JP2004338806A - Powder charging equipment and powder charging method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To restrain soaring of powder charged in a vessel from a charging nozzle, and to prevent the powder from adhering onto the inner surface in the vicinity of the opening of the vessel or onto the wall surface of the charging nozzle. <P>SOLUTION: The charging nozzle (4) is protrusively provided at the lower part of the hopper (2) of powder charging equipment (1), the hopper (2) encasing the powder (3) in its inside. A static eliminator device (10) capable of releasing ions is disposed in the lateral direction of the charging nozzle (4) and the lateral direction of the vessel (8) carried in downward of the charging nozzle (4). The ions released from the static eliminator device (10) neutralize the static electricity born in the nozzle (4), the powder (3) sent out from the charging nozzle (4) and the vessel (8). <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a powder filling apparatus and a filling method using the same, and more particularly, suppresses the soaring of powder filled into a container from a filling nozzle, and the powder is filled on the inner surface near the opening of the container or the wall surface of the filling nozzle. TECHNICAL FIELD The present invention relates to a powder filling apparatus and a powder filling method that prevent the powder from adhering to a powder.

  For example, the two-chamber prefilled syringe (50) shown in FIG. 3 has a needle mounting portion (52) attached to the distal end of a cylindrical body (51), and a front plug (53) is sequentially inserted into the cylindrical body (51) from the distal end side. ), A middle plug (54) and an end plug (55) are inserted to partition the inside of the cylinder (51) into a first chamber (56) and a second chamber (57). The chamber (56) contains a powdered medicine, and the second chamber (57) contains a liquid such as a solution, a dispersion or a liquid medicine. At the time of administration, the end plug (55) and the middle plug (54) are advanced by pushing the end plug (55) with the plunger rod (58). The liquid is injected into the first chamber (56) via the bypass (59) to disperse and dissolve the powder drug. Then, the middle plug (54) is advanced to the predetermined position (60), and the front plug (53) is moved into the plug housing chamber (61) in the needle mounting section (52), whereby the first chamber The inside of (56) is configured to communicate with the communication path (62) in the needle mounting section (52). An injection needle (64) covered with a protective cap (63) is mounted on the needle mounting section (52).

  Conventionally, as a device for filling powder into a container such as the prefilled syringe or vial, the powder is stored in a hopper (funnel) having a filling nozzle protruding below, and the container is placed below the filling nozzle. There is one configured to carry in and fill a predetermined amount of powder from inside the hopper through the filling nozzle into the container (for example, see Patent Document 1).

  That is, this prior art describes the case where the container is a cylinder of a prefilled syringe. For example, as shown in FIG. 4 (a), a filling nozzle is provided at a lower portion of a hopper (71) of a powder filling device (70). (72), and the cylindrical body (51) is loaded below the filling nozzle (72) with the tip opening (73) facing upward, and the filling nozzle (72) is It is inserted into the cylindrical body (51) through the opening (73). Then, the screw (74) in the hopper (71) is rotated to fill a predetermined amount of the powder (75) into the first chamber (56) of the cylindrical body (51).

  As shown in FIG. 4 (b), a screen (78) for preventing powder falling is arranged above the filling nozzle (72) and below the screw (74). The screen (78) is provided with a plurality of small-area through-holes in order to prevent the powder from falling during non-filling, and the total opening area is smaller than the passage cross-sectional area of the filling nozzle (72). However, since the powder filling speed depends on the opening area of the screen (78), the opening area of the screen (78) is made as large as possible. It is about 70%.

  When the filling of the powder (75) is completed, the cylinder (51) is guided below the plugging device (76) as shown in FIG. 4 (c). Then, the capping sleeve (77) is inserted into the opening (73), and the front plug (53) mounted in the capping sleeve (77) is positioned at a predetermined position in the cylindrical body (51). Move to Thereafter, a needle mounting portion is attached to the distal end opening (73) of the cylindrical body (51), for example, to form a two-chamber prefilled syringe shown in FIG.

