JPH09299480A - Method and apparatus for capping, already filled syringe and its preparation and apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method for preparing an already filled syringe with no possibility of remaining of water drops in the neighborhood of a curve and a skirt part of a gasket. SOLUTION: An outer cylinder 2 wherein the apex nozzle 3 is sealed with a cap 4 is kept at a posture with the nozzle 3 downward and a liq. 6 is filled in the outer cylinder 2 from an opening part 5 formed on the back end of the outer cylinder 2 and after the opening part 5 is closed with a gasket 7 under a condition where the inside of the outer cylinder 2 is made vacuum and atmospheric pressure is introduced on the back face side of the gasket 7, the gasket 7 is pushed and inserted into the outer cylinder 2 while the gasket is held.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method and a device for capping an opening of a container, and more particularly to a prefilled syringe (Pre) in which a liquid such as a drug is pre-filled inside an outer cylinder.
The present invention relates to a filled syringe) and a manufacturing method and manufacturing apparatus thereof.

[0002]

2. Description of the Related Art When a drug solution filled in an ampoule or a vial is used as an injection, the ampoule or the vial is opened at the time of use, the drug solution is filled in a syringe and administered to a human body or the like. There is. However, the operation of opening the ampoule or vial and filling the syringe with the drug solution is complicated. Particularly, it is not preferable to perform such a complicated operation in an emergency. Further, when opening the ampoule or the vial, foreign substances such as fine glass powder may be mixed into the drug solution. Therefore, for example, Japanese Patent Application Laid-Open No. 49-28194 discloses a pre-filled syringe in which a medicine is pre-filled inside the outer cylinder.

The prefilled syringe 1 shown in FIG. 1 is generally manufactured by the following steps (1) to (3). (1) The nozzle 4 formed at the tip (lower end in the illustrated example) of the outer cylinder 2 is sealed with a cap 4. (2) An opening 5 formed at the rear end (upper end in the illustrated example) of the outer cylinder 2 with the nozzle 3 sealed by the cap 4 facing downward.
The outer cylinder 2 is filled with the liquid 6 from the inside. (3) The gasket 7 is inserted into the outer cylinder 2 through the opening 5, and the peripheral surface of the gasket 7 is brought into close contact with the inner surface of the outer cylinder 2 to form the outer cylinder 2.
Seal the inside.

Also, the pre-filled syringe 1 manufactured in this way
Is further put into an autoclave or the like for heat sterilization.

When the gasket 7 is inserted through the opening 5 as in the above step (3) in the manufacture of such a prefilled syringe 1, the gasket is kept under atmospheric pressure when air is sufficiently contained in the outer cylinder 2. A considerable force is required to insert 7. Further, even if the gasket 7 is inserted with a strong force, the gasket 7 is pushed back by the pressure of the air inside the outer cylinder 2 unless it is always pressed by a holder or the like, and the opening 5 of the outer cylinder 2 is pushed.
Easily slips out of.

Therefore, the opening 5 is formed as in the above step (3).
When inserting the gasket 7 from the inside, the air inside the outer cylinder 2 is sucked with a pump or the like to reduce the pressure, and the opening 5 at the rear end of the outer cylinder 2 is closed with the gasket 7 under the reduced pressure atmosphere. A method (vacuum stoppering method) in which atmospheric pressure is introduced to the rear surface side of the gasket 7 and the gasket 7 is inserted into the outer cylinder 2 by a differential pressure is adopted.

On the other hand, the outer peripheral surface of the gasket 7 inserted into the outer cylinder 2 has a close contact portion 10 that is in close contact with the inner surface of the outer cylinder 2 in about half of the front end side. About the other half of the upper end) is generally a skirt portion 11 that does not adhere to the inner surface of the outer cylinder 2. In order to improve the slidability of the gasket 7, it is preferable that the contact portion 10 has a small area, and conversely, in order to prevent bacteria and the like from entering the outer cylinder 2 from the outside, the contact portion 10 has a large area. Is preferred. On the other hand, in order to insert the gasket 7 straight into the outer cylinder 2, the gasket 7 needs to have a certain thickness. Therefore, the close contact portion 10 and the skirt portion 11 are provided to maintain both the slidability of the gasket 7 and the bacteria permeation preventive property in a well-balanced manner.

The pre-filled syringe 1 manufactured in this way
2 is used, the tube 13 is attached to the nozzle 3 at the tip of the outer cylinder 2 instead of the cap 4, and the plunger 14 is inserted from the opening 5 at the rear end of the outer cylinder 2 as shown in FIG. The tip of 14 is connected to the rear surface of the gasket 7. To ensure this connection, the plunger 14
In general, a male screw portion 15 is formed at the tip of, and a female screw portion 16 is formed on the rear surface of the gasket 7. Then, the male screw portion 15 is connected to the female screw portion 1
6 is screwed in to connect the tip of the plunger 14 to the rear surface of the gasket 7, and the plunger 14 is pushed to move the gasket 7 forward.
Is appropriately supplied through the tube 13.

