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WO2016140449A1 - Sterilization method and apparatus using the same - Google Patents

Sterilization method and apparatus using the same Download PDF

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Publication number
WO2016140449A1
WO2016140449A1 PCT/KR2016/001596 KR2016001596W WO2016140449A1 WO 2016140449 A1 WO2016140449 A1 WO 2016140449A1 KR 2016001596 W KR2016001596 W KR 2016001596W WO 2016140449 A1 WO2016140449 A1 WO 2016140449A1
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WO
WIPO (PCT)
Prior art keywords
chamber
gas
sterilization
pressure
oxidative
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/KR2016/001596
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French (fr)
Inventor
Sang-Woong Kim
Chang-Ick Lee
Eun-Ju Lee
Solomon L. Kim
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LEADGENEX Inc
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LEADGENEX Inc
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Publication date
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Publication of WO2016140449A1 publication Critical patent/WO2016140449A1/en
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Ceased legal-status Critical Current

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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
    • A61L2/202Ozone
    • 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
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/022Filtration
    • 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
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/14Plasma, i.e. ionised gases
    • 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
    • A61L2/206Ethylene oxide
    • 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
    • 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
    • A61L2202/10Apparatus features
    • A61L2202/15Biocide distribution means, e.g. nozzles, pumps, manifolds, fans, baffles, sprayers
    • 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 disclosure relates to a sterilization method and an apparatus using the sterilization method, and more particularly, to an efficient sterilization method by inducing gas circulation using a high-speed blower instead of using a vacuum pump, and an apparatus using the method.
  • sterilization refers to high-level treatment for completely removing all kinds of living microorganisms through a physical process, a chemical process, or a combination thereof.
  • Devices such as medical devices may be required to be sterilized, and current methods used to sterilize medical devices use ethylene oxide (EO) gas, steam, hydrogen peroxide, plasma, or the like.
  • EO ethylene oxide
  • EO gas has a high degree of reactivity, which may lead to hazards such as explosions, and it has been reported that EO gas may act as a genotoxic agent causing mutations.
  • ACGIH American Conference of Governmental Industrial Hygienists
  • the above-mentioned new sterilization method and apparatus using EO gas are difficult to implement because the amount of EO gas has to be strictly controlled so as not to exceed the permissible amount, and it takes a relatively long time (three to five hours) to perform a sterilization process using the new sterilization method or apparatus.
  • steam sterilizers considered to be safe and possessing a sterilizing ability to a certain degree are inexpensive and allow for nontoxic and rapid sterilization.
  • steam sterilizers result in exposure to moisture and high temperatures, steam sterilizers are limited to applications not affected by exposure to moisture and high temperatures.
  • Korea Patent No.: 1324567 discloses a method for sterilizing a target object contained in a sterilizing chamber using hydrogen peroxide and ozone, the method including an evacuation process
  • Korea Patent No.: 1298730 discloses a sterilization method using plasma.
  • the sterilization method and apparatus may be usefully implemented in a number of related applications, and thus the development of such sterilization methods and apparatuses is required.
  • An aspect of the present disclosure may provide a sterilization method using a flow of gas generated by a high-speed blower.
  • An aspect of the present disclosure may provide a sterilization apparatus using a high-speed blower.
  • a sterilization method may include: forming a low-pressure atmosphere having a pressure lower than atmospheric pressure in a chamber by discharging gas from the chamber using a high-speed blower; primarily supplying an oxidative gas to the chamber maintained at a pressure lower than atmospheric pressure; forming a high-press atmosphere having a pressure higher than atmospheric pressure in the chamber by introducing external gas into the chamber using the high-speed blower; and secondarily supplying the oxidative gas to the chamber maintained at a pressure higher than atmospheric pressure.
  • the chamber may be maintained within a temperature range of 40°C to 60°C.
  • the external gas may be introduced into the chamber after moisture and impurities are removed from the external gas.
  • the sterilization method may further include decomposing the oxidative gas remaining in the chamber into water and oxygen after sterilization is completed.
  • the sterilization method may further include dehumidifying the chamber by discharging gas from the chamber using the high-speed blower, dehumidifying the gas, and supplying the dehumidified gas back to the chamber.
  • the forming of the low-pressure atmosphere may be performed to form a pressure equal to or higher than atmospheric pressure - 5 kPa.
  • the forming of the high-pressure atmosphere may be performed to form a pressure equal to or lower than atmospheric pressure + 5 kPa.
  • the sterilization method may be repeated two to ten times.
  • the high-speed blower may form a pressure of ⁇ 10 kPa to ⁇ 20 kPa based on atmospheric pressure.
  • the sterilization method may further include circulating gas contained in the chamber while generating plasma in the chamber.
  • the oxidative gas may include at least one selected from the group consisting of hydrogen peroxide, ozone, and ethylene oxide.
  • a sterilization apparatus may include: a chamber including an oxidative gas supply unit, an exit through which gas is discharged, and an entrance through which gas is introduced; a high-speed blower connected to an exit line and an entrance line of the chamber; a first valve provided between the exit of the chamber and the high-speed blower; a second valve provided between the high-speed blower and the entrance of the chamber; and a control valve connected to at least one of the exit line and the entrance line so as to control inflow of external gas, outflow of gas, or both inflow and outflow of gas.
  • the control valve may include: a third valve connected to the entrance line of the chamber to discharge gas from the chamber; and a fourth valve connected to the exit line of the chamber to introduce external gas into the chamber.
  • the control valve may be a multi-control valve controlling inflow and outflow of gas
  • the sterilization apparatus may further include at least one of a hydrogen peroxide decomposing unit and a dehumidifying unit that is disposed between the multi-control valve and a bypass line connecting the first and second valves.
  • the sterilization apparatus may further include a filter connected to the fourth valve or the multi-control valve for removing impurities from external gas.
  • the sterilization apparatus may further include a dehumidifying unit connected between the first and fourth valves.
  • the sterilization apparatus may further include an oxidative gas decomposing unit connected between the second and third valves.
  • the chamber may further include a heating unit.
  • the chamber may further include a plasma device at the entrance thereof, and the plasma device may be disposed outside of the chamber.
  • the first, second, third, and fourth valves may be three-way valves.
  • the high-speed blower may form a pressure of ⁇ 10 kPa to ⁇ 20 kPa based on atmospheric pressure.
  • the sterilization apparatus may be used to sterilize medical devices.
  • the oxidative gas supply unit may supply an oxidative gas, and the oxidative gas may include at least one selected from the group consisting of hydrogen peroxide, ozone, and ethylene oxide.
  • sterilization may be effectively performed by adjusting the interior pressure of a chamber using a high-speed blower without using a vacuum pump.
  • time and costs necessary for sterilization may be reduced.
  • continuous circulation of gas in the chamber that is difficult to achieve in a case in which a vacuum pump is used may guarantee effective sterilization, and humidity may easily be adjusted during sterilization.
  • FIGS. 1A and 1B are graphs illustrating the pressure of an example system when a sterilization method is performed according to an example embodiment of the present disclosure.
  • FIG. 2 is a view illustrating an example sterilization apparatus according to the present disclosure.
  • FIG. 3 is a view illustrating an example gas flow during a low-pressure forming process.
  • FIG. 4 is a view illustrating an example gas flow during a high-pressure forming process.
  • FIG. 5 is a view illustrating an example gas flow during an oxidative gas decomposing process.
  • FIG. 6 is a view illustrating an example gas flow during a dehumidifying process.
  • FIG. 7 is a view illustrating an example gas flow during an internal circulation process for circulating gas in a chamber.
  • FIG. 8 is a view illustrating another example sterilization apparatus according to the present disclosure.
  • FIG. 9 is a view illustrating example target objects that may be sterilized according to the present disclosure.
  • the present disclosure provides a sterilization method.
  • gas is forced to continuously circulate in a chamber by a high-speed blower, and the interior pressure of the chamber is adjusted using the circulation of gas.
  • the sterilization method of the present disclosure includes: a low-pressure forming process in which gas is discharged from a chamber using a high-speed blower to form a low-pressure atmosphere having a pressure lower than atmospheric pressure in the chamber; a first oxidative gas supply process in which oxidative gas is supplied to the chamber maintained at a pressure lower than atmospheric pressure; a high-pressure forming process in which external gas is introduced into the chamber using the high-speed blower to form a high-pressure atmosphere having a pressure higher than atmospheric pressure in the chamber; and a second oxidative gas supply process in which oxidative gas is supplied to the chamber maintained at a pressure higher than atmospheric pressure.
  • the sterilization method of the present disclosure is performed to sterilize a target object disposed in the chamber. Therefore, the sterilization method may further include a process of placing a target object in the chamber before the low-pressure forming process.
  • the chamber is not limited to a particular type.
  • the chamber may include an exit through which gas is discharged, an entrance through which a gas is introduced, and an oxidative gas supply unit.
  • the chamber is not limited to a particular type.
  • the chamber may include at least one door to receive a target object to be sterilized.
  • the oxidative gas may include at least one selected from the group consisting of hydrogen peroxide, ozone, and ethylene oxide.
  • hydrogen peroxide may be used as the oxidative gas.
  • FIGS. 2 to 8 illustrate example apparatuses according to the present disclosure.
  • a low-pressure forming process may be performed by discharging gas from the chamber 1 using a high-speed blower 16 to form a low-pressure atmosphere having a pressure lower than atmospheric pressure in the chamber 1.
  • the sterilization method of the present disclosure is performed several times, if oxidative gas is included in gas discharged from the low-pressure forming process, the gas discharged from the low-pressure forming process may be guided to pass through an oxidative gas decomposing unit 15 as shown in FIG. 3, so as to guarantee the safety of operators.
  • an additional filter 23 may be used.
  • the additional filter 23 may be the same kind of filter as a filter 23'.
  • the additional filter 23 may be a high efficiency particulate air (HEPA) filter.
  • the additional filter 23 may be an exhaust gas noise removing filter capable of decreasing noise generated by the high-speed blower 16 and dispersing high-speed exhaust gas.
  • gas may be introduced and discharged through the same line, and thus a HEPA filter may be used as the additional filter 23.
  • the high-speed blower 16 is used to discharge gas from the chamber 1 or introduce gas into the chamber 1 by creating a circulatory gas flow, and thus the high-speed blower 16 may not be limited to a particular blower as long as the high-speed blower 16 is capable of adjusting the interior pressure of the chamber 1 by creating such a gas flow.
  • the high-speed blower it may be preferable that the high-speed blower be capable of forming a pressure of ⁇ 10 kPa to ⁇ 20 kPa, more preferably ⁇ 13 kPa to ⁇ 17 kPa, and even more preferably about ⁇ 15 kPa based on atmospheric pressure.
  • atmospheric pressure is 1 atm.
  • the high-speed blower 16 is not capable of creating a pressure difference of ⁇ 10 kPa based on atmospheric pressure, gas may not be sufficiently discharged from the chamber 1, and thus an intended pressure difference may not be obtained. Conversely, if the high-speed blower 16 creates a pressure difference of greater than ⁇ 20 kPa, the structural strength of the chamber 1 and seals for the door 4 of the chamber 1 may be required to be increased. In this case, the efficiency of processes for manufacturing related devices may be lowered, and thus the price of a sterilization system using the sterilization method of the present disclosure may be increased.
  • the high-speed blower 16 be capable of creating a pressure difference of at least 10 kPa based on atmospheric pressure as illustrated in FIGS. 1A and 1B.
  • a low-pressure atmosphere having a pressure lower than atmospheric pressure may be formed in the chamber 1 by discharging gas from the chamber 1 using the high-speed blower 16.
  • the term "low-pressure" refers to a pressure lower than atmospheric pressure, and in the low-pressure forming process, the pressure in the chamber 1 may be equal to or higher than atmospheric pressure - 10 kPa, that is, about 91 kPa. As the degree of vacuum in the chamber 1 increases, sterilization in the chamber 1 may be promoted.
