JP2005204678A - Prefilled syringe manufacturing method, tool and device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a prefilled syringe manufacturing method surely and sufficiently supplying inert gas in a lumen part of a syringe outer cylinder and efficiently supplying the inert gas to the lumen of the syringe outer cylinder. <P>SOLUTION: This prefilled syringe method is adopted to manufacture a prefilled syringe having the syringe outer cylinder 2, a plug body 3 to be inserted in the lumen part 24 of the syringe outer cylinder 2, and liquid medication 100 filled in a space formed of the syringe outer cylinder 2 and the plug body 3. This prefilled syringe manufacturing method is provided with a first process of mounting a tool 4 to cover a base end opening 26 of the syringe outer cylinder 2, a second process of evacuating the lumen part 24 of the syringe outer cylinder 2 via the tool 4, a third process of supplying nitrogen Q to the evacuated lumen part 24 by the tool 4, and a fourth process of evacuating the lumen part 24 supplied with the nitrogen Q and inserting the plug body 3 in the lumen part 24 of the syringe outer cylinder 2. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a prefilled syringe manufacturing method, a prefilled syringe manufacturing jig, and a prefilled syringe manufacturing apparatus.

  There is known a prefilled syringe in which the inside of a syringe (container) is replaced with nitrogen and a liquid preparation (chemical solution) is aseptically filled therein.

  Such a prefilled syringe is manufactured as follows, for example. That is, first, sterilization with a high-pressure steam sterilization or a sterilization gas such as hydrogen peroxide is performed on each of the syringe and the cap (sealing member) attached to the liquid discharge part (mouth part). Next, in a sterile environment, a cap is attached to the liquid discharge part of the syringe, and then nitrogen is blown into the syringe. Next, after filling the syringe with a liquid preparation, a stopper is attached (plugged) to complete a prefilled syringe.

  However, in such a method, even if nitrogen is blown into the syringe before the liquid preparation is filled in the syringe, the syringe is moved (transferred) to the step (place) where the liquid preparation is filled. There is a problem that nitrogen in the syringe flows out (leaks out) out of the syringe.

  In order to solve such a problem, a method is disclosed in which nitrogen is filled into a place (chamber) where a syringe containing a liquid preparation is disposed and then stoppered in the chamber (for example, a patent). Reference 1).

  However, in Patent Document 1, since it is inside the chamber that is filled with nitrogen, there is a problem that it is difficult to blow (fill) nitrogen into the syringe. Therefore, there has been a problem that there is a possibility that nitrogen is not sufficiently filled in the syringe when it is plugged.

  Further, in Patent Document 1, in order to blow (fill) nitrogen into a syringe, it is necessary to fill almost the entire chamber with nitrogen, so that there is a problem that efficiency in filling nitrogen is deteriorated.

JP-A-6-56196

  An object of the present invention is to provide a prefilled material that can reliably and sufficiently supply an inert gas to a lumen portion of a syringe outer cylinder and can efficiently supply an inert gas to a lumen portion of a syringe outer cylinder. A syringe manufacturing method, a prefilled syringe manufacturing jig, and a prefilled syringe manufacturing apparatus are provided.

  Such an object is achieved by the present inventions (1) to (5) below. Moreover, it is preferable that it is following (6)-(8).

(1) Manufacture a prefilled syringe having a syringe outer cylinder, a plug inserted into a lumen portion of the syringe outer cylinder, and a drug solution filled in a space formed by the syringe outer cylinder and the plug. A prefilled syringe manufacturing method comprising:
A first step of mounting a jig so as to cover a proximal end opening of the syringe outer cylinder;
A second step of degassing the lumen of the syringe outer cylinder via the jig;
A third step of supplying an inert gas to the degassed lumen by the jig;
And a fourth step of inserting the plug into the lumen of the syringe outer cylinder after degassing the lumen supplied with the inert gas.

