JPWO2010098323A1 - Prefilled syringe manufacturing method and prefilled syringe - Google Patents

Abstract

A prefilled syringe manufacturing method manufactures a prefilled syringe comprising an outer cylinder having a mouth portion at a tip, a gasket that can slide within the outer cylinder, and a chemical solution stored in a space surrounded by the outer cylinder and the gasket. It is a method to do. This method is a chemical solution filling step in which a chemical solution is injected into an outer tube in a state where a scale indicating the amount of liquid in the outer tube is not yet attached, and a chemical solution is sealed by inserting a gasket from the proximal end opening of the outer tube And an inspection process for inspecting the inside of the outer cylinder filled with the chemical solution, and a scale application process for applying a scale to the outer peripheral surface of the outer cylinder by printing.

Description

  The present invention relates to a method for producing a prefilled syringe and a prefilled syringe.

  There is known a prefilled syringe in which a liquid preparation is aseptically filled in a syringe outer cylinder.

  Such a prefilled syringe is manufactured as follows (for example, refer patent document 1). First, an empty syringe outer cylinder is filled with a liquid preparation, stoppered and sealed. Next, a scale label with a scale is affixed to the outer peripheral surface of the syringe outer cylinder filled with the liquid preparation. The plunger rod is then connected to complete the prefilled syringe.

  However, in the method for producing a prefilled syringe described in Patent Document 1, when a scale label is affixed, for example, when visually inspecting whether a foreign substance is mixed in the liquid preparation in the syringe outer cylinder, There was a problem that a blind spot was generated in the syringe outer cylinder by the label, and this foreign matter contamination inspection was insufficient. In addition, when the scale label is affixed to the outer peripheral surface of the syringe outer cylinder, the scale label is usually affixed with a deviation within a range of about ± 0.5 mm. There was also a problem that the scale was in a state that was not accurately shown.

JP 2002-95746 A

  An object of the present invention is to provide a manufacturing method of a prefilled syringe capable of providing a scale indicating the amount of liquid to the outer peripheral surface of the outer cylinder with high positional accuracy and reliably inspecting the inside of the outer cylinder, and the prefilled It is providing the prefilled syringe manufactured by the manufacturing method of a syringe.

In order to achieve the above object, the present invention provides:
This is a method for manufacturing a prefilled syringe comprising an outer cylinder having a mouth portion at a tip end, a gasket that can slide within the outer cylinder, and a chemical solution stored in a space surrounded by the outer cylinder and the gasket. And
Filling with a chemical liquid that injects the chemical liquid into an outer cylinder in a state where a scale indicating the liquid amount in the outer cylinder is not yet attached, and inserts the gasket from a base end opening of the outer cylinder to seal the chemical liquid Process,
An inspection step of inspecting the inside of the outer cylinder filled with the chemical solution;
It has the scale provision process which provides the said scale by printing on the outer peripheral surface of the said outer cylinder, It is a manufacturing method of the prefilled syringe characterized by the above-mentioned.

  Moreover, in the manufacturing method of the prefilled syringe of this invention, it is preferable to provide the said scale so that it may respond | correspond to the liquid level of the said chemical | medical solution filled in the said scale provision process.

  Moreover, in the manufacturing method of the prefilled syringe of this invention, it is preferable that the inspection item in the said test process includes the test | inspection of the presence or absence of the foreign material in the said chemical | medical solution.

  Moreover, in the manufacturing method of the prefilled syringe of this invention, it is preferable to have the protective sheet sticking process of sticking the protective sheet which protects the said scale on the outer peripheral surface of the said outer cylinder after the said scale provision process.

  In the prefilled syringe manufacturing method of the present invention, it is preferable to detect the liquid level in the scale application step.

  Moreover, in the manufacturing method of the prefilled syringe of this invention, it is preferable in the said scale provision process to provide the said scale in order toward the downward direction from the position on the basis of the said detected liquid level.

  Moreover, in the manufacturing method of the prefilled syringe of this invention, it is preferable that the said printing in the said scale provision process is inkjet printing, screen printing, or pad printing.

  Moreover, in the prefilled syringe manufacturing method of the present invention, it is preferable that the inspection for the presence or absence of contamination is performed visually.

