Decontamination system

The decontamination system addresses inefficiencies in existing methods by using ultrasonic waves to vaporize hydrogen peroxide gas through a gas-permeable seal member, reducing residual hydrogen peroxide and shortening processing times for pre-filled syringes in storage containers.

JP2025014574AActive Publication Date: 2025-01-30AIREX
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Patent Information

Application Number
JP2023117251
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-07-19
Publication Date
2025-01-30
Estimated Expiration
2043-07-19

AI Technical Summary

Technical Problem

Existing decontamination methods for pre-filled syringes stored in storage containers are inefficient, requiring large facilities, lengthy processing times, and risk introducing bubbles into pharmaceutical solutions due to negative pressure operations, while leaving residual hydrogen peroxide that reduces productivity.

Method used

A decontamination system using a small amount of hydrogen peroxide applied to a gas-permeable seal member, combined with ultrasonic waves, to vaporize and supply hydrogen peroxide gas inside the container, reducing residual hydrogen peroxide and shortening decontamination and aeration times.

Benefits of technology

The system effectively reduces residual hydrogen peroxide, shortens decontamination and aeration times, and allows for large-scale decontamination using small facilities by applying ultrasonic waves to vaporize hydrogen peroxide gas through a gas-permeable seal member.

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Abstract

To provide a decontamination system capable of reducing in a required range, a use amount of hydrogen peroxide water, therefore reducing the amount of the hydrogen peroxide water left in a storage vessel, and significantly reducing a period for decontamination and aeration, and continuously decontaminating a large amount of storage vessels by a small scale facility.SOLUTION: There is provided a continuous supply device used in a decontamination agent supply step. The continuous supply device has in a transport path of transport means: discharge means; heating means; and ultrasonic radiation means. Hydrogen peroxide water discharged to a surface of a seal member of a storage vessel by the discharge means, is heated by heating means and its temperature is raised, and by ultrasonic radiated from the ultrasonic radiation means, the hydrogen peroxide is vaporized, and the vaporized hydrogen peroxide gas receives an acoustic flow of ultrasonic and is supplied to inside of the storage vessel from the surface of the seal member.SELECTED DRAWING: Figure 5
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Description

[Technical field]

[0001] The present invention relates to a decontamination system that decontaminates the outer surface of an item stored inside a storage container while the item remains stored inside the container. [Background technology]

[0002] For convenience in the medical field, prefilled syringes are manufactured by filling them with medicines in advance. In this case, the work of filling the syringes with medicines is carried out in a filling workroom under a sterile environment. However, when the prefilled syringes are stored in a storage container, they are usually stored in a clean environment such as a clean room, but this is not performed at a level that can guarantee strict sterilization of the inside of the storage container.

[0003] Therefore, a container is used for storing the prefilled syringe, which includes a plastic container body molded to fit the shape of the prefilled syringe and a sealing member that is gas-permeable.This sealing member is generally made of Tyvek (trademark), a nonwoven fabric made of high-density polyethylene ultrafine fibers, and gas can pass through the fine holes in Tyvek (trademark) into the plastic container, but the intrusion of microorganisms is prevented.In this case, the prefilled syringe is stored in the storage container, and while it is stored, the outer surface of the prefilled syringe and the inside of the storage container are decontaminated with a decontamination agent such as hydrogen peroxide gas.

[0004] However, after supplying hydrogen peroxide gas through a gas-permeable seal member to the inside of a storage container to decontaminate it, it is necessary to leave it for a considerable long time to completely remove the hydrogen peroxide remaining inside. This leads to a problem that the efficiency of the decontamination operation is poor and the productivity of the prefilled syringe stored in the storage container is reduced. Therefore, in the following Patent Document 1, a sterilization method is proposed that can reliably remove the hydrogen peroxide gas remaining after decontamination with hydrogen peroxide gas in a state where the prefilled syringe is stored inside the storage container. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Publication No. 11-193010 Summary of the Invention [Problem to be solved by the invention]

