JP2010234067A - Gas sterilization, pasteurization method and device of capillary part - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a gas sterilization, pasteurization method and device of a capillary part which can gas-sterilize and pasteurize the capillary part without depending on a kind of gas. <P>SOLUTION: When the capillary part 11 to be sterilized is accommodated in a sterilization chamber 10 to sterilize and pasteurize the capillary part 11, in a vacuum buffer tank 81, an introducing port 83 formed with an orifice and a check valve 85 are provided to form a vacuum cartridge 80. The capillary part 11 is connected to the vacuum buffer tank 81 through the introducing port 83 and the capillary part 11 and the vacuum cartridge 80 are accommodated in the sterilization chamber 10. Then, the pressure of the sterilization chamber 10 is reduced and vacuum energy is accumulated in the vacuum buffer tank 81 through the check valve 85, and a sterilization gas is supplied to the sterilization chamber 10 to suck the sterilization gas to the vacuum buffer tank 81 through the capillary part 11 and the introducing port 83 and sterilize the capillary part 11. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a gas sterilization / sterilization method and apparatus for a thin tube portion for sterilizing the inside and outside of the thin tube portion with a gas such as ozone.

  Gas sterilization / sterilization methods and devices currently used or developed include ethylene oxide gas (EOG) sterilization, hydrogen peroxide gas (VHP) sterilization, low temperature plasma (VHP + plasma) sterilization, formaldehyde gas sterilization, ozone gas sterilization / sterilization, etc. There is.

  The gas sterilization technique is different from a sterilization technique using heat such as high-pressure steam sterilization, in which gas that is a sterilizing agent physically reaches a site to be sterilized and reacts with microorganisms to sterilize. Therefore, in the case of an object to be sterilized such as a narrow tube part such as a catheter, it is difficult for gas to reach. Therefore, it is said that sterilization is difficult only by placing the object in a sterilized gas atmosphere.

  Therefore, generally, as represented by EOG sterilization, a method of increasing the sterilization gas permeation effect into the thin tube object by repeating decompression and gas reintroduction in the sterilization chamber is adopted. However, depending on the diffusion characteristics of the gas species used as the sterilant, there is a problem that the sterilization effect cannot be obtained only by decompression and reintroduction.

  Conventionally, various attempts have been made to solve this problem.

  For example, in low temperature plasma sterilization, a small cartridge system is adopted.

  This method is effective by connecting a small cartridge of liquid hydrogen peroxide, which is a sterilizing agent, to the capillary object, and then supplying VHP vaporized from the small cartridge directly to the capillary object by repeatedly depressurizing and restoring the pressure in the chamber. Sterilization is possible (Patent Document 2).

  However, this method cannot be applied to gas types that are difficult to vaporize, liquefy, and concentrate. In addition, although this small cartridge has been considered to prevent erroneous outflow until it is connected to a thin tube object, a sterilant may remain after sterilization is completed.

  On the other hand, in ozone gas sterilization and sterilization, the self-decomposition of ozone is fast and it is difficult to condense and store it.

  Therefore, a circulation supply system has been proposed for ozone gas sterilization and sterilization. This method is a method in which ozone gas in the chamber is directly circulated and supplied to the capillary object during the sterilization process (Patent Documents 1, 3, and 4).

JP 11-347106 A JP 09-000609 A Japanese National Patent Publication No. 09-501845 Japanese National Patent Publication No. 06-510932

  However, in this method, it is necessary to add a dedicated gas circulation system to the apparatus. In addition, it is difficult to ensure sterility after completion of sterilization in the circulation supply system. In general, the sterilization target is called a sterilization bag, and sterilization is performed with a special packaging material that allows sterilization gas to permeate but bacteria does not. This is because, in the supply system, the gas circulation system on the apparatus side and the thin tube object are connected by piping through a dedicated port installed in the chamber, which causes interference with packaging by a sterilization bag.

