JP2012071046A - Outer cylinder package for prefilled syringe and container body for outer cylinder package for prefilled syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a high-pressure steam sterilizable or high-pressure steam sterilized outer cylinder package for a prefilled syringe, which is easily manufactured and has extremely low possibility of causing degradation in sealability and deformation of a container body after high-pressure steam sterilization.SOLUTION: The high-pressure steam sterilizable or high-pressure steam sterilized outer cylinder package 1 for a prefilled syringe stored with a plurality of outer cylinders for a prefilled syringe includes a container body 2, an outer cylinder holding member 4 holding the plurality of outer cylinders 6 for the prefilled syringe stored in the container body, a releasable sheet shape lid member 3 to seal an upper face opening of the container body. The container body includes opening parts 22 provided on the bottom part, and an air permeable sealing member 5 to seal the openings. The air permeable sealing member has bacteria impermeability and permir free vapor passage. The inside of the container body communicates with outer atmosphere via the air permeable sealing member.

Description

  The present invention relates to an outer cylinder package for a prefilled syringe and a container body for an outer cylinder package for a prefilled syringe that can accommodate and transport a plurality of outer cylinders for a prefilled syringe and can be conveyed under high pressure steam sterilization.

In recent years, many prefilled syringes pre-filled with a chemical solution have been used. In manufacturing a prefilled syringe, it is common to fill a purchased syringe with a medicine without manufacturing the syringe itself. For this reason, it is necessary to prepare a syringe (in particular, a prefilled syringe outer cylinder) before being filled with a chemical solution or the like, and for that purpose, it is necessary to transport the prefilled syringe outer cylinder. Furthermore, it is desirable that the prefilled syringe outer cylinder to be prepared is sterilized. If the prefilled syringe outer cylinder is not sterilized, it is necessary to sterilize before manufacture.
For this reason, the package which accommodated the outer cylinder for several prefilled syringes which can be sterilized or was sterilized is provided. As such a thing, for example, Japanese translations of PCT publication No. 2005-500080 (patent document 1) is proposed.

JP 2005-500080 gazette

  In the plastic package having the contents that can be sterilized at a high temperature of Patent Document 1, the package is a fluid between the inside and the outside of the package, which is composed of at least a frame limiting the opening and an inner seal (18) closing the opening. A communication member (16) is provided. Peripheral edges (18a, 22a) are continuously connected to the frame, the inner seal includes a sheet of selective sealing material, and its external to inward blocking threshold stops contaminating particles and allows the passage of heat sterilization fluid However, the selective sealing material can be deformed in the plane of the sheet at high temperatures. This package comprises means for compensating for the planar deformation of the selective sealing material sheet when the inner seal (18) is in contact with the heat sterilization fluid, the compensating means being added to the frame as a result of the deformation and the fluid communication member ( 16) designed to release at least part of the load in the direction of opening.

  Methods for sterilizing medical members include those using electron beam, radiation, and EOG gas. From the viewpoints of safety and low denaturation to medical member forming materials, high-pressure steam sterilization (so-called autoclave) Sterilization) is desirable. The thing of the patent document 1 mentioned above becomes what can be sterilized by high pressure steam. And as shown also in patent document 1, a fluid communication member shrink | contracts by performing high pressure steam sterilization, the sealing performance fall after sterilization, a deformation | transformation of a container body, etc. arise. Moreover, it has not been easy to provide a peelable sealability between the fluid communication member and the container body and to maintain good peelability even after high-pressure steam sterilization.

Paragraph No. 0039 of Patent Document 1 discloses the following.
In the example illustrated in FIG. 3, the film 18 includes an edge 22 that is a material that may be impermeable to heat sterilization fluid, and its outer limit 22 a is around the periphery of the fluid communication member (upper peripheral edge 14). Continuously sealed and connected. The inner limit 22b of the rim 22 is continuously sealed and connected to the central sheet 19 of selectively impermeable material. The connection between the central sheet 19 of selectively impermeable material and the inner limit 22b of the rim 22 is obtained by all means, in particular by gluing. In this example, the edge 22 is provided with compensation means. The compensation means may be, for example, as relief 22c, for example, about one or more continuous lines surrounding a central sheet 19 of selectively impermeable material that is folded, corrugated or wrinkled. It is made of other shapes. The developed surface area of the rim 22 exceeds the visible surface area of the rim 22 to the extent that it compensates for the stress associated with the planar isotropic shrinkage of the central sheet 19 of selectively impermeable material when it deforms. ing.

However, providing a folded, corrugated or wrinkled compensation means (relief) as described above, the center of the selectively impervious material on such a relief It is not easy to fix the sheet 19, and when shrinkage more than the relief occurs, there is a possibility that the sealing performance after sterilization is deteriorated and the container body is deformed.
Accordingly, an object of the present invention is to provide a prefilled syringe that is easy to manufacture and is capable of high-pressure steam sterilization or high-pressure steam sterilization that is unlikely to cause deterioration in sealing performance and deformation of the container body after high-pressure steam sterilization. The present invention provides a container body for an outer cylinder packaging body for a cylinder packaging body and a prefilled syringe.