  (2) The prefilled syringe manufacturing method according to (1), wherein the second step and the third step are repeated twice or more.

(3) Manufacture of a prefilled syringe having a syringe outer cylinder, a plug inserted into a lumen portion of the syringe outer cylinder, and a drug solution filled in a space formed by the syringe outer cylinder and the plug. A prefilled syringe manufacturing jig used for
A jig body that is mounted so as to cover the proximal end opening of the syringe outer cylinder and has a storage space in which the stopper can be stored;
A pressing member that is installed on the jig main body and presses the stopper so as to be inserted into the lumen of the syringe outer cylinder;
The jig body communicates with the storage space, and is provided with a vent hole capable of supplying and exhausting the storage space and supplying an inert gas.
A jig for producing a prefilled syringe, wherein a gap is formed between the inner wall of the jig main body and the plug when the plug is stored in the storage space.

(4) Manufacture a prefilled syringe having a syringe outer cylinder, a plug inserted into a lumen portion of the syringe outer cylinder, and a drug solution filled in a space formed by the syringe outer cylinder and the plug. A prefilled syringe manufacturing apparatus comprising:
A jig mounted to cover the proximal end opening of the syringe outer cylinder;
Degassing means for degassing the lumen of the syringe outer cylinder;
An inert gas supply means for supplying an inert gas to the lumen of the syringe outer cylinder;
Plugging means for inserting the plug into the lumen of the syringe outer cylinder;
Control means for controlling the operation of the jig, the degassing means, the inert gas supply means and the plugging means,
The control means attaches the jig so as to cover the proximal end opening of the syringe outer cylinder, and then operates so that the deaeration means deaerates the inner cavity of the syringe outer cylinder. The active gas supply means operates to supply the inert gas to the degassed lumen at least once, and then the degassing means removes the lumen to which the inert gas has been supplied. The prefilled syringe manufacturing apparatus is controlled to operate so as to insert the plug into the lumen of the syringe outer cylinder.

(5) Manufacture a prefilled syringe having a syringe outer cylinder, a plug inserted into a lumen portion of the syringe outer cylinder, and a drug solution filled in a space formed by the syringe outer cylinder and the plug. A prefilled syringe manufacturing apparatus comprising:
A jig for producing a prefilled syringe according to (3) above,
Degassing means for degassing the lumen of the syringe outer cylinder;
An inert gas supply means for supplying the inert gas to the lumen of the syringe outer cylinder;
Plugging means for inserting the plug into the lumen of the syringe outer cylinder;
A control means for controlling the operation of the prefilled syringe manufacturing jig, the degassing means, the inert gas supply means and the plugging means,
The control means attaches the prefilled syringe manufacturing jig so as to cover the proximal end opening of the syringe outer cylinder, and then the degassing means operates to deaerate the lumen of the syringe outer cylinder. The inert gas supply means performs an operation for supplying the inert gas to the degassed lumen at least once, and then the degassing means supplies the inert gas. An apparatus for producing a prefilled syringe, wherein the device is operated so as to deaerate the cavity, and the stopper is operated so as to insert the plug into the inner cavity of the syringe outer cylinder.

  (6) The plug body is housed in a housing space formed in the jig, and is separated from the housing space when inserted into the inner cavity of the syringe outer cylinder. ) The prefilled syringe manufacturing method.

  (7) The prefilled syringe manufacturing method according to any one of (1), (2), and (6), wherein the inert gas is nitrogen.

  (8) The jig for producing a prefilled syringe according to (3), wherein the gap is at least one ventilation groove formed on the inner wall of the jig body.

  According to the present invention, in the manufacture of a prefilled syringe, an inert gas is reliably and sufficiently supplied to the lumen of the syringe outer cylinder by supplying the inert gas to the lumen of the syringe outer cylinder via a jig. Can be supplied.

  Further, by the same supply, the inert gas can be efficiently and quickly supplied to the inner cavity of the syringe outer cylinder.

