阅读说明：本技术 带开口的包袋和带盖的包袋 (Bag with opening and bag with cover ) 是由 美尾笃 铃木豊明 野村纯平 鸟屋部果穂 于 2018-12-05 设计创作，主要内容包括：该带开口的包袋(1)具有：通过片材形成为袋状而成的包袋主体(3)；和安装于包袋主体(3)的筒状的开口部件(2),在开口部件(2)能够安装内塞(50)和盖(4)。开口部件(2)具有：在安装有盖(4)的情况下被盖(4)覆盖的被覆部(25)；和朝向开口部件(2)的外侧突出的环状的边缘部(26)。边缘部(26)具有朝向包袋主体(3)侧的环状的卡合面(26A),在沿着被覆部(25)的轴线方向的截面中,卡合面(26A)相对于被覆部(25)的外周面呈45°～135°。(The bag (1) with an opening comprises: a bag body (3) formed by a sheet material into a bag shape; and a cylindrical opening member (2) attached to the bag body (3), wherein the inner plug (50) and the lid (4) can be attached to the opening member (2). The opening member (2) has: a covering part (25) covered by the cover (4) when the cover (4) is mounted; and an annular edge portion (26) protruding outward of the opening member (2). The edge portion (26) has an annular engaging surface (26A) facing the bag main body (3), and the engaging surface (26A) is formed at an angle of 45 DEG to 135 DEG with respect to the outer peripheral surface of the cover portion (25) in a cross section along the axial direction of the cover portion (25).)

1. A bag with an opening, comprising: a bag body formed in a bag shape by a sheet and having a housing section inside; and a cylindrical opening member attached to the bag body, one end of the opening member being communicated with the storage section, and an opening portion of the other end being exposed to the outside of the bag, the opening member being capable of attaching an inner plug and a cap for pressing the inner plug,

the opening member has: a covering portion that is covered by the cover when the cover is attached to the opening member; and an annular edge portion formed around the opening portion and protruding outward of the opening member,

the edge portion has an annular engaging surface facing the bag main body,

in a cross section along the axial direction of the cover, the engagement surface is 45 ° to 135 ° with respect to the outer peripheral surface of the cover.

2. The bag with an opening according to claim 1,

the opening member is made of a material having a flexural modulus of elasticity of 140MPa or more.

3. A lidded bag, comprising:

the bag with an opening of claim 1 or 2;

an inner plug attachable to the opening member; and

the cap of the inner plug is pressed,

the cover has: a top plate portion; a cylindrical skirt portion that stands from the periphery of the top plate portion and can cover the covering portion; and a plurality of engaging pieces provided at a lower end portion of an inner surface of the skirt portion,

the engaging piece has a tip end portion protruding toward the top plate portion and elastically accessible to an inner peripheral surface of the skirt portion,

when the cover is attached to the opening member, the distal end portion of the engagement piece can abut against and be engaged with the engagement surface of the edge portion.

4. The lidded bag of claim 3 wherein,

an opening is formed in the top plate of the lid, a seal member that closes the opening is detachably fixed to the top plate, and the opening can be exposed by detaching the seal member.

5. The lidded bag of claim 3 or 4 wherein,

the storage part of the bag main body is aseptically filled with a content containing at least one substance selected from the group consisting of a plasma component preparation, an enzyme, a thrombofibrinolytic factor, a hormone, a vaccine, an interferon, an erythropoietin, a cytokine, an antibody, and a fusion protein, and the lid is attached to the opening member to seal the content.

6. The lidded bag of claim 3 or 4 wherein,

the storage portion of the bag main body is aseptically filled with a content containing at least one of an albumin preparation and a globulin preparation, and the lid is attached to the opening member to seal the content.

Technical Field

The present invention relates to a bag with an opening, which is provided with an opening as an inlet/outlet port for contents, in a bag body, and a bag with a lid, which is further provided with an inner plug for closing the opening of the opening and a lid for engaging with the opening and pressing the inner plug, and is particularly suitable for aseptic filling of biological medicines and the like.

The present application claims priority based on japanese patent application No. 2017-235604, filed in japan on 12/7/2017, and the contents of the japanese application are incorporated herein by reference.

Background

As a container for containing a drug solution such as an injection, a synthetic resin infusion bag is widely used. The infusion bag has a bag body (bag portion) for containing a liquid such as a drug solution, and an opening for filling the bag body with the liquid or discharging the liquid from the bag body, the opening being formed by joining a cylindrical synthetic resin opening member in a state of penetrating a part of the bag body.

