Decontamination device in aseptic sealed space and decontamination method using the device

Abstract

To provide a highly safe device and method for decontaminating the inside of a sealed space such as in an isolator that cause less post-decontamination damage to cells and have no possibility of adsorption or re-release.SOLUTION: A sealed space 12 of an isolator B and a decontamination device A are connected using a first duct 7 and a second duct 8. The decontamination device A includes a dry fog generator 1, a temperature and humidity sensor 2, a gas collector 3, and a main control / monitoring device 4. The dry fog generator 1 generates dry fog having an average particle diameter of 10 μm or less using a decontaminant formed from a peracetic acid liquid mixture, and sprays the dry fog in the first duct 7 so that a concentration of dry fog is 2% or less to fill an inside of the sealed space 12 with the dry fog. When a humidity measured by the temperature and humidity sensor 2 exceeds a set humidity, the operation of the dry fog generator 1 is stopped, and operation of the gas collector 3 is started, and when the measurement humidity drops below the set humidity, the operation of the gas recovery machine 3 is stopped, and the operation of the dry fog generator 1 is started.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] This invention relates to a decontamination device that enables decontamination of a small amount of peracetic acid decontaminant in a sterile sealed space such as an isolator, and a decontamination method using the decontamination device.

Background Art

[0002] Mainly in the manufacturing environments of products such as sterile pharmaceuticals and regenerative medicine, ensuring the quality and safety of products is strictly obligatory, and preventing microbial contamination of products is an important requirement. Inside an isolator, it is designed to be completely isolated from the outside and capable of maintaining and managing a sterile environment. Also, isolators are widely used in the biotechnology field including the pathogenic microorganism research field and food development field from the viewpoints of data reliability and ensuring the safety of workers, in addition to the pharmaceutical and regenerative medicine fields.

[0003] Isolators have a decontamination function and an aeration function for discharging decontaminants for regular sterilization work, and a function of creating a sterile environment.

[0004] Currently, in the decontamination method of isolators, vaporized hydrogen peroxide (VHP) is most used in terms of its effectiveness, stability, and convenience. The following Patent Documents 1 and 2 are examples of using the hydrogen peroxide as a decontaminant for decontamination in a sealed space such as an isolator.

[0005] The one in Patent Document 1 can perform an effective sterilization treatment in a relatively short time, and by using a relatively limited amount of hydrogen peroxide gas, it provides an efficient and effective decontamination method. It supplies the generated hydrogen peroxide gas into the decontamination target area and adjusts the temperature of the decontamination target area to the temperature at which it condenses from the hydrogen peroxide gas. It is a decontamination method and decontamination system using hydrogen peroxide gas.

[0006] Patent Document 2 describes a hydrogen peroxide gas decontamination method and apparatus that can easily decontaminate a space to be decontaminated in a small-volume enclosure such as a safety cabinet or isolator using hydrogen peroxide gas. The hydrogen peroxide gas decontamination apparatus comprises a container into which hydrogen peroxide solution can be placed, a heater that heats the hydrogen peroxide solution in the container by heating the container, a temperature controller that controls the heater to heat the hydrogen peroxide solution to 70-90°C, a timer connected to the temperature controller, and a neutralization device connected to the timer that has the function of neutralizing and decomposing the hydrogen peroxide gas in the space to be decontaminated. The hydrogen peroxide gas decontamination method uses a hydrogen peroxide gas decontamination apparatus that heats the hydrogen peroxide solution to 70-90°C using the heater, sets the concentration of hydrogen peroxide gas in the space to be decontaminated to 200-400 ppm, and when the decontamination time set by the timer has elapsed, the heating of the hydrogen peroxide gas by the heater stops, the neutralization device automatically activates, and the hydrogen peroxide gas is decomposed to a concentration of 1 ppm or less. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] Japanese Patent Publication No. 2012-147856 [Patent Document 2] Patent No. 6649417 [Disclosure of the Invention] [Problems that the invention aims to solve]

[0008] However, hydrogen peroxide, which is widely used in Patent Documents 1 and 2, is known to adsorb to metals, resins, cellulose, and glass fibers (glass fibers are the main material of HEPA filters), and to be re-released. Even after aeration of the decontamination agent, a small amount of hydrogen peroxide is re-released from the internal surface of the isolator and the HEPA filter. In particular, hydrogen peroxide has high solubility in liquids. Therefore, in the manufacture of pharmaceuticals and regenerative medicine products using liquid formulations or cells, hydrogen peroxide dissolved in the culture medium can damage cells. For this reason, post-decontamination management, such as aeration time, is important.