  • the interior pressure of the chamber 1 in the low-pressure forming process is lower than atmospheric pressure - 10 kPa, that is, about 91 kPa, the structural strength of the chamber 1 and seals for the door 4 of the chamber 1 may be required to be increased. In this case, the efficiency of processes for manufacturing related devices may be lowered, and thus the price of a sterilization system using the sterilization method of the present disclosure may be increased.
  • FIG. 3 illustrates an example gas flow in the low-pressure forming process.
  • the interior pressure of the chamber 1 is decreased slightly from atmospheric pressure of creating a vacuum, and thus expensive devices such as a vacuum pump are not used.
  • the high-speed blower 16 may be a blower capable of changing pressure according to the rotation speed thereof.
  • an oxidative gas may be supplied to the interior of the chamber 1 in a first oxidative gas supply process. Since the first oxidative gas supply process is performed at a low pressure as described above, the oxidative gas may easily be diffused and brought into contact with the target object, and thus the target object may be effectively sterilized.
  • the concentration of the oxidative gas may preferably be within the range of 1,000 ppm to 2,000 ppm. If the concentration of the oxidative gas is less than 1,000 ppm, sterilization may occur insufficiently, and if the concentration of the oxidative gas is greater than 2,000 ppm, the oxidative gas may condense with moisture, and thus the concentration of the oxidative gas may reversely decrease.
  • the oxidative gas used for sterilization refers to a substance having an oxidizing ability in a gaseous state. That is, the oxidative gas is a gaseous substance.
  • gaseous hydrogen peroxide may be used as the oxidative gas.
  • hydrogen peroxide steam may be used.
  • the first oxidative gas supply process may be performed for 1 minute to 1 hour, preferably 2 minutes to 30 minutes, and more preferably 5 minutes to 20 minutes.
  • the low-pressure forming process may be performed for a time period longer than the time period during which a high-pressure forming process is performed.
  • a high-pressure atmosphere having a pressure higher than atmospheric pressure may be formed in the chamber 1 by blowing external gas into the chamber 1 using the high-speed blower 16.
  • the term "high-pressure” refers to a pressure higher than atmospheric pressure, and in the high-pressure forming process, the pressure in the chamber 1 may be equal to or lower than atmospheric pressure + 10 kPa, that is, about 111 kPa.
  • the interior pressure of the chamber 1 in the high-pressure forming process is higher than atmospheric pressure + 10 kPa, that is, about 111 kPa, the structural strength of the chamber 1 and seals for the door 4 of the chamber 1 may be required to be increased. In this case, the efficiency of processes for manufacturing related devices may be lowered, and thus the price of a sterilization system using the sterilization method of the present disclosure may be increased.
  • the term "external gas" refers to gas outside the chamber 1.
  • the external gas may be air.
  • FIG. 4 illustrates an example gas flow in the high-pressure forming process.
  • a pressure lower or higher than atmospheric pressure is formed.
  • the interior pressure of the chamber 1 is increased or decreased according to the sterilization method of the present disclosure, the interior pressure of the chamber 1 may become equal to atmospheric pressure, and this will be apparent to those having ordinary skill in the art.
  • the creation of a vacuum is not required, and when the sterilization method is performed, the interior pressure of the chamber 1 is varied within the range of ⁇ 10 kPa based on atmospheric pressure as illustrated in FIGS. 1A and 1B. That is, the effect of sterilization may be effectively obtained using small pressure variations without using expensive devices such as a vacuum pump.
  • the oxidative gas is supplied to the interior of the chamber 1 in a second oxidative gas supply process. Since the second oxidative gas supply process is performed at a high pressure, the pressure difference between the interior and exterior of the target object may be high, and thus the oxidative gas may deeply permeate into the target object. As a result, the target object may be completely sterilized.
  • the concentration of the oxidative gas may preferably be within the range of 1,000 ppm to 2,000 ppm. If the concentration of the oxidative gas is less than 1,000 ppm, sterilization may insufficiently occur, and if the concentration of the oxidative gas is greater than 2,000 ppm, the oxidative gas may condense with moisture, and thus the concentration of the oxidative gas may reversely decrease.
  • the second oxidative gas supply process may be performed for 1 minute to 1 hour, preferably 2 minutes to 30 minutes, and more preferably 5 minutes to 20 minutes.
  • the high-pressure forming process may be performed for a time period shorter than the time period during which the low-pressure forming process is performed
  • the chamber 1 may preferably be maintained at a temperature of 40°C to 60°C.
  • the temperature of the chamber 1 may be adjusted to be within the above-mentioned range before or when the first oxidative gas supply process is started.
  • the oxidative gas is supplied to the chamber 1 in a gaseous sate for sterilization, if the temperature of the chamber 1 is maintained within the above-mentioned range, condensation of the oxidative gas may be minimized, and the effect of sterilization may be continuously maintained.
  • An oxidative gas which is gaseous by nature or a gas or steam obtained by evaporating a liquid oxidative substance such as an aqueous solution of hydrogen peroxide using an evaporator may be supplied as the oxidative gas (i.e., a gaseous oxidative substance) to the chamber 1.
  • Oxidative gases which are gaseous by nature are unstable, and thus may easily be decomposed into water and oxygen by moisture contained in the air.
  • an aqueous solution of an oxidative substance may be evaporated into gas or steam using an evaporator or any other method, and may then be supplied as the oxidative gas to the chamber 1.
  • an aqueous solution of hydrogen peroxide may be evaporated into gas or steam using an evaporator disposed outside the chamber 1, and may then be supplied as the oxidative gas to the chamber 1.
  • the effect of sterilization may be lowered due to condensation of the oxidative gas, and if the interior temperature of the chamber 1 exceeds 60°C, a target object to be sterilized such as plastics vulnerable to heat may be deformed or damaged.
  • the interior temperature of the chamber 1 may be controlled using a heating unit 5 disposed in the chamber 1.
  • the heating unit 5 is not limited to a particular type.
  • the heating unit 5 may be a general heater.
  • the sterilization method may further include a dehumidifying process in which gas is discharged from the chamber 1 using the high-speed blower 16, dehumidified, and supplied back to the chamber 1.
  • the dehumidifying process may be performed before the low-pressure forming process. If the sterilization method of the present disclosure is performed two or more times, the dehumidifying process may be performed each time before the low-pressure forming process is performed.
  • FIG. 6 illustrates an example gas flow in the dehumidifying process. If the relative humidity of the interior of the chamber 1 is decreased after the dehumidifying process, the efficiency of sterilization may be improved.
  • external gas subjected to a dehumidifying process and an impurity removing process may be supplied to the chamber 1 in the high-pressure forming process. That is, before external gas is introduced into the chamber 1 for sterilization, the external gas may be dehumidified through a dehumidifying process, and unnecessary substances contained in the external gas may be removed through an impurity removing process, so as to more effectively sterilize the target object using the external gas.
  • the dehumidifying process and the impurity removing process may be performed at least once on gas circulated along the chamber 1 as well as newly introduced external gas. That is, if the sterilization method of the present disclosure is performed in a closed system while constantly introducing oxidative gas into the closed system, the relative humidity of the interior of the chamber 1 may increase. If the relative humidity of the interior of the chamber 1 increases, oxidative gas may condense with moisture, and thus the concentration of the oxidative gas may decrease. To solve this problem, gas contained in the chamber 1 may be discharged using the high-speed blower 16 and subjected to the dehumidifying process, and then the dehumidified gas may be supplied back to the chamber 1.
  • the dehumidifying process is not limited to a particular method.
  • the dehumidifying process may be performed by passing gas through an absorbent.
  • the impurity removing process is not limited to a particular method.
  • the impurity removing process may be performed using a filter.
  • the sterilization method may further include a process of decomposing the oxidative gas remaining in the chamber 1 into water and oxygen after completing sterilization.
  • FIG. 5 illustrates an example gas flow in the oxidative gas decomposing process. That is, after completing sterilization, the oxidative gas may be decomposed into water and oxygen using a device such as a catalyst unit, and the oxygen obtained by decomposing the oxidative gas may be introduced into the chamber 1.
  • the oxidative gas of gas contained in the chamber 1 may be decomposed into water and oxygen by passing the gas through the catalyst unit, and the remaining gas which is not harmful after the oxidative gas is removed may be introduced back into the chamber 1. In this manner, the oxidative gas remaining in the target object may be removed, and when the chamber 1 is opened, an operator may be protected.
  • the sterilization method of the present disclosure may be performed two to ten times for a total time period of 1.5 minutes to 90 minutes, preferably for 5 minutes to 1 hour, and more preferably for 5 minutes to 30 minutes.
  • the sterilization method of the present disclosure may further include a process of generating plasma in the chamber 1.
  • the sterilization method may further include an internal circulation process in which gas contained in the chamber 1 is circulated while generating plasma in the chamber 1.
  • FIG. 7 illustrates an example gas flow in the internal circulation process.
  • such a plasma process may be additionally performed after any of the processes of the sterilization method, such as after the second oxidative gas supply process.
  • oxidative gas is used as a precursor of an active species, and if plasma is generated after a target object to be sterilized is brought into contact with the oxidative gas, the time necessary for sterilization and the amount of electricity for generating plasma may be shortened or reduced.
  • sterilization is additionally performed by ozone and radicals generated from plasma in the internal circulation process (plasma process), the effect of sterilization may be enhanced.
  • water and oxygen are produced as byproducts when oxidative gas decomposes in plasma, after the plasma process, toxic substances may not remain on the surface of a sterilized target object.
  • FIG. 1B is a graph illustrating the interior pressure of an example system when the sterilization method including a plasma generating process as described above is performed according to the present disclosure.
  • oxidative gas may be supplied to the chamber 1 while varying the interior pressure of the chamber 1 using the high-speed blower 16, and then a plasma device 6 may be powered on so as to generate plasma in the chamber 1.
  • the plasma device 6 may be operated to circulate gas in the chamber 1.
  • a fourth valve 11 is switched in a direction ba, a first valve 12 is switched in a direction c ⁇ a, a second valve 13 is switched in a direction ab, and a third valve 14 is switched in a direction ac, and thus gas contained in the chamber 1 is circulated through the plasma device 6 by the high-speed blower 16.
  • the gas After passing through the plasma device 6, the gas may be converted into gas or steam including at least one of ozone, electrons, ions, free radicals, and dissociated or excited atoms or molecules, and thus an additional sterilization effect may be obtained.
  • the present disclosure further provides a sterilization apparatus capable of executing the sterilization method.
  • the sterilization apparatus of the present disclosure may include: a chamber including an oxidative gas supply unit, an exit through which gas is discharged, and an entrance through which gas is introduced; a high-speed blower connected to an exit line and an entrance line of the chamber; a first valve provided between the exit of the chamber and the high-speed blower; a second valve provided between the high-speed blower and the entrance of the chamber; and a control valve connected to at least one of the exit line and the entrance line so as to control inflow of external gas, outflow of gas, or both inflow and outflow of gas.
  • FIGS. 2 to 7 illustrate an example sterilization apparatus according to the present disclosure.
  • the sterilization apparatus will now be described in detail with reference to FIG. 2.
  • a chamber 1 may include an oxidative gas supply unit 10, an exit 2 through which gas is discharged from the chamber 1, and an entrance 3 through which gas is introduced into the chamber 1.
  • a tray 7 and a heating unit 5 may be disposed in the chamber 1, and a target object to be sterilized may be placed on the tray 7.
  • a door 4 may be provided on a side of the chamber 1. After a target object to be sterilized is placed in the chamber 1, the chamber 1 may be closed using the door 4.
  • the sterilization apparatus of the present disclosure includes a high-speed blower 16 connected to an exit line 20 and an entrance line 21, and gas contained in the chamber 1 may forcibly be circulated using the high-speed blower 16.
  • the oxidative gas supply unit 10 is not limited to a particular type as long as the oxidative gas supply unit 10 is capable of supplying oxidative gas.
  • the oxidative gas supply unit 10 may include a liquid oxidative substance injection part and an oxidative substance evaporating part. If necessary, a flow rate regulating device may be installed in the oxidative gas supply unit 10.
