JP2007014392A - Cartridge for sterilization and sterilization method using it - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a cartridge for sterilization which is suitable for the sterilization of a closed space, makes it possible to safely handle a sterilizer (sterilization liquid for instance) and surely recognize the using amount (sterilization state), and is recyclable. <P>SOLUTION: The cartridge for sterilization comprises a porous member 101, a sterilizer bag 102 disposed so as to surround the outer peripheral surface of the porous member 101 inside which the sterilizer 102a is enclosed, and a cover 103 disposed so as to cover the outer surface of the porous member 101 and the sterilizer bag 102. The cover 103 is provided with a projection 103a. By making fluid F flow to the flow passage 101a of the porous member 101 and moving the projection 103c in a center axis direction X, the sharp projected end of the projection 103c bursts through the sterilizer bag 102, the sterilizer 102a enclosed inside permeates the porous member 101 and is evaporated by the fluid F flowing through the flow passage 101a, and the sterilizer 102a is mixed in the fluid by a fixed ratio. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a sterilization cartridge and a sterilization method using the same. More specifically, it is suitable for sterilization of closed spaces, and it is possible to safely handle sterilizing agents (for example, liquid sterilizing liquid) and to know the amount of use (sterilization state) with certainty. The present invention relates to a sterilization cartridge that can be reused and recycled and a safe and efficient sterilization method using the same.

Examples of the closed space that requires sterilization include (1) to (3) below.
(1) Isolate the filling device part of the filling machine that fills medicine such as ampoules, syringes, and vials from the outside atmosphere, and the medicine is contaminated by germs, fine powders, etc. in the outside atmosphere, or highly active In the isolator that prevents the medicine from leaking to the outside (2) The room where the filling machine is installed or the room of the drug manufacturing process where the container is cleaned and the lid is attached (3) Patient transport of SARS (Severe Acute Respiratory Syndrome) Transit isolators and isolation zones that sometimes isolate the patient from the external atmosphere

As an apparatus for sterilizing a closed space as in the above (1) to (3), for example, a circuit in which a plurality of valves including a motorized valve are combined is formed, and the opening and closing of these valves is used to open a sterilizing agent. An apparatus that keeps the amount used constant is disclosed (see Patent Document 1). In the apparatus described in Patent Document 1, the sterilizing agent is placed in a container and configured to drop by gravity when the motor-operated valve is opened. Also disclosed is an apparatus for sterilizing a space inside a container or room by vaporizing a sterilizing agent, mixing it in air, inert gas, etc., releasing it to the container or room and holding it for a predetermined concentration and for a predetermined time. (See Patent Document 2). In the apparatus described in Patent Document 2, the sterilizing agent is transferred by a pump, and the weight loss of the container containing the sterilizing agent is measured with a scale to monitor the usage amount of the sterilizing agent.
JP-A-63-258731 JP 2005-160903 A

  However, when a predetermined container as a closed space is sterilized using the sterilization apparatus disclosed in Patent Documents 1 and 2, it is determined whether sterilization in the container is completed with reference to the amount of sterilant used. Since the sterilizing agent may adhere and remain in the system, measurement of the amount of sterilizing agent used has to be inaccurate. Therefore, there is a problem that it is difficult to accurately grasp the completion of sterilization in the container. In addition, when using, for example, hydrogen peroxide or the like, which has high activity and toxicity and is difficult to handle as a sterilizing agent, operations such as an operation of filling a container of a sterilizer from a raw material bottle are dangerous for the operator. There was a problem in terms of safety.

  The present invention has been made to solve the above-described problems, and is suitable for sterilization of a closed space. The sterilant (for example, a liquid sterilizing solution) can be handled safely and the amount used (sterilized state). It is an object of the present invention to provide a sterilization cartridge capable of reliably grasping the component and reusing / recycling the components and a safe and efficient sterilization method using the same.

  In order to achieve the above object, according to the present invention, the following sterilization cartridge is provided.