  In addition, since human work is usually involved during preparatory work for thin tube sterilization, this can be said for both the small cartridge system and the circulation supply system. However, there is a possibility that the thin tube object will be blocked due to human error and cannot be sterilized. is there. Furthermore, in the circulation supply method, the device and the thin tube portion may be broken due to this closed state.

  Accordingly, an object of the present invention is to provide a gas sterilization / sterilization method and apparatus for a thin tube portion that can solve the above-described problems and can sterilize and sterilize the thin tube portion without depending on the gas type.

  In order to achieve the above object, according to the first aspect of the present invention, a narrow tube part to be sterilized is accommodated in a sterilization chamber, a sterilization gas is supplied into the sterilization chamber, and a sterilization gas is supplied into the narrow tube part to sterilize and sterilize. In the gas sterilization / sterilization method for the thin tube portion, the vacuum buffer tank is provided with an inlet port made of an orifice and a check valve to form a vacuum cartridge, and the thin tube portion is connected to the vacuum buffer tank through the inlet port At the same time, the narrow tube part and the vacuum cartridge are accommodated in the sterilization chamber, and then the sterilization chamber is decompressed and vacuum energy is accumulated in the vacuum buffer tank via the check valve, and sterilization gas is supplied into the sterilization chamber. The sterilizing gas is sucked into the vacuum buffer tank through the narrow tube portion and the introduction port, and the inside of the narrow tube portion is sterilized. A gas sterilization method of sterilizing a tubular portion.

  According to the invention of claim 2, a narrow tube portion to be sterilized is housed in a sterilization chamber, a sterilization gas is supplied into the sterilization chamber, and a sterilization gas is supplied into the narrow tube portion for sterilization and sterilization. In a sterilization apparatus, a vacuum cartridge is formed by providing a vacuum buffer tank with an introduction port made of an orifice and a check valve, and a thin tube portion is connected to the vacuum buffer tank via the introduction port, and the thin tube portion and the vacuum cartridge Is stored in the sterilization chamber, and then the sterilization chamber is decompressed and vacuum energy is accumulated in the vacuum buffer tank via the check valve. The sterilization gas is supplied into the sterilization chamber, and the sterilization gas is removed. The gas sterilization / sterilization device for the narrow tube section is characterized by sterilizing the inside of the narrow tube section by sucking into the vacuum buffer tank through the narrow tube section and the introduction port. It is.

  According to the present invention, when the sterilization gas is supplied to the narrow tube portion and sterilized, the sterilization gas can be switched to and supplied to the sterilization chamber and the thin tube portion, whereby the narrow tube portion can be optimally sterilized. Further, the device can be protected by relieving the sterilizing gas supplied to the narrow tube portion when the narrow tube portion is closed. In addition, the thin tube part is connected to the vacuum cartridge, and the entire vacuum cartridge is housed in the sterilization chamber so that it can be sterilized. It is.

It is detail drawing of the sterilization chamber in this invention. It is a figure explaining the sequence of operation | movement of each apparatus at the time of the normal sterilization in FIG. It is a figure explaining the sequence of operation | movement of each apparatus at the time of the disinfection of the thin tube part in FIG. It is a figure which shows one Embodiment of the vacuum cartridge used when sterilizing a thin tube part in a sterilization chamber in this invention.

  A preferred embodiment of the present invention will be described below in detail with reference to the accompanying drawings.

  First, the basic structure of the sterilization chamber will be described with reference to FIG.

  In FIG. 1, reference numeral 10 denotes a sealed sterilization chamber that accommodates a narrow tube portion 11 such as a catheter. A sterilization gas (sterilization gas) such as ozone from the ozone supply means 12 is supplied into the sterilization chamber 10, and the narrow tube Ozone is also supplied into the part 11.

  The ozone supply means 12 adsorbs oxygen in the air, desorbs oxygen after adsorption to produce oxygen, an ozonizer 14 that uses oxygen produced by the oxygen production apparatus 13 as ozone gas, and an ozonizer 14. The ozone supply line 15 supplies ozone gas from the inside of the sterilization chamber 10 and the narrow tube portion 11.

