Decontamination equipment and decontamination method

Abstract

The present invention provides a decontamination device and method that can achieve a high level of decontamination effect in a short time inside a tube where the ratio L / D (the value of the tube length L relative to the inner diameter D) is in the range of 2 to 8. [Solution] The decontamination apparatus comprises a chamber consisting of a decontamination space and an air circulation path. The storage shelves within the chamber accommodate multiple tubular objects to be decontaminated, with one end facing downwards and the other end facing upwards, in a substantially vertical direction. The storage shelf rotation device connects its rotation axis vertically to the storage shelves and rotates the storage shelves horizontally around the rotation axis. In the decontamination process, decontamination mist generated by a mist generator is released from a mist outlet toward the upper ends of the tubular objects to be decontaminated that are rotating horizontally inside the decontamination space. In the aeration process, a clean air circulation device releases circulating air downwards from the upper wall surface of the decontamination space via the air circulation path.

Description

Technical Field

[0001] The present invention relates to a decontamination apparatus and a decontamination method for uniformly decontaminating the inside of a capillary tube, and particularly to a decontamination apparatus and a decontamination method capable of highly decontaminating the inside of a capillary tube having a large value of the capillary tube length relative to the inner diameter.

Background Art

[0002] When decontaminating the inside of a capillary tube, there was a problem that a decontamination agent had to be uniformly supplied to the inside of the capillary tube. Also, when removing the decontamination agent remaining inside after decontamination, there was a problem that it took a long time. In particular, when the value L / D of the capillary tube length L with respect to the inner diameter D of the capillary tube was 2 to 8 or higher, it was difficult to highly and uniformly decontaminate the inside. Furthermore, when the opening at one end of the capillary tube was convergent or blocked, it was particularly difficult to highly and uniformly decontaminate the inside.

[0003] In a manufacturing site for manufacturing pharmaceuticals or foods, or a medical site such as an operating room, it is important to maintain the aseptic state of instruments and the like used. In particular, for instruments and the like used inside an aseptic room, which is a working room for pharmaceutical production, it is necessary to complete a high-level decontamination validation in accordance with GMP (Good Manufacturing Practice).

[0004] In recent years, hydrogen peroxide gas has been widely used for decontaminating working rooms, devices, instruments, etc. that require an aseptic environment. This hydrogen peroxide gas has a strong sterilizing effect, is inexpensive and easily available, and is effective as an environmentally friendly decontamination gas that finally decomposes into oxygen and water.

[0005] For example, if the chamber of an isolator device is designated as the room to be decontaminated, one method is to generate hydrogen peroxide gas by heating and evaporating hydrogen peroxide solution inside the room. This method is called the "flash evaporation decontamination method." In this method, hydrogen peroxide solution at a concentration of, for example, 30-35 W / V% is supplied from outside to inside the room, heated by a high-temperature evaporation device installed inside the room, and hydrogen peroxide gas and water vapor are generated. Then, the air inside the room is circulated to fill the room with hydrogen peroxide gas.

[0006] Furthermore, decontamination with hydrogen peroxide gas is used not only to decontaminate the chamber of an isolator device, but also to decontaminate instruments such as pre-filled syringes. For example, the method for decontaminating pre-filled syringes shown in Patent Document 1 below is proposed as a method for decontaminating the surface of pre-filled syringes using hydrogen peroxide gas. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] Japanese Patent Publication No. 2010-057597 [Overview of the Initiative] [Problems that the invention aims to solve]

[0008] The above-mentioned Patent Document 1 describes a method for decontaminating the surface of pre-filled syringes sealed in packaging containers inside a decontamination room. However, this method only decontaminates the surface of the pre-filled syringe and does not allow for decontamination of the inside of the syringe body or other narrow tubes.

[0009] For example, when using a flash evaporation decontamination method to decontaminate an isolator device, if a high value of L / D (the ratio of the tube length to the inner diameter D) of 2 to 8 is placed inside the chamber and the inner walls of the tubes are decontaminated, a high level of decontamination cannot be achieved within the typical 120-minute decontamination cycle (decontamination process and aeration process) of a normal isolator device. In fact, it may require even longer periods of time, or it may be impossible.

[0010] Therefore, the present invention aims to address the above-mentioned problems and provide a decontamination device and method that can exhibit a high level of decontamination effect in a short time inside a tube where the ratio L / D of the tube length L to the inner diameter D is in the range of 2 to 8. [Means for solving the problem]

[0011] In solving the above problems, the inventors devised a method to uniformly supply hydrogen peroxide mist to the inside of a thin tube instead of hydrogen peroxide water gas as a decontamination solution, and by devising a method to supply clean air during aeration, they found that the above objectives could be achieved, leading to the completion of the present invention.