When filling a bag with an opening with a liquid, a nozzle of a liquid supply source is inserted into the opening, and a chemical liquid is injected into the bag body through the nozzle by a machine or an operator. Generally, when filling is completed, an opening portion of the opening is closed with a rubber inner plug, and then a cap covering the inner plug is attached to the opening, and a boundary between the opening and the cap is fused.

In the case of fusing a lid, conventionally, it is common to employ a method in which an opening end of an opening and a top plate portion of the lid are heated by radiant heat from an electric heater and then are pressure-bonded to each other and cooled, or a method in which after the opening is covered with the lid, an ultrasonic die horn (horn) is pressed against the top plate portion of the lid and the ultrasonic die horn is ultrasonically oscillated, whereby a "rib" formed in the lid is melted and integrated with the opening. Such fusion is necessary for preventing the cap from coming off, ensuring the sealing property of the bag, and preventing contamination of the medicine and/or invasion of bacteria during heat sterilization, transportation, storage, and the like of the infusion bag.

After the cap is fused, the infusion bag is heated with pressurized steam or hot water to sterilize the drug solution filled in the infusion bag. This is defined as a standard method for producing sterile pharmaceuticals by terminal sterilization.

However, in recent years, a "biological medicine" has become widespread as a new medicine. Biological drugs are often derived from, for example, proteins or substances produced by organisms such as mammalian cells, viruses, and bacteria. Unlike "low-molecular-weight drugs" produced by conventional chemical synthesis, such biological drugs have a complicated molecular structure, and the structure thereof is changed by various influences such as heating in the production process, thereby reducing safety and/or effectiveness.

Therefore, in the sterilization of biological medicines, a terminal sterilization method by heating cannot be adopted in many cases, and in this case, a "sterile handling method" is used which completes a series of steps from the production of a raw medicine to the preparation of a pharmaceutical product, filling, and sealing in an environment in which aseptic management is performed. Typical examples of the pharmaceutical products produced by the aseptic technique include a component preparation for blood transfusion produced by centrifuging blood, and a plasma component preparation obtained by purifying a protein useful for therapy from among plasma components.

The filling of the medicine containers by the aseptic technique is carried out in a clean room, an isolation System (RABS) for restricting Access, an isolator, or the like, which is isolated from the operator. In recent years, filling work in an isolator that can be physically and completely isolated from the environment and direct intervention of workers has become the mainstream.

In the case of using the insulator, it is necessary to prevent contamination from the outside environment by supplying air filtered through a HEPA filter or a U L PA filter after removing contamination inside the insulator, and the above-described removal is performed by spraying a disinfectant and/or a cleaning agent containing a high concentration of hydrogen peroxide, peracetic acid, or formaldehyde, etc. into the insulator.

The above-described operation is an important step for ensuring the quality of the pharmaceutical products produced by the aseptic technique, and the implementation and/or management thereof are defined by guidelines such as non-patent document 1 and non-patent document 2.

However, in the aseptic area, it is difficult to perform the above-described fusion operation of the bag with an opening. This is because the structure and/or material of the apparatus for fusion work become an obstacle to the decontamination operation. In addition, there is a possibility that a disinfectant or a cleaning agent used for decontamination may remain in the equipment used for the fusing work. Therefore, a sealing method instead of fusion is sought.

On the other hand, a Vial (visual) is widely used as a medicine container to which an aseptic technique can be applied and which does not require fusing. As the medicine bottles, 2 kinds of glass medicine bottles and synthetic resin medicine bottles were used. Glass vials have a very high gas barrier property as compared with synthetic resin vials, and are used as drug containers requiring a high gas barrier property.

When a medicine bottle is filled with a medicine, an opening of the medicine bottle is sealed with a rubber stopper or the like. As in the case of the bag with an opening, it is not sufficient to seal only the fitting of the rubber stopper into the opening of the medicine bottle, and therefore, it is common to attach an aluminum cap covering the rubber stopper and crimp and fasten the lower end of the cap to the edge of the opening by a crimping machine (patent document 1).

The aluminum cap is easily deformed and is excellent in preventing falling. However, the aluminum cap has problems in that: during manufacture, use, and the like, aluminum particles are easily generated and scattered due to collision of the caps with each other and/or operation of the crimping machine, and it is difficult to separate and discard the caps after use of the medicine bottle. Therefore, in recent years, the use of aluminum caps in medical fields is becoming more and more worried.