In order to achieve the above object, the present invention provides:
It is the prefilled syringe manufactured by the manufacturing method of the prefilled syringe of this invention.

FIG. 1 is a partial longitudinal sectional view showing an embodiment of the prefilled syringe of the present invention. FIG. 2 is a diagram (partial vertical cross-sectional view) for sequentially explaining the manufacturing process (manufacturing method of the prefilled syringe of the present invention) when manufacturing the prefilled syringe shown in FIG. 1. FIG. 3 is a diagram (partial longitudinal cross-sectional view) for sequentially explaining the manufacturing process (the manufacturing method of the prefilled syringe of the present invention) when manufacturing the prefilled syringe shown in FIG. 1. FIG. 4 is a diagram (partial vertical cross-sectional view) for sequentially explaining the manufacturing process (manufacturing method of the prefilled syringe of the present invention) when manufacturing the prefilled syringe shown in FIG. 1. FIG. 5 is a diagram (partial longitudinal cross-sectional view) for sequentially explaining the manufacturing process (manufacturing method of the prefilled syringe of the present invention) when manufacturing the prefilled syringe shown in FIG. 1. FIG. 6 is a diagram (partial vertical cross-sectional view) for sequentially explaining the manufacturing process (the manufacturing method of the prefilled syringe of the present invention) when manufacturing the prefilled syringe shown in FIG. 1. FIG. 7 is a diagram (partial longitudinal cross-sectional view) for sequentially explaining the manufacturing process (manufacturing method of the prefilled syringe of the present invention) when manufacturing the prefilled syringe shown in FIG. 1. FIG. 8 is a diagram (partial vertical cross-sectional view) for sequentially explaining the manufacturing process (manufacturing method of the prefilled syringe of the present invention) when manufacturing the prefilled syringe shown in FIG. 1. 9 is a cross-sectional view taken along line AA in FIG. 10 is a cross-sectional view taken along line BB in FIG.

Hereinafter, the manufacturing method of a prefilled syringe and the prefilled syringe of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
FIG. 1 is a partial longitudinal sectional view showing an embodiment of the prefilled syringe of the present invention, and FIGS. 2 to 8 are production steps for manufacturing the prefilled syringe shown in FIG. 1 (the method for producing the prefilled syringe of the present invention), respectively. ) In order (partial longitudinal sectional view), FIG. 9 is a sectional view taken along line AA in FIG. 7, and FIG. 10 is a sectional view taken along line BB in FIG. In the following, for convenience of explanation, the upper side in FIGS. 1 to 8 is referred to as “base end”, “upper” or “upper”, and the lower side is referred to as “tip”, “lower” or “lower”.

  A prefilled syringe (hereinafter simply referred to as “syringe”) 1 shown in FIG. 1 is one in which a drug solution 100 is stored in advance inside the syringe 1 (lumen portion 24). The syringe 1 includes a syringe outer cylinder 2, a gasket 3 inserted into the lumen portion 24 of the syringe outer cylinder 2, a pusher 40 for moving and operating the gasket 3, and a distal end portion (mouth portion 22) of the syringe outer cylinder 2. ) Provided with a lock adapter 23, a cap 25 connected to the lock adapter 23, and a drug solution 100 filled in a space (inner cavity portion 24) formed by the syringe outer cylinder 2 and the gasket 3. Has been.

The syringe outer cylinder 2 is composed of a bottomed cylindrical member having a bottom portion 211.
At the center of the bottom 211 of the syringe outer cylinder 2, a mouth 22 having a reduced diameter with respect to the body of the syringe outer cylinder 2 is integrally formed.

  A flow path 221 through which the chemical solution 100 can pass is formed inside the mouth portion 22, and the flow path 221 communicates with the lumen portion 24 of the syringe outer cylinder 2.

