JP4863809B2 - Prefilled syringe and manufacturing method thereof - Google Patents

Description

  The present invention relates to a prefilled syringe provided with a cap that is detachable with respect to a syringe body side member and a method for manufacturing the same.

  In general, a prefilled syringe in which a sterilized syringe (syringe) is prefilled with a sterile liquid preparation (medical solution) is used. This is because there is no need to transfer the chemical solution to a syringe, the possibility of foreign matter mixing can be reduced, and there is an advantage that it can be used immediately after opening.

  In this type of prefilled syringe, a cap is placed on the liquid discharge part (mouth) of the syringe outer cylinder, and this cap is covered and covered with a heat-sensitive adhesive film. However, after opening the exterior, there is a possibility that foreign matter may be mixed in, and it is necessary to surely determine whether or not the cap is attached (recapped) again after opening.

  Therefore, for example, a pre-filled syringe disclosed in Patent Document 1 is known. In this pre-filled syringe, a luer lock adapter and a tip cap are attached to the syringe tip, and the side surface of the luer lock adapter to a part of the top surface of the tip cap is covered with a heat-shrinkable resin film. The heat shrinkable resin film is perforated along the circumference.

  FIG. 6 discloses an installation for manufacturing the above-described pre-filled syringe with a chemical solution. This equipment includes transport conveyors 2 and 3 for transporting a syringe 1 pre-filled with a chemical solution (not shown), and rotates the syringe 1 by changing the moving speed of the transport conveyors 2 and 3. Exercise has been granted.

  Heating devices 4 and 5 are arranged along the conveyance direction of the syringe 1, and the heating devices 4 and 5 are hot wires or hot air from both sides of a portion of the heat-shrinkable resin film 6 provided in the syringe 1 to be contracted. It is configured to apply.

  Then, while the rotation speed of the syringe 1 is set to 3 rotations or less, and the rotation speed of the syringe 1 when applying hot rays or hot air is set to 0 to 120 rotations / minute, the medicine in the syringe 1 is set. It is said that physical stress and thermal stress are not affected.

JP 2002-315827 A (FIG. 5)

  However, although the moving distance during which the syringe 1 is exposed to the heat source can be suppressed in the above-described conventional technology, the ambient temperature is as high as about 200 ° C. For this reason, there exists a problem that the chemical | medical solution with which it fills in the syringe 1 tends to deteriorate with a heat | fever.

  The present invention solves this type of problem, and is capable of easily and surely opening the cap and prefilled to prevent the liquid preparation in the syringe body from being exposed to heat during packaging. It aims at providing a syringe and its manufacturing method.

The present invention relates to a prefilled syringe provided with a cap that is detachable from a syringe body side member. This prefilled syringe is provided with a heat-sensitive adhesive film that covers the syringe body-side member and the side surface of the cap, and the heat-sensitive adhesive film is disposed in the vicinity of the boundary portion between the syringe body-side member and the cap along the circumferential direction. A plurality of cuts are provided at predetermined intervals , and a thermally active resin layer is provided on the back surface of the heat-sensitive adhesive film corresponding to a portion not including the cuts, and the part including the cuts The thermal activation type resin layer is not provided or activation suppression means is provided, and the heat-sensitive adhesive film is moved from the tip end surface of the cap to the syringe body side member side by 1 mm or more from the cap. While the cap is made of polypropylene or polyethylene, a convex portion is provided on the outer periphery of the cap. It is.

  Furthermore, this invention relates to the manufacturing method of a prefilled syringe provided with the cap which can be attached or detached with respect to a syringe main body side member. This manufacturing method includes a step of assembling a syringe body side member and a cap, a step of filling a liquid preparation in the syringe body, a step of attaching a plunger to the syringe body, and a heat treatment in advance while rotating the syringe body. A step of affixing the heat-sensitive adhesive film by pressing the heat-sensitive adhesive film on the side of the syringe body side member and the cap.

  According to the present invention, the heat-sensitive adhesive film is activated (tackified) by being heated, and then attached to the syringe body side member and the side surface of the cap. For this reason, when sticking a heat-sensitive adhesive film, it is not necessary to heat a syringe main body, and it becomes possible to prevent reliably that the liquid formulation in the said syringe main body is exposed to a heat | fever.

