JP2016030073A - Manufacturing method of medical container filled with medical liquid, and medical container filled with medical liquid manufactured by manufacturing method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a manufacturing method of a medical container filled with medical liquid in which an amount of air that the medical container holds can be made almost uniform, the coinjection of a predetermined amount of another medicine is possible, and an amount of residual liquid after the administration is small.SOLUTION: A manufacturing method of a medical container includes: a step for preparing a container body; a step for filling the container body with medical liquid in a state that the upper opening is directed upward; a temporary opening blocking step for temporarily blocking the opening of the container body filled with medical liquid; an inner pressure application step for further pressing the container body while maintaining the temporary opening blocking state, and applying inner pressure to the upper part inside the container body; an opening release step for releasing the temporary opening blocking state; and a discharge port mounting step for mounting a medical liquid discharge port on the opening.SELECTED DRAWING: Figure 13

Description

  The present invention relates to a synthetic resin container main body, a method for producing a medical container filled with medical liquid in which a medical liquid is filled, and a medical container filled with medical liquid produced by the production method.

  Conventionally, many medical liquid filled containers (infusion containers) have been used. As a container main body used for these containers, a bag-shaped one formed of a soft sheet, a semi-rigid one formed by blow molding and elastically deforming the main body facing each other (for example, Japanese Patent No. 3013200: Patent Documents) 1) etc. The container body is provided with a scale used for checking the filling amount of the medical liquid and the liquid remaining amount at the time of administration.

  A container body made of blow molding needs to be naturally crushed as the chemical solution is reduced during administration of the chemical solution. For this reason, it is formed thinly as a whole. Further, the container main body has not only a thin-walled main body, but also a closed portion, a neck having an upper opening, and a portion formed thicker than the main body such as a shoulder between the main body and the neck. The container body may come into contact with another container, a manufacturing apparatus, a placement jig for the manufacturing apparatus, or the like by the time of filling with the chemical solution, and dents may occur due to these contacts. Moreover, it may have a dent and a wrinkle resulting from manufacture.

Japanese Patent No. 3013200

The dent and the wrinkle which the container main body which consists of blow molding holds in chemical | medical solution filling do not inhibit the function of a container main body. However, the present inventors have found that when the chemical solution is filled in the container body, the above-mentioned dents and wrinkles may remain as it is, which causes variations in the amount of air retained in the filled chemical solution container. .
In a plurality of medical containers filled with medical liquids (infusion containers) using the same container body, it is not desirable that the amount of retained air is different. In addition, other drugs may be co-injected into the infusion container during use, and it is desired that co-infusion is possible (the amount of retained air is not excessive). On the other hand, if the amount of retained air is too small, all of the filled medical liquid is not discharged, which may cause residual liquid.

  Therefore, an object of the present invention is to make the amount of air held by a manufactured medical liquid-filled medical container substantially uniform, and to allow a predetermined amount of other drugs to be mixed in use. The present invention also provides a method for producing a medical container filled with medical liquid with little residual liquid after administration, and a medical container filled with medical liquid produced by the production method.

What achieves the above object is as follows.
(1) A step of preparing a synthetic resin container main body including a main body portion, a lower end closing portion, and a neck portion having an upper opening, and a medical liquid in the container main body in a state where the upper opening is on the upper side. A step of temporarily closing the upper opening of the container body filled with the medical liquid in a state where the upper opening is on the upper side, and a temporary closing of the upper opening In the state where the container body is maintained, the container body is pressed to apply an internal pressure to the inside upper part of the container body, and after the internal pressure application process, the opening of the upper opening is released after the temporary opening is released. A method of manufacturing a medical container filled with medical liquid, comprising performing a process and a discharge port mounting process of mounting a medical liquid discharge port in the upper opening.

(2) After the step of filling the medical liquid, the container main body is pressed to adjust the amount of air in the container main body, and the opening temporary closing step is performed on the container main body. The method for producing a medical container filled with medical liquid according to the above (1), which is performed in a state where the pressing is maintained.
(3) The method for manufacturing a medical container filled with medical liquid according to the above (1) or (2), wherein the pressing of the container main body is performed by pressing the main body portion of the container main body.
(4) The medical body-filled medical treatment according to (3), wherein the pressing of the main body portion is performed such that an upper end of the main body portion pressing is a predetermined length lower than an upper end of the main body portion. Manufacturing method for container.
(5) The method for manufacturing a medical container filled with medical liquid according to any one of (1) to (4), wherein the lower end closing part and the neck part are formed to be rigid or semi-rigid.
(6) The method for manufacturing a medical container filled with medical liquid according to any one of the above (1) to (5), wherein the container body is formed by stretch blow molding a parison.
(7) The medical treatment according to any one of (1) to (6), wherein the opening opening step for releasing the temporary closing of the upper opening is performed in a state in which the pressure in the internal pressure application step is maintained. For manufacturing liquid filled medical containers.