What achieves the above object is as follows.
(1) A prefilled syringe outer cylinder package capable of high-pressure steam sterilization or high-pressure steam sterilization containing a plurality of prefilled syringe outer cylinders,
The prefilled syringe outer cylinder package includes a container body having an open top surface and shape retention, an outer cylinder holding member housed in the container body, and a plurality of the outer cylinder holding members held in the outer cylinder holding member. A prefilled syringe outer cylinder, and a sheet-like lid member that seals and peels off the upper surface opening of the container body,
The container body includes an opening provided in a bottom part and / or a side part, and a breathable sealing member fixed to the container body so as to encapsulate or seal the opening. The sealing member has a bacteria-impermeable and water vapor flow property, and the inside of the container communicates with the outside through the breathable sealing member.
(2) The breathable sealing member is fixed to the inner surface side of the container body so as to enclose the opening, and the breathable sealing member and the opening are separated from each other. Alternatively, the prefilled syringe outer cylinder package according to the above (1), which is separable and has an effective area of the breathable sealing member larger than the area of the opening.
(3) The breathable sealing member is fixed to a discontinuous annular protrusion provided at the peripheral edge of the opening, and the breathable sealing member and the opening are separated from each other. The outer cylinder package for prefilled syringes as described in said (2).
(4) In the above (1), the container body includes the opening, and the air-permeable sealing member is fixed to each opening without being spaced apart to seal the opening. The outer cylinder packaging body for prefilled syringes of description.
(5) The sheet-like lid member has a seal member main body sealed to the container body, a window portion provided in the seal member main body, and a bacteria-impermeable and water vapor flow property fixed to the window portion. An outer cylinder package for a prefilled syringe according to any one of the above (1) to (4), comprising a breathable sealing member.
(6) The container body and the breathable sealing member are made of thermoplastic resin, and the breathable sealing member is fixed to the container body by heat sealing so as not to be peeled off. 5) The outer cylinder packaging body for prefilled syringes in any one of.
(7) The outer cylinder package for the prefilled syringe is described in any one of the above (1) to (6), which includes a pressure change mitigation unit to cope with an increase in internal pressure in the outer cylinder package for the prefilled syringe. The outer cylinder package for prefilled syringes.
(8) The container body includes a recess that is recessed inward from the outer surface side, and a vent provided in the recess, and the outer cylinder package for the prefilled syringe has the recess provided with the vent. The outer peripheral side of the pre-filled syringe outer cylinder packaging body is adapted to cope with an increase in the internal pressure of the prefilled syringe outer cylinder packaging body. The outer cylinder package for prefilled syringes according to (7), comprising a pressure change reducing part.

Moreover, what achieves the said objective is as follows.
(9) A container body for an outer cylinder packaging body for a prefilled syringe capable of storing a plurality of outer cylinders for a prefilled syringe and capable of high-pressure steam sterilization,
The container body has an opening on the top surface, an opening provided on the bottom or side having shape retention, and a breathable seal fixed to the container body so as to encapsulate or seal the opening. A container for a pre-filled syringe outer cylinder packaging body that is provided with a stop member, and wherein the air-permeable sealing member has a bacteria-impermeable and water vapor flowability.
(10) The breathable sealing member is fixed to the container body so as to enclose the opening, and the breathable sealing member and the opening are separated or separable. The container body for an outer cylinder packaging body for a prefilled syringe according to (9), wherein the effective area of the breathable sealing member is larger than the area of the opening.

The prefilled syringe outer cylinder package capable of being subjected to high-pressure steam sterilization or high-pressure steam sterilization according to the present invention includes a container body having an open top surface and shape retention, an outer cylinder holding member housed in the container body, A plurality of prefilled syringe outer cylinders held by a cylinder holding member, and a sheet-like lid member that hermetically seals the upper surface opening of the container body and can be peeled off. The container body includes an opening provided at the bottom or side, and a breathable sealing member fixed to the container body so as to encapsulate or seal the opening. It is impermeable and has water vapor flow, and the inside of the container communicates with the outside through a breathable sealing member.
Therefore, the breathable sealing member through which water vapor flows during high-pressure steam sterilization encapsulates or seals the opening provided at the bottom or side of the container body, not the top opening of the container body having shape retention As in Patent Document 1, it is not necessary to provide a relief, and it is easy to manufacture morphologically. In addition, it is necessary to fix the breathable sealing member to the container body so that it can be peeled off. Therefore, it is possible to seal with sufficient strength, and the manufacturing operation is easy even in the temperature control in the heat sealing operation. Further, since the breathable sealing member is fixed so as to enclose or seal the opening provided at the bottom or side of the container body, the breathable sealing member and the container body after high-pressure steam sterilization are used. There is very little possibility that the sealing performance is lowered and the container body is deformed.

