Bubble removal device, foreign matter inspection device, and manufacturing device of prefilled syringe
The bubble removal device applies multiple impacts to prefilled syringes to separate air bubbles, improving the accuracy of foreign matter inspection and ensuring efficient manufacturing.
Patent Information
- Application Number
- JP2023112009
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-07-07
- Publication Date
- 2025-01-20
AI Technical Summary
Existing foreign matter inspection devices for prefilled syringes struggle to accurately distinguish between air bubbles attached to the inner surface and actual foreign matter, leading to inaccurate testing results.
A bubble removal device that applies multiple impacts to the prefilled syringe, utilizing a guide part, support part, and impact applying section to separate air bubbles from the inner surface, followed by a foreign matter inspection device to inspect for the presence of foreign matter accurately.
The solution effectively removes air bubbles, enhancing the accuracy of foreign matter inspection and enabling efficient manufacturing of prefilled syringes.
Smart Images

Figure 2025009184000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to an air bubble removal device for removing air bubbles adhering to the inner surface of a prefilled syringe, a foreign matter inspection device for inspecting the presence or absence of foreign matter in a liquid in a prefilled syringe, and a manufacturing device for manufacturing prefilled syringes. [Background technology]
[0002] Patent Document 1 discloses a method for degassing air bubbles contained in a highly viscous fluid by applying a vertical impact to a container that contains the highly viscous fluid. Patent Document 2 discloses a method for promoting the degassing of air bubbles attached to a substrate by applying an impact to the substrate. [Prior art documents] [Patent documents]
[0003] [Patent Document 1] Japanese Patent Application Publication No. 8-290008 [Patent Document 2] JP 2010-70779 A Summary of the Invention [Problem to be solved by the invention]
[0004] However, when a foreign body inspection device is used to inspect the presence or absence of foreign bodies in the liquid filled in the prefilled syringe, it may be difficult to accurately distinguish between air bubbles attached to the inner surface of the prefilled syringe and foreign bodies. Therefore, it is desired to improve the inspection accuracy of the presence or absence of foreign bodies. [Means for solving the problem]
[0005] (1) A first aspect of the present invention is a bubble removal device for removing bubbles adhering to an inner surface forming a filling chamber of a prefilled syringe, the bubble removal device comprising: a cylindrical syringe body having a nozzle at a tip end and a flange at a base end; a gasket slidably inserted into the syringe body; and a liquid filled in a filling chamber formed inside the syringe body between the nozzle and the gasket. The bubble removal device comprises a guide part that guides a portion of the syringe body between the nozzle and the flange in a vertical direction while the tip end of the syringe body is facing upward; and a base end that is positioned away from the guide part in a downward direction. the flange abuts against the stopper at a second position, thereby applying an impact in the upward direction to the base end. The impact applying unit applies a first impact in the upward direction to the base end when the prefilled syringe is at the first position, the prefilled syringe moves in the upward direction upon receiving the first impact, and the flange abuts against the stopper at a second position, thereby applying a second impact to the base end.
[0006] According to this configuration, the prefilled syringe moves upward when it receives a first impact at the first position, and when the flange abuts (collides) with the stopper at the second position, a second impact is applied to the base end, and the prefilled syringe stops moving upward. In this way, by applying two impacts to the base end, it is possible to promote the release of air bubbles attached to the inner surface of the prefilled syringe.
[0007] (2) In the bubble removal device described in (1) above, when the prefilled syringe moves in the downward direction upon receiving the second impact and the base end moves to a third position between the first position and the second position, the impact applying portion may abut against the base end, thereby applying a third impact in the upward direction to the base end.
[0008] According to this configuration, when the prefilled syringe receives the second impact and moves downward, and the base end moves to the third position, a third impact is applied to the base end. By applying the third impact, it is possible to further promote the release of air bubbles adhering to the inner surface of the prefilled syringe.
[0009] (3) In the bubble removal device described in (1) or (2) above, the impact application section may have a pressing section capable of pressing the base end section in the upward direction, and a driving section that moves the pressing section in the up-down direction.
[0010] According to this configuration, it is possible to repeatedly apply impacts to the base end by moving the pressing part up and down relative to the base end, which makes it possible to effectively remove air bubbles adhering to the inner surface of the prefilled syringe.
[0011] (4) In the bubble removal device described in (3) above, the drive unit may be capable of changing the speed at which the pressing unit moves in the upward direction.