  In addition, since the heat-sensitive adhesive film is used, the adhesive force is effectively improved as compared with the heat-shrinkable film. Therefore, only the cap is not removed without damaging a part of the heat-sensitive adhesive film.

  Here, the heat-sensitive adhesive film is provided with a plurality of cuts along the circumferential direction in the vicinity of the boundary portion between the syringe body side member and the cap, and when the cap is rotated, the heat-sensitive adhesive film is It can be reliably damaged from the cut. Thereby, the opening process of a cap is performed easily and reliably.

  FIG. 1 is a schematic configuration explanatory diagram of a prefilled syringe 10 according to an embodiment of the present invention.

  The prefilled syringe 10 includes a syringe outer cylinder (syringe main body) 12, and a gasket 16 is slidably disposed in an arrow L direction on an inner peripheral surface 14 a forming an opening 14 of the syringe outer cylinder 12. This gasket 16 is provided at the tip of the plunger 18 and is slid through the plunger 18. The opening 14 is filled with a liquid preparation (not shown) such as a chemical solution.

  As shown in FIG. 2, a mouth portion 20 is integrally formed on the distal end side of the syringe outer cylinder 12 so as to reduce the outer diameter and project in the direction of the arrow L. The mouth portion 20 is formed with a flow path 22 that communicates with the opening portion 14 and can be opened to the outside. A stopper portion 24 is provided on the outer peripheral portion of the mouth portion 20 so as to bulge outward, and the outer peripheral portion of the mouth portion 20 can be moved by a predetermined distance in the direction of arrow L via the stopper portion 24. A lock adapter (syringe body side member) 26 is provided.

  The lock adapter 26 has a substantially hexagonal cross section, and an internal thread portion 28 is formed on the inner peripheral surface thereof. A cap 30 is attached to the mouth 20 of the syringe outer cylinder 12 via a lock adapter 26.

  On the outer peripheral portion of the cap 30, a male screw portion 32 that is screwed into the female screw portion 28 of the lock adapter 26 is formed over a predetermined length in the axial direction (arrow L direction). A convex portion 34 having a substantially hexagonal cross section is formed on the outer peripheral portion of the cap 30, and a plurality of groove portions 36 are formed on the outer peripheral surface of the convex portion 34 over a predetermined length in the axial direction. By forming the groove portion 36 in the convex portion 34, a grip portion that can be easily gripped by an operator's fingertip is configured. An opening 38 is formed in the cap 30, and a packing 40 is disposed on the bottom side of the opening 38.

  As shown in FIG. 1, in the state where the male threaded portion 32 of the cap 30 is screwed into the female threaded portion 28 of the lock adapter 26, the heat-sensitive adhesive property cut into a band covering the lock adapter 26 and the side surface of the cap 30. A film 42 is provided.

  Specifically, the heat-sensitive adhesive film 42 is selected from materials such as PET (polyethylene terephthalate), PP (polypropylene), PE (polyethylene), PS (polystyrene), PVC (vinyl chloride resin), and the like. Other materials having properties can also be used.

  The heat-sensitive adhesive film 42 is provided with a plurality of cuts (perforations) 44 spaced apart by a predetermined interval along the rotation direction (arrow R direction) of the cap 30. As shown in FIG. 3, on the back surface (attachment surface) of the heat-sensitive adhesive film 42, an adhesive layer 46a to which a thermally active resin is applied corresponding to a portion not including the cut 44, and the cut 44 are provided. Corresponding to the portion to be included, the non-adhesive surface 46b on which the heat activation type resin is not provided or on which activation suppression means is applied is formed. The non-adhesive surface 46b refers to a surface set to a non-adhesive force to a weak adhesive force.

  Specifically, the thermally activated resin is PE (polyethylene), PVA (poval), EVA (ethylene vinyl acetate copolymer), EEA (ethylene-ethyl acrylate copolymer), ionomer resin or a mixed resin thereof. Is done. The melting point of the thermally activated resin is set to 70 ° C to 140 ° C, more preferably 80 ° C to 130 ° C.

The material of the cap 30, PP (polypropylene), PE (polyethylene) or the like of the resin, are selected from metals such as heat-sensitive adhesive film 42 is adhered possible, other materials may also be selected.