[0009]

By the way, in the manufacture of the prefilled syringe 1, when the gasket 7 is inserted into the outer cylinder 2 by the so-called vacuum stoppering method as in the step (3), the gasket 7 is bent. It often takes a posture. Further, there is a phenomenon in which water drops remain in the gap between the skirt portion 11 of the gasket 7 and the inner surface of the outer cylinder 2 in a mist-like state. All of these are considered to be due to the insertion speed of the gasket 7 being too fast, because the gasket 7 is absorbed into the inside of the outer cylinder 2 at the same time when atmospheric pressure is introduced to the rear surface side of the gasket 7. The bending of the gasket 7 and the water droplets remaining around the skirt 11 deteriorate the appearance of the product,
Not only that, but in particular, the bending of the gasket 7 may cause liquid leakage.

The present invention has been made in view of the above conventional circumstances, and an object thereof is to provide a means for manufacturing a prefilled syringe which is free from the risk of water drops remaining around the bend of the gasket or the skirt portion. Especially.

[0011]

According to a first aspect of the present invention, an opening is closed with a stopper while the inside of the container is depressurized, atmospheric pressure is introduced to the rear surface of the stopper, and then the inside of the container is closed. This is a stoppering method in which the body is held and pushed in to be inserted.

According to the second aspect of the present invention, the outer cylinder, which is formed by sealing the nozzle at the tip with a cap, is placed in the outer cylinder from the opening formed at the rear end of the outer cylinder with the nozzle facing downward. After filling the liquid and closing the inside of the outer cylinder in a depressurized state, closing the opening with a gasket and introducing atmospheric pressure to the rear surface side of the gasket, press and insert while holding the gasket inside the outer cylinder. It is a manufacturing method. According to the invention of claim 3, the outer cylinder formed by sealing the nozzle at the tip with a cap is placed in a posture with the nozzle facing downward, and liquid is introduced into the outer cylinder from the opening formed at the rear end of the outer cylinder. After filling, the inside of the outer cylinder is depressurized, the opening is closed with a gasket, atmospheric pressure is introduced to the rear side of the gasket, and the prefilled syringe is inserted by pushing it while holding the gasket inside the outer cylinder. It is a method of manufacturing an already-filled syringe, which is assembled and heat-sterilized. By pressing and inserting the gasket while holding the gasket inside the outer cylinder as in the manufacturing method according to the second and third aspects, it is possible to prevent the gasket from slipping into the outer cylinder due to the differential pressure.

According to the invention of claim 4, the holding means for holding the container, the pressure reducing means for depressurizing the inside of the container, and the stopper body inserted into the inside of the container through the opening of the container held by the holding means. A capping device including a pusher is characterized in that a holding mechanism for holding a plug is provided at a tip of the pusher. According to the invention of claim 5, a gripping means for gripping an outer cylinder whose tip nozzle is sealed with a cap and whose interior is filled with liquid in a posture with the nozzle facing downward, and an outer cylinder. In a manufacturing apparatus including a decompression means for decompressing the inside and a pusher for pushing the gasket into the inside of the outer cylinder from the opening of the rear end of the outer cylinder grasped by the grasping means, the gasket is held at the tip of the pusher. An apparatus for manufacturing an already-filled syringe, characterized in that a holding mechanism is provided.

In the manufacturing apparatus of the fifth aspect, as described in the sixth aspect, the female screw portion for connecting the plunger is formed on the rear surface of the gasket, and the female screw portion is formed in the normal state of the holding mechanism. It is preferable that the expansion member has such a size that it can be fitted into the internal surface of the female threaded portion and has an expansion member that presses against the inner surface of the internal threaded portion to hold the gasket in the expanded state. Further, the insertion of the gasket is performed by inserting the pusher into the outer cylinder by using, for example, a cam mechanism as described in claim 7.

According to the invention of claim 8, the outer cylinder formed by sealing the nozzle at the tip with a cap is placed in a posture in which the nozzle is in the downward direction, and the inside of the outer cylinder is opened from the opening formed at the rear end of the outer cylinder. Manufactured by filling the inside of the outer cylinder with liquid and closing the opening with a gasket to introduce atmospheric pressure to the rear surface side of the gasket, and then pushing it in while holding the gasket inside the outer cylinder. The prefilled syringe with the gasket in a bent posture. According to the invention of claim 9, the outer cylinder formed by sealing the nozzle at the tip with a cap is positioned so that the nozzle is in a downward position, and liquid is introduced into the outer cylinder through an opening formed at the rear end of the outer cylinder. After filling, the inside of the outer cylinder is depressurized and the opening is closed with a gasket to introduce atmospheric pressure to the back side of the gasket. A prefilled syringe having a gasket in a posture without bending, which is manufactured by heat sterilizing the prefilled syringe.

The prefilled syringes according to claims 8 and 9 are:
The manufacturing method according to claims 2 and 3 and claim 5 described above,
It can be suitably manufactured by the manufacturing apparatuses 6 and 7. The liquid filled in these pre-filled syringes is a contrast agent, for example, as described in claim 10.