  In addition, after supplying the inert gas to the inner cavity of the syringe outer cylinder, the stopper can be attached to the syringe outer cylinder at the same location as the supply location (on the spot), so that the prefilled post-manufacturing The residual amount of inert gas in the syringe can be kept high.

  Further, in the production of the prefilled syringe, when the second step and the third step are repeated twice or more, the nitrogen Q can be supplied more reliably and more sufficiently to the lumen of the syringe outer cylinder. it can.

  Before explaining the prefilled syringe manufacturing method, the prefilled syringe manufacturing jig and the prefilled syringe manufacturing apparatus of the present invention, the prefilled syringe will be described.

  FIG. 5 is a partial cross-sectional view of the prefilled syringe. In the following, for convenience of explanation, the upper side in FIG. 5 is referred to as “base end” and the lower side is referred to as “tip”.

  A prefilled syringe (hereinafter simply referred to as “syringe”) 1 shown in FIG. 5 is one in which a drug solution 100 is stored in advance inside the syringe 1 (lumen portion 24). The syringe 1 is provided at a syringe outer cylinder (outer cylinder) 2, a plug 3 inserted into the lumen portion 24 of the syringe outer cylinder 2, and a distal end portion (mouth portion 22) of the syringe outer cylinder 2. The liquid medicine filled in the space (inner cavity part 24) formed by the lock adapter (connecting member) 23, the cap 25 connected (screwed) to the lock adapter 23, the syringe outer cylinder 2 and the plug body 3. 100.

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 communicates with the lumen portion 24 of the syringe outer cylinder 2.

  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 (discharging) from the front end opening of the mouth portion 22.

  A plug body 3 made of an elastic material is accommodated (inserted) in the syringe outer cylinder 2. Two ring-shaped protrusions 31 and 32 are formed on the outer peripheral portion of the plug body 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 airtightness (liquid tightness) can be reliably maintained.

  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 materials, various glass materials, and the like can be used.

  Moreover, it is preferable that the constituent material of the syringe outer cylinder 2 is substantially transparent in order to ensure the internal visibility.

  Further, as the constituent material of the plug body 3, for example, various rubber materials (particularly those vulcanized) such as natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, butyl rubber, styrene-based, polyolefin-based, etc. These thermoplastic elastomers and the like can be mentioned, and one or more of these can be mixed and used.

  Further, as the chemical solution 100, 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, anesthetics , Various drug solutions such as stimulants and narcotics, various diagnostic agents, and the like.

  The prefilled syringe manufacturing method of the present invention is a method for manufacturing the prefilled syringe 1 as described above. Moreover, the prefilled syringe manufacturing method of this invention is implemented using the prefilled syringe manufacturing apparatus 10 provided with the jig | tool 4 for prefilled syringe manufacture of this invention.

  Next, the prefilled syringe manufacturing jig 4 and the prefilled syringe manufacturing apparatus 10 of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

First, the prefilled syringe manufacturing apparatus 10 of the present invention will be described.
FIG. 1 is a schematic diagram of a prefilled syringe manufacturing apparatus according to the present invention, FIG. 2 is a block diagram schematically showing main parts of the prefilled syringe manufacturing apparatus shown in FIG. 1, and FIGS. 3 and 4 are respectively shown in FIG. It is a figure for explaining later the process of manufacturing a prefilled syringe in the prefilled syringe manufacturing apparatus shown. In the following, for convenience of explanation, the upper side of FIGS. 1, 3 and 4 is referred to as a “base end” and the lower side is referred to as a “tip”.