In particular, in the work environment of the aseptic technique, it is necessary to perform work in an isolated space in order to prevent contamination from the outside, and therefore care must be taken to reduce the cleanliness in the management area. In non-patent document 1, there is also a problem that "since a crimping machine of an aluminum lid is a device generating a large amount of dust, it is necessary to install it in a separate place having an appropriate exhaust system", the device becomes complicated, and workability is deteriorated.

Further, since the glass vial container is independent of itself, it is excellent in handling property during storage and/or preparation, but it is poor in flexibility. Therefore, if the drip solution is used directly for drip infusion, the amount of the liquid to be infused in the container decreases as the drip infusion proceeds, the pressure inside the container decreases, and the drip speed decreases. Thus, if the dropping speed decreases as the dropping proceeds, the time required for dropping becomes longer. Furthermore, since it is difficult to predict the end time of the infusion, it is necessary to check the status of the infusion as needed when a plurality of times of infusion are performed, which makes the infusion treatment cumbersome.

Therefore, in the case of directly administering a drug from a vial container, a vent needle for introducing air into the container from the outside is inserted into the container in order to keep the drip speed constant. However, even if the vent needle is used, it is difficult to keep the drip speed constant, and there is a possibility that the infusion solution is contaminated by using the vent needle.

In order to replace the glass vial container, for example, patent document 2 also studies the use of an infusion bag using a flexible film. Such an infusion bag has an advantage that it is difficult to reduce the infusion speed without using a vent needle because it has excellent flexibility and the bag shrinks with the decrease of the infusion, and an infusion pump for keeping the administration speed constant is not necessary.

Patent document 3 discloses a method of filling an albumin preparation into an infusion bag. In this method, the drawn-out roll film is sterilized by a sterilizing section, and the infusion bag is completed by a drying section, an assembling section of a sealing and opening member, a filling section, and an end sealing and cutting section. However, this method has the following problems: most of complicated FFS (Form-Fill-Seal) devices need to be sterilized, and it is difficult to completely remove the disinfectant and/or detergent, which is not desirable in terms of management.

Disclosure of Invention

Technical problem

As described above, the conventional infusion bag is effective as a container for a pharmaceutical product which cannot be heat-sterilized, but the manufacturing is limited by many limitations, and the spread of a bag preparation manufactured by an aseptic technique is limited.

The present invention has been made in view of the above circumstances, and an object thereof is to provide an open-ended pouch and a lidded pouch that can be sealed without using a complicated sealing device and/or method even in, for example, an aseptic environment and that can achieve an aseptic state more easily.

Technical scheme

The bag with an opening of the invention comprises: a bag body formed in a bag shape by a sheet and having a housing section inside; and a tubular opening member attached to the bag body, one end of the opening member communicating with the storage section, and an opening portion at the other end of the opening member being exposed to the outside of the bag, the opening member being capable of attaching an inner plug and a cap for pressing the inner plug, the opening member including: a covering portion that is covered by the cover when the cover is attached to the opening member; and an annular edge portion formed around the opening portion and protruding outward of the opening member, the edge portion having an annular engaging surface facing the bag main body, the engaging surface having an inclination angle of 45 ° to 135 ° with respect to an outer peripheral surface of the cover portion in a cross section along an axial direction of the cover portion. The inclination angle is more preferably 60 ° to 120 °, and still more preferably 90 ° to 105 °.

The opening member may be formed of a material having a flexural modulus of elasticity of 140MPa or more. The bag with the opening can be sterilized.

The bag body may have a rectangular shape, and the length in the major axis direction may be 80 to 400mm, the width in the minor axis direction may be 60 to 350mm, and the filling amount of the contents may be 20 to 1000m L.

In order to protect the active ingredient, a hydrophilic group or a lipophilic group may be provided on the surface of the sheet on the inner surface side of the pouch.

The sheet may have a tensile modulus of elasticity of 1500MPa or less, or 50 to 550 MPa.

The thickness of the sheet can be 100-400 μm, or 150-300 μm, or 180-270 μm.

The product (M × T) of the tensile modulus of elasticity M (MPa) of the sheet and the thickness T (μ M) of the sheet may be 20,000 to 300,000, may be 30,000 to 250,000, and may be 35,000 to 200,000, and the tensile modulus of elasticity M may be measured by the measurement method specified in ISO 527-1.

The bag with opening has sterility assurance level (SA L) of 10 by high temperature sterilization, ultraviolet sterilization or gamma ray sterilization^-6The following.

The size of the opening member may be 10 to 20mm in outer diameter, 0.5 to 5mm in wall thickness, and 30 to 50mm in length, excluding the projection.