[0017]

BEST MODE FOR CARRYING OUT THE INVENTION Preferred embodiments of the present invention will be described below with reference to the drawings. FIG. 3 is a plan view showing the manufacturing line 20 of the pre-filled syringe 1 described above with reference to FIGS.

In this manufacturing line 20, from the right side,
Carry-in device 21, cap mounting device 22, filling device 23,
A degassing device 24 and a gasket mounting device 25 are arranged. These carry-in device 21 and cap mounting device 2
2, a conveyor 26, a conveyor 27, a conveyor 28, and a conveyor 29 are installed between the filling device 23, the degassing device 24, and the gasket mounting device 25. A conveyor 30 is also installed in the gasket mounting device 25.

The carry-in device 21 has an AGV (A
The outer cylinder 2 to which the cap 4 and the gasket 7 are not yet attached is carried in using an automatic guided vehicle) or the like. Then, the carry-in device 21 is configured such that the outer cylinders 2 are aligned in a constant direction and are delivered to the conveyor 26 one by one.

The cap 4 is supplied to the cap mounting device 22 from the cap supply feeder 35 through the conveying path 36. Then, the cap attachment device 22 is configured to attach the cap 4 to the nozzle 3 of the outer cylinder 2 and seal the tip of the outer cylinder 2.

The filling device 23 is configured to fill the inside of the outer cylinder 2 with the liquid 6 through the opening 5 at the rear end of the outer cylinder 2 with the nozzle 3 sealed by the cap 4 facing downward. There is. The liquid 6 filled in the outer cylinder 2 by the filling device 23 is, for example, a contrast agent.

The deaerator 24 is configured to apply a vertical vibration to the outer cylinder 2 by a vibrator to forcibly float the bubbles existing in the liquid 6 inside the outer cylinder 2. By this deaerator 24, the bubbles remaining inside the nozzle 3 are particularly removed.

The gasket 7 is supplied to the gasket mounting device 25 from the gasket supply feeder 40 via the conveying path 41. Then, the gasket mounting device 25
In this way, the gasket 7 supplied from the gasket supply feeder 40 is configured to be inserted into the outer cylinder 2 through the opening 5 of the outer cylinder 2. This gasket mounting device 25
The pre-filled syringe 1 assembled in
After 0, it is properly delivered.

As shown in FIG. 4, the gasket mounting device 2
The reference numeral 5 generally includes three turntable parts 45, 46, 47. The positional relationship is such that the turntable portion 45 and the turntable portion 47 are in contact with the turntable portion 46, but the turntable portion 45 and the turntable portion 47 are not in contact with each other. The turntable portion 45 has a gasket supply table 48 on the upper side and an outer cylinder supply table 49 on the lower side. The gasket supply table 48 and the outer cylinder supply table 49 integrally rotate in the clockwise direction in the figure at the same rotation speed. The turntable portion 46 has a stoppering table 50 on the upper side and an outer cylinder holding table 51 on the lower side. These capping table 50 and outer cylinder gripping table 51
Rotate integrally in the counterclockwise direction in the figure at the same rotation speed. A cylindrical cam 52 is arranged above the stoppering table 50. This cylindrical cam 52 does not rotate. The turntable portion 47 has only the outer cylinder carry-out table 53. The gasket discharge table 53 rotates integrally in the clockwise direction in the figure. Out of these, the outer cylinder supply table 49, the outer cylinder gripping table 51, and the outer cylinder unloading table 53 constitute a transport mechanism mainly for transporting the outer cylinder 2 in the gasket mounting device 25. In the gasket mounting device 25, the stopper table 50 is mainly provided with the opening 5 of the outer cylinder 2.
A capping mechanism that functions to cap the gasket 7 is configured.

Therefore, first, the transport mechanism will be described with reference to FIG. As shown, the outer cylinder supply table 4
9 is arranged in contact with the terminal end of a conveyor 29 that carries the outer cylinder 2 into the gasket mounting device 25. On the circumference of the outer cylinder supply table 49, there are a total of eight notches 55 sized to fit the outer cylinder 2 at equal intervals, that is, the notches 55 adjacent to each other have a central angle of 45. It is arranged so that it becomes °. Further, guides 56 and 57 are provided on both sides of the conveyor 29 to prevent the outer cylinder 2 conveyed by the conveyor 29 from rolling over. The guide 56 supporting the right side surface of the outer cylinder 2 with respect to the transport direction (left direction in FIG. 5) is provided only up to the vicinity of the end of the conveyor 29, but the left side of the outer cylinder 2 with respect to the transport direction. The guide 57 supporting the surface is further extended from the end of the conveyor 29, and is provided up to a position in contact with the outer cylinder gripping table 51 so as to surround the outer cylinder supply table 49 for about half a circumference. As a result, the outer cylinder 2 conveyed by the conveyor 29 while being sandwiched between the guides 56 and 57.
Is guided by the guide 57 at the terminal end of the conveyor 29 and is sequentially fitted into the notches 55 of the outer cylinder supply table 49. In addition, the outer cylinder 2 fitted in the notch 55 of the outer cylinder supply table 49 in this manner contacts the outer cylinder supply table 49 and the outer cylinder gripping table 51 according to the clockwise rotation of the outer cylinder supply table 49 while being guided by the guide 57. It is designed to be transported to the open position.