  Further, the outer peripheral surface 27 of the syringe outer cylinder 2 is provided with a scale 28 indicating the amount of the chemical solution 100 in the lumen portion 24. In the present embodiment, the scale 28 includes a first main scale 281, a second main scale 282, and a plurality (eight in the illustrated configuration) auxiliary scales 283. The first main scale 281 is a scale indicating the maximum value of the liquid amount of the chemical solution 100 to be filled. The second main scale 282 is a scale indicating an intermediate value between the position where the liquid amount becomes zero and the first main scale 281 (maximum value of the liquid amount). Each auxiliary scale 283 is a scale indicating a value between a position where the liquid amount becomes zero and the first main scale 281.

Further, a protective sheet 29 that protects the scale 28 is attached to the outer peripheral surface 27 of the syringe outer cylinder 2. The protective sheet 29 is a substantially transparent film made of a resin material such as polypropylene. Further, the protective sheet 29 has a size that can cover the entire scale 28. The protective sheet 29 is bonded to the outer peripheral surface 27 of the syringe outer cylinder 2 via the adhesive layer 291. The adhesive layer 291 is preferably formed in advance on the back surface of the protective sheet 29.
The protective sheet 29 may be provided with a numerical value corresponding to the scale 28.

  A cylindrical lock adapter 23 is provided on the outer peripheral portion of the mouth portion 22, and a female screw (not shown) is formed on the inner peripheral surface of the lock adapter 23.

  The cap 25 is composed of a bottomed cylindrical member, and a male screw (not shown) that engages with a female screw of the lock adapter 23 is formed on the outer peripheral surface thereof.

  By screwing the male screw of the cap 25 and the female screw of the lock adapter 23, the cap 25 and the lock adapter 23 are connected, that is, the cap 25 is attached to the mouth portion 22 of the syringe outer cylinder 2. Thereby, the front end opening of the mouth portion 22 can be sealed, and therefore, the filled chemical solution 100 can be prevented from leaking from the front end opening of the mouth portion 22.

  In such a syringe outer cylinder 2, a gasket 3 made of an elastic material is accommodated. The gasket 3 can be slid in the syringe outer cylinder 2 by operating the pusher 40. Two ring-shaped protrusions 31 and 32 are formed on the outer peripheral portion of the gasket 3 at predetermined intervals along the axial direction. Since the protrusions 31 and 32 are in close contact with the inner peripheral surface 21 of the syringe outer cylinder 2, the liquid tightness can be reliably maintained. In addition, a concave portion having a female screw 33 on the inner peripheral surface is formed on the base end surface of the gasket 3.

  A pusher 40 for operating the gasket 3 to move in the longitudinal direction within the syringe outer cylinder 2 is connected to the gasket 3.

  The pusher 40 has a main body 400. The main body 400 is configured by a member having a cross-shaped cross section. In addition, a male screw 401 is formed on the outer peripheral portion of the front end of the main body 400. The pusher 40 and the gasket 3 are connected by screwing the male screw 401 of the main body 400 (the pusher 40) and the female screw 33 of the gasket 3 together.

  A flange-like finger pad 405 is formed at the base end of the main body 400. A finger is applied to the distal end surface or the proximal end surface of the finger contact portion 405, and the pusher 40 is pulled toward the proximal end or pushed toward the distal end.

  In addition, as a constituent material of the syringe outer cylinder 2 (including the lock adapter 23) and the cap 25, for example, various hard resin materials, various glass materials, and the like can be used. Moreover, the constituent material of the syringe outer cylinder 2 is substantially transparent in order to ensure internal visibility.

  Examples of the constituent material of the gasket 3 include various rubber materials (particularly vulcanized) such as natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, butyl rubber, styrene-based, polyolefin-based, etc. Various thermoplastic elastomers can be mentioned, and one or more of these can be mixed and used.

  Examples of the drug solution 100 include electrolyte correction injection solutions such as sodium chloride and potassium lactate, vitamin preparations, vaccines, antibiotic injection solutions, steroid agents, proteolytic enzyme inhibitors, fat emulsions, various protein preparations, anticancer agents, Examples include anesthetics, stimulants, various chemical solutions such as narcotics, various diagnostic agents, and the like.

  Next, a method for manufacturing the prefilled syringe 1 having the above configuration will be described with reference to FIGS. The manufacturing method of this prefilled syringe 1 is a method which has a chemical | medical solution filling process, an inspection process, a pushing element connection process, a scale provision process, and a protection sheet sticking process, and performing these processes in this order. Each process is performed under aseptic conditions, for example, in a sterile isolator.