The height of the flange portion from the surface of the opening member may be about 30 to 150% of the height of the outer peripheral surface of the cover when the cover is attached.

The height of the edge portion protruding from the covering portion may be 0.5 to 5mm, or 1 to 3 mm. The width of the front end of the edge part may be 1 to 10mm, or 3 to 6 mm.

The opening member may be 200MPa or more, or 400 to 2000 MPa. The opening member may be formed of polyethylene, polypropylene, or cyclic polyolefin.

The maximum downward pressure of the cover until the engaging piece is elastically deformed to move over the edge portion by pressing the cover downward while covering the opening member may be 10 to 200N. The distance from the tip of the free tip of the engaging piece to the central axis of the cover may be 95 to 105% of the distance from the outer peripheral surface of the covering portion to the central axis of the opening member.

A bag with a lid according to the present invention includes the bag with an opening, an inner plug attachable to the opening member, and a lid for pressing the inner plug, and the lid includes: a top plate portion; a cylindrical skirt portion that stands from the periphery of the top plate portion and can cover the covering portion; and a plurality of engaging pieces provided at a lower end portion of an inner surface of the skirt, the engaging pieces having distal end portions that protrude toward the top plate portion and are capable of elastically approaching an inner peripheral surface of the skirt, the distal end portions of the engaging pieces being capable of abutting against and engaging with the engaging surfaces of the edge portion when the lid is attached to the opening member.

An opening may be formed in the top plate of the lid, a seal member that closes the opening may be detachably fixed to the top plate, and the opening may be exposed by detaching the seal member.

In the pouch according to another aspect of the present invention, the storage portion of the pouch body is aseptically filled with a content containing at least one substance selected from the group consisting of a plasma component preparation such as an albumin preparation or a globulin preparation, an enzyme, a thrombofibrinolytic factor, a hormone, a vaccine, an interferon, an erythropoietin, a cytokine, an antibody, and a fusion protein, and the cap is attached to the opening member to seal the content.

Technical effects

According to the bag with an opening and the bag with a lid of the present invention, the inner plug and the lid that presses the inner plug are pressed so as to cover the opening of the opening, and thereby the plurality of engaging pieces provided at the lower end portion of the inner surface of the skirt portion are elastically deformed to pass over the edge portion, and the tip end portions of the engaging pieces are brought into contact with and engaged with the engaging surfaces of the edge portion. Therefore, since a special device for attaching the cover is not required and the cover is easily attached, the cover can be used without hindering the aseptic work in, for example, an aseptic work area, and the cover is reliably fixed to the edge portion by the elasticity of the engaging piece after the attachment, and therefore, the reliability is high in the point of maintaining the aseptic state. Further, there is an effect that the discharge speed of the content can be made constant even without using the vent needle at the time of use.

Drawings

Fig. 1 is a front view of a lidded bag of a first embodiment of the present invention.

Fig. 2 is a front view of the bag with an opening of the first embodiment.

Fig. 3 is a front view of the opening member used in the first embodiment.

Fig. 4 is an enlarged sectional view of an edge portion of the opening member.

Fig. 5 is a front view of the cover of the first embodiment.

Fig. 6 is a plan view of the cover of the first embodiment.

Fig. 7 is a partially cut-away front view showing a state where a cover is attached to an opening member according to the first embodiment.

Fig. 8 is an enlarged sectional view showing a state in which the engagement piece is engaged with the edge portion in the first embodiment.

Fig. 9 is an enlarged sectional view showing a state where the engagement piece is engaged with the edge portion according to another embodiment of the present invention.

Description of the symbols

1 … bag with opening, 2 … opening component, 3 … bag body, 4 … cover, 10 … sealing part, 12 … containing part, 14 … opening part, 16 … hole, 18 … non-sealing part, 20 … non-sealing part, 22 … holding part, 24 … flange part, 25 … covering part, 26 … edge part, 26a … clamping surface, 26B … front end face, 28 … cover body, 30 … sealing part, 32 … clamping piece, 32a … front end part, 32B … base part, 33 … skirt part, 34 … top plate part, 36 … peripheral wall part, 38 … skirt part, 40 … top plate part, 42 … connecting part, 44 … opening part, 46 … recess, 48 … opening part, 50 … inner plug, 50a disc … part, 50B … recess, 52 … recess

Detailed Description

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. Fig. 1 is a plan view showing a lidded bag according to an embodiment of the present invention, which includes an open-ended bag 1, an inner plug 50 (see fig. 7), and a lid 4. Fig. 2 is a top view showing only the bag 1 with an opening after the cover 4 and the inner plug 50 have been removed. In the following description, for easy understanding, the opening is described in a state of facing upward, but the opening-equipped bag and the lid-equipped bag of the present invention may be used in any posture without being fixed in the facing direction.