The outer cylinder 2 is provided on the circumference of the outer cylinder grip table 51.
A chuck 60 for gripping is attached. The chucks 60 are also arranged at a total of eight positions such that the central angles of the chucks 60 adjacent to each other are 45 °. The chucks 60 are configured to open and close as the outer cylinder grip table 51 rotates, and switch between a state in which the outer cylinder 2 is gripped and a state in which the outer cylinder 2 is not gripped, depending on the position of the rotational movement of the outer cylinder. That is, when the positions of the chucks 60 shown in FIG. 5 are defined as a to h and described, the chucks 60 are in an open state at the positions a to b.
Then, while moving from the position b to the position c, the chuck 60
Is closed. After that, the chuck 60 is in the closed state at the positions c to g. Then, the chuck 60 is in an open state while moving from the position g to the position h.
After that, the chuck 60 is in the open state at the positions h to a. As described above, the outer cylinder 2 that has been conveyed to the position where the outer cylinder supply table 49 and the outer cylinder gripping table 51 are in contact with each other while being supported by the guide 57 while being fitted in the notch 55 of the outer cylinder supply table 49, , Between the chucks 60 in the open state at the position b. And
The outer cylinder 2 thus transferred between the chucks 60 is then moved to the chuck 60 according to the rotation of the outer cylinder gripping table 51.
Is held between the chucks 60 while moving from the position b to the position c. After that, the outer cylinder 2 is moved to the chuck 60.
The outer cylinder gripping table 51 is conveyed to the position h where the outer cylinder gripping table 51 and the outer cylinder unloading table 53 are in contact with each other in accordance with the counterclockwise rotation of the outer cylinder gripping table 51 while being gripped in the position h.
Then, by opening the chuck 60, the outer cylinder 2 is opened.

The outer cylinder carry-out table 53 is arranged in contact with the starting end of the conveyor 30 for carrying the outer cylinder 2 out of the gasket mounting device 25. Outer cylinder supply table 4 described above
Similarly to the notch 55 of 9, the notch 6 is sized to fit the outer cylinder 2 into the circumferential portion of the outer cylinder discharge table 53.
5 are arranged at a total of eight locations such that the central angles of the adjacent notches 65 are all 45 °. Guides 66 and 67 are provided on both sides of the conveyor 30 to prevent the outer cylinder 2 conveyed by the conveyor 30 from rolling over. The guide 66 supporting the right side surface of the outer cylinder 2 with respect to the transport direction (left direction in FIG. 5) is the conveyor 30.
The guide 67 supporting the left side surface of the outer cylinder 2 with respect to the transport direction is further extended beyond the start end of the conveyor 30 and is provided around the outer cylinder unloading table 53. Is provided up to a position where the outer cylinder gripping table 51 and the outer cylinder unloading table 53 are in contact with each other so as to surround the above. As a result, the outer cylinder 2 conveyed by the outer cylinder gripping table 51 while being gripped by the chuck 60 as described above and opened by the opening of the chuck 60 at the position h is then guided by the guide 67 to the outer cylinder 2. It is configured to be sequentially fitted into the notches 65 of the tube unloading table 53. In addition, the outer cylinder 2 fitted in the notch 65 of the outer cylinder unloading table 53 in this way is conveyed in accordance with the clockwise rotation of the outer cylinder unloading table 53 while being guided by the guide 67, and further transferred to the conveyor 30 to be sequentially transferred. It is supposed to be carried out.

Next, the stopper mechanism will be described with reference to FIG. As shown in the drawing, a concave portion 70 for positioning and holding the gasket 7 at a predetermined position is provided in the peripheral portion of the upper surface of the gasket supply table 48. This recess 7
In the case of 0, the central angles of the adjacent recesses 70 are all 45 °, and the recesses 70 are arranged at eight positions in total. Then, from the above-mentioned gasket supply feeder 40 to the conveyance path 41.
The gaskets 7 carried in through the above are sequentially positioned and supplied to the recesses 70 of the gasket supply table 48 one by one. The gasket supply feeder 40 is configured so that the posture of the gasket 7 is such that the rear surface of the gasket 7 (the surface on which the female screw portion 16 described above with reference to FIG. 2 is formed) faces upward. The gasket 70 with the rear surface thereof facing upward is always supplied to the concave portion 70 of the supply table 48.
The gasket 7 thus supplied to the recess 70 is conveyed to a position where the gasket supply table 48 and the stopper table 50 are in contact with each other according to the clockwise rotation of the gasket supply table 48.

