JP5283417B2 - Cap and prefilled syringe manufacturing method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a cap capable of surely applying sterilizing processing to a mouth part in a fitting state where the cap is fitted to the mouth part of a syringe outer tube and surely sealing the mouth part. <P>SOLUTION: The cap 7 is fitted around the mouth part 22 of the outer cylinder 2 including an outer cylinder body 21 having the mouth part 22 and a lock adapter 23 arranged around the outer peripheral part 222a of the mouth part 22 and having a female screw part 232. Also, the cap 7 has a cap body 71 having a bottomed cylindrical shape, around the outer peripheral part of which a male screw part 712 threading with the female screw part 232 is arranged, and in the inner peripheral part of which a plurality of ribs 74 are arranged along an axial direction of the same, and a packing 8 arranged in the bottom part 72 of the cap body 71 and constituted of an elastic material. The top part 741 of the ribs 74 comes into contact with the outer peripheral part 222a of the mouth part 22 thereby suppresses axial displacement of the cap body 71 relative to the mouth part 22 and the packing 8 seals the mouth part 22 in the fitting state. <P>COPYRIGHT: (C)2010,JPO&amp;INPIT

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. However, this work space is limited, and it is necessary to attach the cap to the syringe. The sterilization processing and aseptic maintenance of the devices and instruments are complicated. For this reason, it is difficult to attach the cap to the syringe. Even if the cap is attached to the syringe, the attached state is incomplete (insufficient), that is, the liquid discharge part of the syringe is not reliably sealed, There was a problem that liquid leaked from the liquid discharge part.

  In order to solve such a problem, it is considered effective to perform sterilization 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 portion of the syringe. However, in this case, since the cap is attached to the liquid discharge part of the syringe in advance, the sterilization gas cannot reach the liquid discharge part, and there is a possibility that the liquid discharge part cannot be sufficiently sterilized. There is.

  Incidentally, in Patent Document 1, a method of sterilizing a tubular medical device 3 having a sealing portion 31 at one end with a sterilizing gas is disclosed. There is a risk that the sterilization gas cannot reach the vicinity of the stop portion 31 without excess or deficiency, and there is a possibility that the inside of the medical device 3 cannot be sufficiently sterilized (the reference is quoted from Patent Document 1).

JP-A-10-179700

  An object of the present invention is to provide a cap that can reliably sterilize the mouth and securely seal the mouth with the cap attached to the mouth of the syringe outer cylinder. Is to provide. Moreover, it is providing the manufacturing method of the prefilled syringe using the said cap.

Such an object is achieved by the following inventions (1) to ( 9 ).
(1) An outer cylinder body that has a male taper portion that protrudes in a tubular shape at the distal end and whose outer diameter gradually decreases in the distal direction, and has a mouth portion through which liquid can enter and exit; A cap attached to the mouth portion of the syringe outer cylinder comprising a cylindrical lock adapter having a syringe-side threaded portion on the periphery,
A cap body having a bottomed cylindrical shape, provided with a cap-side screwed portion that is screwed to the syringe-side screwed portion on the outer peripheral portion thereof, and provided with a plurality of ribs along the axial direction of the inner peripheral portion. When,
A sealing member installed at the bottom of the cap body and made of an elastic material;
Each of the ribs extends from the bottom of the cap body to the vicinity of the opening, the width of the rib gradually decreases toward the bottom of the cap body, and gradually decreases toward the top, and , The height of the rib gradually increases toward the bottom side of the cap body,
In the mounted state mounted on the mouth portion, the top portion of the rib abuts on the outer peripheral portion of the male taper portion , and the axial displacement of the cap body with respect to the mouth portion is suppressed, and the sealing member is the mouth portion. It is comprised so that may be sealed.

  (2) The cap according to (1), wherein a curved surface that is curved in an arc shape is formed on the whole or a part of the top of each rib.

  (3) The said curved surface is a cap as described in said (2) extended from the edge part by the side of the opening part of the said cap main body of the said rib to the middle.

  (4) The cap according to any one of (1) to (3), wherein a groove is formed on the top of each of the ribs along the axial direction of the cap body, either entirely or partially.

  (5) The said groove | channel is a cap as described in said (4) extended from the edge part by the side of the opening part of the said cap main body of the said rib to the middle.

  (6) The cap according to any one of (1) to (5), wherein the ribs are arranged at equiangular intervals around an axis of the cap body.

