JP2016182233A - Manufacturing method of syringe and manufacturing apparatus of syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a manufacturing method of a syringe capable of storing a proper amount of water in a closed space, and shortening a sterilization time of a wall surface constituting the closed space; and to provide a manufacturing apparatus of the syringe.SOLUTION: In a manufacturing method of a syringe 10, misty water or steam is introduced from a water supply apparatus 54 into a reception hole 30 of a cap 18 unattached to a syringe body 12. Then, the cap 18 holding water introduced through the reception hole 30 is attached to the syringe body 12. Successively, high pressure steam sterilization by steam is applied to the syringe body 12 and the cap 18 by using a sterilization unit 60.SELECTED DRAWING: Figure 3

Description

  In the present invention, a closed space is formed between the cap and the fluid circulation part in a state where the cap is mounted on the syringe body so that at least a part of the fluid circulation part of the syringe body is accommodated in the accommodation hole of the cap. The present invention relates to a syringe manufacturing method and a syringe manufacturing apparatus.

  For example, Patent Document 1 discloses that a part of a fluid circulation portion (a tip portion of a syringe outer cylinder and a needle tube) of a syringe body is accommodated in an accommodation hole of a cap and a needle hole of the needle tube is sealed. A syringe is disclosed in which a closed space is formed between the cap and the distal end portion of the syringe outer cylinder with the cap attached to the distal end portion of the tube.

US Pat. No. 6,719,732

  By the way, when performing high-pressure steam sterilization with water vapor on the syringe body and the cap with the cap attached to the syringe body, the wall surface constituting the closed space formed between the cap and the fluid circulation part may be sterilized. desirable. However, since it is necessary to permeate water vapor through the cap and introduce it into the closed space, the sterilization time is prolonged.

  Here, it is also conceivable that water is poured into a closed space by dripping water into a cap accommodation hole not previously mounted on the syringe body, and the water is evaporated during high-pressure steam sterilization. However, in such a method by dripping water, it is not easy to adjust the amount of water, so there is a possibility that an appropriate amount of water cannot be put in the closed space.

  The present invention has been made in consideration of such a problem, and is a syringe capable of storing an appropriate amount of water in a closed space and shortening the sterilization time of a wall surface constituting the closed space. An object of the present invention is to provide a manufacturing method and a syringe manufacturing apparatus.

  In order to achieve the above object, the method for manufacturing a syringe according to the present invention includes the cap attached to the syringe body so that at least a part of the fluid circulation portion of the syringe body is accommodated in the accommodation hole of the cap. A syringe manufacturing method in which a closed space is formed between the cap and the fluid circulation part, and water is supplied to the accommodation hole of the cap not attached to the syringe body using mist-like water or water vapor. A water introduction step for introducing, a mounting step for mounting the cap in a state where the water is introduced into the accommodation hole after the water introduction step, and the syringe main body and the syringe after the mounting step. A sterilization step of performing high-pressure steam sterilization with water vapor on the cap.

  According to such a method, water is introduced into the accommodation hole of the cap that is not attached to the syringe body using mist-like water or water vapor, so that an appropriate amount of water can be put in the closed space. And since the wall surface which comprises closed space can be sterilized by evaporating the water of closed space at a sterilization process, shortening of sterilization time can be aimed at.

  In the above manufacturing method, the fluid circulation part may have a needle tube accommodated in the accommodation hole. In such a case, the capacity of the closed space becomes relatively large, but an appropriate amount of water according to the capacity of the closed space can be put in the closed space, so that the wall surfaces constituting the closed space can be efficiently and reliably provided. Can be sterilized.

  In the above manufacturing method, the syringe body may be a syringe outer cylinder for a prefilled syringe. In such a case, in order to suppress water evaporation in the chemical solution, it is necessary to configure the cap with a material having a relatively low water vapor permeability. However, even if such a material is used, the sterilization time can be shortened. be able to.