  As shown in FIG. 1, a prefilled syringe manufacturing apparatus (hereinafter simply referred to as “manufacturing apparatus”) 10 includes a prefilled syringe manufacturing jig (hereinafter simply referred to as “jig”) 4 of the present invention, and an outside of the syringe. Deaeration means 5 for degassing the lumen 24 of the cylinder 2, inert gas supply means 6 for supplying an inert gas to the lumen 24 of the syringe outer cylinder 2, and a lumen 24 of the syringe outer cylinder 2 A plugging means 7 for inserting the plug body 3 into the valve, a valve (switching valve) 9, a moving mechanism 20 for moving the jig 4, and a control means 8 for controlling the operation of each part are provided.

Here, in the prefilled syringe manufacturing apparatus 10, nitrogen Q is used as an inert gas.
Nitrogen Q is effective in producing the prefilled syringe 1 because it is readily available and inexpensive.

  As shown in FIG. 1, the valve 9 is a solenoid valve (electromagnetic valve) having three ports (joints). Tubes (tubes) 91, 92, and 93 are connected to these ports, respectively.

  The valve 9 is connected to a vent hole 44 of the jig 4 described later via a tube 91.

  The deaeration means 5 is composed of a pump 51 and is connected to the valve 9 via a tube 92. The pump 51 is not particularly limited. For example, a syringe pump, a gear pump, a vacuum pump, a blower, or the like is used.

The inert gas supply means 6 is composed of an air tank 61 and is filled with nitrogen Q.
The air tank 61 is connected to the valve 9 via a tube 93.

  The pressure inside the air tank 61 can be appropriately set by the operation of a valve (cock) installed (built in) the air tank 61. With this setting, the pressure in the air tank 61 is set slightly higher than the pressure in the lumen portion 24 of the syringe outer cylinder 2.

  In the circuit having such a configuration, the valve 9 is operated to deaerate (supply / exhaust) the lumen 24 of the syringe outer cylinder 2 by the operation of the pump 51, and from the air tank 61 to the lumen 24 of the syringe outer cylinder 2. The nitrogen Q can be supplied.

As shown in FIG. 1, the plugging means 7 includes an actuator 71.
The actuator 71 is installed on the proximal end side of the pressing member 43 of the jig 4 to be described later, and is connected (connected) to the proximal end 431 of the pressing member 43 in the longitudinal direction (vertical direction in FIG. 1).

  By the operation of the actuator 71, the pressing member 43 is pressed in the distal direction, and accordingly, the plug body 3 is inserted into the lumen portion 24 of the syringe outer cylinder 2. That is, the actuator 71 inserts the plug 3 into the lumen 24 of the syringe outer cylinder 2 via the pressing member 43.

  As shown in FIG. 2, the control unit 8 includes a CPU (Central Processing Unit) 81 and a storage unit (storage unit) 82. The storage unit 82 includes a storage medium (recording medium) that can be read by the CPU 81, and the storage medium includes a magnetic or optical recording medium, a semiconductor memory, or the like.

  The control means 8 having such a configuration controls the operation of the moving mechanism 20, the pump 51 (deaeration means 5), the valve 9 (inert gas supply means 6), and the actuator 71 (plugging means 7).

Next, the prefilled syringe manufacturing jig 4 of the present invention will be described.
As shown in FIG. 1, the jig 4 includes a jig body 41 that is mounted so as to cover the proximal end opening 26 of the syringe outer cylinder 2, and a pressing member 43 that presses the stopper 3.

  The jig main body 41 is formed with a storage space 42 in which the plug body 3 can be stored and a vent hole 44 communicating with the storage space 42.

  The storage space 42 has a substantially circular cross-sectional shape, and is configured to have a diameter substantially equal to or slightly smaller than the diameter of the plug body 3 (projections 31 and 32).

  Further, when the plug body 3 is stored in the storage space 42, an air-permeable gap 45 is formed between the inner wall 411 of the jig body 41 and the plug body 3.

The gap 45 is constituted by a plurality of ventilation grooves 451 formed in the inner wall 411 of the jig body 41. The number of ventilation grooves 451 is not particularly limited, but is preferably 2 to 8, and more preferably 4 to 6.
The ventilation groove 451 extends along the moving direction of the plug body 3 (vertical direction in FIG. 1).