[0012] According to this configuration, by appropriately changing the movement speed depending on the type, viscosity, etc. of the liquid, air bubbles adhering to the inner surface of the prefilled syringe can be appropriately removed.
[0013] (5) In the bubble removal device described in (3) above, when the process of applying multiple impacts to the base end, including at least the first impact and the second impact, is defined as one impact application cycle, the driving unit may perform the impact application cycle multiple times on one prefilled syringe.
[0014] According to this configuration, by performing the impact cycle multiple times, air bubbles adhering to the inner surface of the prefilled syringe can be effectively removed.
[0015] (6) In the bubble removal device described in (5) above, the drive unit may be capable of changing the number of impact application cycles.
[0016] According to this configuration, by appropriately changing the number of impact cycles depending on the type, viscosity, etc. of the liquid, air bubbles adhering to the inner surface of the prefilled syringe can be appropriately removed.
[0017] (7) In the bubble removal device according to any one of (1) to (6) above, the stopper may be provided on a lower surface of the guide portion.
[0018] According to this configuration, when the flange abuts (collides) against the stopper at the second position, a second impact can be effectively applied to the base end portion.
[0019] (8) A second aspect of the present invention is a foreign matter inspection device comprising: an air bubble removal device according to any one of (1) to (7) above; and a foreign matter inspection unit that inspects the prefilled syringe from which the air bubbles have been removed from the inner surface for the presence or absence of foreign matter in the liquid.
[0020] According to this configuration, the prefilled syringe from which air bubbles have escaped from the inner surface is inspected for the presence or absence of foreign matter in the liquid, thereby improving the inspection accuracy.
[0021] (9) A third aspect of the present invention is a manufacturing apparatus for a prefilled syringe, comprising the foreign matter inspection apparatus described in (8) above and an assembly apparatus for assembling the prefilled syringe, wherein the foreign matter inspection apparatus inspects the prefilled syringe assembled by the assembly apparatus for the presence or absence of the foreign matter in the liquid.
[0022] According to this configuration, the inspection accuracy of the foreign matter inspection device is improved, so that pre-filled syringes can be manufactured efficiently. Effect of the Invention
[0023] According to the present invention, the prefilled syringe moves upward when it receives a first impact at the first position, and when the flange abuts (collides) with the stopper at the second position, a second impact is applied to the base end, and the prefilled syringe stops moving upward. In this way, by applying two impacts to the base end, it is possible to promote the release of air bubbles attached to the inner surface of the prefilled syringe.
[0024] Furthermore, according to the present invention, the prefilled syringe from which air bubbles have escaped from the inner surface is inspected for the presence or absence of foreign matter in the liquid, thereby improving the inspection accuracy.
[0025] Furthermore, according to the present invention, the inspection accuracy of the foreign matter inspection device is improved, so that pre-filled syringes can be manufactured efficiently. [Brief description of the drawings]
[0026] [Figure 1] FIG. 1 is a configuration diagram of a manufacturing apparatus according to this embodiment. [Diagram 2] FIG. 2 is a side view of the bubble removal device of FIG. [Diagram 3] FIG. 3 is a flowchart showing the operation (manufacturing method) of the manufacturing apparatus of FIG. [Figure 4] FIG. 4 is a first explanatory diagram showing the operation of the bubble removal device. [Diagram 5] FIG. 5 is a second explanatory diagram showing the operation of the bubble removal device. [Figure 6] FIG. 6 is a third explanatory diagram showing the operation of the bubble removal device. [Figure 7] FIG. 7 is a fourth explanatory diagram showing the operation of the bubble removal device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] FIG. 1 is a configuration diagram of a manufacturing apparatus 10 for a prefilled syringe according to this embodiment (manufacturing apparatus 10 according to this embodiment).
[0028] The manufacturing apparatus 10 is an apparatus for manufacturing a pre-filled syringe 12. The manufacturing apparatus 10 includes an assembly device 14 and a foreign matter inspection device 16. The foreign matter inspection device 16 includes an air bubble removal device 18 and a foreign matter inspection section 20.
[0029] As shown in FIGS. 2 and 4, the pre-filled syringe 12 includes a syringe body 22, a gasket 24, and a cap 26.
[0030] The syringe body 22 has a main body portion 28, a nozzle 30, and a flange 32. The constituent material of the syringe body 22 is, for example, a resin material, a metal material, or glass.
[0031] The main body 28 has a cylindrical body 34 and a shoulder 36. The body 34 is a cylindrical body. The axial direction of the body 34 (the direction of the axis Az) is the axial direction of the syringe body 22 and the axial direction of the prefilled syringe 12. The shoulder 36 extends inward from the tip of the body 34.