[1] A porous body made of a porous material into which a sterilant can permeate and having a fluid flow path in the central axis direction, and an outer peripheral surface of the porous body in which the sterilant is sealed. And a cover disposed so as to cover the outer surface of the porous body and the sterilant bag, the cover facing the outer surface of the sterilant bag The inner surface has a protrusion disposed so that its sharp tip is oriented in a direction substantially perpendicular to the outer surface of the sterilant bag and movable in the direction of the central axis; By flowing a fluid through a body flow path and moving the protrusion in the direction of the central axis, the sharp end of the protrusion breaks through the sterilant bag, and the sterilizing agent enclosed inside the porous body The flow path penetrates from the outer surface to the inner direction. Evaporated by the fluid flowing through the flow channel at the surface, the sterilizing cartridge sterilant characterized by capable of mixing at a constant rate to the fluid (hereinafter sometimes referred to as a first invention).

[2] The shape of the sterilant bag is a flat floating bag shape penetrating the central portion by the porous body, and the shape of the cover corresponds to the shape of the sterilant bag. The portion facing the surface is composed of a portion having flexibility (flexible portion), and the flexible portion of the cover is bent to be disposed on the flexible portion of the cover. The sterilization cartridge according to [1], wherein the sharp tip of the protrusion can move in the central axis direction to break through the sterilant bag.

[3] A porous body made of a porous material into which a sterilant can permeate and having a fluid flow path in the central axis direction, and an outer peripheral surface of the porous body in which the sterilant is sealed. A sterilizing agent bag disposed on the outer surface of the porous body and the sterilizing agent bag, and between the cover and the sterilizing agent bag, The protrusion further includes a protrusion disposed so as to face a direction substantially perpendicular to the outer surface of the sterilant bag, and further includes a protrusion member disposed so as to be movable in the central axis direction; The fluid is passed through the flow path of the porous body and the projecting member is moved in the central axis direction so that the sharp projecting end of the projecting member breaks through the sterilant bag and is sealed inside. Whether the agent is the outer surface of the porous body A sterilization cartridge (hereinafter referred to as a sterilization cartridge), which penetrates in an internal direction and evaporates with a fluid flowing through the flow channel on the surface of the flow channel, and allows the sterilant to be mixed with the fluid at a certain ratio. It may be called the second invention).

[4] The shape of the sterilant bag is a cylindrical shape penetrating the central part by the porous body, and the outer surface of the cover of the sterilant bag has a shape corresponding to the shape of the sterilant bag. The opposing portion has a braking portion that restricts movement of the protrusion in the central axis direction, and supports the protruding member between the braking portion and the protruding member and moves in the central axis direction. The sterilizing agent bag has a support member that can be moved, and by applying a force to the support member from the outside in the direction of the central axis, the sharp end of the protrusion of the protrusion member moves in the direction of the central axis. The cartridge for sterilization according to the above [3], which is capable of breaking through.

[5] A porous body made of a porous material into which a sterilant can permeate and having a fluid flow path in the direction of the central axis, and a sterilizer disposed inside the porous body in which the sterilant is sealed. An agent bag and a cover arranged to cover the outer surface of the porous body, the sharp tip of the sterilant bag being in a direction substantially perpendicular to the outer surface of the sterilant bag. A projection member arranged to face the projection and arranged to be movable in the direction of the central axis, and a fluid is allowed to flow through the flow path of the porous body. By moving the member in the direction of the central axis, the sharp tip of the protrusion in the protrusion member breaks through the sterilant bag, and the sterilant sealed inside penetrates from the center of the porous body toward the outer surface. Flow through the flow path on the surface of the flow path. That the fluid by evaporation, the sterilizing cartridge sterilant characterized by capable of mixing at a constant rate to the fluid (hereinafter sometimes referred to as third invention).

[6] The sterilizing agent bag has a cylindrical shape, and has a supporting member that supports the protruding member in the vicinity of the protruding member and is movable in the central axis direction. On the other hand, when a force is applied from the outside in the direction of the central axis, the sharp tip of the protrusion of the protrusion member can move in the direction of the central axis to break through the sterilant bag. Sterilization cartridge.

[7] The sterilization cartridge according to any one of [1] to [6], wherein a buffer member is disposed between the sharp tip of the protrusion and the sterilizing bag.

