KR101671208B1

KR101671208B1 - Method and apparatus for sterilization

Info

Publication number: KR101671208B1
Application number: KR1020150177914A
Authority: KR
Inventors: 오준용
Original assignee: 주식회사 비욘메디
Priority date: 2015-12-14
Filing date: 2015-12-14
Publication date: 2016-11-01

Abstract

According to an embodiment of the present invention, a sterilization method includes: a primary moisture confirmation step of receiving a sterilized object in a chamber, depressurizing the interior of the chamber for a predetermined decompression time, and confirming an internal pressure of the chamber; And sterilizing the sterilized object if the internal pressure is lower than a first reference pressure.

Description

[0001] METHOD AND APPARATUS FOR STERILIZATION [0002]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a sterilization method and a sterilization apparatus, and more particularly, to a sterilization method and sterilization apparatus capable of confirming moisture in a chamber through a reduced pressure.

Medical apparatuses such as medical instruments and surgical instruments contaminated with germs are usually made by using a high pressure steam sterilization method using saturated steam under high pressure or using ethylene oxide which does not require high temperature, And an ethylene oxide gas sterilization method using a chemical substance such as a nitric acid or the like.

However, since the high-pressure steam sterilizer is sterilized at a high temperature of more than 120 degrees Celsius, recently developed medical instruments made of synthetic resin are deformed, and the medical instruments made of steel are less susceptible to delicate blades, . The ethylene oxide gas sterilizer is sterilized between 40 ° C and 50 ° C, similar to a sterilizer using hydrogen peroxide. However, since ethylene oxide remains in the sterilized material or the reaction product produces carcinogenic and toxic substances, It is necessary to leave more than 12 hours. It is also reported that ethylene oxide gas itself has a high risk of explosion and can act as a genetically toxic substance that can cause mutation, and it is prescribed as a carcinogen.

As such, the sterilization of the medical instrument is carried out under high pressure with saturated vapor or chemical in a gaseous or vapor state. Since most medical devices are sensitive to heat or moisture, the high pressure steam sterilization or ethylene oxide gas sterilization that has been used in the past may be a sterilization method that is not suitable for expensive medical devices, apparatus and devices used today. In addition, formaldehyde and ethylene oxide must be sterilized in the sterilization chamber in the presence of appropriate water. Thus, the device becomes complicated because the chemical must be wetted before it is dispensed into the sterilization chamber or distributed to the water simultaneously with the distribution of the chemical.

On the other hand, the sterilization method using vaporized liquid hydrogen peroxide (H2O2) is sterilized by water (H20) and sterilized after sterilization so that it is harmless to the human body or environment when used at a low temperature of 40 to 60 degrees and a short sterilization time, Decomposes into oxygen (O2) and discharges it to the atmosphere. Therefore, it disadvantageously sterilizes the high pressure steam sterilizer at high temperature and high pressure, and can overcome the disadvantages of carcinogenesis, explosion and infertility of the ethylene oxide gas sterilizer. However, a sterilizer using hydrogen peroxide vaporizes 50% liquid hydrogen peroxide at a pressure lower than atmospheric pressure of about 1 torr into the sterilization chamber, and the sterilization process proceeds. The 50% hydrogen peroxide introduced into the chamber is 50% water (H2O) and 50% hydrogen peroxide (H2O2). Water vaporizes at 100 degrees and hydrogen peroxide vaporizes at 141 degrees because of higher vaporization temperature than hydrogen peroxide. Since the molecular weight of water is lower than that of hydrogen peroxide, water diffuses more rapidly into the gas phase than hydrogen peroxide. Because of this nature, sterilizers that sterilize with hydrogen peroxide will reach products where water is to be sterilized at a higher concentration than hydrogen peroxide when the aqueous hydrogen peroxide solution is evaporated in the space surrounding the product to be sterilized. Water vapor (H2O) spreads more quickly into small diffusion crevices and diffusion confinement spaces such as long narrow lumens, thereby inhibiting the permeation of hydrogen peroxide vapor. That is, the water reaches the sterilized product before the hydrogen peroxide, and the sterilization is not properly performed. As a result, when sterilization is carried out using hydrogen peroxide vapor, moisture may interfere with sterilization.

Further, since the concentration of the hydrogen peroxide solution is limited to less than 60% in handling the hydrogen peroxide solution, it is difficult to use a high concentration of hydrogen peroxide as a sterilizing agent. As the hydrogen peroxide vapor sterilization method has more moisture than the hydrogen peroxide concentration, it is difficult to sterilize. Since the porous sterilized material (sponge, cloth, paper, etc.) absorbs the hydrogen peroxide vapor, There is also a problem.

Korean Unexamined Patent Publication No. 1989-0001593 (Mar. 27, 1989)

It is an object of the present invention to provide a sterilization method and a sterilization apparatus capable of more effectively solving the condensation of water (H2O) and vaporized hydrogen peroxide which interferes with the sterilizing power in the sterilization method using hydrogen peroxide to improve the sterilization power .

In order to improve the sterilizing power, there is a method of removing hydrogen peroxide by removing hydrogen peroxide, increasing the concentration of hydrogen peroxide, separating hydrogen peroxide into a low pressure, maintaining vaporized hydrogen peroxide in a vaporized state, And to provide a device therefor to improve the sterilizing power.

In addition, the present invention solves the problem of water removal, concentration of hydrogen peroxide, and diffusion of hydrogen peroxide into the chamber in a vaporized state only by separating and introducing hydrogen peroxide.

Other objects of the present invention will become more apparent from the following detailed description and the accompanying drawings.

