JP2003210578A - Piston-loading method - Google Patents

Abstract

(57) [Problem] To provide a piston loading method for manufacturing a syringe excellent in liquid sealability. A piston is inserted into a sleeve.
A piston loading method for inserting the sleeve into the syringe body, and withdrawing the sleeve from the syringe body, wherein the piston is loaded into the syringe body; The piston includes a leading end of the sleeve and a distal end of the sleeve facing the leading end of the sleeve. The piston is inserted from the leading end of the sleeve.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a piston loading method, and more particularly to a piston loading method for producing a prefilled syringe preparation having an excellent liquid sealing property.

[0002]

2. Description of the Related Art A syringe is a device for directly injecting a drug solution into a body by moving a piston in a barrel which is a main body of the syringe.
Classified as an injection. The injection is manufactured by loading the piston inside the barrel filled with a drug solution.

FIG. 9 is a process diagram of a conventional piston loading method, and a sleeve is used for loading the piston. Specifically, as shown in FIG. 9A, first, the barrel 30 is filled with the chemical liquid 10. The sleeve 60 includes a sleeve tip portion 61 and a sleeve end portion 62, and the driving guide 70
The piston 40 ′ inserted in ′ is set on the far side from the barrel 30, that is, the liquid contacting portion 41 ′ is set on the upper side of the sleeve end portion 62.

Next, as shown in FIG. 9 (b), the stopper rod 80 has a non-wetted portion 42 'of the piston 40'.
The piston 40 'by pushing downward from above.
The driving guide 70 with the wetted portion 41 ′ at the top.
'Into the sleeve 60 and the sleeve end 62
Is pushed in toward the sleeve tip portion 61. At the same time, the sleeve 60 is inserted into the barrel 30.
The tip end 31 of the barrel 30 has a sealing cap 2
0 is provided.

Then, as shown in FIG. 9 (c), the stopper pushing rod 80 moves the piston 40 'within the sleeve 60, that is, the liquid contact portion 41' contacts the liquid surface of the chemical liquid 10. While lowering the piston 40 'to the sleeve 60, the sleeve 60 is also moved in the barrel 30 and is lowered until the end portion of the sleeve tip 61 contacts the liquid surface of the chemical liquid 10.

Then, as shown in FIG. 9 (d), the sleeve 60 is moved to the barrel 3 while the liquid contact part 41 'is in contact with the liquid surface of the chemical liquid 10 by the stopper pushing rod 80.
0, and finally, as shown in FIG. 9 (e),
The stopper 40 is pushed out of the barrel 30 to load the piston 40 ′ in the barrel 30. This loading method is called stoppering and is a method suitable for high-speed production of syringes.

FIG. 10 is a sectional view of the piston 40 'and the like shown in FIG. As shown in the figure, the piston 40 ′ has a liquid contact portion 41 ′ that has a mountain-shaped taper toward the liquid medicine 10 and a non-contact portion that faces the liquid contact portion 41 ′ and that has a screw hole 44 ′ substantially at the center It is composed of a liquid portion 42 'and a side surface portion 43' connected to the liquid contact portion 41 'and the non-liquid contact portion 42', and the outer diameter a'of the non liquid contact portion 42 'is the sleeve tip. Part 6
It is made larger than the inner diameter b of 1. The piston 4
A laminating process is applied to 0 '.

The side surface 43 'has three pleats 4 in a direction orthogonal to the longitudinal axis of the barrel 30.
5 ', 45', 45 'are provided. The fold 45 '
Is provided along the outer circumference of the piston 40 'in order to improve the straight running stability of the piston 40'. Also,
As another conventional technique for loading the piston, there is also a method that does not use the sleeve, for example, a method that uses a vacuum tap to load the piston by vacuumizing the space in the barrel filled with the chemical liquid.

[0009]

By the way, as in the above-mentioned prior art, the method of plugging the piston using the sleeve is as follows.
Since the piston is set at the end of the sleeve and the piston is pushed through the sleeve to pass through, the piston is strongly compressed in the sleeve and at a high speed in the sleeve. Move
In addition, the side surface of the piston is worn because the sleeve is rubbed over the entire length. this is,
For example, when the accuracy of the roundness of the barrel is poor, or when the piston is inserted into the barrel with a tilt, the pleats are cut off, or the wrinkles of the laminate coated on the piston are wrinkled. Occurs,
This causes inconvenience such as leakage of chemical liquid. Further, the piston has a problem that it is difficult to insert the piston into the sleeve because the outer diameter of the non-wetted portion is larger than the inner diameter of the sleeve tip portion.