[8] A porous body made of a porous material into which a sterilant can permeate and having a fluid flow path in the central axis direction, and a sterilizer disposed inside the porous body in which the sterilant is sealed. A sterilant bag and a cover arranged to cover the outer surface of the porous body, wherein the sterilant bag is made of a material that dissolves by contact with a high-temperature fluid. By flowing a high-temperature fluid through the flow path of the porous body, the sterilant bag is dissolved, and the sterilant sealed inside penetrates from the center of the porous body toward the outer surface, and the flow path A sterilization cartridge (hereinafter, sometimes referred to as a fourth invention) characterized in that the sterilizing agent can be mixed with the fluid at a constant rate by evaporating with a fluid flowing through the flow path on the surface of the cartridge.

[9] The sterilization cartridge according to any one of [1] to [8], wherein the sterilizing agent is hydrogen peroxide or chlorine dioxide.

[10] The sterilization cartridge according to any one of [1] to [9], wherein the porous body is at least one selected from the group consisting of alumina, cordierite, mullite, and sintered metal.

[11] The sterilization cartridge according to any one of [1] to [10], wherein the sterilant bag is resin or glass.

[12] A sterilization method in which a sterilizing agent is mixed with a fluid at a constant ratio using the sterilization cartridge according to any one of [1] to [11] (hereinafter referred to as fifth invention). is there).

  According to the present invention, it is suitable for sterilization of a closed space, it is possible to safely handle a sterilizing agent (for example, a liquid sterilizing solution) and to reliably grasp the amount of use, and to reuse and recycle components. A possible sterilization cartridge and a safe and efficient sterilization method using the same are provided.

  The best mode for carrying out the present invention will be specifically described below with reference to the drawings. FIG. 1 is a cross-sectional view schematically showing an embodiment of the first invention. FIG. 1 (a) shows a state in which the sharp tip of the protrusion is in a state before breaking through the sterilant bag and the cartridge for sterilization is stored. FIG. 1 (b) shows the state after the sharp tip of the protrusion has broken through the sterilant bag.

  As shown in FIGS. 1 (a) and 1 (b), the sterilization cartridge 100 of the first invention is made of a porous material into which the sterilizing agent 102a can permeate and has a flow path 101a of the fluid F in the central axis direction X. A porous body 101, a sterilant bag 102 disposed so as to surround an outer peripheral surface of the porous body 101 in which a sterilizing agent 102a is enclosed, and outer surfaces of the porous body 101 and the sterilizing agent bag 102 Cover 103 (103a and 103b) disposed so as to cover the outer surface of the sterilant bag 102. The cover 103 is on the inner surface opposite to the outer surface of the sterilant bag 102, and the sharp tip is on the outer surface of the sterilant bag 102. The projection 103c is disposed so as to be directed in a substantially vertical direction and movable in the central axis direction X. The fluid F is allowed to flow through the flow path 101a of the porous body 101, and the projection 103c is By moving in the axial direction X, the sharp tip of the protrusion 103c breaks through the sterilizing agent bag 102, and the sterilizing agent 102a enclosed inside penetrates from the outer surface of the porous body 101 to the inside, and the flow channel 101a. The sterilizing agent 102a can be mixed with the fluid F at a certain ratio by evaporating with the fluid F flowing through the flow path 101a on the surface of the liquid.