  As shown in FIG. 1, when the heat-sensitive adhesive film 42 is attached so as to cover the lock adapter 26 and the cap 30, the cut 44 is near the boundary portion between the lock adapter 26 and the cap 30 (between the boundary portion and the surrounding portion). Are intermittently provided along the circumferential direction. The end surface 42a of the heat-sensitive adhesive film 42 is disposed at a position spaced inward from the top surface (tip surface) 30a of the cap 30 by a distance M (M ≧ 1 mm), and the heat-sensitive adhesive film 42 is The cap 30 is covered from the position.

  Next, the manufacturing method of the prefilled syringe 10 which concerns on this invention is demonstrated along the process flow shown in FIG.

  First, after silicone oil is applied to the inner peripheral surface 14 a of the syringe outer cylinder 12, the cap 30 is attached to the lock adapter 26 provided in the mouth portion 20 of the syringe outer cylinder 12. Specifically, by rotating the cap 30 in a predetermined direction with respect to the lock adapter 26, the male screw portion 32 formed on the outer peripheral portion of the cap 30 is screwed into the female screw portion 28 of the lock adapter 26. Then, a syringe assembly process is performed (step S1).

  Next, the process proceeds to step S2, and sterilization is performed on the syringe outer cylinder 12 and the cap 30. Various methods are employed for the sterilization treatment, and for example, autoclave sterilization is performed. In this autoclave sterilization, the syringe outer cylinder 12 fitted with the cap 30 is carried into an autoclave sterilizer (not shown), and high-pressure steam is supplied into the autoclave sterilizer, whereby the cap 30 and the syringe The outer cylinder 12 is sterilized. In addition to the autoclave sterilization described above, gas sterilization using a sterilization gas, radiation sterilization, or the like can be employed.

  Furthermore, in a sterile environment, a liquid preparation (medical solution) that has been sterilized in advance is filled into the opening 14 from the proximal end of the syringe outer cylinder 12 (step S3). Thereafter, the gasket 16 and the plunger 18 are attached to the opening 14 of the syringe outer cylinder 12 (step S4).

  Next, the syringe outer cylinder 12 is attached with the heat-sensitive adhesive film 42 while being rotated at a predetermined speed at a predetermined film application position, as will be described later, with the cap 30 and the plunger 18 attached. (Step S5).

  The operation in step S5 is substantially performed by the facility 50 shown in FIG. The facility 50 can use, for example, a thermal labeler thermal paste activation device disclosed in Japanese Patent No. 3681857, which will be described in brief below.

  As shown in FIG. 5, the facility 50 includes a film feeding portion 54 that feeds out the roll-shaped heat-sensitive adhesive film 52, and a cutter portion that cuts the roll-shaped heat-sensitive adhesive film 52 to form a heat-sensitive adhesive film 42. 56, an adsorbing drum 58 rotating in the direction of arrow A while adsorbing and holding the adhesive layer (glue surface) 46a side of the heat-sensitive adhesive film 42, and receiving the heat-sensitive adhesive film 42 from the adsorption drum 58, The thermosensitive adhesive film 42 is adsorbed with the layer 46a facing outward, and is disposed over a predetermined angular range on the outer peripheral side of the adhering drum 60, the adhering drum 60 rotating in the direction of arrow B, and the thermal adhesive property. The thermal adhesive activation part 62 for heating the adhesive layer 46a side of the film 42, and the thermal adhesive film activated by heating the adhesive layer 46a. The Lum 42, in order to wrap the side and the lock adapter 26 of the cap 30, and a rotary jig 64 for constant speed rotation of the syringe barrel 12 in the arrow C direction.

  The suction drum 58 and the affixing drum 60 are provided with a plurality of suction ports 66a and 66b on the outer peripheral portions thereof, and the suction drum 58 and the affixing drum are sucked from the suction ports 66a and 66b. The heat-sensitive adhesive film 42 is adsorbed and held on the outer peripheral portion of 60. The heat-sensitive paste activating unit 62 can, for example, blow hot air on the adhesive layer 46a of the heat-sensitive adhesive film 42 or heat the ambient temperature of the adhesive layer 46a with a ceramic heater. The temperature of the adhesive layer 46a is set to be 70 ° C to 140 ° C, more preferably 80 ° C to 130 ° C.

