Container with filter and method for manufacturing a container with filter

The container with a welded fixing member and optional surface protection simplifies the filter attachment, ensuring sterility and high gas permeability, addressing the complexity and cost issues of existing freeze-drying containers with sterile filters.

JP2026099077APending Publication Date: 2026-06-18ABLE CO LTD

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
ABLE CO LTD
Filing Date
2024-12-06
Publication Date
2026-06-18

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  • Figure 2026099077000001_ABST
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Abstract

To provide a filter-equipped container that allows for a simplified filter mounting structure. [Solution] A container with a filter, comprising a storage section, a filter 13 provided on a lid member 12 attached to an opening in the storage section, and a welding fixing member 14 for attaching the filter 13, which is positioned to sandwich the filter 13 between itself and the lid member 12 and is welded to the lid member 12.
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Description

Technical Field

[0001] The present invention relates to a container with a filter and a method for manufacturing the same.

Background Art

[0002] Containers are used in various applications, and among such diverse applications, there is a container used for freeze-drying. Patent Document 1 describes a technique related to a container for freeze-drying. In the freeze-drying container of Patent Document 1, in the freeze-drying process, by setting the rubber stopper in a semi-stoppered state, vaporized solvents such as water vapor generated in freeze-drying are discharged outside the container (vial), and the rubber stopper is fully stoppered after the freeze-drying process. In the freeze-drying container of Patent Document 1, when the rubber stopper is in a semi-stoppered state, there are problems that the inside and outside of the container cannot be aseptically separated, and operations for setting the rubber stopper in a semi-stoppered state or a fully stoppered state are required. In response to such problems, Patent Document 2 describes a freeze-drying container provided with a sterile filter.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0004] Patent Document 2 shows a freeze-drying container in which a sterile filter is provided in the stopper of the freeze-drying container. The freeze-drying stopper of Patent Document 2 has a multi-layer structure with a stopper composed of a plurality of members that fit together to incorporate a sterile filter inside the stopper. A freeze-drying container equipped with a sterile filter, such as that described in Patent Document 2, can resolve the problems of the freeze-drying container described in Patent Document 1 (the problem stemming from the requirement to partially seal the stopper). On the other hand, Patent Document 2 has the problem that the structure of the stopper for accommodating the sterile filter is relatively complex. Furthermore, in order to achieve sterile performance with this structure, high dimensional precision is required for each component, which leads to high costs. In addition, the freeze-drying stopper of Patent Document 2 has the problem that the opening for the filter is small, making it difficult to increase the amount of gas permeable through the filter.

[0005] In view of the above, the present invention aims to provide a filter-equipped container and a method for manufacturing the same, which can simplify the filter mounting structure in a filter-equipped container. [Means for solving the problem]

[0006] (Composition 1) A container with a filter, comprising: a storage section; a filter provided in an opening in the storage section or in a lid member attached to the opening; and a welded fixing member positioned to sandwich the filter between the storage section or the lid member and welded to the storage section or the lid member.

[0007] (Configuration 2) The container with a filter according to configuration 1, wherein the welded fixing member is configured to cover at least the entire outer edge of the filter.

[0008] (Composition 3) The container with a filter according to configuration 1 or 2, wherein the welded fixing member is a sheet-like mesh member and is configured to completely cover the filter.

[0009] (Composition 4) A filter-equipped container according to any one of configurations 1 to 3, comprising a surface protection member which is a second mesh member provided so as to sandwich the filter between the welded fixing member.

[0010] (Composition 5) A filter-equipped container according to any one of configurations 1 to 4, wherein both the storage portion or the lid member and the welded fixing member are formed of a polyolefin resin.

[0011] (Composition 6) A filter-equipped container according to any one of configurations 1 to 5, wherein the difference between the melting temperature of the storage section or the lid member and the melting temperature of the welded fixing member is 30°C or less.

[0012] (Composition 7) A container with a filter according to any one of claims 1 to 6, wherein the difference between the melting temperature of the storage section or the lid member and the melting temperature of the filter is 30°C or more.