  (7) The cap according to any one of (1) to (6), wherein an angle formed by the shaft of the cap body and the shaft of the mouth portion is within 1 ° in the mounted state.

  (8) Each said rib is a cap in any one of said (1) thru | or (7) which has a part from which the grade of the height increase is different along the axial direction of the said cap main body.

( 9 ) An outer cylinder body that has a tubular shape protruding from the distal end and has a mouth part through which liquid can enter and exit, and a lock adapter that is installed in the mouth part and has a cylindrical shape having a syringe-side screwing part on the inner peripheral part. A prefilled syringe comprising: a syringe outer cylinder comprising: a cap according to any one of (1) to (8) mounted on the mouth; and a liquid preparation filled in the syringe outer cylinder. A way to
Attach the cap to the mouth, sterilize in this state,
Then, the prefilled syringe manufacturing method characterized by filling the said syringe with the said liquid formulation in an aseptic environment.

  According to the present invention, the top portion of each rib can abut on the outer peripheral portion of the mouth portion while the cap is attached to the mouth portion of the syringe outer cylinder. Thereby, the axis of the cap and the axis of the mouth can be substantially coincided, that is, the cap axis is prevented from being excessively inclined with respect to the axis of the mouth. As a result, the mouth portion can be sufficiently and reliably brought into close contact with the sealing member, so that the mouth portion can be reliably sealed, and thus liquid in the syringe outer cylinder is prevented from leaking from the mouth portion. .

  In addition, when a groove is formed in the top part of each rib in the whole or a part along the axial direction of the cap body, the mouth part of the syringe outer cylinder and the rib are in contact with each other in the mounted state. A relatively large number of points can be secured. Thereby, the rattling (excessive tilting) of the cap is prevented, so that the mouth portion is securely adhered by the sealing member, and the mouth portion is more reliably sealed.

  In addition, when the sterilization treatment for the syringe barrel in the mounted state is, for example, autoclave sterilization, high-pressure steam can flow between the adjacent ribs of the cap. Sterilization can be ensured.

Hereinafter, the manufacturing method of the cap of the present invention and the prefilled syringe will be described in detail based on preferred embodiments shown in the accompanying drawings.
1 is a perspective view of a cap according to the present invention, FIG. 2 is a longitudinal sectional perspective view of the cap shown in FIG. 1, and FIGS. 3 and 4 are views showing a state in which the cap shown in FIG. 5 is a cross-sectional view taken along line AA in FIG. 3, FIG. 6 is a cross-sectional view taken along line BB in FIG. 3, and FIGS. 7 to 9 are prefilled syringes, respectively. FIG. 10 is a partial vertical cross-sectional view of a prefilled syringe. In the following, for convenience of explanation, the upper side in FIGS. 1 to 4 and 10 is referred to as “tip”, the lower side is referred to as “base end”, and the upper side in FIGS. The lower side is called the “tip”. In FIG. 2, the sealing member is omitted, and in FIG. 5, the lock adapter of the syringe outer cylinder is omitted.

  Before explaining the manufacturing method of the cap 7 and the prefilled syringe of the present invention, a prefilled syringe will be described as an example of the syringe that is used with the cap 7 of the present invention.

  A prefilled syringe (hereinafter simply referred to as “syringe”) 1 shown in FIG. 10 is obtained by preliminarily storing (filling) a liquid preparation 200 such as a drug solution in the syringe 1. The syringe 1 includes an outer cylinder (syringe outer cylinder) 2, a gasket 3 that can slide within the syringe outer cylinder 2, and a pusher (plunger) 4 that moves the gasket 3.

  The liquid preparation 200 is not particularly limited. For example, blood preparations, saccharide injection solutions such as glucose, electrolyte correction injection solutions such as sodium chloride and potassium lactate, vitamin agents, vaccines, antibiotic injection solutions, and contrast media Agents, steroids, proteolytic enzyme inhibitors, fat emulsions, various protein preparations, anticancer agents, anesthetics, stimulants, various chemicals such as narcotics, various diagnostic agents, or distilled water, physiological saline, disinfectant, nutrition Liquids such as agents, liquid foods, and alcohols.

The outer cylinder 2 is composed of a bottomed cylindrical member having a bottom portion 211.
A plate-like flange 25 is integrally formed on the outer periphery of the base end of the outer cylinder 2. When the pusher 4 is moved relative to the outer cylinder 2, the operation can be performed by placing a finger on the flange 25.