[0006] Incidentally, the method of Patent Document 1 repeats the operation of permeating hydrogen peroxide gas into the inside of the storage container under negative pressure several times. In addition, after sterilization with hydrogen peroxide gas, the hydrogen peroxide gas is degassed from the inside of the storage container while heating. However, this method has a problem of requiring a large-scale negative pressure chamber. In addition, decontamination using a negative pressure chamber requires repeated negative pressure operation and pressure recovery operation, and there is a problem that the decontamination process takes time. In addition, there is a risk that air bubbles will be mixed into the inside of the drug solution filled in the prefilled syringe due to the negative pressure operation. Furthermore, since the storage containers are decontaminated in a stacked state, there is a problem that the shape of the container needs to be devised and the storage containers that can be used are limited.

[0007] Therefore, the present invention aims to provide a decontamination system that addresses the above-mentioned problems, reduces the amount of hydrogen peroxide used to the necessary extent, thereby reducing the amount of hydrogen peroxide remaining inside a storage container and significantly shortening the decontamination and aeration time, and is capable of continuously decontaminating a large number of storage containers using small equipment. [Means for solving the problem]

[0008] In order to solve the above problems, the inventors conducted extensive research and discovered that by evenly applying a small amount of hydrogen peroxide solution to the surface of a gas-permeable sealing member of a storage container and then irradiating it with ultrasound, hydrogen peroxide gas can be supplied to the inside of the storage container through the sealing member, which led to the completion of the present invention.

[0009] That is, the decontamination system according to the present invention comprises, according to claim 1: A decontamination system for decontaminating an outer surface of a prefilled syringe (S) stored inside a storage container (P) including a container body (P1) and a gas-permeable sealing member (P2) that seals an open portion of the container body, the decontamination system comprising: The method includes a decontamination agent supplying step of supplying a decontamination agent into the storage container using a continuous supply device (100), a decontamination step of maintaining the storage container to which the decontamination agent has been supplied for a predetermined period of time to decontaminate the outer surface of the prefilled syringe, and an aeration step of removing the remaining decontamination agent from the inside of the storage container after decontamination and replacing it with clean air, The continuous supply device includes a conveying means (10) for conveying the storage container from an inlet (111) to an outlet (131), a discharging means (20) for discharging a predetermined amount of hydrogen peroxide solution onto a surface of the sealing member that seals the storage container in a conveying path of the conveying means, and an ultrasonic emitting means (40) for emitting ultrasonic waves toward the surface of the sealing member onto which the hydrogen peroxide solution has been discharged; The hydrogen peroxide solution discharged onto the surface of the sealing member by the discharge means is characterized in that the hydrogen peroxide is vaporized by the ultrasonic waves emitted from the ultrasonic emission means, and the vaporized hydrogen peroxide gas is supplied from the surface of the sealing member to the inside of the storage container by receiving an acoustic flow of the ultrasonic waves.

[0010] According to claim 2, the present invention provides a decontamination system according to claim 1, the continuous supply device (100) has a heating means (30) which is located in a conveying path of the conveying means at a position upstream and / or downstream of the ultrasonic emitting means and which heats the hydrogen peroxide solution discharged onto the surface of the sealing member, The hydrogen peroxide solution discharged onto the surface of the sealing member by the discharge means is heated by the heating means, and the hydrogen peroxide is vaporized by the ultrasound emitted from the ultrasound emission means, and the vaporized hydrogen peroxide gas is supplied from the surface of the sealing member to the inside of the storage container by receiving an acoustic flow of the ultrasound.

[0011] According to claim 3, the present invention provides a decontamination system according to claim 1 or 2, The ultrasonic wave emitting means (40) is an ultrasonic vibration plate having a base (41) and a plurality of wave transmitters (42), The plurality of wave transmitters are arranged on the plane of the base so that the wave transmitting directions of the plurality of wave transmitters are uniformly directed toward the surface of the seal member, and the wave transmitters are operated in the same phase, The ultrasonic waves in the front direction of the multiple transducers are reinforced by each other, and the ultrasonic waves in the lateral direction of the multiple transducers are cancelled out by each other, thereby generating an acoustic stream of ultrasonic waves with strong vertical direction direction from the surface of the ultrasonic vibration plate toward the surface of the sealing member.