[0012] In other words, according to the description in claim 1, the decontamination apparatus according to the present invention is A decontamination device for which the object to be decontaminated is a tube with an inner diameter D of 25 mm or less and a value L / D of the tube length relative to the inner diameter D in the range of 2 to 8, The system comprises a chamber, a decontamination liquid supply device, a mist generator, a mist outlet, a storage shelf for containing the materials to be decontaminated, a storage shelf rotation device, and a clean air circulation device. The aforementioned chamber consists of a decontamination space and an air circulation path. The decontamination liquid supply device stores the decontamination liquid and supplies the decontamination liquid to the mist generator. The mist generating device atomizes the decontamination liquid to generate decontamination mist. The mist outlet opens onto the upper wall surface of the decontamination space and releases the decontamination mist into the interior of the decontamination space. The aforementioned storage rack accommodates multiple thin tubes of decontaminated materials in a substantially vertical orientation, with one end facing downwards and the other end facing upwards. The aforementioned shelf rotation device connects its rotation axis vertically to the shelf, and rotates the shelf horizontally around the rotation axis. The aforementioned clean air circulation device comprises an air circulation blower, an air purification unit, and a decontamination agent decomposition unit. The air circulation blower is characterized by purifying air introduced from the external environment with the air purification unit, and releasing it downward from the upper wall surface of the decontamination space via the air circulation path as circulating air together with air drawn in from below the decontamination space, and releasing a portion of the circulating air to the external environment via the decontamination agent decomposition unit.

[0013] Furthermore, according to claim 2, the present invention relates to the decontamination apparatus described in claim 1, The object to be decontaminated is a tubular tube with one end converging or sealed and the other end open, The aforementioned storage rack is characterized in that it accommodates multiple thin tubes of decontaminated materials in a substantially vertical direction, with one end of the tubes facing downwards and the other open end facing upwards.

[0014] Furthermore, according to claim 3, the present invention relates to the decontamination apparatus described in claim 1 or 2, The clean air circulation device is characterized by releasing clean air with increased air velocity from one or more slit-shaped discharge ports located on the upper wall surface of the decontamination space toward the upper ends of multiple thin tubes of decontaminated objects that rotate horizontally by the storage shelf rotation device.

[0015] Furthermore, according to the description in claim 4, the decontamination method according to the present invention is as follows: A decontamination method in which the object to be decontaminated is a tube with an inner diameter D of 25 mm or less and a value L / D of the tube length relative to the inner diameter D in the range of 2 to 8, Using the decontamination apparatus described in claim 3, the process consists of a decontamination step and an aeration step, In the decontamination process, the decontamination mist generated by the mist generator is discharged from the mist discharge port toward the upper ends of a plurality of contaminated thin tubes that rotate horizontally inside the decontamination space, so as to supply the decontamination mist to the inner wall of the lower end of the thin tube for decontamination. In the aeration process after the decontamination process, clean air with an improved wind speed is discharged from one or a plurality of slit-shaped discharge ports arranged on the upper wall surface of the decontamination space toward the upper ends of a plurality of contaminated thin tubes that rotate horizontally inside the decontamination space, so as to remove the decontamination mist remaining on the inner wall of the lower end of the thin tube and the condensed decontamination liquid.

Advantages of the Invention

[0016] According to the above configuration, the decontamination device according to the present invention uses a thin tube with an inner diameter D of 25 mm or less and a value L / D of the thin tube length L to the inner diameter D in the range of 2 to 8 as the contaminated object. The decontamination device further includes a chamber, a decontamination liquid supply device, a mist generator, a mist discharge port, a storage shelf for accommodating the contaminated objects, a storage shelf rotation device, and a clean air circulation device.

[0017] The chamber consists of a decontamination space and an air circulation path. The decontamination liquid supply device stores the decontamination liquid and supplies the decontamination liquid to the mist generator. The mist generator atomizes the decontamination liquid to generate a decontamination mist. The mist discharge port opens on the upper wall surface of the decontamination space and discharges the decontamination mist into the decontamination space. The storage shelf accommodates a plurality of contaminated thin tubes with one end facing downward and the other end facing upward in a substantially vertical direction. The storage shelf rotation device connects its rotation axis vertically to the storage shelf and rotates the storage shelf horizontally around the rotation axis.