Further, in the vacuum stoppering method of the piston which does not use the sleeve like the other conventional techniques, since the void in the barrel containing the chemical solution is pulled out by the vacuum, the chemical solution is likely to be bumped. Or, the outflow of bubbles due to the bumping may occur in the vacuum line. This is because, for example, when handling different types of products on the same production line, a large-scale washing and sterilizing device is required to prevent contamination due to a slight outflow of the chemical liquid with the outflow of the bubbles, and When bubbles tend to remain in the chemical liquid due to bumping, the bubbles are often erroneously detected as foreign substances in the subsequent foreign substance inspection process. Further, when high-speed production of syringes is required, a plurality of stopper units are required, but when a vacuum leak occurs, it is difficult to find the leak location. Note that the vacuum capping device has a problem that the mechanical structure is more complicated and the manufacturing cost of the device itself is higher than that of the capping device using the sleeve.

That is, the inventor of the present application, when plugging the piston in manufacturing a syringe, adopts a piston loading method using a sleeve capable of high-speed production and enables loading of the piston excellent in liquid sealing property. In order to achieve this, new knowledge has been obtained that some measures are required in the process of inserting the piston into the sleeve. The present invention has been made in view of such problems, and an object thereof is to provide a piston loading method for manufacturing a syringe having an excellent liquid sealing property.

[0012]

[Means for Solving the Problems] To achieve the above object,
A piston loading method according to the present invention includes a step of inserting a piston into a sleeve, a step of inserting the sleeve into a syringe main body, and a step of withdrawing the sleeve from the syringe main body, and the piston inside the syringe main body. The method of loading a piston according to claim 1, wherein the sleeve includes a sleeve distal end portion facing the syringe body, and a sleeve distal end portion facing the sleeve distal end portion, the piston comprising:
It is characterized in that the sleeve is inserted from the tip end side.

In the piston loading method of the present invention configured as described above, since the piston is inserted from the sleeve tip side, that is, the inserting direction into the sleeve is opposite to the conventional direction, It is possible to shorten the moving distance of the piston within the sleeve, reduce the wear of the side surface of the piston to prevent the leakage of chemical liquid, and manufacture a product having excellent liquid sealing properties. it can. Further, a specific aspect of the piston loading method according to the present invention is characterized in that the piston is held by the sleeve tip portion.

Further, in another specific aspect of the piston loading method according to the present invention, the piston has a liquid contact part and a non-liquid contact part, and an outer diameter of the non-liquid contact part is the tip of the sleeve. Smaller than the inner diameter of the part, or the piston,
It has a liquid contact part and a non-wetted part, and one or two folds are provided on the side surface part that is continuous with the liquid contact part and the non-wetted part, or the fold is the syringe. It is characterized in that it is provided in a direction intersecting with the longitudinal axis of the main body.

Still another specific embodiment of the piston loading method according to the present invention is characterized in that the piston is laminated, or the syringe body is made of resin. There is. Further, it is characterized in that it is a prefilled syringe preparation produced by the piston loading method.

[0016]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the present invention will be described below with reference to the drawings. Further, in describing the embodiment, components having the same function are designated by the same reference numerals. 1 to 6 are explanatory views regarding a piston loading method according to the first embodiment of the present invention, and FIG. 1 is a perspective view of a prefilled syringe preparation which is a syringe manufactured by the method according to the present embodiment, and FIG. 1 is an exploded perspective view of the syringe body and the like of FIG. 1, FIG. 3 is a sectional view of the piston and the like of FIG. 1, and FIGS. 4 to 6 are process diagrams of the piston loading method for the formulation of FIG. is there.

As shown in FIG. 1, the prefilled syringe preparation 1 is manufactured by inserting a piston 40 into a barrel 30 which is a main body of a syringe filled with a drug solution 10. Tip 3 of 30
1, a sealing cap 20 for sealing the chemical solution 10, a piston 40 moving in the barrel 30, and a piston 40.
And a piston rod 50 having a substantially cruciform cross section for moving the piston rod according to a desired amount.

The barrel 30 has a tubular shape and has a tip 31 for injecting the filled drug solution 10 into the body through an injection needle (not shown), the drug solution 10 and the piston 40.
And a flange-shaped end portion 34 having an insertion opening 33 for the piston 40 or the like on the end side of the loading portion 32.