A guide 75 is provided on the circumference of the stoppering table 50.
A chamber 76 that is supported so as to be lifted up and down by the above, and a pusher 77 that is configured to pass through the inside of the chamber 76 and move up and down are provided. These guides 75, chambers 76 and pushers 77 are also arranged at a total of eight locations, and each chamber 76 and pusher 77 is
It is arranged so as to come to a position just above the outer cylinder 2 gripped by the chuck 60 of the outer cylinder gripping table 51 below the stoppering table 50.

As shown in FIG. 7, a cam follower 81 is attached to the chamber 76 via an arm 80. The cam follower 81 is formed on the peripheral surface of the cylindrical cam 52 fixed above the stopper table 50. The first cam groove 82 is engaged. The first cam groove 82 has a high surface 83 and a low surface 84, and the cam follower 81 moves along the first cam groove 82 in accordance with the counterclockwise rotation of the stopper table 50. 76
Is configured to move up and down in high and low positions. To be concretely described based on the positions a to h defined in FIG. 5, the first cam groove 8 is located at the positions a to c.
2 is a high surface 83, and the chamber 76 is at a high position. Then, the first cam groove 82 changes from the high surface 83 to the low surface 84 while moving from the position c to the position d, and accordingly, the chamber 76 descends to the lower position. After that, the positions d to f
Then, the first cam groove 82 is the lower surface 84 and the chamber 76 is at the lower position. Then, the first cam groove 82 changes from the lower surface 84 to the higher surface 83 while moving from the position f to the position g, and the chamber 76 is raised to a higher position accordingly.
After that, in the positions g to v, the first cam groove 82 is the high surface 83 and the chamber 76 is in the high position.

As shown in FIG. 8, the chamber 76 has a cylindrical shape with its upper surface closed and its lower surface opened, and a seal member 85 is attached to its inner surface. In FIG. 8, the chamber 76 shown by the solid line shows a state in which the cam follower 81 is engaged with the high surface 83 of the first cam groove 82, so that the chamber 76 is elevated to a high position.
When the chamber 76 rises in this way, the opening 5 at the rear end (upper end in the illustrated example) of the outer cylinder 2 gripped by the chuck 60 of the outer cylinder gripping table 51 below the stoppering table 50. Is open, and air is freely allowed to enter the inside of the outer cylinder 2. Meanwhile, FIG.
In FIG. 11, the chamber 76 indicated by the alternate long and short dash line shows a state in which the chamber 76 is lowered to the lower position because the cam follower 81 is engaged with the lower surface 84 of the first cam groove 82. When the chamber 76 is descending in this way, the seal member 85 on the inner surface of the chamber 76 is pressure-bonded to the rear end of the outer cylinder 2 held by the chuck 60, and the opening 5 at the rear end of the outer cylinder 2 is sealed. It becomes a state. Although not shown, a decompression mechanism configured to decompress the interior of the chamber 76 is provided, and the interior of the chamber 76 is decompressed with the opening 5 at the rear end of the outer cylinder 2 thus sealed. The inside of the outer cylinder 2 can be depressurized by depressurizing.

As shown in FIG. 7, a cam follower 91 is attached to the pusher 77 via an arm 90. The cam follower 91 is formed on the peripheral surface of the cylindrical cam 52 above the first cam groove 82. The second cam groove 92 is engaged. The second cam groove 92 has a high surface 93 and a middle surface 9.
4 and the lower surface 95 and the lowermost surface 96, the pusher 77 moves to the high position and the middle position by the cam follower 91 moving along the second cam groove 92 according to the counterclockwise rotation of the stoppering table 50. It is configured to move to the lower position and the lower position. Concretely explaining based on the positions a to h defined in FIG. 5,
At the position a, the second cam groove 92 is the high surface 93 and the pusher 77 is at a high position. The second cam groove 92 moves from the high surface 93 to the middle surface 94 while moving from the position a to the position b.
, And the pusher 77 descends to an intermediate position accordingly. After that, at the positions b to d, the second cam groove 92 is the middle surface 94 and the pusher 77 is at the intermediate position. Then, the second cam groove 92 changes from the middle surface 94 to the lower surface 95 while moving from the position d to the position e, and the pusher 77 descends to the lower position accordingly. Further, the second cam groove 92 changes from the lower surface 95 to the lowest surface 96 during the shift from the position e to the position f, and the pusher 77 is lowered to the lowest position accordingly. In addition, the second cam groove 92 changes from the lowest surface 96 to the high surface 93 while moving from the position f to the position g, and the pusher 77 rises to a high position accordingly. afterwards,
At the positions g to a, the second cam groove 92 is the high surface 93 and the pusher 77 is at a high position.