  In the ozone supply line 15, a first three-way valve 17 is connected to an upstream main line 16 from the ozonizer 14, and the main line 16 is branched into a chamber side line 18 and a narrow tube side line 19 by the first three-way valve 17. Further, a second three-way valve 20 is connected to the chamber-side line 18, and the second three-way valve 20 includes a chamber-side first line (large resistance) 18 a and a chamber-side second line ( Branching to a small tube side line 19, and a third three-way valve 21 is connected to the thin tube side line 19. The third three-way valve 21 is connected to a thin tube side first line (high resistance) 19a having a different resistance. When branching to the thin tube side second line (small resistance) 19b, the on-off valves 22a, 22b, 23a, 23b are connected to these lines 18a, 18b, 19a, 19b. The downstream lines 18a, 18b, 19a, 19b are joined to the downstream main line 24, the fourth three-way valve 25 is connected to the main line 24, and the main line 24 is connected to the chamber side line 26 again. It is configured to be branched into a narrow tube side line 27.

  The chamber side line 26 is configured to blow ozone directly into the sterilization chamber 10, and the thin tube side line 27 is connected to the thin tube portion 11 via a relief valve 28 and a flow meter 29.

  The cracking pressure of the relief valve 28 is set to be equal to or higher than the piping resistance of the connected narrow tube portion 11 and is equal to or lower than the pressure lower limit value capable of protecting the constituent devices and the thin tube portion 11. A relief line 30 is connected to the secondary side of the relief valve 28 and is connected to the ozone killer 31 side described later. It is noted that the exhaust line 30 may be exhausted directly from the secondary side of the relief valve 28 without connecting the relief line 30.

  Connected to the sterilization chamber 10 is an exhaust line 34 for exhausting ozone in the chamber 10 through an exhaust valve 32, an ozone killer 31, and a vacuum pump 33.

  An ozone concentration monitor 37 comprising an ozone concentration meter 35 and a circulation pump 36 is connected to the sterilization chamber 10. After the ozone in the chamber 10 is sucked through the ozone concentration meter 35, the ozone is returned to the chamber 10 from the circulation pump 36. The ozone concentration can be monitored constantly.

  Connected to the sterilization chamber 10 is an external air suction line 41 to which a prefilter 38, a sterilization filter 39, and an on-off valve 40 are sequentially connected.

  The sterilization chamber 10 is provided with a temperature sensor 42 and a humidity sensor 43.

  As described above, in the present invention, the narrow tube section 11 can be sterilized regardless of the diffusion characteristics, self-decomposition characteristics, vaporization / liquefaction / concentration preservation characteristics of the gas species that are sterilizing agents such as ozone gas, and the sterilized gas is contained in the narrow tube section 11 It is possible to detect the introduction of the liquid, to protect the device and the thin tube portion from a human connection error, and to purge the remaining sterilant. In addition, this invention is applicable without distinction of microorganisms control levels, such as sterilization and disinfection.

  The gas sterilization / sterilization method using the sterilization chamber will be described below.

  The thin tube portion 11 is accommodated in the sterilization chamber 10, and the thin tube portion 11 is connected to the flow meter 29 of the thin tube side line 27. The connection port for the flow meter 29 and the relief valve 28 may be installed on the inlet side of the sterilization chamber 10 in consideration of workability.

  The other end of the thin tube portion 11 is opened in the sterilization chamber 10.

  Oxygen produced by the oxygen producing device 13 is converted into ozone by the ozonizer 14 and supplied from the ozone supply line 15 through the chamber side line 26 into the sterilization chamber 10 or from the narrow tube side line 27 into the narrow tube unit 11. The

  At this time, the chamber side line 26 is introduced from the first three-way valve 17 through the second three-way valve 20 through the large resistance on-off valve 22a or through the small resistance on-off valve 22b. The first three-way valve 17 is introduced through the third three-way valve 21 through the large resistance on-off valve 23a or the small resistance on-off valve 23b.