  As shown in FIGS. 1 (a) and 1 (b), in the present embodiment, the sterilant bag 102 has a flat floating bag shape that is penetrated by the porous body 101 at the center, and the sterilant bag The portion of the cover 103 facing the outer surface of the sterilant bag 102 having a shape corresponding to the shape of the cover 102 is configured by a flexible portion (flexible portion) 103 d, and the flexible portion 103 d of the cover 103 is formed. It is preferable that the sharp tip of the projection 103c disposed on the flexible portion 103d of the cover can be moved in the central axis direction X to break through the sterilant bag 102 by bending. 1A and 1B, reference numeral 105 denotes a buffer member (for example, a porous resin (resin sponge)), and the flexible portion of the cover 103 when the sterilization cartridge 100 is stored. This is for protecting the sharp tip of the projection 103c disposed on 103d from moving in the central axis direction X by vibration or the like to damage or break the sterilant bag 102. The thickness in the direction X is preferably larger than the length in the central axis direction X of the sharp tip of the protrusion 103c. Further, the buffer member 105 absorbs the sterilant 102a leaked from the sterilant bag 102 by the sharp tip of the protrusion 103c moving in the central axis direction X and breaking through the sterilant bag 102, and more quickly. It can be transferred to the porous body 101. Reference numeral 106 denotes a gasket, and 107 and 108 denote O-rings. Reference numerals 109 and 110 denote lids for storing the sterilization cartridge 100. In particular, the lid 109 has a cylindrical portion of the lid 109 fitted to the end of the cover 103a so that the bottom of the lid 109 and the end of the porous body 101 are covered. When the sterilization cartridge 100 is stored, it is possible to prevent the cover 103 from moving in the central axis direction X and the sharp tip piercing the sterilant bag 102 and leaking the sterilant. Further, in FIG. 1A, it is preferable to coat the outer peripheral regions Y1 and Y2 of the porous body 101 by impregnating glaze or a fluororesin material. With this configuration, the fluid F can be prevented from exuding to the outside, and the entire amount of the sterilizing agent 102 a enclosed in the sterilizing agent bag 102 can penetrate into the porous body 101. Further, it is preferable that the covers 103a and 103b are integrated by laser welding at the outer peripheral portion of each flexible portion 103d after the porous body 101, the sterilizing agent bag 102, and the like are inserted. Further, in FIG. 1B, reference numeral 120 denotes a flange of a sterilizer that is used with the sterilization cartridge 100 of the present embodiment mounted, and 121 denotes a clamp of the sterilizer. The sterilization cartridge 100 mounted between the sterilizer flange 120 and the sterilizer clamp 121 is flexible when the space between the sterilizer flange 120 and the sterilizer clamp 121 is compressed. When the portion 103d bends, the sharp tip of the projection 103c disposed on the flexible portion 103d of the cover moves in the central axis direction X and breaks through the sterilant bag 102.

  With this configuration, it is suitable for sterilization in a closed space, and it is possible to safely handle a sterilizing agent (for example, a liquid sterilization solution) and to reliably grasp the amount of use (sterilization state). At the same time, the components can be reused and recycled after being used for sterilization operations. For reuse / recycling of the components of the sterilizing cartridge 100, for example, the cover 103 can be cut and the taken-out porous body 101 can be reused by washing and drying. It can be recycled as a raw material by separating with a simple method.

  FIG. 2 is a cross-sectional view schematically showing one embodiment of the second invention. FIG. 2A is a state before the sharp tip of the protrusion breaks through the sterilant bag and stores the sterilization cartridge. 2 (b) shows the cross-sectional shape of the porous body, and FIG. 2 (c) shows the state after the sharp tip of the protrusion breaks through the sterilant bag.

  As shown in FIGS. 2A, 2B, and 2C, the sterilization cartridge 200 of the second invention is made of a porous material into which the sterilizing agent 202a can permeate and the fluid F in the central axis direction X. A porous body 201 having a flow path 201a, a sterilizing agent bag 202 disposed so as to surround an outer peripheral surface of the porous body 201 in which a sterilizing agent 202a is enclosed, a porous body 201, and a sterilizing agent bag And a cover 203 disposed so as to cover the outer surface of 202, and the sharp tip between the cover 203 and the sterilant bag 202 is oriented in a direction substantially perpendicular to the outer surface of the sterilant bag 202. And a protrusion member 204 disposed so as to be movable in the central axis direction X, and flowing the fluid F through the flow path 201a of the porous body 201, Protruding member 204 By moving in the central axis direction X, the sharp tip of the protrusion 204a in the protrusion member 204 breaks through the sterilant bag 202, and the sterilant 202a enclosed inside penetrates from the outer surface of the porous body 201 in the inner direction. The surface of the flow path 201a is evaporated by the fluid F flowing through the flow path 201a, and the sterilizing agent 202a can be mixed with the fluid F at a certain ratio.

