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WO2018124339A1 - Dispositif de stérilisation et procédé de mesure d'une concentration en peroxyde d'hydrogène d'un dispositif de stérilisation - Google Patents

Dispositif de stérilisation et procédé de mesure d'une concentration en peroxyde d'hydrogène d'un dispositif de stérilisation Download PDF

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Publication number
WO2018124339A1
WO2018124339A1 PCT/KR2016/015521 KR2016015521W WO2018124339A1 WO 2018124339 A1 WO2018124339 A1 WO 2018124339A1 KR 2016015521 W KR2016015521 W KR 2016015521W WO 2018124339 A1 WO2018124339 A1 WO 2018124339A1
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Prior art keywords
hydrogen peroxide
humidity sensor
concentration
humidity
water
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PCT/KR2016/015521
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English (en)
Korean (ko)
Inventor
민흥식
안영근
양성진
김종욱
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CMTech Co Ltd
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CMTech Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/208Hydrogen peroxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26Accessories or devices or components used for biocidal treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/12Apparatus for isolating biocidal substances from the environment
    • A61L2202/122Chambers for sterilisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/14Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • the present invention relates to a sterilization apparatus and a method for measuring hydrogen peroxide concentration of the sterilization apparatus, and more particularly, a sterilization apparatus capable of accurately detecting the concentration of hydrogen peroxide in hydrogen peroxide by a simple method and the measurement of hydrogen peroxide concentration of the sterilization apparatus. It is about a method.
  • Medical instruments are usually sterilized by high pressure steam sterilization using saturated steam under high pressure, or by ethylene oxide gas sterilization using chemicals such as ethylene oxide that does not damage heat-affected instruments or materials.
  • high pressure steam sterilizer sterilizes at a high temperature of more than 120 degrees
  • medical instruments made of synthetic resins that have been recently developed are deformed, and medical instruments made of steel are dulled with fine blades, which are much shorter than the conventional lifespan.
  • high-pressure steam sterilization may be an unsuitable sterilization method because expensive medical devices, instruments, and devices that are increasing due to the development of the latest surgical technology may be damaged during sterilization reprocessing because they are sensitive to heat or moisture.
  • the ethylene oxide gas sterilizer can minimize the damage to the device, it can be sterilized at low temperature, but the ethylene oxide remains in the sterilized product or the reaction product may cause carcinogenic and toxic substances to be generated. Time is required.
  • ethylene oxide gas itself is a high explosion risk, it has been reported that it can act as a genetic toxic substance that can cause mutations, and it is prescribed as a carcinogen, which requires much attention to its use.
  • the sterilization method using hydrogen peroxide steam is a short sterilization time within 30 to 60 minutes at a temperature of 40 to 50 degrees, and the substances discharged to the atmosphere after sterilization are harmless to humans or the environment, so the disadvantages of the high pressure steam sterilizer and ethylene oxide gas Various disadvantages of the sterilizer can be compensated for.
  • the hydrogen peroxide aqueous solution used to generate the hydrogen peroxide vapor makes it difficult to sufficiently diffuse hydrogen peroxide by evaporating and diffusing water before hydrogen peroxide during the vaporization process. This is because water is evaporated more quickly because of the higher vapor pressure than hydrogen peroxide, and because the molecular weight of water is lower than hydrogen peroxide, water vapor diffuses more rapidly into the gas phase than hydrogen peroxide vapor.
  • Water vapor diffuses more quickly into diffusion-limiting spaces, such as smaller crevices or long narrow lumens, to suppress the permeation of hydrogen peroxide vapor. In other words, water reaches the sterilized product before hydrogen peroxide, so that sterilization is not performed properly.
  • a hydrogen peroxide aqueous solution having a handleable concentration of 60 wt% or less through each step of concentration, for example, to a high concentration of hydrogen peroxide solution of 95 wt% or more and use it as a sterilizing agent. It can improve sterilization effect.
  • the problem to be solved by the present invention is that the present invention was developed in order to solve the above problems, it is possible to accurately detect the concentration of hydrogen peroxide in the hydrogen peroxide by a simple method, avoiding the enlargement or complexity of the sterilization apparatus It is to provide a sterilization apparatus and a method for measuring the hydrogen peroxide concentration of the sterilization apparatus.
  • the present invention is a sterilization apparatus including a sterilization chamber, the sterilization chamber, the first humidity sensor and a second humidity located adjacent to the first humidity sensor located in a predetermined region inside And a sensor, wherein the first humidity sensor detects the first relative humidity by the amount of hydrogen peroxide and the amount of water vapor, and the second humidity sensor detects the second relative humidity by the amount of water vapor. to provide.
  • the present invention is characterized in that the first humidity sensor is a humidity sensor of a moisture absorption method, a humidity sensor of a saturation method or a humidity sensor of an absorption method, and the second humidity sensor is a humidity sensor of a spectroscopic method. It provides a sterilization apparatus.
  • the present invention also provides a sterilization apparatus for calculating the concentration of the hydrogen peroxide by calculating a difference between the first relative humidity detected by the first humidity sensor and the second relative humidity detected by the second humidity sensor. do.
  • the present invention comprises the steps of detecting the first relative humidity by the first humidity sensor; Detecting a second relative humidity by a second humidity sensor; Deriving a difference value between the first relative humidity and the second relative humidity; And it provides a hydrogen peroxide concentration measuring method comprising the step of calculating the concentration of hydrogen peroxide through the difference value.
  • the present invention also provides a method for measuring hydrogen peroxide concentration in which the first humidity sensor determines relative humidity by the amount of water vapor and the amount of hydrogen peroxide, and the second humidity sensor determines the relative humidity by the amount of water vapor.
