JP2005034419A - Cap, and production method of prefilled syringe - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a cap with which even inside of a mouth part of a syringe barrel is sufficiently sterilized in the state of mounting the cap to the mouth part and with which a sterilized state after sterilization is maintained, and to provide a production method of prefilled syringe using the cap. <P>SOLUTION: The cap 6 is mounted to the mouth part 22 formed projecting at the tip of the syringe barrel 2. The cap 6 has: a cap main body 7 having an inner hollow part 72; and a cap body 8 which is provided at the cap main body 7 and can be displaced to a first position of permitting the passing of a fluid through the inside of the inner hollow part 72 and the mouth part 22 and a second position blocking this passing through. The production method of the prefilled syringe using the cap 6 mounts the cap 6 to the mouth part 22 with the cap body 8 at the first position, and carries out sterilization in this state. Next, in aseptic environment, the cap body 8 is displaced from the first position to the second position. Thereafter, the syringe barrel 2 is filled up with a liquid preparation in the aseptic environment. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a method for manufacturing a cap and a prefilled syringe.

  A prefilled syringe in which a liquid preparation is aseptically filled in a sterilized syringe (container) is known.

  Such a prefilled syringe is manufactured as follows, for example. That is, first, sterilization with a high-pressure steam sterilization or a sterilization gas such as hydrogen peroxide is performed on each of the syringe and the cap (sealing member) attached to the liquid discharge part (mouth part). Next, in a sterile environment, a cap is attached to the liquid discharge part of the syringe, and then the liquid preparation is filled into the syringe to complete the prefilled syringe.

  However, in such a method, it is necessary to attach a cap to the liquid discharge part of the syringe in an aseptic environment, but there is a problem in that it is difficult to attach the cap to the syringe because of the limited work space. was there.

  In order to solve such a problem, I: Applying a sterilization treatment with a high-pressure steam sterilization or a sterilization gas such as hydrogen peroxide in a state where a cap is previously attached to the liquid discharge part of the syringe, II: having a breathable filter It is considered effective to sterilize with a sterilizing gas using a cap.

  Incidentally, Patent Document 1 discloses a method of sterilizing a tubular medical device 3 having a sealing portion 31 at one end with a sterilizing gas. However, in such a method, sealing in the medical device 3 is performed. There is a possibility that the sterilization gas does not easily reach the vicinity of the stop portion 31 and the medical device 3 cannot be sufficiently sterilized (the reference is quoted from Patent Document 1).

  In the method I described above, similarly to Patent Document 1, there is a high possibility that the sterilization gas is difficult to reach the sealed mouth.

  On the other hand, in the case of the method II described above, in the case of a container that is stored in a state of storing liquid like a prefilled syringe, the liquid in the container may pass through the filter and leak out.

JP-A-10-179700

  An object of the present invention is to provide a cap capable of sufficiently sterilizing the inside of the mouth portion with the cap attached to the mouth portion of the syringe outer cylinder and maintaining the sterilized state after the sterilization. Is to provide. Moreover, it is providing the manufacturing method of the prefilled syringe using this cap.

Such an object is achieved by the present inventions (1) to (14) below.
(1) A cap that is attached to a mouth portion protruding from the tip of a syringe outer cylinder,
A cap body having a lumen;
The cap body is provided with a plug body that is displaceable between a first position that allows passage of fluid through the lumen and the mouth and a second position that prevents passage of the fluid. And cap.

  (2) The cap according to (1), wherein the plug is provided in the lumen so as to be movable along an axial direction of the cap body.

  (3) The cap according to (2), wherein when the plug body is in the first position, a channel through which the fluid passes is formed between the cap body and the plug body.

  (4) The said flow path is a cap as described in said (3) comprised by the convex part and / or recessed part which were formed in the internal peripheral surface of the said cap main body, and / or the outer peripheral surface of the said plug body.

  (5) The plug according to (2) to (4), wherein the plug includes a plug body and an operation unit that operates to irreversibly displace the plug body from the first position to the second position. Cap according to any one.