[0012] According to claim 4, the present invention provides a decontamination system according to claim 1 or 2, The discharge means (20) discharges hydrogen peroxide solution by a dispenser method or an inkjet method, and is characterized in that a small amount of hydrogen peroxide solution is uniformly applied to the surface of the sealing member in the form of minute droplets.

[0013] According to claim 5, the present invention provides a decontamination system according to claim 4, the amount of hydrogen peroxide solution discharged onto the surface of the sealing member by the discharge means (20) is controlled so as to vary depending on the surface portion of the sealing member; The present invention is characterized in that the amount of vaporized hydrogen peroxide gas supplied from the surface of the sealing member to the inside of the storage container is changed in accordance with the location of the prefilled syringe stored inside the storage container. Effect of the Invention

[0014] According to the above configuration, the decontamination system of the present invention has a decontamination agent supplying process, a decontamination process, and an aeration process. Among these, the decontamination system is characterized by the continuous supplying device used in the decontamination agent supplying process. This continuous supplying device is equipped with a conveying means, a discharging means, and an ultrasonic emitting means. The conveying means conveys a storage container from an entrance to an exit. The discharging means discharges a predetermined amount of hydrogen peroxide solution onto the surface of a sealing member that seals the storage container, along the conveying path of the conveying means. The ultrasonic emitting means radiates ultrasonic waves toward the surface of the sealing member, toward the heated hydrogen peroxide solution, along the conveying path of the conveying means.

[0015] Here, the hydrogen peroxide solution discharged onto the surface of the sealing member by the discharge means is vaporized by the ultrasonic waves emitted from the ultrasonic emission means. The vaporized hydrogen peroxide gas is supplied into the storage container from the surface of the sealing member by receiving the acoustic flow of the ultrasonic waves. Thus, according to the above configuration, the amount of hydrogen peroxide solution used can be reduced to a necessary extent, so that the amount of hydrogen peroxide remaining inside the storage container is reduced, and the time for decontamination and aeration can be significantly shortened, thereby providing a decontamination system that can continuously decontaminate a large number of storage containers using small equipment.

[0016] Furthermore, according to the above configuration, the continuous supply device has a heating means. The heating means is located in a position upstream and / or downstream of the ultrasonic wave emitting means on the transport path of the transport means, and heats the hydrogen peroxide solution discharged onto the surface of the sealing member. As a result, the hydrogen peroxide solution discharged onto the surface of the sealing member by the discharging means is heated, and the hydrogen peroxide is vaporized by the ultrasonic waves radiated from the ultrasonic wave emitting means, and the vaporized hydrogen peroxide gas is supplied from the surface of the sealing member into the storage container by receiving the acoustic flow of the ultrasonic waves. This makes it possible to more specifically and effectively exert the above-mentioned effects.

[0017] According to the above configuration, the ultrasonic emitting means is an ultrasonic vibration plate having a base and a plurality of transmitters. The ultrasonic vibration plate is arranged on the plane of the base with the transmission directions of the plurality of transmitters aligned toward the surface of the sealing member. By operating these transmitters in phase, the ultrasonic waves in the front direction of the plurality of transmitters are reinforced with each other, and the ultrasonic waves in the lateral direction of the plurality of transmitters are cancelled with each other. In this way, an acoustic stream is generated by ultrasonic waves with strong vertical directionality from the plate surface of the ultrasonic vibration plate toward the surface of the sealing member. This makes it possible to exert the above-mentioned effects more specifically and effectively.