Moreover, what achieves the said objective is as follows.
(8) A medical liquid-filled medical container manufactured by the method for manufacturing a medical liquid-filled medical container according to any one of (1) to (7) above, wherein the medical container is the medical Liquid and gas are stored, and injection of a mixed injection medicine is possible. Furthermore, the main body portion of the container body is formed thin, and the lower end closing portion, the neck portion, and The shoulder portion between the main body portion and the neck portion is formed thicker than the main body portion, and the shoulder portion has substantially no dents and wrinkles filled with medical liquid. Medical container.

  In the method for manufacturing a medical container filled with medical liquid of the present invention, a step of preparing a synthetic resin container main body including a main body portion, a lower end closing portion, and a neck portion having an upper opening portion, and the upper opening portion upward A step of filling the container body with a medical liquid in a state where the upper opening is temporarily closed, and an opening portion temporary closure for temporarily closing the upper opening portion of the container body filled with the medical liquid with the upper opening portion facing upward In the state where the process and the temporary closing of the upper opening are maintained, the container main body is further pressed to apply an internal pressure to the inner upper part of the container main body, and after the internal pressure applying process, the upper opening is temporarily closed. An opening opening step for releasing the above and a discharge port mounting step for mounting a medical liquid discharge port on the upper opening.

  In particular, by performing the opening part temporary closing process and the internal pressure applying process, when the dent and the wrinkle are formed in the air holding part of the container body, the swelling is eliminated and the container body is corrected to the shape to be provided. And by carrying out the opening part opening process after an internal pressure provision process, the amount of holding | maintenance air is fine-tuned, and the medical container with which the medical liquid with which it fills is manufactured will hold the amount of air of an appropriate level.

  Moreover, the medical container filled with the medical liquid of the present invention is manufactured by the above-described manufacturing method, stores the medical liquid and gas, and is capable of injecting a mixed injection medicine. Further, the main body part of the container body is formed thin, the lower end closing part, the neck part and the shoulder part between the main body part and the neck part are formed thicker than the main body part, and the shoulder part is substantially Since there are no dents and wrinkles, there is no shape change due to elimination of dents and wrinkles during administration of the medical liquid, and stable administration is possible.

FIG. 1 is a front view of a medical container filled with medical liquid according to an embodiment of the present invention. FIG. 2 is a right side view of the medical liquid-filled medical container shown in FIG. 3 is a cross-sectional view taken along line AA in FIG. 4 is an enlarged sectional view taken along line BB in FIG. FIG. 5 is an explanatory diagram for explaining a method of manufacturing a medical container filled with medical liquid according to the present invention. FIG. 6 is an explanatory diagram for explaining a method of manufacturing a medical container filled with medical liquid according to the present invention. FIG. 7 is an explanatory diagram for explaining a method of manufacturing a medical container filled with medical liquid according to the present invention. FIG. 8 is an explanatory diagram for explaining a method of manufacturing a medical container filled with medical liquid of the present invention. FIG. 9 is an explanatory diagram for explaining a method of manufacturing a medical container filled with medical liquid according to the present invention. FIG. 10 is an explanatory diagram for explaining a method for manufacturing a medical container filled with medical liquid according to the present invention. FIG. 11 is an explanatory diagram for explaining a method for manufacturing a medical container filled with medical liquid according to the present invention. FIG. 12 is an explanatory diagram for explaining a method of manufacturing a medical container filled with medical liquid according to the present invention. FIG. 13 is an explanatory diagram for explaining a method of manufacturing a medical container filled with medical liquid according to the present invention. FIG. 14 is a schematic plan view of an example of a medical container opening sealing device having a pressing function used in the method for manufacturing a medical container filled with medical liquid of the present invention.

A method for producing a medical container filled with medical liquid of the present invention and a medical container produced by the production method will be described with reference to the embodiments shown in the drawings.
In the method for manufacturing a medical container filled with medical liquid of the present invention, a step of preparing a synthetic resin container main body including a main body portion, a lower end closing portion, and a neck portion having an upper opening portion, and the upper opening portion upward A step of filling the container body with medical liquid in a state where the upper opening portion is temporarily closed, and an opening portion temporary closing step of temporarily closing the upper opening portion of the container body filled with the medical liquid with the upper opening portion facing upward. In the state where the upper opening is temporarily closed, the container body is further pressed to apply an internal pressure to the inner upper portion of the container body, and the upper opening is maintained while maintaining the pressure in the internal pressure applying process. An opening opening process for releasing the temporary blockage of the part and a discharge port mounting process for mounting the medical liquid discharge port on the upper opening are performed.

