ml / m 2 / 24hrs / MPa , 0~0.1ml / m 2 / 24hrs / More preferably, it is MPa. Further, the water vapor permeation amount of the water vapor barrier property of the index of the gas barrier film is preferably 0~1.0g ^/ m 2 ^/ 24hrs, more to be 0~0.5g ^/ m 2 ^/ 24hrs preferable.

  The thickness of the gas barrier film in the container 81 depends on the type of the film, but in the case of a film containing a resin as a main component, it is preferably about 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.

As a specific example of the gas barrier film of the container 81, the same thing as the gas barrier film 13 in 1st Embodiment can be mentioned, A preferable aspect is also the same.
A protective layer is preferably provided on the outer side of the gas barrier film of the container 81 from the viewpoint of preventing damage to the gas barrier film and maintaining gas barrier properties. The protective layer may be the same protective layer that protects the gas barrier film 13 in the first embodiment, and the preferred thickness is preferably 5 to 100 μm.

In addition, a sealant film is preferably laminated on the content side of the gas barrier film of the container 81 in order to facilitate bag making by heat sealing.
Examples of the sealant film include polyolefin resins such as low density polyethylene, linear low density polyethylene, polypropylene, cyclic polyolefin, and ethylene-vinyl acetate copolymer, vinyl chloride resins, polyester resins, acrylic resins, and the like. The film which consists of those modified resin or mixed resin is mentioned.

  The form of the container 81 is a form (FIG. 13) with a flat bottom in this example. The container 81 may be a non-self-supporting bag in which three sides are welded by heat sealing, or may be another self-supporting bag other than the form illustrated in FIG. 13. Examples of the bags that are not self-supporting include a flat pouch and a partially shaped form (FIG. 16). Moreover, a standing pouch etc. are mentioned as another bag with independence. Especially, it is preferable that it is a bag of the flat form of the bottom illustrated in FIG. 13 from the point which is self-supporting and the contact area of the bottom of the container 81 and a heating-cooling shelf becomes large.

  The opening 82 may be an open end obtained by cutting off one end of the container 81. From the viewpoint of easy sealing operation, the size of the opening 82 is appropriately reduced by welding such as heat sealing, or a freeze-dried product. It is preferable to make a crease so that the portion of the opening 82 has a three-dimensional shape from the viewpoint of easy filling of the raw material.

The adhesive part 83 is a part that serves to temporarily seal the container 81 by pressing.
The adhesive portion 83 is provided on one or both sides of the inner surface of the container 81 that is in close contact with the container 81 when it is temporarily sealed. That is, as long as the container 81 can be temporarily sealed tightly, the adhesive portion 83 may be provided only on one side of the inner surfaces of the containers 81 that are in close contact with each other at the time of temporary sealing. It may be provided on both sides of each other (over the entire inner circumference).
The adhesive part 83 only needs to be provided at a position where the container 81 can be temporarily sealed in a state where the lyophilized material is accommodated, and the opening of the container 81 can be easily adhered by pressing. Preferably, it is provided near 82.

The pressure-sensitive adhesive part 83 is affixed or coated with a pressure-sensitive adhesive or an adhesive.
Examples of the material of the pressure-sensitive adhesive or adhesive include rubber-based, polydiene-based, acrylic-based, silicone-based, urethane-based, and ester-based materials.
Examples of the form of the pressure-sensitive adhesive or adhesive include solid, solution type, and emulsion type.
Examples of the curing method of the pressure-sensitive adhesive or adhesive include a thermosetting type, a light (UV) curable type, a polymerization reaction type, and a pressure-sensitive adhesive type. In any type of pressure-sensitive adhesive or adhesive, it is preferable that the opening 82 is brought into a close contact state by simply pressing after freeze-drying.

The width of the adhesive portion 83 is preferably approximately 0.2 to 5 mm. If it is 0.2 mm or more, the opening 82 can be sufficiently adhered. If it is within 5 mm, the freeze-dried container 80 can be made compact without unnecessarily enlarging the container 81.
As for the thickness of the adhesive or adhesive agent apply | coated to the adhesion part 83, 5-500 micrometers is preferable. If thickness is 5 micrometers or more, the adhesion part 83 can fully be stuck. When the thickness is within 500 μm, the amount of the pressure-sensitive adhesive or adhesive can be suppressed.

The welding part 84 is a part which plays the role which seals the container 81 by welding.
In this example, the welded portion 84 is provided on the content side (the opposite side to the opening 82 side) from the adhesive portion 83 (FIG. 13). Although the welded portion 84 may be provided on the opening 82 side of the adhesive portion 83, it is possible to prevent the adhesive or adhesive of the adhesive portion 83 from flowing into the contents side and mixing into the lyophilized product. It is preferable that it is on the content side of the adhesive portion 83.

  The width of the welded portion 84 is preferably approximately 0.2 to 30 mm, and more preferably 0.5 to 15 mm. If it is 0.2 mm or more, it becomes easy to sufficiently seal the container 81. If it is within 30 mm, the freeze-dried container 80 can be made compact without unnecessarily enlarging the container 81.