  In the equipment 50 configured as described above, when the roll-shaped heat-sensitive adhesive film 52 is unwound from the film unwinding section 54 (step S6 in FIG. 4), the roll-shaped heat-sensitive adhesive film 52 is fixed by the cutter section 56. The heat-sensitive adhesive film 42 is formed by cutting (step S7).

  The adhesive layer 46 a is adsorbed on the outer peripheral surface of the suction drum 58, and the heat-sensitive adhesive film 42 is sent to the attaching drum 60 under the rotating action of the suction drum 58. The heat-sensitive adhesive film 42 is adsorbed and held on the outer peripheral surface of the affixing drum 60 with the adhesive layer 46a side outside, and passes through the heat-sensitive paste activating part 62 so that the adhesive layer 46a has a predetermined temperature of 70 ° C. It is heated to 140 ° C., more preferably 80 ° C. to 130 ° C. (step S8).

  For this reason, the heat-activated resin applied to the adhesive layer 46a of the heat-sensitive adhesive film 42 can be heated to the activation temperature and exhibit desired tackiness. Therefore, immediately after the heating, the heat-sensitive adhesive film 42 is supplied to the syringe outer cylinder 12 held by the rotating jig 64 and rotated at a constant speed.

  In the syringe outer cylinder 12, the thermosensitive adhesive film 42 is pressed at a constant pressure along the side surface of the cap 30 and the lock adapter 26 while rotating at a constant speed in the direction of arrow C. Thereby, the heat sensitive adhesive film 42 is affixed on the outer peripheral surface of the lock adapter 26 from the side surface of the cap 30 (step S5), and the prefilled syringe 10 is completed (step S9).

  At that time, the cut 44 of the heat-sensitive adhesive film 42 is disposed in the vicinity of the boundary portion between the cap 30 and the lock adapter 26 along the circumferential direction. Further, the heat-sensitive adhesive film 42 covers the cap 30 from a position separated from the top surface 30a of the cap 30 by 1 mm or more on the lock adapter 26 side.

  In this case, in this embodiment, the heat-sensitive adhesive film 42 is applied to the side surface of the cap 30 and the outer peripheral surface of the lock adapter 26 after the adhesive layer 46a is activated by being heated by the heat-sensitive glue activating unit 62. It is attached. For this reason, it is not necessary to heat the syringe outer cylinder 12 when the heat-sensitive adhesive film 42 is attached, and the liquid preparation filled in the syringe outer cylinder 12 is reliably prevented from being exposed to heat. It becomes possible.

  Here, the heat-sensitive adhesive film 42 is preliminarily heated to a predetermined activation temperature, and immediately after this heating, it is pressed against the covering portion between the cap 30 and the lock adapter 26, so that the adhesive layer 46a is below the activation temperature. Pasting work is done before it becomes. At that time, the adhesive layer 46a is formed in a thin shape of about several μm and has a very small heat capacity. For this reason, even if the heat-sensitive adhesive film 42 is attached to the syringe outer cylinder 12 side, the temperature of the syringe outer cylinder 12 is not increased. Therefore, there is no thermal influence on the liquid preparation filled in the syringe outer cylinder 12.

  Further, in a state where the adhesive layer 46 a is activated, the heat-sensitive adhesive film 42 can be sufficiently bonded with a small pressure that is in contact with the cap 30 and the lock adapter 26. Thereby, the influence of the physical stress to the liquid formulation in the syringe outer cylinder 12 can be avoided.

  The operation of the prefilled syringe 10 manufactured in this way will be described below.

  In the state shown in FIG. 1, the operator grips the cap 30 integrally with the front end side of the heat-sensitive adhesive film 42 and rotates the cap 30 in one direction of the arrow R. For this reason, the cap 30 rotates with respect to the lock adapter 26, and the heat-sensitive adhesive film 42 covering the cap 30 and the lock adapter 26 is broken and opened.

  At that time, the cuts 44 are intermittently provided in the vicinity of the boundary portion between the cap 30 and the lock adapter 26 along the circumferential direction. Therefore, there is an advantage that the rotational torque required when opening the cap 30 can be reduced as much as possible, and the opening process is effectively simplified.

  Furthermore, the distance M between the top surface 30a of the cap 30 and the end surface 42a of the heat-sensitive adhesive film 42 is set to 1 mm or more. Thereby, when the operator holds the cap 30 together with the heat-sensitive adhesive film 42, the convex portion 34 of the cap 30 can be directly held by the fingertip of the operator. For this reason, the rotation operation of the cap 30 can be performed easily and reliably, and the unsealing performance can be improved.