FIG. 1 is a perspective view of an outer cylinder package for a prefilled syringe according to an embodiment of the present invention. FIG. 2 is an explanatory view for explaining the internal form of the prefilled syringe outer cylinder package shown in FIG. 1. FIG. 3 is a front view of the prefilled syringe outer cylinder package shown in FIG. 1. FIG. 4 is a plan view of the prefilled syringe outer cylinder package shown in FIG. 3. FIG. 5 is a right side view of the prefilled syringe outer cylinder package shown in FIG. 3. 6 is an enlarged cross-sectional view taken along line AA of FIG. FIG. 7 is a plan view of a container used for the prefilled syringe outer cylinder package shown in FIG. 3. FIG. 8 is a perspective view of an outer cylinder holding member used in the outer cylinder package for a prefilled syringe shown in FIG. 3. FIG. 9 is a front view of the outer cylinder holding member shown in FIG. 10 is a plan view of the outer cylinder holding member shown in FIG. FIG. 11: is a top view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention. FIG. 12: is a top view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention. FIG. 13: is a side view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention. FIG. 14: is a side view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention. FIG. 15: is a top view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention. 16 is an enlarged sectional view taken along line BB in FIG. FIG. 17 is a plan view of a sheet-like lid member used for an outer cylinder package for a prefilled syringe according to another embodiment of the present invention. FIG. 18: is a top view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention. 19 is an enlarged cross-sectional view taken along the line CC of FIG. 20 is an enlarged sectional view taken along the line DD of FIG.

Hereinafter, the outer cylinder packaging body for prefilled syringes and the container body for outer cylinder packaging bodies for prefilled syringes of the present invention will be described with reference to the embodiments shown in the drawings.
A prefilled syringe outer cylinder package 1 capable of high-pressure steam sterilization or high-pressure steam sterilization containing a plurality of prefilled syringe outer cylinders according to the present invention includes a container body 2 having an open top surface and shape retention; An outer cylinder holding member 4 capable of holding a plurality of prefilled syringe outer cylinders 6 accommodated in the body 2, a plurality of prefilled syringe outer cylinders 6 held by the outer cylinder holding member 4, and an upper surface of the container body 2 A sheet-like lid member 3 that seals the opening hermetically and is peelable is provided. The container body 2 further includes an opening 22 provided on the bottom or side, and a breathable sealing member 5 fixed to the container so as to encapsulate or seal the opening 22. The sealing member 5 has bacteria-impermeable and water vapor flow characteristics, and the inside of the container body 2 communicates with the outside through the air-permeable sealing member 5.

The prefilled syringe outer cylinder package 1 of the present invention is a prefilled syringe outer cylinder package that can be autoclaved or autoclaved. As shown in FIGS. 1, 2, and 6, the prefilled syringe outer cylinder package 1 of the present invention includes a container body 2, and an outer cylinder holding member 4 that can hold a plurality of prefilled syringe outer cylinders 6; It consists of a plurality of prefilled syringe outer cylinders 6 held by the outer cylinder holding member 4 and a sheet-like lid member 3 that seals the upper surface opening of the container body 2 while being airtight.
As shown in FIGS. 1 to 7, the container body 2 has a tray-like shape having a predetermined depth having a certain degree of strength and shape retention, and has a main body portion 21 and an upper portion of the main body portion 21. The outer cylinder holding member holding part 26 for holding the peripheral part of the outer cylinder holding member 4 holding the formed prefilled syringe outer cylinder, the annular flange part 24 provided in the upper surface opening, and the bottom surface of the main body part 21 And a plurality of openings 22 provided in. Further, the container body 2 of this embodiment includes a first annular rib 51 provided so as to surround the plurality of openings 22. Furthermore, the container body 2 of this embodiment includes a second annular rib 52 provided so as to be close to the first annular rib 51 and to surround the first annular rib 51.

  As shown in FIGS. 6 and 7, the container body 2 in this embodiment is a rectangular bowl-shaped body, and a thin plate-like annular flange formed in the upper end opening so as to extend annularly and outward. A portion 24 is provided. Further, an annular heat sealing convex portion 25 for fixing to the sheet-like lid member 3 is provided on the upper surface of the annular flange portion 24. The annular heat-sealing convex portion 25 is provided so that the entirety is inside the outer edge of the annular flange portion. Further, the annular heat seal convex portion 25 is provided so as to be entirely outside the inner edge of the annular flange portion. Furthermore, a protrusion 25 a extending in the direction of the corner of the annular flange portion 24 is formed at the corner of the annular heat seal convex portion 25.

And the outer cylinder holding member holding | maintenance part 26 is formed in the position which becomes a predetermined long bottom face side from the flange part 24. As shown in FIG. In the container body 2 of this embodiment, the outer cylinder holding member holding part 26 is an annular stepped part, and the peripheral part of the outer cylinder holding member 4 holding the prefilled syringe outer cylinder can be placed thereon. Yes. The outer cylinder holding member holding portion is not continuous in an annular shape, and may be discontinuous.
In the container body 2 of this embodiment, a plurality of (specifically, four) openings 22 are provided on the bottom surface. The shape of the opening is preferably a circle as shown in the figure, but may be an ellipse or a polygon.