[0009] On the other hand, peracetic acid decontamination agents are sold as a mixture of water, acetic acid, hydrogen peroxide, and peracetic acid. This is because peracetic acid decomposes immediately in an aqueous solution and cannot exist on its own; therefore, it exists by repeatedly synthesizing and decomposing in a mixture containing water, acetic acid, and hydrogen peroxide, maintaining an equilibrium state. The concentration of hydrogen peroxide contained in this mixture is very low compared to the concentration used when used as a decontamination agent (mainly a 30-60% aqueous solution), at about 0.8-10.0%, so the risk of re-release is very small.

[0010] Furthermore, in decontamination using peracetic acid, "wet corrosion" in a wet state rapidly corrodes easily corroded metals such as iron, copper, and brass. On the other hand, "dry corrosion" in a dry state is very slow and has virtually no effect. Therefore, it is important to determine the decontamination humidity and strictly control the humidity to prevent metal corrosion due to condensation. Also, because peracetic acid is highly decomposable, as much peracetic acid decontamination agent as possible is sprayed, so the decontamination humidity is relatively high, at 85-95% RH.

[0011] Peracetic acid decontamination agents are sprayed in a dry fog state (they are droplets with a central particle diameter of about 10 μm that bounce off walls without wetting them, hence the name "dry mist"). As they vaporize from the surface of the droplets and gasify, they quickly decompose into safe acetic acid, oxygen, and water. Furthermore, there have been no reports of adsorption and re-release on metals, resins, cellulose, or fiberglass, so the damage to cells is minimal.

[0012] However, even with dry fog, if the fog is supersaturated or the concentration of droplets is high, condensation or aggregation can occur, wetting the surface and causing "wet corrosion," so humidity and concentration control are crucial.

[0013] During the decomposition of peracetic acid, the released reactive oxygen species (a type of radical) act on the SH groups and SS bonds in microbial enzymes, destroying cell membranes and exhibiting a bactericidal effect. However, radicals are highly reactive and have a short lifespan, so the decontamination effect does not last long. Furthermore, humidity is maintained even after decomposition, making it impossible to spray additional decontamination agents in a humidity-controlled, sealed space. For these reasons, decontamination of sealed spaces with peracetic acid is considered difficult. In fact, although it is highly safe, there are no known examples worldwide of using peracetic acid decontamination agents to decontaminate isolators.

[0014] Furthermore, while there are fog (suction), ultrasonic, and nozzle-compressor methods for atomizing peracetic acid decontamination agents, all of these methods involve a tank for diluted decontamination agents. Since the diluted solution has a short shelf life, the remaining diluted solution after decontamination becomes dead volume (unnecessary amount), and depending on the facility, it may be considered medical or industrial waste. Therefore, a mechanism to minimize dead volume is crucial. At the same time, the undiluted peracetic acid solution, which is highly concentrated, contains more than 6% hydrogen peroxide and is therefore designated as a highly toxic substance not for medical use. To prevent human error during dilution and ensure worker safety, automation of the dilution process is required.

[0015] Furthermore, an emergency stop mechanism is crucial because a malfunction in the humidity sensor during decontamination would prevent accurate control. Additionally, when decontaminating inside an isolator, it is common practice to maintain a weak positive pressure throughout the process to prevent external contaminants from entering.

[0016] Furthermore, in the decontamination of the isolator, the decontamination equipment will be connected to the isolator by two ducts: one for blowing and one for returning. The ducts will have an inner diameter of about 10 cm, but the concentration of dry fog will increase inside the duct, causing it to aggregate and increase the mist particle size, which can lead to wetting, so the concentration needs to be kept low.

[0017] The present invention aims to solve the above-mentioned problems and provides a device and method for decontaminating a sealed space such as an isolator under weak positive pressure, using a highly safe peracetic acid decontamination agent that causes little damage to cells after decontamination and does not adsorb or re-release, while minimizing dead volume, preventing human error and maintaining safety through automation of dilution and other processes, emergency stopping in the event of humidity sensor failure, and keeping the particle concentration of the dry fog below 2%. [Means for solving the problem]

[0018] This invention is based on the decontamination apparatus and decontamination method using the decontamination apparatus described in Japanese Patent No. 6285060 (hereinafter simply referred to as the "peracetic acid cycle decontamination method").