  (6) When the plug body is in the second position, the inner peripheral surface of the cap main body and the outer peripheral surface of the plug main body are in close contact, and / or the end of the plug main body on the mouth side. The cap according to (5), wherein the fluid is prevented from passing through the lumen part and the mouth part by closely contacting the tip of the mouth part.

  (7) The cap according to (4) or (5), wherein the plug body is made of an elastic material.

(8) The cap body has a step portion on the lumen portion side,
The plug body according to any one of (5) to (7), wherein the plug body is inserted into the mouth side space from the stepped portion of the lumen when the plug body is in the second position. Cap.

  (9) The cap according to (8), wherein the volume of the space on the mouth side from the stepped portion is smaller than the volume of the plug body.

  (10) The cap according to (8) or (9), wherein the cap body has a portion that gradually decreases as the cross-sectional area of the lumen portion approaches the mouth portion in the vicinity of the stepped portion.

  (11) The cap according to any one of (5) to (10), wherein at least a portion of the operation portion that contacts the inner peripheral surface of the cap body is made of a hard material.

  (12) The cap according to any one of (1) to (11), wherein the syringe outer cylinder is an outer cylinder for a prefilled syringe.

(13) A syringe outer cylinder having a mouth portion protruding from the tip, a cap according to any one of (1) to (12) attached to the mouth portion, and the syringe outer cylinder are filled A method for producing a prefilled syringe comprising a liquid formulation,
In the state where the plug body is in the first position, it is attached to the mouth, sterilized in this state,
Next, in a sterile environment, the stopper is displaced from the first position to the second position,
Then, the prefilled syringe manufacturing method characterized by filling the said syringe with the said liquid formulation in an aseptic environment.

  (14) The method for producing a prefilled syringe according to (13), wherein the sterilization is autoclave sterilization.

  According to the present invention, for example, in the production of a prefilled syringe, each part of the syringe outer cylinder can be sufficiently sterilized, and a cap attaching operation after sterilization can be omitted.

  In particular, since the cap attaching operation is performed in a very small work space such as a sterile chamber, the workability at the time of manufacturing the prefilled syringe is improved by omitting the operation. As a result, it is possible to reduce the manufacturing time and manufacturing cost of the prefilled syringe.

  Before explaining the manufacturing method of the cap and prefilled syringe of the present invention, the prefilled syringe will be described as an example of the syringe that is used with the cap of the present invention.

  FIG. 11 is a partial cross-sectional view of a prefilled syringe. In the following, for convenience of explanation, the upper side in FIG. 11 is referred to as a “tip” and the lower side is referred to as a “base end”.

  A prefilled syringe (hereinafter simply referred to as “syringe”) 1 shown in FIG. 11 is one in which a liquid preparation such as a drug solution is stored in advance in the syringe 1. The syringe 1 includes a syringe outer cylinder (outer cylinder) 2, a gasket 3 that can slide within the syringe outer cylinder 2, and a plunger (presser) 4 that moves the gasket 3.

The syringe outer cylinder 2 is composed of a bottomed cylindrical member having a bottom portion 211.
A plate-like flange 23 is integrally formed on the outer periphery of the proximal end of the syringe outer cylinder 2. When the plunger 4 is moved and operated relative to the syringe outer cylinder 2, the operation can be performed by placing a finger on the flange 23.

  At the center of the bottom 211 of the syringe outer cylinder 2, a mouth 22 having a reduced diameter with respect to the body of the syringe outer cylinder 2 is integrally formed.

  A flow path 221 through which the fluid Q can pass is formed inside the mouth portion 22 and communicates with a lumen portion (a space 24 described later) of the syringe outer cylinder 2.

  A cylindrical lock adapter (connection member) 5 is provided on the outer peripheral portion of the mouth portion 22, and a female screw 52 is formed on the inner peripheral surface of the lock adapter 5.

