JPH08217196A - Sterilizing apparatus and method for vacuum capping machine - Google Patents

Abstract

PURPOSE: To facilitate sterilization in a vacuum chamber and pipes by connecting both of a feeding means for feeding a sterilizing fluid into the vacuum chamber and a discharging means for discharging the sterilizing fluid to the vacuum chamber in which a capping means is provided, and providing a passage for overflowing the sterilizing fluid in the vacuum chamber. CONSTITUTION: In the case where a vacuum capping machine for capping a syringe, which is filled with a liquid medicine and transferred into a vacuum chamber 2, under vacuum with aid of a capping means is sterilized, a lower casing 2a of the vacuum chamber 2 is first elevated and brought into close contact with an upper casing 2b thereof, thereby forming the sealed vacuum chamber 2. Under this condition, a hot water feed valve 42 is opened to feed hot water into the vacuum chamber 2 from a hot water feeding means 38 through a portion on the downstream side of a vacuum pipe 6. Also, simultaneously, the hot water is overflowed through an overflow pipe 46, and hot-water sterilization is performed by feeding hot water continuously. Thereafter, the hot water feed valve 42 is closed, and a drain valve 44 is opened, whereby the hot water in the vacuum chamber 2 is discharged to finish sterilizing work.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a vacuum stoppering machine for accommodating a large number of syringes filled with chemicals in a vacuum chamber and capping the openings thereof. The present invention relates to a sterilizing apparatus and a sterilizing method for sterilizing the inside of a pipe connecting a vacuum chamber and a vacuum pump.

[0002]

2. Description of the Related Art In recent years, disposable cartridge injectors have been used in medical institutions. Such a cartridge-type syringe is a syringe
After installing a sealing plug on the injection needle mounting port of this and filling the syringe with the drug solution, the mouth plug is inserted from the opening side to the liquid surface of the drug solution and sealed. It is strictly required that no bubbles remain.

Therefore, in order to prevent bubbles from remaining in the drug solution, a vacuum plugging machine has been already proposed in which the work of inserting the plug into the syringe is carried out in a vacuum chamber (Japanese Patent Publication No. 4). -28386). The vacuum plugging machine described in this publication is tightly plugged at the fitting end of the injection needle, and is supported in the rack body with the open ends of many syringe outer cylinders filled with drug solution inside and placed in a vacuum box. Then, after placing an inner stopper gripping plate that holds a large number of inner stoppers on the rack body, seal the inside of the vacuum box and evacuate the sealed vacuum box to remove the drug solution and the air in the syringe barrel. Is removed in advance, and then the push plate on which a large number of push pins corresponding to the respective inner plugs held by the inner plug holding plate is projected is lowered to insert the inner plug into the mouth of the injection cylinder. In the above, the inside of the vacuum box is returned to atmospheric pressure, and the inner stopper is pushed to the liquid surface of the chemical liquid due to the pressure difference between the vacuum inside the syringe and the atmospheric pressure. The bubbles remaining in the can be significantly reduced.

The above-mentioned vacuum stopper machine is provided with parts for loading and placing the injection cylinder inside the vacuum box, parts for performing stoppering, plates for supporting these parts, and the like. Since some of these parts come into direct contact with the syringe barrel, the rubber inner stopper, etc., it is necessary to sterilize them regularly at the end of production in one day.

[0005]

Conventionally, when sterilizing the inside of the vacuum stoppering machine and the pipes connected to the vacuum pump as described above, each part such as the plate is disassembled for thermal sterilization. I was going to assemble again after that.
However, since the inside plug gripping plate, the push plate and the like are large and heavy and cannot be divided, they require a great deal of labor and time to be attached and detached. In addition, since dismantling and assembling involve human intervention, there have been various problems such as the possibility of re-contamination during attachment after sterilization or during transfer.

The present invention has been made to eliminate the above problems, and a sterilizing apparatus and a sterilizer for a vacuum stoppering machine, which can sterilize the inside of a vacuum chamber and the inside of piping without disassembling the vacuum stoppering machine. It is intended to provide a method.