As the material of the barrel 30, for example, glass or polypropylene, polyethylene, cyclic polyolefin, a copolymer of cyclic polyolefin and α-olefin, polyethylene terephthalate, polystyrene, ABS resin, polyester, polyvinyl chloride, nylon, Plastics such as polytetrafluoroethylene, polymethylpentene, hexafluororesin, polymethylmethacrylate, and polycarbonate, metals such as stainless steel, gold, aluminum, aluminum alloys, titanium, ceramics, carbon composite materials, etc. The material can be selected from materials such as quartz, but is not limited thereto. It is preferable to use a resin such as a cyclic polyolefin because it is lighter and less likely to be damaged than glass.

The piston 40 is the piston rod 50.
In accordance with the desired amount of pushing from the inside, the barrel 30 is moved toward the tip portion 31, and thereby the liquid medicine 10 is injected into the body. In addition, as the material of the piston 40, for example, rubber such as butyl rubber may be mentioned. However, these are used to ensure the stability of the prefilled syringe preparation 1.
A laminated product can also be used. The laminating treatment is to coat the surface of the elastic piston with a fluororesin to prevent elution of a component that adversely affects the chemical liquid 10 or the like.

FIG. 2 is an exploded perspective view of the barrel 30 and the like. A sleeve 60 is used to plug the piston 40 of the present embodiment. The sleeve 60 has a tubular shape, and a sleeve tip 61 toward the barrel 30.
And the sleeve end portion 6 facing the sleeve tip portion 61.
2, the piston 40 inserted into the inside of the sleeve 60 from the sleeve distal end portion 61 is loaded into the barrel 30 pre-filled with the chemical liquid 10 by the stopper pushing rod 80.

FIG. 3 is a sectional view of the piston 40 and the like. As shown in the figure, the piston 40 has a liquid contact portion 41 having a mountain-shaped taper toward the chemical liquid 10, and a screw hole 44 facing the liquid contact portion 41 and engaged with a piston rod 50 or the like at a substantially central portion. The non-wetted portion 42 and the side portion 43 that is continuous with the liquid-contacting portion 41 and the non-wetted portion 42 and secures the liquid sealing property. As described above, the inner diameter b of the sleeve tip portion 61 is made smaller. Specifically, the inner diameter b of the sleeve tip portion 61 is set to 1
Then, the outer diameter a of the non-wetted portion 42 is set to a ratio of 0.8 to 0.99.

The side surface 43 has a piston 4
In order to improve the straight running stability of 0, one fold 45 is provided in the direction orthogonal to the longitudinal axis of the barrel 30, and the number of folds 45 is reduced as compared with the conventional technique. It enables the formation of a tough liquid-sealed part.

Next, a method for loading the piston having the above-described structure will be described. 4 to 6 are flow charts showing a piston loading method for the prefilled syringe preparation 1 of FIG. First, FIG. 4 and FIG.
The process up to inserting 0 into the sleeve 60 is shown.

As shown in FIG. 4A, the stroke 1 is as follows.
The piston 40 is mounted on the piston transport rail 90 such that the liquid contact portion 41 of the piston 40 faces the piston transport rail 90 and the non-wetted portion 42 faces the driving guide 70. Then, the piston 40 is conveyed below the driving guide 70.

The driving guide 70 is for inserting the piston 40 into the sleeve 60, and a piston inlet 71 and a sleeve inlet 72 communicate with each other at substantially the center.
The piston inlet 71 and the sleeve inlet 72 are tapered to facilitate the insertion of the piston 40 and the sleeve 60, respectively.
The minimum diameter portion 73 of the hole communicating with the sleeve inlet 72 is slightly smaller than the inner diameter of the sleeve tip portion 61, for example. This is because when the sleeve 60 contacts the sleeve inlet 72, the sharp end portion of the sleeve tip 61 receives the piston 40 without damaging the piston 40. In addition, the driving guide 70 is the piston 4
In order to minimize the damage due to friction of 0, it is desirable to finish the surface smoothly with a slippery resin material. Also,
The piston transfer rail 90 is provided with a rod insertion hole 91 for a driving pushing rod 81.

Next, as shown in FIG. 4 (b), as stroke 2, the driving push-in rod 81 moves upward through the rod insertion hole 91, and the piston in which the liquid contact portion 41 is directed downward. 40 is pushed up, and the non-wetted part 42 of the piston 40
Is inserted into the driving guide 70 with the head as the head.

Then, as shown in FIG. 4C, step 3
As a result, the sleeve 60 is set near the sleeve inlet 72 by moving from the upper side to the lower side. That is, the piston 40 inserted in the driving guide 70
Is set below the sleeve tip 61. In addition, the pushing rod 80 for stoppering is provided in the sleeve end portion 62.
It is inserted into the sleeve 60 from the side.

Then, as shown in FIG.
As a driving push rod 81, the piston 4
No. 0 liquid contact part 41 is further pushed upward,
The piston 40 with the bottom facing downward is inserted from the sleeve tip 61 side and held by the sleeve tip 61.