  As shown in FIGS. 2A, 2B, and 2C, in the present embodiment, the sterilant bag 202 has a cylindrical shape that is penetrated by the porous body 201 at the center, and is sterilized. The portion of the cover 203 facing the outer surface of the sterilant bag 202 having a shape corresponding to the shape of the agent bag 202 has braking portions 203a and 203b that restrict the movement of the projection 204a in the central axis direction X. A support member (compression ring) 204b that supports the projection member 204 and is movable in the central axis direction X is provided between the braking portion 203b and the projection member 204, with respect to the support member (compression ring) 204b. By applying a force in the central axis direction X from the outside, the sharp projecting end of the projection 204a of the projection member 204 can move in the central axis direction X to break through the sterilant bag 202. It is preferable. 2A, 2 </ b> B, and 2 </ b> C, the pawl 203 c has an appropriate number of ends of the cover 203 bent toward the inner diameter side so that the porous material 201 does not move in the axial direction. Is. Reference numeral 205 (205a and 205b) denotes a buffer member (for example, porous resin (resin sponge)), 207 and 208 denote O-rings, and 209 and 210 denote lids. In addition, the recesses 203a on the cover 203 serve as two or more stoppers for holding the sterilant bag 202 and the like inside the cover 203 and holding them in the cover 203. It should be noted that the thickness of the buffer member 205 and other components, such as the configuration and operation of the lids 209 and 210, are the same as in the case of the first invention. In FIG. 2 (b), reference numeral 220 denotes a flange of a sterilization apparatus used with the sterilization cartridge 200 of the present embodiment mounted thereon, and 221 denotes a clamp of the sterilization apparatus. When the sterilization cartridge 200 mounted between the sterilizer flange 220 and the sterilizer clamp 221 is compressed between the sterilizer flange 220 and the sterilizer clamp 221, the sterilizer clamp 221 is disengaged. By pushing up the support member (compression ring) 204b, the sharp end of the protrusion 204a of the protrusion member 204 moves in the central axis direction X and breaks through the sterilant bag 202.

  FIG. 3 is a cross-sectional view schematically showing one embodiment of the third invention. FIG. 3A is a state before the sharp tip of the protrusion breaks through the sterilant bag, and the sterilization cartridge is stored. 3 (b) shows the cross-sectional shape of the porous body, and FIG. 3 (c) shows the state after the sharp tip of the protrusion breaks through the sterilant bag.

  As shown in FIGS. 3A, 3B, and 3C, the sterilization cartridge 300 of the third invention is made of a porous material into which the sterilant 302a can permeate and the fluid F in the central axis direction X. A porous body 301 having a flow path 301a, a sterilizing agent bag 302 disposed inside the porous body 301 in which a sterilizing agent 302a is enclosed, and an outer surface of the porous body 301 are disposed. Provided with a cover 303 provided, having a protrusion 304a disposed in the vicinity of the sterilant bag 302 so that the sharp tip thereof faces in a direction substantially perpendicular to the outer surface of the sterilant bag 302, and the central axis A protrusion member 304 disposed so as to be movable in the direction X, and flowing the fluid F through the flow path 301a of the porous body 301 and moving the protrusion member 304 in the central axis direction X; Protruding member 30 The sharp tip of the projection 304a at the top breaks through the sterilant bag 302, the sterilant 302a enclosed inside penetrates from the center of the porous body 301 toward the outer surface, and flows through the channel 301a on the surface of the channel 301a. It is characterized by being able to evaporate by the fluid F and mix the sterilizing agent 302a with the fluid F at a certain ratio.

  As shown in FIGS. 3A, 3 </ b> B, and 3 </ b> C, in the present embodiment, the sterilant bag 302 has a cylindrical shape and supports the protruding member 304 in the vicinity of the protruding member 304. And a support member 304b movable in the central axis direction X. By applying a force to the support member 304b from the outside in the central axis direction X, the sharp end of the projection 304a of the projection member 304 is center axis. It is preferable to move in direction X so that the sterilant bag 302 can be broken through. 3A, 3B, and 3C, reference numeral 305 denotes a buffer member (for example, a porous resin (resin sponge)), 307 and 308 are corner packings, and 309 and 310 are lids. Show. In FIG. 3B, reference numeral 320 indicates a flange of a sterilizer that is used with the sterilization cartridge 300 of the present embodiment, and reference numeral 321 indicates a clamp of the sterilizer. The sterilization cartridge 300 mounted between the sterilizer flange 320 and the sterilizer clamp 321 applies a force to the support member 304b from the outside in the central axial direction X (in FIG. 3C). When the pressing bar 330 is pushed up with respect to the support member 304b, the sharp tip of the protrusion 304a of the protrusion member 304 moves in the central axis direction X and breaks through the sterilant bag 302. It should be noted that the thickness of the buffer member 305 and other components, for example, the configurations and actions of the lids 309, 310, etc. are the same as in the case of the first invention.