  • the present invention is characterized in that the first humidity sensor is a humidity sensor of a moisture absorption method, a humidity sensor of a saturation method or a humidity sensor of an absorption method, and the second humidity sensor is a humidity sensor of a spectroscopic method. It provides a method for measuring the hydrogen peroxide concentration.
  • the present invention is a target space for measuring the concentration of hydrogen peroxide, wherein the target space includes a first humidity sensor located in a predetermined internal area and a second humidity sensor located adjacent to the first humidity sensor; The first humidity sensor detects a first relative humidity by the amount of hydrogen peroxide and the amount of water vapor, and the second humidity sensor provides a target space for detecting the second relative humidity by the amount of water vapor.
  • the present invention is characterized in that the first humidity sensor is a humidity sensor of a moisture absorption method, a humidity sensor of a saturation method or a humidity sensor of an absorption method, and the second humidity sensor is a humidity sensor of a spectroscopic method. Provide the target space.
  • the present invention provides a target space, characterized in that the temperature of the first humidity sensor and the second humidity sensor is controlled higher than the temperature of the target space.
  • the relative humidity is detected by each of these sensors, the concentration of hydrogen peroxide by the difference in these relative humidity It can be measured easily.
  • FIG. 1 is a schematic perspective view showing a sterilizer using an aqueous solution of a sterilant according to the present invention
  • Figure 2 is a schematic configuration diagram showing a sterilizer using an aqueous solution of a sterilant according to the present invention.
  • Figure 3 is a flow chart illustrating a sterilization method of the sterilization apparatus using a sterilant aqueous solution according to the present invention.
  • Figure 4 is a graph showing the response of the capacitive humidity sensor in the sterilization apparatus.
  • FIG. 5 is a flowchart illustrating a method for measuring hydrogen peroxide concentration according to the present invention.
  • first, second, etc. are used to describe various components, these components are of course not limited by these terms. These terms are only used to distinguish one component from another. Therefore, of course, the first component mentioned below may be a second component within the technical spirit of the present invention.
  • spatially relative terms below “, “ beneath “, “ lower”, “ above “, “ upper” It can be used to easily describe a component's correlation with other components. Spatially relative terms are to be understood as including terms in different directions of components in use or operation in addition to the directions shown in the figures. For example, when flipping a component shown in the drawing, a component described as “below” or “beneath” of another component may be placed “above” the other component. Can be. Thus, the exemplary term “below” can encompass both an orientation of above and below. The components can be oriented in other directions as well, so that spatially relative terms can be interpreted according to the orientation.
  • FIG. 1 is a schematic perspective view showing a sterilizer using an aqueous solution of a sterilant according to the present invention
  • Figure 2 is a schematic configuration diagram showing a sterilizer using an aqueous solution of a sterilant according to the present invention.
  • the sterilizing agent may be hydrogen peroxide
  • the sterilizing agent aqueous solution may be hydrogen peroxide
  • the sterilizing agent is hydrogen peroxide
  • the sterilizing agent aqueous solution will be described in correspondence with hydrogen peroxide. do.
  • the sterilization apparatus 100 using hydrogen peroxide according to the present invention includes a sterilization chamber (110).
  • the sterilization chamber 110 represents a container into which sterilized substances, such as medical instruments or surgical instruments, to be sterilized are put. At this time, one side of the sterilization chamber 110 may include a door for access to the sterilized material.
  • the vacuum pump 120 may draw a gas inside the sterilization chamber 110 to form a vacuum state.
  • a vacuum valve 121 for controlling the operation of the vacuum pump 120 is connected.
  • the sterilization apparatus 100 using hydrogen peroxide water according to the present invention is connected to the other side of the sterilization chamber 110 to supply hydrogen peroxide vapor to the sterilization chamber 110.
  • the sterilization chamber 110 and the vaporizer 130 may include a vaporization valve 131.
  • the sterilization apparatus 100 using hydrogen peroxide one side is connected to the vaporizer 130, the other side is connected to the sterilization chamber 110, the vaporizer 130 A collector 140 (or may be termed a collector vaporizer) for concentrating the supplied hydrogen peroxide.
  • the sterilization chamber 110 and the collector 140 may include a vaporization valve 131.
  • the sterilization chamber 110 and the collector 140 may include a collection valve 141.
  • the vaporization valve 131 and the collection valve 141 may be connected in parallel between the sterilization chamber 110 and the collector 140.
  • between the sterilization chamber 110 and the vaporizer 130 may include a vaporization valve 131, that is, one side of the vaporization valve 130 and the sterilization chamber 110 and The other side may be connected in parallel with the vaporizer 130 and the collector 140.
  • the sterilization apparatus 100 using hydrogen peroxide includes a first connection pipe 142 and the vaporization connecting the collector 140 and the vaporization valve 131. It may include a second connecting pipe 133 connecting the valve 131 and the sterilization chamber 110.
  • a third connecting pipe 143 connecting the collector 140 and the collection valve 141 and a fourth connecting pipe 144 connecting the collection valve 141 and the sterilization chamber 110. can do.
  • the fourth connection pipe 144 is connected to the second connection pipe 133, and the vaporization valve 131 and the collection valve 141 are disposed between the sterilization chamber 110 and the collector 140.
  • the fourth connection pipe 144 is connected directly to the sterilization chamber 110, the vaporization valve 131 between the sterilization chamber 110 and the collector 140, in contrast.
  • the collection valve 141 may be connected in parallel.