  The distal end portion of the mouth portion 22 is inserted into a lumen portion 72 of a cap body 7 (cap 6) to be described later, and the male screw 71 of the cap body 7 and the female screw 52 of the lock adapter 5 are screwed together, whereby a syringe The cap 6 of the present invention can be attached to the mouth portion 22 of the outer cylinder 2 (prefilled syringe 1).

  As a constituent material of the syringe outer cylinder 2 (including the lock adapter 5) and a plunger 4 described later, for example, various hard materials, various glass materials, and the like can be used.

  In addition, it is preferable that the constituent material of the syringe outer cylinder 2 is substantially transparent in order to ensure the internal visibility.

  Further, a scale (not shown) is preferably formed on the outer peripheral surface of the outer cylinder 2. Thereby, the liquid quantity of the liquid formulation accommodated in the syringe 1 can be grasped | ascertained.

  In such a syringe outer cylinder 2, a gasket 3 made of an elastic material is accommodated. Two ring-shaped protrusions 31 and 32 are formed on the outer peripheral portion of the gasket 3 at predetermined intervals along the axial direction. By sliding these protrusions 31 and 32 in close contact with the inner peripheral surface 21 of the syringe outer cylinder 2, airtightness (liquid tightness) can be reliably maintained and slidability can be improved.

  Further, the gasket 3 is formed with a hollow portion opened to the base end surface. The head portion of the plunger 4 is inserted (inserted) into the hollow portion.

  The plunger 4 moves the gasket 3 in the syringe outer cylinder 2 in the longitudinal direction.

  The plunger 4 has a main body portion 40 mainly composed of a plate piece having a cross section in a cross section, a plate member 41 at the distal end, and a flange-like (plate-like) finger contact portion 42 at the proximal end. Are integrally formed with the main body 40. The plunger 4 is moved in the distal direction by pressing the finger rest 42 with a finger or the like.

  The cap 6 of the present invention is detachably attached to the mouth portion 22 of the prefilled syringe 1 (syringe outer cylinder 2) as described above.

  Next, the manufacturing method of the cap and prefilled syringe of this invention is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.

<First Embodiment>
First, the cap 6 of the present invention will be described.

  FIG. 1 is an exploded longitudinal sectional view showing a first embodiment of the cap of the present invention, FIG. 2 is a view from the front end side of the cap body provided in the cap shown in FIG. 1, and FIGS. FIG. 5 is a side view showing a state in which the cap shown in FIG. 1 is attached to a prefilled syringe. In the following, for convenience of explanation, the upper side of FIGS. 1 and 3 to 10 is referred to as a “tip”, and the lower side is referred to as a “base end”.

A cap 6 shown in FIG. 1 includes a cap body 7 and a plug body 8.
The cap body 7 is formed of a substantially cylindrical member, and has a lumen 72 therein.

  The plug 8 is inserted into the lumen 72 so as to be movable along the axial direction of the cap body 7.

  In a state where the cap 6 is attached to the distal end portion of the syringe 1 (the mouth portion 22 of the syringe outer cylinder 2) (hereinafter, this state is referred to as a “cap attachment state”), the plug body 8 has the lumen 72 of the fluid Q. In addition, it is movable (displaceable) between a first position (see FIG. 3) that allows passage through the flow path 221 (in the mouth portion 22) and a second position (see FIG. 4) that blocks passage. ing.

  The plug body 8 includes a cylindrical plug body 81 and an operation portion 82, which are connected via a connection portion 83 having a diameter smaller than that of the plug body 81 and the operation portion 82.

  By pressing the operation portion 82, the stopper body 81 can be moved from the first position to the second position in the cap body 7.

  The cap body 7 has a male screw 71 formed on the outer periphery of the base end portion. When the cap is attached, the male screw 71 is screwed into a female screw 52 formed on the inner surface of the lock adapter 5.

  A stepped portion 74 is formed on the side of the lumen 72 of the cap body 7. With the stepped portion 74 as a boundary, the lumen 72 is partitioned into a first space 723 on the distal end side and a second space 724 on the proximal end side.