Further, the container 81 is provided with a take-out portion 85 for inserting a syringe needle when taking out the contents. The take-out portion 85 is provided with a reseal layer that is in close contact with the injection needle and maintains confidentiality inside and outside the container 81 when the injection needle is inserted. The reseal layer only needs to be provided so as to cover at least the take-out portion 85, and is provided outside or inside the gas barrier film constituting the container 81.
Further, the reseal layer may be integrated with a gas barrier film and / or a protective layer or a sealant film constituting the container 81. When the reseal layer is provided over the entire container, it is not necessary to provide a specific part as the extraction part 85 of this embodiment as an extraction part for inserting the injection needle.
The reseal layer only needs to be in close contact with the gas barrier film and / or the protective layer or the sealant film, and is provided by welding by heat seal or impulse seal, or pasting via an adhesive or adhesive. Also good.

  Examples of the resin that forms the reseal layer in the container 81 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 is preferably 50 to 500 μm.

The freeze-drying container 80 described above is manufactured as follows, for example.
The container 81 can be formed by a method usually used for manufacturing a pouch. For example, a gas barrier film and a sealant film are laminated by laminating, folded so that the sealant film is inside, and one end A method of heat sealing so as to form the opening 82 can be used. When providing a protective layer, a sealant film, a gas barrier film, and a protective layer can be laminated simultaneously by laminating. Moreover, when setting it as the container 81 with self-supporting property, the process which provides self-supporting property by a well-known method is performed. The sticking or application of the pressure-sensitive adhesive or adhesive to the pressure-sensitive adhesive portion 83 may be performed in advance on a portion that becomes the pressure-sensitive adhesive portion 83 before bag making, or may be performed during or after the bag making process.
The freeze-dried container 80 can be manufactured by the method as described above.

(Method for producing freeze-dried product)
Next, a method for producing a freeze-dried product using the freeze-drying container 80 of the second embodiment will be described.
First, as in the first embodiment, the lyophilized product stock solution is filled in the container 81 of the lyophilization container 80 and placed on a heating / cooling shelf in the lyophilization apparatus. Then, the container 81 filled with the stock solution of the freeze-dried product is cooled using a heating / cooling shelf, and the stock solution of the freeze-dried product is frozen. Next, the stock solution of the lyophilized product is dried under reduced pressure while being kept in a frozen state, thereby sublimating moisture and obtaining a lyophilized product. Next, nitrogen gas is supplied into the freeze-drying apparatus to return to atmospheric pressure, and the atmosphere in the container 81 is replaced with nitrogen gas.

Next, as shown in FIG. 14, the pressing machine provided in the freeze-drying apparatus in a state where the portion provided with the adhesive portion 83 of the container 81 is arranged on the base 301 provided in the freeze-drying apparatus. 302 is pressed against the adhesive part 83, and the container 81 of the freeze-dried container 80 containing the freeze-dried product is temporarily sealed. Thereafter, the freeze-drying container 80 is taken out from the freeze-drying apparatus.
Next, as shown in FIG. 15, the welding part 84 inside the adhesive part 84 of the freeze-drying container 80 taken out from the freeze-drying apparatus is welded by heat sealing with a hot plate 303, and the container 81 is sealed. Thereby, the airtightness of the freeze-drying container 80 is ensured. In this way, the freeze-dried product is stored in the freeze-drying container 80. Note that the welding of the welded portion 84 is not limited to the hot plate welding, and may be performed by means such as ultrasonic welding, laser welding, and impulse welding.

According to the method for producing a lyophilized product of the present embodiment, since the aluminum fasteners required for a conventional lyophilized container using a glass container and a rubber stopper are not used, the lyophilized container 80 after use is Separate disposal is not necessary. Further, since the container 81 is temporarily sealed by pressing, the nitrogen gas in the container 81 does not leak immediately even if the freeze-dried container 80 is taken out of the freeze-drying apparatus, and the subsequent welding of the welding portion 84 is performed. Can be performed outside the freeze-drying apparatus.
Moreover, since the freeze-drying container 80 of this embodiment can be stored and discarded in a smaller state than the freeze-drying container 10 of the first embodiment, the storage space before use and the disposal space after use are reduced. It is preferable in that it can be performed.
As described above, the method for producing a lyophilized product of the present embodiment is a method of freeze-drying using a general freeze-drying apparatus by simply adding a pedestal or the like to the freeze-dried container of the present invention that does not require separation and disposal after use. Since the product can be accommodated, an efficient freeze-dried product can be produced.

(Removal of lyophilized product)
Next, a procedure for taking out the lyophilized material stored in the lyophilization container 80 of the present embodiment and disposal after use will be described.
First, an injection needle is inserted through the opening 82 and penetrated, and a predetermined solution for dissolving the lyophilized product is injected into the lyophilized container 80. Then, the freeze-dried product is dissolved with the solution. Next, the lyophilized solution is aspirated with an injection needle. In this way, the freeze-dried product is made into a solution and taken out from the freeze-drying container 80.