As shown in FIGS. 6 and 7, in the container body 2 of this embodiment, the opening 22 of the container body 2 is encapsulated by a breathable sealing member 5 that is impermeable to bacteria and has water vapor flow. ing. In particular, in this embodiment, the air-permeable sealing member 5 is provided so as to cover the upper surface side (inner surface side) of the opening 22 provided in the container body 2, and the peripheral edge thereof is fixed to the container body 2. ing. In particular, in this embodiment, the air-permeable sealing member 5 is fixed to the bottom surface of the container body 2 so as to cover the upper surface side (inner surface side) of all the openings 22. Specifically, as shown in FIG. 6, the breathable sealing member 5 is not fixed to the opening 22, and the breathable sealing member 5 and the opening 22 are separated or separable. It has become a thing. By doing in this way, the effective area of the air permeable sealing member 5 can be made larger than the total opening area of the opening part 22, and the water vapor | steam flowability high to the container body 2 can be provided. In addition, in the container body 2 of this embodiment, one sheet of air-permeable sealing member is used, and by doing so, it is easy to fix the container body 2 and it is preferable. Moreover, like the container body shown in FIG. 18 to be described later, the breathable sealing member is not a single member, and each of the openings may cover the upper surface side (inner surface side).
And in the container body 2 of this Example, the air-permeable sealing member 5 which has the bacteria-impermeable and water vapor | steam flowability which encapsulates all the some opening parts 22 is the bottom face of the container body 2 in the peripheral part. And is fixed to the first annular rib 51. Furthermore, in the container body 2 of this embodiment, the breathable sealing member 5 is also fixed to the second annular rib 52 of the container body 2 at the peripheral edge portion. Then, the air-permeable sealing member 5 and the opening 22 are separated from each other by the protruding height of the first annular rib 51 and the second annular rib 52. The inside of the container body 2 communicates with the outside through a breathable sealing member 5. The container body 2 and the breathable sealing member 5 are preferably made of a thermoplastic resin, and in this way, the breathable sealing member 5 can be fixed to the container body 2 by heat sealing. In addition, the breathable sealing member 5 does not need to be fixed to the container body 2 so as to be peeled off, it is only necessary to fix the air-tight sealing member 5 so that it is airtight and cannot be peeled off, and temperature management for fixing is easy.
Further, as in the container body 2 a shown in FIG. 11, the breathable breathable sealing member 5 is fixed to the discontinuous annular protrusion 23 provided at the peripheral edge of the opening 22 of the container body 2 a by the fixing portion 53. May be.
The air-permeable sealing member 5 may be any material as long as it is bacteria-impermeable and has water vapor flowability, and the air-permeable sealing member 5 can be heat sealed to the container body 2. It is preferable. As the breathable sealing member 5, for example, a synthetic resin nonwoven fabric, specifically, a nonwoven fabric made of a synthetic resin material such as polyolefin known as Tyvek (registered trademark), a synthetic resin porous membrane, or the like is suitable. Can be used for Furthermore, as the breathable sealing member 5, a heat-heated and heat-shrinkable member may be used.

  The container body 2 preferably has a certain degree of shape retention and rigidity. In order to cope with high-pressure steam sterilization, it is desirable to use a thermoplastic material having heat resistance (120 ° C. or higher). Examples of materials having a certain degree of shape retention, a certain degree of rigidity, heat resistance and thermoplasticity include polyolefins such as polypropylene and polyethylene, vinyl chloride resins, polystyrene / polypropylene resins, polyethylene / ionomers (eg, ethylene-based, styrene). Type, fluorine type) / polyethylene, polyester resin (for example, polyethylene terephthalate, polybutylene terephthalate, amorphous-polyethylene terephthalate), PP / EVOH / PP (laminate), and the like. In this case, the thickness of the container body 2 is preferably about 0.05 to 4.00 mm, and more preferably 1.00 to 2.00 mm.

  Furthermore, the container body 2 may be capable of radiation or electron beam sterilization. In this case, it is desirable to use what is called a radiation resistant material. Radiation-resistant materials (for example, radiation-resistant polyolefins) are those that have been given radiation resistance by adding hindered amines, antioxidants, nucleating agents, etc. to polyolefins (for example, polypropylene, polyethylene). Can be used. Examples of hindered amines include bis (2,2,6,6-tetramethylpiperidyl) sebacate, bis (2,2,6,6-tetramethylpiperidyl) adipate, and bis (2,2,6,6-tetramethylpiperidyl). Examples include fumarate. Antioxidants include 1,1,3-tris (2-methyl-hydroxy-5-t-butylphenyl) butane, tris (3,5-di-T-butyl-4-hydroxybenzyl) isocyanurate, tetrakis (Methylene-3- (3,5-di-t-butyl-4-hydroxyphenyl) propionate) methane and the like are exemplified. Examples of the nucleating agent include 1,3,2,4-dibenzylidene sorbitol, 1,3,2,4-di (p-methylbenzylidene) sorbitol and the like.

  As shown in FIGS. 2, 6, 8 to 10, the outer cylinder holding member 4 capable of holding a plurality of prefilled syringe outer cylinders 6 includes a substrate part 41 and a plurality of protrusions protruding above the substrate part 41. The cylindrical part 42 is provided. An opening 43 is formed at the upper end of the cylindrical portion 42, and a gripping cutout portion 44 is formed on the side portion of the substrate portion 41. The inner diameters of the cylindrical portion 42 and the opening 43 are larger than the main body portion of the prefilled syringe outer cylinder 6 to be held, and the passage of the flange portion of the held prefilled syringe outer cylinder 6 is prevented. It is impossible. For this reason, as shown in FIG. 6, the outer cylinder 6 is in a state in which the flange of the outer cylinder is suspended by the opening 43 while penetrating the cylindrical portion 42. Further, as shown in FIG. 6, the lower end (the tip of the cap member) of the prefilled syringe outer cylinder 6 held by the outer cylinder holding member 4 is not in contact with the bottom surface of the container body 2. In other words, the bottom surface of the container body 2 and the lower end (the tip of the cap member) of the prefilled syringe outer cylinder 6 held by the outer cylinder holding member 4 are separated from each other and do not hinder the flow of water vapor. It is desirable that the material for forming the outer cylinder holding member 4 has heat resistance (120 ° C. or higher) in order to cope with high-pressure steam sterilization.