As shown in FIG. 9, a holding mechanism 100 for holding the gasket 7 is provided at the lower end of the pusher 77. In FIG. 9, the pusher 77 shown by a solid line
With the holding mechanism 100, the cam follower 91 is engaged with the high surface 93 of the second cam groove 92, so that the pusher 77 is
And the holding mechanism 100 is raised to a higher position. In this state, the holding mechanism 100 is raised inside the chamber 76. On the other hand, in FIG. 9, first, the holding mechanism 100x indicated by the alternate long and short dash line has a structure in which the cam follower 91 is engaged with the middle surface 94 of the second cam groove 92.
00 is in a state of being lowered to an intermediate position. When the holding mechanism 100 descends to the intermediate position in this way, the holding mechanism 100 is attached to the female screw portion 16 of the gasket 7 supplied by the recess 70 of the gasket supply table 48.
It is designed to be located at the height where it fits in. Further, the holding mechanism 100y indicated by the one-dot chain line in FIG. 9 shows a state in which the cam follower 91 is engaged with the lower surface 95 of the second cam groove 92 so that the holding mechanism 100 is lowered to a lower position. When the holding mechanism 100 is lowered to the lower position as described above, the gasket 7 is just inserted into the opening 5 at the rear end of the outer cylinder 2 which is gripped by the chuck 60 of the outer cylinder gripping table 51 below the stoppering table 50. For the first time, the holding mechanism 100 is positioned at the height where the opening 5 is closed by the gasket 7. Further, the holding mechanism 100z indicated by the alternate long and short dash line in FIG. 9 shows a state in which the holding mechanism 100 is lowered to the lowest position because the cam follower 91 is engaged with at least 96 of the second cam groove 92. In this way, when the holding mechanism 100 is lowered to the lowest position, the holding mechanism 100 is positioned at the height at which the gasket 7 has been inserted into the outer cylinder 2 held by the chuck 60.

FIG. 10 is an enlarged sectional view of the holding mechanism 100 provided at the lower end of the pusher 77. As shown in this drawing, a compressed air introducing circuit 101 is formed inside the pusher 77.
A cylindrical expansion member 102 made of an elastic material is attached so as to surround the lower edge of the pusher 77 in which 01 is open. The expansion member 102 can be made of, for example, silicon rubber. In a normal state where compressed air is not introduced from the introduction circuit 101,
The expansion member 102 has such a size that it can be just fitted into the female screw portion 16 on the rear surface of the gasket 7 described above with reference to FIG. On the other hand, when compressed air is introduced from the introduction circuit 101, the expansion member 102 expands, and the state shown by the alternate long and short dash line 102 'in FIG. 10 is obtained. Therefore, the expansion member 102 provided at the lower end of the pusher 77 is fitted into the female screw portion 16 on the rear surface of the gasket 7, and then compressed air is introduced from the introduction circuit 101 to expand the expansion member 102 without introducing compressed air. Then, the expansion member 102 is pressure-bonded to the inner surface of the female screw portion 16, whereby the gasket 7 is held at the lower end of the pusher 77.

Now, the manufacturing process of the prefilled syringe 1 performed by the manufacturing line 20 will be described with reference to FIG. First, in the carry-in device 21 shown in FIG. 3, an AGV (Automatic Guided Ve) (not shown) is installed.
The outer cylinder 2 is carried in using a single) or the like. At this time, as shown in FIG. 11A, the cap 4 and the gasket 7 are not yet attached to the outer cylinder 2. Loading device 21
In this way, the outer cylinders 2 thus carried in are aligned in the same direction, and are transferred to the conveyor 26 one by one. The conveyor 26 sequentially conveys the delivered outer cylinder 2 to the cap mounting device 22.

Next, the cap mounting device 22 sequentially mounts the cap 4 supplied from the cap supply feeder 35 on the nozzle 3 of the outer cylinder 2 conveyed by the conveyor 26, and as shown in FIG. 11B, the outer cylinder. 2. Seal the tip of 2. The outer cylinder 2 with the cap 4 attached in this way is delivered to the conveyor 27 and conveyed to the next filling device 23.

In the filling device 23, as shown in FIG. 11C, the inside of the outer cylinder 2 is filled with the liquid 6 through the opening 5 at the rear end of the outer cylinder 2 with the nozzle 3 sealed by the cap 4 facing downward. To do. Then, the outer cylinder 2 filled with the liquid 6 by the filling device 23 is transferred to the conveyor 28 while keeping the posture in which the nozzle 3 sealed by the cap 4 is turned down, and is transferred to the next degassing device 24. It will be transported.

The outer cylinder 2 thus carried into the deaerator 24.
Are conveyed while maintaining an inverted posture with the nozzle 3 sealed by the cap 4 facing down. During this transportation, FIG. 11D
As shown in (3), the vibration of the vibrator 24 is applied to the outer cylinder 2, and the bubbles a existing in the liquid 6 inside the outer cylinder 2 float up and are removed from the liquid 6. The outer cylinder 2 from which air bubbles have been removed in this way is delivered to the conveyor 29 and conveyed to the next gasket mounting device 25.

The outer cylinder 2 carried into the gasket mounting device 25 via the conveyor 29 is first fitted into the notch 55 of the outer cylinder supply table 49, and is rotated in accordance with the clockwise rotation of the outer cylinder supply table 49. It is conveyed to a position where the supply table 49 and the outer cylinder gripping table 51 are in contact with each other, and sequentially delivered to the chuck 60 of the outer cylinder gripping table 51. Then, while the outer cylinder gripping table 51 makes almost one rotation, the gasket 7 is inserted into the outer cylinder 2 from the opening 5 of the outer cylinder 2 and the stopper is performed.