  The gap 45 (ventilation groove 451) having such a configuration allows the gas on the distal end side of the plug body 3 and the gas on the proximal end side of the plug body 3 to pass (traverse) each other.

  The vent hole 44 is connected to the pump 51 and the air tank 61 via the valve 9 and the tubes 91, 92, 93 as described above. Thereby, while supplying / exhausting the storage space 42, nitrogen Q can be supplied.

  As shown in FIG. 1, the pressing member 43 is a member (member) that presses the plug 3 to be inserted into the lumen 24 of the syringe outer cylinder 2 by the operation of the actuator 71.

  The pressing member 43 is installed on the central axis of the jig body 41 and is installed so as to be movable along the central axis (longitudinal direction).

  As shown in FIG. 1, a packing (gasket) 46 is installed at the tip of the jig body 41 so as to surround the tip opening 412 of the jig body 41. Thereby, when the jig main body 41 (jig 4) is attached to the syringe outer cylinder 2, the lumen portion 24 of the syringe outer cylinder 2 can be hermetically sealed (liquid-tight). It is possible to prevent the gas (nitrogen Q) in the lumen portion 24 from leaking more reliably.

  With the jig 4 having such a configuration, in a state where the jig 4 is mounted on the syringe outer cylinder 2, the nitrogen Q is supplied to the lumen portion 24 of the syringe outer cylinder 2 through the jig 4. The nitrogen Q can be supplied to the lumen portion 24. Further, since the proximal end opening 26 of the syringe outer cylinder 2 is covered with the jig 4, it is possible to prevent the nitrogen Q from leaking out from the lumen portion 24 (the proximal end opening 26) of the syringe outer cylinder 2. Therefore, the nitrogen Q can be sufficiently supplied.

  Next, the process (prefilled syringe manufacturing method) which manufactures the prefilled syringe 1 in the manufacturing apparatus 10 is demonstrated with reference to FIG. 3 and FIG. The following steps are performed under the control of the control means 8 as described above.

[1] Jig mounting process (first process)
First, the jig 4 in which the plug 3 is stored in the storage space 42 is moved to the base end side (upward) of the syringe outer cylinder 2 containing (filled) the chemical solution 100. Thereafter, as shown in FIG. 3A, the jig 4 is moved (lowered), and the jig 4 (jig body 41) is mounted so as to cover the proximal end opening 26 of the syringe outer cylinder 2. To do. Thereby, the lumen 24 (including the storage space 42 of the jig 4) of the syringe outer cylinder 2 is blocked from the outside of the syringe outer cylinder 2.

[2] Deaeration process (second process)
Next, with the jig 4 mounted as described above, the pump 51 (degassing means 5) is operated as shown in FIG. The inner lumen 24 is degassed (depressurized).

[3] Nitrogen supply step (third step)
Next, after the deaeration is finished, by operating the valve 9, the communication between the lumen 24 of the syringe outer cylinder 2 and the pump 51 is blocked, and the lumen 24 of the syringe outer cylinder 2 and the air tank 61 Communicate. Thereby, as shown in FIG.3 (c), nitrogen Q is supplied to the lumen | bore part 24 of the syringe outer cylinder 2 (inflow). By the degassing step (second step) and this step, the air in the lumen portion 24 of the syringe outer cylinder 2 can be substantially replaced with nitrogen Q.

[4] Capping process (fourth process)
Next, the operation of the valve 9 causes the lumen 24 of the syringe outer cylinder 2 to communicate with the pump 51 again, and the lumen of the syringe outer cylinder 2 is made in the same manner as in the deaeration process (second process). The part 24 is degassed (reduced pressure) (see FIG. 3D).