  A central portion of the bottom portion 211 of the outer cylinder 2 is integrally formed with a mouth portion 22 that is reduced in diameter relative to the body portion (outer cylinder main body 21) of the outer cylinder 2 and protrudes into a tubular shape.

  Inside the mouth portion 22, a flow path 221 through which the liquid preparation 200 can pass (can enter and exit) is formed, and communicates with the lumen portion (space 24) of the outer cylinder 2.

  The distal end portion of the mouth portion 22 is provided with a male tapered portion 222 whose outer diameter and inner diameter gradually decrease toward the distal end direction.

  A cylindrical lock adapter (connecting member) 23 is installed in the mouth portion 22 on the outer peripheral portion 222 a of the mouth portion 22. In the present embodiment, the lock adapter 23 is provided so as to be movable along the direction of the shaft 223, but may be one that does not move. A female screw portion (syringe side screwing portion) 232 is formed on the inner peripheral portion of the lock adapter 23. As shown in FIGS. 3, 4, and 7, a plurality of protrusions 233 are formed to protrude from the proximal end portion of the inner peripheral portion of the lock adapter 23. These protrusions 233 are arranged intermittently (at equal angular intervals) along the circumferential direction of the inner peripheral portion of the lock adapter 23. Each protrusion 233 has a hemispherical shape (dome shape). The top of each protrusion 233 abuts on the outer peripheral portion 222 a of the mouth portion 22, whereby the lock adapter is supported on the outer peripheral portion 222 a of the mouth portion 22.

  The distal end portion of the mouth portion 22 is inserted into a lumen portion 711a of a cap body 71 (cap 7), which will be described later, and a male screw portion (cap side screwing) 712 of the cap main body 71 and a female screw portion 232 of the lock adapter 23. And the cap 7 can be attached to the mouth portion 22 of the outer cylinder 2 (syringe 1). Hereinafter, this state is referred to as “wearing state”.

  As a constituent material of the outer cylinder 2 (including the lock adapter 23) and a pusher 4 described later, for example, polyvinyl chloride, polyethylene, polypropylene, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic Resin, polyester such as acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, butadiene-styrene copolymer, polyamide (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12), cyclic polyolefin, etc. Various resins.

  In addition, it is preferable that the constituent material of the outer cylinder 2 is substantially transparent in order to ensure 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 200 accommodated in the syringe 1 can be grasped | ascertained.

  In such an 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 the protrusions 31 and 32 in close contact with the inner peripheral surface 20 of the 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 (not shown) that opens to the base end surface thereof. A head portion (not shown) of the pusher 4 is inserted (inserted) into the hollow portion.

  The constituent material of the gasket 3 is not particularly limited. For example, natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, Various rubber materials (especially those vulcanized) such as silicone rubber and fluoro rubber, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluorine Various thermoplastic elastomers such as rubber and chlorinated polyethylene can be mentioned, and one or more of these can be used in combination.

The pusher 4 moves the gasket 3 in the outer cylinder 2 in the longitudinal direction.
The pusher 4 has a main body 40 mainly composed of a cross-shaped plate piece, a plate member 41 at the tip, a plate member 43 at the middle, and a base end. A flange-like (plate-like) finger contact part 42 is formed integrally with the main body part 40. The pusher 4 is moved in the distal direction by pressing the finger rest 42 with a finger or the like.

The flange 25 of the outer cylinder 2 is provided with a detachment preventing member 27 that comes into contact with the plate member 43 when the pusher 4 is moved in the proximal direction. In the detachment preventing member 27, when the pusher 4 is moved in the proximal direction, the surface 271 on the distal end side of the detachment preventing member 27 and the surface 431 on the proximal end side of the plate member 43 are within the space 24. It abuts and restricts the movement of the pusher 4. This prevents the gasket 3 and the pusher 4 from being detached from the outer cylinder 2.
The cap 7 is detachably attached to the mouth portion 22 of the syringe 1 (outer cylinder 2) as described above.

Next, the manufacturing method of the cap 7 and the prefilled syringe 1 is demonstrated.
First, the cap 7 will be described.

  A cap 7 shown in FIG. 1 includes a cap body 71 having a bottomed cylindrical shape, and a packing (sealing member) 8 installed on a bottom portion 72 of the cap body 71.