Here, the outer cylinder holding table 5 is based on the positions a to h of the chucks 60 defined in FIG.
12 will be described in detail with reference to FIG. 12. First, as shown in FIG. 12Ea, the chuck 60 is open at the position a, the chamber 76 is at a high position, and the pusher 77 is also at a high position. It is in a high position.

Next, the pusher 77 descends to an intermediate position while moving from the position a to the position b in accordance with the rotation of the outer cylinder gripping table 51, and thus at the position b, FIG. 12Eb.
As shown in FIG.
The holding mechanism 100 is fitted into the female screw portion 16 on the rear surface of the gasket 7 supplied by. After this insertion, compressed air is introduced through the introduction circuit 101 inside the pusher 77 described with reference to FIG. 10, and the expansion member 102 expands. In this way, the expansion member 102 is pressure-bonded to the inner surface of the female screw portion 16, whereby the holding mechanism 1 provided at the lower end of the pusher 77.
00 holds the gasket 7.

Next, the chuck 60 is closed while moving from the position b to the position c according to the rotation of the outer cylinder gripping table 51, and thus, at the position c, the outer cylinder 2 is moved to the chuck 60 as shown in FIG. 12Ec. It is in a state of being completely gripped between the two. After that, the outer cylinder 2 is conveyed in accordance with the rotation of the outer cylinder gripping table 51 to a position h described later while being held between the chucks 60.

Next, while the outer cylinder holding table 51 is rotated, the chamber 76 is lowered to the lower position while moving from the position c to the position d. Thus, at position d, FIG.
As shown in d, the opening 5 at the rear end of the outer cylinder 2 gripped by the chuck 60 is sealed by the chamber 76. Then, after this sealing, decompression is started by a decompression mechanism (not shown), and the inside of the outer cylinder 2 is decompressed.

Next, the pusher 77 first descends to a lower position while moving from the position d to the position e according to the rotation of the outer cylinder gripping table 51. Thus, at the position e, as shown in FIG.
As shown by 2Ee, the gasket 7 has just begun to be inserted into the opening 5 at the rear end of the outer cylinder 2 held by the chuck 60, and the opening 5 is closed by the gasket 7.
Then, after closing the opening 5 at the rear end of the outer cylinder 2 with the gasket 7, the atmospheric pressure is introduced into the chamber 76. Thus, at the position e, the inside of the outer cylinder 2 is in a depressurized state and the rear surface side of the gasket 7 is in a state where a differential pressure such as atmospheric pressure is generated, but the gasket 7 is firmly held by the holding mechanism 100 at the lower end of the pusher 77. Therefore, there is no concern that the gasket 7 will fall into the inside of the outer cylinder 2 due to this differential pressure.

Next, the pusher 77 descends to the lowest position while moving from the position e to the position f according to the rotation of the outer cylinder gripping table 51, and thus at the position f, the outer cylinder gripped by the chuck 60. The state where the gasket 7 is completely inserted into the inside 2 is obtained. In this way, the gasket 7
By pushing and inserting while holding at the tip of the pusher 77, the gasket 7 can be pushed in relatively slowly as compared with the conventional case where the gasket 7 is inserted into the outer cylinder 2 all at once due to the differential pressure. This enables the gasket 7 to be inserted straight into the outer cylinder 2. Also, the skirt portion 1 of the gasket 7
There is no concern that water droplets will remain in the gap between 1 and the inner surface of the outer cylinder 2. Then, when the insertion of the gasket 7 is completed, the introduction of the compressed air from the introduction circuit 101 described in FIG. 10 is finished,
Gasket 7 by holding mechanism 100 at the lower end of pusher 77
Is released.

Next, the chamber 76 moves up to a high position while the pusher 77 also moves up to a high position while moving from the position f to the position g according to the rotation of the outer cylinder gripping table 51.
Thus, at the position g, the prefilled syringe 1 in which the insertion of the gasket 7 is completed is held by the chuck 60.

Next, the chuck 60 is opened during the movement from the position g to the position h in accordance with the rotation of the outer cylinder gripping table 51. Thus, at the position h, the pre-filled syringe 1 is released from the chuck 60, and then the pre-filled syringe 1 is guided by the guide 67 and the notch 6 of the outer cylinder carry-out table 53.
It is conveyed while being held by 5, and is further transferred to the conveyor 30 and carried out.

The prefilled syringe 1 thus carried out is
Next, as shown in FIG. 11F, for example, the autoclave 1
It is put in 20 and heat-sterilized. Thus, the skirt portion 1 in which the gasket 7 is inserted straight into the outer cylinder 2
It is possible to manufacture the pre-filled syringe 1 with excellent appearance in which no water droplets remain around the syringe 1.