According to one embodiment of the present invention, a sterilization method includes: a primary moisture confirmation step of receiving a sterilized object in a chamber, depressurizing the interior of the chamber for a predetermined time, and confirming a first internal pressure of the chamber; When the first internal pressure exceeds the first reference pressure, the interior of the chamber is pressurized for a predetermined period of time and then is depressurized for a predetermined time, and the pressure inside the chamber is maintained to remove moisture contained in the sterilized product A water removal step; A second moisture confirmation step of confirming a second internal pressure of the chamber; And sterilizing the sterilized object if the second internal pressure of the chamber is less than the first reference pressure, wherein the water removal step is repeated two or more times.

The first reference pressure may be 3 torr.

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Wherein the sterilizing step comprises: an inflow step of introducing hydrogen peroxide into the chamber in a vaporized state; And concentrating the hydrogen peroxide by reducing the pressure in the chamber to the fourth reference pressure.

The fourth reference pressure may be 40 torr.

In the inflow step, the hydrogen peroxide may be introduced until the internal pressure of the chamber reaches 40 to 50 torr.

The sterilizing step may further include a preliminary step of depressurizing the interior of the chamber to a fifth reference pressure before the inflow step.

The fifth reference pressure may be 0.5 torr.

Wherein the sterilizing step comprises: a diffusion step of diffusing the hydrogen peroxide by maintaining the internal pressure of the chamber constant after the concentration step; An adsorption step of liquefying the hydrogen peroxide by pressurizing the inside of the chamber to a seventh reference pressure; And sterilizing the sterilized object using the hydrogen peroxide by keeping the internal pressure of the chamber constant at the seventh reference pressure.

The seventh reference pressure may be 400 torr.

The preliminary step and the sterilization step may be repeated two or more times.

The amount of hydrogen peroxide required to sterilize the sterilized product may be divided into the number of sterilization steps and introduced into the chamber.

And a regeneration step of decompressing the inside of the chamber to a sixth reference pressure to regenerate the hydrogen peroxide.

The water removal step may be repeated two or more times.

The sixth reference pressure may be greater than the first reference pressure and less than the fifth reference pressure.

According to an embodiment of the present invention, a sterilization apparatus includes a chamber in which a sterilized object is accommodated; A vacuum device capable of decompressing the interior of the chamber; A sensor capable of sensing an internal pressure of the chamber; A sterilizing agent feeder in which the sterilizing agent is contained; A vaporizer installed between the sterilizer feeder and the chamber to introduce the sterilant into the chamber in a vaporized state; A vent valve operable to allow external air to enter said chamber; And a controller electrically connected to the sensor and the sterilizer feeder, the vaporizer, and the vent valve, wherein the controller is configured to receive the sterilized object in the chamber and to open the interior of the chamber using the vacuum device The pressure inside the chamber is reduced for a predetermined period of time after the chamber is pressurized for a predetermined period of time and the pressure inside the chamber is maintained to maintain the pressure of the sterilized chamber when the first internal pressure exceeds the first reference pressure, The process of removing water contained in water is repeated at least twice, and then the second internal pressure of the chamber is checked. When the second internal pressure of the chamber is not higher than the first reference pressure, the sterilizing agent supply device and the vaporizer The sterilant is introduced into the chamber in a vaporized state.

According to an embodiment of the present invention, the water remaining on the surface of the sterilized object and the moisture contained in the hydrogen peroxide can be removed from the sterilization chamber during the sterilization process.

During the first sterilization process, the bacterium is not killed by the water remaining on the surface of the sterilized object. However, as in the present invention, removal of water before hydrogen peroxide is introduced effectively kills bacteria. In addition, as in the present invention, removal of water after the introduction of hydrogen peroxide, including removing water before hydrogen peroxide is introduced, can provide a concentration effect of hydrogen peroxide. The higher the concentration of hydrogen peroxide in the sterilization method using hydrogen peroxide, the higher the sterilizing power that can kill the bacteria.

According to the present invention, the pressure inside the sterilization chamber can be maintained at a low pressure by using the separation / inflow of hydrogen peroxide, thereby improving the sterilizing power.

When the pressure is excessively increased during the sterilization process, the hydrogen peroxide is not uniformly applied to the sterilized product because the vaporized hydrogen peroxide flows into the sterilization chamber and is not diffused but condensed into the liquid. Thus, uniform sterilization power can not be obtained.

In this way, water is removed before hydrogen peroxide is introduced and hydrogen peroxide is separated and removed to remove water from the hydrogen peroxide. The low pressure inside the chamber can be maintained to promote the diffusion of hydrogen peroxide and to improve the sterilizing power.

1 is a schematic view of a sterilization apparatus according to an embodiment of the present invention.
FIG. 2 is a graph illustrating a change in pressure in the sterilization chamber when the sterilization method according to an embodiment of the present invention is used.
FIG. 3 is a graph showing the pressure change in the sterilization chamber when the sterilization method according to another embodiment of the present invention is used.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. The embodiments of the present invention can be modified in various forms, and the scope of the present invention should not be construed as being limited to the embodiments described below. The embodiments are provided to explain the present invention to a person having ordinary skill in the art to which the present invention belongs. Accordingly, the shape of each element shown in the drawings may be exaggerated to emphasize a clearer description.

In the present invention, the moisture adsorbed in the sterilized water contained in the sterilization chamber can be removed by repeatedly condensing and vaporizing the water.

FIG. 1 is an embodiment to which the present invention is applied. In the case of loading sterilized water containing moisture in the sterilization chamber 2, moisture is automatically sensed by sensing moisture, and hydrogen peroxide is removed from the sterilization chamber 2 And the concentration of hydrogen peroxide is increased to remove sterilization power by using concentrated hydrogen peroxide.