  Further, when supplying ozone into the sterilization chamber 10, the inside of the sterilization chamber 10 is depressurized by the vacuum pump 33 of the exhaust line 34, then ozone is supplied, and after sterilization and sterilization by ozone supply, outside air is inhaled. Aeration is performed by introducing outside air from the line 41.

  FIG. 2 shows normal sterilization in the sterilization chamber 10, and FIG. 3 shows a sterilization / sterilization sequence of the thin tube portion 11.

  In FIG. 2, after each device is prepared for start-up, the pressure is reduced by the vacuum pump 33, the operation of the ozonizer 14, the large open / close valve 22 a is opened, and ozone gas is allowed to flow into the sterilization chamber 10 at a small flow rate for sterilization. Next, after opening the open / close valve 22b with low resistance and performing the first exposure process for sterilizing ozone, the second exposure process is performed in the same manner, and then the pressure is reduced by the vacuum pump 33 and the outside air suction line 41 is used. After the aeration process is performed by alternately repeating the air introduction, the tidying process is performed.

  In FIG. 3, after starting preparation of each device, decompression by the vacuum pump 33, operation of the ozonizer 14, opening the on-off valve 23a, flowing ozone gas at a small flow rate through the narrow tube portion 11, and opening / closing of the large resistance Open the valve 22a, flow ozone gas into the sterilization chamber 10 at a small flow rate, then open the on-off valve 23b, flow ozone gas at a large flow rate into the narrow tube portion 11, then open the on-off valve 22b with low resistance, After the first exposure process for ozone sterilization by flowing ozone gas at a large flow rate into the sterilization chamber 10, the second exposure process is performed in the same manner, and then the pressure is reduced by the vacuum pump 33 and the air is supplied by the outside air suction line 41. The aeration process is performed by alternately repeating the introduction, and then the tidying process is performed.

  This sequence control is performed by switching between the three-way valves 17, 20, 21 and the on-off valves 22 a, 22 b, 23 a, 23 b installed in the pipe branch during ozone introduction in the decompression / ozone introduction process during normal sterilization. This is achieved by switching the sterilization system. When the pressure reduction / introduction is performed a plurality of times, the valve may be switched every time.

  The optimum values of valve switching timing, number of times, and time for normal sterilization and capillary sterilization during ozone introduction depend on the dimensional conditions and material conditions of the target capillary tube 11; The optimal conditions can be set only by setting the valve switching sequence. Although it is possible to introduce all ozone gas into the chamber through a thin tube object, ozone gas is alternately applied under optimum conditions in consideration of damage to the material constituting the thin tube object and promotion of self-decomposition by the material constituting the thin tube object. It is desirable to introduce.

  In general, the ozone gas concentration generated by the ozonizer is sufficiently higher than the sterilization conditions, but the ozone supply to the capillary object is a direct supply of high concentration ozone generated by the ozonizer. This makes it possible to satisfy the sterilization conditions (product of CT value = ozone concentration × exposure time) in consideration of the self-decomposition of ozone gas.

  Multiple systems with different automatic pressure control functions and pipe resistances for the purpose of canceling the difference in pipe resistance between the normal sterilization system and the thin tube sterilization system, or adjusting the pipe resistance according to the change in the degree of vacuum in the chamber during gas introduction By adding a function for switching the line, the pressure acting on the ozonizer may be maintained in an optimum state to improve the ozone generation efficiency.

  Next, protection of the apparatus and the thin tube portion will be described.

  When the thin tube portion 11 is closed due to a human error, an excessive pressure is applied to components such as the ozonizer 14 and the device or the thin tube portion may be damaged. In order to avoid this, the relief valve 28 connected to the narrow tube side line 27 reliefs at the relief line 30 and exhausts from the ozone killer 32 with the vacuum pump 33. Thereby, components such as the ozonizer 14 and the thin tube portion can be protected.