[0049]

According to the present invention, since the gasket is pushed by the pusher and inserted into the outer cylinder while being held at the tip of the pusher, the gasket does not slip into the outer cylinder due to the differential pressure. The gasket is inserted into the outer cylinder at a relatively slow speed.
Therefore, the prefilled syringe obtained according to the present invention has a state in which the gasket is inserted straight and has a good appearance in which no water drops remain around the skirt portion. In the pre-filled syringe obtained by the present invention, the gasket is inserted straight and in the correct posture, so that there is no fear of liquid leakage.

[Brief description of drawings]

FIG. 1 is a cross-sectional view of a prefilled syringe.

FIG. 2 is an explanatory view of a usage state of an already filled syringe.

FIG. 3 is a plan view showing a manufacturing line for a prefilled syringe according to an embodiment of the present invention.

FIG. 4 is a perspective view of a gasket mounting device.

FIG. 5 is a plan view of a transport mechanism of the gasket mounting device.

FIG. 6 is a plan view of a stopper mechanism of the gasket mounting device.

FIG. 7 is a front view of a cylindrical cam.

FIG. 8 is an explanatory diagram of the operation of the chamber.

FIG. 9 is a diagram for explaining the operation of the pusher.

FIG. 10 is an explanatory diagram of a holding mechanism.

FIG. 11 is an explanatory diagram showing a manufacturing process of an already filled syringe.

FIG. 12 is an explanatory diagram showing a gasket plugging step.

[Explanation of symbols]

 1 Filled Syringe 2 Outer Cylinder 3 Nozzle 4 Cap 5 Opening 6 Liquid 7 Gasket a Bubble

Claims (10)

[Claims] 1. A stopper that is inserted by closing the opening of the container with a stopper while the inside of the container is depressurized, introducing atmospheric pressure to the rear surface side of the stopper, and then inserting the container while holding the stopper inside the container. Method. 2. An outer cylinder, in which a nozzle at the tip is sealed with a cap, is placed in a posture with the nozzle facing downward, and liquid is filled inside the outer cylinder through an opening formed at the rear end of the outer cylinder. A method for manufacturing a pre-filled syringe, which comprises: inserting an atmospheric pressure into a rear surface of a gasket by closing an opening with a gasket while depressurizing the inside of the cylinder; 3. An outer cylinder formed by sealing a nozzle at the tip with a cap is placed in a posture in which the nozzle is in a downward position, and the inside of the outer cylinder is filled with a liquid through an opening formed at the rear end of the outer cylinder. After the inside of the cylinder is depressurized, the opening is closed with a gasket and atmospheric pressure is introduced to the rear side of the gasket, and then the prefilled syringe is assembled by pressing and inserting the gasket while holding the gasket inside the outer cylinder. A method for manufacturing an already filled syringe, which comprises sterilizing a filled syringe by heating. 4. A stopper including a gripping means for gripping the container, a depressurizing means for depressurizing the inside of the container, and a pusher for pushing and inserting the plug into the container from an opening of the container gripped by the gripping means. In the device, a stopper mechanism for holding a stopper is provided at the tip of the pusher. 5. A gripping means for gripping an outer cylinder whose tip nozzle is sealed with a cap and whose interior is filled with liquid in a posture with the nozzle facing downward, and decompressing the inside of the outer cylinder. In a manufacturing apparatus including a pressure reducing means and a pusher for pushing the gasket into the inside of the outer cylinder from the opening of the rear end of the outer cylinder gripped by the gripping means, a holding mechanism for holding the gasket at the tip of the pusher is provided. An apparatus for manufacturing an already-filled syringe, which is characterized in that 6. A female screw portion for connecting a plunger is formed on a rear surface of the gasket, and the holding mechanism has a size capable of being fitted into the female screw portion in a normal state, and has a size capable of being fitted into the female screw portion in an expanded state. The manufacturing apparatus for a prefilled syringe according to claim 5, further comprising an expansion member that presses the inner surface to hold the gasket. 7. The prefilled syringe manufacturing apparatus according to claim 5, wherein the gasket is inserted by inserting a pusher into the outer cylinder using a cam mechanism. 8. An outer cylinder formed by sealing a nozzle at the tip with a cap is placed in a posture in which the nozzle is in a downward position, and the inside of the outer cylinder is filled with liquid through an opening formed at the rear end of the outer cylinder. The inside of the cylinder is depressurized, the opening is closed with a gasket, atmospheric pressure is introduced to the rear side of the gasket, and then the gasket is manufactured by inserting it while holding the gasket inside the outer cylinder. A pre-filled syringe that is not in a posture. 9. An outer cylinder, in which a nozzle at the tip is sealed with a cap, is placed in a posture with the nozzle facing downward, and liquid is filled into the outer cylinder through an opening formed at the rear end of the outer cylinder. After the inside of the cylinder is depressurized, the opening is closed with a gasket and atmospheric pressure is introduced to the back side of the gasket, and then the gasket is pushed into the outer cylinder while being inserted to assemble the pre-filled syringe. A pre-filled syringe that is manufactured by heat sterilizing the syringe and the gasket is in a posture without bending. 10. The prefilled syringe according to claim 8, wherein the liquid is a contrast agent.