[0018] The clean air circulation device includes an air circulation blower, an air purification unit, and a decontamination agent decomposition unit. The air circulation blower purifies the air introduced from the external environment with the air purification unit, and discharges it downward from the upper wall surface of the decontamination space as circulating air together with the air sucked from below the decontamination space through the air circulation path, and discharges a part of the circulating air to the external environment through the decontamination agent decomposition unit.

[0019] By these means, it is possible to provide a decontamination device that can exhibit a high decontamination effect in a short time inside a thin tube in which the value L / D of the thin tube length L with respect to the inner diameter D is in the range of 2 to 8.

[0020] Further, according to the above configuration, the object to be decontaminated may be a thin tube having one end converged or blocked and the other end open. The storage shelf accommodates the converged or blocked one ends of the thin tubes of a plurality of objects to be decontaminated in a substantially vertical direction with the converged or blocked one ends facing downward and the open other ends facing upward. By this, the above-described effects can be highly exhibited with respect to thin tubes with high difficulty.

[0021] Further, according to the above configuration, the clean air circulation device discharges clean air with an improved wind speed from one or a plurality of slit-shaped discharge ports arranged on the upper wall surface of the decontamination space toward the upper end portions of the thin tubes of a plurality of objects to be decontaminated that rotate horizontally by the storage shelf rotating device. By this, the above-described effects can be more highly exhibited.

[0022] Further, according to the above configuration, the decontamination method according to the present invention uses, as the object to be decontaminated, a thin tube having an inner diameter D of 25 mm or less and a value L / D of the thin tube length L with respect to the inner diameter D in the range of 2 to 8. Further, it is composed of a decontamination step and an aeration step using the decontamination device described in claim 3. In the decontamination step, the decontamination mist generated by the mist generating device is discharged from the mist discharge port toward the upper end portions of the thin tubes of a plurality of objects to be decontaminated that rotate horizontally inside the decontamination space. Thereby, the decontamination mist can be supplied to the inner wall of the lower end portion of the thin tube to perform decontamination.

[0023] In the aeration process following the decontamination process, clean air with increased airflow velocity is released from one or more slit-shaped discharge ports located on the upper wall surface of the decontamination space toward the upper ends of multiple thin tubes of decontaminated materials that rotate horizontally inside the decontamination space. This makes it possible to remove the decontamination mist and condensed decontamination liquid remaining on the inner walls of the lower ends of the thin tubes.

[0024] These factors enable the provision of a decontamination method that can achieve a high level of decontamination effect in a short time inside a tube where the ratio L / D (the value of the tube length L relative to the inner diameter D) is in the range of 2 to 8. [Brief explanation of the drawing]

[0025] [Figure 1] As an example of a tubular material to be decontaminated, this is an external photograph showing the composition of a pre-filled syringe injection. [Figure 2] Figure 1 is a schematic diagram showing the external appearance of the syringe's outer barrel. [Figure 3] This is an internal cross-sectional view of a decontamination apparatus, showing the decontamination process of the first embodiment, viewed from the front. [Figure 4] Figure 3 is an internal cross-sectional view of the decontamination equipment, showing the decontamination process, viewed from above. [Figure 5] This is an internal cross-sectional view of a decontamination apparatus showing the aeration process of the first embodiment, viewed from the front. [Figure 6] This is an internal cross-sectional view of a decontamination apparatus showing the aeration process of the second embodiment, viewed from the front. [Figure 7] Figure 6 is an internal cross-sectional view from above of the decontamination apparatus showing the aeration process. [Modes for carrying out the invention]

[0026] In this invention, "mist" is interpreted in a broad sense and includes decontamination liquid in droplet form suspended in the air, a state in which the decontamination liquid is a mixture of gas and droplets, and a state in which the decontamination liquid undergoes repeated phase changes of condensation and evaporation between gas and droplets. Furthermore, the particle size is also interpreted in a broad sense, including finely divided categories such as mist, fog, aerosol, and droplets.

[0027] Therefore, the mist according to the present invention may include what is sometimes called mist (which may be defined as having a particle size of 10 μm or less) or fog (which may be defined as having a particle size of 5 μm or less), as well as particles having a particle size greater than that.

[0028] First, let's explain the decontamination solution. In this invention, hydrogen peroxide is used as the decontamination solution, and it is atomized to generate a decontamination mist. This decontamination mist is released into the decontamination space inside the chamber to decontaminate the tubular objects to be decontaminated, which are stored in the storage shelves. The concentration of hydrogen peroxide used as the decontamination solution is not particularly limited, but generally, considering the handling of hazardous materials, it is preferable to use one with a concentration of 30-35 W / V%.