And the medical container 1 filled with the medical liquid of this invention is manufactured by said manufacturing method. The medical container 1 contains a medical liquid 3 and a gas 4 and is capable of injecting a mixed injection drug.
And the container main body 2 is provided with the neck part 23, the shoulder part 24, the main-body part 21, and the lower end obstruction | occlusion part 22 from the upper side as shown in FIG. The container body 2 is formed thin as a whole. The neck portion 23 is rigid in order to prevent the needle from penetrating during rubber plug attachment and draining needle insertion. The main body 21 is soft in order to provide drainage without using a ventilation needle. Moreover, the shoulder part 24 has a corner | angular part in the container width direction both ends, as shown in FIG. This corner portion is a portion where the dent 28 is easily formed as shown by a one-dot chain line in FIG. And when the container main body 2 is manufactured by blow molding, as shown in FIG. 4, it becomes thin gradually from a neck part to a main body part. Moreover, the container main body 2 may have a wrinkle formed at the time of shaping | molding. In the container main body shown in FIG. 4, the shoulder portion 24 does not have substantial dents and wrinkles. Further, the container body 2 of this embodiment has an extending portion 27 that protrudes downward from the lower end closing portion 22, and the hanging hole 6 is provided in the extending portion 27.

In the method for manufacturing a medical container filled with medical liquid of the present invention, first, a step of preparing a synthetic resin container main body including a main body portion, a lower end closing portion, and a neck portion having an upper opening portion is performed.
As the container body 2, for example, a container body having a form as shown in FIGS. 1 to 4 is preferably used. FIG. 4 illustrates an enlarged cross section taken along line BB in FIG. The container body 2 includes a body portion 21, a neck portion 23 having an upper opening 25, a shoulder portion 24 located between the neck portion 23 and the body portion, and a lower end closing portion 22 continuous with the lower end of the body portion 21. ing. And the main-body part 21 has a curved both-sides part, can form a flat internal space, and can be elastically deformed.

  In particular, the main body portion 21 of the container main body 2 of this embodiment can be deformed until the facing flat plate-like portions (facing side wall portions) approach each other, specifically, contact. The neck 23 is connected to the upper end of the shoulder 24 and has an upper opening 25 at the upper end. The shoulder portion 24 is formed between the neck portion 23 and the main body portion 21, and the inner diameter (inner cross-sectional area) is abruptly reduced from the end portion of the main body portion 21 toward the neck portion. The lower end closing portion 22 is connected to the lower end of the main body portion 21 to form a closed bottom portion. Further, in the container body 2 of this embodiment, an annular flange portion 26 is provided on the upper end of the neck portion 23 so as to protrude outward from the upper opening 25. Further, the container body 2 of this embodiment has an extending portion 27 that protrudes downward from the lower end closing portion 22, and the hanging hole 6 is provided in the extending portion 27.

  Filling the container main body with blow molding is usually performed such that the liquid level reaches the upper part of the main body and does not reach the shoulder with the upper opening of the neck facing upward. For this reason, the upper part of the container body is not filled with liquid and air is present. Then, in a state where the air is retained, a discharge port is attached to the upper opening and sealed. Therefore, in the liquid-filled container, the amount of retained air varies depending on the shape of the container body. In other words, the amount of retained air is smaller when the container body has dents and wrinkles than when the container body does not have deformed portions (dents and wrinkles). In addition, when the deformation | transformation part (dent / crease) in a container main body is formed in the liquid filling part, a deformation | transformation part is expanded by the dead weight of a liquid, and a deformation | transformation part lose | disappears. However, when the deforming part is formed in the air holding part (liquid non-filling part), the liquid does not take its own weight, and the deforming part may remain.

  And the average thickness of the main-body part 21 is formed thinner than the average thickness of the shoulder part 24. FIG. The shoulder portion 24 of the container body 2 may have a substantially uniform thickness of the annular portion in the cross section of FIG. 1, but may have a partially different thickness. Similarly, the main body portion 21 of the container main body 2 may have a substantially uniform thickness of the annular portion in the cross section of FIG. 1, but may have a partially different thickness. For example, the main body portion 21 of the container main body 2 is thick at the longitudinal center portion (the portion connecting the center of the neck portion 23 and the center of the extending portion 27) of the flat wall portion 21a in FIG. It may gradually become thinner toward 21b. In this case, as the container main body 2, the curved side portions 21 b of the main body portion 21 are the thinnest portions. For this reason, the both side parts 21b of the main body part 21 are easily bent, and the remaining liquid is difficult to remain.

  Similarly, the shoulder portion 24 of the container body 2 may be thick at the central portion in the vertical direction in FIG. 1 and gradually thin toward both curved side portions. If it is such, the bending of the both sides of the main-body part 21 is not inhibited. The curved side portions of the shoulder portion 24 may be thinner than the longitudinal central portion of the flat wall portion 21a of the main body portion 21. In the medical liquid-filled medical container 1 of this embodiment using such a container body 2, the shoulder portion 24 does not have substantial dents and wrinkles as a whole.