  When the plug body 8 is in the first position, almost all of the plug bodies 8 are located in the first space 723. In this state, a flow path 61 is formed between the cap body 7 and the plug body 8, and the fluid Q can pass through the flow path 61 into the mouth portion 22 (flow path 221). .

  In the cap-mounted state, the mouth portion 22 is inserted into the base end side (lower portion in FIG. 3) of the second space 724, and the small space is inserted into the tip end portion of the second space 724. 724a is formed. The plug body 81 is inserted into the small space 724a when the plug body 8 is in the second position.

  The volume of the small space 724a is set so as to be smaller than the volume of the plug body 81. Thus, when the plug body 81 is inserted into the small space 724a, the cap body 7 and the plug body 81 are firmly adhered. .

  Specifically, the inner peripheral surface 721 of the cap main body 7 (small space 724a) and the outer peripheral surface 811 of the plug main body 81 are in close contact, and the base end surface 812 (surface on the mouth portion 22 side) of the plug main body 81 and the mouth portion. 22 is in close contact with the front end surface 222. Thereby, the passage of the fluid Q through the lumen 72 and the flow path 221 of the mouth 22 is blocked.

  A plurality (six in this embodiment) of convex portions 73 extend from the tip to a position beyond the stepped portion 74 along the axial direction of the cap body 7 on the inner peripheral surface 721 of the cap body 7. Is provided. The outer peripheral surface 821 of the operation portion 82 of the plug body 8 is in pressure contact with the convex portions 73, respectively. Thereby, as described above, when the plug body 8 is in the first position, the flow path 61 through which the fluid Q passes is formed between the cap body 7 and the inner peripheral surface 721. In addition, the plug body 8 moves from the first position to the second position while the outer peripheral surface 821 of the operation unit 82 is in sliding contact with each convex portion 73.

  The convex portions 73 are substantially equal in height and are formed at substantially equal intervals along the circumferential direction of the cap body 7. As a result, the plug body 8 is held substantially evenly in the circumferential direction of the cap body 7, so that the flow path 61 can be more reliably secured and the plug body 8 is moved from the first position to the second position. When moving to this position, the movement can be performed reliably and with high straightness.

  Further, the lumen 72 is configured to gradually decrease in the vicinity of the stepped portion 74 as its cross-sectional area approaches the mouth portion 22. Accordingly, the convex portions 73 also approach each other at the stepped portion 74 toward the mouth portion 22. With such a configuration, when the plug body 8 is moved from the first position to the second position, the plug body 81 can be easily and reliably guided to the small space 724a.

  In addition, after the plug main body 81 is inserted into the small space 724a, the base end portion of each convex portion 73 presses the boundary portion with the connection portion 83 of the plug main body 81 toward the mouth portion 22, The plug body 81 (plug body 8) is reliably prevented from returning from the second position to the first position. That is, the plug body 8 (plug body 81) can move only in one direction (irreversibly).

  Further, a protrusion 813 is formed on the proximal end surface 812 of the plug body 81 so as to protrude toward the proximal end. The protrusion 813 is formed at substantially the center of the base end face 812. As shown in FIG. 4, when the plug 8 is in the second position, at least a part of the protrusion 813 is in the mouth 22 (the flow path 221). ) Is inserted.

  By providing the protrusion 813, even when the shaft of the plug body 8 and the shaft of the cap body 7 are slightly displaced when the plug body 8 is moved from the first position to the second position, the plug body 8 When the position is set to the second position, the protrusion 813 is inserted into the flow path 221 so that the positional deviation can be eliminated.

  Further, in such a cap 6, almost all of the plug body 8 exists in the lumen portion 72 at any one of the first position and the second position. Thereby, it is possible to prevent the cap 8 from being inadvertently touched and to prevent the cap 6 from becoming large.