[0029] Next, the objects to be decontaminated will be described. The objects to be decontaminated according to the present invention include tubular tubes with both ends open and having the same inner diameter, tubular tubes with one end converging to reduce the open diameter, and, in special cases, tubular tubes with one end sealed. Furthermore, the objects to be decontaminated according to the present invention are tubular tubes with an inner diameter D of 25 mm or less and a ratio L / D of the tubular length L to the inner diameter D in the range of 2 to 8. In particular, tubular tubes with an inner diameter D of 25 mm or less are difficult to decontaminate, and decontamination is even more difficult when the L / D ratio is 2 to 8 or higher.

[0030] In this invention, the object to be decontaminated is not limited to specific instruments or the like, but the outer barrel of a syringe, which is a component of a pre-filled syringe injection, will be used as an example. The outer barrel of a syringe is a narrow tube with one end open and the other end converging to reduce the open diameter. In addition, if necessary, the converging end may be sealed with a top cap for decontamination.

[0031] Figure 1 is an external photograph showing the configuration of a pre-filled syringe injection, as an example of a tubular tube to be decontaminated. In Figure 1, the syringe 1 consists of an outer barrel 2 that acts as an injection container during storage and becomes a syringe when in use, a flange 3 that forms part of the outer barrel 2, a gasket 4 that acts as a lid for the injection container during storage and pushes the drug solution when in use, a plunger 5 that is attached to the gasket 4 and pushes the gasket 4, a Luer lock 6 for stably fixing the needle, and a top cap 7 that acts as a lid.

[0032] In syringe 1, the outer cylinder 2 corresponds to the tubular material to be decontaminated according to the present invention. Figure 2 is a schematic diagram showing the external appearance of the outer cylinder of the syringe in Figure 1. In Figure 2, the outer cylinder 2 consists of the outer cylinder body 2a in the center of the figure, an open end 2b with a wide inner diameter at the right end X of the figure, and a converging end 2c with a narrowed inner diameter at the left end Y of the figure.

[0033] Furthermore, in Figure 2, when the length of the outer cylinder body 2a is L and the inner diameter of the outer cylinder body 2a is D, the value L / D, which is the ratio of the inner diameter D to the length of the tube L, is in the range of 2 to 8.

[0034] The decontamination apparatus and decontamination method according to the present invention will be described below based on embodiments. However, the present invention is not limited to the embodiments shown below.

[0035] 《First Embodiment》 1. Decontamination process A decontamination apparatus according to the first embodiment will now be described. Figure 3 is an internal cross-sectional view of the decontamination apparatus as seen from the front, showing the decontamination process of the first embodiment. Figure 4 is an internal cross-sectional view of the decontamination apparatus as seen from above, showing the decontamination process of Figure 3. In Figure 3, the decontamination apparatus has a stainless steel chamber 100, the inside of which is divided into a decontamination space 10, air circulation paths 20, 30, and an upper machine room 30 and a lower machine room 40 above and below the decontamination space 10. The upper machine room 30 is also an air circulation path 30.

[0036] In the lower interior of the decontamination space 10, a storage shelf 11 is arranged to accommodate the outer cylinders 2, which are the materials to be decontaminated. Multiple outer cylinders 2 are housed in the storage shelf 11 in a substantially vertical direction, with their convergent ends 2c facing downwards and their open ends 2b facing upwards. A storage shelf rotation device 41 is also located in the lower machine room 40, and the rotation axis (not shown) of the storage shelf rotation device 41 is connected vertically to the storage shelf 11. As a result, the storage shelf 11 rotates horizontally around the rotation axis of the storage shelf rotation device 41 (see Figure 4). In Figure 4, the rotation axis of the storage shelf rotation device 41 is located at the center of the storage shelf 11, but this is not the only option. For example, the rotation axis may be positioned eccentrically from the center of the storage shelf 11 to change the rotation of the storage shelf.

[0037] A mist generator 31 is located in the upper machine room 30, and the mist outlet 32 ​​of the mist generator 31 opens from the ceiling of the decontamination space 10 toward the interior of the decontamination space 10. In Figure 3, one set of mist generator 31 and mist outlet 32 ​​is shown, but it is not limited to one set; multiple sets may be arranged. In addition, a decontamination liquid supply device 33 is located outside the upper machine room 30 to store decontamination liquid (hydrogen peroxide solution) and supply it to the mist generator 31, and is connected to the mist generator 31 via a decontamination liquid supply pipe 34.