[0032] The nozzle 30 protrudes in the distal direction from the tip of the shoulder portion 36. The flange 32 protrudes in the radial direction of the body portion 34 from the base end of the body portion 34. Thus, the nozzle 30 is provided at the tip end 38 of the syringe body 22, and the flange 32 is provided at the base end 40 of the syringe body 22.
[0033] The gasket 24 is disposed within the syringe body 22 (inside the barrel 34). The gasket 24 is inserted so as to be slidable along the axial direction within the barrel 34. The gasket 24 is made of an elastic material, such as rubber.
[0034] A filling chamber 42 is formed between the nozzle 30 and the gasket 24 inside the syringe body 22. That is, the filling chamber 42 is formed by the inner wall 44 of the body 34, the inner surface 46 of the shoulder 36, and the tip surface 48 of the gasket 24 among the inner surfaces of the prefilled syringe 12. The filling chamber 42 is filled with a liquid 50 such as a medicine. In the following description, the inner wall 44 of the body 34, the inner surface 46 of the shoulder 36, and the tip surface 48 of the gasket 24 may be referred to as the inner surface 52 of the prefilled syringe 12 that forms the filling chamber 42.
[0035] The cap 26 is placed over the nozzle 30. The liquid 50 in the filling chamber 42 is sealed by the cap 26 and the gasket 24.
[0036] 1 assembles the pre-filled syringe 12. The method of assembling the pre-filled syringe 12 will be described later.
[0037] The foreign matter inspection device 16 inspects the pre-filled syringe 12 assembled by the assembly device 14 for the presence or absence of foreign matter in the liquid 50 (see FIG. 4).
[0038] The air bubble removal device 18 constituting the foreign matter inspection device 16 is a pretreatment device for the foreign matter inspection section 20. As shown in FIG. 2, the air bubble removal device 18 removes air bubbles 54 adhering to the inner surface 52 (see FIG. 4) of the prefilled syringe 12 from the inner surface 52 in a state in which the prefilled syringe 12 is set with the tip direction of the syringe body 22 facing upward.
[0039] The bubble removal device 18 has a base 56 , a support 58 , a guide portion 60 , a support portion 62 , an impact applying portion 64 , and a position adjustment mechanism 66 .
[0040] The support pillar 58 extends upward from the base 56. The guide portion 60 is attached to the upper end of the support pillar 58. The guide portion 60 is a rectangular block. The guide portion 60 is attached to the upper end of the support pillar 58 so as to face the base 56 in the up-down direction.
[0041] A guide hole 68 is formed in the guide portion 60, penetrating in the vertical direction. The diameter of the guide hole 68 is slightly larger than the outer diameter of the barrel 34 of the syringe body 22 (the portion between the nozzle 30 and the flange 32 of the syringe body 22). In other words, the guide hole 68 has a size that allows the barrel 34 to move in the vertical direction. The guide portion 60 guides the barrel 34 to move in the guide hole 68 in the vertical direction.
[0042] The guide portion 60 can be divided into a first portion 92 and a second portion 94 by the dividing surface 90. That is, the guide portion 60 has the first portion 92 and the second portion 94. The first portion 92 is a portion of the guide portion 60 that is connected to the support 58. The second portion 94 is a portion that is connected to the first portion 92. The dividing surface 90 is formed in the guide portion 60 parallel to the axis Az so as to divide the guide hole 68. The first portion 92 and the second portion 94 are connected to each other by a connecting member (not shown) so as to be separable from each other. The dividing surface 90 and the guide hole 68 are formed by connecting the first portion 92 and the second portion 94 by the connecting member. By separating the second portion 94 from the first portion 92, the guide hole 68 is divided, and the inner surface of the guide hole 68 is exposed in the horizontal direction. The connecting member is, for example, a hinge, a screw member, or the like. When the connecting member is a hinge, the first part 92 and the second part 94 are separated in the rotation direction by rotating the second part 94 relative to the first part 92 around the hinge. When the connecting member is a screw member, the second part 94 can be separated from the first part 92 by loosening the screw member.