Referring to FIG. 1, the sterilization chamber 2 represents a container into which a sterilized object such as a medical instrument or surgical instrument to be sterilized can be put. On one side of the sterilization chamber (2), a door (1) for accessing the sterilized object is provided. The vacuum pump 5 is connected to one side of the sterilization chamber 2 and the inside of the sterilization chamber 2 can be formed in a vacuum state. A vacuum valve 3 for controlling the operation of the vacuum pump 5 is connected between the sterilization chamber 2 and the vacuum pump 5. A plasma generator 4 may be connected between the vacuum pump 5 and the vacuum valve 3 and the plasma generator 4 may be connected to the vacuum pump 3 through various methods such as an arc discharge method using an AC high voltage or an AC high voltage, Method can be applied.

The hydrogen peroxide feeder 6 is connected to the other side of the sterilization chamber 2, and the hydrogen peroxide solution is introduced into the sterilization chamber 2. At this time, hydrogen peroxide is introduced at a predetermined pressure using the pressure value output from the pressure sensor 8, at which time the hydrogen peroxide solution is separated at least three times at a predetermined ratio, . A vaporizer 7 is connected between the sterilization chamber 2 and the hydrogen peroxide feeder 6 and the hydrogen peroxide solution is introduced into the sterilization chamber 2 in a vaporized state via the vaporizer 7. The vent valve 9 can release the vacuum state inside the sterilization chamber 2. The HEPA filter 10 is connected to the vent valve 9 to remove foreign substances introduced into the vent valve 9.

FIG. 2 is a view showing a process for increasing the sterilizing power by automatically removing moisture when the sterilization chamber 2 containing moisture is loaded in the sterilization chamber 2 according to an embodiment of the present invention. First, the sterilized object to be sterilized can be placed inside the sterilization chamber 2. The first depressurization step of operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 can be performed (step 1). At this time, if the pressure inside the sterilization chamber 2 exceeds 3 torr by the moisture contained in the sterilized object, the step 2 process is performed. However, if the pressure inside the sterilization chamber 2 is less than 3 torr, the step 2 process of FIG. 3 proceeds.

The vent valve 9 is operated to increase the pressure inside the sterilization chamber 2 to perform a primary pressurization process for condensing moisture in the sterilization chamber 2 into the sterilized material. At this time, the pressure inside the sterilization chamber 2 should be 650 torr. The sterilization chamber 2 can be operated by operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2. Step 3 At this time, If the internal pressure is less than 10 torr, proceed to step 4.

When the pressure is less than 10 torr, the operation of the vacuum pump 5 and the vacuum valve 3 is stopped, and the first water vaporization step (step 4) is carried out to maintain the pressure in the sterilization chamber 2 and to vaporize the water. At this time, the pressure inside the sterilization chamber (2) is 10 torr or less and the pressure holding time is 1 to 10 minutes.

After the first water vaporization step (step 4), the steps from step 2 to step 4 are performed again. The pressure in the sterilization chamber 2 is increased by operating the vent valve 9 to perform a secondary pressurization process for condensing moisture in the sterilization chamber 2 into the sterilized water. At this time, similarly, the pressure inside the sterilization chamber 2 is set to 650 torr.

The sterilization chamber 2 can be operated by operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2. Step 6 At this time, If the internal pressure is less than 10 torr, proceed to step 7.

When the pressure is less than 10 torr, the operation of the vacuum pump 5 and the vacuum valve 3 is stopped, and the second water vaporization step (step 4) is carried out to maintain the pressure inside the sterilization chamber 2 and to vaporize water. At this time, similarly, the pressure inside the sterilization chamber (2) is 10 torr or less, and the pressure holding time is 1 to 10 minutes.

After the second water vaporization step (step 4), the steps from step 5 to step 7 are performed again. That is, by operating the vent valve 9, the pressure inside the sterilization chamber 2 can be increased to perform a tertiary pressure process for condensing the moisture inside the sterilization chamber 2 to the sterilized object. (Step 5) At this time, similarly, the pressure inside the sterilization chamber 2 is set to 650 torr.

The vacuum pump 5 and the vacuum valve 3 may be operated to perform a fourth vacuum process for reducing the pressure inside the sterilization chamber 2. Step 6 At this time, ) If the internal pressure is less than 10 torr, proceed to step 10.

When the pressure is less than 10 torr, the operation of the vacuum pump 5 and the vacuum valve 3 is stopped, and the tertiary water vaporization process (Step 10) is carried out to maintain the pressure in the sterilization chamber 2 and to vaporize the moisture. At this time, similarly, the pressure inside the sterilization chamber (2) is 10 torr or less, and the pressure holding time is 1 to 10 minutes.

After the third water vaporization step (step 4), the steps from step 8 to step 10 are performed again. That is, the vent valve 9 may be operated to increase the pressure inside the sterilization chamber 2 to perform a fourth-order pressurization process for condensing the moisture inside the sterilization chamber 2 into the sterilized object. (Step 11) At this time, similarly, the pressure inside the sterilization chamber 2 is set to 650 torr.

The fifth pressure reducing step of operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 can be performed. (Step 12) At this time, similarly, the sterilization chamber 2 If the internal pressure is less than 10 torr, proceed to step 13.

When the pressure is less than 10 torr, the operation of the vacuum pump 5 and the vacuum valve 3 is stopped, and the pressure in the sterilization chamber 2 is maintained to carry out the fourth water vaporization step (step 13) for vaporizing water. At this time, similarly, the pressure inside the sterilization chamber 2 is 10 torr or less, and the pressure holding time is preferably 1 to 10 minutes. More preferably, the water vaporization step (steps 4, 7, 10, 13) is carried out in four steps at a pressure of 10 torr.