[0019] The most distinctive feature of this peracetic acid cycle decontamination method is that it continuously produces radicals by repeatedly spraying particles consisting of a low-concentration peracetic acid mixture and recovering (dehumidifying) the entire gas in the decontamination area (space), thereby creating a radical-rich environment that can kill all microorganisms. The operation involves stopping the spraying of dry fog and starting the gas recovery machine when the measured humidity in the decontamination area exceeds a predetermined set humidity, and stopping the operation of the gas recovery machine and starting the dry fog generator when the measured humidity falls below the set humidity. This cycle is repeated to decontaminate the area.

[0020] Furthermore, since decontamination is performed under weak positive pressure in the sealed space of the decontamination device and the sterile sealed space device of this invention, the decontamination mist and gas need to be circulated between the sterile sealed space and the decontamination device while maintaining airtightness. For this reason, the sealed space to be decontaminated and the decontamination device are connected by two ducts, and a highly airtight gas circulation space is incorporated into the decontamination device. The decontamination device also consists of a dry fog generator, a humidity sensor, a gas recovery unit, and a control unit.

[0021] Specifically, the invention of claim 1 is a decontamination device in a sterile sealed space having a sterile sealed space, in which a sterile sealed space and a decontamination device are connected by two ducts, and the decontamination device is equipped with a dry fog generator, a temperature and humidity sensor, a gas recovery device, and a main control and monitoring device, wherein the dry fog generator is provided with a purified water tank and a decontamination agent tank consisting of a peracetic acid mixture, a first stepping motor and a second stepping motor are provided in the output path of each tank, the respective output paths are connected at a confluence point, a filter is provided at the confluence point, and a micronozzle is provided at the end of the confluence path led out from the confluence point, and the micronozzle The decontamination device in a sterile, sealed space comprises a small compressor that supplies compressed air into the duct, a blower fan that sends the dry fog sprayed by the dry fog generator into the sterile, sealed space through one duct, an intake fan that draws the gas from the sterile, sealed space into the decontamination device through the other duct, a gas recovery unit that recovers the gas from within the decontamination device, a temperature and humidity sensor that measures the temperature and humidity within the decontamination device, and a main control and monitoring device that computer-controls the operation or stopping of the dry fog generator and the gas recovery unit according to the measurements of the temperature and humidity sensor.

[0022] Furthermore, the invention of claim 2 is a decontamination device in a sterile, sealed space as described in claim 1, wherein a branching path leading to a drainage tank is provided in the confluence path via a connector, and a third stepping motor is provided in the branching path to guide the liquid in the output path and the confluence path to the drainage tank.

[0023] Furthermore, the invention of claim 3 relates to a method of decontaminating a sterile sealed space using a decontamination device within a sterile sealed space, wherein the sealed space of an apparatus having a sterile sealed space is connected to a decontamination device by two ducts, and the decontamination device is equipped with a dry fog generator, a temperature and humidity sensor, a gas recovery device, and a main control and monitoring device. The dry fog generator is equipped with a purified water tank and a decontamination agent tank consisting of a peracetic acid mixture, the output paths of each tank are connected to a confluence point via a first stepping motor and a second stepping motor, respectively, a filter is provided in the confluence path leading out from the confluence point, a micronozzle is provided at the end of the confluence path, and a small compressor is provided to supply compressed air into the micronozzle. A blower fan is provided to send the dry fog sprayed by the dry fog generator into the sterile sealed space through one duct, and an intake fan is provided to draw the gas from the sterile sealed space into the decontamination device through the other duct. The gas recovery device recovers the gas in the decontamination device, the temperature and humidity sensor measures the temperature and humidity inside the decontamination device, and the main control and monitoring device is configured to computer-control the operation or stop of the dry fog generator and the operation or stop of the gas recovery device according to the measured values ​​of the temperature and humidity sensor, and the set humidity inside the decontamination device is set in advance, and the dry fog generated by the dry fog generator Dry fog lights A device having a sterile, sealed space through one of the ductsFill the sealed space, and when the measured humidity of the temperature and humidity sensor becomes equal to or higher than the set humidity, stop the operation of the dry fog generator, operate the gas recovery machine to recover the gas in the aseptic sealed space through the other duct, and when the measured humidity of the temperature and humidity sensor becomes lower than the set humidity, stop the operation of the gas recovery machine and repeat the operation of operating the dry fog generator by computer control with the main control and monitoring device. This is a method for decontaminating the inside of an aseptic sealed space.