[0043] When the first portion 92 and the second portion 94 are relatively separated and the inner surface of the guide hole 68 is exposed in the horizontal direction, the prefilled syringe 12 is placed on the upper surface 74 of the support portion 62, which will be described later, with the tip direction (nozzle 30) of the syringe body 22 facing upward. In this state, the first portion 92 and the second portion 94 are connected by a connecting member, so that the body portion 34 is guided inside the guide hole 68, and the prefilled syringe 12 is set in the air bubble removal device 18. In addition, when the second portion 94 is relatively separated from the first portion 92, the set prefilled syringe 12 can be removed from the air bubble removal device 18.
[0044] The method of setting the prefilled syringe 12 in the bubble removal device 18 is not limited to the above description. A notch or groove may be formed in the guide portion 60 in the vertical direction, and the guide hole 68 may be formed by blocking the communication portion of the notch or groove with an unillustrated blocking member. In this case, the notch or groove may be blocked with a blocking member in a state where the barrel portion 34 of the syringe body 22 is inserted into the back side of the notch or groove. Alternatively, the guide portion 60 may be detachable from the support 58. In this case, the guide portion 60 may be attached to the support 58 in a state where the barrel portion 34 of the syringe body 22 is inserted into the guide hole 68. Alternatively, the position of the guide portion 60 relative to the support 58 may be configured to be movable in the vertical direction.
[0045] In the following description, a case will be described in which the guide portion 60 has a divided structure including a first portion 92 and a second portion 94 as shown in FIG.
[0046] When the prefilled syringe 12 is set in the bubble removal device 18, the flange 32 of the syringe body 22 is located below the lower surface 70 of the guide part 60. The lower surface 70 of the guide part 60 functions as a stopper 72 for restricting the upward movement of the prefilled syringe 12. That is, when the prefilled syringe 12 is guided by the guide part 60 and moves upward, if the flange 32 of the syringe body 22 abuts (collides) against the lower surface 70 (stopper 72) of the guide part 60, the upward movement of the prefilled syringe 12 stops.
[0047] In this embodiment, the guide portion 60 and the stopper 72 may be separate members. In this case, the stopper 72 configured as a separate member is fixed to the lower surface 70 of the guide portion 60, for example.
[0048] The support portion 62 is attached to the support column 58 so as to be spaced downward from the lower surface 70 of the guide portion 60. In other words, the support portion 62 is disposed between the lower surface 70 of the guide portion 60 and the base 56. Therefore, the guide portion 60 and the support portion 62 are attached to the support column 58 with a gap therebetween in the up-down direction.
[0049] The support portion 62 is a plate-like member extending horizontally from the support column 58. The flange 32 of the syringe body 22 is located between a lower surface 70 of the guide portion 60 and an upper surface 74 of the support portion 62. The support portion 62 supports the syringe body 22 when the flange 32 is in contact with the upper surface 74 of the support portion 62.
[0050] Hereinafter, as shown in Fig. 2 and Fig. 4, the position of the prefilled syringe 12 when the support part 62 supports the syringe body 22 is referred to as the first position. Also, as shown in Fig. 6, the position of the prefilled syringe 12 when the flange 32 abuts (collides) against the stopper 72 (the lower surface 70 of the guide part 60) is referred to as the second position. In the second position, as described above, the upward movement of the prefilled syringe 12 is restricted by the stopper 72. The prefilled syringe 12 is vertically movable between the first position and the second position.
[0051] As shown in Fig. 4, the support portion 62 has an insertion hole 76 formed therethrough in the up-down direction. The insertion hole 76 is formed coaxially with the prefilled syringe 12 and the guide hole 68. The diameter of the insertion hole 76 is smaller than the outer diameter of the flange 32 of the syringe body 22 and larger than the inner diameter of the barrel 34. When the flange 32 of the syringe body 22 is supported by the support portion 62, the insertion hole 76 is covered from above by the base end portion 40 of the syringe body 22.
[0052] The support part 62 is not limited to the configuration shown in Fig. 2 and Fig. 4. The support part 62 only needs to be able to support the syringe body 22 when the prefilled syringe 12 is located at the first position. Therefore, the support part 62 may support the syringe body 22 at the first position above the guide part 60.
[0053] The position adjustment mechanism 66 is attached to a portion of the support column 58 between the support portion 62 and the base 56. The impact application portion 64 is attached to the position adjustment mechanism 66. The position adjustment mechanism 66 is capable of adjusting the position of the impact application portion 64 in the up-down direction.
[0054] The impact applying portion 64 has a driving portion 78, a rod 80, and a pressing portion 82.