JP-A-64-84801

  In general, powders used as pharmaceuticals such as injections have a low water content and are handled in a low humidity environment such as a humidity of 15% RH or less. Therefore, when filling, friction with a rotary screw in a hopper or filling is required. Static electricity is generated by repeated contact and separation with the inner wall of the nozzle, and the charge amount is large. For this reason, the powder filled in the cylinder is likely to soar by the action of static electricity, and may reach the vicinity of the opening at the tip of the cylinder. Further, due to the action of the static electricity, there is a possibility that the powder (75) adheres to the inner surface or the outer surface of the filling nozzle (72) as shown in FIG. 4B, for example.

Increasing the filling capacity of the powder to be filled into the cylinder increases the filling time, the soaring of the powder in the cylinder, and the amount of static electricity generated by friction between the powder and the inner surface of the filling nozzle during filling And the powder soared in the cylinder easily adheres to the filling nozzle.
In addition, if the syringe size is large, for example, if the filling nozzle is widened and the discharge rate per unit time is increased, the powder falling in the cylinder spreads over the entire horizontal direction inside the cylinder, and the impact due to the drop increases. Powder easily rises.

When the above-mentioned powder soars up in the cylinder, there are the following problems.
(1) The powder that has reached the tapping position of the front plug body or the tip end position may be attached to the inner surface of the cylinder, causing the appearance failure of the prefilled syringe and sticking to this position. There is a concern that the powder may deteriorate or harden to lower the sliding performance of the front plug.
(2) For example, as shown in FIG. 4 (c), when the front plug is mounted, powder (75) may adhere to the outer surface of the plugging sleeve (77), and this powder is subsequently plugged. There is a risk of secondary contamination of the body surface.
(3) Since the front plug needs to be mounted above the rising position, the front plug cannot be plugged sufficiently deeply from the opening at the end.

Further, if powder adheres to the above-mentioned filling nozzle, there is the following problem.
(4) The amount of filling in the first chamber is insufficient for the amount attached to the filling nozzle. When the amount of the attached powder increases, the amount of the attached powder drops due to the action of gravity or the like, and the amount of the powder increases. For this reason, the filling amount tends to vary.
(5) If the powder soared up in the container adheres to the outer surface of the filling nozzle due to the action of static electricity, the powder adhered to the inner surface of the cylinder easily moves when the filling nozzle is inserted into and removed from the cylinder. There is a possibility that the powder may adhere to the tip side position of the inner surface of the cylinder.

  In order to suppress the powder soaring phenomenon, it is conceivable to lengthen the filling nozzle and insert the tip of the nozzle deep into the cylinder.However, when the filling nozzle is longer, the powder passing through the inside of the nozzle has a contact length with the inner surface of the nozzle. , And static electricity is more easily generated. Since the charged powder penetrates into the gap between the outer surface of the filling nozzle and the inner surface of the cylinder, even if the filling nozzle is lengthened, the powder soaring phenomenon cannot be suppressed.

  Eliminating the charge by bringing the powder in the hopper or the filling nozzle into direct contact with the conductive member cannot be employed in a pharmaceutical production line that maintains the hopper in an aseptic state. It is also conceivable to ground the filling nozzles and containers with earth ground, but it is not easy to sufficiently remove the static electricity charged on the powder, and it is easy to maintain the sterile and dust-free state of the line. In addition, there is a problem that the filling operability is lowered.

  The present invention solves the above problems, suppresses the sowing of the powder filled into the container from the filling nozzle, and prevents powder from adhering to the inner surface near the opening of the container and the wall surface of the filling nozzle. It is a technical object to provide an apparatus and a powder filling method.

The present invention has the following configuration in order to solve the above-described problems, for example, based on FIGS. 1 and 2 showing an embodiment of the present invention.
That is, the present invention 1 relates to a powder filling apparatus, which includes a hopper (2) that accommodates a powder (3) inside and a protruding nozzle (4) at a lower portion thereof. A powder filling apparatus for filling the above powder (3) into a container (8) located below (4), wherein at least one of the above filling nozzle (4) and the above container (8) is provided. On one side, a static eliminator (10) capable of discharging ions is arranged, and the ions discharged from the static eliminator (10) are sent out from the filling nozzle (4) and the filling nozzle (4). The present invention is characterized in that static electricity charged in at least one of the powder (3) and the container (8) can be neutralized.