As the prefilled syringe outer cylinder 6, a known one can be used. The prefilled syringe outer cylinder 6 includes an outer cylinder main body 60 and a cap 61 that seals a nozzle portion provided at a distal end portion of the outer cylinder main body 60. A flange 62 is provided at the base end of the outer cylinder main body 60. The flange 62 is an elliptical donut-shaped disc part formed so as to protrude in the vertical direction from the entire rear end circumference of the outer cylinder main body 61.
Examples of the material for forming the outer cylinder 6 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyesters and cyclic polyolefins are preferable, and among them, resins such as polypropylene and cyclic polyolefins are preferable because they are easy to mold and have heat resistance.

The sheet-like lid member 3 encapsulates and seals the upper end opening of the container body 2 and can be peeled from the container body 2. The sheet-like lid member 3 is substantially impermeable to bacteria and water vapor, and can be peeled off from the container body 2.
Specifically, the sheet-like lid member 3 has a film (base film) that does not substantially transmit bacteria and water vapor, and an adhesive resin layer fixed to at least the outer peripheral portion of the lower surface of the film. It is more preferable to have a surface protective layer provided on the upper surface of the film. Examples of the base film include metal foils such as aluminum, silver, and gold, metal vapor-deposited films on which aluminum, silver, and gold are vapor-deposited, inorganic vapor-deposited films on which SiOX and the like are vapor-deposited, gas barrier resin films, Films such as polyvinylidene chloride, polyvinylidene chloride-polyvinyl chloride, polyvinylidene chloride-acrylic acid ester copolymer, and high-density polyethylene can be preferably used.

  The adhesive resin layer is for heat-sealing the base film and the container body 2 so that the base film and the container body 2 can be peeled, and various easy peeling mechanisms as described below can be used. For example, when polypropylene is used for the heat seal surface of the container body 2, an olefin resin such as an ethylene-vinyl acetate resin, an ethylene-acrylic acid resin, or a blend of polypropylene and polyethylene is used as the adhesive resin layer. A two-component curable urethane-based dry laminate adhesive can be suitably used. Further, when polyvinyl chloride is used as the container body 2, an olefin-based resin such as an ethylene-vinyl acetate-based resin or an ethylene-acrylic acid-based resin, polystyrene, and a styrene-butadiene block copolymer are used as an adhesive resin layer. A blended product, a vinyl chloride-vinyl acetate copolymer, a two-component curable urethane-based dry laminate adhesive, or the like can be suitably used. Furthermore, when using polyester as the container 2, olefin resins such as ethylene-vinyl acetate resin and ethylene-acrylic acid resin, copolyester, and two-component curable urethane-based dry laminate adhesive can be suitably used. .

  The surface protective layer is formed by coating a synthetic resin, for example, polyester such as PET, polypropylene, polyethylene, nylon, epoxy resin, polyamide resin, or by laminating the above synthetic resin film or paper. Is preferred. This surface protective layer is printed to describe necessary items such as the name and size of the medical product to be stored, the name of the medicine filled in the syringe when the medical product is, for example, a prefilled syringe, and the filling amount. Can also be used as a layer. A light shielding material such as white ink may be interposed between the surface protective layer and the gas barrier film to form a light shielding film.

Specific examples of the sheet-like lid member 3 include four layers of polyethylene terephthalate / polyethylene / polyethylene terephthalate / adhesive resin, polyethylene terephthalate / ethylene-vinyl alcohol copolymer / stretched nylon / adhesive resin, polyethylene terephthalate / One consisting of three layers of stretched nylon / adhesive resin is conceivable.
And the sheet-like cover member 3 is heat-sealed so that the peripheral part can be peeled off to the heat-sealing convex part 25 provided in the annular flange part 24 of the container body 2. In this embodiment, the outer edge of the sheet-like lid member is not heat-sealed to the annular flange portion 24 of the container body 2 and can be easily peeled off. Moreover, the protrusion part 25a provided in the corner | angular part of the convex part 25 for heat sealing functions as a peeling start part. The sheet-like lid member 3 preferably has a thickness of about 0.05 to 1.00 mm, and more preferably about 0.10 to 0.50 mm.

Moreover, as a container body used for the outer cylinder packaging body for prefilled syringes of this invention, the container body 2b as shown in FIG. 12 may be sufficient.
FIG. 12: is a top view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention.
The difference between the container body 2b and the container body 2 described above is only the bottom shape. Therefore, regarding the shape other than the bottom surface shape (for example, the flange portion 24, the outer cylinder holding member holding portion 26, etc.), the description in the container body 2 is referred to.
And in the container body 2b of this Example, many small opening parts 22a are provided in the bottom face. Thus, the number and area of the openings are not particularly limited, and can be appropriately determined as long as the strength of the container body 2 can be maintained. Further, the shape of the opening is preferably a circle as shown in the figure, but may be an ellipse or a polygon. Furthermore, the container body 2b includes an annular rib 51 formed so as to surround a large number of openings 22a.