  • the chamber 1 may include the heating unit 5 to adjust the interior temperature of the chamber 1.
  • the heating unit 5 is not limited to a particular type.
  • the heating unit 5 may be a general heater.
  • the chamber 1 may further include a plasma device 6 at the entrance 3 through which gas is introduced into the chamber 1.
  • the plasma device 6 may be disposed outside the chamber 1.
  • the plasma device 6 is not limited to a particular type as long as the plasma device 6 is capable of supplying plasma.
  • the plasma device 6 may include a plasma chamber 1 in which two mutually-facing electrodes are disposed and a power supply configured to supply power through the electrodes for generating plasma between the electrodes.
  • the high-speed blower 16 is used to discharge gas from the chamber 1 or introduce gas into the chamber 1.
  • the high-speed blower 16 is not limited to a particular blower as long as the high-speed blower 16 is capable of adjusting the interior pressure of the chamber 1 by creating such a gas flow.
  • the high-speed blower 16 it may be preferable that the high-speed blower 16 be capable of creating a pressure of ⁇ 10 kPa to ⁇ 20 kPa, more preferably ⁇ 13 kPa to ⁇ 17 kPa, and even more preferably about ⁇ 15 kPa based on atmospheric pressure.
  • atmospheric pressure is 1 atm.
  • Flow of gas in the chamber 1 may be controlled using first, second, third, and fourth valves 12, 13, 14 or 14', and 11, and the interior pressure of the chamber 1 may be adjusted according to the control of the flow of gas.
  • the third valve 14 may be connected to the entrance line 21 of the chamber 1 for discharging gas contained in the chamber 1, and the fourth valve 11 may be connected to the exit line 20 of the chamber 1 for introducing external gas into the chamber 1.
  • a control valve 14' may control both the inflow and outflow of gas.
  • the first, second, third, and fourth valves 12, 13, 14, and 11 may be multi-way valves.
  • the first, second, third, and fourth valves 12, 13, 14, and 11 may be three-way valves constituting an efficient sterilization system.
  • the sterilization apparatus may additionally perform a dehumidifying process to discharge gas from the chamber 1 using the high-speed blower 16, dehumidify the gas, and supply the gas back to the chamber 1.
  • the first valve 12 When the dehumidifying process is performed in the sterilization apparatus, the first valve 12 is maintained in a direction ba, the second valve 13 is maintained in a direction a ⁇ b, and the third valve 14 is maintained in a direction ac.
  • the three valves are opened in the above-described directions to create a flow of gas, the other valve is closed in such a manner that the other valve may not affect the flow of gas.
  • the first valve 12 is opened to allow for a flow of air in the direction ba. In this case, a portion c of the first valve 12 is closed.
  • the fourth valve 11 is maintained in a direction ac
  • the first valve 12 is maintained in a direction ba
  • the second valve 13 is maintained in a direction a ⁇ b
  • the third valve 14 is maintained in a direction ac.
  • the other valve is closed to block a flow through the other valve.
  • the first valve 12 is opened to allow for a flow of air in the direction ba
  • a portion c of the first valve 12 is closed.
  • the third valve 14 is not involved in the flow of gas in the dehumidifying process, the flow of gas is maintained in the direction ac. That is, a portion b of the third valve 14 is closed so as not to allow a flow of gas therethrough.
  • gas contained in the chamber 1 may be guided to pass through a dehumidifying unit 17, and may then be supplied back to the chamber 1 so as to decrease the humidity inside the chamber 1 and the target object.
  • the sterilizing efficiency of oxidative gas may be improved in a later sterilizing process.
  • the dehumidifying process if the second valve 13 is switched in a direction ac and the third valve 14 is switched in the direction a ⁇ c while maintaining the fourth valve 11 in the direction ca and the first valve 12 in the direction ca, gas contained in the chamber 1 is discharged by the high-speed blower 16, and thus the interior pressure of the chamber 1 may be decreased to be lower than atmospheric pressure. That is, a low-pressure forming process may be performed according to the present disclosure.
  • oxidative gas is supplied to the chamber 1.
  • the oxidative gas supply unit 10 includes a liquid oxidative substance injection part and an oxidative substance evaporating part
  • the temperature of the oxidative substance evaporating part may be increased to 100°C or higher to evaporate a solution of an oxidative substance, and then oxidative gas may be supplied from the liquid oxidative substance injection part to the chamber 1 through the oxidative substance evaporating part.
  • sterilization may be performed in the chamber 1.
  • the sterilization apparatus may further include a filter 23' connected to the fourth valve 11 for removing impurities from external gas.
  • the sterilization apparatus may further include a filter 23 connected to the control valve 14' for removing impurities from external gas.
  • a high-pressure forming process may be performed to introduce external gas into the chamber 1 using the high-speed blower 16, and thus to form a high-pressure atmosphere having a pressure higher than atmospheric pressure.
  • the fourth valve 11 is adjusted in a direction ba
  • the first valve 12 is adjusted in a direction b ⁇ a
  • the second valve 13 is adjusted in a direction ab
  • the third valve 14 is adjusted in a direction ac.
  • external gas is introduced through the filter 23' and the dehumidifying unit 17.
  • the interior pressure of the chamber 1 may be maintained at a level higher than atmospheric pressure.
  • any filter capable of removing dust particles such as fine dust particles from external gas may be used.
  • a HEPA filter capable of removing particles having a size of 0.3 ⁇ m or greater may be used.
  • the sterilization apparatus may include the dehumidifying unit 17 connected between the first valve 12 and the fourth valve 11, the oxidative gas decomposing unit 15 connected between the second valve 13 and the third valve 14, or both of the dehumidifying unit 17 and the oxidative gas decomposing unit 15.
  • oxidative gas discharged through the second valve 13 may completely be decomposed into water and oxygen while the oxidative gas passes through the oxidative gas decomposing unit 15, and then the water and oxygen may be discharged through the third valve 14.
  • gas discharged from the chamber 1 may pass through the dehumidifying unit 17 disposed between the first valve 12 and the fourth valve 11, and may then flow back to the chamber 1.
  • control valve 14' controls both the inflow and outflow of gas, and at least one of the oxidative gas decomposing unit 15 and the dehumidifying unit 17 may be disposed between the control valve 14' and a bypass line 22 connecting the first and second valves 12 and 13.
  • the sterilization apparatus of the present disclosure may include the bypass line 22 connecting the first valve 12 and the second valve 13, and at least one of the oxidative gas decomposing unit 15 and the dehumidifying unit 17 between the bypass line 22 and the third valve 14.
  • the bypass line 22 connecting the first valve 12 and the second valve 13
  • the oxidative gas decomposing unit 15 and the dehumidifying unit 17 between the bypass line 22 and the third valve 14.
  • gas dehumidified by the dehumidifying unit 17 may be supplied back to the chamber 1.
  • gas discharged from the chamber 1 may be directed to pass through the dehumidifying unit 17 and the oxidative gas decomposing unit 15, and may then be supplied back to the chamber 1 so as to dry a target object and replace gas contained in the chamber 1 with harmless gas after the target object is sterilized.
  • gas may be directed to pass through at least one of the oxidative gas decomposing unit 15 and the dehumidifying unit 17 in each process performed for sterilization. Therefore, although not illustrated in FIG. 7, the dehumidifying unit 17 and the oxidative gas decomposing unit 15 may be connected in series or parallel between the second valve 13 and the third valve 14, and valves may be properly arranged according to line designs.
  • the oxidative gas decomposing unit 15 is not limited to a particular type as long as the oxidative gas decomposing unit 15 is capable of decomposing oxidative gas into water and oxygen.
  • the oxidative gas decomposing unit 15 may have a ceramic honey comb shape, a bead agglomerate shape, a pellet agglomerate shape, or a granule agglomerate shape coated with a catalyst or absorbent.
  • the oxidative gas decomposing unit 15 may have a cartridge shape in which a pellet type catalyst is contained for decomposing oxidative gas, or a heating unit may be disposed in the oxidative gas decomposing unit 15 to facilitate the decomposition of oxidative gas by heating a catalyst.
  • the catalyst or absorbent may include at least one of platinum (Pt), palladium (Pd), rhodium (Rh), and ruthenium (Ru) supported in a metal oxide; transition metal oxides such as CrOx and CuOx supported in a metal oxide; molecular seives such as a zeolite molecular sieve; and semiconductors such as TiO 2 , ZrO 2 , and MgO.
  • a manganese-based catalyst may be used.
  • the dehumidifying unit 17 may remove moisture from external gas to be introduced into the chamber 1, so as to adjust the humidity of the chamber 1. Even when gas is internally circulated, the gas may be guided to pass through the dehumidifying unit 17 by controlling valves. In this case, the humidity of gas circulated for sterilization may be easily adjusted.
  • FIGS. 2 to 8 illustrate example arrangements of elements of the sterilization apparatus.
  • the arrangement structure of the sterilization apparatus is not limited to those illustrated in FIGS. 2 to 8.
  • the oxidative gas decomposing unit 15 and the dehumidifying unit 17 are connected in series between the third valve 14 and the bypass line 22 connecting the first and second valves 12 and 13.
  • the oxidative gas decomposing unit 15 and the dehumidifying unit 17 may be connected in parallel, or a module having both the functions of the oxidative gas decomposing unit 15 and the dehumidifying unit 17 may be used.
  • the oxidative gas decomposing unit 15 and the dehumidifying unit 17 may be connected in series, and the bypass line 22 may be provided to allow for a flow of gas through only one of the oxidative gas decomposing unit 15 and the dehumidifying unit 17.
  • the chamber 1 may further include the plasma device 6 at the entrance 3 of the chamber 1.
  • the plasma device 6 may be disposed inside and/or outside the chamber 1.
  • the plasma device 6 may be disposed outside the chamber 1.
  • the plasma device 6 may be disposed between the high-speed blower 16 and the entrance 3 of the chamber 1.
  • oxidative gas is used as a precursor of an active species, and if plasma is generated after a target object to be sterilized is brought into contact with the oxidative gas, the time necessary for sterilization and the amount of electricity necessary for generating plasma may be shortened or reduced. Furthermore, if plasma is used in the internal circulation process (plasma process), ozone and radicals generated from the plasma additionally facilitate sterilization, and thus the effect of sterilization may be increased. Furthermore, since water and oxygen are produced as byproducts when oxidative gas decomposes in plasma, after the plasma process, toxic substances may not remain on the surface of a sterilized target object.
  • a target object to be sterilized may be damaged by plasma.
  • this may cause significant problems if the target object is a medical device.
  • the sterilization apparatus of the present disclosure includes the plasma device 6 disposed outside the chamber 1, and thus a target object to be sterilized may not be damaged by plasma.
  • the plasma device 6 is not limited to a particular type.
  • the plasma device 6 may include a plasma chamber 1 in which two mutually facing electrodes are disposed and a high electric power supply electrically connected to the electrodes for optimally generating plasma.
  • the plasma device 6 may generate plasma by a method such as a radio frequency (RF) discharge method or an arc discharge method using direct current (DC) high-voltage power or alternating current (AC) high-voltage power.
  • RF radio frequency
  • DC direct current
  • AC alternating current
  • the sterilization apparatus of the present disclosure may be used to sterilize various objects such as medical devices.
  • the sterilization apparatus may be used to sterilize dental devices such as handpieces or medical devices made of polymers.
  • the application of the sterilization apparatus is not limited thereto.
  • oxidative gas is supplied to a chamber after evacuating the chamber using a vacuum pump in such a manner that the oxidative gas may simply diffuse in the evacuated chamber instead of flowing or circulating in the chamber. That is, in a vacuum, oxidative gas may diffuse but may not circulate continuously. In this case, for example, if plasma is used, the diffusion of ozone (O 3 ) or radicals generated from the plasma may be limited, and thus the effect of plasma on sterilization may be low.
  • the sterilization method and apparatus use the high-speed blower 16, and thus the interior pressure of the chamber 1 may be adjusted.