Then, by operating the vent valve 9, the pressure inside the sterilization chamber 2 is increased to perform a fifth-order pressure process for condensing the moisture inside the sterilization chamber 2 into the sterilized object. )

The sterilization chamber 2 is then operated to operate the vacuum pump 5 and the vacuum valve 3 so that the pressure inside the sterilization chamber 2 is reduced. If the internal pressure is less than 0.5 torr, proceed to step 4.

When the pressure inside the sterilization chamber 2 is 0.5 torr, the hydrogen peroxide solution is supplied from the hydrogen peroxide feeder 6 through the vaporizer 7 into the sterilization chamber 2 in a vaporized state at 40 to 50 torr, A hydrogen peroxide inflow process may be performed (step 16). At this time, the hydrogen peroxide solution may have a concentration of 30 to 50%.

The primary hydrogen peroxide concentration process for discharging the water contained in the hydrogen peroxide can be performed by operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 to 40 torr Step 17). At this time, it is preferable that the pressure inside the sterilization chamber 2 is reduced to less than 30 torr and less than the elevated pressure due to the inflow of hydrogen peroxide, more preferably within the range of 30 torr to 40 torr. As a specific example, the temperature condition of the sterilization chamber (2) was set at 50 ° C, the pressure before the hydrogen peroxide was set at 0.5 torr, the concentration of hydrogen peroxide was set at 50 Wt% 90 (Wt%) or more.

It is also assumed that the experiment is successful when the yield is 40% or more. As shown in Table 3, when the pressure was reduced to 40 torr, the water contained in 50% hydrogen peroxide evaporated to obtain a final concentration of 92.5 Wt%, and the yield was found to be 41.8% . The concentration of hydrogen peroxide which can further improve the sterilizing power is 80 Wt% and the yield is 50% or more, more preferably the concentration of hydrogen peroxide is 90 Wt%, and the yield is preferably 40% or more.

Temperature (℃) Initial concentration (Wt%) Pressure (torr) Final concentration (Wt%) Yield (%) 50 50 60 62.8 62.8 50 50 50 78.3 51 50 50 40 92.5 41.8 50 50 30 94.2 22.3 50 50 20 96.3 8.2

Then, a first hydrogen peroxide vapor diffusion process in which the hydrogen peroxide vapor is uniformly diffused in the hydrogen peroxide vapor sterilization chamber 2 for a sufficient time to sterilize the sterilized product can be performed. (Step 18) At this time, Follow the diffusion time for 1 to 10 minutes.

The first hydrogen peroxide adsorption process can be carried out by operating the vent valve 9 to pressurize the inside of the sterilization chamber 2 to convert hydrogen peroxide vapor into liquid so that the hydrogen peroxide vapor can be converted into liquid and adsorbed to the sterilized material (Step 19) At this time, the pressure inside the sterilization chamber 2 is 400 torr or more.

Then, the primary sterilization step of sterilizing the bacteria by using the hydrogen peroxide adsorbed on the sterilized material can be performed by maintaining the pressure inside the sterilization chamber 2. (Step 20) At this time, Keep for 1 to 10 minutes.

After the primary sterilization step (step 20), the steps from step 15 to step 20 are performed. That is, the seventh step of reducing pressure inside the sterilization chamber 2 can be performed by operating the vacuum pump 5 and the vacuum valve 3. (Step 21) At this time, similarly, the sterilization chamber 2 ) If the internal pressure is less than 0.5 torr, proceed to step 10.

When the pressure inside the sterilization chamber 2 is 0.5 torr, the hydrogen peroxide solution is supplied from the hydrogen peroxide feeder 6 through the vaporizer 7 to the sterilization chamber 2 in a vaporized state at 40 to 50 torr, A hydrogen peroxide inflow process may be performed (step 22). At this time, the hydrogen peroxide solution may also be a concentration of 30 to 50%.

The second hydrogen peroxide concentration process for discharging the water contained in the hydrogen peroxide can be performed by operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 to 40 torr Step 23). At this time, similarly, the pressure inside the sterilization chamber 2 is preferably reduced within a range of 30 torr to less than the pressure elevated by the introduction of hydrogen peroxide, more preferably within a range of 30 torr to 40 torr. As a specific example, the sterilization chamber 2 temperature condition was set at 50 占 폚 and the concentration of hydrogen peroxide was set at 50 Wt% as shown in Table 1 below, and the final concentration would be 90 (Wt%) or more, %, It is assumed that the experiment is successful. As shown in Table 1, when the pressure was reduced to 40 torr, the moisture contained in 50% hydrogen peroxide evaporated to a final concentration of 92.5 Wt%, and the yield was found to be 41.8% . The concentration of hydrogen peroxide which can further improve the sterilizing power is 80 Wt% and the yield is 50% or more, more preferably the concentration of hydrogen peroxide is 90 Wt%, and the yield is preferably 40% or more.

Then, a second hydrogen peroxide vapor diffusion process may be performed in which the hydrogen peroxide vapor is uniformly diffused in the hydrogen peroxide vapor sterilization chamber 2 for a sufficient time to sterilize the sterilized material. Step 24 At this time, And the diffusion time is carried out for 1 to 10 minutes.

A second hydrogen peroxide adsorption process can be carried out by operating the vent valve 9 to pressurize the inside of the sterilization chamber 2 to convert the hydrogen peroxide vapor into a liquid so that the hydrogen peroxide vapor can be converted into liquid and adsorbed to the sterilized material (Step 25) At this time, similarly, the pressure inside the sterilization chamber 2 should be 400 torr or more.

