JP4491215B2 - Prefilled syringe and method for producing prefilled syringe - Google Patents

Description

The present invention relates to a prefilled syringe and a method for producing 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 disclosed in which a lock adapter is provided on the outer peripheral portion of the liquid discharge portion (mouth portion) (for example, Patent Document 1).

  The lock adapter has a threaded portion formed on the inner peripheral surface thereof, and is configured such that the threaded portion and a threaded portion of a connector (connector) to which a tube (tube body) is connected, for example, are screwed together. Has been. By this screwing, the prefilled syringe can be connected to the connector. And the liquid formulation filled beforehand can be inject | poured into a tube via a connector.

  Now, the prefilled syringe provided with the lock adapter has a problem that there is no cap for sealing (sealing) the liquid discharge part. For this reason, when this prefilled syringe is connected to the connector, the liquid discharge part is exposed to the outside air (air) for a long time, and this liquid discharge part may be contaminated with bacteria.

Japanese Patent Laid-Open No. 08-126701

The objective of this invention is providing the prefilled syringe which can be mounted | worn with the prefilled syringe provided with the lock | rock adapter, and can maintain the mouth part periphery of the syringe outer cylinder after a sterilization process in a sterilization state. Moreover, it is providing the manufacturing method of the prefilled syringe which manufactures this prefilled syringe.

Such an object is achieved by the present inventions (1) to (4) below.
(1) it is projectingly formed at the tip, and the mouth portion having a Osutepa portion to the tip portion, provided on the outer peripheral portion of the mouth portion, and a syringe barrel and a lock adapter having a male threaded portion on the inner peripheral surface , a prefilled syringe and a cap to be attached to the mouth portion,
The cap is a bottomed cylindrical cap main body having a lumen portion and a female side screwing portion formed on the outer peripheral surface and screwed with the male side screwing portion;
It is composed of an elastic material, and includes a packing provided in the lumen of the cap body,
When the cap body is attached to the mouth portion, the proximal end portion of the inner peripheral surface of the lumen portion is in close contact with the male taper portion over the entire circumference, and the packing is connected to the end surface of the lumen portion. A prefilled syringe characterized by being sandwiched between the tip of the mouth and sealing the mouth in a liquid-tight manner .

(2) The prefilled syringe according to (1), wherein the lock adapter is movable along the axial direction of the mouth.

(3) A method for producing the prefilled syringe according to (1) or (2) above ,
Sterilize the syringe barrel and the cap,
Next, in a sterile environment, the cap is attached to the mouth,
Then, the prefilled syringe manufacturing method characterized by filling the said syringe with the said liquid formulation in an aseptic environment.

(4) A method for producing the prefilled syringe according to (1) or (2) above ,
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, in manufacturing a prefilled syringe equipped with a lock adapter, each part of the syringe outer cylinder can be sufficiently sterilized, and the periphery of the mouth of the syringe outer cylinder after sterilization can be kept in a sterilized state. Can do.

The prefilled syringe of this invention and the manufacturing method of a prefilled syringe are demonstrated .

  FIG. 4 is a partial longitudinal sectional view of the prefilled syringe. In the following, for convenience of explanation, the upper side in FIG. 4 (the same applies to FIGS. 1 to 3) is referred to as “tip”, and the lower side is referred to as “base end”.

  A prefilled syringe (hereinafter simply referred to as “syringe”) 1 shown in FIG. 4 is one in which a liquid preparation 200 such as a drug solution is stored in advance inside 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 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 projecting mouth portion 22 that is reduced in diameter relative to the body portion (outer cylinder main body 21) of the outer cylinder 2.

  A flow path 221 through which the fluid Q can pass is formed inside the mouth portion 22, and communicates with a 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 provided on the outer peripheral portion of the mouth portion 22 so as to be relatively movable along the axial direction of the mouth portion 22. A screw thread (male side screwing portion) 232 is formed on the inner peripheral surface of the lock adapter 23.