  • the vaporizer 130 may include a fifth connection pipe 132 connecting the vaporization valve 131, in this case, the fifth connection pipe 132 is the first connection pipe 142 in the drawing Is connected to the vaporization valve 130 and the vaporizer 130 and the collector 140, but in contrast, the fifth connection pipe 132 is directly connected to the vaporization valve 131
  • the vaporization valve 130 may be connected in parallel with the vaporizer 130 and the collector 140.
  • the vaporization valve 131 and the collection valve 141 may control the flow of the fluid of the first connection pipe 142 to the fifth connection pipe 132 by the open / close operation,
  • the open / close operation of the vaporization valve 131 and the collection valve 141 may be controlled by a separate controller.
  • the first connection pipe 142 for connecting the collector 140 and the vaporization valve 131 and the second connection pipe 133 for connecting the sterilization chamber 110 and the vaporization valve 131. May have a larger inner diameter than other connection pipes, that is, the third connection pipes 143 to the fifth connection pipes 132, for example, the third connection pipes 143 to the fifth connection pipes 132.
  • the first connection pipe 142 and the second connection pipe 133 may be 1 inch pipe. This will be described later.
  • the temperature control means may be a heater, which Since it is obvious in the art, a detailed description thereof will be omitted.
  • the collector 140 may further include a cooling means as a temperature control means, and the cooling means may use a suitable means such as direct cooling using cooling water or a thermoelectric element or air cooling by blowing a heat exchanger. .
  • Figure 3 is a flow chart illustrating a sterilization method of the sterilization apparatus using a sterilant aqueous solution according to the present invention.
  • the sterilizing agent may be hydrogen peroxide
  • the sterilizing agent aqueous solution may be hydrogen peroxide
  • the sterilizing agent is hydrogen peroxide
  • the sterilizing agent aqueous solution will be described in correspondence with hydrogen peroxide. do.
  • the sterilization method of the sterilization apparatus using hydrogen peroxide includes the step of evacuating the sterilization chamber 110 (or, may be named sterilization chamber) and the vaporizer 130 ( S110).
  • Evacuating the sterilization chamber 110 and the vaporizer 130 may be evacuated by operating the vacuum pump 120 (on) and opening the vacuum valve 121.
  • step S110 that is, the step of evacuating the sterilization chamber and the vaporizer may be continued until step S160 to be described later, when the sterilization chamber reaches a predetermined set pressure, and the hydrogen peroxide liquid from which the water is removed is collected in the collector This step can be completed.
  • the vaporization valve 131 between the sterilization chamber 110 and the vaporizer 130, or between the sterilization chamber 110 and the collector 140 is in an open state, is in communication with the sterilization chamber in the vacuum exhaust to be a pressure below atmospheric pressure and closed in the next step.
  • the sterilization chamber and the vaporizer may be maintained at a temperature set by the above-described temperature control means.
  • the hydrogen peroxide solution may be introduced through a hydrogen peroxide supply device 150 for storing hydrogen peroxide water at a first concentration. Meanwhile, although not shown in FIGS. 1 and 2, the vaporizer 130 and the hydrogen peroxide supply are provided. A hydrogen peroxide water supply control valve (not shown) may be provided between the devices 150 to supply an appropriate amount of hydrogen peroxide water.
  • the first concentration of the hydrogen peroxide solution may be 60% by weight or less.
  • the concentration of hydrogen peroxide is limited to 60% by weight or less in the handling of hydrogen peroxide solution, i.e., hydrogen peroxide water, so it is practically difficult to use a higher concentration of hydrogen peroxide as a sterilant.
  • the first concentration of the hydrogen peroxide water indicates the concentration of the hydrogen peroxide water that can be handled and does not have an important meaning in understanding the meaning of the present invention.
  • the first temperature may be 60 to 70 °C
  • the first pressure may be 800 mb (pre-bar) to atmospheric pressure.
  • step S120 while the hydrogen peroxide water of the first concentration is introduced into the vaporizer 130, the vaporization valve 131 and the collection valve 141 may correspond to a close state, but, depending on the supply device open It may be a state.
  • step S120 the pressure of the sterilization chamber 110 is 600 mb to atmospheric pressure, the temperature may be 45 to 55 °C, the pressure of the collector 140 is 800 mb to atmospheric pressure, the temperature is 38 to May be 42 ° C.
  • the first temperature in the present invention is characterized in that higher than the temperature of the sterilization chamber.
  • the first temperature corresponds to the temperature of the vaporizer in the process of vaporizing more water vapor from the hydrogen peroxide water, the vaporization process of the water vapor very strong endothermic reaction occurs to suppress the vaporization rate very strongly.
  • the first temperature is at least higher than the temperature of the sterilization chamber.
  • the hydrogen peroxide water of the first concentration injected into the vaporizer 130 is vaporized (ie, water is removed) to form hydrogen peroxide water of the second concentration.
  • the second concentration of the hydrogen peroxide solution may be 75% by weight to 85% by weight, and step S130 may be performed by vaporizing water in 60% by weight or less of hydrogen peroxide, thereby forming hydrogen peroxide water at a concentration of 75% by weight to 85% by weight. It may be a first concentration step.
  • water ie, moisture
  • water in the hydrogen peroxide water is evaporated / diffused before hydrogen peroxide, and thus a second concentration of hydrogen peroxide water may be formed.
  • the evaporated water is evacuated through the vacuum pump via the sterilization chamber 110, and thus, in step S130 to operate (on) the vacuum pump 120, the vacuum valve 121 and the vaporization valve 131 corresponds to an open state.
  • step S130 the temperature of the vaporizer 130 is temporarily lowered by the endothermic reaction of the vaporization process, the temperature is in the range of 55 to 65 °C, the pressure can be 30 to 800 mb (pre-bar) have.