  As a constituent material of the cap body 7, for example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene Polyesters such as terephthalate and polyethylene naphthalate, butadiene-styrene copolymers, polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12), ethylene-vinyl alcohol copolymers, polyallylsulfone, poly Various resins such as ether sulfone, methacryl-styrene copolymer, polyarylate, styrene-acrylonitrile copolymer can be mentioned. Among them, polypropylene, ring Polyolefins, polyesters, poly - (4-methylpentene-1) resin such as is preferred.

  Examples of the constituent material of the plug body 8 include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, and silicone rubber. , Various rubber materials (especially those vulcanized) such as fluoro rubber, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluoro rubber And various thermoplastic elastomers such as chlorinated polyethylene, and relatively soft resin materials such as polyethylene and vinyl chloride resin. One or more of these may be used in combination.

  In the present embodiment, the flow path 61 is described as being configured by the convex portion 73 formed on the inner peripheral surface 721 of the cap body 7 and the outer peripheral surface of the plug body 8, but is not limited thereto. For example, the cap body 7 may be configured by a recess formed on the inner peripheral surface 721 of the cap body 7 and the outer peripheral surface of the plug body 8, or a protrusion or recess formed on the outer peripheral surface of the plug body 8 and the cap body 7. The inner peripheral surface 721 may be configured, or one or any two or more of these may be combined. Also in the case of providing the recesses, it is preferable to provide the recesses on the outer peripheral surface of the plug body 8 or the inner peripheral surface 721 of the cap body 7 at substantially equal intervals, similarly to the convex portion 73. Moreover, when providing a convex part, in order to hold | maintain the plug body 8 in the cap main body 7 with sufficient balance, it is sufficient to provide at least three or more, and when providing a concave part, it is sufficient to provide at least one. .

  In the present embodiment, when the plug body 8 is in the second position, the outer peripheral surface 811 of the plug main body 81 and the inner peripheral surface 721 of the cap main body 7 are in close contact with each other, and the base end surface 812 of the plug main body 81 is connected to the mouth. Although the front end surface 222 of the portion 22 is in close contact with the fluid Q, the fluid Q is prevented from passing therethrough, but the fluid Q may be prevented from passing through only one of them.

  In the present embodiment, the plug body 8 has been described as being composed of one member. However, the plug body 8 is composed of the plug body 81, the operation section 82, and the connection section 83 as separate members. They may be joined together. In this case, at least the outer peripheral portion of the plug body 81 may be made of the elastic material as described above.

  Moreover, the attachment method with respect to the opening | mouth part 22 of the cap 6 is not limited to the thing by screwing, For example, what kind of methods, such as fitting and caulking, may be sufficient.

  Next, a manufacturing method (assembly method) of the prefilled syringe 1 using the cap 6 will be described.

  [1] First, the syringe outer cylinder 2 and the cap 6 are prepared, and the cap 6 is attached to the mouth portion 22 of the syringe outer cylinder 2. At this time, the cap 6 keeps the plug body 8 in the first position (see FIG. 3).

  [2] In this state, the syringe barrel 2 is placed in an autoclave sterilizer. In this state, high-pressure steam R is supplied into the apparatus for sterilization.

  At this time, a channel 61 through which the high-pressure steam R passes is formed in the cap 6. Thereby, the high-pressure steam R passes through the flow path 61 and the flow path 221 and is sufficiently sterilized in the syringe outer cylinder 2, in particular, in the mouth portion 22 (flow path 221).

  [3] Next, after completion of sterilization, the syringe outer cylinder 2 is moved into an isolator in an aseptic environment, and the operation portion 82 is pressed in the proximal direction by a pressing machine (not shown), and the plug body 8 is moved to the first position. The position is moved (displaced) from the position to the second position. Thereby, the mouth part 22 is sealed.

  At this time, the plug body 81 moves toward the small space 724a while being deformed in the vicinity of the stepped portion 74. Then, after passing through the stepped portion 74 and reaching the small space 724a, the plug body 81 is almost restored to its original shape, but is slightly compressed in order to maintain the sealing performance.