  The preparation step of the synthetic resin container body 2 is preferably performed by stretch blow molding the parison, that is, by injection stretch blow molding (injection blow molding). Injection stretch blow molding is a molding method in which a test tubular preform is formed by injection molding, and the preform is stretch blow molded at a temperature equal to or higher than the glass transition point (Tg) of the molding resin. Depending on the difference in the thermal history of the injection-molded preform, the preform is roughly classified into a hot parison method and a cold parison method.

The hot parison method is a method in which the preform is not completely cooled and is transferred to a temperature control process, and then stretch blow molding is performed. Preform injection molding and stretch blow molding are continuously performed on the same molding machine. . On the other hand, in the cold parison method, after producing a preform, the preform is once cooled to room temperature and reheated by a stretch blow molding machine to perform stretch blow molding.
The preparation step of the synthetic resin container body 2 is preferably performed by injection stretch blow molding (injection blow molding), and may be either a hot parison method or a cold parison method. Preferably, the cold parison method is preferred because the preform can be molded and stored in advance and the productivity is good.

As a forming material of the synthetic resin container body 2, a polyolefin resin is preferable.
Examples of polyolefin resins include, for example, polyethylene resins such as low density polyethylene (LDPE), medium density polyethylene (MDPE), high density polyethylene (HDPE), and linear low density polyethylene (LLDPE); propylene homopolymer (homo PP), propylene-ethylene random copolymer (random copolymer PP), propylene-ethylene block copolymer (block copolymer PP), or propylene and 1-butene, 1-pentene, 1-hexene, 1-octene, 1 A random copolymer with at least one α-olefin selected from the group consisting of heptene, 4-methyl-butene-1, 4-methyl-pentene-1, and 4-methyl-hexene-1, a block copolymer Polypropylene resin such as polymer or graft copolymer Ethylene-vinyl acetate copolymer (EVA), ethylene-methyl methacrylate copolymer (EMMA), ethylene-ethyl acrylate copolymer (EEA), ethylene-methyl acrylate (EMA) copolymer, ethylene-ethyl acrylate- Ethylene copolymers such as maleic anhydride copolymer (E-EA-MAH), ethylene-acrylic acid copolymer (EAA), ethylene-methacrylic acid copolymer (EMAA); ethylene-acrylic acid copolymer And ionomers of ethylene-methacrylic acid copolymer; cyclic olefin copolymer (COC), cyclic olefin polymer (COP) and the like. These polyolefin resins can be used alone or in combination of two or more.
Among these polyolefin resins, homo PP, random copolymer PP, block copolymer PP, ethylene-vinyl acetate copolymer (EVA), and cyclic olefin copolymer (COC) from the viewpoints of compatibility as a medical container and moldability. A cyclic olefin polymer (COP) is preferred.

In addition, a resin material (hereinafter also simply referred to as a blend) in which the polyolefin resin and the rubber component as described above are mixed can be suitably used. Examples of rubber components include, for example, olefinic elastomers such as ethylene-propylene rubber (EPM) and ethylene-propylene-diene rubber (EPDM), styrene butadiene rubber (SBR), styrene-butadiene block copolymer (SB), and styrene. -Butadiene-styrene block copolymer (SBS), styrene-ethylene-butylene-styrene block copolymer (SEBS), styrene-isoprene block copolymer (SI), styrene-isoprene-styrene block copolymer (SIS) , Styrene elastomers such as styrene-ethylene-propylene-styrene block copolymer (SEPS), hydrogenated styrene butadiene rubber (HSBR), natural rubber, polyisoprene rubber, butyl rubber, nitrile rubber, acrylic rubber, silico Ngomu, polyester elastomers, polyurethane elastomers, polybutadiene elastomers, polyvinyl chloride-based elastomer, polyamide-based elastomers, and the like. These rubber components can be used alone or in combination of two or more. Among these rubber components, EPM and EPDM are preferable from the viewpoint of the impact resistance improving effect.
The content of the rubber component in the blend is preferably 5 to 70% by mass, more preferably 10 to 60% by mass, based on 100% by mass of the entire blend.
And the process of filling the medical liquid to the synthetic resin container main body 2 prepared as described above is performed.

  In the medical liquid filling process, as shown in FIG. 5, the container body 2 is suspended by the flange portion 26 on the slit-shaped holding portion 72 of the holding member 7, and the container body 2 is positioned with the upper opening 25 facing upward. State. Then, as shown in FIG. 6, the nozzle 8 connected to the liquid supply unit (not shown) is arranged above the upper opening 25 of the container body 2, and the nozzle 8 is lowered to discharge the nozzle 81. Is inserted into the upper opening 25 of the container body 2, and then a medical liquid is discharged to fill the interior space 20 of the container body 2. As shown in FIG. 6, the medical liquid 3 is filled so that the air holding part 4 is formed in the upper part of the container body 2. In the state where the medical liquid is filled in FIG. 6, it is preferable that the liquid surface of the liquid 3 is the upper part of the main body part 21 and does not reach the shoulder part 24 or reaches the lower part of the shoulder part 24. And in the medical liquid filling state shown in FIG. 6, the average thickness of the container main body 2 is T1. In addition, the container main body 2 may be in a state where the lower portion is swollen by the filled liquid, and T1 is an average thickness in the main body portion. Then, the nozzle 8 is separated from the container body.