  Moreover, in the manufacturing method of the prefilled syringe 1, the chemical | medical solution filling apparatus 5 and the stopper device 4 are used in a chemical | medical solution filling process, and the liquid level detection apparatus 6 and the inkjet apparatus 7 are used in a scale provision process. First, each device will be described.

  As shown in FIG. 2, the chemical solution filling apparatus 5 includes a nozzle 51, a chemical solution tank 52, and a tube 53 that connects the nozzle 51 and the chemical solution tank 52.

  The nozzle 51 is composed of a tubular member, and discharges the chemical solution 100 from the tip opening 511 thereof. The chemical liquid filling device 5 can supply the chemical liquid 100 into the syringe outer cylinder 2 in a state where the tip opening 511 of the nozzle 51 faces the base end opening 26 of the syringe outer cylinder 2.

  The chemical solution tank 52 stores the chemical solution 100. The chemical solution 100 in the chemical solution tank 52 is sent to the nozzle 51 via the tube 53 by, for example, operation of a pump or the like.

  As shown in FIG. 3, the stopper device 4 drives the apparatus main body 41 that is mounted so as to cover the proximal end opening 26 of the syringe outer cylinder 2, the pressing member 43 that presses the gasket 3, and the pressing member 43. And a cylinder 47.

  The apparatus main body 41 is a cylindrical member having a lumen portion 413 that opens at the tip thereof. The gasket 3 can be held and stored in the lumen portion 413. Further, the stopper device 4 inserts the gasket 3 from the proximal end opening 26 in a state where the distal end opening 412 of the apparatus main body 41 is liquid-tightly connected to the proximal end opening 26 of the syringe outer cylinder 2.

  The pressing member 43 has a cylindrical shape and is supported by the apparatus main body 41 so as to be movable along the longitudinal direction thereof. The pressing member 43 presses the gasket 3 so as to be inserted into the lumen portion 24 of the syringe outer cylinder 2 by the operation of the cylinder 47.

  A cylinder 47 is connected to the proximal end portion of the pressing member 43. As the cylinder 47, for example, an air cylinder or the like can be used.

  In the plugging device 4 having such a configuration, the pressing member 43 presses the gasket 3 in the device main body 41 by operating the cylinder 47 in a state where the device main body 41 is connected to the syringe outer cylinder 2. The apparatus main body 41 is connected to a decompression mechanism (not shown) such as a vacuum pump. When the gasket 3 is pressed, the lumen 413 is in a decompressed state by the operation of the decompression mechanism. The gasket 3 is inserted into the syringe outer cylinder 2 by such an operation of the stopper device 4.

  As shown in FIG. 6, the liquid level detection device 6 has a liquid level sensor 61 that detects the liquid level 101 of the chemical solution 100 in the syringe outer cylinder 2. The liquid level sensor 61 includes an ultrasonic transmission unit 611 and an ultrasonic reception unit 612 installed on the opposite side of the ultrasonic transmission unit 611 via the syringe outer cylinder 2. The liquid level sensor 61 receives the ultrasonic wave 62 transmitted from the ultrasonic wave transmitting unit 611 by the ultrasonic wave receiving unit 612, and utilizes the fact that the chemical liquid 100 and the air have different ultrasonic transmittances, thereby making the liquid level sensor 61 The boundary with air, that is, the liquid level 101 can be detected. The liquid level sensor 61 is not limited to the ultrasonic type as described above, but may be another type such as an optical type.

  As shown in FIG. 7, the inkjet device 7 includes a nozzle 71, an ink tank 72, and a tube 73 that connects the nozzle 71 and the ink tank 72.

  The nozzle 71 is composed of a tubular member, and ejects the ink 200 from its tip opening (one end side opening) 711. The ink jet device 7 discharges ink 200 to the outer peripheral surface 27 by the operation of the piezoelectric element 712 built in the nozzle 71 in a state where the tip opening 711 of the nozzle 71 faces the outer peripheral surface 27 of the syringe outer cylinder 2. be able to.