[0055] The driving unit 78 is attached to the position adjustment mechanism 66 so as to be located directly below the insertion hole 76 of the support unit 62. The driving unit 78 is a drive source for the pressing unit 82 and the rod 80. The driving unit 78 is, for example, a cylinder, a solenoid, a linear motor, or the like.
[0056] The rod 80 extends upward from the drive portion 78 coaxially with the insertion hole 76. The outer diameter of the rod 80 is smaller than the diameter of the insertion hole 76.
[0057] The pressing part 82 is a cylindrical member attached to the tip of the rod 80. The outer diameter of the pressing part 82 is larger than the outer diameter of the rod 80 and the inner diameter of the body part 34, and is smaller than the diameter of the insertion hole 76. The rod 80 and the pressing part 82 are movable in the vertical direction by the driving part 78.
[0058] The pressing portion 82 is moved upward by the driving portion 78 and can abut (collide) against the base end portion 40 of the syringe body 22 by passing through the insertion hole 76. When the pressing portion 82 collides against the base end portion 40 of the syringe body 22, the prefilled syringe 12 is bounced off and moves upward.
[0059] The driving unit 78 can change the speed at which the pressing unit 82 moves upward in accordance with the type, viscosity, etc. of the liquid 50 filled in the filling chamber 42. Alternatively, the driving unit 78 can change the speed at which the pressing unit 82 moves upward and downward in accordance with the type, viscosity, etc. of the liquid 50.
[0060] Furthermore, when a process of applying multiple impacts, including at least a first impact and a second impact (described later), to the base end 40 of the syringe body 22 is defined as one impact application cycle, the drive unit 78 may perform the impact application cycle multiple times on one prefilled syringe 12. In this case, the drive unit 78 can change the number of impact application cycles depending on the type, viscosity, etc. of the liquid 50.
[0061] Note that the pressing portion 82 only needs to flip the base end 40 of the syringe body 22 upward. Therefore, the pressing portion 82 may collide with the base end of the barrel 34 of the syringe body 22, or may collide with the flange 32 of the syringe body 22. Alternatively, the pressing portion 82 may collide with both the base end of the barrel 34 and the flange 32.
[0062] 2 and 4, the air bubble removal device 18 guides the barrel 34 of the syringe body 22 to the guide portion 60 in a position in which the tip direction (nozzle 30) of the syringe body 22 faces upward. The pressing portion 82 abuts (collides) against the base end 40 of the syringe body 22 and applies an upward impact (impact force with upward acceleration) to the base end 40, thereby removing the air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12.
[0063] As shown in FIG. 1, the foreign body inspection unit 20 constituting the foreign body inspection device 16 inspects the prefilled syringe 12 from which the air bubbles 54 have been removed from the inner surface 52 (see FIG. 4) of the prefilled syringe 12 by the air bubble removal device 18 to check for the presence or absence of foreign bodies in the liquid 50. The foreign body inspection unit 20 inspects for the presence or absence of foreign bodies by, for example, X-ray inspection, image recognition, or the like. In the X-ray inspection, the prefilled syringe 12 is irradiated with X-rays, and the presence or absence of foreign bodies is inspected by detecting the X-rays that have passed through the prefilled syringe 12. In the image recognition, the prefilled syringe 12 is photographed by a camera, and the presence or absence of foreign bodies is inspected by checking whether or not a foreign body is captured in the image of the photographed prefilled syringe 12.
[0064] Next, a description will be given of a manufacturing method of the pre-filled syringe 12 using the manufacturing apparatus 10. As shown in Fig. 3, the manufacturing method includes an assembly step, an air bubble removal step, and a foreign matter inspection step.
[0065] First, in an assembly process (step S1), the assembly device 14 assembles the prefilled syringe 12 (see Figs. 2 and 4). Specifically, the assembly device 14 first covers the nozzle 30 of the syringe body 22 with the cap 26. Next, the assembly device 14 fills the syringe body 22 with the liquid 50. Next, the assembly device 14 inserts the gasket 24 into the syringe body 22 to seal the liquid 50 filled in the syringe body 22. In this manner, the prefilled syringe 12 is assembled.
[0066] In the next air bubble removal process (step S2), the air bubble removal device 18 removes the air bubbles 54 adhering to the inner surface 52 of the prefilled syringe 12 assembled in the assembly process. In the air bubble removal process, the operations shown in Figures 4 to 6 are performed as one impact cycle to remove the air bubbles 54 (first embodiment). Alternatively, in the air bubble removal process, the operations shown in Figures 4 to 7 are performed as one impact cycle to remove the air bubbles 54 (second embodiment).