  The cracking pressure of the relief valve 28 is set to a value equal to or lower than the lower limit of pressure at which the component device can be caught by the piping resistance of the connected narrow tube portion 11 or more. The secondary side of the relief valve 28 may be opened to the sterilization chamber 10.

  The detection of the introduction of sterilization gas into the thin tube will be described.

  There is a possibility that ozone gas may not be introduced into the thin tube sterilization system when the thin tube portion 11 is closed due to a human error. In order to detect that the ozone gas has been introduced and sterilized, a pressure switch (not shown) for detecting the cracking pressure of the relief valve 28 is installed in the capillary sterilization system.

  In order to know before the start of the sterilization operation whether or not the narrow tube portion 11 is closed due to human error, a mode for supplying only ozone source gas (oxygen gas or air) without generating ozone is prepared. Thus, the cracking pressure of the relief valve 28 may be detected.

  A confirmation means such as a flow meter 29 may be installed in the thin tube sterilization system so that a person can easily visually check whether or not the thin tube object is blocked due to a human error.

  As a method for checking the occlusion state other than the pressure switch, the ozone introduction is detected by the ozone concentration measurement monitor 37 in the chamber before the ozone introduction after the first decompression is started from the introduction of the ozone into the capillary sterilization system and before switching to the normal sterilization system. Accordingly, it may be confirmed that the ozone gas has been introduced into the narrow tube portion 11.

  Conversely, a second relief valve or a flow meter (not shown) is installed at the secondary side end of the narrow tube portion 11 in order to detect a state in which the thin tube object is not connected to the dedicated port due to human error. The presence or absence of connection to the thin tube object may be confirmed by a pressure switch or visual confirmation. In this case, the cracking pressure of the second relief valve is made smaller than the cracking pressure of the first relief valve.

  In purging the residual sterilization gas in the narrow tube portion 11, the fact that the sterilization gas does not easily reach the narrow tube portion 11 means that the sterilization gas is difficult to remove even by aeration. In the present invention, the purge gas can be supplied from the apparatus side to the capillary sterilization system at the time of aeration after completion of sterilization, so that the sterilization gas can be sufficiently removed. Moreover, although the thin tube part 11 is taken out from the sterilization chamber 10 after ozone sterilization, the pipe connection part of the thin tube part 11 is not sterilized because it does not come into contact with ozone, but the end may be cut and discarded like tubes. In the case of a thin tube portion, the connection portion is cut immediately before use.

  The pipe connection part of the thin tube part 11 can be a machine groove that can be released from gripping by remote operation or timer operation, and the connection part can be sterilized by releasing the gripping in a sterilizing gas atmosphere after completion of the thin tube sterilization. . The pipe connection part of the thin tube object can be a mechanism that can move the grip part by remote operation or timer operation, and the connection part can be sterilized by changing it several times during the thin tube sterilization.

  Furthermore, when the pipe connection portion of the thin tube portion 11 is made of metal, it can be sterilized by heat during thin tube sterilization by providing a heating means in the connection mechanism.

  Next, a vacuum cartridge attached to the tip of the thin tube portion 11 accommodated in the sterilization chamber 10 will be described with reference to FIG.

  FIG. 4 shows an example of a vacuum cartridge 80 used for sterilization of the narrow tube portion 11 independent of the gas type.

  The vacuum cartridge 80 is composed of a vacuum buffer tank 81 having a capacity necessary for capillary sterilization, a connection port 82 connected to the capillary tube portion 11, and an ozone formed of an orifice formed in the vacuum buffer tank 81 facing the connection port 82. It comprises an introduction port 83, a pressure reducing port 84, and a check valve 85 provided in the pressure reducing port 84. The check valve 85 includes a valve body 87 urged in a direction in which the pressure reducing port 84 is always closed by a spring 86.