  • gas may continuously be circulated in the chamber 1 at high-pressure, low-pressure, or atmospheric-pressure conditions by using the high-speed blower 16 and valves.
  • oxidative gas may be effectively distributed in the chamber 1 by the continuous circulation of gas in the chamber 1, and if plasma is used, the effect of plasma may be markedly increased.
  • Example 1 manufacturing of sterilization apparatus, and sterilization method using the sterilization apparatus
  • the example sterilization apparatus illustrated in FIG. 2 was manufactured according to the present disclosure.
  • a tray 7 and a heating unit 5 were disposed in a chamber 1, and a door 4 was installed on a side of the chamber 1.
  • a high-speed blower 16 was connected to an exit 2 and an entrance 3 of the chamber 1 so as to forcibly circulate gas in the chamber 1 to which an oxidative gas supply unit 10 was connected.
  • the oxidative gas supply unit 10 included a liquid oxidative substance injection part and an oxidative substance evaporating part so as to supply oxidative gas to the chamber 1.
  • a flow rate regulating device was disposed on the oxidative gas supply unit 10.
  • a plasma device 6 was disposed at the entrance 3 of the chamber 1.
  • the plasma device 6 included a plasma chamber in which two mutually facing electrodes were disposed, and a high electric power supply was electrically connected to the electrodes so as to optimally generate plasma.
  • the chamber 1 was configured in such a manner that gas could be forcibly circulated through the entrance 3 and the exit 2 of the chamber 1 by the high-speed blower 16.
  • a filter 23' was provided to remove impurities or foreign substances from external gas to be introduced into the chamber 1, and an oxidative gas decomposing unit 15 containing a catalyst and a dehumidifying unit 17 were provided.
  • the dehumidifying unit 17 contained a commercially available absorbent.
  • the dehumidifying unit 17 included a heater for removing moisture from the absorbent or a replaceable absorbent cartridge. In the former case, moisture removed using the heater was discharged through the high-speed blower 16 and the oxidative gas decomposing unit 15 to prevent the moisture from entering the chamber 1.
  • the oxidative gas vaporizer and the heating unit 5 and 5' of the chamber 1 were powered on to maintain the temperature of the chamber 1 at 40°C to 60°C.
  • a target object to be sterilized was placed on the tray 7 of the chamber 1, and the door 4 of the chamber 1 was closed. Thereafter, valves were adjusted to allow for forcible circulation of gas through the chamber 1 using the high-speed blower 16.
  • a fourth valve 11 was maintained in a direction ca
  • a first valve 12 was maintained in a direction b ⁇ a
  • a second valve 13 was maintained in a direction ab
  • a third valve 14 was maintained in a direction ac.
  • gas contained in the chamber 1 was guided to pass through the dehumidifying unit 17, and was then supplied to the chamber 1 by the high-speed blower 16 in such a manner that the relative humidity of the chamber 1 could be reduced.
  • hydrogen peroxide was used as an oxidative substance.
  • the high-speed blower 16 was operated, and the heater 5 disposed in the chamber 1 and the oxidative gas supply unit 10 being an oxidative substance evaporator were powered on to maintain the temperature of the chamber 1 at 40°C to 60°C.
  • the second valve 13 was switched in a direction ac and the third valve 14 was switched in the direction a ⁇ c while maintaining the fourth valve 11 in the direction ba and the first valve 12 in the direction ca, so as to forcibly discharge gas contained in the chamber 1 using the high-speed blower 16, and thus to adjust the interior pressure of the chamber 1 to be lower than atmospheric pressure.
  • the temperature of the oxidative substance evaporating part of the oxidative gas supply unit 10 was increased to a temperature of 100°C or higher at which a solution of an oxidative substance could evaporate, and oxidative gas was supplied to the chamber 1 from the liquid oxidative substance injection part through the oxidative substance evaporating part so as to sterilize the target object.
  • Oxidative gas discharge through the second valve 13 was completely decomposed into water and oxygen while passing through the oxidative gas decomposing unit 15 and was then discharged through the third valve 14.
  • the fourth valve 11 was switched in a direction ba, the first valve 12 was switched in a direction b ⁇ a, the second valve 13 was switched in a direction ab, and the third valve 14 was switched in a direction ac, so as to introduce external gas into the chamber 1 through the filter 23' and the dehumidifying unit 17.
  • external gas was introduced into the chamber 1 using the high-speed blower 16, and thus the interior pressure of the chamber 1 could be adjusted to be higher than atmospheric pressure.
  • oxidative gas was supplied to the chamber 1 using the oxidative gas supply unit 10. As the oxidative gas was continuously supplied to the chamber 1, the concentration of the oxidative gas in the chamber 1 was increased, and since the temperature of the chamber 1 was maintained at 40°C to 60°C, condensation of the oxidative gas was minimized for continuous sterilization.
  • Example 1 The sterilization apparatus manufactured in Example 1 was used to perform Comparative Experiment 1 in which sterilization was carried out while operating the high-speed blower 16 without varying the interior pressure of the chamber 1, and Inventive Experiment 1 in which sterilization was carried out while operating the high-speed blower 16 and adjusting three-way valves to vary the interior pressure of the chamber 1. Results of the experiments are shown in Table 1.
  • Geobacillus Stearothermophilus Spores (HMV-091) by USA company A were used as a biological indicator (BI) to check the degree of sterilization.
  • a sterilization pouch in which the BI was inserted was placed in the chamber 1 and was sterilized according to a sterilization process of Comparative Experiment 1, and another sterilization pouch in which the BI was inserted was placed in the chamber 1 and was sterilized according to a sterilization process of Inventive Experiment 1. Then, collected BI samples were placed in the same incubator and were cultivated at 55°C for 48 hours to 7 days. Thereafter, variations of the colors of the BI samples were checked.
  • Comparative Experiment 1 and Inventive Experiment 1 was performed ten times, and the number of times the experiment (sterilization) was successful (no growth) was recorded as illustrated in Table 1.
  • the success ratio was 10 times to 10 times. That is, according to the present disclosure, the sterilization time could be reduced, and the efficiency of sterilization could be improved by varying the interior pressure of the chamber 1 using the high-speed blower 16 and valves.
  • the sterilization apparatus manufactured in Example 1 was used to perform Comparative Experiment 2 in which sterilization was carried out while operating the high-speed blower 16 without varying the pressure of the chamber 1, and Inventive Experiment 2 in which sterilization was carried out while operating the high-speed blower 16 and adjusting three-way valves to vary the pressure of the chamber 1.
  • Comparative Experiment 2 and Inventive Experiment 2 sterilization was performed ten times, and each of the Comparative Experiment 2 and Inventive Experiment 2 was performed twenty times. Results of the experiments are illustrated in Table 2 below.
  • Comparative Experiment 2 gas was circulated in the sterilization apparatus as illustrated in FIG. 7, and BI samples were disposed in structures as illustrated in FIG. 9 and described below so as to check whether the insides of the structures were sterilized.
  • Structure 1 a needle connection part of a 15-cc syringe was opened.
  • Structure 2 an end of a polyethylene (PE) tube (lumen) having an inner diameter of 2 mm and a length of 50 mm was connected to a needle connection part of a 15-cc syringe, and the other end of the tube was opened.
  • PE polyethylene
  • Structure 3 an end of a polyethylene (PE) tube (lumen) having an inner diameter of 2 mm and a length of 100 mm was connected to a needle connection part of a 15-cc syringe, and the other end of the tube was opened.
  • PE polyethylene
  • Structure 4 an end of a polyethylene (PE) tube (lumen) having an inner diameter of 2 mm and a length of 150 mm was connected to a needle connection part of a 15-cc syringe, and the other end of the tube was opened.
  • PE polyethylene

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Abstract

A sterilization method and a sterilization apparatus using the sterilization method are provided. The sterilization method includes: forming a low-pressure atmosphere having a pressure lower than atmospheric pressure in a chamber by discharging gas from the chamber using a high-speed blower; primarily supplying an oxidative gas to the chamber maintained at a pressure lower than atmospheric pressure; forming a high-pressure atmosphere having a pressure higher than atmospheric pressure in the chamber by introducing external gas into the chamber using the blower; and secondarily supplying the oxidative gas to the chamber maintained at a pressure higher than atmospheric pressure. Therefore, sterilization may be effectively performed by adjusting the interior pressure of the chamber using the blower without using a vacuum pump. Furthermore, continuous circulation of gas in the chamber that is difficult in case of using a vacuum pump may guarantee effective sterilization, and humidity may easily be adjusted during sterilization.

Description

STERILIZATION METHOD AND APPARATUS USING THE SAME
The present disclosure relates to a sterilization method and an apparatus using the sterilization method, and more particularly, to an efficient sterilization method by inducing gas circulation using a high-speed blower instead of using a vacuum pump, and an apparatus using the method.
Unlike cleaning or disinfection, sterilization refers to high-level treatment for completely removing all kinds of living microorganisms through a physical process, a chemical process, or a combination thereof.
Devices such as medical devices may be required to be sterilized, and current methods used to sterilize medical devices use ethylene oxide (EO) gas, steam, hydrogen peroxide, plasma, or the like.
Recently, a new sterilization method and an apparatus that uses 100% EO gas but does not use chlorofluorocarbons (CFC) as a carrier have been introduced. However, as is well known, EO gas has a high degree of reactivity, which may lead to hazards such as explosions, and it has been reported that EO gas may act as a genotoxic agent causing mutations. Thus, the American Conference of Governmental Industrial Hygienists (ACGIH) has named EO gas as a potential carcinogen, and has set a limit on the permissible amount of EO gas used in the working environment to be 1 ppm. Thus, the above-mentioned new sterilization method and apparatus using EO gas are difficult to implement because the amount of EO gas has to be strictly controlled so as not to exceed the permissible amount, and it takes a relatively long time (three to five hours) to perform a sterilization process using the new sterilization method or apparatus.
Conversely, steam sterilizers considered to be safe and possessing a sterilizing ability to a certain degree are inexpensive and allow for nontoxic and rapid sterilization. However, since steam sterilizers result in exposure to moisture and high temperatures, steam sterilizers are limited to applications not affected by exposure to moisture and high temperatures.
Other sterilization methods and apparatuses using a proper combination of hydrogen peroxide, ozone, and plasma generating devices are known. For example, Korea Patent No.: 1324567 discloses a method for sterilizing a target object contained in a sterilizing chamber using hydrogen peroxide and ozone, the method including an evacuation process, and Korea Patent No.: 1298730 discloses a sterilization method using plasma.
However, such sterilization methods and apparatuses of the related art require additional devices such as a vacuum pump for creating a vacuum or an expensive plasma generating device, thereby increasing the volume of overall sterilization systems and sterilization costs, and resulting in inefficiency and uneconomical sterilization. Furthermore, techniques using ozone may be harmful, or may cause physical harm due to the strong oxidizing and sterilizing power of ozone.
Thus, if a sterilization method and apparatus using a oxidative gas instead of a vacuum pump and a small plasma generating device instead of an expensive plasma generating device are developed to maximize the efficiency of sterilization, reduce the time necessary for sterilization, and guarantee equipment efficiency, the sterilization method and apparatus may be usefully implemented in a number of related applications, and thus the development of such sterilization methods and apparatuses is required.
An aspect of the present disclosure may provide a sterilization method using a flow of gas generated by a high-speed blower.
An aspect of the present disclosure may provide a sterilization apparatus using a high-speed blower.
According to an aspect of the present disclosure, a sterilization method may include: forming a low-pressure atmosphere having a pressure lower than atmospheric pressure in a chamber by discharging gas from the chamber using a high-speed blower; primarily supplying an oxidative gas to the chamber maintained at a pressure lower than atmospheric pressure; forming a high-press atmosphere having a pressure higher than atmospheric pressure in the chamber by introducing external gas into the chamber using the high-speed blower; and secondarily supplying the oxidative gas to the chamber maintained at a pressure higher than atmospheric pressure.
In the primary supplying of the oxidative gas and the secondary supplying of the oxidative gas, the chamber may be maintained within a temperature range of 40°C to 60°C.