[0013] (Composition 8) The container with a filter according to any one of configurations 1 to 7, wherein the container with a filter is a container for freeze-drying.

[0014] (Composition 9) A method for manufacturing a filter-equipped container having a storage section and a filter provided on an opening in the storage section or on a lid member attached to the opening, wherein a weldable fixing member made of a material that can be welded to the storage section or the lid member is used, and the filter is provided on the opening or the lid member by welding the storage section or the lid member and the weldable fixing member in such an arrangement that the filter is sandwiched between the storage section or the lid member and the weldable fixing member. [Effects of the Invention]

[0015] According to the present invention, it is possible to provide a container with a filter and a method for manufacturing the same, which can simplify the attachment structure of the filter in the container with a filter.

Brief Description of the Drawings

[0016] [Figure 1] Schematic diagram showing a container with a filter according to an embodiment of the present invention [Figure 2] Schematic cross-sectional view showing a container with a filter according to an embodiment [Figure 3] Schematic diagram for explaining the attachment structure of the filter of the container with a filter according to an embodiment

Mode for Carrying Out the Invention

[0017] Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings. The following embodiments are one form when embodying the present invention and do not limit the present invention within its scope.

[0018] FIG. 1 is a schematic diagram showing a container 1 with a filter according to an embodiment of the present invention, and is a view in a state where the lid (lid member 12) is removed. FIG. 2 is a cross-sectional view, FIG. 2(a): cross-sectional view in a state where the lid is attached, FIG. 2(b): cross-sectional view in a state where the lid is removed (and before the filter is attached to the lid). Further, FIG. 3 is a conceptual diagram for explaining the attachment structure of the filter 13 to the lid member 12, FIG. 3(a): exploded perspective view (conceptual diagram), FIG. 3(b): cross-sectional view (conceptual diagram). The container 1 with a filter according to the present embodiment is a container for freeze-drying (more specifically, a container for freeze-drying the contained drug to generate a freeze-dried drug and holding the same), a housing portion 11 having an opening 111, a lid member 12 attached to the opening 111 and having an opening 121, The filter 13 provided in the lid member 12 (opening 121) allows vapors (moisture and solvent) generated by sublimation during freeze-drying to pass through, while also providing a sterile (or sterilizing) separation between the inside and outside of the container. A welded fixing member 14 is a component for attaching the filter 13, A surface protection member 15 for protecting the filter 13, It is equipped with.

[0019] The storage section 11 and the lid member 12 are made of thermoplastic resin, and the filter-equipped container 1 is a so-called plastic container (a container with a cap). The filter-equipped container 1 of this embodiment is a container for holding pharmaceuticals, and polyolefin resins such as PP (polypropylene) and PE (polyethylene), which are non-toxic and have excellent chemical resistance, are used as thermoplastic resins to form the storage section 11 and the lid member 12. The storage section 11 is formed as a storage section (cup-shaped member) with an opening 111 at the top. The cylindrical side portion, on the upper outer surface, has screw threads 114 formed on it and is molded from polyolefin resin. A polycarbonate (PC) film member 112 is joined (heat-welded in this embodiment) to the bottom portion. By using a thin film member for the bottom portion, heat is transferred quickly during freeze-drying, shortening the drying time. The lid member 12 is constructed by integrally molding a cylindrical side portion having a screw groove 124 on its inner surface and a top portion having an opening 121 and a ring-shaped rib 122 protruding inward, both made of polyolefin resin. The opening 121 formed in the lid member 12 is for allowing vapors (moisture and solvents) generated by sublimation during freeze-drying to pass through (discharge), and by providing a filter 13 in the opening 121, vapors (moisture and solvents) are allowed to pass through, while the inside and outside of the container are separated aseptically (or sterilely). In other words, in the container 1 with a filter, the sterile (sterile) state inside is maintained even when placed in a general environment. At the upper end of the housing section 11, a tapered section 113 is formed such that the diameter (inner diameter) of the opening 111 decreases from top to bottom. Furthermore, at the lower end of the ring-shaped rib 122 of the lid member 12, a tapered section 123 is formed such that its outer diameter decreases from top to bottom, and it engages with the tapered section 113 of the opening 111. When the lid member 12 is closed, as shown in Figure 2(a), the threads 114 and screw grooves 124 engage, causing the tapered section 113 and the tapered section 123 to press against each other, resulting in an airtight seal between them. In this document, a container with a screw-on cap is used as an example of a filter-equipped container. However, the present invention is not limited to this, and any container of any shape and structure made of thermoplastic resin (a weldable material) can be used when applying the concept of filter attachment described below.