And the container body 2b is provided with the air-permeable sealing member 5 having the bacteria-impermeable and water vapor flowability that encloses all of the many small openings 22a, similarly to the container body 2 described above. . In this embodiment, similarly to the container body 2 described above, the breathable sealing member 5 is fixed to the bottom surface of the container body 2b so as to cover the top surfaces of all the openings 22a. Further, the breathable sealing member 5 is not fixed to the opening 22a, and the breathable sealing member 5 and the opening 22a are separated or separable.
In addition, in the container body 2b of this embodiment, a single air-permeable sealing member is used. By doing so, it is easy to fix the container body 2b to the container body 2b. The breathable sealing member 5 has a breathable breathable sealing member on a discontinuous annular protrusion provided at the peripheral edge of the opening 22a of the container body as in the container body shown in FIG. 5 may be fixed. Moreover, like the container body shown in FIG. 18 to be described later, the breathable sealing member is not a single member, and each of the openings may cover the upper surface side (inner surface side).
The breathable sealing member 5 is fixed to the annular rib 51 of the container body 2b at the peripheral edge. The inside of the container body 2 b communicates with the outside through the breathable sealing member 5. The container body 2b and the breathable sealing member 5 are preferably made of a thermoplastic resin, and in this way, the breathable sealing member 5 can be fixed to the container body 2b by heat sealing.

Moreover, as a container body used for the outer cylinder packaging body for prefilled syringes of this invention, the container body 2c as shown in FIG. 13 may be sufficient.
FIG. 13: is a side view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention.
The difference between the container body 2c and the container body 2 described above in this embodiment is only the side surface shape and the bottom surface shape. Therefore, for the portions other than the side surface and the bottom surface (for example, the flange portion 24, the outer cylinder holding member holding portion 26, etc.), the description in the container body 2 is referred to.

And in the container body 2c of this Example, the opening part is not provided in the bottom face like the container body 2 mentioned above. Instead, an opening 28 is provided on the side surface 21a. In this embodiment, a plurality of (specifically, two) openings 28 are provided on the side surface. The opening 28 may be provided on only one side, but is preferably provided on the opposite side. Furthermore, you may provide in three or more side surfaces, and you may provide the opening part 28 in all (4) side surfaces especially.
When many openings are provided on such side surfaces, the number and area of the openings are not particularly limited, and can be appropriately determined as long as the strength of the container body 2 can be maintained. Further, the shape of the opening is preferably a circle as shown in the figure, but may be an ellipse or a polygon. Furthermore, the container body 2c includes an annular rib 54 that is formed so as to surround the plurality of openings 28 and protrudes inward of the container body 2c.

And the opening part 28 of the container body 2c is encapsulated by the air permeable sealing member 5a which has microbe impermeable and water vapor | steam flowability. Specifically, the air-permeable sealing member 5a is fixed to an annular rib 54 formed inside the side portion of the container body 2c so as to cover the inner surface side of a plurality (specifically, two) of the opening portions 28. Has been. The inside of the container body 2c communicates with the outside through a breathable sealing member 5a. Further, the breathable sealing member 5a is not fixed to the opening 28, and the breathable sealing member 5a and the opening 28 are separated or separable. The breathable sealing member 5a has a breathable breathable sealing member on a discontinuous annular protrusion provided at the peripheral edge of the opening 28 of the container body, like the container body shown in FIG. 5a may be fixed. The container body 2c and the breathable sealing member 5a are preferably made of a thermoplastic resin, and in this way, the breathable sealing member 5a can be fixed to the container body 2c by heat sealing.
As described above, the breathable sealing member 5a and the opening 28 are preferably separated or separable, but the breathable sealing member 5b is shown in FIG. As in the container body 2d of the example, each opening 28 may be individually sealed, that is, the breathable sealing member 5a may be fixed to each opening 28 without being separated. In this case, the air-permeable sealing member 5 b is preferably fixed to the annular protrusion 29 provided at the peripheral edge of the opening 28. It is also possible to fix the breathable sealing member 5a directly to the inside of the side part of the container body 2c. In this case, the annular protrusion 29 is unnecessary.

Moreover, as a container body used for the outer cylinder packaging body for prefilled syringes of this invention, the container body 2e as shown to FIG. 15 and FIG. 16 may be sufficient.
FIG. 15: is a top view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention. 16 is an enlarged sectional view taken along line BB in FIG.
The difference between the container body 2e in this embodiment and the container body 2 described above is only the bottom surface shape. Therefore, regarding the shape other than the bottom surface shape (for example, the flange portion 24, the outer cylinder holding member holding portion 26, etc.), the description in the container body 2 is referred to.

  Also in the container body 2e of this embodiment, a plurality of (specifically, four) openings 22 are provided on the bottom surface. And the opening part 22 of the container body 2e is sealed with the air permeable sealing member 5b which has microbe impermeable and water vapor | steam flowability. That is, the air-permeable sealing member 5b is fixed to each opening 22 without being separated. Specifically, a breathable sealing member 5b is fixed to the annular protrusion 23 provided at the peripheral edge of each opening 22 from the inner surface side of the container body 2e, and the breathable sealing member 5b opens the opening. The part 22 is sealed. The inside of the container body 2e communicates with the outside through a breathable sealing member 5b. The breathable sealing member 5b may be fixed to the outer surface side of the container body 2e. It is also possible to fix the air-permeable sealing member 5b directly to the container body 2e. In this case, the annular protrusion 23 is unnecessary.