[0018] Furthermore, according to the above-mentioned configuration, the discharge means discharges hydrogen peroxide solution using a dispenser method or an inkjet method, and applies a small amount of hydrogen peroxide solution evenly to the surface of the sealing member as minute droplets, thereby making it possible to more specifically and effectively exert the above-mentioned effects.

[0019] In addition, according to the above configuration, the amount of hydrogen peroxide solution discharged by the discharge means onto the surface of the seal member is controlled to change depending on the surface portion of the seal member. Therefore, the amount of vaporized hydrogen peroxide gas supplied from the surface of the seal member to the inside of the container can be changed according to the portion of the prefilled syringe stored inside the container. This makes it possible to more specifically and effectively exert the above-mentioned effects. [Brief description of the drawings]

[0020] [Figure 1] 1 is a plan view showing a state before a container body of a storage container storing a prefilled syringe that is a target for decontamination by a decontamination system according to the present invention is sealed with a sealing member. FIG. [Diagram 2] 2 is a right side view showing a state in which a container body of the storage container storing the prefilled syringe of FIG. 1 is sealed with a sealing member. FIG. [Diagram 3] 2 is a front view showing a state in which a container body of a storage container storing the prefilled syringe of FIG. 1 is sealed with a sealing member. FIG. [Figure 4] FIG. 2 is a schematic perspective view showing the appearance of a continuous supply device used in the decontamination system according to the present invention. [Diagram 5] 5 is a side cross-sectional view showing the inside of the continuous supply device of FIG. 4. [Figure 6] FIG. 5 is a front view of a storage container in a decontamination system using the continuous supply device of FIG. 4, showing (A) before operation, (B) discharge operation, (C) heating operation, (D) ultrasonic operation, followed by (E) decontamination process, and (F) aeration process in the decontamination agent supply process. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] The decontamination system according to the present invention will be described in detail below with reference to the embodiments. Note that the present invention is not limited to the following embodiments. In the decontamination system according to the embodiments described below, hydrogen peroxide solution is used as a decontamination agent. First, an article to be decontaminated with hydrogen peroxide solution will be described. In this embodiment, the outer surface of a prefilled syringe stored in a storage container and the inside of the storage container are to be decontaminated.

[0022] FIG. 1 is a plan view showing a state before the container body of a storage container storing prefilled syringes, which are the decontamination targets of the decontamination system according to the present invention, is sealed with a sealing member. In FIG. 1, the storage container P includes a polyethylene container body P1 and a Tyvek (trademark) sealing member P2. A prefilled syringe S is stored inside the container body P1. In FIG. 1, a four-unit storage container P storing four prefilled syringes S is used, but this is not limited to this. In FIG. 1, the container body P1 and the sealing member P2 are in a state before being sealed.

[0023] Fig. 2 is a right side view showing a state in which the container body of the storage container storing the prefilled syringe of Fig. 1 is sealed with a seal member. Fig. 3 is a front view showing a state in which the container body of the storage container storing the prefilled syringe of Fig. 1 is sealed with a seal member. In the states of Fig. 2 and Fig. 3, the inside of the storage container P and the prefilled syringe S stored therein are in a state before decontamination.

[0024] The decontamination system according to this embodiment is composed of a decontamination agent supplying process, a decontamination process, and an aeration process. The decontamination system according to this embodiment is characterized by the decontamination agent supplying process. The following description will focus on the decontamination agent supplying process.

[0025] In this embodiment, 35 W / V% hydrogen peroxide solution is used as the decontamination agent, and hydrogen peroxide gas is generated for decontamination. Hydrogen peroxide gas has a strong sterilizing effect, is inexpensive and easy to obtain, and is effective as an environmentally friendly decontamination gas that eventually decomposes into oxygen and water.

[0026] Next, the continuous supply device used in the decontamination agent supplying step will be described. Fig. 4 is a schematic perspective view showing the appearance of the continuous supply device. Fig. 5 is a side cross-sectional view showing the inside of the continuous supply device. The continuous supply device 100 according to this embodiment gasifies and supplies hydrogen peroxide solution, which is a decontamination agent, to the inside of a storage container P in which a prefilled syringe S, which is an object to be decontaminated, is stored.