  The removal of the lyophilized product from the lyophilized container 80 is not limited to using an injection needle, and may be taken as it is without dissolving the lyophilized product, or a tube having a plurality of channels from the opening 82 or the like. It may be inserted and transported to the outside of the freeze-dried container 10 as a fine powder freeze-dried product under air flow, and may be taken.

After taking out the lyophilized product in this way, the lyophilized container 80 is discarded. Here, the freeze-drying container 80 of the present invention can be discarded as plastic and does not require separation after use.
In addition, when metal foil is used for the gas barrier film of the container 81, it can be discarded as metal, and when a metal foil laminated film is used, it can be discarded as plastic if plastic is mainly used by mass ratio. Is unnecessary.

The freeze-dried container of the present invention can be used for production of a freeze-dried product using a general freeze-drying apparatus, and does not require separation after use.
According to the method for producing a freeze-dried product of the present invention, the freeze-dried product can be stored in a freeze-dried container that does not require separation after use using a general freeze-drying apparatus, and the freeze-dried product is efficiently produced. be able to.

It is a perspective view which shows the freeze-drying container of the example of 1 embodiment of this invention. It is a longitudinal cross-sectional view which shows the freeze-drying container of one example of embodiment of this invention. It is sectional drawing which showed the example in which the elastic layer was provided in the stopper of the freeze-drying container of FIG. It is a fragmentary longitudinal cross-section which shows the freeze-drying container of other embodiment. It is a fragmentary longitudinal cross-section which shows the freeze-drying container of other embodiment. It is a fragmentary longitudinal cross-section which shows the freeze-drying container of other embodiment. It is a fragmentary longitudinal cross-section which shows the freeze-drying container of other embodiment. It is a fragmentary longitudinal cross-section which shows the freeze-drying container of other embodiment. It is side surface sectional drawing which shows the freeze-drying container of other example embodiments. It is a longitudinal cross-sectional view which shows the manufacturing process of a freeze-dried material. It is a longitudinal cross-sectional view which shows the manufacturing process of a freeze-dried material. It is a longitudinal cross-sectional view which shows the manufacturing process of a freeze-dried material. It is the figure which showed an example of the bag-like freeze-drying container of this invention. (A) Open state, (b) Sealed state. It is a schematic diagram which shows the manufacturing process of the freeze-dried material using the freeze-drying container of FIG. It is a schematic diagram which shows the manufacturing process of the freeze-dried material using the freeze-drying container of FIG. It is the figure which showed other embodiment examples of the bag-like freeze-drying container of this invention. (A) is a front view, (b) is a side view, and shows a sealed state.

Explanation of symbols

10, 50, 100, 110, 120, 130, 140 Freeze-dried container 11, 51 Container body 17, 55 Opening 21, 61 Plug 31, 71 Edge 32, 72 Adhesive part 33, 73 Welding part 34, 74 Spacing part 80 Freezing Drying container 81 Container 82 Opening 83 Adhesive part 84 Welding part A Stock solution of freeze-dried product B Freeze-dried product

Claims (7)

A plastic container having an opening used for packaging lyophilizate,
The freeze-dried container, wherein the container is provided with an adhesive part for temporarily sealing the container by pressing and a welding part for sealing the container by welding. A freeze-drying container comprising a plastic container body having an opening at the upper end and a plastic stopper plugged into the opening,
An adhesive portion is provided on the edge and / or stopper of the opening so that the edge and the stopper are brought into close contact with each other by plugging the stopper into the opening.
The freeze-drying container according to claim 1, wherein a welding portion welded to the stopper is provided over the entire periphery of the edge of the opening.   The freeze-drying container according to claim 2, wherein the welded portion is provided on the inner peripheral side of the edge and the adhesive portion is provided on the outer peripheral side of the edge.   The freeze-drying container according to claim 2 or 3, wherein a separating portion that separates the adhesive portion and the welding portion is provided over the entire circumference of the edge. The container has a bag shape having the opening at one end;
The freeze-dried container according to claim 1, wherein the adhesive portion is provided on one side or both sides of the inner surface of the container that is in close contact with the container when the container is temporarily sealed. A method for producing a lyophilized product using the lyophilized container according to claim 2,
The container body is filled with a stock solution of lyophilized material, the stock solution of the lyophilized material is freeze-dried, the stopper is then plugged into the opening, and the stopper is brought into close contact with the container body. A method for producing a freeze-dried product, comprising welding a main body and the stopper. A method for producing a freeze-dried product using the freeze-dried container according to claim 5,
The bag-shaped container is filled with a stock solution of lyophilized product, and after freeze-drying the stock solution of the lyophilized product, the container is temporarily sealed by pressing the adhesive portion, and then, A method for producing a freeze-dried product, comprising welding a welded portion.

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