  The present invention 2 also relates to a powder filling method, comprising a container (8) containing a powder (3) in a hopper (2) having a filling nozzle (4) protruding at a lower portion and having an opening (9) at an upper portion. A powder filling method comprising: placing the powder (3) in the hopper (2) from the filling nozzle (4) into a container (8) after being positioned below the filling nozzle (4). A static eliminator (10) capable of discharging ions is arranged on at least one side of the filling nozzle (4) and the container (8), and discharges ions from the static eliminator (10). By doing so, it is possible to neutralize the static electricity charged in at least one of the filling nozzle (4), the powder (3) sent out from the filling nozzle (4), and the container (8). Features.

  The term “neutralize the static electricity” means to reduce the amount of charge of the static electricity, and the charge amount may remain to such an extent that the adverse effect of the static electricity does not occur.

  Positive ions and negative ions are generated from the static eliminator in a well-balanced manner. The ion balance may be configured such that a charge amount of an object to be neutralized such as a filling nozzle is detected by a sensor, and a generation amount of a positive ion and a negative ion is adjusted based on the detected charge amount. Positive ions and negative ions generated by the static eliminator reach the above-described filling nozzle and container, and are also sent into the container by, for example, a downflow in a sterile room. As a result, the static electricity charged in the above-mentioned filling nozzle, the container, or the powder sent from the filling nozzle is neutralized by the ions released from the above-described static eliminator, and the powder adheres to the filling nozzle or the inside of the container. Phenomena are suppressed.

  The above-mentioned powder is preferably set in a low-humidity environment when it is sent out from the filling nozzle. However, in order to neutralize static electricity with ions released from the static eliminator, a high-humidity environment is preferable because the amount of ions generated can be increased. For this reason, for example, in the case of powder filling in a low humidity environment, it is preferable that the container located below the filling nozzle be preliminarily neutralized by ions emitted from the static elimination device in an environment of 35% RH or more.

  It is more preferable that the above-described static eliminator be of a pulse AC type or a pulse DC type because the amount of generated ions is large. In particular, the pulse AC method emits + ions and-ions from a single electrode needle. Therefore, when a bar-shaped static eliminator is used, unevenness of the generated ions can be reduced and the ion balance can be improved, which is more preferable.

  It is preferable that the filling nozzle is tapered toward the tip. That is, when the outer surface of at least the distal end portion of the filling nozzle is formed in a tapered shape, the inner diameter of the base end of the nozzle is increased to secure a discharge amount per time (that is, filling speed), and the nozzle is provided near the nozzle tip. The distance between the outer surface of the container and the inner surface of the container can be widened. As a result, the powder adhering to the outer surface of the filling nozzle is prevented from migrating to the inner surface of the container.

  Further, when at least the inner surface of the leading end of the filling nozzle is formed in a tapered shape, the flow of the powder discharged from the filling nozzle and falling in the container converges. As a result, even if the filling capacity or the filling rate is increased, the soaring of the powder can be effectively suppressed, which is preferable.

  A powder drop prevention screen is arranged above the above-described filling nozzle, as in the above-described conventional technology. However, as described above, the opening area of the screen is limited by the passage cutoff at the nozzle base end of the filling nozzle. The area is set to be smaller than the area, for example, about 50 to 70% of the area. For this reason, in the above-described tapered filling nozzle, if the opening area at the nozzle tip becomes smaller than the opening area of the screen, the opening at the nozzle tip becomes a resistance, and the filling speed may be reduced. . Therefore, the opening area of the above-mentioned filling nozzle at the nozzle tip is preferably set to 50% or more, more preferably 60% or more of the passage cross-sectional area at the nozzle base end.

  The present invention is configured and operated as described above, and has the following effects.