[0027] 4 and 5, the continuous supply device 100 is a box having walls made of stainless steel metal plates, and is placed on the floor. The interior of the continuous supply device 100 is partitioned by the walls into a front chamber 110, a decontamination agent supply chamber 120, and a rear chamber 130. Mechanical and electrical devices are housed inside a stand 140 of the continuous supply device 100.

[0028] The continuous supply device 100 is provided with a transport conveyor 10 that runs from the outside of the entrance 111 through the front chamber 110, the decontamination agent supply chamber 120, and the rear chamber 130 to the outside of the exit 131, and transports the storage container P. In this embodiment, a belt conveyor is used as the transport conveyor 10. In addition, on the transport path of the transport conveyor 10, a discharge device 20, a heater 30, and an ultrasonic vibration plate 40 are provided in the decontamination agent supply chamber 120. Note that, although the heater 30 is provided in this embodiment, the present invention is not limited thereto, and there are also cases where only the ultrasonic vibration plate 40 is used (described later).

[0029] The operation of each device for the storage container P transported by the transport conveyor 10 will be described below. In Fig. 5, the inside of the front chamber 110 and the rear chamber 130 are evacuated from the exhaust ports 112, 132 by an exhaust device (not shown) to a negative pressure. This is to prevent a portion of the hydrogen peroxide solution supplied in the decontamination agent supply chamber 120 from being released into the external environment. In this state, the transport conveyor 10 rotates at a constant speed toward the right in the figure.

[0030] Outside the carry-in entrance 111, the robot arm of the carry-in device R1 places the storage container P on the belt of the transport conveyor 10 with the sealing member P2 facing up. The storage container P on the transport conveyor 10 enters the decontamination agent supply chamber 120 from the carry-in entrance 111 through the antechamber 110. In the decontamination agent supply chamber 120, the storage container P is moved under the discharge device 20 by the transport conveyor 10, while hydrogen peroxide is discharged from the discharge device 20 toward the surface of the sealing member P2.

[0031] Here, the discharge device 20 will be described. In the present invention, the type of the discharge device 20 is not particularly limited. Therefore, various types of spray nozzles, two-fluid nozzles, etc. can be used. In particular, in order to uniformly apply a small amount of hydrogen peroxide onto the surface of the sealing member P2, it is preferable to discharge it using a dispenser method or an inkjet method.

[0032] In this case, the discharge method is not particularly limited, and may be any of the air pulse method, plunger method, screw pump method, piezo method, thermal method, bubble method, etc. Also, it may be a fixed type with multiple nozzles that match the width of the seal member P2, or a traveling type that traverses to match the width of the seal member P2. In this embodiment, an inkjet type discharge nozzle is used.

[0033] In this embodiment, the amount of hydrogen peroxide solution to be applied in advance is determined based on the internal volume of the storage container P that stores the prefilled syringe S and the surface area of ​​the sealing member P2 corresponding to the internal volume, for example, 0.05 mg / cm 2 ~2mg / cm 2 It is preferable to set the amount of hydrogen peroxide solution within the range of 100 to 200 μm. In this embodiment, by using an inkjet discharge nozzle, a preset amount of hydrogen peroxide solution can be uniformly applied to the surface of the sealing member P2. Although a larger amount of hydrogen peroxide solution may be applied, this will result in a problem that the subsequent aeration time will be longer, thereby extending the process time.

[0034] In this embodiment, the hydrogen peroxide solution is applied uniformly to the surface of the sealing member P2, but this is not limited to this, and the amount of hydrogen peroxide solution sprayed onto the surface of the sealing member P2 may be controlled to vary depending on the surface area of ​​the sealing member P2 (described later).

[0035] In this way, the storage container P, with hydrogen peroxide evenly applied to the surface of the sealing member P2, is moved under the heating heater 30 by the transport conveyor 10, and the hydrogen peroxide applied to the surface of the sealing member P2 is heated by the heating heater 30.