The distal end portion of the mouth portion 22 is inserted into a lumen portion 711a of a cap body 71 (cap 7) described later, and a screw groove (female side screwing portion) 712 of the cap body 71 and a screw thread 232 of the lock adapter 23 are formed. By screwing, the cap 7 can be attached to the mouth 22 of the outer cylinder 2 (syringe 1).

  As a constituent material of the outer cylinder 2 (including the lock adapter 23) and the pusher 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 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 opened to the base end surface. The head portion of the pusher 4 is inserted (inserted) into the hollow portion.

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 a cap and a prefilled syringe is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.

First, the cap 7 will be described.
FIG. 1 and FIG. 2 are half-longitudinal sectional views showing embodiments of the cap , respectively.

  The cap 7 shown in FIGS. 1 and 2 includes a cap body 71 and a packing (sealing member) 72.

  As shown in FIG. 1, the cap main body 71 is configured by a member having a bottomed cylindrical shape, and has a lumen portion 711 a and a screw groove 712.

  The lumen portion 711 a has a substantially cylindrical shape, and is formed from the base end surface 713 of the cap body 71 to the vicinity of the intermediate portion 714.

  A plate-like (disk-shaped) packing 72 made of an elastic material is provided in parallel with the tip surface 711b on the tip surface 711b that surrounds the lumen 711a. The diameter of the packing 72 is preferably about the same as or slightly larger than the diameter of the lumen portion 711a. Thereby, it is possible to prevent the packing 72 from being easily detached from the lumen portion 711a (cap body 71).

The screw groove 712 is formed on the outer peripheral surface 715 on the proximal end side of the cap body 71.
In addition, a concave portion 718 having a substantially regular hexagonal shape in a plan view is formed on the distal end surface 717 of the cap body 71.

  When attaching the cap 7 to the mouth portion 22, a hexagon wrench (not shown) is fitted into the recess 718. Then, by applying a torque around the axis of the cap 7 (cap body 71) to the hex wrench, the cap 7 is rotated, and the screw thread 232 of the lock adapter 23 and the screw groove 712 of the cap body 71 are easily and It can be reliably screwed together.

  Next, a state where the cap 7 (cap body 71) is attached to the mouth portion 22 of the outer cylinder 2 (hereinafter, this state is referred to as “cap attachment state”) will be described (see FIG. 2).

  In this cap mounting state, the cap 7 is configured such that a part of the inner peripheral surface 711c of the surface surrounding the lumen portion 711a is in close contact with the male taper portion 222 over the entire periphery.

  Specifically, a reduced diameter portion 716 in which the inner diameter of the lumen portion 711 a is reduced is formed at the proximal end portion of the lumen portion 711 a (inner peripheral surface 711 c), and this reduced diameter portion 716 is the mouth portion 22. (Male taper portion 222). Thereby, the reduced diameter part 716 and the base end part of the opening part 22 are comprised so that it may closely_contact | adhere.

  Similarly, in the cap mounting state, the lock adapter 23 is located on the distal end side of the mouth portion 22, and the screw thread 232 of the lock adapter 23 is screwed into the screw groove 712 of the cap 7.

  With such a configuration, the inside of the lumen portion 711a can be kept sealed. That is, the outer surface 222 a of the mouth portion 22 (male taper portion 222) in the lumen portion 711 a can be isolated from the outside of the syringe 1 by the cap 7.

  Similarly, in the cap-mounted state, the packing 72 is sandwiched between the distal end surface 711b (end surface) of the lumen portion 711a and the distal end of the mouth portion 22 to make the mouth portion 22 (flow path 221) liquid-tight (airtight). Sealing). The thickness of the packing 72 is preferably about the same as or slightly larger than the distance between the front end surface 711 b and the front end of the mouth portion 22. Thereby, the packing 72 in the cap-mounted state is elastically deformed in the thickness direction, and the mouth portion 22 can be more reliably sealed.

  With such a configuration, it is possible to prevent the liquid preparation 200 from leaking from the mouth portion 22 when the liquid preparation 200 such as a chemical solution is stored (filled) in the syringe 1 (the space 24 of the outer cylinder 2).