Then, following the medical liquid filling step, an air amount adjustment step is performed in which the container body filled with the medical liquid is pressed in a state where the upper opening is on the upper side, and the air amount in the container body is adjusted. Is preferred. This air amount adjustment step may be performed subsequent to the “medical liquid filling step” or may be performed subsequent to the “opening opening step”.
This air amount adjustment step can be referred to as a step of performing pressurization by subtracting the internal pressure application amount from the pressurization amount necessary for the set remaining air amount, and is a pre-pressurization position. By performing this step, the remaining amount can be adjusted to a certain set value.
The air amount adjustment step is performed by raising the liquid level by pressing the container body filled with the liquid. In particular, as shown in FIG. 7, the container body 2 is preferably pressed by pressing the body portion 21 of the container body 2. In particular, as shown in FIG. 7, it is preferable to press the opposing flat wall portions of the main body portion 21 from both sides.

Further, as shown in FIG. 7, it is preferable that the pressing of the main body portion 21 is performed so that the upper end of the main body portion pressing is a predetermined length lower than the upper end of the main body portion 21. By doing in this way, the deformation | transformation of the shoulder part 24 at the time of the press of the main-body part 21 can be prevented.
And it is preferable to perform the press of the main-body part 21 so that the upper end of a main-body part press may become a predetermined length downward side from the upper end of the main-body part 21. FIG. In particular, the upper end of the main body portion pressing is lower than the lower one of the shoulder portion and the non-pressing liquid level (when the liquid level is located in the main body portion), and from the longitudinal intermediate position of the main body portion 21. It is preferable to carry out so that it may become an upper side.
And the press of the main-body part 21 is performed so that the thickness of the main-body part 21 may become T2. T2 is preferably 80 to 90% of T1. And by the liquid level rise by press, some air is discharged | emitted from the container main body 2,

Subsequently, an opening portion temporary closing step for temporarily closing the upper opening portion 25 of the container body 2 is performed. In addition, when said air quantity adjustment process is performed, an opening part temporary obstruction | occlusion process is performed in the state which maintained the press of said container main body 2. FIG.
In the opening temporary closing step, for example, as shown in FIG. 8, the temporary closing portion 10 is disposed at the upper portion of the upper opening portion 25 of the container body 2 and is attached to the tip of the shaft portion 12 of the temporary closing portion 10. The tip of the sealing member 11 is inserted into the upper opening 25 and sealed. Thereby, the container main body 2 filled with the liquid is sealed (temporarily closed). In addition, you may perform an opening part temporary obstruction | occlusion process using the member for discharge ports (sealing member) 5 with which the container main body 2 is mounted | worn in a subsequent process. In particular, the discharge port member 5 to be described later includes a protrusion corresponding to the seal member 11 that can enter the upper opening 25 of the container body 2 and form an airtight state. It can be sealed and can withstand a subsequent internal pressure application step.
Moreover, in what is shown in FIG. 8, the opening part temporary closure process which temporarily closes the upper opening part 25 is performed in the state which maintained the press of the container main body 2 in the air amount adjustment process as it is. However, you may perform an opening part temporary obstruction | occlusion process in the state which maintained the press state and changed the press degree. In addition, when the degree of pressing is changed, the degree of pressing is preferably about ± 30% of the degree of pressing in the opening temporary closing step.

Subsequently, in the state where the upper opening 25 is temporarily closed, the container main body 2 is further pressed, and an internal pressure application process is performed in which an internal pressure is applied to the inner upper portion of the container main body 2.
When the deformed portion (dent or wrinkle) of the container body 2 before filling the liquid is formed in the liquid filling portion, the deformed portion is expanded by the weight of the liquid, and the deformed portion disappears. However, when the deforming part is formed in the air holding part (liquid non-filling part), the liquid does not take its own weight, and the deforming part remains. The internal pressure application step is performed by pressing the container body 2 filled with the liquid and closed by the seal member 11. When the air holding part of the container main body 2 has a deformed part (dent, wrinkle), it is deformed to the outside due to an increase in internal pressure, and the dent and wrinkle disappear. In addition, when there is no dent or wrinkle, the container body 2 is not deformed even when this internal pressure is applied. The internal pressure is preferably applied so as to cause plastic deformation to such an extent that dents and wrinkles formed on the shoulder portion disappear.
And the press of the main-body part 21 in an internal pressure provision process is performed so that the thickness of the main-body part 21 may become T3. T3 is preferably 80 to 90% of T2.