[0036] Here, the heater 30 will be described. The heater 30 is arranged in parallel to the surface of the seal member P2, and uniformly heats the hydrogen peroxide solution applied to the surface of the seal member P2 to raise the temperature. In the present invention, the type of the heater 30 is not particularly limited. In this embodiment, it is preferable to use a far-infrared heater or an infrared laser, etc., in order to heat uniformly in a short time. In addition, the temperature at which the hydrogen peroxide solution is raised is preferably set so that the surface temperature of the seal member P2 is within a range of, for example, 30°C to 50°C. In addition, the temperature may be increased, but there is a possibility that a problem of affecting the medicinal liquid filled in the prefilled syringe S may occur.

[0037] In this way, the storage container P, in which the hydrogen peroxide solution applied to the surface of the sealing member P2 has been uniformly heated, is moved under the ultrasonic vibration plate 40 by the transport conveyor 10, while ultrasonic waves are radiated to the hydrogen peroxide solution heated on the surface of the sealing member P2. As a result, the hydrogen peroxide solution applied to the surface of the sealing member P2 receives the acoustic flow of the ultrasonic waves and is supplied from the surface of the sealing member P2 into the inside of the storage container P while being gasified.

[0038] In this embodiment, a plurality of heaters 30 and a plurality of ultrasonic vibration plates 40 are alternately arranged behind the discharge device 20 in the decontamination agent supply chamber 120. As a result, the hydrogen peroxide solution applied to the surface of the seal member P2 is repeatedly heated and irradiated with ultrasonic waves, and the applied hydrogen peroxide solution is completely vaporized and receives an acoustic flow of ultrasonic waves, and is supplied from the surface of the seal member P2 to the inside of the storage container P. In this embodiment, a plurality of heaters 30 and a plurality of ultrasonic vibration plates 40 are alternately arranged, but the present invention is not limited to this (described later).

[0039] In this way, the hydrogen peroxide solution applied to the surface of the sealing member P2 becomes hydrogen peroxide gas, which is supplied to the inside of the storage container P by receiving the acoustic flow of the ultrasonic waves. In this state, the storage container P passes through the rear chamber 130 by the transfer conveyor 10 and reaches the outside of the carry-out port 131. Outside the carry-out port 131, the robot arm of the carry-in device R2 carries the storage container P out of the transfer conveyor 10.

[0040] Here, we will explain the effects of the discharge device 20, heater 30, and ultrasonic vibration plate 40 of the continuous supply device 100. Figure 6 is a front view of a storage container of a decontamination system using a continuous supply device, showing (A) before operation, (B) discharge operation, (C) heating operation, (D) ultrasonic operation, and the subsequent (E) decontamination process and (F) aeration process in the decontamination agent supply process.

[0041] <Decontamination agent supply process> First, Fig. 6(A) shows the state before operation in which the storage container P is carried into the decontamination agent supply chamber 120. In this state, hydrogen peroxide solution has not been applied to the surface of the sealing member P2. Next, Fig. 6(B) shows the state during the discharge operation in which hydrogen peroxide solution is discharged from the discharge device 20 onto the surface of the sealing member P2. As described above, by using an inkjet type discharge nozzle, a preset amount of hydrogen peroxide solution can be uniformly applied to the surface of the sealing member P2.

[0042] Next, Fig. 6(C) shows a state of a heating operation in which the hydrogen peroxide solution applied to the surface of the sealing member P2 is heated and discharged by the heater 30. As described above, by using a far-infrared heater or the like, the surface temperature of the sealing member P2 can be raised to within a range of 30°C to 50°C. Next, Fig. 6(D) shows a state of an ultrasonic operation in which ultrasonic waves are radiated from the ultrasonic vibration plate 40 toward the surface of the sealing member P2.