[0024] Moreover, the invention of claim 4 is A method for decontaminating a sterile, sealed space according to claim 3, wherein the flow rate of a decontamination agent consisting of purified water and the peracetic acid mixture is controlled by controlling the first stepping motor and the second stepping motor. as

[0025] Moreover, the invention of claim 5 is to provide a branch path leading to a drain tank via a connector in the confluence path, and provide a third stepping motor in the branch path to guide the liquid in the output path and the confluence path to the drain tank. Before the start of the decontamination operation, the liquid in the output path and the confluence path after the first stepping motor and the second stepping motor is sucked into the drain tank by the third stepping motor. This is a method for decontaminating the inside of an aseptic sealed space as described in claim Either 3 or 4

[0026] [[ID= fixed]]Moreover, the invention of claim 6 is to provide two temperature and humidity sensors, operate the two temperature and humidity sensors constantly, and when the time when the difference in the measured humidity of the two temperature and humidity sensors exceeds the threshold exceeds the specified time, stop the operation of the entire device by the main control and monitoring device. This is a method for decontaminating the inside of an aseptic sealed space as described in claim 3.

Effect of the Invention

[0027] According to each of the inventions of claim 1 and 3 , the sealed space of a device having an aseptic sealed space such as an isolator can be decontaminated quickly and surely by the cycle decontamination method using peracetic acid without corroding the devices installed in the isolator. Also, unlike the conventional method using hydrogen peroxide as a decontaminant, the decontaminant is not re-released from the inner surface of the sealed space of the isolator or inside the HEPA filter, and the damage to cells is minimal. ​

[0028] Conventionally, decontamination agents consisting of a peracetic acid mixture were diluted with purified water and stored in a decontamination agent tank, and the liquid in the tank was atomized. However, because the shelf life of the diluted solution is short, the diluted solution becomes dead volume after the expiration date and is disposed of. According to the invention of claim 1, such a tank is unnecessary, and the wasteful use of decontamination agents and purified water can be reduced. In addition, the amount of decontamination agent and purified water used and the remaining amount can be easily managed. Furthermore, the compressor used to atomize the decontamination agent can also be made smaller.

[0029] To minimize the dead volume mentioned above, when using a micronozzle and a small compressor with a maximum pressure of 0.2 MPa, specifically when measurements were taken with a laser diffraction particle size distribution analyzer HELOS-KR at a flight distance of 30 cm and the measured concentration, determined by the light shielding rate, was 2% or less, no droplets were observed inside the duct.

[0030] Furthermore, according to the inventions of claims 2 and 5, in order to clean the inside of the tubes (output path, confluence path, etc.) before starting the decontamination work, the liquid in the output path and confluence path from the first stepping motor and the second stepping motor onward can be sucked into the drainage tank by the third stepping motor, so that when the dry fog generator is started again, there is no expired decontamination agent or purified water remaining in the path, and the decontamination work can always be performed using fresh decontamination agent and purified water.

[0031] Furthermore, according to the invention of claim 4, the dilution ratio of the decontamination agent to be delivered to the micronozzle and the amount of dilution solution delivered can be automatically set.

[0032] Furthermore, according to the invention of claim 6, when the time during which the difference in the humidity measured by the two temperature and humidity sensors exceeds a threshold exceeds a specified time, the main control and monitoring device stops the operation of the entire device. Therefore, even if a temperature and humidity sensor malfunctions during decontamination, it is possible to protect the device installed inside the isolator from corrosion. [Brief explanation of the drawing]

[0033] [Figure 1]This is a schematic diagram of the decontamination device for a sterile, sealed space according to Embodiment Example 1 of this invention. [Figure 2] This is a schematic diagram showing a state in which a decontamination device for a sterile sealed space and a device having a sterile sealed space are connected by a duct, according to Embodiment Example 1 of this invention. [Figure 3] This diagram shows the dry fog generator of a decontamination device for a sterile, sealed space according to Embodiment Example 1 of the present invention. [Figure 4] This is a diagram showing the configuration of the mounting locations for the blower fan of the micronozzle and the intake fan of the gas recovery section of the dry fog generator of the decontamination device for a sterile sealed space according to Embodiment Example 1 of this invention. [Modes for carrying out the invention]

[0034] (Example of Embodiment 1) A decontamination device A for decontaminating a sterile, sealed space according to Embodiment Example 1 of this invention will be described with reference to Figures 1 to 4.