[0020] As described above, filter 13 is a sterile filter (or sterilization filter) that allows vapor (moisture or solvent) to pass from the inside of the container to the outside while simultaneously separating the inside and outside of the container sterilely (or sterilizingly). It is a membrane filter formed from a fluororesin such as PTFE (polytetrafluoroethylene) or glass fiber, from the viewpoint of maintaining a relatively high cross-sectional airflow rate (airflow rate) even with a mesh size that does not allow microorganisms to pass through (for example, a mesh size of 0.1 μm to 0.2 μm). PTFE (polytetrafluoroethylene) and glass resin are practically difficult to heat-weld to PP (polypropylene) or PE (polyethylene). Therefore, filter 13 can be said to be a filter that is practically "formed from a material that cannot be welded to the lid member." The filter 13 in this embodiment is a membrane filter that is substantially circular in plan view, but the present invention is not limited to this, and may have any shape as long as it has the size and shape to cover the opening portion (opening 121 in this embodiment) in which the filter is provided.

[0021] The weldable fixing member 14 is positioned to sandwich the filter 13 between itself and the mounting target (in this embodiment, the lid member 12), and is welded to the mounting target (in this embodiment, the lid member 12). Therefore, the weldable fixing member 14 is made of a material that can be welded to the mounting target, and in this embodiment, it is made of the same material as the lid member 12 (a polyolefin resin such as PP (polypropylene) or PE (polyethylene)). The weldable fixing member 14 in this embodiment is a sheet-like mesh member, and is formed larger than the filter 13 so as to completely cover the filter 13 and to have an overlap 141 for welding to the lid member 12 (an overlap that allows the filter 13 to be closed all around). The weldable fixing member 14 in this embodiment has a diameter that is approximately the same as (or slightly larger than) that of the lid member 12. The mesh size of the welded fixing member 14 is equal to or greater than the mesh size of the filter 13, and it is more preferable that the mesh size be such that the mesh openings collapse as the welding process occurs (creating a circumferentially closed system around the filter 13). For example, the mesh size of the welded fixing member is formed in the range of 10 μm to 1.0 mm. By having a mesh size of the welded fixing member 14 equal to or greater than the mesh size of the filter 13, the function of allowing vapor (moisture and solvent) to pass from the inside of the container to the outside is ensured, and by having a mesh size such that the mesh openings collapse when melted at the welded portion (not an excessively large mesh size), it is possible to seal the outer circumference of the filter 13 to the object it is attached to (creating a closed system). Therefore, it is more preferable because it allows the filter 13 to be attached while maintaining the function of allowing vapor (moisture and solvent) to pass through during freeze-drying, and while maintaining the function of a sterile (or sterilized) filter. The welded fixing member 14 in this embodiment has a substantially circular shape in plan view, corresponding to the shapes of the filter 13 and the lid member 12. However, the present invention is not limited to this, and any shape is acceptable as long as it has the size and shape to cover the entire outer circumference of the filter, depending on its shape.