  Next, as shown in FIG. 3 (e), the actuator 71 (plugging means 7) is actuated to move the pressing member 43 in the distal direction, then the pump 51 is actuated, and the syringe outer cylinder 2 is moved. Gas is supplied to the lumen portion 24, that is, the lumen portion 24 of the syringe outer cylinder 2 is decompressed. As a result, the pressing member 43 presses the plug body 3, and the plug body 3 is inserted into the lumen 24 of the syringe outer cylinder 2 from the proximal end opening 26 of the syringe outer cylinder 2, that is, the plug body 3 is a jig. 4 is detached from the storage space 42 and attached (inserted) to the syringe outer cylinder 2 (see FIG. 3F).

  Next, the actuator 71 (plugging means 7) is actuated to move (upward) the pressing member 43 in the proximal direction (see FIG. 3 (f)).

  By passing through the above process, the prefilled syringe 1 by which the space 11 (gap in the prefilled syringe 1) formed with the syringe outer cylinder 2, the plug body 3, and the chemical solution 100 is replaced with nitrogen Q is manufactured. Is done.

  That is, the proximal end opening 26 (lumen portion 24) of the syringe outer tube 2 is covered with the jig 4 until the plug 3 is inserted after the nitrogen Q is supplied to the lumen portion 24 of the syringe outer tube 2. Therefore, nitrogen Q can be reliably and sufficiently supplied to the lumen portion 24 of the syringe outer cylinder 2. Therefore, the prefilled syringe 1 as described above is manufactured.

  According to the manufacturing method as described above, the proportion of oxygen in the space 11 in the prefilled syringe 1 can usually be within 6%.

  In addition, the prefilled syringe 1 may be manufactured by repeating the degassing step (second step) and the nitrogen supply step (third step) two or more times.

  Thereby, nitrogen Q can be supplied more reliably and more sufficiently to the lumen part 24 of the syringe outer cylinder 2, that is, the amount of oxygen in the lumen part 24 of the syringe outer cylinder 2 is reduced, The amount of can be increased. Therefore, the proportion of oxygen remaining in the space 11 (residual oxygen rate) in the prefilled syringe 1 can be made lower (smaller).

  As mentioned above, although the prefilled syringe manufacturing method, the prefilled syringe manufacturing jig, and the prefilled syringe manufacturing apparatus of the present invention have been described with respect to the illustrated embodiment, the present invention is not limited to this, and the prefilled syringe manufacturing jig And each part which comprises a prefilled syringe manufacturing apparatus can be substituted with the thing of the arbitrary structures which can exhibit the same function. Moreover, arbitrary components may be added.

  Further, the number of vent holes is not limited to one. For example, a plurality of vent holes may be formed, and each may be divided for gas supply and exhaust.

  Moreover, as an inert gas, it is not limited to nitrogen, For example, helium, neon, argon, krypton, xenon, radon etc. can be used.

It is a schematic diagram of the prefilled syringe manufacturing apparatus of the present invention. It is a block diagram which shows roughly the principal part of the prefilled syringe manufacturing apparatus shown in FIG. It is a figure for explaining the process which manufactures a prefilled syringe in order in the prefilled syringe manufacturing apparatus shown in FIG. It is a figure for explaining the process which manufactures a prefilled syringe in order in the prefilled syringe manufacturing apparatus shown in FIG. It is a fragmentary sectional view of a prefilled syringe.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Prefilled syringe 11 Space 2 Syringe outer cylinder 21 Inner peripheral surface 211 Bottom part 22 Mouth part 221 Channel 23 Lock adapter 24 Lumen part 25 Cap 26 Base end opening 3 Plug body 31, 32 Projection part 4 Prefilled syringe manufacturing jig ( jig)
41 Jig body 411 Inner wall 412 Front end opening 42 Storage space 43 Press member 431 Base end 44 Vent hole 45 Gap 451 Vent groove 46 Packing 5 Deaeration means 51 Pump 6 Inert gas supply means 61 Air tank 7 Plug means 71 Actuator 8 Control Means 81 CPU
82 storage unit 9 valve 91, 92, 93 tube 10 prefilled syringe manufacturing device (manufacturing device)
20 Jig moving mechanism 100 Chemical Q Nitrogen