The bag with an opening 1 includes a rectangular bag body 3 and a cylindrical opening member 2, the bag body 3 has a housing portion 12 capable of housing a content therein, and the opening member 2 is fixed through an opening portion 14 formed in a central portion of one end of the bag body 3. The bag body 3 is a portion formed by bonding or heat-sealing outer peripheral portions of two resin rectangular sheets to each other, forming a seal portion 10 around the entire periphery except for an opening 14, and forming a storage portion 12 inside the seal portion. A circular hole 16 is formed in the sealing portion 10 at the end of the bag body 3 opposite to the opening 14. Non-sealing portions 18 are formed on both sides of the hole 16, and non-sealing portions 20 are formed on both sides of the opening 14, respectively, so that the sealing width of each portion is substantially constant by the non-sealing portions 18, 20.

The bag body 3 is not limited to the illustrated shape, and may have any shape as long as it is a bag shape. For example, one sheet may be folded in half, and the other part may be joined with the fold line at the center as the bottom of the bag body 3, or the sheet may be rolled into a cylinder and both ends may be joined to the joint surfaces. The sheet material may be formed into a three-dimensional box shape. Even if formed in a box-like or cylindrical shape, the bag body 3 can maintain flexibility.

The size of the bag body 3 is not limited in the present invention, but if the length in the major diameter direction is 80 to 400mm, the width in the minor diameter direction is 60 to 350mm, and the filling amount of the content is about 20 to 1000m L, the bag body is suitable as an infusion bag for pharmaceuticals and the like.

The sheet material is not limited in the present invention, but a laminate having a sealant at least on one side can be used, and for example, a laminate film can be used in which the sealant is oriented inward, a polyolefin resin layer such as Polyethylene (PE), polypropylene (PP), ethylene-vinyl acetate copolymer (EVA), or cyclic polyolefin is used as an innermost layer, a stretched film such as a biaxially stretched nylon film, a biaxially stretched polyethylene terephthalate film, or a biaxially stretched polypropylene film is used as a base material, and an intermediate layer such as an ethylene-vinyl alcohol copolymer, a vapor-deposited layer of a metal or an inorganic compound, or a metal foil such as an aluminum foil is provided between the innermost layer and the base material as necessary. The materials and/or thicknesses of the sheets may be the same or different from each other as long as the sheets can be joined to each other by welding, adhesion, or the like. A film having a high barrier property against water vapor and/or oxygen, which is generally used, can also be used as the sheet. The sheet may have a deterioration prevention ability to prevent the content liquid from being deteriorated due to permeation or adsorption of the active ingredient of the internal solution or elution of the low-molecular-weight component contained in the resin constituting the sheet. For example, a hydrophilic group or a lipophilic group capable of protecting the medicinal component may be provided on the surface of the sheet on the inner surface side of the pouch according to the medicinal component of the stored preparation.

The bag body 3 is preferably rich in flexibility within a range that does not cause problems in terms of manufacturing and use, for example, from the viewpoint that the feeding speed of the bag body 3 is kept constant by appropriately contracting the bag body as the content decreases, and therefore, the tensile elastic modulus M (MPa) of the sheet constituting the bag body 3 is preferably 1500MPa or less, and more preferably 50 to 550MPa, although not limited, the thickness T (μ M) of the sheet is preferably 100 to 400 μ M, more preferably 150 to 300 μ M, and further preferably 180 to 270 μ M, and when the tensile elastic modulus M is too small or the thickness T of the sheet is too small, the sheet is easily stretched and hardly manufactured at the time of manufacturing, and when the tensile elastic modulus M is too large or the thickness T of the sheet is too large, the bag body 3 is not soft, and the constancy of the dropping speed becomes difficult, the product of the tensile elastic modulus M (MPa) and the thickness T (μ M) of the sheet (M × T) is preferably 20,000 to 300,000, more preferably 30,000, and more preferably 250,000 to 250,000, and more preferably, the tensile elastic modulus M is measured by a predetermined method of 527.