[0067] A first embodiment will be described. In the first embodiment, first, the second portion 94 is relatively spaced from the first portion 92 (see FIG. 2) of the guide portion 60, and the guide hole 68 is exposed in the horizontal direction. Next, the base end portion 40 of the syringe body 22 is placed on the lower surface 70 of the guide portion 60 with the tip direction (tip portion 38, nozzle 30) of the syringe body 22 facing upward. In this case, the base end portion 40 of the syringe body 22 is supported on the upper surface 74 of the support portion 62 so that the syringe body 22 and the insertion hole 76 of the support portion 62 are coaxial. In this state, the first portion 92 and the second portion 94 are connected via a connecting member. As a result, with the base end portion 40 of the syringe body 22 spaced downward from the lower surface 70 of the guide portion 60, the barrel portion 34 of the syringe body 22 is guided in the vertical direction by the guide portion 60 inside the guide hole 68.
[0068] 2 and 4, the prefilled syringe 12 is set in the air bubble removal device 18 and supported by the support part 62 in the first position. When the prefilled syringe 12 is set in the air bubble removal device 18, the pressing part 82 is located away from the base end part 40 of the syringe body 22 in the downward direction.
[0069] As shown in Fig. 4, in the filling chamber 42, air bubbles 54 are attached to the inner surface 52 of the prefilled syringe 12. For example, in the filling chamber 42, air bubbles 54 are attached to the tip surface 48 of the gasket 24. In addition, in the filling chamber 42, air bubbles 54 are attached to the inner wall 44 of the body 34. Note that Fig. 4 shows the air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12 in a schematic manner.
[0070] When the driving unit 78 is driven while the prefilled syringe 12 is in the first position, the pressing unit 82 and the rod 80 rise. As shown in Fig. 5, when the pressing unit 82 abuts (collides) against the base end 40 of the syringe body 22, the pressing unit 82 applies a first impact in the upward direction to the base end 40 of the syringe body 22. Due to the first impact, an impact force of upward acceleration is applied to the base end 40 of the syringe body 22. The air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12 are slightly deformed by receiving this impact force.
[0071] The prefilled syringe 12 receives the first impact and is bounced upward to move. As a result, as shown in FIG. 6, the flange 32 collides with the stopper 72 (the lower surface 70 of the guide portion 60) at the second position. As a result, the stopper 72 applies a second impact to the base end 40 of the syringe body 22, and the prefilled syringe 12 stops moving upward. The second impact applies an impact force of downward acceleration to the base end 40 of the syringe body 22. The air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12 are further deformed by this impact force and the inertial force accompanying the stop of the prefilled syringe 12.
[0072] The air bubbles 54 are deformed by the two impacts and the inertial force, which promotes the removal of the air bubbles 54 from the inner surface 52 of the prefilled syringe 12. In this manner, the air bubble removal device 18 applies two impacts to the base end 40 of the syringe body 22 by operating as shown in Figures 4 to 6, and the air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12 can be easily removed from the inner surface 52.
[0073] Thereafter, the driving unit 78 lowers the pressing unit 82 and the rod 80, and the tip surface of the pressing unit 82 is retracted downward from the upper surface 74 of the support unit 62. After the flange 32 collides with the stopper 72 at the second position, the prefilled syringe 12 bounces downward and moves back to the first position (see FIGS. 2 and 4).
[0074] The air bubble removal device 18 removes the air bubbles 54 from the inner surface 52 of the prefilled syringe 12 by performing a plurality of impact cycles, with the operations of Fig. 4 to Fig. 6 being one impact cycle. In this case, the driving unit 78 reciprocates the pressing unit 82 and the rod 80 in the up-down direction to repeatedly apply impacts to the base end 40 of the syringe body 22, thereby effectively removing the air bubbles 54 from the inner surface 52 of the prefilled syringe 12. Note that, if the air bubbles 54 can be sufficiently removed from the inner surface 52 of the prefilled syringe 12 by one impact cycle, the air bubble removal device 18 only needs to perform one impact cycle.
[0075] After the air bubbles 54 are removed from the inner surface 52 of the prefilled syringe 12, the second portion 94 is relatively separated from the first portion 92 (see FIG. 2) of the guide part 60. In this state, the prefilled syringe 12 is removed from the air bubble removal device 18.