  The cap body 71 includes a male screw portion 712 provided at a base end side portion (base end outer peripheral portion) of an outer peripheral portion and a grip portion (head portion) provided at a tip side portion (tip outer peripheral portion) of the outer peripheral portion. ) 73 and six ribs (projections) 74 provided on the inner periphery. In addition, this cap main body 71 can be comprised with the material which was mentioned by description about the outer cylinder 2. FIG.

  The male screw part 712 is a part that is screwed with the female screw part 232 of the lock adapter 23 of the outer cylinder 2 in the mounted state.

  The grip part 73 is a part that is gripped (held) when the cap 7 is attached to the lock adapter 23 of the outer cylinder 2 or the attached cap 7 is removed (removed). A plurality of concave portions 731 (or convex portions) are formed in the grip portion 73 along the direction of the cap 7 (cap body 71) axis 70, and these are arranged around the axis 70 at equal angular intervals (FIG. 1). reference). By forming such a recess 731, it is possible to reliably prevent the cap 7 from sliding from the finger when performing the attaching / detaching operation of the cap 7, and thus the operation can be easily and reliably performed. Can do.

  As shown in FIG. 2, a tip recess (tip recess) 721 may be formed on the bottom 72 of the cap body 71 from the tip side to the base side.

  A base end recess 722 is formed on the bottom 72 of the cap body 71 on the side opposite to the tip recess 721. The base end concave portion 722 is located at the center of the bottom portion 72, and is a portion into which a distal end convex portion 81 of the packing 8 described later is inserted.

  Six ribs 74 are integrally formed on the inner peripheral portion of the cap body 71 along the axial direction thereof. The ribs 74 are arranged at equiangular intervals around the axis 70 of the cap body 71 (see FIGS. 5 and 6). As shown in FIGS. 3 to 6, in the mounted state, each rib 74 abuts part or all of the top portion 741 against the outer peripheral portion 222 a of the mouth portion 22. Further, since the six ribs 74 are arranged at equiangular intervals around the axis 70 of the cap body 71, the top portions 741 of the ribs 74 are equally (with uniform force) the outer peripheral portion 222a of the mouth portion 22. Can abut. Thereby, the shaft 70 of the cap 7 and the shaft 223 of the mouth portion 22 can be substantially coincided with each other in the mounted state, that is, the shaft 70 of the cap 7 is excessively inclined with respect to the shaft 223 of the mouth portion 22. It is prevented (axis deviation is suppressed) (see FIG. 3). Thereby, the front-end opening 224 of the mouth portion 22 (flow path 221) is sufficiently and reliably in close contact with the packing 8, and the front-end opening 224 can be reliably sealed (see FIG. 3). Therefore, in the mounted syringe 1, the liquid preparation 200 is prevented from leaking from the distal end opening 224 of the mouth portion 22.

  Further, as shown in FIG. 4, when the cap 7 and the outer cylinder 2 are assembled (set to the mounted state), for example, depending on the degree of assembling error, the shaft 70 of the cap 7 may move relative to the shaft 223 of the mouth portion 22. In some cases, the angle (inclination between the shaft 70 of the cap 7 and the shaft 223 of the mouth portion 22) θ can be within 1 °. Even in this case, the front end opening 224 of the mouth portion 22 is sufficiently and surely adhered to the packing 8 so that the front end opening 224 can be reliably sealed (see FIG. 4). Thereby, as described above, in the syringe 1 in the mounted state, the liquid preparation 200 is prevented from leaking from the distal end opening 224 of the mouth portion 22.

  Since the six ribs 74 have the same configuration, only one rib 74 will be representatively described below.

  As shown in FIGS. 2 to 4, the rib 74 extends from the bottom 72 of the cap body 71 to the vicinity of the proximal end opening 713. Accordingly, when the mouth portion 22 of the outer cylinder 2 is inserted into the cap 7, the rib 74 is formed over substantially the entire length of the outer peripheral portion 222 a of the portion where the mouth portion 22 is inserted (male taper portion 222). The top 741 comes into contact (see FIG. 3). Thereby, the posture of the cap 7 in the mounted state is reliably corrected, so that the front end opening 224 of the mouth portion 22 is in close contact with the packing 8, and the front end opening 224 is more reliably sealed.