  (1) Since the static electricity charged to the powder sent from the filling nozzle, the container, or the filling nozzle is neutralized by the ions released from the static eliminator, the powder is filled inside the filling nozzle at the time of filling. It can be prevented from adhering to the like. As a result, a predetermined amount of powder sent out from the hopper can be reliably guided into the container, and variation in the filling amount can be reduced.

  (2) Since the powder guided into the container is less affected by static electricity, it falls down and calms down, and is prevented from flying up inside the container. Therefore, it is possible to prevent the powder from adhering to the inner surface of the container at or above the mounting position of the plug, and to prevent the occurrence of poor appearance, deterioration, and the like due to these.

  (3) Since the filled powder is prevented from rising, it is possible to prevent the powder from adhering to the outer surface of the filling nozzle. Therefore, when the filling nozzle is inserted into or removed from the container, the powder does not adhere to the filling nozzle. There is no danger of migration from the outer surface to the inner surface of the container.

  (4) Since the filled powder is prevented from rising, the filling amount can be increased without adhering the powder to the upper wall surface of the container.

  (5) Since the static eliminator only generates ions at the side of the filling nozzle or the container, the aseptic level of the whole powder filling system can be easily maintained at a high level. It is suitable for.

  (6) Since the powder can be prevented from adhering to the inner surface of the container at or above the mounting position of the stopper, when the container is a prefilled syringe cylinder, the sliding performance of the stopper is improved. Can be maintained. In addition, the transfer of powder to the outer surface of the plugging sleeve can be prevented when the plug is attached, and there is no fear that the cylinder to be plugged thereafter will be soiled by the transfer of the powder from the plugging sleeve. Furthermore, since the powder is calmed down in the cylinder, the front plug can be mounted at a position deep from the opening, and the range of design and specifications of the prefilled syringe can be expanded.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 shows a first embodiment of the present invention. FIG. 1 (a) is a schematic configuration diagram of a powder filling device, FIG. 1 (b) is a schematic configuration diagram for explaining the operation of the powder filling device, and FIG. 1 (c). FIG. 1 is a schematic configuration diagram for explaining the operation of the tapping device, and FIG. 1D is a cross-sectional view of a main part of a cylindrical body in a state where a needle mounting portion is attached.

As shown in FIG. 1 (a), the powder filling device (1) includes a conical hopper (funnel) (2), and a powder (3) such as an injection is stored in the hopper (2). I have. A filling nozzle (4) projects downward from the lower part of the hopper (2).
A rotary shaft (5) is disposed in the hopper (2) in the vertical direction, and a screw (6) attached to the lower end of the rotary shaft (5) is inserted into the filling nozzle (4). There is not. The rotating shaft (5) is provided with a stirring means (7). When the rotating shaft (5) is rotated, the powder (3) is stirred by the stirring means (7). A predetermined amount of powder (3) is sent out from the filling nozzle (4) by the screw (6).

The above-mentioned powder filling device (1) is entirely installed in a clean room, is maintained in an aseptic state, and forms a clean air flow (downflow) from above to below.
A loading / unloading device (not shown) is provided below the powder filling device (1). This loading / unloading device guides a cylinder (8) of a prefilled syringe used as a powder container to a position below the above-mentioned filling nozzle (4) with the front end opening (9) facing upward to ascend. After a predetermined amount of the powder (3) is filled, the cylindrical body (8) is lowered and carried out to the next step.

  A static eliminator (10) capable of generating and emitting ions is arranged on the side of the filling nozzle (4). The static eliminator (10) is formed in a bar shape elongated in the horizontal direction, and includes a plurality of discharge electrodes (11). One or more discharge electrodes (11) are exposed to the filling nozzle (4), and the remaining discharge electrodes (11) are guided under the filling nozzle (4). It faces the vicinity of the tip opening (9) of the cylindrical body (8). Positive ions and negative ions are generated in a well-balanced manner from the discharge electrode (11), and are discharged toward the filling nozzle (4) and the tip opening (9) of the cylindrical body (8).