[0035] First, as shown in Figure 1, the decontamination device A consists of a dry fog generator 1, a temperature and humidity sensor 2, and a gas recovery device 3, all of which are computer-controlled by a main control and monitoring device 4. The dry fog generator 1 uses a peracetic acid mixture containing low-concentration peracetic acid, water, acetic acid, and hydrogen peroxide as a decontamination agent to generate dry fog consisting of particles with an average particle size of 10 μm. The gas recovery device 3 is a dehumidifier that recovers the gas consisting of acetic acid, water, and active oxygen generated by the decomposition of the dry fog particles in the peracetic acid mixture in a sterile, sealed space described later, as well as the entire peracetic acid mixture gas. The gas recovery device 3 is equipped with a waste liquid tank 5 for storing the moisture in the gas recovered by the gas recovery device 3.

[0036] Furthermore, the main control and monitoring device 4 controls the dry fog generator 1 and the gas recovery unit 3 by turning them on and off using a computer based on the temperature and humidity information measured by the temperature and humidity sensor 2. It also has a monitoring function. The main control and monitoring device 4 can also transmit information to an external control device via wired or wireless connection using a communication device 6, and can be controlled by the external control device (computer).

[0037] The decontamination device A is used to decontaminate the sealed space of isolator B, which is a device having a sterile, sealed space. Specifically, as shown in Figure 2, the decontamination device A and isolator B are connected by two ducts, a first duct 7 and a second duct 8.

[0038] The first duct 7 sends the dry fog sprayed from the decontamination device A to the spare chamber 9 at the top of the isolator B by a blower fan 34, which will be described later. The dry fog is then blown from the spare chamber 9 by a fan 10. HEPA The contents are sent through the filter 11 to the sealed space 12, where they are decontaminated.

[0039] In the sealed space 12, the peracetic acid in the dry fog, which consists of a peracetic acid mixture, decomposes quickly. During the decomposition process, the released reactive oxygen species (a type of radical) act on the SH groups and SS bonds in the enzymes of microorganisms, destroying the cell membrane and thus killing the organism. Furthermore, radicals are highly reactive and have a short lifespan, so the decontamination effect does not last long. In addition, since humidity is maintained even after decomposition, it is not possible to spray additional decontamination agents in a humidity-controlled sealed space.

[0040] Therefore, the temperature and humidity sensor 2 measures the humidity, and when the measured humidity reaches a predetermined set humidity value or higher, the main control and monitoring device 4 stops the operation of the dry fog generator 1 and starts the operation of the gas recovery device 3. The intake fan 36, described later, is also activated. This dehumidifies the humidity in the sealed circulating space consisting of the sealed space 12, the first duct 7, the second duct 8, and the space inside the decontamination device A. When the humidity measured by the temperature and humidity sensor 2 decreases, the operation of the gas recovery device 3 is stopped and the operation of the dry fog generator 1 is restarted.

[0041] By repeating this cycle, the sealed space 12 continues to produce radicals, creating a state with a high concentration of radicals (called radical-rich), which can kill all microorganisms.

[0042] The air in the sealed space 12 of the isolator B then passes through the lower grating 13 and enters the lower passage 14, where some of the air enters the second duct 8 and is absorbed by the gas recovery unit 3 in the decontamination device A. Other air passes through the lower passage 14 and the vertical passage 15 to the reserve chamber 9, and then passes through the HEPA filter 11 via the fan 10 back to the sealed space 12. This sealed circulating space is maintained at a weak positive pressure.

[0043] Next, a specific example of the dry fog generator 1 is shown in Figure 3. The dry fog generator 1 is equipped with a purified water tank 18 and a decontamination agent tank 19 consisting of the acetic acid mixture. A first stepping motor 21 is provided in the output path 20 of the purified water tank 18, and a second stepping motor 23 is provided in the output path 22 of the decontamination agent tank 19. These output paths 20 and 23 are merged at a merging point 24, and an in-line filter 26 is provided in the merging path 25.

[0044] The tip of the confluence path 25 is connected to a micronozzle 27, into which compressed air flows from a compressor 28, and the mixture of purified water and decontamination agent can be sprayed from the micronozzle 27 as a dry fog with an average particle size of 10 μm.