  The ink tank 72 stores the ink 200. The ink 200 in the ink tank 72 is sent to the nozzle 71 via the tube 73 by an operation of a pump or the like, for example. Examples of the ink 200 include a solution based on an organic solvent, an oil-based ink, a solid ink that is solid at room temperature and is ejected in a heated and melted state.

Further, the ink jet apparatus 7 is configured such that the nozzle 71 can move along the vertical direction (longitudinal direction of the syringe outer cylinder 2) by a moving mechanism (not shown). As a moving mechanism,
Although not particularly limited, for example, a motor, a ball screw connected to the motor, and a linear guide connected to the ball screw via the nozzle 71 can be used.

  The manufacturing method of the prefilled syringe 1 is demonstrated. As described above, the method for manufacturing the prefilled syringe 1 includes a chemical solution filling step, an inspection step, a pusher connecting step, a scale applying step, and a protective sheet attaching step.

[1] Chemical Solution Filling Step First, as shown in FIG. 2, the syringe outer cylinder 2 to which the cap 25 is attached is installed so that the cap 25 side is vertically downward. In this state, the syringe outer cylinder 2 is sterilized. The syringe outer cylinder 2 is in a state where the scale 28 is not yet attached.

  Next, the distal end opening 511 of the nozzle 51 of the chemical solution filling device 5 is positioned so as to face the proximal end opening 26 of the syringe outer cylinder 2. In this state, a predetermined amount of the chemical solution 100 is injected into the syringe outer cylinder 2 from the tip opening 511 of the nozzle 51.

  Immediately after injecting a predetermined amount of the chemical solution 100, the syringe outer cylinder 2 is withdrawn from the chemical solution filling device 5, and the syringe outer cylinder 2 is connected to the apparatus main body 41 of the stopper device 4 as shown in FIG. The gasket 3 is already attached to the apparatus main body 41. Then, with the syringe outer cylinder 2 connected to the stopper device 4, the cylinder 47 is operated, the gasket 3 is inserted into the syringe outer cylinder 2 by the pressing member 43, and the syringe outer cylinder 2 is sealed. The insertion amount of the gasket 3 is preferably set such that, for example, the tip 34 of the gasket 3 is in contact with the liquid surface 101 of the chemical solution 100 (see FIG. 1).

  By such a process, the liquid medicine 100 is reliably filled in the syringe outer cylinder 2, and it is possible to prevent the liquid quantity of the liquid medicine 100 from changing due to, for example, evaporation. The liquid volume can be maintained.

[2] Inspection Step Next, the syringe outer cylinder 2 is retracted from the stopper device 4, and the inside of the syringe outer cylinder 2 filled with a predetermined amount of the chemical solution 100 is visually inspected as shown in FIG. As this inspection item, there is an inspection for the presence or absence of foreign matter in the chemical solution 100 (hereinafter, this inspection is referred to as “foreign matter mixing inspection”).

  As described above, since the scale 28 is not yet attached to the syringe outer cylinder 2, it is reliably prevented that a blind spot is generated in the syringe outer cylinder 2 by the scale 28 when the foreign matter mixing inspection is performed. A foreign matter mixing inspection can be reliably performed.

  As a result of the foreign matter contamination test, if there is no foreign matter, the process proceeds to the next step. If foreign matter is mixed, the corresponding syringe outer cylinder 2 is regarded as a defective product and discarded. Thereby, for example, the scale 28 is not applied to the defective syringe outer cylinder 2, so that waste can be omitted. Moreover, it turns out that the syringe outer cylinder 2 which was removed from the series of processes in the manufacturing method of the prefilled syringe 1 and not provided with the scale 28 is a defective product.

  The foreign matter mixing inspection is performed visually, but is not limited to this. For example, foreign matters are mixed depending on the optical method, that is, the degree of transmittance of light transmitted through the syringe outer cylinder 2. It may be performed by a method of determining whether or not.

  Further, as an inspection item in this step, in addition to the foreign substance contamination inspection, for example, whether or not the chemical solution 100 in the syringe outer cylinder 2 is a chemical solution to be filled, that is, whether or not it is a correct chemical solution. Inspection, foreign matter inspection of the gasket 3 in the syringe outer cylinder 2 and the like can be mentioned.