[0043] Here, the ultrasonic vibration plate 40 will be described. The ultrasonic vibration plate 40 is arranged parallel to the surface of the sealing member P2, and irradiates ultrasonic waves to the heated hydrogen peroxide solution that has been applied to the surface of the sealing member P2. In this embodiment, the ultrasonic vibration plate 40 has a plurality of wave transmitters (ultrasonic speakers) 42 provided on the flat surface of a base (speaker base) 41. Moreover, the wave transmitting directions of the plurality of wave transmitters (ultrasonic speakers) 42 are unified and arranged facing the surface of the sealing member P2.

[0044] In this state, the multiple wave transmitters (ultrasonic speakers) 42 are operated in the same phase. This causes ultrasonic waves in the front direction of the multiple wave transmitters (ultrasonic speakers) 42 to reinforce each other, and ultrasonic waves in the lateral direction of the multiple wave transmitters (ultrasonic speakers) 42 to cancel each other out. As a result, an acoustic stream can be generated by ultrasonic waves with strong vertical directionality from the plate surface of the ultrasonic vibration plate 40 toward the surface of the sealing member P2.

[0045] In this way, when the surface of the sealing member P2 is irradiated with acoustic streaming due to highly directional ultrasonic waves from the ultrasonic vibration plate 40, the heated hydrogen peroxide solution applied to the surface of the sealing member P2 is vaporized by the energy of the ultrasonic waves and becomes hydrogen peroxide gas. Furthermore, the vaporized hydrogen peroxide gas is supplied into the storage container P from the surface of the sealing member P2 by receiving the acoustic streaming of the ultrasonic waves.

[0046] <Decontamination process> 6(E) shows the state of the decontamination process. After the discharge operation, heating and ultrasonic operations are repeated inside the decontamination agent supply chamber 120, and a preset amount of hydrogen peroxide gas is supplied into the inside of the storage container P. Note that decontamination of the inside of the storage container P starts halfway through the decontamination agent supply process, but the decontamination process is completed by storing the storage container P carried out from the transport conveyor 10 for a predetermined period of time.

[0047] <Aeration process> Next, Fig. 6(F) shows the state of the aeration process. In this embodiment, since a small but appropriate amount of hydrogen peroxide solution is supplied, it is considered that almost no hydrogen peroxide remains inside the storage container P after the decontamination process is completed. However, by replacing the inside of the chamber containing the storage container P after the decontamination process with clean air, a more perfect aeration process can be completed. In addition, it is also possible to shorten the time for the aeration process by heating the inside of the chamber during aeration.

[0048] As described above, according to the above embodiment, the amount of hydrogen peroxide used can be reduced to the minimum amount necessary for decontamination, thereby reducing the amount of hydrogen peroxide remaining inside the storage container and significantly shortening the decontamination and aeration time, thereby providing a decontamination system that can continuously decontaminate a large number of storage containers using small equipment.

[0049] The present invention is not limited to the above-described embodiment, and various modifications may be made as follows. (1) In the above embodiment, the heater 30 is installed, but the present invention is not limited to this. In the present invention, the amount of hydrogen peroxide solution applied to the surface of the sealing member P2 is appropriate and small, so that the hydrogen peroxide solution can be vaporized by the action of the ultrasonic vibration plate 40 alone without increasing the temperature by the heater 30. (2) In the above embodiment, the heaters 30 and the ultrasonic vibration plates 40 are alternately arranged, but this is not limited to this. In this case, the heaters 30 may be arranged only in front of the ultrasonic vibration plate 40 or only in the rear of the ultrasonic vibration plate 40, without arranging multiple heaters 30 and multiple ultrasonic vibration plates 40. (3) In the above embodiment, the hydrogen peroxide solution is applied uniformly to the surface of the seal member P2, but the present invention is not limited to this. For example, the amount of hydrogen peroxide solution discharged onto the surface of the seal member P2 may be controlled to vary depending on the surface part of the seal member P2. It is considered that the amount of hydrogen peroxide gas required for decontamination differs depending on the structure of each part of the prefilled syringe S stored inside the storage container P. Therefore, it is preferable to control the amount of hydrogen peroxide solution required for decontamination to an appropriate and small amount depending on the structure of each part of the prefilled syringe S. [Explanation of symbols]