[0038] An air circulation path 20 is provided on the side (right side in the diagram) of the decontamination space 10, and a clean air circulation device 50 is located inside it. The clean air circulation device 50 consists of an air circulation blower 51, a HEPA filter 52 as an air purification unit, and a decontamination agent decomposition unit 53. Note that the clean air circulation device 50 is stopped during the decontamination process. Below the decontamination space 10, a vent 21 is provided in the boundary wall between the space and the lower part of the air circulation path 20. Note that the vent 21 is closed during the decontamination process. The function of the vent 21 will be explained later in the aeration process section.

[0039] During the decontamination process, the temperature and humidity inside the decontamination space 10 are controlled. In this state, decontamination liquid (hydrogen peroxide solution) is supplied from the decontamination liquid supply device 33 to the mist generator 31 via the decontamination liquid supply pipe 34.

[0040] In the first embodiment, an ultrasonic atomizer (nebulizer) was used as the mist generator 31, but it is not limited to this. For example, a one-fluid spray nozzle that directly atomizes hydrogen peroxide, an ejector or two-fluid spray nozzle that atomizes hydrogen peroxide with high-pressure air may also be used.

[0041] As shown in Figure 3, the decontamination mist M generated by the mist generator 31 is discharged from the mist outlet 32 ​​towards the upper open ends 2b of the multiple outer cylinders 2 located below the decontamination space 10. The decontamination liquid is in the form of hydrogen peroxide mist, not hydrogen peroxide gas. Therefore, in addition to gas diffusion, there is also an element of downward fall, and the mist is efficiently supplied from the upper open ends 2b of the vertically arranged outer cylinders 2 to the inner wall of the lower converging ends 2c.

[0042] At this time, the multiple outer cylinders 2, which are the objects to be decontaminated, are housed in the storage rack 11 and rotated horizontally within the decontamination space 10 by the operation of the storage rack rotating device 41 (see Figure 4). As a result, the positional relationship between the mist discharge port 32 and the upper open end 2b of the outer cylinder 2 changes, and the decontamination mist M is supplied uniformly and efficiently to the multiple outer cylinders 2.

[0043] 2. Aeration process After the decontamination process is completed, an aeration process is performed. Figure 5 is an internal cross-sectional view of the decontamination apparatus as seen from the front, showing the aeration process of the first embodiment. Note that the internal cross-sectional view of the decontamination apparatus as seen from above, showing the aeration process, is the same as that shown in Figure 4, which shows the decontamination process (see Figure 4 for the aeration process as well). In Figure 5, the supply of decontamination liquid (hydrogen peroxide) from the decontamination liquid supply pipe 34 is stopped, and the mist generator 31 is also stopped.

[0044] In the air circulation path 20 shown in Figure 5, the air circulation blower 51 of the clean air circulation device 50 is in operation. When the air circulation blower 51 is in operation, the vent 21 provided in the boundary wall between the lower part of the decontamination space 10 and the air circulation path 20 opens, and air containing the decontamination mist M used in the decontamination process flows from the decontamination space 10 into the air circulation path 20 through the vent 21. This air that flows into the air circulation path 20 mixes with the air introduced from the external environment to become circulating air A. In Figure 5, the flow of circulating air A, etc., is indicated by arrows.

[0045] A portion of the circulating air A inside the air circulation path 20 is purified by the HEPA filter 42. Another portion of the circulating air A is purified via the decontamination agent decomposition unit 43 and released into the external environment. The circulating air A that has passed through the HEPA filter 42 is supplied from the air circulation path 20 to the air circulation path 30.

[0046] The circulating air A supplied to the air circulation path 30 is discharged downward through a flow straightening member 13 provided on the upper wall surface 12 of the decontamination space 10. This downward-discharged circulating air A flows in a unidirectional direction within the decontamination space 10 and is efficiently supplied from the upper open end 2b of the vertically positioned outer cylinder 2 to the inner wall portion of the lower converging end 2c. In this way, each time the circulating air A circulates between the air circulation paths 20, 30 and the decontamination space 10, it mixes with air introduced from the external environment and is transformed into clean air.

[0047] At this time, the multiple outer cylinders 2, which are the objects to be decontaminated, are housed in the storage rack 11 and rotated horizontally within the decontamination space by the operation of the storage rack rotating device 41 (see Figure 4). As a result, clean air is supplied uniformly and efficiently to the upper open ends 2b of the multiple outer cylinders 2. This dilutes the decontamination mist M remaining at the lower converging ends 2c of the outer cylinders 2 with the circulating air A, and efficiently removes the decontamination liquid (hydrogen peroxide) condensed on the inner wall of the lower converging ends 2c of the outer cylinders 2.