  In addition, as described above, the sealed state in the lumen portion 711a is maintained by the close contact between the cap body 71 (the reduced diameter portion 716) and the mouth portion 22 (male taper portion 222). The sealed state is configured to be maintained by the close contact between the packing 72 and the tip of the mouth portion 22.

  Examples of the constituent material of the cap body 71 include polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene. Polyester such as terephthalate and polyethylene naphthalate, butadiene-styrene copolymer, polyamide (eg, nylon 6, nylon 6,6, nylon 6,10, nylon 12), ethylene-vinyl alcohol copolymer, polyallylsulfone, poly Various resins such as ether sulfone, methacryl-styrene copolymer, polyarylate, styrene-acrylonitrile copolymer can be mentioned. Among them, polypropylene, Jo polyolefins, polyesters, poly - (4-methylpentene-1) resin such as is preferred.

  Examples of the constituent material of the packing 72 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, silicone rubber, Various rubber materials such as fluoro rubber (especially those vulcanized), styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluoro rubber, Examples include various thermoplastic elastomers such as chlorinated polyethylene, and relatively soft resin materials such as polyethylene and vinyl chloride resin. One or more of these can be used in combination.

  Next, a manufacturing method (assembly method) of the prefilled syringe 1 using the cap 7 will be described.

<First Embodiment>
FIG. 3 is a side view of the prefilled syringe with the cap shown in FIG. 1 attached.
Hereinafter, each process which manufactures the prefilled syringe 1 is demonstrated.

[A1] Sterilization step (first step)
First, the outer cylinder 2 and the cap 7 are prepared and sterilized.

  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. Hereinafter, each case using such a sterilization method will be described.

[A1-1] Process using autoclave sterilization (autoclave sterilization process)
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 reaches the lumen portion 711a of the cap 7, and the cap 7, particularly the lumen portion 711a, is sufficiently sterilized (see FIG. 1). Further, the high-pressure steam R sufficiently sterilizes the surface of the mouth portion 22 and also passes through the flow path 221 and is sufficiently sterilized in the outer cylinder 2, particularly into the mouth portion 22 (flow path 221) (see FIG. 4).

[A1-2] Process using gas sterilization (gas sterilization process)
Much like the above step [A1-1], the outer tube 2 and the cap 7, respectively, are sterile.

[A1-3] Process using radiation sterilization (radiation sterilization process)
The outer cylinder 2 and the cap 7 are each stored in a storage member (packaging material) that can be stored, and the opening of the storage member is sealed to keep the inside airtight. In this state, radiation sterilization is performed by irradiating with radiation.

[A2] Cap mounting process (second process)
Next, after the sterilization is completed, the cap 7 and the outer cylinder 2 are moved into an isolator in an aseptic environment, and the cap 7 is attached to the mouth portion 22 of the outer cylinder 2 (see FIG. 2).

  At this time, the configuration described above can prevent the mouth portion 22 in the lumen portion 711a from coming into contact with other parts and the like, and the risk of generation and adhesion of foreign matter, fine particles, and the like to the mouth portion 22 can be prevented. Sex can be avoided. Therefore, the outer surface 222a of the mouth portion 22 can be maintained in a sterile state.

[A3] Liquid preparation filling step (third step)
Thereafter, in a sterile environment, the liquid preparation 200 that has been previously sterilized (for example, filter sterilization or the like) is filled into the outer cylinder 2 from the opening at the base end of the 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 200, the gasket 3 and the pusher 4 are attached, and the prefilled syringe 1 is completed as shown in FIG.

In this state, as described above, since the mouth portion 22 (flow path 221) of the outer cylinder 2 is sealed in a liquid-tight (air-tight) manner by the packing 72, the liquid preparation 200 is discharged from the syringe 1 inside. There is no leakage.
By such a method, the prefilled syringe 1 can be manufactured aseptically.

  Liquid preparations 200 include 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, narcotics, various diagnostic agents, distilled water, physiological saline, disinfectants, nutrients, liquid food, alcohol, etc. Of liquid is stored.