[0076] A second embodiment will be described. In the second embodiment, only the differences from the first embodiment will be described. In the second embodiment, the prefilled syringe 12 receives a second impact and bounces downward and moves by the operation of FIG. 6. At this time, the drive unit 78 further raises the pressing unit 82 and the rod 80 upward. As a result, as shown in FIG. 7, when the base end 40 of the syringe body 22 descends (moves) to a position between the first position and the second position (the third position of the prefilled syringe 12), the pressing unit 82 collides with the base end 40 of the syringe body 22. As a result, a third impact is given upward from the pressing unit 82 to the base end 40 of the syringe body 22. The third impact applies an impact force of upward acceleration to the base end 40 of the syringe body 22. In this case, since the pressing part 82 applies an upward impact to the base end 40 of the syringe body 22 while the prefilled syringe 12 is descending, the impact force of the third impact is a larger impact force in the upward direction. This impact force further deforms the air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12. The further deformation of the air bubbles 54 further promotes the release of the air bubbles 54 from the inner surface 52 of the prefilled syringe 12. In this way, by applying three impacts to the base end 40 of the syringe body 22, the air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12 can be efficiently released from the inner surface 52.
[0077] Thereafter, the driving unit 78 lowers the pressing unit 82 and the rod 80, and the tip surface of the pressing unit 82 is retracted downward from the upper surface 74 of the support unit 62. In addition, the pre-filled syringe 12 returns from the third position to the first position (see FIGS. 2 and 4).
[0078] 4 to 7 as one impact cycle, the air bubble removal device 18 removes the air bubbles 54 from the inner surface 52 of the prefilled syringe 12 through multiple impact cycles. In this case, the driving unit 78 reciprocates the pressing unit 82 and the rod 80 in the up-down direction to repeatedly apply impacts to the base end 40 of the syringe body 22, thereby effectively removing the air bubbles 54 from the inner surface 52 of the prefilled syringe 12. Note that, if the air bubbles 54 can be sufficiently removed from the inner surface 52 of the prefilled syringe 12 through one impact cycle, the air bubble removal device 18 only needs to perform one impact cycle.
[0079] In the above-mentioned air bubble removal process, the driving unit 78 may change the moving speed of the pressing unit 82 depending on the type, viscosity, etc. of the liquid 50. For example, when the viscosity of the liquid 50 is relatively high, the driving unit 78 may increase the upward moving speed of the pressing unit 82. This increases the impact force when an impact is applied to the base end 40 of the syringe body 22, so that the air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12 can be easily removed.
[0080] Alternatively, the driving unit 78 may change the number of impact cycles depending on the type, viscosity, etc. of the liquid 50. For example, when the viscosity of the liquid 50 is relatively high, the driving unit 78 may increase the number of impact cycles. This applies impact force to the air bubbles 54 multiple times, so that the air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12 can be easily detached.
[0081] In the next foreign matter inspection process (step S3 in FIG. 3), the foreign matter inspection unit 20 (see FIG. 1) inspects the prefilled syringe 12 from which the air bubbles 54 (see FIG. 4) have been removed in the air bubble removal process to determine whether or not there is a foreign matter in the liquid 50. The prefilled syringe 12 determined to be free of foreign matter by the foreign matter inspection process is shipped to the outside as a product.
[0082] This embodiment provides the following advantages.
[0083] As in the first embodiment, the prefilled syringe 12 moves upward upon receiving the first impact at the first position (see FIG. 5), and when the flange 32 abuts (collides) against the stopper 72 at the second position shown in FIG. 6, a second impact is applied to the base end 40 of the syringe body 22, and the prefilled syringe 12 stops moving upward. In this way, by applying two impacts to the base end 40 of the syringe body 22, it is possible to promote the release of the air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12.
[0084] As in the second embodiment, when the prefilled syringe 12 receives the second impact and moves downward, and the base end 40 of the syringe body 22 moves to the third position (see FIG. 7), a third impact is applied to the base end 40 of the syringe body 22. By applying the third impact, it is possible to further promote the release of the air bubbles 54 attached to the inner surface 52 of the prefilled syringe 12.
[0085] 2, by moving the pressing part 82 in the vertical direction relative to the base end 40 of the syringe body 22, it is possible to repeatedly apply impacts to the base end 40 of the syringe body 22. This makes it possible to effectively remove air bubbles 54 adhering to the inner surface 52 (see FIG. 4) of the prefilled syringe 12.
[0086] By appropriately changing the moving speed of the pressing portion 82 depending on the type, viscosity, etc. of the liquid 50, the air bubbles 54 adhering to the inner surface 52 of the prefilled syringe 12 can be appropriately removed.