In the forming of the high-pressure atmosphere, the external gas may be introduced into the chamber after moisture and impurities are removed from the external gas.
The sterilization method may further include decomposing the oxidative gas remaining in the chamber into water and oxygen after sterilization is completed.
The sterilization method may further include dehumidifying the chamber by discharging gas from the chamber using the high-speed blower, dehumidifying the gas, and supplying the dehumidified gas back to the chamber.
The forming of the low-pressure atmosphere may be performed to form a pressure equal to or higher than atmospheric pressure - 5 kPa.
The forming of the high-pressure atmosphere may be performed to form a pressure equal to or lower than atmospheric pressure + 5 kPa.
The sterilization method may be repeated two to ten times.
The high-speed blower may form a pressure of ±10 kPa to ±20 kPa based on atmospheric pressure.
The sterilization method may further include circulating gas contained in the chamber while generating plasma in the chamber.
The oxidative gas may include at least one selected from the group consisting of hydrogen peroxide, ozone, and ethylene oxide.
According to another aspect of the present disclosure, a sterilization apparatus may include: a chamber including an oxidative gas supply unit, an exit through which gas is discharged, and an entrance through which gas is introduced; a high-speed blower connected to an exit line and an entrance line of the chamber; a first valve provided between the exit of the chamber and the high-speed blower; a second valve provided between the high-speed blower and the entrance of the chamber; and a control valve connected to at least one of the exit line and the entrance line so as to control inflow of external gas, outflow of gas, or both inflow and outflow of gas.
The control valve may include: a third valve connected to the entrance line of the chamber to discharge gas from the chamber; and a fourth valve connected to the exit line of the chamber to introduce external gas into the chamber.
The control valve may be a multi-control valve controlling inflow and outflow of gas, and the sterilization apparatus may further include at least one of a hydrogen peroxide decomposing unit and a dehumidifying unit that is disposed between the multi-control valve and a bypass line connecting the first and second valves.
The sterilization apparatus may further include a filter connected to the fourth valve or the multi-control valve for removing impurities from external gas.
The sterilization apparatus may further include a dehumidifying unit connected between the first and fourth valves.
The sterilization apparatus may further include an oxidative gas decomposing unit connected between the second and third valves.
The chamber may further include a heating unit.
The chamber may further include a plasma device at the entrance thereof, and the plasma device may be disposed outside of the chamber.
The first, second, third, and fourth valves may be three-way valves.
The high-speed blower may form a pressure of ±10 kPa to ±20 kPa based on atmospheric pressure.
The sterilization apparatus may be used to sterilize medical devices.
The oxidative gas supply unit may supply an oxidative gas, and the oxidative gas may include at least one selected from the group consisting of hydrogen peroxide, ozone, and ethylene oxide.
According to the present disclosure, sterilization may be effectively performed by adjusting the interior pressure of a chamber using a high-speed blower without using a vacuum pump. In addition, time and costs necessary for sterilization may be reduced. Furthermore, continuous circulation of gas in the chamber that is difficult to achieve in a case in which a vacuum pump is used may guarantee effective sterilization, and humidity may easily be adjusted during sterilization.
FIGS. 1A and 1B are graphs illustrating the pressure of an example system when a sterilization method is performed according to an example embodiment of the present disclosure.
FIG. 2 is a view illustrating an example sterilization apparatus according to the present disclosure.
FIG. 3 is a view illustrating an example gas flow during a low-pressure forming process.
FIG. 4 is a view illustrating an example gas flow during a high-pressure forming process.
FIG. 5 is a view illustrating an example gas flow during an oxidative gas decomposing process.
FIG. 6 is a view illustrating an example gas flow during a dehumidifying process.
FIG. 7 is a view illustrating an example gas flow during an internal circulation process for circulating gas in a chamber.
FIG. 8 is a view illustrating another example sterilization apparatus according to the present disclosure.
FIG. 9 is a view illustrating example target objects that may be sterilized according to the present disclosure.
Example embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. The disclosure may, however, be exemplified in many different forms, and should not be construed as being limited to the specific embodiments set forth herein.
The present disclosure provides a sterilization method. According to the sterilization method, gas is forced to continuously circulate in a chamber by a high-speed blower, and the interior pressure of the chamber is adjusted using the circulation of gas.
In detail, the sterilization method of the present disclosure includes: a low-pressure forming process in which gas is discharged from a chamber using a high-speed blower to form a low-pressure atmosphere having a pressure lower than atmospheric pressure in the chamber; a first oxidative gas supply process in which oxidative gas is supplied to the chamber maintained at a pressure lower than atmospheric pressure; a high-pressure forming process in which external gas is introduced into the chamber using the high-speed blower to form a high-pressure atmosphere having a pressure higher than atmospheric pressure in the chamber; and a second oxidative gas supply process in which oxidative gas is supplied to the chamber maintained at a pressure higher than atmospheric pressure.
The sterilization method of the present disclosure is performed to sterilize a target object disposed in the chamber. Therefore, the sterilization method may further include a process of placing a target object in the chamber before the low-pressure forming process.
In the sterilization method of the present disclosure, the chamber is not limited to a particular type. As described in detail in the following description of a sterilization apparatus of the present disclosure, the chamber may include an exit through which gas is discharged, an entrance through which a gas is introduced, and an oxidative gas supply unit. As long as the chamber is capable of forming a closed system, the chamber is not limited to a particular type. For example, the chamber may include at least one door to receive a target object to be sterilized.
The oxidative gas may include at least one selected from the group consisting of hydrogen peroxide, ozone, and ethylene oxide. For example, hydrogen peroxide may be used as the oxidative gas.
FIGS. 2 to 8 illustrate example apparatuses according to the present disclosure.
After placing a target object to be sterilized in a chamber 1, a low-pressure forming process may be performed by discharging gas from the chamber 1 using a high-speed blower 16 to form a low-pressure atmosphere having a pressure lower than atmospheric pressure in the chamber 1.
For example, after the sterilization method of the present disclosure is performed several times, if oxidative gas is included in gas discharged from the low-pressure forming process, the gas discharged from the low-pressure forming process may be guided to pass through an oxidative gas decomposing unit 15 as shown in FIG. 3, so as to guarantee the safety of operators. In addition, if necessary, an additional filter 23 may be used.
The additional filter 23 may be the same kind of filter as a filter 23'. The additional filter 23 may be a high efficiency particulate air (HEPA) filter. For example, the additional filter 23 may be an exhaust gas noise removing filter capable of decreasing noise generated by the high-speed blower 16 and dispersing high-speed exhaust gas. In another example embodiment illustrated in FIG. 8, gas may be introduced and discharged through the same line, and thus a HEPA filter may be used as the additional filter 23.
In the present disclosure, the high-speed blower 16 is used to discharge gas from the chamber 1 or introduce gas into the chamber 1 by creating a circulatory gas flow, and thus the high-speed blower 16 may not be limited to a particular blower as long as the high-speed blower 16 is capable of adjusting the interior pressure of the chamber 1 by creating such a gas flow. However, it may be preferable that the high-speed blower be capable of forming a pressure of ±10 kPa to ±20 kPa, more preferably ±13 kPa to ±17 kPa, and even more preferably about ±15 kPa based on atmospheric pressure. Herein, atmospheric pressure is 1 atm.
If the high-speed blower 16 is not capable of creating a pressure difference of ±10 kPa based on atmospheric pressure, gas may not be sufficiently discharged from the chamber 1, and thus an intended pressure difference may not be obtained. Conversely, if the high-speed blower 16 creates a pressure difference of greater than ±20 kPa, the structural strength of the chamber 1 and seals for the door 4 of the chamber 1 may be required to be increased. In this case, the efficiency of processes for manufacturing related devices may be lowered, and thus the price of a sterilization system using the sterilization method of the present disclosure may be increased.
That is, in the present disclosure, it may be preferable that the high-speed blower 16 be capable of creating a pressure difference of at least 10 kPa based on atmospheric pressure as illustrated in FIGS. 1A and 1B.
A low-pressure atmosphere having a pressure lower than atmospheric pressure may be formed in the chamber 1 by discharging gas from the chamber 1 using the high-speed blower 16. In the present disclosure, the term "low-pressure" refers to a pressure lower than atmospheric pressure, and in the low-pressure forming process, the pressure in the chamber 1 may be equal to or higher than atmospheric pressure - 10 kPa, that is, about 91 kPa. As the degree of vacuum in the chamber 1 increases, sterilization in the chamber 1 may be promoted. However, if the interior pressure of the chamber 1 in the low-pressure forming process is lower than atmospheric pressure - 10 kPa, that is, about 91 kPa, the structural strength of the chamber 1 and seals for the door 4 of the chamber 1 may be required to be increased. In this case, the efficiency of processes for manufacturing related devices may be lowered, and thus the price of a sterilization system using the sterilization method of the present disclosure may be increased.
FIG. 3 illustrates an example gas flow in the low-pressure forming process. According to the present disclosure, the interior pressure of the chamber 1 is decreased slightly from atmospheric pressure of creating a vacuum, and thus expensive devices such as a vacuum pump are not used.
Furthermore, in the present disclosure, the high-speed blower 16 may be a blower capable of changing pressure according to the rotation speed thereof.
After the interior pressure of the chamber 1 is adjusted to be lower than atmospheric pressure as described above, an oxidative gas may be supplied to the interior of the chamber 1 in a first oxidative gas supply process. Since the first oxidative gas supply process is performed at a low pressure as described above, the oxidative gas may easily be diffused and brought into contact with the target object, and thus the target object may be effectively sterilized.
In the first oxidative gas supply process, the concentration of the oxidative gas may preferably be within the range of 1,000 ppm to 2,000 ppm. If the concentration of the oxidative gas is less than 1,000 ppm, sterilization may occur insufficiently, and if the concentration of the oxidative gas is greater than 2,000 ppm, the oxidative gas may condense with moisture, and thus the concentration of the oxidative gas may reversely decrease.
In the present disclosure, the oxidative gas used for sterilization refers to a substance having an oxidizing ability in a gaseous state. That is, the oxidative gas is a gaseous substance. For example, gaseous hydrogen peroxide may be used as the oxidative gas. In other words, hydrogen peroxide steam may be used.
The first oxidative gas supply process may be performed for 1 minute to 1 hour, preferably 2 minutes to 30 minutes, and more preferably 5 minutes to 20 minutes. In addition, the low-pressure forming process may be performed for a time period longer than the time period during which a high-pressure forming process is performed.
Next, in a high-pressure forming process, external gas is blown into the chamber 1 using the high-speed blower 16 to form a high-pressure atmosphere having a pressure higher than atmospheric pressure in the chamber 1. That is, a high-pressure atmosphere having a pressure higher than atmospheric pressure may be formed in the chamber 1 by blowing external gas into the chamber 1 using the high-speed blower 16. In the present disclosure, the term "high-pressure" refers to a pressure higher than atmospheric pressure, and in the high-pressure forming process, the pressure in the chamber 1 may be equal to or lower than atmospheric pressure + 10 kPa, that is, about 111 kPa. If the interior pressure of the chamber 1 in the high-pressure forming process is higher than atmospheric pressure + 10 kPa, that is, about 111 kPa, the structural strength of the chamber 1 and seals for the door 4 of the chamber 1 may be required to be increased. In this case, the efficiency of processes for manufacturing related devices may be lowered, and thus the price of a sterilization system using the sterilization method of the present disclosure may be increased. The term "external gas" refers to gas outside the chamber 1. For example, the external gas may be air. FIG. 4 illustrates an example gas flow in the high-pressure forming process.
In the low-pressure forming process and the high-pressure forming process of the present disclosure, a pressure lower or higher than atmospheric pressure is formed. However, while the interior pressure of the chamber 1 is increased or decreased according to the sterilization method of the present disclosure, the interior pressure of the chamber 1 may become equal to atmospheric pressure, and this will be apparent to those having ordinary skill in the art.