[0007]

A sterilizer for a vacuum stoppering machine according to the present invention comprises an openable / closable vacuum chamber, stoppering means provided inside the vacuum chamber, and a vacuum connected to the vacuum chamber. Provided in a vacuum capping machine equipped with a pump and an air valve for introducing air into the vacuum chamber, carrying a syringe filled with a chemical solution into the vacuum chamber, and capping in vacuum by the capping means. The vacuum chamber was connected to a supply means for supplying a sterilizing fluid into the vacuum chamber and a discharging means for discharging the sterilizing fluid from the vacuum chamber, and was supplied into the vacuum chamber. An overflow passage for overflowing the sterilizing fluid is provided.

Further, in the sterilizing method of the vacuum stoppering machine according to the second aspect of the invention, the syringe filled with the drug solution is housed in the vacuum chamber, and the stopper is provided in the vacuum chamber by the stoppering means. A method of sterilizing a vacuum stoppering machine that performs, while supplying a sterilizing fluid into the vacuum chamber,
Sterilize the inside of the vacuum chamber by overflowing from the overflow passage provided in the vacuum chamber,
After that, the sterilizing fluid is discharged from the vacuum chamber through the discharge means, then the overflow passage is sealed and the vacuum chamber is evacuated by a vacuum pump, and then air is introduced into the vacuum chamber. Thus, the vacuum stoppering machine is sterilized and dried.

[0009]

In the sterilization method using the sterilizer of the vacuum stoppering machine, a sterilizing fluid such as warm water, hydrogen peroxide gas or steam is supplied from the sterilizing fluid supply means into the vacuum chamber, and the sterilizing fluid is supplied. Sterilization in the vacuum chamber is performed by continuing the supply while overflowing from the overflow passage, and then the fluid in the vacuum chamber is discharged by the discharge means, then the overflow passage is sealed and the vacuum chamber is sucked by the vacuum pump. Then, the inside of the vacuum chamber is dried by causing air to flow by introducing air while continuing the evacuation. Therefore, without disassembling each plate of the stoppering means provided inside the vacuum chamber,
It is possible to sterilize the entire vacuum chamber including the internal parts and the inside of the piping.

[0010]

The present invention will be described below with reference to illustrated embodiments. 1 is a vertical sectional view showing an example of a vacuum tapping machine sterilized by a sterilizing apparatus and a sterilizing method according to an embodiment of the present invention, and FIG. 2 is a transverse sectional view thereof. The configuration of the stoppering machine will be briefly described. In this vacuum stoppering machine, the vacuum chamber can be opened and closed up and down, and FIG. 2 shows a state in which the left half opens the vacuum chamber and the right half closes the vacuum chamber. The vacuum chamber (generally indicated by reference numeral 2) of this vacuum stoppering machine is divided into two parts, an upper part and a lower part.
A is supported on a base 4 so as to be able to move up and down, and a vacuum pipe 6 connected to a vacuum pump, which will be described later, is connected and opened at the center of the bottom surface thereof. Further, the upper box body 2b of the vacuum chamber 2 is attached to the upper fixing plate 10 fixed to the base 4 via the support column 8 so that the upper and lower positions of the lower box body 2a are aligned with each other. Upper box 2b
A seal member 12 is mounted on the entire circumference of the lower end portion of the four wall surfaces of the above, and when the lower box body 2a is raised and the four wall surfaces are brought into close contact with the four wall surfaces of the upper box body 2b, these upper and lower walls are The vacuum chamber 2 including both boxes 2a and 2b has a sealed space formed therein.

A vacuum pump, which will be described later, is connected to the vacuum chamber 2 via the vacuum pipe 6, and
An atmosphere release valve is provided. The inside of the vacuum chamber 2 can be evacuated by a vacuum pump and can be opened to the atmosphere.