  When the plug main body 81 reaches the small space 724a, the plug main body 81 is firmly adhered to the inner peripheral surface 721 of the cap main body 7 and the tip end surface 222 of the mouth portion 22, and the flow path 61 is closed and then filled. Block the passage of chemicals. Thereby, the passage of the high-pressure steam R in the flow path 61 is prevented.

  Thus, with the cap 6 of the present invention, the plug body 8 can be moved from the first position to the second position by a simple operation called a pressing operation, so that the operation can be reliably performed even in a small work space. It can be carried out.

  [4] Thereafter, in a sterile environment, the liquid preparation 100 that has been previously sterilized (for example, filtration sterilization) is filled into the syringe outer cylinder 2 from the opening at the proximal end of the syringe outer cylinder 2. This filling amount corresponds to the capacity of the syringe 1 and is about 0.1 to 100 mL. After filling the liquid preparation 100, the gasket 3 and the plunger 4 are attached, and the prefilled syringe is completed as shown in FIG.

  In this state, since the mouth portion 22 (flow path 221) of the syringe outer cylinder 2 is sealed airtight (liquid tight) by the plug body 8, the liquid preparation 100 leaks out of the syringe 1. There is no.

  The liquid preparation 100 includes blood preparations, sugar injection solutions such as glucose, injection correction solutions such as sodium chloride and potassium lactate, vitamins, vaccines, antibiotic injections, contrast agents, steroids, and proteolysis. Enzyme inhibitors, fat emulsions, various protein preparations, anticancer agents, anesthetics, stimulants, various chemicals such as narcotics, various diagnostic agents, or distilled water, physiological saline, disinfectants, nutrients, liquid foods, alcohol, etc. Of liquid is stored.

  The sterilization of the syringe outer cylinder 2 is not limited to autoclave sterilization. For example, gas sterilization using a sterilizing gas such as hydrogen peroxide or EOG, radiation sterilization by irradiation with γ rays, or the like may be used. it can.

Second Embodiment
FIG. 6 is a longitudinal sectional view showing a second embodiment of the cap of the present invention.

  Hereinafter, although the cap of 2nd Embodiment is demonstrated, it demonstrates centering around difference with 1st Embodiment mentioned above, The description of the same matter is abbreviate | omitted.

The second embodiment is the same as the first embodiment except that the configuration of the plug body is different.
The plug body 8A shown in FIG. 6 includes a columnar plug body 81 in which the operation section 82 and the connection section 83 are omitted.

A concave indentation 815 is formed on the upper portion of the plug body 8A (plug body 81).
When the distal end of the plug body 8A is pressed and the plug body 8A is moved from the first position to the second position in the cap body 7, the outer peripheral surface 811 is sequentially pressed from the base end surface 812 by the vicinity of the stepped portion 74. . Thereby, the plug body 8A has a shape in which the distal end portion of the plug body 8A is inclined toward the dent 815 and easily passes through the stepped portion 74.

  That is, in this embodiment, by providing the dent 815, the operation of moving the plug 8A from the first position to the second position can be performed more easily.

<Third Embodiment>
FIG. 7 is a longitudinal sectional view showing a third embodiment of the cap of the present invention.

  Hereinafter, although the cap of 3rd Embodiment is demonstrated, it demonstrates centering around difference with 1st Embodiment mentioned above, The description of the same matter is abbreviate | omitted.

The third embodiment is the same as the first embodiment except that the configuration of the plug body is different.
The plug body 8 </ b> B shown in FIG. 7 is configured by a cylindrical plug body 81 without the operation section 82 and the connection section 83.

  A concave portion 817 is formed along the circumferential direction at a substantially central portion in the axial direction of the outer peripheral surface 811 of the plug body 8B (plug body 81). Thereby, the plug 8B has a constricted shape in the middle of the axial direction.

  With such a configuration, when the plug body 8B is stored in the second space 724, the compressed volume is applied to the constricted portion, thereby reducing the pushing force and exhibiting an appropriate adhesion force. The effect of being able to be obtained.

  The plug body 8B may be formed in a straight shape without the concave portion 817 being formed.