  • the pressure of the sterilization chamber 110 is in the range of 10 to 600 mb, the temperature may be 45 to 55 °C In addition, the pressure of the collector 140 is in the range of 20 to 500 mb, the temperature may be 35 to 40 °C.
  • the vacuum pump 120 In order to inject the hydrogen peroxide solution of the second concentration into the collector 140 of the second temperature and the second pressure, the vacuum pump 120 is operated (on), and the vacuum valve 121 is opened, The vaporization valve 131 may be controlled in a close state, and the collection valve 141 may be controlled in an on state.
  • the second temperature may be 35 to 42 °C
  • the second pressure may be 8 to 50 mb.
  • the pressure of the vaporizer 130 may be 10 to 60 mb
  • the temperature may be 55 to 60 °C
  • the second The concentration of hydrogen peroxide solution may move from the vaporizer 130 to the collector 140 via the fifth connection pipe 132 and the first connection pipe 142.
  • step S140 the sterilization chamber 110 is continuously evacuated, the pressure of the sterilization chamber 110 is 1 to 10 mb, the temperature may be 45 to 55 °C.
  • the second temperature in the present invention is characterized in that lower than the temperature of the sterilization chamber.
  • the second temperature corresponds to the temperature of the collector in which the hydrogen peroxide water of the second concentration is collected, and if the saturated hydrogen peroxide vapor from the vaporizer is higher than the temperature of the chamber in the course of passing through the collector, the hydrogen peroxide vapor cannot be condensed in the collector. May be exhausted through the chamber.
  • the second temperature is preferably at least lower than the temperature of the sterilization chamber.
  • step S140 that is, the second temperature and the second Injecting the second concentration of hydrogen peroxide water into the collector of 2 pressure.
  • the first concentration of hydrogen peroxide water directly into the collector it may be considered that the first concentration of hydrogen peroxide water directly into the collector, but is not preferable for the following reasons.
  • Table 1 below shows an example of the vaporization rate of hydrogen peroxide vapor by the concentration of hydrogen peroxide water.
  • the vaporization rate of hydrogen peroxide vapor in a 60% by weight hydrogen peroxide solution is 13%, which means that the remaining 87% is water vapor, and the vaporization rate of hydrogen peroxide vapor in an 80% by weight hydrogen peroxide solution. Is 40%, which means that the remaining 60% is water vapor.
  • performing step S140 without step S130 may mean, for example, adding 60% by weight of hydrogen peroxide to a collector, and performing step S140 after performing step S130 is performed by 80% by weight. This could mean adding hydrogen peroxide to the collector.
  • the ratio of the water vapor passing through the collector in the initial stage is relatively higher than when the step S140 is performed after the step S130 is performed.
  • the collector is introduced into the collector when the pressure of the collector is high (saturated water vapor pressure is 75mb when the collector temperature is 40 ° C). It can also be condensed in the collector.
  • the condensation of water vapor into the collector means that there is a limit to the concentration of hydrogen peroxide that is concentrated by the amount of water vapor that is condensed.
  • step S130 that is, the hydrogen peroxide water of the second concentration by vaporizing the first concentration of hydrogen peroxide water
  • step S140 that is, the step of introducing the hydrogen peroxide water of the second concentration to the collector of the second temperature and the second pressure.
  • the hydrogen peroxide vapor in the second concentration of hydrogen peroxide water is condensed in the collector, and the step of evacuating the water vapor from the collector (S150).
  • the water is faster than the hydrogen peroxide because of the higher vapor pressure
  • Water is diffused into the gas phase more quickly than hydrogen peroxide because the molecular weight of water is lower than hydrogen peroxide, and therefore, at the same temperature and pressure conditions, water (i.e., moisture) evaporates and diffuses faster than hydrogen peroxide. Since water of evaporates / diffuses before hydrogen peroxide, hydrogen peroxide vapor is condensed in the collector, and water vapor is exhausted from the collector, so that a third concentration of hydrogen peroxide water can be formed.
  • the hydrogen peroxide water condensed in the collector may include hydrogen peroxide at a concentration higher than the concentration of the hydrogen peroxide water at the second concentration.
  • the hydrogen peroxide vapor and steam passing through the pipe at step S140 is moved in the order of the fifth connection pipe, the first connection pipe, the third connection pipe, the fourth connection pipe, in this case, the smaller inner diameter of these connection pipes
  • the temperature of must be higher than the temperature of the collector 140.
  • the gaseous hydrogen peroxide vapor and water vapor differ in temperature at which they can condense at the same pressure. For example, at 35 degrees, hydrogen peroxide condenses above 5 mb and water vapor condenses above 55 mb.
  • this difference is, for example, when the collector temperature being evacuated through the collecting valve is 35, the hydrogen peroxide vapor is condensed when the pressure is in the range of 5 mb to 55 mb, and the steam can be exhausted from the collector.
  • the third concentration of the hydrogen peroxide solution may be 90% by weight to 95% by weight, and step S150 by vaporizing water in 75% by weight to 85% by weight of hydrogen peroxide, 90% by weight to 95% by weight of hydrogen peroxide It may be a second concentration step of hydrogen peroxide solution to form water.
  • the hydrogen peroxide vapor in the second concentration of hydrogen peroxide in the step and the second concentration of hydrogen peroxide in the collector of the second temperature and the second pressure of step S140 and condensed in the collector The exhaust gas from the collector is described as being sequentially performed, but, alternatively, the steps S140 and S150 may be performed at the same time.
  • the evaporated water is evacuated through the vacuum pump, and thus, in operation S150, the vacuum pump 120 may be operated (on), and the vacuum may be evacuated by opening the vacuum valve 121.