A support plate 16 on which a large number of syringes 14 are mounted is provided inside the lower box 2a.
It is arranged so that it can be moved up and down relatively. On the support plate 16, a sealing plug is attached to the attachment port of the injection needle,
A large number of syringes 14 each filled with a drug solution are carried in while being held in a carrier 18 in an inverted state. On the other hand, inside the upper box 2b, in order from the bottom, an inner stopper holding plate 20 that holds a large number of inner stoppers attached to the opening of each syringe 14, and when these inner stoppers are inserted into the opening of each syringe 14. The pin holding plate 22 having a large number of air bleeding pins interposed between the inner surface of the syringe 14 and the outer surface of the inner stopper and the inner stopper are attached to the syringe 1
A knocker support plate 24 that supports a knocker to be pushed into the opening of No. 4 is provided.

A large number of syringes 14 arranged in the lower box 2a and the plates 20, 22, 2 in the upper box 2b.
The inner stopper, the air bleeding pin, and the knocker supported by 4 are arranged with their upper and lower positions aligned,
After the lower box body 2a is raised and brought into close contact with the upper box body 2b to form the chamber 2 which is shielded from the outside, the inside of the chamber 2 is evacuated by a vacuum pump (not shown) to bring the inside of the chamber 2 into a vacuum state. Then, the knocker support plate 24 to which the knocker is attached is lowered to push the inner plug held by the lower inner plug holding plate 20 into the opening of the lower syringe 14. Next, the atmosphere opening valve is opened to open the inside of the vacuum chamber 2 to the atmosphere. Then, since the inside of the syringe 14 is in a vacuum state and the inside of the chamber 2 outside thereof is at atmospheric pressure, the inner plug is pushed to the height of the liquid surface inside the syringe 14 due to the pressure difference between the inside and the outside. After that, the lower box 2a is lowered, and the syringe 14 for which the stopper has been completed is carried out from the chamber 2.

Next, the structure of the sterilizing apparatus for sterilizing the vacuum stoppering machine will be described with reference to FIGS. 3 and 4.
FIG. 3 is a plan view showing the arrangement of the vacuum piping 6 in the vacuum chamber 2 of the vacuum stoppering machine and the piping for sterilization, and FIG.
[Fig. 3] is a perspective view showing the configuration in a simplified manner. At the center of the bottom surface of the lower box 2a of the vacuum chamber 2, the vacuum pipe 6 is connected and opened as described above. This vacuum piping 6
Is connected to a vacuum pump 32 via a first vacuum valve 26, a second vacuum valve 28, and a strainer 30, and the vacuum pump 32 can act to bring the inside of the vacuum chamber 2 into a vacuum state. Further, an atmosphere opening valve 36 is connected to the upper box 2b of the vacuum chamber 2 via a filter 34, so that the vacuum chamber 2 in a sealed state can be opened to the atmosphere. A vacuum chamber 2 in which a capping mechanism composed of the above plates 20, 22, 24, etc. is provided, a vacuum pump 32 connected through a vacuum pipe 6, and an atmosphere opening valve 36 to form a vacuum capping machine. It is configured.

Further, in the sterilizer according to this embodiment, the vacuum pipe 6 connecting the vacuum pump 32 is located downstream of both the vacuum valves 26 and 28, that is, the vacuum chamber 2.
The hot water supply means 38 for supplying hot water into the vacuum chamber 2 through the vacuum pipe 6 and the discharge means 40 for discharging the hot water supplied into the vacuum chamber 2 by the hot water supply means 38 are provided near the hot water supply valve 42 and the hot water supply valve 42, respectively. It is connected via a discharge valve 44. Also, the upper box 2b
An overflow pipe 46 that causes the hot water supplied into the vacuum chamber 2 to overflow is attached to the upper part of the.