  The vacuum cartridge 80 is accommodated in the sterilization chamber 10 shown in FIG. 1 with the connection port 82 connected to the narrow tube portion 11, and the other end is left open in the sterilization chamber 10.

  In the vacuum cartridge 80 of FIG. 4, when the inside of the sterilization chamber 10 is decompressed, the check valve 85 is opened. At this time, the fluid resistance of the ozone introduction port 83 formed of an orifice is large. Air escapes from 84 to the sterilization chamber 10 side. When the pressure reduction in the sterilization chamber 10 is completed, the vacuum buffer tank 81 reaches a vacuum level lower than the cracking pressure of the check function, and the vacuum energy can be stored in the vacuum buffer tank 81.

  When the introduction of ozone into the sterilization chamber 10 is started from the chamber side line 26 in FIG. 1, the inside of the thin tube portion 11 is restored at a speed substantially following the pressure in the chamber 10 and after taking in ozone in proportion to the volume, Although ozone is only decomposed, the vacuum energy inside the vacuum buffer tank 81 of the vacuum cartridge 80 remains in a reduced pressure state even after the completion of ozone introduction, and gradually returns through the ozone introduction port 83, resulting in the inside of the sterilization chamber 10. It is possible to constantly introduce ozone into the narrow tube portion 11 by the volume of the vacuum buffer tank 81.

  By using the vacuum cartridge 80, the thin tube portion 11 can be accommodated in the chamber 10 without connecting the thin tube portion 11 to the thin tube side line 27. Therefore, it is not necessary to remove the thin tube portion 11 after sterilization treatment, and the vacuum cartridge 80 is used as it is. Or can be removed from the vacuum cartridge 80 and taken out of the chamber 10.

  Moreover, the sterility after a process is securable by putting in a general sterilization bag in the state which connected the vacuum cartridge and the thin tube part.

DESCRIPTION OF SYMBOLS 10 Sterilization chamber 11 Narrow pipe part 27 Narrow pipe side line 28 Relief valve 80 Vacuum cartridge 81 Vacuum buffer tank 83 Ozone introduction port 85 Check valve

Claims (2)

  In a gas sterilization / sterilization method for a thin tube portion in which a narrow tube portion to be sterilized is housed in a sterilization chamber and sterilization gas is supplied into the sterilization chamber and sterilization gas is supplied into the narrow tube portion for sterilization and sterilization. A tank is provided with an inlet port consisting of an orifice and a check valve to form a vacuum cartridge. A thin tube portion is connected to the vacuum buffer tank via the introduction port, and the thin tube portion and the vacuum cartridge are accommodated in a sterilization chamber. Then, the inside of the sterilization chamber is depressurized and vacuum energy is accumulated in the vacuum buffer tank through the check valve. The sterilization gas is supplied into the sterilization chamber, and the sterilization gas is passed through the narrow tube portion and the introduction port. A method for gas sterilization and sterilization of a thin tube part, wherein the tube part is sterilized by suction into a vacuum buffer tank.   In a gas sterilization / sterilization apparatus of a thin tube section that houses a narrow tube part to be sterilized in a sterilization chamber, supplies sterilization gas into the sterilization chamber, and supplies sterilization gas into the narrow tube part to perform sterilization and sterilization. A tank is provided with an inlet port consisting of an orifice and a check valve to form a vacuum cartridge. A thin tube portion is connected to the vacuum buffer tank via the introduction port, and the thin tube portion and the vacuum cartridge are accommodated in a sterilization chamber. Then, the inside of the sterilization chamber is depressurized and vacuum energy is accumulated in the vacuum buffer tank through the check valve. The sterilization gas is supplied into the sterilization chamber, and the sterilization gas is passed through the narrow tube portion and the introduction port. A gas sterilization / sterilization apparatus for a thin tube part, which is sterilized by sucking it into a vacuum buffer tank.

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