  • the collection valve 141 corresponds to an open state.
  • the method includes lowering the sterilization chamber to a predetermined pressure and concentrating the third concentration of hydrogen peroxide water to a fourth concentration of hydrogen peroxide water (S160).
  • the predetermined pressure should be a set pressure for sterilization in the sterilization chamber, and, if the sterilant is hydrogen peroxide vapor, it should be easy to diffuse vacuum degree.
  • the set pressure may be 0.5 to 1.3 mb
  • the temperature of the sterilization chamber may be 45 to 55 °C.
  • the fourth concentration of the hydrogen peroxide solution may be greater than or equal to 95% by weight, the third concentration of hydrogen peroxide to form more than 95% by weight of hydrogen peroxide by evaporating water in the hydrogen peroxide solution of the concentration of 90% to 95% by weight in step S160 It may be a step.
  • the evaporated water is evacuated through the vacuum pump, and thus, in step S160, the vacuum pump 120 may be operated (on) and vacuumed by opening the vacuum valve 121.
  • step S160 the collection valve 141 may repeat the open state and the close state.
  • hydrogen peroxide evaporates at a pressure of about 20mb or less in 80% by weight hydrogen peroxide solution, but hydrogen peroxide does not evaporate at a pressure of about 11mb or less in 90% by weight hydrogen peroxide solution. Done.
  • the high concentration of hydrogen peroxide can continue the decomposition reaction, the water generated during the decomposition will lower the concentration of hydrogen peroxide.
  • This water removal method takes a very long time in the low concentration step, but is effective to remove a small amount of water in the high concentration step, it can be said to be effective to maintain at least a high concentration.
  • the pressure of the collector 140 containing a third concentration of hydrogen peroxide is continuously lowered to prevent the hydrogen peroxide from evaporating at a lower pressure, the collection
  • the valve 141 may prevent the pressure of the collector 140 from continuously lowering by repeating the open state and the close state.
  • the pressure of the collector 140 is 5 to 10 mb
  • the temperature may be 35 to 40 °C
  • the pressure of the vaporizer 130 may be 7 to 10 mb
  • the temperature may be 60 to 70 °C.
  • step S160 since the aqueous solution of the vaporizer is completely exhausted, the temperature is restored in a vacuum state, and the collector is concentrated with high concentration of hydrogen peroxide, and a small amount of water is removed, or stays in the collector while maintaining an appropriate pressure.
  • the collector can then be lowered to a lower temperature by temperature control means to prevent excessive exhaustion of hydrogen peroxide.
  • the hydrogen peroxide vapor of the hydrogen peroxide solution of the fourth concentration is put into a sterilization chamber, and the step of sterilizing the object to be treated (S170).
  • step S170 in order to inject the hydrogen peroxide vapor of the hydrogen peroxide solution of the fourth concentration located in the collector 140 to the sterilization chamber 110, the vaporization valve 131 is open, the collection valve corresponds to the open or close state. .
  • the hydrogen peroxide vapor from the collector 140 to the sterilization chamber 110 may move through the first connection pipe 142 and the second connection pipe 133.
  • the first connection pipe 142 connecting the collector 140 and the vaporization valve 131 and the second connection pipe connecting the vaporization valve 131 and the sterilization chamber 110 may have a larger inner diameter than other connection pipes, that is, the third connection pipe 143 to the fifth connection pipe 132, for example, the third connection pipe 143 to the fifth connection pipe 132.
  • the first connection pipe 142 and the second connection pipe 133 may be a 1 inch pipe.
  • hydrogen peroxide vapor flows into the sterilization chamber 110 from the collector 140 through the first connection pipe 142 and the second connection pipe 133, and the hydrogen peroxide vapor flows into the fifth connection pipe 132.
  • hydrogen peroxide vapor may be introduced into the first connection pipe 142 having a relatively large inner diameter, and hydrogen peroxide vapor may not be introduced into the fifth connection pipe 132 having a relatively small inner diameter.
  • the hydrogen peroxide vapor is added to the sterilization chamber, the sterilization treatment target, it is preferable that the hydrogen peroxide vapor is added in a state where the temperature of the hydrogen peroxide vapor is not high.
  • the sterilization chamber enters the sterilization chamber at a temperature higher than the temperature of the sterilization chamber before the hydrogen peroxide vapor is sufficiently saturated in the sterilization chamber, the density of the hydrogen peroxide vapor in the entry path becomes excessive and easily condensed.
  • the gas phase reduces the absolute amount of diffusion into the sterilization chamber and can adversely affect the diffusion effect for sterilization.
  • the pipe of the path between the collector 140 and the sterilization chamber 110 may have an inner diameter larger than that of other paths, and the large inner diameter of the pipe means that a large amount of gas is moved. If the inner diameter is large, the gaseous driving force increases by the degree of vacuum as the amount of gas moving increases, thereby preventing the temperature rise of the gaseous hydrogen peroxide vapor.
  • the pipe of the path between the collector 140 and the sterilization chamber 110 has a larger inner diameter than the pipe of the other path, so that the temperature of the hydrogen peroxide vapor can be added to the sterilization chamber in accordance with the temperature, Since the decomposition reaction is minimized and the hydrogen peroxide vapor easily accesses the sterilized product through sufficient diffusion into the gas phase, a good sterilization effect can be obtained.
  • the hydrogen peroxide vapor of the fourth concentration of hydrogen peroxide into the sterilization chamber hydrogen peroxide is evaporated and diffused into the sterilization chamber, the vaporization of the hydrogen peroxide before the temperature of the collector 140 reaches the temperature of the sterilization chamber
  • the temperature increase rate of the collector 140 may be controlled to be completed.