Next, a powder filling operation by the above powder filling apparatus will be described.
As shown in FIG. 1 (a), the cylinder (8) of the prefilled syringe is guided directly below the filling nozzle (4) by the loading / unloading device with the tip opening (9) facing upward. . In the carrying-in process, the positive ions and the negative ions generated from the neutralization device (10) reach the tip opening (9) of the cylindrical body (8). At this time, some of these ions enter the inside of the cylindrical body (8) by, for example, riding down flow in the sterile room. The cylindrical body (8) is charged with static electricity during the transportation process and the like, and the static electricity is neutralized by the above-mentioned ions. In the present invention, the static electricity charged in the cylinder (8) is neutralized by another static eliminator in advance in the step immediately before the step of loading the cylinder (8) below the filling nozzle (4). You may keep it.

The above-mentioned cylinder (8) is raised immediately below the filling nozzle (4), and as shown in FIG. 1 (b), the lower end of the filling nozzle (4) is inserted into the cylinder (8) at the tip opening (9). Inserted from. The charge nozzle (4) has been neutralized in advance by ions emitted from the neutralization device (10).
In this state, the rotation shaft (5) is rotated by a predetermined angle. Thus, the powder in the hopper (2) is stirred by the stirring means (7), and a predetermined amount of the powder (3) is sent out from the filling nozzle (4) by the screw (6). At this time, the filling nozzle (4) is charged with static electricity due to contact, separation, friction and the like with the powder (3). However, the static electricity charged in the filling nozzle (4) is quickly neutralized by the ions released from the static eliminator (10). Although the lower end of the filling nozzle (4) is inserted into the cylinder (8), a part of the above ions are sent into the cylinder (8), so that the charging nozzle (4) is charged. The static electricity is effectively neutralized.

  On the other hand, the powder (3) sent out from the filling nozzle (4) is also charged with static electricity due to contact, separation, friction and the like with the inner surface of the filling nozzle (4). However, the static electricity charged in the powder (3) is neutralized by the ions released from the static eliminator (10) and entering the cylinder (8), so that the powder (3) is charged with the static electricity. Influence is suppressed and falls in the cylinder (8), and calms down without soaring.

When a predetermined amount of the powder (3) is filled in the cylinder (8) and the rotation of the rotation shaft (5) is stopped, the cylinder (8) is lowered and moves to the next stoppering step. It is carried out.
In the plugging step, as shown in FIG. 1 (c), the plugging sleeve (16) of the plugging device (15) is connected to the cylindrical body (8) through the tip opening (9) of the cylindrical body (8). It is inserted into. A front plug (17) is mounted in the capping sleeve (16), and the front plug (17) is separated from the capping sleeve (16) by a push rod (18). Is moved to a predetermined position.
Thereafter, as shown in FIG. 1D, a needle mounting portion (19) is externally fitted and fixed to the distal end opening (9) of the cylindrical body (8).

FIG. 2 shows a second embodiment of the present invention. FIG. 2 (a) is a schematic configuration diagram near a filling nozzle, and FIG. 2 (b) is an enlarged cross-sectional view of the IIB portion in FIG. 2 (a).
As shown in FIG. 2A, in the powder filling apparatus (1) of the second embodiment, the filling nozzle (4) is formed in a cylindrical shape from the nozzle base end (12) to the middle part. The outer surface (4a) of the distal end portion (13) below the intermediate portion is tapered toward the nozzle distal end (14). As shown in FIG. 2 (b), the tip portion (13) of the filling nozzle (4) is formed such that the thickness thereof is gradually reduced toward the nozzle tip (14), and the inner surface (4b) is also formed at the tip end of the nozzle. It is formed in a tapered shape toward (14). Above the filling nozzle (4), a powder drop prevention screen (20) is arranged below the screw (6). The opening area of the screen (20) is set to, for example, the cross-sectional area of the passage at the base end (12) of the nozzle in order to prevent the powder from dropping from the filling nozzle (4) during non-filling while securing a predetermined filling speed. It is set to 50-70%.

  The opening area at the nozzle tip (14) is preferably as small as possible to achieve the effects described below, such as suppression of powder soaring. However, if the area is too narrow, the filling speed decreases. For this reason, the opening area is set to be equal to or slightly larger than the opening area of the screen (20). For example, the opening area is 50% or more, preferably 60 to 60% of the passage cross-sectional area at the nozzle base end (12). It is set to about 70%. The other configuration is the same as that of the first embodiment, and the description is omitted.