As described above, according to the present disclosure, the creation of a vacuum is not required, and when the sterilization method is performed, the interior pressure of the chamber 1 is varied within the range of ±10 kPa based on atmospheric pressure as illustrated in FIGS. 1A and 1B. That is, the effect of sterilization may be effectively obtained using small pressure variations without using expensive devices such as a vacuum pump.
After the interior pressure of the chamber 1 is adjusted to be higher than atmospheric pressure as described above, the oxidative gas is supplied to the interior of the chamber 1 in a second oxidative gas supply process. Since the second oxidative gas supply process is performed at a high pressure, the pressure difference between the interior and exterior of the target object may be high, and thus the oxidative gas may deeply permeate into the target object. As a result, the target object may be completely sterilized.
In the second oxidative gas supply process, the concentration of the oxidative gas may preferably be within the range of 1,000 ppm to 2,000 ppm. If the concentration of the oxidative gas is less than 1,000 ppm, sterilization may insufficiently occur, and if the concentration of the oxidative gas is greater than 2,000 ppm, the oxidative gas may condense with moisture, and thus the concentration of the oxidative gas may reversely decrease.
The second oxidative gas supply process may be performed for 1 minute to 1 hour, preferably 2 minutes to 30 minutes, and more preferably 5 minutes to 20 minutes. However, as described above, the high-pressure forming process may be performed for a time period shorter than the time period during which the low-pressure forming process is performed
In the first oxidative gas supply process and the second oxidative gas supply process, the chamber 1 may preferably be maintained at a temperature of 40°C to 60°C. The temperature of the chamber 1 may be adjusted to be within the above-mentioned range before or when the first oxidative gas supply process is started. In the present disclosure, since the oxidative gas is supplied to the chamber 1 in a gaseous sate for sterilization, if the temperature of the chamber 1 is maintained within the above-mentioned range, condensation of the oxidative gas may be minimized, and the effect of sterilization may be continuously maintained.
An oxidative gas which is gaseous by nature or a gas or steam obtained by evaporating a liquid oxidative substance such as an aqueous solution of hydrogen peroxide using an evaporator may be supplied as the oxidative gas (i.e., a gaseous oxidative substance) to the chamber 1. Oxidative gases which are gaseous by nature are unstable, and thus may easily be decomposed into water and oxygen by moisture contained in the air. Thus, an aqueous solution of an oxidative substance may be evaporated into gas or steam using an evaporator or any other method, and may then be supplied as the oxidative gas to the chamber 1. In the present disclosure, for example, an aqueous solution of hydrogen peroxide may be evaporated into gas or steam using an evaporator disposed outside the chamber 1, and may then be supplied as the oxidative gas to the chamber 1.
In the first oxidative gas supply process and the second oxidative gas supply process, if the interior temperature of the chamber 1 is lower than 40°C, the effect of sterilization may be lowered due to condensation of the oxidative gas, and if the interior temperature of the chamber 1 exceeds 60°C, a target object to be sterilized such as plastics vulnerable to heat may be deformed or damaged.
The interior temperature of the chamber 1 may be controlled using a heating unit 5 disposed in the chamber 1. The heating unit 5 is not limited to a particular type. For example, the heating unit 5 may be a general heater.
The sterilization method may further include a dehumidifying process in which gas is discharged from the chamber 1 using the high-speed blower 16, dehumidified, and supplied back to the chamber 1. In the sterilization method of the present disclosure, the dehumidifying process may be performed before the low-pressure forming process. If the sterilization method of the present disclosure is performed two or more times, the dehumidifying process may be performed each time before the low-pressure forming process is performed. FIG. 6 illustrates an example gas flow in the dehumidifying process. If the relative humidity of the interior of the chamber 1 is decreased after the dehumidifying process, the efficiency of sterilization may be improved.
Furthermore, external gas subjected to a dehumidifying process and an impurity removing process may be supplied to the chamber 1 in the high-pressure forming process. That is, before external gas is introduced into the chamber 1 for sterilization, the external gas may be dehumidified through a dehumidifying process, and unnecessary substances contained in the external gas may be removed through an impurity removing process, so as to more effectively sterilize the target object using the external gas.
The dehumidifying process and the impurity removing process may be performed at least once on gas circulated along the chamber 1 as well as newly introduced external gas. That is, if the sterilization method of the present disclosure is performed in a closed system while constantly introducing oxidative gas into the closed system, the relative humidity of the interior of the chamber 1 may increase. If the relative humidity of the interior of the chamber 1 increases, oxidative gas may condense with moisture, and thus the concentration of the oxidative gas may decrease. To solve this problem, gas contained in the chamber 1 may be discharged using the high-speed blower 16 and subjected to the dehumidifying process, and then the dehumidified gas may be supplied back to the chamber 1.
The dehumidifying process is not limited to a particular method. For example, the dehumidifying process may be performed by passing gas through an absorbent. In addition, the impurity removing process is not limited to a particular method. For example, the impurity removing process may be performed using a filter.
The sterilization method may further include a process of decomposing the oxidative gas remaining in the chamber 1 into water and oxygen after completing sterilization. FIG. 5 illustrates an example gas flow in the oxidative gas decomposing process. That is, after completing sterilization, the oxidative gas may be decomposed into water and oxygen using a device such as a catalyst unit, and the oxygen obtained by decomposing the oxidative gas may be introduced into the chamber 1.
In other words, after completing sterilization, the oxidative gas of gas contained in the chamber 1 may be decomposed into water and oxygen by passing the gas through the catalyst unit, and the remaining gas which is not harmful after the oxidative gas is removed may be introduced back into the chamber 1. In this manner, the oxidative gas remaining in the target object may be removed, and when the chamber 1 is opened, an operator may be protected.
The sterilization method of the present disclosure may be performed two to ten times for a total time period of 1.5 minutes to 90 minutes, preferably for 5 minutes to 1 hour, and more preferably for 5 minutes to 30 minutes.
In addition, the sterilization method of the present disclosure may further include a process of generating plasma in the chamber 1. In other words, the sterilization method may further include an internal circulation process in which gas contained in the chamber 1 is circulated while generating plasma in the chamber 1. FIG. 7 illustrates an example gas flow in the internal circulation process.
According to the present disclosure, such a plasma process may be additionally performed after any of the processes of the sterilization method, such as after the second oxidative gas supply process. In the present disclosure, oxidative gas is used as a precursor of an active species, and if plasma is generated after a target object to be sterilized is brought into contact with the oxidative gas, the time necessary for sterilization and the amount of electricity for generating plasma may be shortened or reduced. In addition, since sterilization is additionally performed by ozone and radicals generated from plasma in the internal circulation process (plasma process), the effect of sterilization may be enhanced. Furthermore, since water and oxygen are produced as byproducts when oxidative gas decomposes in plasma, after the plasma process, toxic substances may not remain on the surface of a sterilized target object.
FIG. 1B is a graph illustrating the interior pressure of an example system when the sterilization method including a plasma generating process as described above is performed according to the present disclosure.
In detail, oxidative gas may be supplied to the chamber 1 while varying the interior pressure of the chamber 1 using the high-speed blower 16, and then a plasma device 6 may be powered on so as to generate plasma in the chamber 1.
While maintaining the interior pressure of the chamber 1 to be higher or lower than atmospheric pressure using the high-speed blower 16 and three-way valves or maintaining internal circulation in the chamber 1 at atmospheric pressure, the plasma device 6 may be operated to circulate gas in the chamber 1.
At this time, in the internal circulation process, as shown in FIG. 7, a fourth valve 11 is switched in a direction ba, a first valve 12 is switched in a direction c→a, a second valve 13 is switched in a direction ab, and a third valve 14 is switched in a direction ac, and thus gas contained in the chamber 1 is circulated through the plasma device 6 by the high-speed blower 16. After passing through the plasma device 6, the gas may be converted into gas or steam including at least one of ozone, electrons, ions, free radicals, and dissociated or excited atoms or molecules, and thus an additional sterilization effect may be obtained.
The present disclosure further provides a sterilization apparatus capable of executing the sterilization method.
The sterilization apparatus of the present disclosure may include: a chamber including an oxidative gas supply unit, an exit through which gas is discharged, and an entrance through which gas is introduced; a high-speed blower connected to an exit line and an entrance line of the chamber; a first valve provided between the exit of the chamber and the high-speed blower; a second valve provided between the high-speed blower and the entrance of the chamber; and a control valve connected to at least one of the exit line and the entrance line so as to control inflow of external gas, outflow of gas, or both inflow and outflow of gas.
FIGS. 2 to 7 illustrate an example sterilization apparatus according to the present disclosure. In the following description, the sterilization apparatus will now be described in detail with reference to FIG. 2.
In detail, according to the present disclosure, a chamber 1 may include an oxidative gas supply unit 10, an exit 2 through which gas is discharged from the chamber 1, and an entrance 3 through which gas is introduced into the chamber 1. If necessary, a tray 7 and a heating unit 5 may be disposed in the chamber 1, and a target object to be sterilized may be placed on the tray 7. In addition, a door 4 may be provided on a side of the chamber 1. After a target object to be sterilized is placed in the chamber 1, the chamber 1 may be closed using the door 4.
The sterilization apparatus of the present disclosure includes a high-speed blower 16 connected to an exit line 20 and an entrance line 21, and gas contained in the chamber 1 may forcibly be circulated using the high-speed blower 16.
The oxidative gas supply unit 10 is not limited to a particular type as long as the oxidative gas supply unit 10 is capable of supplying oxidative gas. For example, the oxidative gas supply unit 10 may include a liquid oxidative substance injection part and an oxidative substance evaporating part. If necessary, a flow rate regulating device may be installed in the oxidative gas supply unit 10.
The chamber 1 may include the heating unit 5 to adjust the interior temperature of the chamber 1. The heating unit 5 is not limited to a particular type. For example, the heating unit 5 may be a general heater.
In addition, the chamber 1 may further include a plasma device 6 at the entrance 3 through which gas is introduced into the chamber 1. In this case, the plasma device 6 may be disposed outside the chamber 1. The plasma device 6 is not limited to a particular type as long as the plasma device 6 is capable of supplying plasma. For example, the plasma device 6 may include a plasma chamber 1 in which two mutually-facing electrodes are disposed and a power supply configured to supply power through the electrodes for generating plasma between the electrodes.
In the present disclosure, the high-speed blower 16 is used to discharge gas from the chamber 1 or introduce gas into the chamber 1. The high-speed blower 16 is not limited to a particular blower as long as the high-speed blower 16 is capable of adjusting the interior pressure of the chamber 1 by creating such a gas flow. However, it may be preferable that the high-speed blower 16 be capable of creating a pressure of ±10 kPa to ±20 kPa, more preferably ±13 kPa to ±17 kPa, and even more preferably about ±15 kPa based on atmospheric pressure. Herein, atmospheric pressure is 1 atm.
Flow of gas in the chamber 1 may be controlled using first, second, third, and fourth valves 12, 13, 14 or 14', and 11, and the interior pressure of the chamber 1 may be adjusted according to the control of the flow of gas.
In more detail, as illustrated in FIG 2, the third valve 14 may be connected to the entrance line 21 of the chamber 1 for discharging gas contained in the chamber 1, and the fourth valve 11 may be connected to the exit line 20 of the chamber 1 for introducing external gas into the chamber 1. Alternatively, as illustrated in FIG. 8, a control valve 14' may control both the inflow and outflow of gas.
The first, second, third, and fourth valves 12, 13, 14, and 11 may be multi-way valves. For example, the first, second, third, and fourth valves 12, 13, 14, and 11 may be three-way valves constituting an efficient sterilization system.
The sterilization apparatus may additionally perform a dehumidifying process to discharge gas from the chamber 1 using the high-speed blower 16, dehumidify the gas, and supply the gas back to the chamber 1.
When the dehumidifying process is performed in the sterilization apparatus, the first valve 12 is maintained in a direction ba, the second valve 13 is maintained in a direction a→b, and the third valve 14 is maintained in a direction ac. When the three valves are opened in the above-described directions to create a flow of gas, the other valve is closed in such a manner that the other valve may not affect the flow of gas. For example, the first valve 12 is opened to allow for a flow of air in the direction ba. In this case, a portion c of the first valve 12 is closed.