  • the collector 140 may be heated by a temperature control means, wherein heating the collector is such that vaporization of hydrogen peroxide before the temperature of the collector reaches the temperature of the sterilization chamber
  • the temperature increase rate can be controlled to complete more than 80%.
  • the pressure of the sterilization chamber 110 may be 0.5 to 15 mb, the temperature may be 45 to 55 °C.
  • the pressure of the collector 140 is 0.5 to 15 mb
  • the temperature may be 30 to 70 °C
  • the pressure of the vaporizer 130 may be 0.5 to 15 mb
  • the temperature may be 60 to 70 °C or more.
  • the concentration of the hydrogen peroxide solution in handling the hydrogen peroxide solution is 60% by weight or less. There is a difficulty in using a high concentration of hydrogen peroxide as a sterilizing agent.
  • the water is brought into contact with the collector by proceeding with steps S140 and S150 described above. Can reduce the likelihood of doing so.
  • the saturated steam pressure of the water according to the collector pressure of the hydrogen peroxide collector and the temperature of the collector, that is, the vaporization / condensation boundary pressure is lowered, so that even if the water contacts the collector, it cannot condense. This can be done.
  • the above sterilization apparatus and the sterilization method using the same it is possible to sterilize the object, the above sterilization apparatus and the sterilization method using the same is just one example, in the present invention the configuration of the basic sterilization apparatus and the same It does not limit the sterilization method used.
  • the concentration of the hydrogen peroxide solution in handling the hydrogen peroxide solution is 60% by weight or less. There is a difficulty in using a high concentration of hydrogen peroxide as a sterilizing agent.
  • the sterilization apparatus is a sterilization chamber; A vacuum pump connected to one side of the sterilization chamber; A vaporizer connected to the other side of the sterilization chamber; And one side is connected to the carburetor, the other side comprises a collector connected to the sterilization chamber.
  • the sterilization apparatus is the first humidity sensor 111 and the second humidity sensor 112 located adjacent to the first humidity sensor 111 located in a predetermined region of the sterilization chamber 110. It includes.
  • the concentration of hydrogen peroxide in the sterilization chamber 110 is measured through the first humidity sensor 111 and the second humidity sensor 112.
  • the sterilization chamber corresponds to the target space for measuring the concentration of hydrogen peroxide
  • the target space may be a sterilization chamber as described above, alternatively, may be an operating room or a sterile room requiring aseptic breeding. have.
  • the object space may be a chamber or an operating room or a sterile room, but the type of the object space is not limited in the present invention.
  • the first humidity sensor 111 is a sensor in which the relative humidity is determined by the amount of water vapor and the amount of hydrogen peroxide, and the second humidity sensor 112 is determined only by the amount of water vapor. Corresponds to the sensor.
  • the relative humidity is determined only by the amount of water vapor in the second humidity sensor 112, or the second humidity sensor directly measures the relative humidity with respect to the amount of water vapor, or the second humidity. This includes the case where the sensor measures absolute humidity with respect to the amount of water vapor and converts the absolute humidity into relative humidity.
  • the first humidity sensor may be a humidity sensor of a moisture adsorption method, a humidity sensor of a saturation method, or a humidity sensor of an absorption method.
  • the moisture sensor of the moisture adsorption method is a capacitance type.
  • Humidity sensor, resistance change type humidity sensor, hair hygrometer, carbon film hygrometer, electric hygrometer, color hygrometer, the humidity sensor according to the saturation method may be dew point hygrometer, lithium chloride dew point hygrometer, and also by absorption method
  • the humidity sensor may be a volumetric hygrometer, an electrolytic hygrometer, a weight hygrometer.
  • the first humidity sensor 111 is a sensor in which the relative humidity is determined by the amount of water vapor and the amount of hydrogen peroxide.
  • the principle of measuring the hydrogen peroxide concentration using a sensor for measuring the relative humidity of water such as the first humidity sensor described above
  • the VHP (highly concentrated hydrogen peroxide vapor) vapor pressure is measured on the measuring sensor as the principle of measuring the relative humidity of water It is measured by the degree of humidity reduction.
  • a capacitive humidity sensor corresponds to a very important principle that the relative dielectric constant of water and hydrogen peroxide can be directly substituted and used.
  • the first humidity sensor such as a capacitive humidity sensor
  • the relative humidity can be determined by the amount of water vapor and the amount of hydrogen peroxide will be.
  • the second humidity sensor 112 is a humidity sensor according to a spectroscopic method
  • the humidity sensor according to the spectroscopic method may be a non-dispersive infrared (NDIR) hygrometer or a near infrared hygrometer.
  • NDIR non-dispersive infrared
  • the relative humidity may be determined by the amount of water vapor and the amount of hydrogen peroxide.
  • the spectroscopic second humidity sensor corresponds to a sensor whose relative humidity is determined only by the amount of water vapor.
  • the non-dispersive infrared hygrometer is a method of calculating the absorbance of the selective IR of 6.1um, which is an absorption spectrum region of water in the IR region, so that hydrogen peroxide (H 2 O 2 ) having absorption bands of different regions ( 2.93um) corresponds to a hygrometer with a very high selectivity.
  • the humidity sensor is a sensor for detecting the humidity in the object, the concept of the humidity is well known relative humidity and absolute humidity.
  • absolute humidity is the mass of the actual water vapor contained in 1 liter of air
  • relative humidity is the percentage of the actual water vapor contained in the air divided by the maximum amount of water the air can contain at a given temperature and pressure. to be.
  • 1 liter of air at 37 ° C at 1 atmosphere can contain as much as 44 grams of steam. If an air with the same pressure and temperature now has 11 grams of steam, the relative humidity is 25% (11 grams / minute). 44 g ⁇ 100).
