Decontamination system

Abstract

Provided is a decontamination system that is capable of reducing the quantity of use of hydrogen peroxide water within a necessary range, thus enabling reduction of the quantity of hydrogen peroxide remaining inside a storage container and significant shortening of decontamination and aeration times, which further enables continuous decontamination, in a small facility, of a large quantity of storage containers. The present invention is characterized by a continuous supply device that is used in a decontaminant supply step. This continuous supply device is provided with a discharge means, a heating means, and an ultrasonic radiation means on a conveyance path of a conveyance means. Hydrogen peroxide water discharged onto a surface of a seal member of a storage container by the discharge means is raised in temperature by the heating means, hydrogen peroxide is gasified by ultrasonic waves radiated from the ultrasonic radiation means, and hydrogen peroxide gas produced by the gasification is supplied from the surface of the seal member to the interior of the storage container by being subjected to acoustic streaming of the ultrasonic waves.

Description

Decontamination System

[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 storage container.

[0002] For convenience in medical settings, prefilled syringes are manufactured, which are filled 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, this is usually done in a clean environment such as a clean room, but this is not done at a level that can guarantee strict sterilization of the inside of the storage container.

[0003] Therefore, the storage of prefilled syringes is made of a plastic container body that is molded according to the shape of the prefilled syringe and a gas-permeable sealing member.This sealing member is generally made of Tyvek (trademark), a nonwoven fabric made of high-density polyethylene ultrafine fibers, and the micropores of Tyvek (trademark) allow gas to pass through the plastic container, but prevent microorganisms from entering.In this case, the prefilled syringe is stored in the storage container, and the outer surface of the prefilled syringe and the inside of the storage container are decontaminated with a decontaminant such as hydrogen peroxide gas while being stored.

[0004] However, after decontamination by supplying hydrogen peroxide gas to the inside of a storage container through a gas-permeable sealing member, it is necessary to leave the container for a considerable long time to completely remove the hydrogen peroxide remaining inside. This results in poor efficiency of the decontamination operation and reduces the productivity of prefilled syringes stored in the storage container. Therefore, Patent Document 1 below proposes a sterilization method that can reliably remove the hydrogen peroxide gas remaining after decontamination with hydrogen peroxide gas when a prefilled syringe is stored inside a storage container.

[0005] Japanese Patent Application Publication No. 11-193010

[0006] The method of Patent Document 1 involves repeatedly infiltrating hydrogen peroxide gas into the interior of a storage container under negative pressure. After sterilization with hydrogen peroxide gas, the hydrogen peroxide gas is degassed from the interior of the storage container while heating. However, this method requires a large-scale negative pressure chamber. Decontamination using a negative pressure chamber requires repeated negative pressure and pressure recovery operations, resulting in a time-consuming decontamination process. Furthermore, negative pressure operations pose a risk of air bubbles being introduced into the medicinal solution filled in the prefilled syringe. Furthermore, since decontamination is performed while the storage containers are stacked, the shape of the containers must be carefully designed, limiting the types of storage containers that can be used.

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

[0008] In order to solve the above problems, the inventors conducted extensive research and discovered that by uniformly applying a small amount of hydrogen peroxide water 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 into the interior of the storage container through the sealing member, leading to the completion of the present invention.

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

[0010] Furthermore, according to claim 2, the present invention is a decontamination system as defined in claim 1, wherein the continuous supply device (100) has a heating means (30) located in a position upstream and / or downstream of the ultrasonic radiation means on the transport path of the transport means, which heats the hydrogen peroxide solution sprayed onto the surface of the sealing member, and the hydrogen peroxide solution sprayed onto the surface of the sealing member by the spraying means is heated by the heating means, and the hydrogen peroxide solution sprayed onto the surface of the sealing member by the ultrasonic radiation means is vaporized by the ultrasonic waves emitted from the ultrasonic radiation means, and the vaporized hydrogen peroxide gas is supplied from the surface of the sealing member into the interior of the storage container by receiving acoustic streaming of the ultrasonic waves.