[0050] P: storage container, P1: container body, P2: sealing member, R1: loading device, R2: discharge device, S: prefilled syringe, 10: conveyor, 20: discharge device, 30: heater, 40: ultrasonic vibration plate, 41...board (speaker board), 42...transmitter (ultrasonic speaker), 100... continuous supply device, 110... front room, 120... decontamination agent supply room, 130... rear room, 111... loading entrance, 131... loading exit, 112, 132... exhaust port, 140... stand section.

Claims

1. A decontamination system for decontaminating an outer surface of a prefilled syringe stored in a storage container including a container body and a gas-permeable sealing member that seals an open portion of the container body, the prefilled syringe being stored in the storage container, The method includes a decontamination agent supplying step of supplying a decontamination agent into the storage container using a continuous supply device, a decontamination step of maintaining the storage container to which the decontamination agent has been supplied for a predetermined period of time to decontaminate the outer surface of the prefilled syringe, and an aeration step of removing the remaining decontamination agent from the inside of the storage container after decontamination and replacing it with clean air, the continuous supply device includes a conveying means for conveying the storage container from an inlet to an outlet, a discharging means for discharging a predetermined amount of hydrogen peroxide solution onto a surface of the sealing member that seals the storage container along a conveying path of the conveying means, and an ultrasonic emitting means for emitting ultrasonic waves toward the surface of the sealing member onto which the hydrogen peroxide solution has been discharged; A decontamination system characterized in that the hydrogen peroxide solution discharged onto the surface of the sealing member by the discharge means is vaporized by the ultrasound emitted from the ultrasonic emission means, and the vaporized hydrogen peroxide gas is supplied from the surface of the sealing member to the inside of the storage container by receiving an acoustic flow of the ultrasound.

2. the continuous supply device has a heating means, which is located in a conveying path of the conveying means at a position upstream and / or downstream of the ultrasonic emitting means and which heats the hydrogen peroxide solution discharged onto the surface of the sealing member; 2. The decontamination system according to claim 1, wherein the hydrogen peroxide solution discharged onto the surface of the sealing member by the discharge means is heated by the heating means, and the hydrogen peroxide is vaporized by the ultrasonic waves emitted from the ultrasonic emission means, and the vaporized hydrogen peroxide gas is supplied from the surface of the sealing member to the inside of the storage container by receiving an acoustic stream of the ultrasonic waves.

3. The ultrasonic wave emitting means is an ultrasonic vibration plate having a base and a plurality of wave transmitters, The plurality of wave transmitters are arranged on the plane of the base so that the wave transmitting directions of the plurality of wave transmitters are uniformly directed toward the surface of the seal member, and the wave transmitters are operated in the same phase, The decontamination system according to claim 1 or 2, characterized in that ultrasonic waves in the front direction of the multiple transducers are reinforced by each other and ultrasonic waves in the lateral direction of the multiple transducers are canceled out by each other, thereby generating an acoustic stream by ultrasonic waves with strong vertical direction direction from the plate surface of the ultrasonic vibration plate toward the surface of the sealing member.

4. 3. The decontamination system according to claim 1, wherein the discharging means discharges hydrogen peroxide solution using a dispenser method or an inkjet method, and applies a small amount of hydrogen peroxide solution uniformly to the surface of the sealing member as minute droplets.

5. a discharge amount of the hydrogen peroxide solution discharged onto the surface of the sealing member by the discharge means is controlled so as to vary depending on a surface portion of the sealing member; The decontamination system according to claim 4, characterized in that the amount of vaporized hydrogen peroxide gas supplied from the surface of the sealing member to the inside of the storage container is changed in accordance with the location of the prefilled syringe stored inside the storage container.

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