  In the syringe manufacturing apparatus according to the present invention, the cap and the fluid circulation part are installed in the state where the cap is attached to the syringe body so that at least a part of the fluid circulation part of the syringe body is accommodated in the accommodation hole of the cap. An apparatus for manufacturing a syringe in which a closed space is formed between the cap holding portion for holding the cap, and the accommodation hole of the cap held by the cap holding portion in a state where the cap is not attached to the syringe body And a water supply device for supplying mist-like water or water vapor toward the surface.

  According to such an apparatus, there can exist an effect similar to the manufacturing method of the syringe mentioned above.

  According to the present invention, water can be introduced into the accommodation hole of the cap using mist-like water or water vapor, so that an appropriate amount of water can be put in the closed space and the wall surface constituting the closed space can be provided. The sterilization time can be shortened.

It is a section explanatory view showing the water introduction process in the manufacturing method of the syringe concerning one embodiment of the present invention. It is sectional explanatory drawing which shows the mounting process in the manufacturing method of the said syringe. It is sectional explanatory drawing which shows the sterilization process in the manufacturing method of the said syringe. It is a longitudinal cross-sectional view of the syringe obtained by the manufacturing method of the said syringe.

  DESCRIPTION OF EXEMPLARY EMBODIMENTS Hereinafter, preferred embodiments of a manufacturing method of a syringe and a manufacturing apparatus used in the method according to the invention will be described with reference to the accompanying drawings.

  First, the structure of the syringe 10 obtained by the manufacturing method of the syringe 10 which concerns on one Embodiment of this invention is demonstrated, referring FIG. In the description of the syringe 10, the left side of FIG.

  As shown in FIG. 4, the syringe 10 is configured as a prefilled syringe, and includes a syringe body 12, a gasket 14 and a pusher 16 provided on the syringe body 12, and a cap 18 that can be attached to and detached from the syringe body 12. And. The syringe body 12 has a syringe outer cylinder 20 filled with a chemical solution and a fluid circulation part 22 provided at the tip of the syringe outer cylinder 20.

  The syringe outer cylinder 20 is made of a material having a relatively low water vapor permeability in order to prevent moisture in the chemical solution from evaporating. The gasket 14 is made of rubber or the like, and slides along the axial direction of the syringe outer cylinder 20 in a liquid-tight manner with respect to the inner surface of the syringe outer cylinder 20. The pusher 16 is made of a resin material or the like, and extends from the opening on the proximal end side of the syringe outer cylinder 20 to the outside of the syringe outer cylinder 20 while being connected to the gasket 14.

  The fluid circulation part 22 has a hub 24 provided at the tip of the syringe outer cylinder 20 and a needle tube 26 fixed to the hub 24. The hub 24 is integrally formed with the syringe outer cylinder 20 with the same material as the syringe outer cylinder 20. The hub 24 extends along the axial direction of the syringe outer cylinder 20, and an annular locking portion 28 that can be locked to the cap 18 is formed on the distal end side of the hub 24.

  The needle tube 26 is made of a metal material such as stainless steel. However, the needle tube 26 can be made of a resin material or the like. The needle tube 26 is exposed for a predetermined length on the distal end side while the proximal end side is fixed to the hub 24.

  The cap 18 is a protector (needle shield) for protecting the exposed portion on the distal end side of the needle tube 26 while being attached to the hub 24, and is formed to be slightly elongated as a whole. The cap 18 is made of a material having a relatively low water vapor permeability in order to prevent moisture in the chemical solution in the syringe outer cylinder 20 from evaporating through the needle tube 26. Examples of such a material include isoprene rubber, butadiene rubber, and butyl rubber.

  The cap 18 is formed with an accommodation hole 30 that extends in the longitudinal direction of the cap 18 and accommodates the distal end side of the fluid circulation portion 22. The accommodation hole 30 is closed at one end and opened at the other end. An annular recess 32 into which the locking portion 28 of the hub 24 is fitted is formed on the inner surface of the housing hole 30 on the other end (opening) side slightly from the center in the depth direction of the housing hole 30.