  Further, since the heat-sensitive adhesive film 42 is used, the adhesive force is effectively improved as compared with the case where the heat-shrinkable film is used. Therefore, only the cap 30 is not removed without damaging a part of the heat-sensitive adhesive film 42, and the opening of the cap 30 can be easily and reliably visually recognized.

It is schematic structure explanatory drawing of the prefilled syringe which concerns on embodiment of this invention. It is principal part disassembly explanatory drawing of the said prefilled syringe. It is an expansion | deployment explanatory drawing of the heat-sensitive adhesive film which comprises the said prefilled syringe. It is a processing flow explaining the manufacturing method of this invention. It is a schematic explanatory drawing of the equipment used for the said manufacturing method. It is explanatory drawing of the manufacturing method of the chemical | medical solution prefilled syringe currently disclosed by patent document 1. FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 ... Prefilled syringe 12 ... Syringe outer cylinder 14, 38 ... Opening part 16 ... Gasket 18 ... Plunger 20 ... Mouth part 22 ... Flow path 24 ... Stopper part 26 ... Lock adapter 28 ... Female screw part 30 ... Cap 32 ... Male screw part 34 ... Convex part 42 ... Thermal adhesive film 44 ... Cut 50 ... Equipment 54 ... Film feeding part 56 ... Cutter part 58 ... Adsorption drum 60 ... Pasting drum 62 ... Thermal paste activation part 64 ... Rotating jig

Claims (5)

A prefilled syringe provided with a cap that is detachable with respect to the syringe body side member,
A heat-sensitive adhesive film that covers the syringe body side member and the side surface of the cap is provided,
In the heat-sensitive adhesive film, a plurality of cuts are provided along the circumferential direction in the vicinity of the boundary portion between the syringe body-side member and the cap, and the heat-sensitive adhesive film is provided on the back surface of the heat-sensitive adhesive film. In addition, a thermally active resin layer is provided corresponding to the portion not including the cut line,
Corresponding to the portion containing the cut, the thermal activation resin layer is not provided or activation suppression means is applied,
The heat-sensitive adhesive film covers the cap from a position separated from the tip end surface of the cap by 1 mm or more on the syringe body side member side,
The material of the cap is polypropylene or polyethylene,
The outer peripheral portion of said cap, prefilled syringe according to claim Rukoto convex portion is provided. In pre-filled syringe according to claim 1, wherein the convex portion, prefilled syringes cross section and wherein the substantially hexagonal shape der Rukoto. In pre-filled syringe according to claim 1 or 2, wherein the outer peripheral surface of the convex portion is prefilled syringe according to claim Rukoto plurality of grooves in the axial direction is formed. A cap that is detachable from the syringe body side member is provided , and a heat-sensitive adhesive film that covers the syringe body side member and the side surface of the cap is provided.
In the heat-sensitive adhesive film, a plurality of cuts are provided along the circumferential direction in the vicinity of the boundary portion between the syringe body-side member and the cap, and the heat-sensitive adhesive film is provided on the back surface of the heat-sensitive adhesive film. In addition, a thermally active resin layer is provided corresponding to the portion not including the cut line,
Corresponding to the portion containing the cut, the thermal activation resin layer is not provided or activation suppression means is applied,
The heat-sensitive adhesive film covers the cap from a position separated from the tip end surface of the cap by 1 mm or more on the syringe body side member side,
The material of the cap is polypropylene or polyethylene,
The outer peripheral portion of the cap is a method for manufacturing a prefilled syringe protrusions that provided,
Assembling the syringe body-side member and the cap;
Filling the syringe body with a liquid preparation;
Attaching a plunger to the syringe body;
While rotating the syringe body, the steps of the heat-sensitive adhesive film which is previously heated, by pressing the side surface of the syringe body side member and the cap, to paste the thermal adhesive film,
The manufacturing method of the prefilled syringe characterized by having. The manufacturing method according to claim 4, wherein the convex portion has a substantially hexagonal cross-sectional shape,
Wherein the outer peripheral surface of the projection, prefilled syringe preparation method characterized by Rukoto plurality of grooves are formed in the axial direction.

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