  The filling operation by the above powder filling device (1) is performed in the same manner as in the first embodiment. That is, the tip portion (13) of the above-mentioned filling nozzle (4) is inserted into the cylinder (8) of the prefilled syringe guided immediately below the filling nozzle (4), and the powder in the hopper (not shown) is filled with this filling nozzle. It is sent out from (4) into the cylinder (8). During this time, ions are being discharged from the static eliminator (10) arranged beside the filling nozzle (4) and the cylinder (8), so that the filling nozzle (4), the cylinder (8), the filling nozzle The static electricity charged to the powder (3) discharged from (4) is neutralized by these ions.

  The powder (3) sent out from the filling nozzle (4) falls as a converged flow in the cylinder (8) because the inner surface (4b) of the filling nozzle (4) is tapered. For this reason, the powder (3) is hardly diffused in the cylinder (8), and the soaring phenomenon in the cylinder (8) is suppressed. Even if the powder (3) soars in the cylinder (8), it is neutralized by the ions from the static eliminator (10). It does not easily adhere to the outer surface (4a) of the filling nozzle (4). Furthermore, even if the sowed powder (3) adheres to the outer surface (4a) of the filling nozzle (4), the outer surface (4a) has a tapered shape, so that the distance from the inner surface of the cylindrical body (8) is large. The transfer of the powder (3) attached to the outer surface (4a) of the filling nozzle (4) to the inner surface of the cylindrical body (8) is suppressed.

In the second embodiment, the distal end portion below the middle portion of the filling nozzle is formed in a tapered shape. However, in the present invention, the entire filling nozzle from the base end to the distal end may be formed in a tapered shape.
In the second embodiment, both the outer surface and the inner surface of the filling nozzle are formed in a tapered shape. However, in the present invention, it is also possible to make only one of the tapered shapes, for example, to make only the inner surface tapered.

Next, the inner and outer diameters and length of the filling nozzle (4) were set according to the inner diameter of the cylinder (8), and the filling performance of each was confirmed.
(Example 1) For a cylindrical body having an inner diameter of 10.5 mm, a filling nozzle having a cylindrical shape (hereinafter, referred to as a straight shape) having a length of 10 mm, an outer diameter of 8.0 mm, and an inner diameter of 6.0 mm was used.
(Example 2) For a cylindrical body having an inner diameter of 10.5 mm, the length of the straight portion on the proximal side is 2 mm, the length of the tapered portion on the distal side is 13 mm, the outer diameter at the proximal end is 8.0 mm, and the inner diameter is 6 A filling nozzle having a diameter of 0.0 mm, an outer diameter of 5.7 mm at the tip and an inner diameter of 4.7 mm was used.
(Example 3) For a cylindrical body having an inner diameter of 10.5 mm, the length of the straight portion on the proximal end side is 2 mm, the length of the tapered portion on the distal end side is 18 mm, the outer diameter at the proximal end is 8.0 mm, and the inner diameter is 6 mm. A filling nozzle having a diameter of 0.0 mm, an outer diameter of 5.7 mm at the tip and an inner diameter of 4.7 mm was used.

In Examples 1 to 3 described above, the opening area of the powder drop prevention screen was set to about 60% of the passage cross-sectional area at the nozzle base end. On the other hand, based on the above dimensions, in Examples 2 and 3, the opening area at the nozzle tip is set to 61.4% of the passage cross-sectional area at the nozzle base end.
In the first embodiment, the thickness from the base end to the tip is substantially uniform and set to 1 mm. In the second and third embodiments, the thickness is reduced toward the tip, and the thickness at the base end is reduced. While the thickness is 1 mm, the tip is set to 0.5 mm.
As a result, the distance between the outer surface and the inner surface of the cylinder at the tip of the nozzle is 1.25 mm on average in Example 1, whereas it is 2.4 mm on average at the nozzle tip in Examples 2 and 3. That is, the gap with the inner surface of the cylinder is increased by a maximum of 1.92 times by forming the tip portion into a tapered shape and forming a thin wall.