[0048] 《Second Embodiment》 1. Decontamination process A decontamination apparatus according to the second embodiment will now be described. In the decontamination process of the second embodiment, the same operations as in the first embodiment are performed. The reference numerals for each device are basically the same as in the first embodiment. Therefore, the description of each device and operation in the decontamination process will be omitted here (see Figures 3 and 4).

[0049] 2. Aeration process After the decontamination process is completed, an aeration process is performed. Figure 6 is an internal cross-sectional view of the decontamination apparatus as seen from the front, showing the aeration process of the second embodiment. Figure 7 is an internal cross-sectional view of the decontamination apparatus as seen from above, showing the aeration process of Figure 6. In Figure 6, the supply of decontamination liquid (hydrogen peroxide) from the decontamination liquid supply pipe 34 is stopped, and the mist generator 31 is also stopped.

[0050] In the air circulation path 20 shown in Figure 6, the air circulation blower 51 of the clean air circulation device 50 is in operation. When the air circulation blower 51 is in operation, the vent 21 provided in the boundary wall between the lower part of the decontamination space 10 and the air circulation path 20 opens, and air containing the decontamination mist M used in the decontamination process flows from the decontamination space 10 into the air circulation path 20 through the vent 21, mixes with the air introduced from the external environment to become circulating air A. In Figure 6, the flow of circulating air A, etc., is indicated by arrows.

[0051] A portion of the circulating air A inside the air circulation path 20 is purified by the HEPA filter 42. Another portion of the circulating air A is purified via the decontamination agent decomposition unit 43 and released into the external environment. The circulating air A that has passed through the HEPA filter 42 is supplied from the air circulation path 20 to the air circulation path 30.

[0052] The circulating air A supplied to the air circulation path 30 is discharged downward through two slit-shaped discharge ports 14 provided on the upper wall surface 12 of the decontamination space 10. This downward-discharged circulating air A becomes circulating air A with increased air velocity and is efficiently supplied from the upper open end 2b of the vertically positioned outer cylinder 2 to the inner wall portion of the lower converging end 2c. In this way, each time the circulating air A circulates between the air circulation paths 20, 30 and the decontamination space 10, it mixes with air introduced from the external environment and is transformed into clean air.

[0053] In Figure 7, two slit-shaped discharge ports 14a are shown at the top of the storage shelf 11, which rotates horizontally inside the decontamination space. Thus, in the second embodiment, two slit-shaped discharge ports 14 are used, but this is not the only option. For example, one, three or more, or multiple ports may be arranged radially from above the center of the storage shelf 11 toward the periphery.

[0054] Thus, in the second embodiment, the method of supplying circulating air A from the upper wall surface 12 of the decontamination space 10 to the upper open end 2b of the outer cylinder 2 differs from that of the first embodiment. As a result, in the second embodiment, the air velocity of circulating air A inside the decontamination space 10 is increased compared to the first embodiment, and it is supplied more efficiently from the upper open end 2b of the vertically positioned outer cylinder 2 to the inner wall portion of the lower converging end 2c.

[0055] At this time, the multiple outer cylinders 2, which are the objects to be decontaminated, are housed in the storage rack 11 and rotated horizontally within the decontamination space by the operation of the storage rack rotating device 41 (see Figure 7). As a result, the clean air released from the two slit-shaped discharge ports 14 is uniformly and efficiently supplied to the upper open ends 2b of the multiple outer cylinders 2. Therefore, the decontamination mist M remaining at the lower converging ends 2c of the outer cylinders 2 is diluted by the circulating air A, and the decontamination liquid (hydrogen peroxide) condensed on the inner wall of the lower converging ends 2c of the outer cylinders 2 can be removed even more efficiently. [Examples]

[0056] The decontamination effect on the tubular tube was confirmed using the decontamination device of the second embodiment described above. In this embodiment, in order to conduct a more difficult test, a syringe outer barrel 2 with a top cap 7 installed and sealed at the converging end 2c was used. The length L of the outer barrel body 2a was 80 mm, the inner diameter D of the outer barrel body 2a was 10 mm, and the value L / D at the innermost part on the sealed converging end 2c side was 8.