<Second Embodiment>
Hereinafter, although the manufacturing method of the prefilled syringe of 2nd Embodiment is demonstrated, it demonstrates centering around difference with 1st Embodiment mentioned above, and abbreviate | omits the description about the same matter.

  In the second embodiment, the first embodiment is different from the first embodiment except that the order of sterilizing the outer cylinder 2 and the cap 7 (sterilization process) and the process of mounting the cap 7 to the mouth portion 22 (cap mounting process) are different. It is the same as the form.

[B1] Cap mounting process (first process)
First, the outer cylinder 2 and the cap 7 are prepared, and the cap 7 is attached to the mouth portion 22 of the outer cylinder 2 (see FIG. 2).

[B2] Sterilization step (second step)
In this state (cap mounting state), the outer cylinder 2 (including the cap 7) is sterilized.

The sterilization at this time includes, for example, radiation sterilization by irradiation with radiation such as γ rays and electron radiation. When using this radiation sterilization, the process similar to the said process [A1-3] is performed.
At this time, the above-described configuration can provide the same effect as described above.

[B3] Liquid preparation filling step (third step)
A step similar to the step [A3] is performed.

  By such a method, the prefilled syringe 1 can be manufactured aseptically as in the first embodiment.

As described above, the prefilled syringe and the prefilled syringe manufacturing method of the present invention have been described with respect to the illustrated embodiment. However, the present invention is not limited to this, and each part constituting the prefilled syringe exhibits the same function. It can be replaced with any configuration obtained. Moreover, arbitrary components may be added.

It is a half longitudinal section showing an embodiment of a cap . It is a half longitudinal section showing an embodiment of a cap . It is a side view of the prefilled syringe of the state which mounted | wore the cap shown in FIG. It is a fragmentary longitudinal cross-sectional view of a prefilled syringe.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Syringe 2 Outer cylinder 20 Inner peripheral surface 21 Outer cylinder main body 211 Bottom part 22 Portion 221 Flow path 222 Male taper part 222a Outer surface 23 Lock adapter 232 Thread 24 Space 25 Flange 27 Detachment prevention member 271 Surface 3 Gaskets 31 and 32 Projection 4 Pusher 40 Main Body 41 Plate Member 42 Finger Contact 43 Plate Member 431 Surface 7 Cap 71 Cap Body 711a Lumen 711b Tip Surface 711c Inner Surface 712 Screw Groove 713 Base Surface 714 Intermediate Portion 715 Outer Diameter Surface 716 Reduced Diameter Portion 717 Tip surface 718 Recess 72 Packing 200 Liquid preparation Q Fluid R High-pressure steam

Claims (4)

Formed to protrude the tip, and the mouth portion having a Osutepa portion to the tip portion, provided on the outer peripheral portion of the mouth portion, and a syringe barrel and a lock adapter having a male threaded portion on the inner peripheral surface, said port A prefilled syringe having a cap attached to the part,
The cap is a bottomed cylindrical cap main body having a lumen portion and a female side screwing portion formed on the outer peripheral surface and screwed with the male side screwing portion;
It is composed of an elastic material, and includes a packing provided in the lumen of the cap body,
When the cap body is attached to the mouth portion, the proximal end portion of the inner peripheral surface of the lumen portion is in close contact with the male taper portion over the entire circumference, and the packing is connected to the end surface of the lumen portion. A prefilled syringe characterized by being sandwiched between the tip of the mouth and sealing the mouth in a liquid-tight manner . The prefilled syringe according to claim 1, wherein the lock adapter is movable along an axial direction of the mouth portion. A method for producing the prefilled syringe according to claim 1 or 2 ,
Sterilize the syringe barrel and the cap,
Next, in a sterile environment, the cap is attached to the mouth,
Then, the prefilled syringe manufacturing method characterized by filling the said syringe with the said liquid formulation in an aseptic environment. A method for producing the prefilled syringe according to claim 1 or 2 ,
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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