[0087] By performing the impact cycle multiple times, the air bubbles 54 adhering to the inner surface 52 of the prefilled syringe 12 can be effectively removed.
[0088] By appropriately changing the number of impact cycles depending on the type, viscosity, etc. of the liquid 50, the air bubbles 54 adhering to the inner surface 52 of the prefilled syringe 12 can be appropriately removed.
[0089] As shown in FIG. 6, when the flange 32 abuts (collides) against the lower surface 70 of the guide portion 60, which is the stopper 72, at the second position, a second impact can be effectively applied to the base end portion 40 of the syringe body 22.
[0090] As shown in FIG. 1, the foreign matter inspection unit 20 inspects the prefilled syringe 12 from which air bubbles 54 have escaped from the inner surface 52 (see FIG. 4) of the prefilled syringe 12 for the presence or absence of foreign matter in the liquid 50, thereby improving the inspection accuracy for inspecting for the presence or absence of foreign matter.
[0091] By improving the inspection accuracy of the foreign matter inspection unit 20, the pre-filled syringe 12 can be manufactured efficiently.
[0092] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention. [Explanation of symbols]
[0093] 10...Manufacturing equipment (prefilled syringe manufacturing equipment) 12. Prefilled syringe 14...Assembly equipment 16…Foreign body inspection device 18...Air bubble removal device 20…Foreign body inspection department 22...Syringe body 24…Gasket 30…Nozzle 32...Flange 38...Tip 40...Proximal end 42...Filling chamber 50…Liquid 52…Inner 54...Air bubble 60…Guide section 62...Support part 64...Impact applying part 72...Stopper
Claims
1. A prefilled syringe includes a cylindrical syringe body having a nozzle at a tip end and a flange at a base end, a gasket slidably inserted into the syringe body, and a liquid filled in a filling chamber formed between the nozzle and the gasket inside the syringe body. The prefilled syringe includes an air bubble removal device for removing air bubbles adhering to an inner surface forming the filling chamber, the air bubble removal device comprising: a guide portion that guides a portion of the syringe body between the nozzle and the flange in a vertically movable manner in a position in which a tip direction of the syringe body is directed upward; a support portion that supports the syringe body at a first position where the base end portion is positioned downwardly away from the guide portion; a stopper located above the flange in a state in which the syringe body is supported by the support portion; an impact applying portion that applies an impact in the upward direction to the base end portion; Equipped with When the prefilled syringe is located at the first position, the impact applying unit abuts against the base end to apply a first impact in the upward direction to the base end, The prefilled syringe moves in the upward direction upon receiving the first impact, and the flange abuts against the stopper at a second position, thereby applying a second impact to the base end portion.
2. 2. The bubble removal device according to claim 1, When the prefilled syringe moves in the downward direction upon receiving the second impact and the base end moves to a third position between the first position and the second position, the impact applying portion abuts against the base end, thereby applying a third impact in the upward direction to the base end.
3. The bubble removal device according to claim 1 or 2, The impact applying unit has a pressing unit capable of pressing the base end portion in the upward direction, and a drive unit that moves the pressing unit in the up-down direction.
4. 4. The bubble removal device according to claim 3, The drive unit is capable of changing the speed at which the pressing unit moves in the upward direction.
5. 4. The bubble removal device according to claim 3, A bubble removal device, wherein when a process of applying multiple impacts, including at least the first impact and the second impact, to the base end is defined as one impact application cycle, the driving unit performs the impact application cycle multiple times on one prefilled syringe.
6. 6. The bubble removal device according to claim 5, The drive unit is capable of changing the number of impact cycles.
7. The bubble removal device according to claim 1 or 2, The stopper is provided on a lower surface of the guide portion.
8. The bubble removal device according to claim 1 or 2, A foreign matter inspection unit that inspects the prefilled syringe from which the air bubbles have been removed from the inner surface for the presence or absence of foreign matter in the liquid; A foreign body inspection device comprising:
9. The foreign matter inspection device according to claim 8, An assembly device for assembling the prefilled syringe; Equipped with The foreign matter inspection device is a manufacturing device for a prefilled syringe that inspects the prefilled syringe assembled by the assembly device for the presence or absence of the foreign matter in the liquid.
Citation Information
Patent Citations
Defoaming method
JP1996290008A
Defoaming device, bubble removing method, plating method and micro-metallic structure
JP2010070779A
Cited By
Defoaming device and foreign matter inspection system
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