The sterilization chamber 2 is maintained at a pressure to perform a secondary sterilization process in which bacteria are killed by using hydrogen peroxide adsorbed on the sterilized material. For 1 to 10 minutes.

After the secondary sterilization step (step 26), the steps from step 21 to step 26 are performed again. That is, it is possible to perform an eighth-order depressurization step of operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2. (Step 27) At this time, similarly, the sterilization chamber 2 If the internal pressure is less than 0.5 torr, proceed to step 16.

When the pressure inside the sterilization chamber 2 is 0.5 torr, the hydrogen peroxide solution is supplied from the hydrogen peroxide feeder 6 through the vaporizer 7 into the sterilization chamber 2 in a vaporized state at 40 to 50 torr, A hydrogen peroxide inflow process may be performed (step 28). At this time, the hydrogen peroxide solution may also be a concentration of 30 to 50%.

The tertiary hydrogen peroxide concentration process for discharging the water contained in the hydrogen peroxide can be performed by operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 to 40 torr Step 29). At this time, similarly, the pressure inside the sterilization chamber 2 is preferably reduced within a range of 30 torr to less than the pressure elevated by the introduction of hydrogen peroxide, more preferably within a range of 30 torr to 40 torr. As a specific example, the sterilization chamber 2 temperature condition was set at 50 占 폚 and the concentration of hydrogen peroxide was set at 50 Wt% as shown in Table 1 below, and the final concentration would be 90 (Wt%) or more, %, It is assumed that the experiment is successful. As shown in Table 1, when the pressure was reduced to 40 torr, the moisture contained in 50% hydrogen peroxide evaporated to a final concentration of 92.5 Wt%, and the yield was found to be 41.8% . The concentration of hydrogen peroxide which can further improve the sterilizing power is 80 Wt% and the yield is 50% or more, more preferably the concentration of hydrogen peroxide is 90 Wt%, and the yield is preferably 40% or more.

Then, a tertiary hydrogen peroxide vapor diffusion process in which the hydrogen peroxide vapor is uniformly diffused in the hydrogen peroxide vapor sterilization chamber 2 for a sufficient time to sterilize the sterilized material can be performed. (Step 30) And the diffusion time is carried out for 1 to 10 minutes.

The third hydrogen peroxide adsorption process can be performed by operating the vent valve 9 to pressurize the inside of the sterilization chamber 2 to convert the hydrogen peroxide vapor into a liquid so that the hydrogen peroxide vapor can be converted into liquid and adsorbed to the sterilized material (Step 31) At this time, similarly, the pressure inside the sterilization chamber 2 should be 400 torr or more.

Then, the sterilization chamber 2 is maintained at a pressure to perform a tertiary sterilization process in which the bacteria are killed by using hydrogen peroxide adsorbed on the sterilized material. (Step 32) For 1 to 10 minutes.

In the present invention, the amount of hydrogen peroxide that is introduced is at least 3 times higher in the case of the first hydrogen peroxide inflow step (step 16), the second hydrogen peroxide inflow step (step 22), and the third hydrogen peroxide inflow step (step 28) So that they are separated and introduced. At this time, the amount to be introduced may be determined at a predetermined ratio.

For example, it is possible to divide the amount of the current flowing into the existing No. 1 into two portions in half, but the present invention is not limited thereto. In other words, it is most preferable to separate the water into 1: 1: 1, but the first inflow may be larger than the second and third inflows, or the first inflow may be less than the second and third inflows. For example, the amount of 60% can be introduced in the first hydrogen peroxide injection process and 40% in the second and third hydrogen peroxide injection process. Or 30% in the first hydrogen peroxide inflow process and 70% in the second and third hydrogen peroxide inflow process. This can be determined experimentally to see which case results in more efficient sterilization treatment results.

However, the amount of hydrogen peroxide removed should be accurately calculated by calculating the yield of hydrogen peroxide and the amount of hydrogen peroxide inflow in [Table 1].

When the amount of hydrogen peroxide is introduced at a time, hydrogen peroxide containing a large amount of water is introduced, which causes an excessive pressure rise and weakens sterilization performance. Because of the characteristics of hydrogen peroxide steam sterilization, sterilization performance is improved with higher concentration of hydrogen peroxide solution, lower pressure and higher temperature. Therefore, sterilization performance can be greatly improved when the pressure rise is small when hydrogen peroxide solution is introduced.

Thereafter, the ninth pressure reducing step of reducing the pressure inside the sterilization chamber 2 can be performed by operating the vacuum pump 5 and the vacuum valve 3. (Step 33) At this time, the sterilization chamber 2 ) The internal pressure shall be 10 torr or less.

The hydrogen peroxide is regenerated by maintaining the pressure inside the sterilization chamber 2 and diffused into the sterilization chamber 2. Step 34 At this time, Should be maintained for 1 to 10 minutes.

Then, the first atmospheric pressure process for operating the vent valve 9 to pressurize the inside of the sterilization chamber 2 to make the pressure inside the sterilization chamber 2 at atmospheric pressure can be performed (step 35). After the pressure inside the sterilization chamber 2 has become the atmospheric pressure, the door 2 of the sterilization chamber 2 is opened and the sterilized product is taken out to complete the sterilization process.

Thereafter, the steps from the first pressure reducing step (step 1) to the first atmospheric pressure step (step 35) may be repeated. In this case, there is no limitation on the number of times, but preferably the steps from the first pressure reducing step (step 1) to the first atmospheric pressure step (step 23) are repeated one more time.