<Fourth embodiment>
FIG. 8 is a longitudinal sectional view showing a fourth embodiment of the cap of the present invention.

  Hereinafter, although the cap of 4th Embodiment is demonstrated, it demonstrates centering around difference with 1st Embodiment mentioned above, The description of the same matter is abbreviate | omitted.

The fourth embodiment is the same as the first embodiment except that the configuration of the plug body is different.
The plug body 8 </ b> C shown in FIG. 8 is configured by a columnar plug body 81 without the operation unit 82 and the connection unit 83.

  A plurality of (two in this embodiment) grooves 818 are formed along the circumferential direction at a predetermined interval in the axial direction on the outer peripheral surface 811 of the plug body 8C (plug body 81). In other words, a plurality (three in the present embodiment) of ring-shaped ribs 819 are formed on the outer peripheral surface 811 of the plug body 8C at a predetermined interval in the axial direction.

  When the distal end of the plug body 8C is pressed to move the plug body 8C from the first position to the second position in the cap body 7, the rib 819 is compressed by the vicinity of the stepped portion 74. Accordingly, the plug body 8C has a shape that easily passes through the stepped portion 74.

  That is, in the present embodiment, by providing the rib 819, the operation of moving the plug body 8C from the first position to the second position can be performed more easily.

  Note that the plug body 8C may be configured such that not only the rib 819 but also the entirety thereof is compressed.

  The number of ribs 819 installed is not limited to the illustrated configuration, and may be one, two, or four or more.

<Fifth Embodiment>
FIG. 9 is a longitudinal sectional view showing a fifth embodiment of the cap of the present invention.

  Hereinafter, the cap of the fifth embodiment will be described, but the description will focus on the differences from the first embodiment described above, and the description of the same matters will be omitted.

The fifth embodiment is the same as the first embodiment except that the configuration of the plug body is different.
The plug body 8D shown in FIG. 9 is configured by a columnar plug body 81 and an operation section 82, with the connecting section 83 omitted.

  The plug body 8 </ b> D is configured such that the operation portion 82 protrudes from the cap body 7 when the plug body 8 </ b> D is in any of the first position and the second position. Further, when the plug body 8D is in the first position, a part of the plug body 81 is also configured to protrude from the cap body 7. The length (height) of the plug body 81 at this protruding portion is set to be approximately equal to the moving distance that the plug body 8D moves from the first position to the second position. When the plug body 8D is moved to the second position, the above-described portions are in close contact with each other, and the distal end surface 75 of the cap body 7 and the proximal end surface 822 of the operation portion 82 are in close contact with each other. Thereby, the airtightness (liquid tightness) of the syringe 1 can be made higher.

<Sixth Embodiment>
FIG. 10 is a longitudinal sectional view showing a sixth embodiment of the cap of the present invention.

  Hereinafter, although the cap of 6th Embodiment is demonstrated, it demonstrates centering around difference with 1st Embodiment mentioned above, The description of the same matter is abbreviate | omitted.

  The sixth embodiment is the same as the first embodiment except that the configuration of the flow path and the plug is different.

  In the cap 6 shown in FIG. 10, the flow path 61 includes a convex portion 73 formed on the cap body 7 similar to that described above, the outer peripheral surface 821 of the plug body 8, and the tip of the plug body 8 (plug body 81). A concave portion 814 formed in the portion and an inner peripheral surface 721 of the cap body 7 (near the stepped portion 74).

  As shown in FIG. 10, the operation portion 82 may be configured such that at least the outer peripheral surface 821 that is in contact with the inner peripheral surface 721 (convex portion 73) of the cap body 7 is made of a hard material. Thereby, the slidability with respect to the cap main body 7 of the plug body 8 increases, and the operation of moving the plug body 8 from the first position to the second position can be performed more smoothly.

  Examples of such a hard material include titanium, aluminum, an aluminum alloy, stainless steel, and the like, in addition to the resin materials mentioned in the cap body 7.