(Example 4) A filling nozzle having a length of 10 mm and a straight shape having an outer diameter of 11.0 mm and an inner diameter of 9.0 mm was used for a cylindrical body having an inner diameter of 14.0 mm.
(Example 5) For a cylindrical body having an inner diameter of 14.0 mm, the length of the straight portion on the proximal end side was 2 mm, the length of the tapered portion on the distal end side was 13 mm, the outer diameter at the proximal end was 11.0 mm, and the inner diameter was 9 A filling nozzle having a diameter of 0.0 mm, an outer diameter of 8.4 mm at the tip, and an inner diameter of 7.4 mm was used.

In the above Examples 4 and 5, the opening area of the powder drop prevention screen was set to about 66.5% of the cross-sectional area of the passage at the base end of the nozzle. On the other hand, from the above dimensions, in the fifth embodiment, the opening area at the nozzle tip is set to 67.6% of the passage cross-sectional area at the nozzle base.
In the fourth embodiment, the thickness from the base end to the tip is substantially uniform and set to 1 mm. In the fifth embodiment, the thickness is reduced toward the tip, and the thickness at the base is reduced. At the tip, it is set to 0.5 mm, whereas it is 1 mm.
As a result, the distance between the outer surface and the inner surface of the cylinder at the tip of the nozzle is 1.5 mm on average in Example 4, while it is 2.8 mm on average in the tip of nozzle in Example 5. That is, the gap with the inner surface of the cylinder is increased by a maximum of 1.87 times by forming the tip portion into a tapered shape and forming a thin wall.

As a result of filling with the above-described filling nozzles, the following was found.
(1) In the case of the second, third and fifth embodiments using the tapered filling nozzle, the flow of the powder discharged from the nozzle tip is converged, and the first and fourth embodiments using the straight-shaped filling nozzle In comparison, even if the filling capacity was about 2 to 4 times, the rise of the powder and the transfer of the powder from the outer surface of the filling nozzle to the inner surface of the cylinder could be effectively suppressed.
(2) In the case of the filling nozzle having a tapered shape, in the fifth embodiment in which the inner diameter of the base end is increased, the filling speed can be approximately twice as fast as that in the first embodiment in which the inner diameter of the base end is small, and the rising of the powder can be reduced. The transfer of the powder from the outer surface of the filling nozzle to the inner surface of the cylinder was effectively suppressed.
(3) In Example 3 in which the length of the tapered portion of the filling nozzle was increased, and in Example 2 in which the length of the tapered portion was short, the filling performance was almost the same. It was possible to effectively suppress the powder rising and the transfer of the powder from the outer surface of the filling nozzle to the inner surface of the cylinder at the filling speed.

In each of the embodiments described above, the cylinder of the prefilled syringe is used as the container. However, the present invention is not limited to these embodiments, and can be applied to other containers such as vials. It is particularly suitable when the above-mentioned container is made of a material which is easily charged such as glass or synthetic resin.
In addition, the powder that can be handled by the powder filling apparatus of the present invention is not limited to a specific material, application, shape and the like, but is particularly required to have a low water content and is suitable for pharmaceuticals such as injections to be filled in an aseptic state.

The above-mentioned hopper, filling nozzle, static eliminator, container, and the like are not limited to those having a specific shape, size, or structure, and the size of the filling nozzle entering the container can be arbitrarily set.
For example, in each of the above embodiments, a bar-shaped static eliminator is used, but in the present invention, one or more spot-type static eliminators having a single discharge electrode may be used. In the above-described embodiment, the loading / unloading device guides the cylindrical body, which is a container, directly below the filling nozzle. Alternatively, in the present invention, the filling nozzle is moved to a position immediately above the container by moving the hopper. You may be guided.
Further, in the above embodiment, the static eliminator is arranged on both sides of both the filling nozzle and the container guided below, but in the present invention, it may be arranged only on either one side, in this case, Static electricity charged on the other side may be removed by, for example, grounding.