The process of sterilizing with the sterilizer of the vacuum stoppering machine having the above structure will be described with reference to FIGS. 4 to 9. First, the lower box body 2a is lifted to bring the upper ends of the four wall surfaces into close contact with the lower ends of the four wall surfaces of the upper box body 2b to form a sealed vacuum chamber 2.
In this state, the hot water supply valve 42 is opened and hot water is supplied from the hot water supply means 38 into the vacuum chamber 2 through the downstream side portion of the vacuum pipe 6. In order to raise the temperature of each part in the chamber 2, hot water is continuously supplied while overflowing from the overflow pipe 46 (see FIG. 5). By this step, the vacuum chamber 2 and each plate 20, 22, 24 for capping the inside of the vacuum chamber 2, parts such as knockers and air vent pins, and most of the inside of the vacuum pipe 6 are sterilized with warm water. .

Next, the hot water supply valve 42 is closed and the drainage valve 44 is opened to discharge the hot water in the vacuum chamber 2 (see FIG. 6). The vacuum chamber 2 and the vacuum pipe 6 according to this embodiment have a structure with as little liquid pool as possible so that water can be easily discharged, and hot water can be almost completely discharged. Then, the blind plug 50 is attached to the overflow pipe 46, the first vacuum valve 26 is opened, and the vacuum in the vacuum chamber 2 is evacuated (see FIG. 7). When the inside of the chamber 2 is evacuated, the water vaporizes, and the temperature of the residual water portion decreases. In some cases, it may freeze.

With the first vacuum valve 26 left open, the atmosphere open valve 36 is opened. Then, the air flowing into the vacuum chamber 2 from the atmosphere release valve 36 is
Since it is sucked by the vacuum pump 32, an air flow is generated from the vacuum chamber 2 through the vacuum pipe 6, and the heat of the atmosphere is given to the member inside the chamber 2 that has been cooled during the evacuation to recover the temperature. (See Figure 8).

The process shown in FIG. 7 in which the first vacuum valve 26 is opened to evacuate the vacuum chamber 2 and the atmosphere opening valve 36 is opened with the first vacuum valve 26 open to introduce the atmosphere into the vacuum chamber 2. Then, the inside of the vacuum chamber 2 and the inside of the vacuum pipe 6 are completely dried by alternately repeating the process of FIG. The sterilization and cleaning of the inside of the vacuum chamber 2 and the inside of the vacuum pipe 6 are completed through the above steps (see FIG. 9). As described above, according to the sterilization method using the apparatus according to the present embodiment, each stopper plate 20, 22, 24 provided inside the vacuum chamber 2 is provided.
Sterilization and cleaning can be performed without detaching other members. Therefore, since no human intervention is required, recontamination after sterilization can be prevented by moving, attaching, or the like. In addition, it is possible to prevent damage to the pins and the like that tend to occur when attaching and detaching. Furthermore, the plates 20, 22, inside the vacuum chamber 2 can be
It is possible to sterilize not only the parts such as 24, but also the transport part on the lower box 2a side, the rod part that supports the support plate 16 so as to be able to move up and down, and the inside of the vacuum pipe 6 at the same time, so it is extremely efficient. Is.

In the above embodiment, the vacuum chamber 2
Although the case of performing sterilization by supplying hot water into the inside has been described, the present invention is not limited to hot water sterilization.
It can also be applied to gas sterilization in which hydrogen peroxide gas, steam, etc. are supplied for sterilization. Further, in the above-described embodiment, in the process shown in FIG. 8, the atmosphere opening valve 36 is opened and the atmosphere is introduced into the vacuum chamber 2 to perform drying, but hot air is not used instead of opening to the atmosphere. By supplying it into the chamber, it is possible to shorten the drying time. Further, the vacuum stoppering machine sterilized by the sterilizing apparatus according to the above configuration is not limited to the one shown in FIGS. 1 and 2, and a mechanism for stoppering is provided in the vacuum chamber 2. Needless to say, the sterilizing apparatus and the sterilizing method according to the present invention can be applied as long as the inside of the vacuum chamber 2 is in a vacuum state and the stopper is inserted into the syringe 14. Further, in the above embodiment, since the hot water supply means 38 and the drainage means 40 are connected in the middle of the vacuum pipe 6, it is possible to sterilize the inside of the pipe downstream of the connecting portion, but it is directly connected to the vacuum chamber 2. You may make it sterilize only the inside. Also,
In the above configuration, the blind plug 50 is attached to close the overflow pipe 46 provided in the vacuum chamber 2, but a valve may be attached to the overflow pipe 46 to open and close the valve.