  As described above, even when the stopper and the cap body having the configurations described in the second to sixth embodiments are used, the prefilled syringe can be manufactured in the same manner as in the first embodiment.

  As mentioned above, although the manufacturing method of the cap of the present invention and the prefilled syringe has been described with respect to the illustrated embodiment, the present invention is not limited to this, and each part constituting the cap can arbitrarily exhibit the same function. It can be replaced with the configuration of Moreover, arbitrary components may be added.

  In the cap of the present invention, any two or more configurations (features) of the first to sixth embodiments may be combined.

  Moreover, in the manufacturing method of the prefilled syringe of this invention, arbitrary 1 or 2 or more processes can also be added.

It is an exploded longitudinal section showing a 1st embodiment of a cap of the present invention. It is a figure from the front end side of the cap main body with which the cap shown in FIG. 1 is provided. It is a longitudinal cross-sectional view (The state which has a plug body in a 1st position) which shows the operation state of the cap shown in FIG. It is a longitudinal cross-sectional view (The state which has a stopper in a 2nd position) which shows the operation state of the cap shown in FIG. It is a side view which shows the state which mounted | wore the prefilled syringe with the cap shown in FIG. It is a longitudinal cross-sectional view which shows 2nd Embodiment of the cap of this invention. It is a longitudinal cross-sectional view which shows 3rd Embodiment of the cap of this invention. It is a longitudinal cross-sectional view which shows 4th Embodiment of the cap of this invention. It is a longitudinal cross-sectional view which shows 5th Embodiment of the cap of this invention. It is a longitudinal cross-sectional view which shows 6th Embodiment of the cap of this invention. It is a fragmentary sectional view of a prefilled syringe.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Prefilled syringe 2 Syringe outer cylinder 21 Inner peripheral surface 211 Bottom part 22 Mouth part 221 Flow path 222 Front end surface 23 Flange 24 Space 3 Gasket 31, 32 Protrusion part 4 Plunger 40 Main part 41 Plate member 42 Finger rest part 5 Lock adapter 51 Inside Cavity 52 Female Thread 6 Cap 61 Channel 7 Cap Body 71 Male Thread 72 Internal Cavity 721 Inner Peripheral Surface 723 First Space 724 Second Space 724a Small Space 73 Protrusion 74 Stepped Part 75 Tip Surface 8 Plug 8A Plug body 8B Plug body 8C Plug body 8D Plug body 81 Plug body 811 Outer peripheral surface 812 Base end surface 813 Projection 814 Recess 815 Recess 817 Concave 818 Groove 819 Rib 82 Operation unit 821 Outer peripheral surface 822 Base end surface 83 Fluid formulation 100 Liquid preparation 100 R high pressure steam

Claims (6)

A cap that is attached to a mouth formed to protrude from the tip of a syringe outer cylinder,
A cap body having a lumen;
The cap body is provided with a plug body that is displaceable between a first position that allows passage of fluid through the lumen and the mouth and a second position that prevents passage of the fluid. And cap.   The cap according to claim 1, wherein the plug is provided in the lumen so as to be movable along an axial direction of the cap body.   The cap according to claim 2, wherein when the plug is in the first position, a channel through which the fluid passes is formed between the cap body and the plug.   The cap according to any one of claims 1 to 3, wherein the syringe outer cylinder is an outer cylinder for a prefilled syringe. A pre-filled comprising a syringe outer cylinder having a mouth part protruding from the tip, a cap according to any one of claims 1 to 4 attached to the mouth part, and a liquid preparation filled in the syringe outer cylinder. A method of manufacturing a syringe comprising:
In the state where the plug body is in the first position, it is attached to the mouth, sterilized in this state,
Next, in a sterile environment, the stopper is displaced from the first position to the second position,
Then, the prefilled syringe manufacturing method characterized by filling the said syringe with the said liquid formulation in an aseptic environment.   The method for producing a prefilled syringe according to claim 5, wherein the sterilization is autoclave sterilization.

Images