  In such a syringe 10, a predetermined closed space 34 is formed between the cap 18 and the hub 24 in a state where the cap 18 is attached to the syringe body 12. In other words, a predetermined closed space 34 is formed between the distal end portion of the hub 24 and the bottom surface of the receiving hole 30 in a state where the engaging portion 28 of the hub 24 is fitted in the annular recess 32 of the cap 18. .

  The syringe 10 according to the present embodiment is basically configured as described above. Next, a method for manufacturing the syringe 10 will be described in relation to a manufacturing apparatus for the syringe 10. In the following description, it is assumed that the syringe body 12, the gasket 14, the pusher 16, and the cap 18 are preliminarily molded in the initial state. Moreover, the manufacturing apparatus 48 of the syringe 10 is provided with the cap holding | maintenance part 50, the conveying apparatus 52, the water supply apparatus 54, the outer cylinder holding | maintenance part 58, and the sterilization apparatus 60 (refer FIGS. 1-3).

  In the manufacturing method of the syringe 10, first, as shown in FIG. 1, a water introduction step of introducing mist-like water into the accommodation hole 30 of the cap 18 that is not attached to the syringe body 12 is performed. In this water introduction step, for example, the plurality of caps 18 are attached to the cap holding unit 50 in the same direction.

  And the cap holding | maintenance part 50 is conveyed by conveyance apparatuses 52, such as a belt conveyor, and each cap 18 is passed to the location where the mist-like water is supplied from the nozzle 56 of the water supply apparatus 54. FIG. At this time, the opening of the accommodation hole 30 faces the nozzle 56 of the water supply device 54. Thereby, a very small amount (for example, several μL) of water adheres substantially uniformly to the entire inner surface constituting the accommodation hole 30.

  In the present embodiment, the cap 18 is moved with respect to the water supply device 54 in the water introduction step. However, the water supply device 54 may be moved with the cap 18 stopped, or the cap 18 and the water may be moved. Both supply devices 54 may be moved.

  Further, in the water introduction step, each cap 18 is passed through the nozzle 56 of the water supply device 54 to a location where the water vapor is supplied, thereby introducing the water vapor into the accommodation hole 30 and condensing it on the wall surface constituting the accommodation hole 30. Water may be attached.

  Subsequently, as shown in FIG. 2, an attachment process for attaching the cap 18 to the syringe body 12 is performed. In this mounting step, the outer cylinder holding section is held in a state where the plurality of syringe main bodies 12 held by the outer cylinder holding section 58 are opposed to the openings of the accommodation holes 30 of the plurality of caps 18 held by the cap holding section 50. 58 is moved to the cap 18 side.

  Then, the needle tube 26 is inserted into the accommodation hole 30 and the engaging portion 28 of the hub 24 is fitted into the annular recess 32, whereby the cap 18 is attached to the fluid circulation portion 22. At this time, the water introduced in the water introduction process is present in the closed space 34 formed between the cap 18 and the fluid circulation part 22.

  In the present embodiment, the syringe body 12 is moved with respect to the cap 18 in the mounting step. However, the cap 18 may be moved with the syringe body 12 stopped, and the syringe body 12 and the cap 18 may be moved. Both may be moved.

  Next, as shown in FIG. 3, high-pressure steam sterilization (autoclave) with water vapor is performed on the syringe body 12 and the cap 18 to evaporate water in the closed space 34 and sterilize the wall surface 36 constituting the closed space 34. Perform the sterilization process.