Then, the opening part opening process which cancels | releases temporary obstruction | occlusion of an upper opening part is performed. In addition, the opening part opening process which cancels | releases temporary obstruction | occlusion of an upper opening part cancels | releases the press in an internal pressure provision process (specifically cancellation | release of the amount of additional press in an internal pressure provision process), or the state (for example, internal pressure provision process) The pressure may be reduced by less than the additional pressurization, or the pressurization slightly increased by the internal pressure application step. However, it is preferable to perform this opening part opening process in the state which maintained the press in an internal pressure provision process.
This opening process is performed by separating the sealing member 11 of the temporary closing part 10 from the upper opening 25 of the container body 2 and separating the temporary closing part 10 from the container body. And when the air holding part (specifically, neck part and shoulder part) of the container main body 2 has dents and wrinkles and they disappear by the internal pressure applying step, the internal space is slightly expanded. . In addition, it is preferable to perform this opening part opening process in the state which maintained the press in an internal pressure provision process as mentioned above.

Then, a discharge port member mounting step of mounting the medical liquid discharge port member (sealing member) 5 provided with the plug 51 that closes the upper opening 25 on the upper opening 25 is performed.
As the discharge port member 5, a known member can be used. In the illustrated embodiment, the discharge port member 5 is constituted by a ring-shaped member 52 that houses a seal member (plug body) 51 that can puncture a drug discharge needle (not shown). Further, the plug body 51 of the discharge port member 5 of this embodiment is provided with a protrusion that can enter the upper opening 25 of the container body 2 to form an airtight state.

The ring-shaped member 52 is formed of a thermoplastic resin and includes an annular protrusion that extends outward from the side at the lower portion. The discharge port member 5 is preferably fixed by thermally fusing the lower surface of the annular protrusion of the ring-shaped member 52 to the upper surface of the flange portion 26 of the container body 2 using an ultrasonic fusion method or the like.
And as shown in FIG. 11, it is preferable to perform the member installation process for discharge ports in the state which maintained the press of the container main body in an internal pressure provision process. However, the discharge port member mounting step may be performed such that the pressure on the container body is relieved from the pressure in the air amount adjustment step, that is, the thickness of the main body portion 21 is T2. Furthermore, the discharge port member mounting step may be performed in a state where the container body is not pressed.

And as shown in FIG. 12, the medical container filled with the medical liquid of this invention is manufactured by releasing the press of the container main body 2. FIG.
And the press of the container main body 2 in the said manufacturing method can be performed by the press member 9 as shown to FIG. The pressing member 9 includes two pressing plates 91 and 92 that face each other, and can press the main body portion 21 of the container main body 2 when they are close to each other.

Note that the pressing of the container body 2 is not limited to the pressing by the above-described pressing plate. For example, you may carry out by the press apparatus 30 using many roll bodies as shown in FIG. In the pressing device 30, the container body 2 filled with the chemical solution is sequentially pressed by passing through the pressing device 30.
In this pressing device 30, a large number of two roll bodies 31a and 31b that are spaced apart from each other by a predetermined length and are opposed to each other are arranged so that the side portions are in contact with each other in the longitudinal direction (advancing direction of the container body). ing. And the separation distance between the roll bodies 31a and 31b changes suitably. In the pressing device 30 shown in FIG. 13, the container main body 2 moves from the left side to the right side in the figure. And in the entrance part (left side of a figure) of the press apparatus 30, between the roll bodies 31a and 31b is wider than the thickness of the container main body 2, and the entrance of a container main body is enabled. And until it goes to P1, between the roll bodies 31a and 31b is gradually approaching.

  And when P1 is reached, the container body is gradually pressed from the advancing side. Thereby, the container main body with which the medical liquid was filled in the state which the upper opening part mentioned above becomes upper can be pressed, and the air quantity adjustment process which adjusts the air quantity in a container main body can be performed. In addition, from P1 to P2 in FIG. 13, the distance between the roll bodies 31a and 31b is substantially constant. And it is preferable that the distance between both is T2 mentioned above.

  And while the container main body 2 moves from P2 to P3, the opening temporary closure process which temporarily closes the upper opening 25 is performed in the state which maintained the press of the container main body 2. FIG. And in the site | part beyond P3, between the roll bodies 31a and 31b becomes a nearer thing, and the temporary obstruction | occlusion of the upper opening part 25 was maintained while the container main body 2 moved from P3 to P4. In the state, the container main body 2 is pressed, and an internal pressure applying step for applying an internal pressure to the upper part inside the container main body 2 is performed. And when it reaches P4, the opening part opening process which cancels | releases temporary obstruction | occlusion is performed, and while the container main body 2 moves to P5 from P4, the discharge | emission port mounting | wearing process which mounts | wears with a medical liquid discharge | emission port in an upper opening part is carried out. It has been done.