[0011] Furthermore, according to claim 3, the present invention provides a decontamination system as defined in claim 1 or 2, characterized in that the ultrasonic emission means (40) is an ultrasonic vibration plate having a base (41) and a plurality of wave transmitters (42), and the wave transmitting directions of the plurality of wave transmitters are unified and arranged on the plane of the base toward the surface of the sealing member, and these wave transmitters are operated in the same phase, so that ultrasonic waves in the front direction of the plurality of wave transmitters reinforce each other and ultrasonic waves in the lateral direction of the plurality of wave transmitters cancel each other out, thereby generating an acoustic stream of ultrasonic waves with strong vertical directionality from the plate surface of the ultrasonic vibration plate toward the surface of the sealing member.

[0012] Furthermore, according to claim 4 of the present invention, there is provided a decontamination system according to claim 1 or 2, characterized in that the discharge means (20) 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.

[0013] Furthermore, according to claim 5 of the present invention, there is provided a decontamination system as defined in claim 1 or 2, characterized in that the amount of hydrogen peroxide solution discharged onto the surface of the sealing member by the discharge means (20) is controlled to change depending on the surface portion of the sealing member, and the amount of vaporized hydrogen peroxide gas supplied from the surface of the sealing member to the inside of the storage container is changed according to the portion of the prefilled syringe stored inside the storage container.

[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 continuous supplying device used in the decontamination agent supplying process is characterized. 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 inlet to an outlet. The discharging means, along the conveying path of the conveying means, discharges a predetermined amount of hydrogen peroxide solution onto the surface of a sealing member that seals the storage container. The ultrasonic emitting means, along the conveying path of the conveying means, radiates ultrasonic waves toward the heated hydrogen peroxide solution and the surface of the sealing member.

[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 then supplied from the surface of the sealing member into the storage container by receiving the acoustic streaming of the ultrasonic waves. Thus, with the above configuration, the amount of hydrogen peroxide solution used can be reduced to the necessary extent, reducing the amount of hydrogen peroxide remaining inside the storage container and significantly shortening the decontamination and aeration times. This makes it possible to provide 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 includes a heating means. The heating means is located upstream and / or downstream of the ultrasonic wave emitting means on the transport path of the transport means and heats the hydrogen peroxide solution dispensed onto the surface of the sealing member. Therefore, the temperature of the hydrogen peroxide solution dispensed onto the surface of the sealing member by the dispensing means increases, and the hydrogen peroxide is vaporized by the ultrasonic waves radiated from the ultrasonic wave emitting means. The vaporized hydrogen peroxide gas is then supplied from the surface of the sealing member into the container by receiving acoustic streaming of the ultrasonic waves. This allows the above-mentioned effects to be exerted more specifically and effectively.

[0017] Furthermore, according to the above configuration, the ultrasonic wave emitting means is an ultrasonic vibration plate having a base and multiple transmitters. This ultrasonic vibration plate is arranged on the plane of the base with the multiple transmitters' transmission directions aligned toward the surface of the sealing member. Furthermore, by operating these transmitters in phase, ultrasonic waves in the front direction of the multiple transmitters are reinforced by each other, and ultrasonic waves in the lateral direction of the multiple transmitters are canceled by each other. In this way, acoustic streaming is generated by ultrasonic waves with strong vertical directional direction from the plate surface of the ultrasonic vibration plate toward the surface of the sealing member. This makes it possible to more specifically and effectively achieve the above-mentioned effects.

[0018] Furthermore, with the above-described configuration, the discharging means uses a dispenser or inkjet system to discharge hydrogen peroxide solution, and applies a small amount of hydrogen peroxide solution evenly to the surface of the sealing member in the form of minute droplets, thereby achieving the above-described effects more specifically and effectively.

[0019] Furthermore, with the above configuration, the amount of hydrogen peroxide solution dispensed onto the surface of the seal member by the dispensing means is controlled to vary depending on the surface area of ​​the seal member. Thus, the amount of vaporized hydrogen peroxide gas supplied from the surface of the seal member to the interior of the container can be varied depending on the location of the prefilled syringe housed inside the container. This allows the above-mentioned effects to be exerted more specifically and effectively.

[0020] 4 is a plan view showing a state before the container body of a storage container storing a prefilled syringe to be decontaminated in a decontamination system according to the present invention is sealed with a sealing member. FIG. 5 is a right side view showing a state in which the container body of a storage container storing the prefilled syringe of FIG. 1 is sealed with a sealing member. FIG. 6 is a front view showing a state in which the container body of a storage container storing the prefilled syringe of FIG. 1 is sealed with a sealing member. FIG. 7 is a schematic perspective view showing the appearance of a continuous supply device used in a decontamination system according to the present invention. FIG. 8 is a cross-sectional view from the side showing the interior of the continuous supply device of FIG. 4. FIG. 9 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 of a decontamination agent supply process, and the subsequent (E) decontamination process and (F) aeration process.