  In this sterilization process, a plurality of syringe bodies 12 with caps 18 attached thereto are arranged in a container 62 of a sterilizer 60, and high-pressure and high-temperature steam is supplied into the container 62. Thereby, the outer surface of the cap 18 and the syringe body 12 and the inner surface of the syringe outer cylinder 20 are sterilized. Further, since water adhering to the inner surface constituting the accommodation hole 30 evaporates due to the temperature rise of the cap 18 itself, water vapor is generated in the closed space 34. Therefore, the wall surface constituting the closed space 34 (the bottom surface of the accommodation hole 30). The inner surface constituting the side, the distal end surface of the hub 24, and the outer peripheral surface of the needle tube 26) 36 are efficiently sterilized.

  When the sterilization process is completed, a drying process for drying the syringe body 12 and the cap 18 is performed. Then, after the drying step, for example, the syringe 10 shown in FIG. 4 according to this embodiment is filled with the chemical solution in the syringe outer cylinder 20 and the gasket 14 and the pusher 16 are attached to the syringe outer cylinder 20. Manufactured.

  According to the present embodiment, since water is introduced into the accommodation hole 30 of the cap 18 using mist-like water or water vapor, an appropriate amount of water can be put (sealed) in the closed space 34. . And since the wall surface 36 which comprises the closed space 34 can be sterilized by evaporating the water of the closed space 34 at a sterilization process, sterilization time can be shortened.

  In this embodiment, since the fluid circulation part 22 has the needle tube 26 that is accommodated in the accommodation hole 30, the capacity of the closed space 34 is relatively large, but an appropriate amount of water corresponding to the capacity of the closed space 34 is supplied. Since it can put in the closed space 34, the wall surface 36 which comprises the closed space 34 can be sterilized efficiently and reliably.

  Since the syringe outer cylinder 20 is filled with a chemical solution, the cap 18 is made of a material having a relatively low water vapor permeability. However, even if such a material is used, the sterilization time can be shortened. Can do.

  This embodiment is not limited to the manufacturing method and manufacturing apparatus described above. For example, high-pressure steam sterilization may be performed on the syringe 10 that is assembled by filling the syringe outer cylinder 20 with the chemical solution and mounting the gasket 14 and the pusher 16 on the syringe outer cylinder 20. Even in this case, the sterilization time can be shortened.

  The syringe according to the present invention may not have a needle tube. That is, any syringe may be used as long as a closed space is formed between the cap and the fluid circulation portion in a state where the cap is attached to the syringe body. The syringe is not limited to a prefilled syringe.

DESCRIPTION OF SYMBOLS 10 ... Syringe 12 ... Syringe main body 18 ... Cap 22 ... Fluid distribution | circulation part 30 ... Accommodating hole 34 ... Closed space 36 ... Wall surface 48 ... Manufacturing apparatus 54 ... Water supply apparatus 60 ... Sterilization apparatus

Claims (4)

A syringe in which a closed space is formed between the cap and the fluid circulation part in a state in which the cap is attached to the syringe body so that at least a part of the fluid circulation part of the syringe body is accommodated in the accommodation hole of the cap. A manufacturing method comprising:
A water introduction step of introducing water using mist-like water or water vapor into the accommodation hole of the cap not attached to the syringe body;
A mounting step of mounting the cap on the syringe body in a state where the water is introduced into the accommodation hole after the water introducing step;
And a sterilization step of performing high-pressure steam sterilization with water vapor on the syringe body and the cap after the mounting step. In the manufacturing method of the syringe of Claim 1,
The method for manufacturing a syringe, wherein the fluid circulation part has a needle tube accommodated in the accommodation hole. In the manufacturing method of the syringe according to claim 1 or 2,
The syringe body is a syringe outer cylinder for a prefilled syringe. A syringe in which a closed space is formed between the cap and the fluid circulation part in a state in which the cap is attached to the syringe body so that at least a part of the fluid circulation part of the syringe body is accommodated in the accommodation hole of the cap. Manufacturing equipment,
A cap holding part for holding the cap;
A water supply device that supplies mist-like water or water vapor toward the accommodation hole of the cap held by the cap holding portion when not attached to the syringe body. manufacturing device.

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