  • such a humidity sensor is well known as a sensor for detecting the amount of water vapor contained in the air.
  • the representative types of humidity sensors include a capacitive humidity sensor and a resistance-type humidity sensor.
  • the resistance change type humidity sensor uses a characteristic in which the resistance changes according to the moisture content in the moisture sensitive film in response to the humidity change, and obtains a change signal by applying an alternating current to the polymer type and the ceramic type according to the material of the moisture sensitive material. Can be classified.
  • the moisture sensitive material is a polymer
  • moisture and polymer are combined to form ions in air, and electrical conductivity is generated.
  • moisture adsorbed on the porous surface of the moisture sensitive material is used. The pores are separated to form ions, which cause electrical conductivity.
  • the concentration of ions is changed according to the change of relative humidity, which is measured by the change of impedance of the sensor element to detect the relative humidity, and the conversion circuit for obtaining the electrical signal from the sensor is simple, which has the advantages of miniaturization and cost. .
  • the resistance change type humidity sensor may be formed by sputtering and depositing a platinum (Pt) thin film on the upper surface of the sintered alumina substrate to form a pattern in the shape of an electrode, and applying a moisture-sensitive polymer on the upper surface of the platinum thin film pattern.
  • Pt platinum
  • the capacitive humidity sensor has a lower electrode on a substrate, the upper electrode having a property to uniformly apply a polymer dampener to the upper portion of the lower electrode, the humidity can be injected into the upper portion of the damper. It is composed.
  • Au electrodes and moisture resistant materials are used for glass or ceramic substrates, and the moisture-sensitive material applied to the sensor may be a cellulose ester compound such as cellulose acetone, or a polymer material such as polyvinyl alcohol, polyacryl, or polyvinyl pyride. Used.
  • the principle of detecting humidity in the capacitive humidity sensor is as follows.
  • the relative dielectric constant of the polymer material is about 3 in a dry state, while the relative dielectric constant is changed while absorbing water molecules (relative dielectric constant 80) in the air, and through the change of the relative dielectric constant, the amount of water vapor in the air is changed. Can be detected.
  • the capacitive humidity sensor may include a lower electrode formed on a substrate; A moisture sensitive layer applied on the lower electrode to absorb and desorb moisture; And a plurality of upper electrodes formed on the moisture sensitive layer.
  • the humidity sensor that is, the capacitance type humidity sensor and the resistance change type humidity sensor are well known as a sensor for detecting the amount of water vapor contained in the air.
  • the Applicant has confirmed that the value detected by the amount of water vapor, as well as the amount of hydrogen peroxide, in the case of the capacitive humidity sensor is changed, and in view of this, the first humidity sensor 111 and the second Through the humidity sensor 112, a method of measuring the concentration of hydrogen peroxide in the interior of the sterilization chamber 110 was developed.
  • the detected value is changed not only by the amount of water vapor but also by the amount of hydrogen peroxide.
  • Figure 4 is a graph showing the response of the capacitive humidity sensor in the sterilization apparatus.
  • the reaction of the capacitive humidity sensor in the process of sterilization in the sterilization apparatus is measured.
  • the relative humidity of the capacitive humidity sensor when the temperature of the sterilization chamber is 50 ° C, the value of the pressure inside the sterilization chamber must exceed 120 mb even by the pressure of steam alone. However, in reality, only 12 ⁇ 15mb of the sterilization chamber.
  • the capacitance-type humidity sensor can be seen that the relative humidity is determined not only by the amount of water vapor but also by the amount of hydrogen peroxide.
  • the relative humidity detected by the capacitive humidity sensor is determined by the amount of water vapor and the amount of hydrogen peroxide.
  • the humidity sensor based on the spectroscopic method determines relative humidity only according to the amount of water vapor.
  • the relative humidity is determined by the amount of water vapor and the amount of hydrogen peroxide, but in the case of the humidity sensor according to the spectroscopic method that is the second humidity sensor, only the water vapor The relative humidity is determined by the amount.
  • the ratio of the relative humidity determined by the amount of hydrogen peroxide can be calculated.
  • the relative humidity is determined only by the amount of water vapor in the second humidity sensor 112, or the second humidity sensor directly measures the relative humidity relative to the amount of water vapor
  • the second humidity sensor measures an absolute humidity with respect to the amount of water vapor and converts the absolute humidity into a relative humidity.
  • the absolute humidity of the target space may be measured through the second humidity sensor, and the absolute humidity may be converted into a relative humidity to detect the second relative humidity of the target space through the second humidity sensor.
  • Method for measuring the concentration of hydrogen peroxide according to the present invention is as follows.
  • FIG. 5 is a flowchart illustrating a method for measuring hydrogen peroxide concentration according to the present invention.
  • the method for measuring hydrogen peroxide concentration according to the present invention includes detecting a first relative humidity by a first humidity sensor (S210).
  • the first humidity sensor may typically be a capacitive humidity sensor.
  • the capacitive humidity sensor may determine relative humidity according to the amount of water vapor and the amount of hydrogen peroxide. 1 Relative humidity corresponds to relative humidity depending on the amount of water vapor and the amount of hydrogen peroxide.
  • the hydrogen peroxide concentration measuring method includes the step of detecting the second relative humidity by the second humidity sensor (S220).
  • the second humidity sensor may typically be a non-dispersion infrared humidity sensor, as described above, the non-dispersion infrared humidity sensor is determined relative humidity only by the amount of water vapor, and thus, the second relative humidity is Corresponds to relative humidity depending on the amount of water vapor.