  By using a pressing device having such a continuous pressing function, it is possible to efficiently manufacture a medical container filled with medical liquid. Furthermore, as a pressing device having a continuous pressing function using a roll body, the separation distance between the facing roll bodies can be adjusted (specifically, each roll body is moved in a direction perpendicular to the traveling direction of the container body). It is possible to deal with various infusion agents (variations such as container size and filling amount).

Next, a medical container opening sealing device provided with the continuous pressing function (pressing device) shown in FIG. 14 will be described.
The medical container opening sealing device 40 of this embodiment includes a rotary table 41 having a rotation mechanism, a rotating cylindrical portion 45 that rotates in synchronization with the rotary table 41, a pressing device 30 having a continuous pressing function, and liquid filling A medical container supply machine 50, a discharge port member supply machine 60, and a sealed medical container transfer machine 70 are provided.
As shown in FIG. 14, the rotary table 41 having a rotary mechanism is a disk-like rotary plate. The container holding part 42 is provided. The container holding part 42 is provided with a notch. The container holding part 42 receives the neck part 23 of the container main body 2 in a notch part, The flange 26 of the container main body 2 can be suspended on the upper surface. The rotary table 41 is continuously rotated counterclockwise by a drive mechanism (not shown).

As shown in FIG. 14, the rotating cylindrical portion 45 includes a cylindrical body 46 having a smaller diameter than the rotary table 41, and a chuck vertical that moves in a vertical direction with respect to the cylindrical body 46 (in other words, with respect to the rotary table). The chuck horizontal direction drive unit 48 that moves in the front-rear direction (horizontal direction, in other words, close to and away from the container holding unit 42) with respect to the direction drive unit 47 and the chuck movement unit, and the tip of the chuck horizontal direction drive unit 48 And a discharge port member holding chuck 49 that is fixed to the opening and closing operation. The chuck vertical drive unit 47, the chuck horizontal drive unit 48, and the discharge port member holding chuck 49 constitute a discharge port holding mechanism. The cylindrical body 46 may be fixed to the rotary table 41 and rotated together.
Also, each discharge port holding mechanism (each chuck vertical direction drive unit 47, each chuck horizontal direction drive unit 48, and each discharge port member holding chuck 49) has a fixed pitch (cylinder) with respect to the central axis of the cylindrical body 46. A plurality of them are provided at equal angles with respect to the central axis of the body. Further, each discharge port holding mechanism (each chuck vertical drive unit 47, each chuck horizontal drive unit 48, and each discharge port member holding chuck 49) corresponds to each container holding unit 42 provided on the rotary table 41. It is provided to do. Therefore, each discharge port holding mechanism is arranged at an equal angle with respect to the central axis of the rotary table. Further, each discharge port member holding chuck 49 can be positioned directly above each container holding portion 42 of the rotary table 41 as the chuck horizontal driving portion 48 advances.

  The discharge port member supply device 60 takes out and holds the discharge port member 5 from the discharge port member transfer unit 66 capable of storing a plurality of discharge port members (discharge port members) 5 and the transfer unit 66. , A discharge port member supply unit 65 for supplying to the discharge port member holding chuck 49 is provided. The discharge port member supply unit 65 includes a rotary plate and a plurality of discharge port member supply chucks 67 arranged on the outer periphery at a constant pitch (equal angle with respect to the central axis of the rotary plate).

The discharge port member holding chuck 49 is opened and closed to receive the discharge port member 5 from the discharge port member supply machine 60, to attach the discharge port member 5 to the container main body 2, and to open after the mounting. I do. The chuck horizontal direction drive unit 48 holds the chuck 49 on the rotary table 41 (specifically, the tip does not protrude from the outer edge of the rotary table 41), and the center of the opening / closing part of the chuck 49 holds the container of the rotary table 41. It is possible to reciprocate in the horizontal direction between the position states on the center of the cutout portion of the portion 42.
The chuck vertical drive unit 47 holds the discharge port member 5, and the chuck 49 in a state of being positioned above the medical container starts from an upper position where the held discharge port member does not contact the upper end of the container body 2. The discharge port member 5 to be held can be reciprocated in the vertical direction between the states where the discharge port member 5 can be pressed against the upper opening of the container body 2 and sealed.

As shown in FIG. 14, the liquid-filled medical container feeder 50 includes a rotating unit 56 that supplies the container holding unit 42 of the rotary table 41 so that the neck flange of the container body 2 is suspended, and the rotating unit 56. A container transfer part 55 for feeding the container body 2 to the container is provided.
As shown in FIG. 14, the liquid-filled container transfer machine 70 holds the neck portion of the container 1 that is suspended and sealed by the container holding portion 42 of the rotary table 41, and the container holding portion 42 of the rotary table 41 A separation rotating part 75 for separation and a container transfer part 76 for sending the container 1 held by the separation rotation part 75 to a subsequent process are provided.