The following Tables 1 and 2 show the effect of the present invention as an example of a test to which the present invention is applied. In this embodiment of the present invention, the inner temperature of the sterilization chamber (2) is set to 50 degrees and the pressure is reduced from atmospheric pressure to 10 torr, and the water removal process is repeated four times from one to four times , And the sterilization efficiency according to the number of water removal times.

In this example, a 50-liter sterilization chamber (2) and 50% hydrogen peroxide were used. A total of four water removal processes were performed from one to four times, and the success rate of sterilization Respectively. The sterilization process of FIG. 2 was applied.

In addition, PCD was used as the sterilized material of this test, and since the penetration of the hydrogen peroxide vapor is difficult as the diameter of the PCD is small, the sterilization power of the PCD is required. Therefore, in this experiment, 20 ml of water is applied to the PCD, X-length 25 mm PCD, the present inventors tried to show the remarkable effect of the present invention. The PCD has also become an international standard as a device for measuring sterilization power in Europe.

Table 2 summarizes the results of the tests of Example 1 and Comparative Example 2 in four steps from the second depressurization process (Step 3) to the third depressurization process (Step 6), the fourth depressurization process (Step 9) And the time for which the pressure is reduced to a predetermined value.

collection Time (sec) at which the pressure is reduced from atmospheric pressure to 10 torr The capacity of the sterilization chamber 2 (liter) 1 time 172 50 Episode 2 154 50 3rd time 128 50 4 times 100 50

Table 3 shows the result of three times of inserting a plate of SUS316 material having 4.6 X 10 < 6 > Geobacillus stearothermophilus as a 4.6 x 10 6 Geobacillus stearate inside the PCD into the PCD. Five types of PCDs were used as PCD types: a diameter of 2 mm, a length of 25 mm, a diameter of 3 mm, a length of 25 mm, a diameter of 5 mm, a length of 25 mm, a diameter of 4 mm, a length of 50 mm and a length of 50 mm.

Number of times PCD classification Success 1 time φ2 * 25mm 0/3 φ3 * 25mm 0/3 φ5 * 25mm 2/3 φ4 * 50mm 1/3 φ5 * 50mm 0/3 Episode 2 φ2 * 25mm 1/3 φ3 * 25mm 1/3 φ5 * 25mm 2/3 φ4 * 50mm 0/3 φ5 * 50mm 1/3 3rd time φ2 * 25mm 2/3 φ3 * 25mm 3/3 φ5 * 25mm 3/3 φ4 * 50mm 2/3 φ5 * 50mm 2/3 4 times φ2 * 25mm 3/3 φ3 * 25mm 3/3 φ5 * 25mm 3/3 φ4 * 50mm 3/3 φ5 * 50mm 3/3

(Number of sterilization success / number of sterilization execution)

Table 2 and Table 3 show that when the water was removed once, the sterilization success frequency using a PCD with a diameter of 2 mm and a length of 25 mm was zero, and when the moisture was removed twice, sterilization with a PCD having a diameter of 2 mm and a length of 25 mm When the number of successes is 1, and when the water is removed three times, the number of successes of sterilization using a PCD of 2 mm in diameter and 25 mm in length is twice, and the number of successes of sterilization using a PCD with a diameter of 2 mm and a length of 25 mm is 4 Four times. As can be seen from the experimental results, when the water is applied to the sterilized material, the success rate of sterilization is decreased, but the more sterilization success rate is 100%, the more sterilization power is remarkably improved as the applied water of the sterilized material is removed have.

In the examples of this test, four cases of water removal are taken as an example, but this is merely an example, and the case of removing water at least once is also included in the scope of the present invention.

FIG. 3 is a diagram illustrating an embodiment in which the present invention is applied. In the sterilization chamber, when moisture of the sterilized object is not applied, the process of automatically removing water is omitted, and water contained in hydrogen peroxide is removed, And the sterilization is carried out using a high concentration of hydrogen peroxide in a dried environment.

1, first, the sterilized object to be sterilized can be placed in the sterilization chamber 2. The first depressurization step of operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 can be performed (step 1). At this time, if the pressure inside the sterilization chamber 2 is less than 3 torr, the step 2 process is performed. If the pressure inside the sterilization chamber 2 exceeds 3 torr, the step 2 process of FIG.

The vent valve 9 is operated to increase the pressure inside the sterilization chamber 2 to perform a primary pressurization process for condensing moisture in the sterilization chamber 2 into the sterilized material. )

The sterilization chamber 2 can be operated by operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2. Step 3 At this time, If the internal pressure is less than 0.5 torr, proceed to step 4.

When the pressure inside the sterilization chamber 2 is 0.5 torr, the hydrogen peroxide solution is supplied from the hydrogen peroxide feeder 6 through the vaporizer 7 into the sterilization chamber 2 in a vaporized state at 40 to 50 torr, A hydrogen peroxide inflow process may be performed (step 4). At this time, the hydrogen peroxide solution may have a concentration of 30 to 50%.

The primary hydrogen peroxide concentration process for discharging the water contained in the hydrogen peroxide can be performed by operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 to 40 torr Step 5). At this time, it is preferable that the pressure inside the sterilization chamber 2 is reduced to less than 30 torr and less than the elevated pressure due to the inflow of hydrogen peroxide, more preferably within the range of 30 torr to 40 torr. As a specific example, the temperature condition of the sterilization chamber 2 was set at 50 ° C, the pressure before the hydrogen peroxide was set at 0.5 torr, the concentration of hydrogen peroxide was set at 50 Wt%, and the final concentration 90 (Wt%) or more.