Claims (5)

A prefilled syringe for manufacturing a prefilled syringe having a syringe outer cylinder, a plug inserted into a lumen portion of the syringe outer cylinder, and a drug solution filled in a space formed by the syringe outer cylinder and the plug A manufacturing method comprising:
A first step of mounting a jig so as to cover a proximal end opening of the syringe outer cylinder;
A second step of degassing the lumen of the syringe outer cylinder via the jig;
A third step of supplying an inert gas to the degassed lumen by the jig;
And a fourth step of inserting the plug into the lumen of the syringe outer cylinder after degassing the lumen supplied with the inert gas.   The prefilled syringe manufacturing method according to claim 1, wherein the second step and the third step are repeated twice or more. A prefill used for manufacturing a prefilled syringe having a syringe outer cylinder, a plug inserted into a lumen portion of the syringe outer cylinder, and a drug solution filled in a space formed by the syringe outer cylinder and the plug. A syringe manufacturing jig,
A jig body that is mounted so as to cover the proximal end opening of the syringe outer cylinder and has a storage space in which the stopper can be stored;
A pressing member that is installed on the jig main body and presses the stopper so as to be inserted into the lumen of the syringe outer cylinder;
The jig body communicates with the storage space, and is provided with a vent hole capable of supplying and exhausting the storage space and supplying an inert gas.
A jig for producing a prefilled syringe, wherein a gap is formed between the inner wall of the jig main body and the plug when the plug is stored in the storage space. A prefilled syringe for manufacturing a prefilled syringe having a syringe outer cylinder, a plug inserted into a lumen portion of the syringe outer cylinder, and a drug solution filled in a space formed by the syringe outer cylinder and the plug Manufacturing equipment,
A jig mounted to cover the proximal end opening of the syringe outer cylinder;
Degassing means for degassing the lumen of the syringe outer cylinder;
An inert gas supply means for supplying an inert gas to the lumen of the syringe outer cylinder;
Plugging means for inserting the plug into the lumen of the syringe outer cylinder;
Control means for controlling the operation of the jig, the degassing means, the inert gas supply means and the plugging means,
The control means attaches the jig so as to cover the proximal end opening of the syringe outer cylinder, and then operates so that the deaeration means deaerates the inner cavity of the syringe outer cylinder. The active gas supply means operates to supply the inert gas to the degassed lumen at least once, and then the degassing means removes the lumen to which the inert gas has been supplied. The prefilled syringe manufacturing apparatus is controlled to operate so as to insert the plug into the lumen of the syringe outer cylinder. A prefilled syringe for manufacturing a prefilled syringe having a syringe outer cylinder, a plug inserted into a lumen portion of the syringe outer cylinder, and a drug solution filled in a space formed by the syringe outer cylinder and the plug Manufacturing equipment,
A jig for producing a prefilled syringe according to claim 3,
Degassing means for degassing the lumen of the syringe outer cylinder;
An inert gas supply means for supplying the inert gas to the lumen of the syringe outer cylinder;
Plugging means for inserting the plug into the lumen of the syringe outer cylinder;
A control means for controlling the operation of the prefilled syringe manufacturing jig, the deaeration means, the inert gas supply means, and the plugging means,
The control means attaches the prefilled syringe manufacturing jig so as to cover the proximal end opening of the syringe outer cylinder, and then the degassing means operates to deaerate the lumen of the syringe outer cylinder. The inert gas supply means performs an operation for supplying the inert gas to the degassed lumen at least once, and then the degassing means supplies the inert gas. An apparatus for producing a prefilled syringe, wherein the device is operated so as to deaerate the cavity, and the stopper is operated so as to insert the plug into the inner cavity of the syringe outer cylinder.

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