  The medical container opening sealing device 40 according to this embodiment includes an ultrasonic sealing machine 85 for fusing the discharge port member 5 to the upper opening of the container main body 2. Note that the fusion of the discharge port member 5 to the upper opening of the container body 2 may be performed by a separate process. The ultrasonic sealer 85 is provided so as to be movable in the vertical direction, and includes ultrasonic seal portions 86 and 87 capable of enclosing the discharge port member at the tip. Further, the ultrasonic sealing machine 85 is intermittently moved between the arrows S6 shown in FIG.

  And the medical container opening part sealing device 40 of this Example is provided with the press apparatus 30 arrange | positioned under the container holding part 42 of the turntable 41. As shown in FIG. The pressing device 30 is capable of passing through the inside thereof while a liquid-filled medical container is in contact therewith. In this embodiment, the pressing device 30 has a first arc array roller group having a radius larger than the outer edge of the rotary table 41 by a predetermined length, and a first arc array roller having a radius greater than the first arc array roller group by a predetermined length. Two arc array roller groups are provided.

  In this pressing device 30, the distance from the start end to P <b> 1 is a proximity distance changing portion where the distance between the two roller groups gradually approaches, and P <b> 1 to P <b> 2 are sections in which the first predetermined distance is maintained. P2 to P3 are proximity distance changing portions where the distance between the two roller groups gradually approaches, and P3 to P4 maintain a second predetermined distance that is narrower than the first predetermined distance. This is a section, and P4 to P5 are proximity distance changing portions where the distance between the two roller groups is gradually separated.

  And in the medical container opening part sealing device 40 of this Example, the side part pressing process at the time of non-sealing of the medical container filled with a chemical | medical solution is performed in step S1, and the side part pressing process at the time of non-sealing in step S2 The discharge port member temporary sealing step in a state where the side pressing is maintained is performed. In step S3, a temporary sealing side portion pressing step is performed in which the temporarily sealed medical solution filled medical container is pressed stronger than the side portion pressing in the non-sealing side portion pressing step. Thereby, when a dent and a wrinkle exist in the upper part of the container main body 2, they lose | disappear. Subsequently, in step S4, the discharge port member is temporarily opened in a state in which the side pressing in the temporary sealing time side pressing step is maintained, and the inside of the container main body 2 becomes normal pressure. In step S5, re-sealing by the discharge port member is performed. Subsequently, a fixing process (heat sealing process) of the discharge port member 5 to the container body 2 is performed.

DESCRIPTION OF SYMBOLS 1 Medical container filled with medical liquid 2 Container main body 3 Medical liquid 4 Air holding 5 Discharge port member 9 Press member 21 Main body part 22 Lower end obstruction | occlusion part 23 Neck part 24 Shoulder part 30 Press apparatus

Claims (8)

A step of preparing a synthetic resin container main body including a main body portion, a lower end closing portion, and a neck portion having an upper opening; and filling the container main body with a medical fluid in a state where the upper opening is on the upper side. Maintaining the temporary opening of the upper opening, the opening temporary closing process of temporarily closing the upper opening of the container body filled with the medical liquid in a state where the upper opening is in the upper side In the state, pressing the container main body, applying an internal pressure to the inner upper portion of the container main body, and after the internal pressure applying process, an opening opening process of releasing the temporary closing of the upper opening, A method of manufacturing a medical container filled with medical liquid, comprising performing a discharge port mounting step of mounting a medical liquid discharge port on the upper opening. After the step of filling the medical liquid, the container main body is pressed to adjust the amount of air in the container main body, and the opening temporary closing step maintains the pressure on the container main body. The method for producing a medical container filled with medical liquid according to claim 1, wherein the method is performed in a state of being performed. The method for manufacturing a medical container filled with medical liquid according to claim 1 or 2, wherein the pressing of the container body is performed by pressing the body part of the container body. The manufacturing of a medical container filled with medical liquid according to claim 3, wherein the pressing of the main body is performed such that the upper end of the main body pressing is a predetermined length lower than the upper end of the main body. Method. The method for producing a medical container filled with medical liquid according to any one of claims 1 to 4, wherein the lower end closing part and the neck part are formed to be hard or semi-hard. The method for manufacturing a medical container filled with medical liquid according to any one of claims 1 to 5, wherein the container body is formed by stretch blow molding a parison. 7. The medical liquid-filled medical device according to claim 1, wherein the opening opening step for releasing the temporary closing of the upper opening portion is performed in a state in which the pressure in the internal pressure application step is maintained. Container manufacturing method. A medical container filled with medical liquid manufactured by the method for manufacturing a medical container filled with medical liquid according to claim 1, wherein the medical container contains the medical liquid and gas. In addition, it is possible to inject a mixed injection medicine, and the main body portion of the container body is formed thin, and the lower end closing portion, the neck portion, the main body portion and the neck portion A medical liquid-filled medical device characterized in that the shoulder portion between them is formed thicker than the main body portion, and the shoulder portion does not have substantial dents and wrinkles. Container.

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