[0045] Furthermore, a T-connector 29 is provided in the confluence path 25, and a branch path 30 is provided. A third stepping motor 31 provided in the branch path 30 can suck up the purified water, decontamination agent, and mixtures thereof remaining in the output paths 20, 22 and the confluence path 25 from the first stepping motor 21 and the second stepping motor 23 onwards, and store them in the drainage tank 32. Note that the output paths 20, 22, the confluence path 25, and the branch path 30 are all made up of tubes or thin pipes.

[0046] Thus, the present invention employs a small nozzle (micro nozzle 27) with no dead volume and does not require a diluent tank. The decontamination agent and purified water are combined in a thin tube immediately before use, and pass through an in-line filter 26 to filter out impurities and mix, thereby reducing dead volume.

[0047] Furthermore, the compressor 28 used is a small one without a compressed air tank. With a small compressor, the effective maximum pressure is about 0.2 MPa, so the particle size sprayed from the micro nozzle 27 is a dry fog with an SMD (scalculated particle size from surface area) of about 11.0 ± 1.0 μm, but with natural water supply, the measured concentration is about 10.9%. At this concentration, liquid accumulates in the duct, consuming radicals at the liquid surface and reducing the decontamination effect. To solve this, the flow rate of the decontamination agent and purified water is controlled by the first and second stepping motors 21 and 23, respectively, and by precisely controlling the spray volume, the concentration can be maintained at 2% or less, and decontamination in a dry state is possible even with low-pressure compressed air.

[0048] Simultaneously, by controlling the stepping motors 21 and 23, the dilution ratio and the amount of diluent dispensed can be automatically set. This prevents human error during dilution and ensures worker safety. In addition, as a decontamination parameter for the sealed space 12, it is possible to manage the decontamination time after reaching the set humidity level, as well as manage the amount of purified water and decontamination agent used, taking into account the effect of temperature rise. Furthermore, it is possible to manage the remaining amount of purified water and decontamination agent, and by setting an expiration date, it is possible to prevent accidental use of expired products.

[0049] Furthermore, as shown in Figure 4, the micronozzle 27 of the dry fog generator 1 is supported and fixed within the air outlet pipe 33 of the decontamination device A, and a blower fan 34 is provided in the air outlet pipe 33 behind the micronozzle 27. The first duct 7 is connected to the front end of the air outlet pipe 33.

[0050] In addition, an intake pipe 35 is provided in the decontamination device A alongside the blower pipe 33. The second duct 8 is connected to the front end of the intake pipe 35, and an intake fan 36 is connected to the rear end. The blower fan 34 and the intake fan 36 operate continuously during decontamination work, forming a circulation path from the decontamination device A through the first duct 7, isolator B, second duct 8, and back to the decontamination device A. Dry fog, gas, and radicals circulate through this path, increasing the overall amount of radicals.

[0051] Furthermore, the intake pipe 35 of the decontamination device A is equipped with temperature and humidity sensors 37 and 38 that measure the temperature and humidity inside the intake pipe 35. These two temperature and humidity sensors 37 and 38 are calibrated sensors with small errors and synchronized measurements. Therefore, a threshold for the error of the measured humidity (RH%) of these temperature and humidity sensors and the time of deviation from that threshold are predetermined, and the device is configured to detect an abnormality in the temperature and humidity sensor when the deviation time exceeds the threshold, trigger an alarm, and stop the decontamination process.

[0052] In the above embodiment example, the decontamination of the sealed space 12 of the isolator B was described using the decontamination device A. However, the decontamination target of this invention is not limited to the isolator B, but can be applied to other devices having a sterile sealed space.

[0053] Furthermore, although the decontamination device A and isolator B are connected by a duct in the above embodiment example, if pipes other than ducts such as air supply pipes are used, ru It is also possible that the decontamination device A is independent of the device having a sterile, sealed space to be decontaminated, or that the decontamination device A is built into the device. [Explanation of Symbols]

[0054] A Decontamination device B Isolator 1. Dry fog generator 2. Humidity sensor 3. Gas recovery machine 4. Control device 5. Waste liquid tank 6. Communication device 7. First duct 8. Second duct 9 Spare room 10 Fan 11 HEPA filter 12 Sealed space 13 Grating 14 Lower walkway 15 Vertical passage 18 Purified water tank 19 Decontamination tank 20 Output side path 21 First stepping motor 22 Output path 23 Second stepping motor 24 Confluence point 25. Confluence route 26. Inline filter 27 Micro nozzles 28 Compressors 29 T-connector 30 Branch route 31 Third stepping motor 32 Drainage tank 33 Air outlet pipe 34 Blower fan 35 Intake pipe 36 Intake fan 37 Temperature and humidity sensor 38 Temperature and humidity sensor