[0022] The surface protection member 15 is provided on the side of the filter 13 opposite to the side with the welded fixing member 14, so that the filter 13 is sandwiched between the welded fixing member 14 and the surface protection member 15. In this embodiment, the surface protection member 15 is provided on the back side of the filter 13. The surface protection member 15 protects the surface (back side) of the filter 13 and prevents clogging of the filter 13 (for example, clogging due to oils and grease from human contact, which reduces the cross-sectional airflow rate). It may also function as a reinforcing material for the filter 13. The surface protection member 15 is a sheet-like mesh member, and its mesh size is formed in the range of, for example, 10 μm to 1.0 mm. By having a mesh size equal to or greater than the mesh size of the filter 13, it ensures the function of allowing vapor (moisture and solvent) to pass from inside the container to the outside. The surface protection member 15 is a "second mesh member provided so as to sandwich the filter between the welded fixing member." The surface protection member 15 is formed to be of a size and shape that can cover at least the portion of the filter 13 that is exposed from the mounting object (the lid member 12 in this embodiment) (i.e., the opening 121 in this embodiment). In this embodiment, the surface protection member 15 is formed from the same material as the welded fixing member 14 (however, the present invention is not limited thereto, and the surface protection member may be formed from a different material than the welded fixing member). In this embodiment, as shown in Figure 3, the surface protection member 15 is formed to be substantially the same size and shape as the welded fixing member 14, and during welding, it is welded together with the welded fixing member 14 to the object to be attached (lid member 12). Furthermore, the surface protection member in the present invention is not limited to one that can be welded to the object to be attached, but may also be made of a material that cannot be welded to the object to be attached (similar to a filter, in which the surface protection member is attached by a welding fixing member).

[0023] The manufacturing method of the filter-equipped container 1 of this embodiment having the above configuration is as follows: The steps include preparing a housing 11 having an opening 111 and a lid member 12 having an opening 121, The steps include preparing a filter 13, a lid member 12, a weldable fixing member 14 made of a weldable material, and a surface protection member 15, respectively. The method includes the step of providing the filter 13 (and surface protection member 15) to the lid member 12 by welding the lid member 12 and the welding fixing member 14 together (in this embodiment, the surface protection member 15 is also welded) with the filter 13, welding fixing member 14 and surface protection member 15 in the positional relationship shown in Figure 3 (the filter 13 is sandwiched between the lid member 12 using the welding fixing member 14). Furthermore, the area to which heat is applied during the welding process is limited to the area where the weldable fixing member 14 is welded to the lid member 12 (the donut-shaped area of ​​the overlap 141). More specifically, the donut-shaped area to be welded has an inner diameter equal to or greater than the opening 121, preferably less than or equal to the outer diameter of the filter 13, and the outer diameter of the donut shape is at least greater than the outer diameter of the filter 13 and less than or equal to the outer diameter of the weldable fixing member 14. Any welding method that can weld the necessary parts of the weldable fixing member 14 to the lid member 12 can be used, such as high-frequency welding, ultrasonic welding, or laser welding.

[0024] According to the filter-equipped container 1 of this embodiment, even when the material that is desirable or optimized for the container and the material that is desirable or optimized for the filter are materials that cannot be practically welded together, the filter-equipped container can be manufactured simply and at low cost. Furthermore, since the filter can be attached to the object to be attached (in this embodiment, the lid member) as a closed system, a container with high sterility (or bactericidal performance) can be made.

[0025] In this embodiment, a container for generating and holding freeze-dried chemicals is given as an example of a container with a filter, but the use of the container with a filter according to the present invention is not limited to this. For example, as a container for freeze-drying, it may be used for cosmetics, food products, etc., in addition to pharmaceuticals. Furthermore, the present invention is not limited to freeze-drying, and can be applied to any container equipped with a filter, such as a culture vessel. Although a hard-type container is used as an example in the embodiment, the present invention is not limited to this, and can also be applied to flexible containers (bags), etc.

[0026] In this embodiment, an example is given in which the filter is provided on the lid of the container (the weldable fixing member is welded to the lid), but the present invention is not limited to this, and for example, in a container without a lid such as a culture bag, the filter may be provided directly on the container itself (the storage section having an opening) or via another member (the storage section is the target of the weldable fixing member). By applying the concept of the present invention, a filter made of a material that cannot be practically welded to a container can be attached by the weldable fixing member. Of course, the concept of the present invention can also be applied to filters made of materials that can be welded to a container (attached by the weldable fixing member).