Moreover, as a container body used for the outer cylinder packaging body for prefilled syringes of this invention, the container body 2f as shown to FIG. 18 thru | or FIG. 20 may be sufficient.
FIG. 18: is a top view of the container body used for the outer cylinder packaging body for prefilled syringes of the other Example of this invention. 19 is an enlarged cross-sectional view taken along the line CC of FIG. 20 is an enlarged sectional view taken along the line DD of FIG.
The difference between the container body 2f and the container body 2 described above is only the bottom shape. Therefore, regarding the shape other than the bottom surface shape (for example, the flange portion 24, the outer cylinder holding member holding portion 26, etc.), the description in the container body 2 is referred to.

Also in the container body 2f of this embodiment, a plurality of (specifically, four) openings 22 are provided on the bottom surface. The number and area of the openings are not particularly limited and can be appropriately determined as long as the strength of the container body 2 can be maintained. Further, the shape of the opening is preferably a circle as shown in the figure, but may be an ellipse or a polygon.
And the opening part 22 of the container body 2f is encapsulated by the air-permeable sealing member 5 which is bacteria-impermeable and has water vapor flow. Specifically, the breathable sealing member 5 is fixed to the annular rib 56 surrounding each opening 22 from the inner surface side of the container body 2f, and the opening 22 is sealed by the breathable sealing member 5. ing. The inside of the container body 2 f communicates with the outside through a breathable sealing member 5. In this embodiment, the breathable sealing member 5 is not fixed to the opening 22, and the breathable sealing member 5 and the opening 22 are separated or separable. In particular, in this embodiment, the air-permeable sealing member 5 and the opening 22 are separated by the protrusion height of the annular rib 56. The breathable sealing member 5 has a breathable breathable sealing member on a discontinuous annular protrusion provided at the peripheral edge of the opening 22 of the container body, like the container body shown in FIG. 5 may be fixed. Further, the breathable sealing member 5 is fixed to an annular projecting portion provided at the peripheral portion of the opening 22 so as to project inward of the container body 2f as in the container body of FIGS. 15 and 16 described above. It may be. As the breathable sealing member 5, those described above can be used.

  The outer cylinder package for a prefilled syringe according to this embodiment includes a pressure change mitigation unit to cope with an increase in internal pressure in the outer cylinder package for a prefilled syringe. Specifically, the container body 2f of this embodiment includes a recess 71 recessed inward from the outer surface side and a vent 72 provided in the recess 71 on the bottom surface. Furthermore, the outer cylinder package (container body) for prefilled syringes encloses the concave portion 71 provided with the vent 72 from the outer surface side of the container body 2f, or closely adheres along the outer surface of the concave portion 71. The peripheral part is provided with the soft film (soft sheet) 73 which does not have air permeability fixed to the container body 2f. That is, at least the central part of the soft film 73 is movable with respect to the container body 2f. For this reason, this outer cylinder packaging body (container body) for prefilled syringes is provided with the pressure change reduction part for the time of the internal pressure rise of the outer cylinder packaging body for prefilled syringes.

As the soft film 73, a flexible film (flexible sheet) or an elastic film (elastic sheet) is used. In the case where a flexible film is used as the soft film, it is preferable that the flexible film has a clear portion 73a rather than a taut state. When the pressure in the prefilled syringe outer cylinder package rises during sterilization, transportation, etc., as shown in FIG. 20, the space 53a of the soft film 73 extends, and the outer surface side of the recess 71 and the soft film 73 are partitioned. As a result of the appearance or expansion of the space 74, the increase in the internal pressure can be reduced by the volume increase, and the peeling due to the increase in the internal pressure between the container body 2f and the lid member can be prevented. When an elastic film is used as the soft film, even if the elastic film has a space as described above and is stretched tightly, the elastic film stretches due to an increase in pressure in the prefilled syringe outer cylinder package. The same effect as described above can be obtained. Further, if the vent hole 72 has a sufficient size, an elastic film may be fixed to the inner surface side of the concave portion 71 of the container body 2f.
Further, in the container body of the embodiment provided with the pressure change reducing portion for coping with the increase in the internal pressure in the outer cylinder package body, like the container body of the embodiment shown in FIGS. The breathable sealing member may be provided on the side surface instead of the bottom surface of the container body. In this case, as the form of the opening and the air-permeable sealing member, the form described in FIGS. 13 and 14 can be used effectively.