When the bag 1 with an opening is used as an infusion bag for pharmaceutical products, it is preferable that the inner surface of the bag 1 with an opening, that is, at least the inner surfaces of the bag main body 3 and the opening member 2 are sterilized, and it is preferable that the sterility assurance level (SA L) is 10 by a method such as high-temperature sterilization, ultraviolet sterilization, or radiation sterilization such as gamma ray sterilization as the sterilization treatment^-6The following. Likewise, the cap 4 and the inner plug 50 are also sterilized. The sterilization process should be performed on at least the inner surface of the bag, but actually, the entire bag including the lid 4 and the inner plug 50 is sterilized by the above-mentioned means in a state of being sealed in the outer bag. In use, for example, the outer bag is opened in a sterile room, the contents are poured into the bag 1 with an opening, and the inner plug 50 and the cap 4 are attached to the bag for use.

As shown in fig. 3, the opening member 2 has a cylindrical shape, and is bonded or heat-sealed to the sheets on both sides without any gap in a state where the base end portion thereof is inserted into the opening portion 14 of the bag body 3. The size of the opening member 2 is not limited in the present invention, but for example, the opening member is suitable as an infusion bag for pharmaceuticals when the outside diameter excluding the convex portion is 10 to 20mm, the wall thickness is 0.5 to 5mm, and the length is about 30 to 50 mm.

An annular edge portion 26 protruding outward of the opening member 2 is formed coaxially with the opening member 2 around the distal end opening of the opening member 2. An annular flange portion 24 is formed on the outer peripheral surface of the opening member 2 with a constant width at a constant distance from the edge portion 26, and when the cover 4 is attached to the opening member 2, the opening end of the cover 4 faces the flange portion 24 with a slight gap. The height of the flange 24 from the surface of the opening member 2 is about 30 to 150% of the height of the outer peripheral surface of the cover 4 when the cover 4 is attached. The flange portion 24 prevents the lower end of the lid 4 from being pushed upward and the lid 4 from being accidentally detached. However, the flange portion 24 may not be formed in the opening member 2.

Between the edge portion 26 and the flange portion 24, a covering portion 25 having a constant width is provided to be covered by the cover 4 when the cover 4 is attached to the opening member 2. In this embodiment, the opening member 2 is linear, but the covering portion 25 may be bent with respect to the main body of the opening member 2 as needed.

The edge portion 26 has an annular engaging surface 26A facing the bag main body 3. The engaging surface 26A has a constant width over the entire circumference, and as shown in fig. 4, in a cross section along the axial direction of the cover 25, the inclination angle θ of the engaging surface 26A with respect to the outer circumferential surface of the cover 25 is set to 45 ° to 135 °. The inclination angle θ is more preferably 60 ° to 120 °, and still more preferably 90 ° to 105 °. When the angle is 90 ° or less, the engagement surface 26A is in a suspended state. Even the overhanging shape can be manufactured by the design of the mold structure. In the case where the inclination angle θ is large, the cover 4 is easily detached from the opening member 2 when the seal member 30 (see fig. 1, 5, and 6) provided to the upper surface of the cover 4 is removed. When the inclination angle θ is excessively small, the engagement and locking performance of the cap 4 is high, but the mold structure for injection molding the opening member 2 is limited, and the productivity is lowered. The inclination angle θ is preferably in the above range in order to achieve both the prevention of the detachment of the lid 4 and the productivity of the opening member 2. The engaging surface 26A may have a circular shape in the cross section or may have a locally variable inclination angle, but the inclination angle of the region of the engaging surface 26A in contact with the engaging piece 32 preferably satisfies the above range.

As shown in fig. 9, in the region of the engagement surface 26A that abuts against the engagement piece 32, a groove 52 of a certain depth extending over the entire circumference of the engagement surface 26A may be formed so that the tip end portion 32A of the engagement piece 32 enters the groove 52. In this case, the force for engaging and stopping the engagement piece 32 is increased as compared with the case where the engagement surface 26A is simply a flat surface. The inclination angle θ of the engagement surface 26A is defined as an inclination angle of a position against which the distal end portion 32A abuts, and when the distal end portion 32A abuts at a plurality of positions, is defined as an average value of the inclination angles at the plurality of positions. In the example shown in fig. 9, the shallow groove 52 having an arc-shaped cross section is formed in the portion of the engagement surface 26A close to the covering portion 25, but the position and shape are not limited thereto, and the groove 52 having a rectangular cross section or the like may be formed in the central portion of the engagement surface 26A.

The height H of the edge portion 26 shown in FIG. 3 protruding from the covering portion 25 is not limited in the present invention, but is preferably 0.5 to 5mm, more preferably 1 to 3 mm. The width W of the edge 26 at the tip is not limited in the present invention, but is preferably 1 to 10mm, and more preferably 3 to 6 mm. In this case, there is an advantage that a reduction in shape accuracy due to shrinkage (ヒケ) at the time of molding can be suppressed by the groove, while the strength of the edge portion 26 is reduced by the formed groove.