[0027] In this embodiment, the filter is attached to the container (lid member) from the outside, and therefore the welded fixing member is positioned on the outside of the filter as an example. However, the present invention is not limited to this, and for example, the filter may be attached to the container from the inside (for example, attached from the inner surface side of the lid member (the lower side in Figure 3(b))). In this case, the welded fixing member will be positioned on the inside of the container relative to the filter (and if a surface protection member is used, the surface protection member will be positioned on the outside of the container relative to the filter).

[0028] In this embodiment, the welded fixing member 14 is formed to completely cover the filter 13 as an example, but the present invention is not limited to this. The welded fixing member only needs to be configured to completely cover at least the outer edge of the filter (configured to create a completely closed system around the filter), and may, for example, have a donut shape. In the case of such a donut shape, the welded fixing member does not have to be a mesh member (because there is a donut-shaped hole, the material of the welded fixing member itself does not need to have the function of permeating vapor (moisture or solvent)). However, providing the welded fixing member completely as in this embodiment is preferable because it can increase the holding force of the filter 13, and the welded fixing member 14 also functions as a protective member that protects the filter 13.

[0029] In this embodiment, the weldable fixing member 14 is made of the same material as the object to be attached (in this embodiment, the lid member 12), but the present invention is not limited to this. The weldable fixing member can be made of any material that can be welded to the object to be attached. For example, the materials may be made of similar materials with similar melting temperatures (and therefore practically weldable to each other), such that the difference in melting temperature between the weldable fixing member and the object to be attached is 30°C or less. Even in cases where the difference in melting temperature between the object to be attached (the housing or lid member) and the filter is greater than 30°C, making it practically difficult to weld them to each other, the filter can still be attached to the object to be attached by welding by using a weldable fixing member with a melting temperature difference of 30°C or less with the object to be attached. Furthermore, it is more preferable that the welded fixing member and the object to which it is attached (such as the housing or the lid member) be made of the same material.

[0030] In this embodiment, a configuration with a surface protection member 15 is used as an example. As described above, this configuration is preferable because it can protect the filter 13. However, in the present invention (a concept of attaching a filter that cannot be welded to the mounting object using a welding fixing member), the surface protection member is not an essential component, and therefore, the configuration may be made without it. [Explanation of symbols]

[0031] 1... Container with filter 11...Detention Unit 111...Opening 12...Lid component 121...Aperture 13...filter 14...Welded fixing member 15...Surface protection material

Claims

1. The containment section, A filter provided in the opening in the aforementioned housing or in a lid member attached to the opening, The filter is positioned between the housing portion or the lid member and a welded fixing member is welded to the housing portion or the lid member, A container equipped with a filter.

2. The container with a filter according to claim 1, wherein the welded fixing member is configured to cover at least the entire outer edge of the filter.

3. The container with a filter according to claim 2, wherein the welded fixing member is a sheet-like mesh member and is configured to completely cover the filter.

4. A container with a filter according to claim 3, comprising a surface protection member which is a second mesh member provided so as to sandwich the filter between the welded fixing member.

5. A container with a filter according to any one of claims 1 to 4, wherein both the housing portion or the lid member and the welded fixing member are formed of a polyolefin resin.

6. A filter-equipped container according to any one of claims 1 to 4, wherein the difference between the melting temperature of the storage section or the lid member and the melting temperature of the welded fixing member is 30°C or less.

7. A container with a filter according to any one of claims 1 to 4, wherein the difference between the melting temperature of the storage section or the lid member and the melting temperature of the filter is 30°C or more.

8. The container with a filter according to any one of claims 1 to 4, wherein the container with a filter is a container for freeze-drying.

9. A method for manufacturing a filter-equipped container having a storage section and a filter provided on an opening in the storage section or on a lid member attached to the opening, A method for manufacturing a container with a filter, comprising using a weldable fixing member formed of a material that can be welded to the housing portion or the lid member, and positioning the filter between the housing portion or the lid member and the weldable fixing member, thereby welding the housing portion or the lid member and the weldable fixing member to provide the filter in the opening or the lid member.