  • the method for measuring hydrogen peroxide concentration according to the present invention includes deriving a difference value between the first relative humidity and the second relative humidity (S230).
  • the relative humidity is determined by the amount of water vapor and the amount of hydrogen peroxide, but in the case of the second humidity sensor, the relative humidity is determined only by the amount of water vapor.
  • the ratio of the relative humidity determined by the amount of hydrogen peroxide can be calculated.
  • the hydrogen peroxide concentration measuring method includes the step of calculating the concentration of hydrogen peroxide through the difference value (S240).
  • measuring the concentration of hydrogen peroxide vapor in the present invention corresponds to the principle of measuring the ratio of the saturated steam pressure, therefore, when the supersaturated hydrogen peroxide vapor is introduced into the chamber of the sterilization apparatus, etc.
  • the temperature of the humidity sensor is present at a temperature lower than the measurement target space, the supersaturated hydrogen peroxide vapor may be condensed on the humidity sensor and measured to be lower than the concentration actually present.
  • the temperature of the first humidity sensor and the second humidity sensor is preferably controlled higher than the measurement target space, that is, a chamber, an operating room or a clean room.
  • Table 4 shows the saturated steam pressure with temperature.
  • Table 4 shows examples of saturated steam pressure and hydrogen peroxide saturated steam pressure according to respective temperatures.
  • the first relative humidity detected by the first humidity sensor is 80%
  • the second relative humidity detected by the second humidity sensor is 30%.
  • the second relative humidity detected by the second humidity sensor is 30%
  • the humidity sensor measures absolute humidity with respect to the amount of water vapor and converts the absolute humidity into relative humidity.
  • the assumption that the second relative humidity is 30% may be a case where it is converted from the absolute humidity measured by the second humidity sensor.
  • the temperature in the sterilization chamber is 45 °C
  • the air pressure is 1000mb
  • the volume of the sterilization chamber is 1000L.
  • the difference between the first relative humidity and the second relative humidity is 50%, and thus, 50%, the difference between the first relative humidity and the second relative humidity, corresponds to the ratio of relative humidity determined by the amount of hydrogen peroxide. do.
  • the relative humidity reacted by the hydrogen peroxide vapor in the air in the sterilization chamber corresponds to 50%.
  • the saturated steam pressure of hydrogen peroxide at a temperature of 45 °C corresponds to 9.8mb.
  • the molecular weight of hydrogen peroxide is 34g / mol, it may be represented by a concentration of 6.4mg / L.
  • the hydrogen peroxide concentration can be measured by the first humidity sensor and the second humidity sensor.
  • the first humidity sensor and the second humidity sensor are included in a target space such as a sterilization chamber, and the relative humidity is detected by each of these sensors, and the concentration of hydrogen peroxide is determined by the difference in these relative humidity. Can be measured easily.

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  • Life Sciences & Earth Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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Abstract

La présente invention concerne un dispositif de stérilisation et un procédé de mesure d'une concentration en peroxyde d'hydrogène du dispositif de stérilisation, le dispositif de stérilisation comprenant une chambre de stérilisation, la chambre de stérilisation comprenant un premier capteur d'humidité situé dans une certaine zone en son sein et un second capteur d'humidité situé de manière adjacente au premier capteur d'humidité, et le premier capteur d'humidité détectant une première humidité relative en utilisant la quantité de peroxyde d'hydrogène et la quantité de vapeur, et le second capteur d'humidité détectant une seconde humidité relative en utilisant la quantité de vapeur. Étant donné que le premier capteur d'humidité et le second capteur d'humidité sont inclus dans la chambre de stérilisation, l'humidité relative est mesurée par chacun des capteurs, et la concentration en peroxyde d'hydrogène peut être facilement mesurée par une différence d'humidité relative.
PCT/KR2016/015521 2016-12-29 2016-12-29 Dispositif de stérilisation et procédé de mesure d'une concentration en peroxyde d'hydrogène d'un dispositif de stérilisation Ceased WO2018124339A1 (fr)

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EP0774263B1 (fr) * 1995-11-20 2003-03-12 Bioquell UK Limited Procédé et appareil pour la stérilisation par la vapeur de peroxyde d'hydrogène
KR101087306B1 (ko) * 2009-09-28 2011-11-25 유영종 의료용 멸균 장치 및 방법
KR101111388B1 (ko) * 2010-04-13 2012-02-24 (주)우정비에스씨 과산화수소 증기를 이용한 이동식 멸균장치
KR20140049347A (ko) * 2012-10-17 2014-04-25 우병훈 멸균방법
KR101653173B1 (ko) * 2015-02-03 2016-09-02 (주) 씨엠테크 과산화수소수 공급장치

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US6953549B2 (en) * 2003-07-15 2005-10-11 Steris Inc. System and method for determining concentration of sterilant
JP2007202628A (ja) * 2006-01-31 2007-08-16 Daikin Ind Ltd 滅菌装置及び滅菌システム

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Publication number Priority date Publication date Assignee Title
EP0774263B1 (fr) * 1995-11-20 2003-03-12 Bioquell UK Limited Procédé et appareil pour la stérilisation par la vapeur de peroxyde d'hydrogène
KR101087306B1 (ko) * 2009-09-28 2011-11-25 유영종 의료용 멸균 장치 및 방법
KR101111388B1 (ko) * 2010-04-13 2012-02-24 (주)우정비에스씨 과산화수소 증기를 이용한 이동식 멸균장치
KR20140049347A (ko) * 2012-10-17 2014-04-25 우병훈 멸균방법
KR101653173B1 (ko) * 2015-02-03 2016-09-02 (주) 씨엠테크 과산화수소수 공급장치

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