Claims

1. A decontamination device in a sterile sealed space, in which the sealed space of the device and a decontamination device are connected by two ducts, and the decontamination device is equipped with a dry fog generator, a temperature and humidity sensor, a gas recovery device, and a main control and monitoring device, The dry fog generator comprises a purified water tank and a decontamination agent tank made of a peracetic acid mixture, a first stepping motor and a second stepping motor respectively provided in the output path of each tank, the output paths being connected at a junction, a filter provided at the junction, a micro-nozzle provided at the end of the junction path leading out from the junction, and a small compressor for sending compressed air into the micro-nozzle; a blower fan is provided to send the dry fog sprayed by the dry fog generator through the one duct into the sterile sealed space; an intake fan that draws the gas in the sterile sealed space into the decontamination apparatus through the other duct; A decontamination device in a sterile, sealed space, characterized in that the gas recovery machine recovers gas within the decontamination device, the temperature and humidity sensor measures the temperature and humidity within the decontamination device, and the main control and monitoring device is configured to computer-control the operation or stop of a dry fog generator and the operation or stop of the gas recovery machine according to the measurements of the temperature and humidity sensor.

2. 2. A decontamination device for a sterile enclosed space as described in claim 1, characterized in that a branch path leading to a drainage tank via a connector is provided in the confluence path, and a third stepping motor is provided in the branch path to guide the liquid in the output path and the confluence path to the drainage tank.

3. A method for decontaminating a sterile sealed space using a decontamination device in a sterile sealed space, the decontamination device being connected to the sealed space of an apparatus having the sterile sealed space by two ducts, the decontamination device being equipped with a dry fog generator, a temperature and humidity sensor, a gas recovery device, and a main control and monitoring device, The dry fog generator comprises a purified water tank and a decontamination agent tank made of a peracetic acid mixture, the output paths of the tanks being connected to a junction via a first stepping motor and a second stepping motor, respectively, a filter being provided in the junction path extending from the junction, a micro-nozzle being provided at an end of the junction path, and a small compressor being provided to send compressed air into the micro-nozzle; a blower fan is provided to send the dry fog sprayed by the dry fog generator into the sterile sealed space through one of the ducts, and an intake fan is provided to draw the gas in the sterile sealed space into the decontamination apparatus through the other duct; the gas recovery machine recovers gas within the decontamination equipment, the temperature and humidity sensor measures the temperature and humidity within the decontamination equipment, and the main control and monitoring device is configured to computer-control the operation or stop of the dry fog generator and the operation or stop of the gas recovery machine according to the measured values ​​of the temperature and humidity sensor; A set humidity in the decontamination apparatus is set in advance, a main control and monitoring device that performs computer control to repeatedly operate the dry fog generator and the dry fog generator when the humidity measured by the temperature and humidity sensor reaches or exceeds the set humidity, and to stop the operation of the dry fog generator and activate the gas recovery device to recover the gas in the sterile sealed space through the other duct; and a main control and monitoring device that performs computer control to repeatedly operate the dry fog generator and the dry fog generator when the humidity measured by the temperature and humidity sensor reaches or exceeds the set humidity, and to stop the operation of the gas recovery device and activate the dry fog generator.

4. A method for decontaminating a sterile enclosed space as described in claim 3, characterized in that the flow rate of a decontamination agent consisting of a mixture of purified water and peracetic acid is controlled by controlling the first stepping motor and the second stepping motor.

5. A method for decontaminating a sterile enclosed space according to claim 3 or 4, characterized in that a branch path leading to a drainage tank via a connector is provided in the confluent path, a third stepping motor is provided in the branch path to direct the liquid in the output path and the confluent path to the drainage tank, and before decontamination work begins, the liquid in the output path and the confluent path after the first stepping motor and the second stepping motor is sucked into the drainage tank by the third stepping motor.

6. The decontamination method for a sterile enclosed space according to claim 3, characterized in that two temperature and humidity sensors are provided, the two temperature and humidity sensors are constantly operated, and when the time during which the difference in humidity measured by the two temperature and humidity sensors exceeds the threshold exceeds a specified time, the main control and monitoring device stops the operation of the entire device.

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