[0021]

As described above, according to the present invention, the supply means for supplying the sterilizing fluid into the vacuum chamber having the capping means therein, and the sterilizing fluid from the vacuum chamber. A discharge passage for discharging the fluid is connected, and an overflow passage for overflowing the sterilization fluid supplied into the vacuum chamber is provided.
While supplying the sterilizing fluid into the vacuum chamber to overflow, then discharge the fluid in the vacuum chamber,
Next, the step of evacuating the vacuum chamber and the step of introducing air are repeated to sterilize the inside of the vacuum chamber. Therefore, each part of the stoppering means provided in the vacuum chamber, etc. The inside can be sterilized by a simple operation without disassembling. Further, it is possible to prevent recontamination during assembly or movement after sterilization.

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view of a vacuum stoppering machine sterilized by a sterilizing apparatus according to an embodiment of the present invention.

FIG. 2 is a transverse cross-sectional view of a main part of the vacuum stoppering machine.

FIG. 3 is a plan view showing piping of a sterilizer for a vacuum stoppering machine according to an embodiment of the present invention.

FIG. 4 is a perspective view showing the sterilization device in a simplified manner.

FIG. 5 is a diagram showing a first step of sterilization steps using the sterilization apparatus.

FIG. 6 is a diagram showing a step subsequent to the step of FIG.

FIG. 7 is a diagram showing a step that follows the step of FIG. 6.

FIG. 8 is a diagram showing a step that follows the step of FIG. 7.

FIG. 9 is a diagram showing a final step of sterilization steps using the sterilization apparatus.

[Explanation of symbols]

 2 Vacuum Chamber 14 Syringe 20 Inner Stopper Holding Plate (Stopping Means) 22 Pin Holding Plate (Stopping Means) 24 Knocker Support Plate (Stopping Means) 32 Vacuum Pump 36 Air Valve (Air Opening Valve) 38 Supply of Sterilizing Fluid Means (Hot Water Supply Means) 40 Sterilizing Fluid Discharging Means 46 Overflow Passage (Overflow Pipe)

Front page continuation (72) Inventor Hideki Montani 58 Kou, Soybean Tahoncho, Kanazawa, Ishikawa Prefecture Shibuya Industry Co., Ltd.

Claims (2)

[Claims] 1. A chemical solution comprising an openable / closable vacuum chamber, a capping means provided in the vacuum chamber, a vacuum pump connected to the vacuum chamber, and an air valve for introducing air into the vacuum chamber. In a vacuum stoppering machine that carries a syringe filled with the above into the vacuum chamber and performs stoppering in a vacuum by the stoppering means, a supplying means for supplying a sterilizing fluid into the vacuum chamber. And a discharge means for discharging the sterilizing fluid from the vacuum chamber, and an overflow passage for overflowing the sterilizing fluid supplied into the vacuum chamber is provided. . 2. A method for sterilizing a vacuum stoppering machine, in which a syringe filled with a chemical solution is housed in a vacuum chamber and stoppering is performed in vacuum by a stoppering means provided in the vacuum chamber. While sterilizing fluid is being supplied to the sterilizing fluid, the inside of the vacuum chamber is sterilized by overflowing from the overflow passage provided in the vacuum chamber, and then the sterilizing fluid is discharged from the vacuum chamber through the discharging means. The overflow stopper is sealed to make the inside of the vacuum chamber into a vacuum state by a vacuum pump, and then air is introduced into the vacuum chamber to sterilize and dry the vacuum stopper machine. Sterilization method.