Further, as shown in FIG. 5 (b), as stroke 5, the sleeve 60 is lifted and separated from the driving guide 70, so that the piston 40 held by the sleeve tip 61 is pushed in for stoppering. It rises with the rod 80. The driving pushing rod 81 descends to the standby position and stands by until the next insertion of the piston 40 into the sleeve 60.

FIG. 6 shows the process of inserting the sleeve 60 into the barrel 30 and the process of withdrawing the sleeve 60 from the barrel 30. As shown in FIG. 6A, as a stroke 6, the sleeve 60 in which the piston 40 is held by the sleeve tip 61 moves above the barrel 30 pre-filled with the chemical liquid 10.

Next, as shown in FIG. 6 (b), in step 7, the pushing plug pushing rod 80 engages with the screw hole 44 on the non-wetted portion 42 side and presses the screw hole 44. The sleeve 60 is lowered, and the sleeve 60 is inserted into the loading portion 32 of the barrel 30 from the sleeve tip portion 61 via the insertion opening 33. The pushing with the stopper pushing rod 80 is performed until the liquid contact portion 41 and the end portions of the sleeve tip portion 61 descend and come into contact with the liquid surface of the chemical liquid 10. In addition,
The liquid contact part 41 can be set at an appropriate position from the vicinity of the insertion port 33 to the liquid surface, in addition to contacting the liquid surface of the chemical liquid 10.

Then, as shown in FIG. 6C, step 8
As for the sleeve 60, the liquid contact portion 41 is held at an appropriate position by the stopper pushing rod 80.
6 is withdrawn from the barrel 30 and, as shown in FIG. 6 (d), as a stroke 9, the stopper plug pushing rod 80 is withdrawn from the barrel 30, so that the barrel 30
The piston 40 is plugged inside and a series of strokes is completed.

FIGS. 7 and 8 are explanatory views relating to the piston loading method of the second embodiment of the present invention, and show the process steps of the piston loading method for the prefilled syringe preparation 1 of the present embodiment. And the piston 40
Since this is based on the same point of interest as in the first embodiment except for the step of inserting the piston into the sleeve 60, the point of inserting the piston 40 into the sleeve 60 will be described in detail.

That is, this embodiment takes into consideration the sanitary aspect of the piston liquid contact portion 41, and as shown in FIG. 7A, the stroke 1 is set up until the stroke of inserting the piston 40 into the sleeve 60. The piston 40 is placed on the piston transfer rail 90 so that the non-wetted portion 42 faces the piston transfer rail 90, and is transferred to the upper side of the driving guide 70. Here, the driving guide 7
0 is set with the piston inlet 71 facing upward.

Then, as shown by the chain line in FIG.
In the second stroke, the pushing rod 82 for driving moves downward to push down the piston 40, and the non-wetted portion 42 of the piston 40 with the liquid contact portion 41 facing upward is inserted into the driving guide 70. . Next, as shown by the solid line in FIG. 7 (b), the driving guide 70 is inverted 180 ° about the guide rotation shaft 74 provided at the end of the driving guide 70, and the piston inlet 71 is moved downward and the sleeve. The inlet 72 is fixed at a position facing upward.

Then, as shown in FIG. 7C, step 3
As the sleeve 60 moves downward from above, the piston 40 inserted into the driving guide 70 is set below the sleeve tip 61. Further, the pushing rod 80 for tapping is inserted into the sleeve 60 from the sleeve end portion 62 side, and the pushing rod 81 for driving rises toward the liquid contact portion 41.

Then, as shown in FIG.
As a driving push rod 81, the piston 4
The piston 40 with the liquid contact part 41 of 0 pushed up and the liquid contact part 41 facing downward is inserted from the sleeve tip 61 side and held by the sleeve tip 61. Also,
As shown in FIG. 8 (b), as the stroke 5, the sleeve 60
Is lifted and released from the driving guide 70,
The piston 40 held by the sleeve tip portion 61 rises together with the stopper pushing rod 80. The process of inserting the sleeve 60 into the barrel 30 and the process of withdrawing the sleeve 60 from the barrel 30 are the same as the processes 6 to 9 of the piston loading method according to the first embodiment.

As described above, the above-described embodiments of the present invention have the following functions due to the above-mentioned configuration. That is, in the piston loading method according to the first and second embodiments, since the piston 40 is inserted from the sleeve distal end 31 side and held at that position, the piston 40 is more It becomes possible to shorten the moving distance of the piston 40, and it is also possible to reduce the pressure applied to the piston 40 from the stopper plug pushing rod 80, so that the side surface portion 43 of the piston 40 is not worn. The amount of the drug solution 10 can be reduced to prevent the drug solution 10 from leaking, and the prefilled syringe preparation 1 having excellent liquid sealing properties can be manufactured.