[0021] The decontamination system according to the present invention will be described in detail below through 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 interior 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 containing prefilled syringes to be decontaminated by 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. Note that Fig. 1 shows a four-unit storage container P containing four prefilled syringes S, but this is not limited to this. Also, 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 comprised 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 wt. / vol.% 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 easily available, and is effective as an environmentally friendly decontamination gas that ultimately decomposes into oxygen and water.

[0026] Next, the continuous supply device used in the decontamination agent supply process 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 interior 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 that stores a prefilled syringe S to be decontaminated.

[0027] 4 and 5, the continuous supply device 100 is a box-like structure with walls made of stainless steel metal plates, and is placed on the floor. The interior of the continuous supply device 100 is divided by the walls into a front chamber 110, a decontamination agent supply chamber 120, and a rear chamber 130. Mechanical and electrical equipment are housed inside a base 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 carry-in entrance 111 through the front chamber 110, the decontamination agent supply chamber 120, and the rear chamber 130 to the outside of the carry-out exit 131, and transports the storage containers 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 to this, and there is also a case 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 Figure 5, the insides of the front chamber 110 and rear chamber 130 are evacuated from the respective exhaust ports 112, 132 by an exhaust device (not shown), creating 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 in the right direction 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 by the transport conveyor 10 below the discharge device 20, and hydrogen peroxide solution is discharged from the discharge device 20 toward the surface of the sealing member P2.

[0031] The discharge device 20 will now be described. In the present invention, the type of 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 apply a small amount of hydrogen peroxide solution evenly to 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 an air pulse method, a plunger method, a screw pump method, a piezo method, a thermal method, a bubble method, etc. Also, a fixed type with multiple nozzles that match the width of the seal member P2 may be used, or a traveling type that traverses to match the width of the seal member P2 may be used. In this embodiment, inkjet type discharge nozzles are 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 corresponding surface area of ​​the sealing member P2, for example, 0.05 mg / cm ２ ~2 mg / cm ２ In this embodiment, by using an inkjet discharge nozzle, a predetermined 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 increases the subsequent aeration time, which results in a problem of 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 (as described below).

[0035] In this way, the storage container P, with hydrogen peroxide solution 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 solution 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 disposed parallel to the surface of the seal member P2 and uniformly heats and raises the temperature of the hydrogen peroxide solution applied to the surface of the seal member P2. The present invention is not particularly limited to the type of heater 30. In this embodiment, it is preferable to use a far-infrared heater or an infrared laser, etc., to achieve uniform heating in a short period of time. The temperature to 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. While the temperature may be raised higher, this may result in a problem of adverse effects on the medicinal solution filled in the prefilled syringe S.

[0037] In this way, the storage container P, in which the hydrogen peroxide solution coated on the surface of the sealing member P2 has been uniformly heated, is moved by the transport conveyor 10 under the ultrasonic vibration plate 40, and 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 coated on the surface of the sealing member P2 is subjected to the acoustic flow of the ultrasonic waves and is supplied into the storage container P from the surface of the sealing member P2 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 sealing member P2 is repeatedly heated and irradiated with ultrasonic waves, and the applied hydrogen peroxide solution is completely vaporized and receives 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. In this embodiment, a plurality of heaters 30 and a plurality of ultrasonic vibration plates 40 are alternately arranged, but the arrangement is not limited to this (as will be 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 streaming of the ultrasonic waves. In this state, the storage container P travels by the transfer conveyor 10 through the rear chamber 130 to 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 of 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, no hydrogen peroxide solution has 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 being discharged from the discharge device 20 onto the surface of the sealing member P2. As described above, by using an inkjet discharge nozzle, a predetermined amount of hydrogen peroxide solution can be uniformly applied to the surface of the sealing member P2.

[0042] Next, Figure 6(C) shows the 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, Figure 6(D) shows the 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 onto 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 mounted on the flat surface of a base (speaker base) 41. The wave transmitting directions of these plurality of wave transmitters (ultrasonic speakers) 42 are aligned and are arranged facing the surface of the sealing member P2.