  The present invention suppresses the sowing of the powder filled into the container from the filling nozzle and prevents the powder from adhering to the inner surface near the opening of the container and the wall surface of the filling nozzle, so that the powder can be applied to a prefilled syringe or a vial. It can be used particularly preferably for filling powdered pharmaceuticals, but it goes without saying that it can also be used for filling other powders.

FIG. 1A is a schematic configuration diagram of a powder filling device, FIG. 1B is a schematic configuration diagram illustrating an operation of the powder filling device, and FIG. FIG. 1D is a schematic configuration diagram illustrating the operation of the tapping device, and FIG. 1D is a cross-sectional view of a main part of the cylindrical body in a state where a needle mounting portion is attached. FIG. 2A is a schematic configuration diagram near a filling nozzle, and FIG. 2B is an enlarged cross-sectional view of a portion IIB in FIG. 2A, showing a second embodiment of the present invention. It is sectional drawing of a two-chamber type prefilled syringe. 4 (a) is a schematic configuration diagram illustrating the operation of the powder filling apparatus, FIG. 4 (b) is an enlarged sectional view of the IVB part in FIG. 4 (a), and FIG. It is a schematic block diagram explaining operation | movement of an apparatus.

Explanation of reference numerals

1: powder filling device 2: hopper 3: powder 4: filling nozzle
4a: Outside surface of filling nozzle (4)
4b: Inside surface of filling nozzle (4) 8: Container (tubular body)
9 Opening (tip opening)
10 ... static eliminator
12 ... Nozzle base end
13: Tip of filling nozzle (4)
14 ... Nozzle tip

Claims (12)

A hopper (2) containing powder (3) therein and having a filling nozzle (4) protruding at the lower portion, and a container positioned below the filling nozzle (4) from the filling nozzle (4). (8) A powder filling device for filling the above powder (3) into the powder filling device,
A static eliminator (10) capable of releasing ions is arranged on at least one side of the filling nozzle (4) and the container (8),
At least one of the charging nozzle (4), the powder (3) sent out from the charging nozzle (4), and the container (8) is charged by ions released from the static eliminator (10). A powder filling device characterized by being capable of neutralizing static electricity.   The powder filling device according to claim 1, wherein the powder (3) is an injection.   The powder filling device according to claim 2, wherein the container (8) is a cylinder of a prefilled syringe.   4. The powder filling device according to claim 1, wherein at least the outer surface (4a) of the tip (13) of the filling nozzle (4) has a tapered shape.   The powder filling device according to any one of claims 1 to 4, wherein at least the inner surface (4b) of the tip (13) of the filling nozzle (4) has a tapered shape.   The powder filling apparatus according to claim 5, wherein an opening area of the filling nozzle (4) at a nozzle tip (14) is set to 50% or more of a passage cross-sectional area at a nozzle base (12). The powder (3) is accommodated in a hopper (2) having a filling nozzle (4) projecting downward, and a container (8) having an opening (9) at the top is positioned below the filling nozzle (4). A powder filling method of filling the powder (3) in the hopper (2) from the filling nozzle (4) into the container (8).
A static eliminator (10) capable of releasing ions is arranged on at least one side of the filling nozzle (4) and the container (8),
By discharging ions from the static eliminator (10), at least one of the filling nozzle (4), the powder (3) sent out from the filling nozzle (4), and the container (8) is charged. A powder filling method characterized by neutralizing static electricity.   The powder filling method according to claim 7, wherein the powder (3) is an injection.   The method according to claim 8, wherein the container (8) is a cylinder of a prefilled syringe.   The powder filling method according to any one of claims 7 to 9, wherein at least the outer surface (4a) of the tip (13) of the filling nozzle (4) is formed in a tapered shape.   The powder filling method according to any one of claims 7 to 10, wherein at least an inner surface (4b) of a tip portion (13) of the filling nozzle (4) is formed in a tapered shape.   The powder filling method according to claim 11, wherein an opening area of the filling nozzle (4) at a nozzle tip (14) is set to 50% or more of a passage cross-sectional area at a nozzle base (12).

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