[3] Pusher Connection Step Next, as shown in FIG. 5, the female screw 33 of the gasket 3 inserted into the syringe outer cylinder 2 and the male screw 401 of the pusher 40 are screwed together. Thereby, the pusher 40 is connected to the gasket 3.

  Note that this connection work may be performed manually by an operator or may be performed using an apparatus, for example.

[4] Scale Application Step Next, as shown in FIG. 6, the syringe outer cylinder 2 is installed between the ultrasonic transmission unit 611 and the ultrasonic reception unit 612 of the liquid level detection device 6. At this time, it installs so that the liquid level 101 of the chemical | medical solution 100 in the syringe outer cylinder 2 may be substantially located with the height of the ultrasonic transmitter 611 and the ultrasonic receiver 612. In this state, the liquid level detection device 6 is operated to detect the liquid level as described above. The detection result is stored in a storage unit (not shown) of the liquid level detection device 6.

  Next, the syringe outer cylinder 2 is retracted from the liquid level detection device 6, and the syringe outer cylinder 2 is installed on the inkjet device 7 as shown in FIG. 7. Then, the inkjet device 7 calls the liquid level detection result from the storage unit of the liquid level detection device 6. Based on the detection result, the nozzle is formed on the portion of the outer peripheral surface 27 corresponding to the position of the liquid surface 101 of the drug solution 100 in the syringe outer cylinder 2, that is, the portion to which the first main scale 281 of the outer peripheral surface 27 is attached. The front end opening 711 of 71 faces. In this state, the ink 200 is ejected from the tip opening 711 of the nozzle 71, and the first main scale 281 is formed by the ink 200. The formed first main scale 281 is disposed at the same position as the height of the liquid surface 101 of the chemical solution 100.

  Thereafter, the ink 200 is ejected from the tip opening 711 while moving the nozzle 71 downward. As a result, the second main scale 282 and the auxiliary scale 283 are formed sequentially at predetermined intervals. Note that the timing (the predetermined interval) at which the ink 200 is ejected from the nozzles 71 when the second main scale 282 and the auxiliary scale 283 are formed is stored in advance in a storage unit (not shown) of the inkjet device 7. .

  Further, when the ink 200 is ejected from the tip opening 711 of the nozzle 71, the syringe outer cylinder 2 is rotated by a rotation mechanism (not shown) that rotates the syringe outer cylinder 2 about its axis. The injection is performed (see FIGS. 9 and 10). As the rotation angle of the syringe outer cylinder 2, the rotation angle when forming the first main scale 281 (the same applies to the second main scale 282) is θ1, and the rotation when forming each auxiliary scale 283. When the angle is θ2, it is set to satisfy θ1> θ2.

  As described above, the scale 28 is first attached with the first main scale 281 so that the position of the liquid surface 101 coincides with the liquid surface 101 of the drug solution 100 in the syringe outer cylinder 2 as a reference. . Thereafter, the second main scale 282 and the auxiliary scale 283 are attached at the predetermined intervals sequentially from the first main scale 281 (the liquid level 101) that has become the reference position downward. Therefore, the syringe outer cylinder 2 (prefilled syringe 1) has the scale 28 attached to the outer peripheral surface 27 with high positional accuracy. Specifically, the scale 28 is arranged with a positional accuracy within a normal allowable range (within ± 0.15 mm) with respect to the liquid level 101 of the chemical solution 100 in the syringe outer cylinder 2.

  As described above, the scale 28 is attached by printing with the ink 200. On the other hand, for example, when the ink 200 having UV curable property or thermosetting property is used, energy such as ultraviolet rays or heat is applied to the ink 200 applied to the outer peripheral surface 27 of the syringe outer cylinder 2. Must be granted. For this reason, there exists a possibility that the chemical | medical solution 100 may change in quality or deteriorate with the said energy. However, in the present invention, such a problem can be reliably prevented.

  In addition, as printing in this step, ink jet printing by the ink jet device 7 is used in the present embodiment, but the present invention is not limited to this, and for example, screen printing or pad printing may be used.