Referring to FIG. 6, when the dehumidifying process is performed in the sterilization apparatus, the fourth valve 11 is maintained in a direction ac, the first valve 12 is maintained in a direction ba, the second valve 13 is maintained in a direction a→b, and the third valve 14 is maintained in a direction ac. At this time, the other valve is closed to block a flow through the other valve. For example, if the first valve 12 is opened to allow for a flow of air in the direction ba, a portion c of the first valve 12 is closed. Similarly, since the third valve 14 is not involved in the flow of gas in the dehumidifying process, the flow of gas is maintained in the direction ac. That is, a portion b of the third valve 14 is closed so as not to allow a flow of gas therethrough.
In the dehumidifying process, gas contained in the chamber 1 may be guided to pass through a dehumidifying unit 17, and may then be supplied back to the chamber 1 so as to decrease the humidity inside the chamber 1 and the target object. In this case, the sterilizing efficiency of oxidative gas may be improved in a later sterilizing process.
In the dehumidifying process, if the second valve 13 is switched in a direction ac and the third valve 14 is switched in the direction a→c while maintaining the fourth valve 11 in the direction ca and the first valve 12 in the direction ca, gas contained in the chamber 1 is discharged by the high-speed blower 16, and thus the interior pressure of the chamber 1 may be decreased to be lower than atmospheric pressure. That is, a low-pressure forming process may be performed according to the present disclosure.
After a low-pressure atmosphere is formed in the chamber 1 as described above, oxidative gas is supplied to the chamber 1. For example, if the oxidative gas supply unit 10 includes a liquid oxidative substance injection part and an oxidative substance evaporating part, the temperature of the oxidative substance evaporating part may be increased to 100°C or higher to evaporate a solution of an oxidative substance, and then oxidative gas may be supplied from the liquid oxidative substance injection part to the chamber 1 through the oxidative substance evaporating part. As a result, sterilization may be performed in the chamber 1.
According to the present disclosure, the sterilization apparatus may further include a filter 23' connected to the fourth valve 11 for removing impurities from external gas. However, in the case in which the sterilization apparatus includes the control valve 14' controlling both the inflow and outflow of gas, the sterilization apparatus may further include a filter 23 connected to the control valve 14' for removing impurities from external gas.
After a first oxidative gas supply process, a high-pressure forming process may be performed to introduce external gas into the chamber 1 using the high-speed blower 16, and thus to form a high-pressure atmosphere having a pressure higher than atmospheric pressure. To this end, the fourth valve 11 is adjusted in a direction ba, the first valve 12 is adjusted in a direction b→a, the second valve 13 is adjusted in a direction ab, and the third valve 14 is adjusted in a direction ac. In this case, external gas is introduced through the filter 23' and the dehumidifying unit 17. In this case, since external gas is introduced into the chamber 1 through the high-speed blower 16, the interior pressure of the chamber 1 may be maintained at a level higher than atmospheric pressure.
In the present disclosure, any filter capable of removing dust particles such as fine dust particles from external gas may be used. For example, a HEPA filter capable of removing particles having a size of 0.3 μm or greater may be used.
In the present disclosure, the sterilization apparatus may include the dehumidifying unit 17 connected between the first valve 12 and the fourth valve 11, the oxidative gas decomposing unit 15 connected between the second valve 13 and the third valve 14, or both of the dehumidifying unit 17 and the oxidative gas decomposing unit 15.
For example, when a low-pressure atmosphere is formed in the chamber 1, oxidative gas discharged through the second valve 13 may completely be decomposed into water and oxygen while the oxidative gas passes through the oxidative gas decomposing unit 15, and then the water and oxygen may be discharged through the third valve 14. Furthermore, in the dehumidifying process, gas discharged from the chamber 1 may pass through the dehumidifying unit 17 disposed between the first valve 12 and the fourth valve 11, and may then flow back to the chamber 1.
In the case in which the sterilization apparatus has a structure illustrated in FIG. 8, the control valve 14' controls both the inflow and outflow of gas, and at least one of the oxidative gas decomposing unit 15 and the dehumidifying unit 17 may be disposed between the control valve 14' and a bypass line 22 connecting the first and second valves 12 and 13.
In this case, the sterilization apparatus of the present disclosure may include the bypass line 22 connecting the first valve 12 and the second valve 13, and at least one of the oxidative gas decomposing unit 15 and the dehumidifying unit 17 between the bypass line 22 and the third valve 14. For example, when a low-pressure atmosphere is formed in the chamber 1, oxidative gas discharged from the chamber 1 through the second valve 13 may be completely decomposed into water and oxygen as the oxidative gas passes through the oxidative gas decomposing unit 15, and may then be discharged through the third valve 14. In the dehumidifying process, gas dehumidified by the dehumidifying unit 17 may be supplied back to the chamber 1. In addition, gas discharged from the chamber 1 may be directed to pass through the dehumidifying unit 17 and the oxidative gas decomposing unit 15, and may then be supplied back to the chamber 1 so as to dry a target object and replace gas contained in the chamber 1 with harmless gas after the target object is sterilized. As described above, if necessary, gas may be directed to pass through at least one of the oxidative gas decomposing unit 15 and the dehumidifying unit 17 in each process performed for sterilization. Therefore, although not illustrated in FIG. 7, the dehumidifying unit 17 and the oxidative gas decomposing unit 15 may be connected in series or parallel between the second valve 13 and the third valve 14, and valves may be properly arranged according to line designs.
The oxidative gas decomposing unit 15 is not limited to a particular type as long as the oxidative gas decomposing unit 15 is capable of decomposing oxidative gas into water and oxygen. In a non-limiting example, the oxidative gas decomposing unit 15 may have a ceramic honey comb shape, a bead agglomerate shape, a pellet agglomerate shape, or a granule agglomerate shape coated with a catalyst or absorbent. For example, the oxidative gas decomposing unit 15 may have a cartridge shape in which a pellet type catalyst is contained for decomposing oxidative gas, or a heating unit may be disposed in the oxidative gas decomposing unit 15 to facilitate the decomposition of oxidative gas by heating a catalyst.
For example, the catalyst or absorbent may include at least one of platinum (Pt), palladium (Pd), rhodium (Rh), and ruthenium (Ru) supported in a metal oxide; transition metal oxides such as CrOx and CuOx supported in a metal oxide; molecular seives such as a zeolite molecular sieve; and semiconductors such as TiO2, ZrO2, and MgO. For example, a manganese-based catalyst may be used.
In addition, the dehumidifying unit 17 may remove moisture from external gas to be introduced into the chamber 1, so as to adjust the humidity of the chamber 1. Even when gas is internally circulated, the gas may be guided to pass through the dehumidifying unit 17 by controlling valves. In this case, the humidity of gas circulated for sterilization may be easily adjusted.
FIGS. 2 to 8 illustrate example arrangements of elements of the sterilization apparatus. However, the arrangement structure of the sterilization apparatus is not limited to those illustrated in FIGS. 2 to 8.
For example, referring to FIG. 7, the oxidative gas decomposing unit 15 and the dehumidifying unit 17 are connected in series between the third valve 14 and the bypass line 22 connecting the first and second valves 12 and 13. However, the oxidative gas decomposing unit 15 and the dehumidifying unit 17 may be connected in parallel, or a module having both the functions of the oxidative gas decomposing unit 15 and the dehumidifying unit 17 may be used. In addition, the oxidative gas decomposing unit 15 and the dehumidifying unit 17 may be connected in series, and the bypass line 22 may be provided to allow for a flow of gas through only one of the oxidative gas decomposing unit 15 and the dehumidifying unit 17.
The chamber 1 may further include the plasma device 6 at the entrance 3 of the chamber 1. In this case, the plasma device 6 may be disposed inside and/or outside the chamber 1. For example, the plasma device 6 may be disposed outside the chamber 1. Specifically, the plasma device 6 may be disposed between the high-speed blower 16 and the entrance 3 of the chamber 1.
That is, in the present disclosure, oxidative gas is used as a precursor of an active species, and if plasma is generated after a target object to be sterilized is brought into contact with the oxidative gas, the time necessary for sterilization and the amount of electricity necessary for generating plasma may be shortened or reduced. Furthermore, if plasma is used in the internal circulation process (plasma process), ozone and radicals generated from the plasma additionally facilitate sterilization, and thus the effect of sterilization may be increased. Furthermore, since water and oxygen are produced as byproducts when oxidative gas decomposes in plasma, after the plasma process, toxic substances may not remain on the surface of a sterilized target object.
In particular, if a plasma generating device is disposed in the chamber 1, a target object to be sterilized may be damaged by plasma. For example, this may cause significant problems if the target object is a medical device. However, the sterilization apparatus of the present disclosure includes the plasma device 6 disposed outside the chamber 1, and thus a target object to be sterilized may not be damaged by plasma.
In the present disclosure, the plasma device 6 is not limited to a particular type. For example, the plasma device 6 may include a plasma chamber 1 in which two mutually facing electrodes are disposed and a high electric power supply electrically connected to the electrodes for optimally generating plasma. In more detail, the plasma device 6 may generate plasma by a method such as a radio frequency (RF) discharge method or an arc discharge method using direct current (DC) high-voltage power or alternating current (AC) high-voltage power.
The sterilization apparatus of the present disclosure may be used to sterilize various objects such as medical devices. For example, the sterilization apparatus may be used to sterilize dental devices such as handpieces or medical devices made of polymers. However, the application of the sterilization apparatus is not limited thereto.
In the case of sterilization methods and apparatuses of the related art that use vacuum pumps, oxidative gas is supplied to a chamber after evacuating the chamber using a vacuum pump in such a manner that the oxidative gas may simply diffuse in the evacuated chamber instead of flowing or circulating in the chamber. That is, in a vacuum, oxidative gas may diffuse but may not circulate continuously. In this case, for example, if plasma is used, the diffusion of ozone (O3) or radicals generated from the plasma may be limited, and thus the effect of plasma on sterilization may be low.
In the present disclosure, however, the sterilization method and apparatus use the high-speed blower 16, and thus the interior pressure of the chamber 1 may be adjusted. In addition, gas may continuously be circulated in the chamber 1 at high-pressure, low-pressure, or atmospheric-pressure conditions by using the high-speed blower 16 and valves. As a result, oxidative gas may be effectively distributed in the chamber 1 by the continuous circulation of gas in the chamber 1, and if plasma is used, the effect of plasma may be markedly increased.
Hereinafter, the present disclosure will be described more specifically through examples. The following examples are for illustrative purposes only and are not intended to limit the scope of the present invention.
EXAMPLES
Example 1: manufacturing of sterilization apparatus, and sterilization method using the sterilization apparatus
(1) Sterilization Apparatus
The example sterilization apparatus illustrated in FIG. 2 was manufactured according to the present disclosure.
In detail, a tray 7 and a heating unit 5 were disposed in a chamber 1, and a door 4 was installed on a side of the chamber 1. A high-speed blower 16 was connected to an exit 2 and an entrance 3 of the chamber 1 so as to forcibly circulate gas in the chamber 1 to which an oxidative gas supply unit 10 was connected. The oxidative gas supply unit 10 included a liquid oxidative substance injection part and an oxidative substance evaporating part so as to supply oxidative gas to the chamber 1. In addition, a flow rate regulating device was disposed on the oxidative gas supply unit 10.
A plasma device 6 was disposed at the entrance 3 of the chamber 1. The plasma device 6 included a plasma chamber in which two mutually facing electrodes were disposed, and a high electric power supply was electrically connected to the electrodes so as to optimally generate plasma. The chamber 1 was configured in such a manner that gas could be forcibly circulated through the entrance 3 and the exit 2 of the chamber 1 by the high-speed blower 16.