[0057] 1. Decontamination process In the decontamination process of this embodiment, the temperature inside the decontamination space 10 is controlled to 21°C and the humidity to 35%RH. In this state, hydrogen peroxide is supplied from the decontamination liquid supply device 33 to the mist generator 31 via the decontamination liquid supply pipe 34. In this embodiment, the volume of the decontamination space 10 is 0.036 m³. 3 The dimensions are (300mm x 300mm x 400mm), and the supply rate of the decontamination solution (30W / V% hydrogen peroxide solution) is 12.6g / m². 3 Decontamination was carried out as part of this effort.

[0058] The decontamination procedure was timed to match that of a standard isolator chamber decontamination, consisting of 32 minutes of spraying decontamination mist, 43 minutes of holding the mist in that state, and 45 minutes of subsequent aeration, for a total of 120 minutes.

[0059] The decontamination effect was confirmed using enzyme indicators (EI) and biological indicators (BI). Specifically, the outer cylinder 2, which was the object to be decontaminated, was fitted with a total of 20 test specimens: 10 test specimens with EIs placed at a position where the L / D value from the open end 2b of the outer cylinder body 2a to the innermost end was 8, and 10 test specimens with BIs placed at the same position.

[0060] 2. Aeration process In this embodiment, the decontamination apparatus of the second embodiment was used, and therefore, the storage shelf 11 that rotates horizontally inside the decontamination space has two slit-shaped discharge ports 14 with openings 14a at its top (see Figures 6 and 7). In this embodiment, the airflow rate of the circulating air A released from the openings 14a of the slit-shaped discharge ports 14 during aeration is 2.4 m³. 3 The value was / min, and the wind speed was assumed to be 12 m / s.

[0061] 3.Results The effectiveness of EI was evaluated by measuring the luminescence intensity using a luciferase assay after the test to assess the decontamination strength. Specifically, the LRD value (Log Spore Reduction) was calculated from the luminescence intensity of EI after decontamination, based on the logarithmic reduction in bacterial count, and the decontamination strength inside the test specimen (outer cylinder 2) (at the position where the L / D value is 8) was evaluated. On the other hand, the effectiveness of BI was evaluated by culturing spores. Table 1 shows the decontamination effect of a total of 20 test specimens: 10 with EI and 10 with BI.

[0062] [Table 1]

[0063] As can be seen from Table 1, the LRD values ​​of the 10 test specimens equipped with EI ranged from 5.4 to 6.4, and all showed good decontamination results around 6. Here, an LRD value of 6 (also called "6 Log reduction") refers to a decontamination effect that reduces microorganisms to 1 / 1,000,000th. On the other hand, the results of the spore culture operation of the 10 test specimens equipped with BI were all negative (no germination was observed), indicating a good decontamination effect. Comparative Example

[0064] The comparative test used the same outer cylinder 2 with the same converging end 2c sealed as in the above embodiment. The length L of the outer cylinder body 2a was 80 mm, the inner diameter D of the outer cylinder body 2a was 10 mm, and the value L / D at the innermost part on the sealed converging end 2c side was 8.

[0065] In this comparative example, when decontaminating the chamber of the isolator device using a normal flash evaporation decontamination method, test specimens were placed inside the chamber. Twenty test specimens were prepared, each with multiple BIs placed at 10 mm intervals from the open end 2b of the outer cylinder body 2a. Ten of the test specimens were placed vertically inside the chamber, and ten were placed horizontally inside the chamber.

[0066] 1. Decontamination conditions In this comparative example, the decontamination conditions were as follows: as initial conditions, a temperature of 21°C and a humidity of 35% RH were set in a chamber, and a decontamination solution (30 W / V% hydrogen peroxide solution) was evaporated using a flash evaporation decontamination method, and hydrogen peroxide gas was introduced. The volume of the chamber was 2.0 m³. 3 The total amount of hydrogen peroxide solution added was 125g, with a rate of 3.5g / min (20 minutes) in Stage 1 and 2.5g / min (20 minutes) in Stage 2, and the total decontamination time, including the aeration process, was 120 minutes. The target decontamination level was 6LRD.

[0067] 2.Results BI was evaluated by spore culture. The results for the vertically positioned specimens were as follows: at a position 10 mm from the open end 2b of the outer cylinder 2 (value L / D of 0.8), the evaluation was △ (1 / 3 positive) at a position 20 mm from the open end 2b (value L / D of 1.6), and at a position 30 mm from the open end 2b (value L / D of 2.4), the evaluation was × (all positive).

[0068] On the other hand, the results for the test specimens placed horizontally showed that the evaluation at a position 10 mm from the open end 2b of the outer cylinder 2 (value L / D of 0.8) was ○ (all negative), but the evaluation at a position 20 mm from the open end 2b (value L / D of 1.6) was × (all positive).