[5] Protective sheet pasting step Next, the syringe outer cylinder 2 is retracted from the ink jet device 7 and the protective sheet 29 is attached to the portion of the outer peripheral surface 27 of the syringe outer cylinder 2 where the scale 28 is attached as shown in FIG. Affix. A release paper (not shown) is attached to the adhesive layer 291 of the protective sheet 29. When sticking the protective sheet 29, the release paper is peeled off and the sticking operation is performed.

  By sticking the protective sheet 29, the scale 28 is protected, and thus the scale 28 can be reliably prevented from being peeled off. The protective sheet 29 can also be referred to as “fixing means” for fixing the scale 28 attached to the outer peripheral surface 27 of the syringe outer cylinder 2 to the outer peripheral surface.

  In addition, this pasting operation may be performed, for example, by an operator's manual operation or using an apparatus.

  As mentioned above, although the manufacturing method of the prefilled syringe and prefilled syringe of this invention were demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a prefilled syringe exhibits the same function. It can be replaced with any configuration obtained. Moreover, arbitrary components may be added.

  Moreover, in the scale provision process of the manufacturing method of a prefilled syringe, although it started writing from the 1st main scale, it is not limited to this, For example, the position of the 1st main scale, the 2nd main scale, and each auxiliary scale is shown. You may calculate and start writing from any of these scales.

  Moreover, in the scale provision process of the manufacturing method of a prefilled syringe, since the 1st main scale, the 2nd main scale, and an auxiliary scale are provided using an inkjet device, the color of each scale can be changed. Moreover, the number corresponding to each scale can also be provided.

  The prefilled syringe manufacturing method of the present invention includes an outer cylinder having a mouth portion at a distal end, a gasket that can slide in the outer cylinder, and a chemical solution stored in a space surrounded by the outer cylinder and the gasket. The chemical solution is injected into the outer cylinder in a state where a scale indicating the amount of liquid in the outer cylinder is not yet attached, and the gasket is inserted from the proximal end opening of the outer cylinder. A chemical solution filling step for sealing the chemical solution by inserting a liquid, an inspection step for inspecting the inside of the outer cylinder filled with the chemical solution, and a scale application step for applying the scale to the outer peripheral surface of the outer cylinder by printing And have. Therefore, in the inspection process, since the outer cylinder is not yet graduated, for example, when inspecting the inside of the outer cylinder by visual inspection, it is reliably prevented that a blind spot is generated in the outer cylinder by the scale, and therefore the inspection is performed. It can be done reliably. Moreover, since the scale which shows a liquid quantity is provided to the outer peripheral surface of the outer cylinder in a state where the chemical liquid is filled in the scale application process, it is possible to provide a scale with high positional accuracy with respect to the chemical liquid. Therefore, the manufacturing method of the prefilled syringe of this invention has industrial applicability.

Claims (5)

This is a method for manufacturing a prefilled syringe comprising an outer cylinder having a mouth portion at a tip end, a gasket that can slide within the outer cylinder, and a chemical solution stored in a space surrounded by the outer cylinder and the gasket. And
Filling with a chemical liquid that injects the chemical liquid into an outer cylinder in a state where a scale indicating the liquid amount in the outer cylinder is not yet attached, and inserts the gasket from a base end opening of the outer cylinder to seal the chemical liquid Process,
An inspection step of inspecting the inside of the outer cylinder filled with the chemical solution;
The manufacturing method of the prefilled syringe characterized by having the scale provision process which provides the said scale by printing on the outer peripheral surface of the said outer cylinder.   The manufacturing method of the prefilled syringe of Claim 1 which provides the said scale so that it may respond | correspond to the liquid level of the said filled chemical | medical solution in the said scale provision process.   The method for manufacturing a prefilled syringe according to claim 1, wherein the inspection item in the inspection step includes an inspection of presence or absence of contamination in the chemical solution.   The manufacturing method of the prefilled syringe of Claim 1 which has a protection sheet sticking process of sticking the protective sheet which protects the said scale on the outer peripheral surface of the said outer cylinder after the said scale provision process.   A prefilled syringe manufactured by the method for manufacturing a prefilled syringe according to claim 1.

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