  As shown in FIGS. 5 and 6, the width 74 of the rib 74 gradually decreases in the distal direction (the bottom 72 side of the cap body 71). That is, the rib 74 is thicker at the base end portion than at the tip end portion. As a result, the cap 7 is preferentially supported by the proximal end portion of the mouth portion 22 rather than the distal end portion of the mouth portion 22 in the mounted state. As a result, rattling (excessive tilting) of the cap 7 is prevented, so that the front end opening 224 of the mouth portion 22 is in close contact with the packing 8, and the front end opening 224 is more reliably sealed. Moreover, it becomes easy to wind a shrink fill around the cap 7 and the lock adapter 23. Further, there is an advantage that the packing 8 can be easily inserted into the bottom portion 72 of the cap 7 or can be easily removed from the mold during injection molding (can be easily released).

  The rib 74 has a substantially trapezoidal cross-sectional shape, and the width w gradually decreases toward the top 741. That is, the rib 74 is thicker on the inner peripheral side of the cap body 71 than on the top 741 side. As a result, when the cap 7 is rotated around its axis 70 and attached to the mouth portion 22 of the outer cylinder 2 (the male screw portion 712 of the cap 7 and the female screw portion 232 of the lock adapter 23 are screwed together), the rib 74 can receive the force (torque) around the shaft 70 of the cap 7 to reliably prevent the rib 74 from being unintentionally detached (lost) from the inner peripheral portion of the cap body 71. Further, there is an advantage that the torque when the cap 7 is opened can be reduced.

  As shown in FIGS. 3 and 4, the height 74 of the rib 74 gradually increases in the distal direction. That is, the rib 74 has a top 741 inclined with respect to the shaft 70. This inclination angle is almost the same as the taper angle (inclination angle) of the male taper part 222 (mouth part 22) of the outer cylinder 2 in most parts (excluding the base end part 742) of the rib 74 (top part 741). is there. Thereby, the top part 741 of the rib 74 reliably contacts the male taper part 222 (mouth part 22) of the outer cylinder 2 in the mounted state.

  Further, the height h of the base end portion 742 of the rib 74 is larger than the degree of gradual increase in the height h of the portion on the distal end side. Accordingly, when the mouth portion 22 of the outer cylinder 2 is inserted into the lumen portion 711 a of the cap 7, the distal end edge portion 225 of the mouth portion 22 comes into contact with the proximal end portion 742 of the rib 74 and enters the lumen portion 711 a. Guided and can be easily inserted.

  As shown in FIGS. 2 and 5, a groove 75 is formed in the top portion 741 of the rib 74 along the direction of the axis 70 of the cap body 71. The groove 75 extends partway from the base end 742 of the rib 74 (the end on the base end opening 713 side of the cap body 71). Specifically, the length of the groove 75 is preferably 10 to 80% of the length of the rib 74, and more preferably 50 to 80%.

  By forming such a groove 75, the cap 7 abuts on the base end side portion of the mouth portion 22 with twice the number of contacts at the front end portion of the mouth portion 22. . As a result, rattling (excessive tilting) of the cap 7 is prevented, and the angle θ in the mounted state is reliably within 1 °. Therefore, the front end opening 224 of the mouth portion 22 is in close contact with the packing 8, and the front end opening 224 is more reliably sealed.

  The cross-sectional shape of the groove 75 is not particularly limited. For example, the groove 75 may have a semicircular arc shape as shown in FIG. 5, a V shape, or a U shape. It may be.

  Further, the top portion 741 of the rib 74 has a shape in which the groove 75 is formed in a region along the longitudinal direction of the rib 74 along the curved shape of the outer peripheral portion 222a of the mouth portion 22. Curved in an arc. Thereby, a relatively large contact area between the top portion 741 of the rib 74 and the outer peripheral portion 222a of the mouth portion 22 can be secured in the mounted state. The region excluding the region where the groove 75 of the top 741 of the rib 74 is formed may be curved in an arc shape, or may be a flat surface as shown in FIG.

  As shown in FIGS. 3 and 4, a packing 8 made of an elastic material is installed on the bottom 72 of the cap body 71. The packing 8 is sandwiched (compressed) by the bottom 72 of the cap body 71 and the mouth portion 22 in a mounted state, and is in close contact with the tip opening 224 of the mouth portion 22. Thereby, the front end opening 224 of the mouth portion 22 can be reliably sealed, and thus the liquid preparation 200 is prevented from leaking from the front end opening 224.

  The packing 8 is formed of a disk-shaped member, and is compressed in the radial direction (toward the shaft 70 side) by a portion on the tip end side of the top portion 741 of each rib to be inside the lumen portion 711a of the cap body 71. It is stored in. Thereby, the separation packing 8 is prevented from unintentionally removing from the inside of the lumen portion 711 a of the cap body 71.