[0069] Thus, in the comparative example, it can be seen that the conventional flash evaporation decontamination method cannot decontaminate the inside of the outer cylinder 2 with an inner diameter D of 10 mm, whether it is positioned vertically or horizontally.

[0070] As described above, the present invention provides a decontamination device and a decontamination method that can exhibit a high level of decontamination effect in a short time inside a tube where the value L / D of the tube length relative to the inner diameter D is in the range of 2 to 8. [Explanation of Symbols]

[0071] 1... Syringe, 2... Outer barrel, 2a... Outer barrel body, 2b... Open end, 2c... Converging end, 3...Flange, 4...Gasket, 5...Plunger, 6...Luer lock, 7...Top cap, 10...Decontamination space, 11...Storage shelf, 12...Upper wall, 13...flow straightening member, 14...slit-shaped discharge port, 14a...opening, 20...Part of the air circulation path, 21...Ventilation opening, 30... Upper machinery room (also serves as part of the air circulation path), 31... Mist generator, 32...Mist discharge port, 33...Decontamination liquid supply device, 34...Decontamination liquid supply piping, 40...Lower machine room, 41...Storage shelf rotation device, 43...Decontamination agent decomposition unit, 50...Air circulation device, 51...Air circulation blower, 52...HEPA filter, 53...Decontamination agent decomposition unit, 100...Chamber, A...Circulating air, M...Decontamination mist.

Claims

1. A decontamination device for which the object to be decontaminated is a tube with an inner diameter D of 25 mm or less and a value L / D of the tube length relative to the inner diameter D in the range of 2 to 8, The system comprises a chamber, a decontamination liquid supply device, a mist generator, a mist outlet, a storage shelf for containing the materials to be decontaminated, a storage shelf rotation device, and a clean air circulation device. The aforementioned chamber consists of a decontamination space and an air circulation path. The decontamination liquid supply device stores the decontamination liquid and supplies the decontamination liquid to the mist generator. The mist generating device atomizes the decontamination liquid to generate decontamination mist. The mist outlet opens onto the upper wall surface of the decontamination space and releases the decontamination mist into the interior of the decontamination space. The aforementioned storage rack accommodates multiple thin tubes of decontaminated materials in a substantially vertical orientation, with one end facing downwards and the other end facing upwards. The aforementioned shelf rotation device connects its rotation axis vertically to the shelf, and rotates the shelf horizontally around the rotation axis. The aforementioned clean air circulation device comprises an air circulation blower, an air purification unit, and a decontamination agent decomposition unit. The decontamination apparatus is characterized in that the air circulation blower purifies the air introduced from the external environment using the air purification unit, and releases it downward from the upper wall surface of the decontamination space via the air circulation path as circulating air together with the air drawn in from below the decontamination space, and also releases a portion of the circulating air to the external environment via the decontamination agent decomposition unit.

2. The object to be decontaminated is a tubular tube with one end converging or sealed and the other end open, The decontamination method according to claim 1, characterized in that the storage rack accommodates a plurality of tubular materials to be decontaminated in a substantially vertical direction, with one end of the converged or sealed material facing downwards and the other open end facing upwards.

3. The decontamination apparatus according to claim 1 or 2, characterized in that the clean air circulation device discharges clean air with increased air velocity from one or more slit-shaped discharge ports arranged on the upper wall surface of the decontamination space toward the upper ends of multiple thin tubes of objects to be decontaminated that rotate horizontally by the storage shelf rotation device.

4. A decontamination method in which the object to be decontaminated is a tube with an inner diameter D of 25 mm or less and a value L / D of the tube length relative to the inner diameter D in the range of 2 to 8, Using the decontamination apparatus described in claim 3, the process consists of a decontamination step and an aeration step, In the decontamination process, the decontamination mist generated by the mist generator is discharged from the mist outlet toward the upper end of a plurality of thin tubes of objects to be decontaminated that rotate horizontally within the decontamination space, thereby supplying the decontamination mist to the inner wall of the lower end of the thin tubes and performing decontamination. A decontamination method characterized in that, in the aeration step after the decontamination step, clean air with increased airflow velocity is released from one or more slit-shaped discharge ports arranged on the upper wall surface of the decontamination space toward the upper end of a plurality of thin tubes of objects to be decontaminated that rotate horizontally inside the decontamination space, thereby removing the decontamination mist and condensed decontamination liquid remaining on the inner wall of the lower end of the thin tubes.

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