Then, a first hydrogen peroxide vapor diffusion process may be performed to uniformly diffuse the inside of the hydrogen peroxide vapor sterilization chamber 2 for a sufficient time to sterilize the sterilized object. (Step 6) At this time, Follow the diffusion time for 1 to 10 minutes.

The first hydrogen peroxide adsorption process can be carried out by operating the vent valve 9 to pressurize the inside of the sterilization chamber 2 to convert hydrogen peroxide vapor into liquid so that the hydrogen peroxide vapor can be converted into liquid and adsorbed to the sterilized material (Step 7) At this time, the pressure inside the sterilization chamber 2 should be 400 torr or more.

Then, the primary sterilization step of sterilizing the bacteria by using the hydrogen peroxide adsorbed on the sterilized material can be performed by maintaining the pressure in the sterilization chamber 2. (Step 8) At this time, Keep for 1 to 10 minutes.

After the primary sterilization step (step 8), the steps from step 3 to step 8 are carried out. That is, the vacuum pump 5 and the vacuum valve 3 can be operated to perform a tertiary depressurization process for reducing the pressure inside the sterilization chamber 2. (Step 9) At this time, similarly, the sterilization chamber 2 ) If the internal pressure is less than 0.5 torr, proceed to step 10.

When the pressure inside the sterilization chamber 2 is 0.5 torr, the hydrogen peroxide solution is supplied from the hydrogen peroxide feeder 6 through the vaporizer 7 to the sterilization chamber 2 in a vaporized state at 40 to 50 torr, A hydrogen peroxide inflow process may be performed (step 10). At this time, the hydrogen peroxide solution may also be a concentration of 30 to 50%.

The second hydrogen peroxide concentration process for discharging the water contained in the hydrogen peroxide can be performed by operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 to 40 torr Step 11). At this time, similarly, the pressure inside the sterilization chamber 2 is preferably reduced within a range of 30 torr to less than the pressure elevated by the introduction of hydrogen peroxide, more preferably within a range of 30 torr to 40 torr. As a specific example, the sterilization chamber 2 temperature condition was set at 50 占 폚 and the concentration of hydrogen peroxide was set at 50 Wt% as shown in Table 1 below, and the final concentration would be 90 (Wt%) or more, %, It is assumed that the experiment is successful. As shown in Table 1, when the pressure was reduced to 40 torr, the moisture contained in 50% hydrogen peroxide evaporated to a final concentration of 92.5 Wt%, and the yield was found to be 41.8% . The concentration of hydrogen peroxide which can further improve the sterilizing power is 80 Wt% and the yield is 50% or more, more preferably the concentration of hydrogen peroxide is 90 Wt%, and the yield is preferably 40% or more.

Then, a secondary hydrogen peroxide vapor diffusion process may be performed in which the hydrogen peroxide vapor is uniformly diffused in the hydrogen peroxide vapor sterilization chamber 2 for a sufficient time to sterilize the sterilized product. (Step 12) And the diffusion time is carried out for 1 to 10 minutes.

A second hydrogen peroxide adsorption process can be carried out by operating the vent valve 9 to pressurize the inside of the sterilization chamber 2 to convert the hydrogen peroxide vapor into liquid so that hydrogen peroxide vapor can be converted into liquid and adsorbed to the sterilized material (Step 12) At this time, similarly, the pressure inside the sterilization chamber 2 should be 400 torr or more.

Then, a secondary sterilization step of sterilizing the bacteria by using hydrogen peroxide adsorbed on the sterilized material can be performed by maintaining the pressure in the sterilization chamber 2. (Step 14) In this case, similarly, For 1 to 10 minutes.

After the secondary sterilization step (step 14), the steps from step 9 to step 14 are performed again. That is, the vacuum pump 5 and the vacuum valve 3 are operated to perform the fourth pressure reduction process for reducing the pressure inside the sterilization chamber 2. (Step 15) At this time, similarly, the sterilization chamber 2 If the internal pressure is less than 0.5 torr, proceed to step 16.

When the pressure inside the sterilization chamber 2 is 0.5 torr, the hydrogen peroxide solution is supplied from the hydrogen peroxide feeder 6 through the vaporizer 7 into the sterilization chamber 2 in a vaporized state at 40 to 50 torr, A hydrogen peroxide inflow process may be performed (step 16). At this time, the hydrogen peroxide solution may also be a concentration of 30 to 50%.

The tertiary hydrogen peroxide concentration process for discharging the water contained in the hydrogen peroxide can be performed by operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 to 40 torr Step 17). At this time, similarly, the pressure inside the sterilization chamber 2 is preferably reduced within a range of 30 torr to less than the pressure elevated by the introduction of hydrogen peroxide, more preferably within a range of 30 torr to 40 torr. As a specific example, the sterilization chamber 2 temperature condition was set at 50 占 폚 and the concentration of hydrogen peroxide was set at 50 Wt% as shown in Table 1 below, and the final concentration would be 90 (Wt%) or more, %, It is assumed that the experiment is successful. As shown in Table 1, when the pressure was reduced to 40 torr, the moisture contained in 50% hydrogen peroxide evaporated to a final concentration of 92.5 Wt%, and the yield was found to be 41.8% . The concentration of hydrogen peroxide which can further improve the sterilizing power is 80 Wt% and the yield is 50% or more, more preferably the concentration of hydrogen peroxide is 90 Wt%, and the yield is preferably 40% or more.