The edge portion 26 may have one or more notches (not shown) formed at intervals in the circumferential direction, for example, and in this case, the condition of "annular" is satisfied. The width of the notch in the peripheral edge direction needs to be smaller than the width of the front end portion 32A of the engagement piece 32 in the lid peripheral direction. The edge portion 26 may not be a complete ring, and as long as a width necessary for the engagement surface 26A can be secured, for example, the outer peripheral surface may be a polygon formed by a plurality of flat surfaces, and in such a case, the condition of "ring shape" is satisfied. That is, the "ring shape" is not limited to a circular shape, and a slight shape change is allowed as long as it can perform a sealing function equivalent to that in the case of a circular shape.

The opening member 2 is preferably formed of a material having a flexural modulus of elasticity of 140MPa or more. As a material satisfying this condition, synthetic resins such as polyethylene, polypropylene, and cyclic polyolefin can be exemplified, and the material can be appropriately selected in combination with the material of the bag body 3. When a material that is highly flexible and easily deformed by application of force is used, the lid 4 may fall off when the seal 30 of the lid 4 is removed even if the inclination angle θ of the engagement surface 26A is an appropriate angle. Therefore, the flexural modulus is preferably 140MPa or more. The flexural modulus of elasticity is more preferably 200MPa or more, and still more preferably 400 to 2000 MPa. The flexural modulus can be measured by the measurement method specified in ISO 178. Fig. 7 shows a state in which the seal 30 is removed from the cap 4.

As shown in fig. 5 and 6 (bottom view), the cap 4 has a cap main body 28 and a sealing member 30 fixed above the cap main body 28, and the sealing member 30 is removed from the cap main body 28 by lifting the periphery of the sealing member 30 with fingers.

The lid main body 28 includes a disc-shaped top plate 34, a cylindrical skirt 33 extending perpendicularly from the periphery of the top plate 34, and a plurality of (4 in the present embodiment) engagement pieces 32 provided at the lower end portion of the inner surface of the skirt 33. A recess 46 is formed in the outer peripheral surface of the skirt portion 33 at a position corresponding to a portion between the engagement pieces 32 to prevent slipping of the hand. The engaging piece 32 has a rectangular plate shape, and includes a base portion 32B integrally formed with the lower end inner peripheral surface of the skirt portion 33, and a tip portion 32A protruding upward from the base portion 32B toward the top plate portion 34 side toward the lid inner side, and the tip portion 32A can elastically approach the inner peripheral surface of the skirt portion 33.

The distance from the front end of the free front end portion 32A of the engaging piece 32 to the central axis of the cover 4 is smaller than the distance from the outer peripheral surface of the edge portion 26 to the central axis of the opening member 2. At the same time, the distance from the tip of the tip portion 32A, which is in a state of being closest to the inner peripheral surface of the skirt portion 33 by elastically deforming the engaging piece 32, to the central axis of the lid 4 is set to be equal to or greater than the distance from the outer peripheral surface of the edge portion 26 to the central axis of the opening member 2. Thus, when the cover 4 is pressed downward while covering the opening member 2, the distal end portion 32A of the engagement piece 32 elastically deforms to go over the edge portion 26, and then opens again to come into contact with the engagement surface 26A of the edge portion 26 to be engaged therewith. The maximum downward pressure of the lid 4 until the engagement piece 32 elastically deforms and goes over the edge portion 26 by pressing the lid 4 downward while covering the opening member 2 is about 10 to 200N, which facilitates use. The maximum pressing force is more preferably 20 to 100N. However, in the case of mechanically attaching the cover 4, the maximum pressing force of the cover 4 may be used within a range where the opening member 2 and the cover 4 are not plastically deformed.

The distance from the front end of the free front end portion 32A of the engaging piece 32 to the central axis of the cover 4 is slightly larger or substantially equal to or slightly smaller than the distance from the outer peripheral surface of the covering portion 25 to the central axis of the opening member 2. If the distance is within this range, the distance from the distal end of the free distal end portion 32A of the engaging piece 32 to the central axis of the cover 4 may be preferably about 95 to 105% of the distance from the outer peripheral surface of the covering portion 25 to the central axis of the opening member 2.