[0044] In this state, the multiple wave transmitters (ultrasonic speakers) 42 are operated in phase. This causes the ultrasonic waves emitted in the front direction from the multiple wave transmitters (ultrasonic speakers) 42 to reinforce each other, while the ultrasonic waves emitted in the lateral direction from the multiple wave transmitters (ultrasonic speakers) 42 to cancel each other out. As a result, acoustic streaming can be generated by ultrasonic waves with strong vertical directional direction from the 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 the acoustic streaming of the ultrasonic waves.

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

[0047] <Aeration Process> Next, Figure 6(F) shows the state of the aeration process. In this embodiment, because a small but appropriate amount of hydrogen peroxide solution is supplied, it is thought that almost no hydrogen peroxide will remain inside the storage container P after the decontamination process is completed. However, by replacing the air inside the chamber containing the storage container P after the decontamination process with clean air, a more complete aeration process can be completed. In addition, the time required for the aeration process can be shortened by heating the inside of the chamber during aeration.

[0048] As explained 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 time required for decontamination and aeration, 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 embodiment, and various modifications can be made, as follows. (1) In the above embodiment, a heater 30 is provided, but the present invention is not limited to this. In the present invention, the amount of hydrogen peroxide applied to the surface of the sealing member P2 is appropriate and small, so that the hydrogen peroxide can be vaporized by the ultrasonic vibration plate 40 alone, without increasing the temperature with the heater 30. (2) In the above embodiment, multiple heaters 30 and multiple ultrasonic vibration plates 40 are alternately arranged, but the present invention is not limited to this. In this case, instead of providing multiple heaters 30 and multiple ultrasonic vibration plates 40, the heaters 30 may be provided only upstream or downstream of the ultrasonic vibration plates 40. (3) In the above embodiment, the hydrogen peroxide is uniformly applied to the surface of the sealing member P2, but the present invention is not limited to this. For example, the amount of hydrogen peroxide sprayed onto the surface of the sealing member P2 may be controlled to vary depending on the surface area of ​​the sealing member P2. It is thought that the amount of hydrogen peroxide gas required for decontamination varies 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.

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

Claims

1. A decontamination system for decontaminating the outer surface of a prefilled syringe stored inside a storage container comprising a container body and a gas-permeable sealing member that seals an open portion of the container body, the system comprising: 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 residual decontamination agent from the inside of the storage container after decontamination and replacing it with clean air; the continuous supply device comprises a transport means for transporting the storage container from an entrance to an exit, a discharge means in a transport path of the transport means for discharging a predetermined amount of hydrogen peroxide solution onto the surface of the sealing member that seals the storage container, and an ultrasonic emission 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 decontamination system described in claim 1, characterized in that the continuous supply device has a heating means located in a position upstream and / or downstream of the ultrasonic emission means on the transport path of the transport means, which heats the hydrogen peroxide solution sprayed onto the surface of the sealing member, and the hydrogen peroxide solution sprayed onto the surface of the sealing member by the spraying 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 flow of the ultrasonic waves.

3. The decontamination system described in claim 1 or 2, characterized in that the ultrasonic emission means is an ultrasonic vibration plate having a base and a plurality of wave transmitters, and the plurality of wave transmitters are arranged on the flat surface of the base with the same transmission direction toward the surface of the sealing member, and these wave transmitters are operated in phase, so that the ultrasonic waves in the front direction of the plurality of wave transmitters reinforce each other and the ultrasonic waves in the lateral direction of the plurality of wave transmitters cancel each other out, thereby generating an acoustic stream of ultrasonic waves with strong vertical directionality from the plate surface of the ultrasonic vibration plate toward the surface of the sealing member.

4. A decontamination system as described in claim 1 or 2, characterized in that the dispensing means dispenses 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 tiny droplets.

5. A decontamination system as described in claim 1 or 2, characterized in that the amount of hydrogen peroxide solution discharged by the discharge means onto the surface of the sealing member is controlled to change depending on the surface portion of the sealing member, and the amount of vaporized hydrogen peroxide gas supplied from the surface of the sealing member to the inside of the storage container is changed corresponding to the portion of the prefilled syringe stored inside the storage container.

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