Then, a tertiary hydrogen peroxide vapor diffusion process in which hydrogen peroxide vapor is uniformly diffused in the hydrogen peroxide vapor sterilization chamber 2 for a sufficient time to sterilize the sterilized material can be performed. (Step 18) And the diffusion time is carried out for 1 to 10 minutes.

The third hydrogen peroxide adsorption process can be performed by operating the vent valve 9 to pressurize the inside of the sterilization chamber 2 to convert the hydrogen peroxide vapor into a liquid so that the hydrogen peroxide vapor can be converted into liquid and adsorbed to the sterilized material (Step 19) At this time, similarly, the pressure inside the sterilization chamber 2 should be 400 torr or more.

Then, the sterilization chamber 2 is maintained at a pressure to perform a tertiary sterilization process in which bacteria are killed by using hydrogen peroxide adsorbed on the sterilized material. (Step 20) For 1 to 10 minutes.

In the present invention, the amount of hydrogen peroxide introduced into the first hydrogen peroxide inflow step (step 4), the second hydrogen peroxide inflow step (step 10), and the third hydrogen peroxide inflow step (step 16) So that they are separated and introduced. At this time, the amount to be introduced may be determined at a predetermined ratio.

Thereafter, a fifth-order depressurization step of operating the vacuum pump 5 and the vacuum valve 3 to reduce the pressure inside the sterilization chamber 2 can be performed. (Step 21) At this time, the sterilization chamber 2 ) The internal pressure shall be 10 torr or less.

The hydrogen peroxide in the sterilization chamber 2 is regenerated and diffused into the sterilization chamber 2. Step 22 At this time, the pressure inside the sterilization chamber 2 is 1 It should be kept for ~ 10 minutes.

Then, a first atmospheric pressure process in which the vent valve 9 is operated to pressurize the inside of the sterilization chamber 2 to bring the pressure inside the sterilization chamber 2 to atmospheric pressure can be performed (step 23). After the pressure inside the sterilization chamber 2 has become the atmospheric pressure, the door 2 of the sterilization chamber 2 is opened and the sterilized product is taken out to complete the sterilization process.

Thereafter, the steps from the first pressure reducing step (step 1) to the first atmospheric pressure step (step 23) may be repeated. In this case, there is no limitation on the number of times, but preferably the steps from the first pressure reducing step (step 1) to the first atmospheric pressure step (step 23) are repeated one more time.

Although the present invention has been described in detail by way of preferred embodiments thereof, other forms of embodiment are possible. Therefore, the technical idea and scope of the claims set forth below are not limited to the preferred embodiments.

1: Door
2: Sterilization chamber
3: Vacuum valve
4: Plasma generator
5: Vacuum pump
6: hydrogen peroxide feeder
7: Carburetor
8: Pressure sensor
9: Bent valve
10: Hepa filter

Claims

A first moisture check step of receiving a sterilized object in the chamber, depressurizing the interior of the chamber for a predetermined time, and confirming a first internal pressure of the chamber;
When the first internal pressure exceeds the first reference pressure, the interior of the chamber is pressurized for a predetermined period of time and then is depressurized for a predetermined time, and the pressure inside the chamber is maintained to remove moisture contained in the sterilized product A water removal step;
A second moisture confirmation step of confirming a second internal pressure of the chamber; And
Sterilizing the sterilized object when the second internal pressure of the chamber is below the first reference pressure,
Wherein the water removal step is repeated twice or more.

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The method according to claim 1,
The sterilization step comprises:
Introducing hydrogen peroxide into the chamber in a vaporized state; And
And concentrating the hydrogen peroxide by depressurizing the interior of the chamber to a fourth reference pressure.

The method of claim 3,
Wherein the sterilizing step further comprises a preliminary step of depressurizing the interior of the chamber to a fifth reference pressure prior to the introducing step.

5. The method of claim 4,
Wherein the sterilizing step comprises, after the concentration step,
A diffusion step of diffusing the hydrogen peroxide by keeping the internal pressure of the chamber constant;
An adsorption step of liquefying the hydrogen peroxide by pressurizing the inside of the chamber to a seventh reference pressure; And
Further comprising sterilizing the sterilized object with the hydrogen peroxide by keeping the internal pressure of the chamber constant at the seventh reference pressure.

6. The method of claim 5,
Wherein the preliminary step and the sterilization step are repeated two or more times.

The method according to claim 6,
Wherein the amount of hydrogen peroxide required to sterilize the sterilized material is divided and introduced into the chamber in accordance with the number of sterilization steps.

6. The method of claim 5,
Further comprising a regeneration step of decompressing the inside of the chamber to a sixth reference pressure to regenerate the hydrogen peroxide.

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A chamber in which the sterilized object is housed;
A vacuum device capable of decompressing the interior of the chamber;
A sensor capable of sensing an internal pressure of the chamber;
A sterilizing agent feeder in which the sterilizing agent is contained;
A vaporizer installed between the sterilizer feeder and the chamber to introduce the sterilant into the chamber in a vaporized state;
A vent valve operable to allow external air to enter said chamber; And
And a controller electrically connected to the sensor and the sterilizer feeder, the vaporizer, and the vent valve,
The controller comprising:
Receiving the sterilized object in the chamber, depressurizing the interior of the chamber for a predetermined depressurization time using the vacuum apparatus and confirming the first internal pressure of the chamber through the sensor,
The pressure inside the chamber is depressurized for a predetermined time after the first internal pressure exceeds the first reference pressure and the pressure in the chamber is maintained to remove moisture contained in the sterilized water The process is repeated two or more times,
And then introducing the sterilant into the chamber in a vaporized state via the sterilizer feeder and the vaporizer if the second internal pressure of the chamber is below the first reference pressure, Sterilization device.