In addition, a filter 23' was provided to remove impurities or foreign substances from external gas to be introduced into the chamber 1, and an oxidative gas decomposing unit 15 containing a catalyst and a dehumidifying unit 17 were provided. The dehumidifying unit 17 contained a commercially available absorbent. The dehumidifying unit 17 included a heater for removing moisture from the absorbent or a replaceable absorbent cartridge. In the former case, moisture removed using the heater was discharged through the high-speed blower 16 and the oxidative gas decomposing unit 15 to prevent the moisture from entering the chamber 1.
(2) Sterilization Method
The oxidative gas vaporizer and the heating unit 5 and 5' of the chamber 1 were powered on to maintain the temperature of the chamber 1 at 40°C to 60°C. A target object to be sterilized was placed on the tray 7 of the chamber 1, and the door 4 of the chamber 1 was closed. Thereafter, valves were adjusted to allow for forcible circulation of gas through the chamber 1 using the high-speed blower 16. In a dehumidifying process, a fourth valve 11 was maintained in a direction ca, a first valve 12 was maintained in a direction b→a, a second valve 13 was maintained in a direction ab, and a third valve 14 was maintained in a direction ac. In the dehumidifying process, gas contained in the chamber 1 was guided to pass through the dehumidifying unit 17, and was then supplied to the chamber 1 by the high-speed blower 16 in such a manner that the relative humidity of the chamber 1 could be reduced. In the example, hydrogen peroxide was used as an oxidative substance.
The high-speed blower 16 was operated, and the heater 5 disposed in the chamber 1 and the oxidative gas supply unit 10 being an oxidative substance evaporator were powered on to maintain the temperature of the chamber 1 at 40°C to 60°C.
As illustrated in FIG. 3, the second valve 13 was switched in a direction ac and the third valve 14 was switched in the direction a→c while maintaining the fourth valve 11 in the direction ba and the first valve 12 in the direction ca, so as to forcibly discharge gas contained in the chamber 1 using the high-speed blower 16, and thus to adjust the interior pressure of the chamber 1 to be lower than atmospheric pressure. After a low-pressure atmosphere was formed as described above, the temperature of the oxidative substance evaporating part of the oxidative gas supply unit 10 was increased to a temperature of 100°C or higher at which a solution of an oxidative substance could evaporate, and oxidative gas was supplied to the chamber 1 from the liquid oxidative substance injection part through the oxidative substance evaporating part so as to sterilize the target object.
Oxidative gas discharge through the second valve 13 was completely decomposed into water and oxygen while passing through the oxidative gas decomposing unit 15 and was then discharged through the third valve 14.
After sterilization was completed, as shown in FIG. 4, the fourth valve 11 was switched in a direction ba, the first valve 12 was switched in a direction b→a, the second valve 13 was switched in a direction ab, and the third valve 14 was switched in a direction ac, so as to introduce external gas into the chamber 1 through the filter 23' and the dehumidifying unit 17. In this manner, external gas was introduced into the chamber 1 using the high-speed blower 16, and thus the interior pressure of the chamber 1 could be adjusted to be higher than atmospheric pressure.
After the interior pressure of the chamber 1 was increased to be higher than the atmospheric pressure, oxidative gas was supplied to the chamber 1 using the oxidative gas supply unit 10. As the oxidative gas was continuously supplied to the chamber 1, the concentration of the oxidative gas in the chamber 1 was increased, and since the temperature of the chamber 1 was maintained at 40°C to 60°C, condensation of the oxidative gas was minimized for continuous sterilization.
1. The effect of sterilization was checked according to the interior pressure of the chamber
The sterilization apparatus manufactured in Example 1 was used to perform Comparative Experiment 1 in which sterilization was carried out while operating the high-speed blower 16 without varying the interior pressure of the chamber 1, and Inventive Experiment 1 in which sterilization was carried out while operating the high-speed blower 16 and adjusting three-way valves to vary the interior pressure of the chamber 1. Results of the experiments are shown in Table 1.
In Comparative Experiment 1, gas was guided to flow as illustrated in FIG. 7.
Geobacillus Stearothermophilus Spores (HMV-091) by USA company A were used as a biological indicator (BI) to check the degree of sterilization. In detail, a sterilization pouch in which the BI was inserted was placed in the chamber 1 and was sterilized according to a sterilization process of Comparative Experiment 1, and another sterilization pouch in which the BI was inserted was placed in the chamber 1 and was sterilized according to a sterilization process of Inventive Experiment 1. Then, collected BI samples were placed in the same incubator and were cultivated at 55°C for 48 hours to 7 days. Thereafter, variations of the colors of the BI samples were checked. Each of Comparative Experiment 1 and Inventive Experiment 1 was performed ten times, and the number of times the experiment (sterilization) was successful (no growth) was recorded as illustrated in Table 1.
BI samples successfully sterilized (tested negative) were not changed in color, and BI samples unsuccessfully sterilized (tested positive) turned purple.
Sterilization time Comparative Experiment 1 Inventive Experiment 1
5 minutes 4 times/10 times 10 times/10 times
As illustrated in Table 1, when sterilization was performed according to the sterilization method and apparatus of the present disclosure, the success ratio was 10 times to 10 times. That is, according to the present disclosure, the sterilization time could be reduced, and the efficiency of sterilization could be improved by varying the interior pressure of the chamber 1 using the high-speed blower 16 and valves.
2. The effect of sterilization according to the structures of target objects to be sterilized
The sterilization apparatus manufactured in Example 1 was used to perform Comparative Experiment 2 in which sterilization was carried out while operating the high-speed blower 16 without varying the pressure of the chamber 1, and Inventive Experiment 2 in which sterilization was carried out while operating the high-speed blower 16 and adjusting three-way valves to vary the pressure of the chamber 1. In each of the Comparative Experiment 2 and Inventive Experiment 2, sterilization was performed ten times, and each of the Comparative Experiment 2 and Inventive Experiment 2 was performed twenty times. Results of the experiments are illustrated in Table 2 below.
In Comparative Experiment 2, gas was circulated in the sterilization apparatus as illustrated in FIG. 7, and BI samples were disposed in structures as illustrated in FIG. 9 and described below so as to check whether the insides of the structures were sterilized.
Structure 1: a needle connection part of a 15-cc syringe was opened.
Structure 2: an end of a polyethylene (PE) tube (lumen) having an inner diameter of 2 mm and a length of 50 mm was connected to a needle connection part of a 15-cc syringe, and the other end of the tube was opened.
Structure 3: an end of a polyethylene (PE) tube (lumen) having an inner diameter of 2 mm and a length of 100 mm was connected to a needle connection part of a 15-cc syringe, and the other end of the tube was opened.
Structure 4: an end of a polyethylene (PE) tube (lumen) having an inner diameter of 2 mm and a length of 150 mm was connected to a needle connection part of a 15-cc syringe, and the other end of the tube was opened.
After sterilization was performed as described above, BI samples were collected and cultivated in the same incubator at 55°C for 48 hours to 7 days. Then, the colors of the BI samples were checked. After each experiment was performed twenty times, the number of times the experiment was successful (no growth) was recorded as illustrated in Table 2.
Structures Number of times of sterilization Sterilization time Comparative Experiment 2 Inventive Experiment 2
Structure 1 10 times 90 minutes 14 times/20 times 20 times/20 times
Structure
2 10 times 90 minutes 5 times/20 times 20 times/20 times
Structure
3 10 times 90 minutes 0 times/20 times 20 times/20 times
Structure
4 10 times 90 minutes 0 times/20 times 20 times/20 times
As illustrated in Table 2, even the inside of a narrow and low structure was effectively sterilized within 90 minutes by the sterilization method and apparatus of the present disclosure. That is, the sterilization method and apparatus of the present disclosure guarantee satisfactory sterilization.
While example embodiments have been shown and described above, it will be apparent to those skilled in the art that modifications and variations could be made without departing from the scope of the present invention as defined by the appended claims.

Claims (23)

  1. A sterilization method comprising:
    forming a low-pressure atmosphere having a pressure lower than atmospheric pressure in a chamber by discharging gas from the chamber using a high-speed blower;
    primarily supplying an oxidative gas to the chamber maintained at a pressure lower than atmospheric pressure;
    forming a high-press atmosphere having a pressure higher than atmospheric pressure in the chamber by introducing external gas into the chamber using the high-speed blower; and
    secondarily supplying the oxidative gas to the chamber maintained at a pressure higher than atmospheric pressure.
  2. The sterilization method of claim 1, wherein in the primary supplying of the oxidative gas and the secondary supplying of the oxidative gas, the chamber is maintained within a temperature range of 40°C to 60°C.
  3. The sterilization method of claim 1, wherein in the forming of the high-pressure atmosphere, the external gas is introduced into the chamber after moisture and impurities are removed from the external gas.
  4. The sterilization method of claim 1, further comprising decomposing the oxidative gas remaining in the chamber into water and oxygen after sterilization is completed.
  5. The sterilization method of claim 1, further comprising dehumidifying the chamber by discharging gas from the chamber using the high-speed blower, dehumidifying the gas, and supplying the dehumidified gas back to the chamber.
  6. The sterilization method of claim 1, wherein the forming of the low-pressure atmosphere is performed to form a pressure equal to or higher than atmospheric pressure - 5 kPa.
  7. The sterilization method of claim 1, wherein the forming of the high-pressure atmosphere is performed to form a pressure equal to or lower than atmospheric pressure + 5 kPa.
  8. The sterilization method of claim 1, wherein the sterilization method is repeated two to ten times.
  9. The sterilization method of claim 1, wherein the high-speed blower forms a pressure of ±10 kPa to ±20 kPa based on atmospheric pressure.
  10. The sterilization method of claim 1, further comprising circulating gas contained in the chamber while generating plasma in the chamber.
  11. The sterilization method of claim 1, wherein the oxidative gas comprises at least one selected from the group consisting of hydrogen peroxide, ozone, and ethylene oxide.
  12. A sterilization apparatus comprising:
    a chamber comprising an oxidative gas supply unit, an exit through which gas is discharged, and an entrance through which gas is introduced;
    a high-speed blower connected to an exit line and an entrance line of the chamber;
    a first valve provided between the exit of the chamber and the high-speed blower;
    a second valve provided between the high-speed blower and the entrance of the chamber; and
    a control valve connected to at least one of the exit line and the entrance line so as to control inflow of external gas, outflow of gas, or both inflow and outflow of gas.
  13. The sterilization apparatus of claim 12, wherein the control valve comprises:
    a third valve connected to the entrance line of the chamber to discharge gas from the chamber; and
    a fourth valve connected to the exit line of the chamber to introduce external gas into the chamber.
  14. The sterilization apparatus of claim 12, wherein the control valve is a multi-control valve controlling inflow and outflow of gas, and the sterilization apparatus further comprises at least one of a hydrogen peroxide decomposing unit and a dehumidifying unit that is disposed between the multi-control valve and a bypass line connecting the first and second valves.
  15. The sterilization apparatus of claim 13 or 14, further comprising a filter connected to the fourth valve or the multi-control valve for removing impurities from external gas.
  16. The sterilization apparatus of claim 13, further comprising a dehumidifying unit connected between the first and fourth valves.
  17. The sterilization apparatus of claim 13, further comprising an oxidative gas decomposing unit connected between the second and third valves.
  18. The sterilization apparatus of claim 12, wherein the chamber further comprises a heating unit.
  19. The sterilization apparatus of claim 12, wherein the chamber further comprises a plasma device at the entrance thereof, and the plasma device is disposed outside the chamber.
  20. The sterilization apparatus of claim 12 or 13, wherein at least one selected from the group consisting of the first, second, third, and fourth valves are three-way valves.
  21. The sterilization apparatus of claim 12, wherein the high-speed blower forms a pressure of ±10 kPa to ±20 kPa based on atmospheric pressure.
  22. The sterilization apparatus of claim 12, wherein the sterilization apparatus is used to sterilize medical devices.
  23. The sterilization apparatus of claim 12, wherein the oxidative gas supply unit supplies an oxidative gas, and the oxidative gas comprises at least one selected from the group consisting of hydrogen peroxide, ozone, and ethylene oxide.
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