As the flexible film (flexible sheet), a thermoplastic synthetic resin flexible film is preferable. Specifically, polyester or stretched polyester such as polyethylene terephthalate and stretched polyethylene terephthalate, polyethylene, stretched polyethylene, polypropylene, stretched Soft resin films made of polyolefins such as polypropylene or stretched polyolefins, polyamides, etc. are suitable. Furthermore, such a soft resin film is used as a base material, and the heat sealability is improved by using an adhesive or directly. It is preferable to laminate a hot melt adhesive layer (for example, low density polyethylene, ethylene vinyl acetate).
As the elastic film (elastic sheet), a thermoplastic synthetic resin elastic film is preferable. Specifically, olefin elastomer (polyethylene elastomer, polypropylene elastomer), amide elastomer (polyamide elastomer), styrene elastomer (for example, styrene- An elastic resin film formed of a butadiene-styrene copolymer, a styrene-isoprene-styrene copolymer, a styrene-ethylenebutylene-styrene copolymer) or the like is preferable, and the elastic resin film is used as a base material and bonded thereto. A laminate obtained by laminating a hot melt adhesive layer (for example, low density polyethylene, ethylene vinyl acetate) for improving the heat sealability directly or via an agent is suitable.

  In all the embodiments described above, the sheet-like lid member may be a sheet-like lid member 3a as shown in FIG. The lid member 3a is substantially impermeable to bacteria and water vapor, can be peelably sealed from the container body 2, and has a lid member body 32 having a window 33, and a window of the lid member body 32. A breathable sealing member 34 that is fixed to the part and has a bacteria-impermeable and water vapor flow property is provided. Specifically, the air-permeable sealing member 34 has a peripheral edge portion 35 fixed to the window portion of the lid member main body 32 by heat sealing from the inner surface side to seal the window portion. In addition, as the air-permeable sealing member 34, what was demonstrated in the air-permeable sealing member 5 mentioned above can be used conveniently. Further, as the lid member main body 32, those described in the above-described lid member 3 can be suitably used.

DESCRIPTION OF SYMBOLS 1 Outer cylinder packaging body 2, 2a, 2b, 2c, 2d, 2e, 2f for prefilled syringes Container body 3 Sheet-like cover member 4 Outer cylinder holding member 5 Breathable sealing member 6 Outer cylinder 22 for prefilled syringes Opening

Claims (10)

A prefilled syringe outer cylinder package capable of high-pressure steam sterilization or high-pressure steam sterilization containing a plurality of prefilled syringe outer cylinders,
The prefilled syringe outer cylinder package includes a container body having an open top surface and shape retention, an outer cylinder holding member housed in the container body, and a plurality of the outer cylinder holding members held in the outer cylinder holding member. A prefilled syringe outer cylinder, and a sheet-like lid member that seals and peels off the upper surface opening of the container body,
The container body includes an opening provided in a bottom part and / or a side part, and a breathable sealing member fixed to the container body so as to encapsulate or seal the opening. The sealing member has a bacteria-impermeable and water vapor flow property, and the container body communicates with the outside through the breathable sealing member, and the prefilled syringe outer cylinder packaging is characterized in that body. The breathable sealing member is fixed to the inner surface of the container body so as to enclose the opening, and the breathable sealing member and the opening are separated or separable. The outer cylinder package for prefilled syringes according to claim 1, wherein the effective area of the breathable sealing member is larger than the area of the opening. The air-permeable sealing member is fixed to a discontinuous annular protrusion provided at a peripheral edge of the opening, and the air-permeable sealing member and the opening are separated from each other. An outer cylinder package for a prefilled syringe according to 1. 2. The prefilled syringe according to claim 1, wherein the container body includes the opening, and the breathable sealing member is fixed to each opening without being spaced apart to seal the opening. 3. Outer cylinder package. The sheet-like lid member includes a seal member main body sealed to the container body, a window portion provided in the seal member main body, and a gas-impermeable and water vapor permeable gas-permeability fixed to the window portion. The outer cylinder packaging body for prefilled syringes in any one of Claim 1 thru | or 4 provided with the sealing member. The said container body and the said air permeable sealing member are the products made from a thermoplastic resin, and the said air permeable sealing member is fixed to the said container body by the heat seal so that peeling is impossible. The outer cylinder packaging body for prefilled syringes of description. The prefilled syringe outer cylinder according to any one of claims 1 to 6, wherein the prefilled syringe outer cylinder package is provided with a pressure change reduction portion for coping with an increase in internal pressure in the prefilled syringe outer cylinder package. Packaging body. The container body includes a recess recessed inward from the outer surface side and a vent provided in the recess, and the prefilled syringe outer cylinder package includes the recess provided with the vent on the outer surface side. A pressure change corresponding to an increase in the internal pressure of the outer cylinder package for the prefilled syringe, having a soft film with a peripheral edge fixed to the container body so as to be further encapsulated or closely adhered along the concave portion The outer cylinder package for prefilled syringes according to claim 7, comprising a lightening part. A container body for a prefilled syringe outer cylinder capable of storing a plurality of prefilled syringe outer cylinders and capable of high-pressure steam sterilization,
The container body has an opening on the top surface, an opening provided on the bottom or side having shape retention, and a breathable seal fixed to the container body so as to encapsulate or seal the opening. A container body for a prefilled syringe outer cylinder package, comprising a stopper member, wherein the air-permeable sealing member has a bacteria-impermeable and water vapor permeable property. The breathable sealing member is fixed to the container body so as to enclose the opening, and the breathable sealing member and the opening are separated or separable. The container body for an outer cylinder packaging body for a prefilled syringe according to claim 9, wherein the effective area of the breathable sealing member is larger than the area of the opening.

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