The number of the engaging pieces 32 is not limited, but is preferably 3 to 6, and most preferably 4, from the viewpoint of stability of fixation of the cover. The distal end portion 32A of the engagement piece 32 is preferably bent so as to be in contact with the engagement surface 26A over the entire length in the horizontal direction in accordance with the bent shape of the edge portion 26. Rectangular openings 44 are formed in the top plate 34 at positions corresponding to the respective engaging pieces 32, and serve as escape passages for the cores when the overhanging engaging pieces 32 are injection molded.

The inside plug 50 for closing the opening of the opening is made of elastic rubber, elastomer, or the like, and has a disk-like portion 50A and a projection 50B projecting from the center of the lower surface of the disk-like portion 50A, and the disk-like portion 50A has substantially the same outer diameter as the upper end of the opening member 2. The projection 50B has an original outer diameter slightly larger than the opening diameter of the opening member 2, and when the inner plug 50 is fitted into the opening member 2, the projection 50B enters the opening member 2, and the disc-shaped portion 50A abuts against the upper surface of the rim portion 26 of the opening member 2. By attaching the cap 4 from above the inside plug 50, the inside plug 50 is compressed by the cap 4, the disk-shaped portion 50A is pressed against the annular end surface of the opening member 2, and the projection 50B expands and is pressed against the inner peripheral surface of the opening member 2. Thereby, the opening part 2 is hermetically sealed and maintained in an aseptic state.

The inside plug 50 may be mechanically integrated with the lid 4 in advance, or may be bonded to the lid 4 by bonding or welding in advance, or may be integrally formed with the lid 4 in advance.

The inside plug 50 may have a main body made of rubber or elastomer and a covering layer formed by covering at least a surface of the main body that contacts the content with a fluororesin. The method for forming the cover layer is not limited, and the cover layer may be formed by lamination or by spraying.

A circular opening 48 is formed in the center of the top plate 34 of the lid 4, and the seal 30 that closes the opening 48 is joined to the top plate 34 via the connecting portion 42 in the top plate 34. The outer diameter of the seal 30 is slightly larger than the outer diameter of the cap 4, and if the periphery of the seal 30 is pulled up by force, the connecting portion 42 is broken and the seal 30 is detached from the cap body 28. Thereby, the opening 48 is opened, and the contents of the bag body 3 can be discharged by piercing an injection needle or the like into the inner plug 50.

Any substance can be contained in the containing portion 12 of the bag main body 3 as long as it is a substance such as a liquid, a powder, a gas, or a mixture thereof that passes through the opening member 2, but this embodiment is particularly suitable for a biological medicine that cannot be heat-sterilized. Examples of such a drug include at least one selected from the following: plasma component preparations such as albumin preparations and globulin preparations, enzymes, thrombofibrinolytic factors, hormones, vaccines, interferons, erythropoietins, cytokines, antibodies, and fusion proteins. The contents containing the biological medicine are aseptically filled in the housing portion 12 in an aseptic environment, the inner plug 50 is fitted into the opening of the opening member 2, the lid 4 is attached to the opening member 2 and pressed downward, and the engagement piece 32 is engaged with the edge portion 26, whereby the contents can be sealed and stored while maintaining an aseptic state. Therefore, unlike a conventional bag with an opening that needs to be fused and a vial container that needs to be crimped and fastened with an aluminum cap, a special device for sealing is not required to prevent the sterilization work or generate dust that reduces cleanliness, and the bag can be used easily.

In order to take out a medicine from a bag with a lid storing the medicine, the lid 4 is not removed, but the seal 30 is pulled up to break the connection portion 42, and the seal 30 is removed from the lid main body 28. By inserting an injection needle or the like through the opening 48 and piercing the inner plug 50, and hanging the lidded bag by inserting the hole 16 of the bag main body 3 through the hook, the medicine can be discharged through the injection needle and the catheter by gravity, and the bag main body 3 can be gradually contracted as the content decreases. Therefore, since there is no need to use a vent needle like a vial container, there is no risk of contamination of the contents by the entry of external air through the vent needle.

As described above, according to the bag with an opening and the bag with a lid of the present embodiment, unlike the conventional bag with an opening requiring a fusing device and the vial container requiring a crimping device of an aluminum lid, a special device for sealing is not required to prevent the aseptic work or generate dust which impairs the aseptic state, and the sealing work of the contents can be easily performed and the cost can be reduced. Further, since the flexible vent tube is gradually contracted as the contents are discharged, it is not necessary to use a vent needle as in a vial container, and there is no risk of contamination of the contents through the vent needle. Therefore, the method has the advantages of reducing the cost for producing the medicine and being easy to use in the medical field.