  Further, the packing 8 has a tip convex portion 81 projecting from the tip end surface thereof and a base end convex portion 82 projecting from the base end surface thereof. The tip convex portion 81 and the base end convex portion 82 are hemispherical portions, respectively. The tip convex portion 81 is inserted into the base end concave portion 722 of the bottom portion 72 of the cap body 71. The base end convex portion 82 is inserted into the distal end opening 224 (flow path 221) of the mouth portion 22 of the outer cylinder 2 in the mounted state.

  Although it does not specifically limit as a constituent material of the packing 8, For example, the elastic material which was mentioned by description about the gasket 3 can be used.

  Next, the manufacturing method (manufacturing process) of the syringe 1 using the cap 7 will be described with reference to FIGS.

[1] Cap mounting process (first process)
First, the outer cylinder 2 and the cap 7 on which the lock adapter 23 is installed are prepared, and the cap 7 is attached to the mouth portion 22 of the outer cylinder 2 (see FIG. 7).

[2] Sterilization process (second process)
The outer cylinder 2 (including the cap 7) is sterilized with the cap 7 attached to the mouth portion 22 of the outer cylinder 2 (attached state) (see FIG. 7).

  The sterilization at this time is not particularly limited, and examples thereof include autoclave sterilization, gas sterilization using a sterilization gas such as hydrogen peroxide and EOG, and radiation sterilization by irradiation with radiation such as γ rays and electron radiation. Can be used. Here, as an example, the case of autoclave sterilization will be described.

  Put the outer cylinder 2 and the cap 7 in the autoclave sterilizer. In this state, high-pressure steam R is supplied into the apparatus for sterilization.

  At this time, the high-pressure steam R sequentially passes between the base opening 234 and the protrusions 233 of the lock adapter 23 of the outer cylinder 2 and reaches the base opening 713 of the cap 7. Then, the high-pressure steam R flows between the ribs 74, that is, into the lumen portion 711 a through the proximal end opening 713 of the cap 7. By the high-pressure steam R flowing in this way, the mouth portion 22 of the outer cylinder 2 to which the cap 7 is attached can be surely sterilized (see FIG. 7).

[3] Liquid preparation filling step (third step)
Thereafter, the mounted outer cylinder 2 is moved into an isolator in a sterile environment. And this outer cylinder 2 is arrange | positioned so that the front end side may become vertically downward. In this state, the liquid preparation 200 that has been previously sterilized (for example, filter sterilization) is filled into the outer cylinder 2 from the opening at the proximal end of the outer cylinder 2 (see FIG. 8). This filling amount corresponds to the capacity of the syringe 1 and is about 0.1 to 100 mL.

[4] Capping process (4th process)
After filling the liquid preparation 200, the gasket 3 is inserted into the outer cylinder 2 (see FIG. 9). The gasket 3 can be easily inserted by reducing the pressure in the isolator (making it in a vacuum state).
Then, the pusher 4 is connected to the gasket 3 to complete the prefilled syringe 1.
By such a method, the syringe 1 can be manufactured aseptically.

  Moreover, since the manufactured syringe 1 has the mouth portion 22 (flow path 221) of the outer cylinder 2 sealed in a liquid-tight (air-tight) manner by the packing 8 as described above, the liquid preparation 200 is a syringe. Leakage from inside 1 is prevented.

  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.

  The number of ribs formed on the cap body is not limited to six, and may be two, three, four, five, seven or more, for example.

  Moreover, the groove | channel currently each formed in the top part of each rib is not limited to being formed in a part of top part of the said rib, For example, you may be formed over the whole top part of a rib.

  In the prefilled syringe manufacturing process, the attached outer cylinder is sterilized in the sterilization process, but the present invention is not limited to this. For example, the outer cylinder and the cap may be individually sterilized. In this case, after the sterilization treatment, the outer cylinder and the cap can be moved into, for example, an isolator in a sterile environment, and the cap can be attached to the mouth portion of the outer cylinder to be in an attached state. Thereafter, the liquid preparation filling step and the plugging step can be performed in order.