The shape of the piston 40 is such that the outer diameter a of the non-wetted portion 42 is smaller than the inner diameter b of the sleeve tip 31 to be engaged, so that the piston 40 can be inserted into the barrel 30. Can be easier and moreover,
Since the number of pleats 45 on the side surface portion 43 is one,
The pleats are tougher than in the conventional case, the pleats are prevented from being damaged, and the leakage of the chemical liquid 10 can be further prevented.

Furthermore, in the piston loading method according to the second embodiment, since the contact between the liquid contact portion 41 and the piston transport rail 90 is reduced, the hygiene of the piston 40 can be improved. Therefore, the reliability of the prefilled syringe preparation 1 can be further enhanced.

Further, the prefilled syringe preparation 1 produced as described above can be produced at a higher speed than the vacuum filling method which does not use a sleeve, and the drug solution 10 filled in the barrel 30 is a proteinaceous material. Alternatively, even if it is a peptide type, it is possible to provide a suitable prefilled syringe preparation 1 in which generation of bubbles is suppressed. that's all,
Although one embodiment of the present invention has been described in detail, the present invention is not limited to the above embodiment, and various modifications can be made in design without departing from the spirit of the invention described in the claims. Is.

For example, the piston 4 in the above embodiment
One side fold 45 is provided on the side surface portion 43 of 0. In addition to this structure, a fold that is stronger than the conventional one can be formed. It is a good thing to have. Further, the pleats 45 are provided in a direction perpendicular to the longitudinal axis of the barrel 30, but the pleats 45 are not limited to this configuration, and may be provided in a direction intersecting with the longitudinal axis of the barrel. Good, in this case also, the same effect as described above can be obtained.

[0044]

As can be understood from the above description, according to the piston loading method of the present invention, the moving distance of the piston within the sleeve is shortened, so that the wear of the piston is reduced and a product excellent in liquid sealing property is obtained. It can be manufactured.

[Brief description of drawings]

FIG. 1 is a perspective view of a prefilled syringe preparation manufactured by a piston loading method according to a first embodiment of the present invention.

FIG. 2 is an exploded perspective view of the syringe body and the like shown in FIG.

3 is a cross-sectional view of the piston and the like of FIG.

4 is a process flow diagram of a piston loading method for the formulation of FIG.

5 is a process flow diagram of a piston loading method for the formulation of FIG.

FIG. 6 is a process flow diagram of a piston loading method for the formulation of FIG.

FIG. 7 is a process chart of a piston loading method according to the second embodiment of the present invention.

8 is a process flow diagram of a piston loading method for the formulation of FIG. 7. FIG.

FIG. 9 is a process chart of a piston loading method according to the related art.

10 is a cross-sectional view of the piston and the like of FIG.

[Explanation of symbols]

1 Prefilled syringe formulation (syringe) 30 Syringe body (barrel) 40 pistons 41 Wetted part 42 Non-wetted part 43 Side 45 folds 60 sleeves 61 Sleeve tip 62 end of sleeve

Claims (8)

[Claims] 1. A step of inserting a piston into a sleeve,
A piston loading method, comprising a step of inserting the sleeve into a syringe body and a step of withdrawing the sleeve from the syringe body, wherein the piston is loaded into the syringe body, wherein the sleeve is attached to the syringe body. A piston loading method, comprising: a forward sleeve tip portion; and a sleeve distal end portion facing the sleeve tip portion, wherein the piston is inserted from the sleeve tip end side. 2. The piston loading method according to claim 1, wherein the piston is held by the tip of the sleeve. 3. The piston has a liquid contact portion and a liquid non contact portion, and an outer diameter of the liquid non contact portion is smaller than an inner diameter of the sleeve tip portion. 1 or 2
The described piston loading method. 4. The piston has a wetted portion and a non-wetted portion, and one or two pleats are provided on a side surface portion connecting the wetted portion and the non-wetted portion. The piston loading method according to any one of claims 1 to 3, wherein: 5. The piston loading method according to claim 4, wherein the pleats are provided in a direction intersecting with a longitudinal axis of the syringe body. 6. The piston loading method according to claim 1, wherein the piston is laminated. 7. The piston loading method according to claim 1, wherein the syringe body is made of resin. 8. A prefilled syringe preparation manufactured by the piston loading method according to any one of claims 1 to 7.