It is a perspective view of the cap of this invention. It is a longitudinal cross-sectional perspective view of the cap shown in FIG. It is a longitudinal cross-sectional view which shows the state (mounting state) which mounted | wore the syringe outer cylinder with the cap shown in FIG. It is a longitudinal cross-sectional view which shows the state (mounting state) which mounted | wore the syringe outer cylinder with the cap shown in FIG. It is the sectional view on the AA line in FIG. FIG. 5 is a sectional view taken along line BB in FIG. 3. It is a figure which shows the process of manufacturing a prefilled syringe in order. It is a figure which shows the process of manufacturing a prefilled syringe in order. It is a figure which shows the process of manufacturing a prefilled syringe in order. It is a fragmentary longitudinal cross-sectional view of a prefilled syringe.

Explanation of symbols

1 Syringe (Prefilled syringe)
2 outer cylinder (syringe outer cylinder)
20 Inner peripheral surface 21 Outer cylinder main body 211 Bottom 22 Portion 221 Flow path 222 Male taper part 222a Outer peripheral part 223 Shaft 224 Tip opening 225 Tip edge 23 Lock adapter 232 Female screw part (syringe side screwing part)
233 Projection 234 Base end opening 24 Space 25 Flange 27 Detachment prevention member 271 Surface 3 Gasket 31, 32 Projection 4 Pusher (plunger)
40 body part 41 plate member 42 finger contact part 43 plate member 431 surface 7 cap 70 shaft 71 cap body 711a lumen part 712 male screw part (cap side screwing)
713 Base end opening 72 Bottom 721 Tip recess (tip recess)
722 Base end recess 73 Grip part (head part)
731 Concave part 74 Rib (projection)
741 Top part 742 Base end part 75 Groove 8 Packing 81 Tip convex part 82 Base end convex part 200 Liquid preparation R High-pressure steam h Height w Width θ angle

Claims (9)

An outer cylinder main body having a mouth portion through which liquid can go in and out , which has a male taper portion whose outer diameter is formed to project in a tubular shape at the tip portion and gradually decreases in the tip direction, and is installed in the mouth portion. A cap attached to the mouth portion of the syringe outer cylinder including a cylindrical lock adapter having a syringe-side threaded portion,
A cap body having a bottomed cylindrical shape, provided with a cap-side screwed portion that is screwed to the syringe-side screwed portion on the outer peripheral portion thereof, and provided with a plurality of ribs along the axial direction of the inner peripheral portion. When,
A sealing member installed at the bottom of the cap body and made of an elastic material;
Each of the ribs extends from the bottom of the cap body to the vicinity of the opening, the width of the rib gradually decreases toward the bottom of the cap body, and gradually decreases toward the top, and , The height of the rib gradually increases toward the bottom side of the cap body,
In the mounted state mounted on the mouth portion, the top portion of the rib abuts on the outer peripheral portion of the male taper portion , and the axial displacement of the cap body with respect to the mouth portion is suppressed, and the sealing member is the mouth portion. It is comprised so that may be sealed. The cap according to claim 1 , wherein a curved surface curved in an arc shape is formed on the whole or a part of the top of each rib. The said curved surface is a cap of Claim 2 extended from the edge part by the side of the opening part of the said cap main body of the said rib to the middle. The cap according to any one of claims 1 to 3 , wherein a groove is formed in the top of each of the ribs along the axial direction of the cap main body, either entirely or partially. The said groove | channel is a cap of Claim 4 extended from the edge part by the side of the opening part of the said cap main body of the said rib to the middle. The cap according to any one of claims 1 to 5 , wherein the ribs are arranged at equiangular intervals around an axis of the cap body. The cap according to any one of claims 1 to 6 , wherein an angle formed by the shaft of the cap body and the shaft of the mouth portion is 1 ° or less in the mounted state. The cap according to any one of claims 1 to 7, wherein each of the ribs has a portion in which the degree of a gradual increase in height differs along the axial direction of the cap body. An outer cylinder main body having a mouth portion that protrudes in a tubular shape at the distal end portion and has a mouth portion through which liquid can enter and exit, and a lock adapter that is installed in the mouth portion and has a cylindrical shape that has a syringe-side screwing portion on the inner peripheral portion. A method for producing a prefilled syringe comprising a syringe outer cylinder, the cap according to any one of claims 1 to 8 attached to the mouth, and a liquid preparation filled in the syringe outer cylinder,
Attach the cap to the mouth, sterilize in this state,
Then, the prefilled syringe manufacturing method characterized by filling the said syringe with the said liquid formulation in an aseptic environment.

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