  Examples of the buffer member disposed between the sharp tip of the protrusion used in the first to third inventions and the sterilant bag include, for example, a porous resin (resin sponge), specifically polyurethane, A suitable example is a polypropylene sponge. Further, the buffer member may be made of a material having a void and reducing its volume when compressed, such as a knitted felt or metal fine wire.

  FIG. 4 is a cross-sectional view schematically showing one embodiment of the fourth invention. FIG. 4A is a state before the sterilant bag is dissolved, and a state in which the sterilization cartridge is stored. 4 (b) shows the cross-sectional shape of the porous body, and FIG. 4 (c) shows the state after the sterilant bag is dissolved.

  As shown in FIGS. 4A, 4B, and 4C, the sterilization cartridge 400 of the fourth invention is made of a porous material into which the sterilizing agent 402a can permeate and the fluid F in the central axis direction X. A porous body 401 having a flow path 401a, a sterilizing agent bag 402 disposed inside the porous body 401 in which a sterilizing agent 402a is enclosed, and an outer surface of the porous body 401 are disposed. The sterilizing agent bag 402 is made of a material that dissolves by contact with a high-temperature fluid. The sterilization bag 402 is sterilized by flowing the high-temperature fluid through the channel 401a of the porous body 401. The agent bag 402 is dissolved, the sterilizing agent 402a enclosed inside penetrates from the center of the porous body 401 toward the outer surface, evaporates by the fluid F flowing through the channel 401a on the surface of the channel 401a, and sterilized. 402a and characterized in that that can be mixed at a constant ratio to the fluid F. 4A, 4B, and 4C, reference numeral 406 is a plug for holding the sterilant bag 402 inside the porous body 401, 407 and 408 are corner packings, and 409 and 410 Indicates a lid, respectively. In FIG. 4B, reference numeral 420 indicates a flange of a sterilizer used by mounting the sterilization cartridge 400 of the present embodiment, and 421 indicates a clamp of the sterilizer. The sterilizing cartridge 400 mounted between the sterilizer flange 420 and the sterilizer clamp 421 evaporates the sterilant 402a into the flow path 401a as the sterilant bag 402 is dissolved.

  Examples of the sterilizing agent used in the first to fourth inventions include hydrogen peroxide, chlorine dioxide, formalin, methyl alcohol, and ethyl alcohol. Among these, hydrogen peroxide is preferable because it decomposes into water and active oxygen, and does not corrode or foul equipment installed in a closed space to be sterilized. The sterilizing agent is preferably a liquid in terms of ease of handling.

  The porous body is selected from the group consisting of ceramic materials such as alumina, cordierite, mullite, magnesia, silicon carbide, silicon nitride, sintered metal, and foamed resin such as polyetheretherketone (PEEK). At least one can be mentioned. Among these, alumina is cheaper in raw material, and the molding temperature is as low as about 1300 ° C., so the firing cost is low, and when it is reused, it has high strength for handling porous materials, and it has corrosion resistance to sterilizing agents. Pore can be easily formed by mixing fine powder of foaming resin and extruding it into the desired shape, then heating, dissolving the foamed resin, forming fine pores and firing It is preferable because it can be controlled and the porosity can be easily controlled.

  Examples of the sterilizing bag include resin and glass. Among these, polypropylene is preferable because it can easily form a floating bag shape by blow molding, and after injecting an internal sterilant, the hole used for injection can be sealed by welding or welding. Also in the case of glass, after forming a floating bag shape having a sterilant injection hole by blow molding, the sterilant can be injected, and the hole used for injection can be dissolved to seal the sterilant. In the case of 4th invention, what melt | dissolves at the temperature of 300 degreeC or more is preferable, and a polypropylene and polyethylene can be mentioned as a suitable example.

  A fifth invention is a sterilization method characterized in that a sterilizing agent is mixed with a fluid at a certain ratio using the sterilization cartridge described above. After the sterilizing agent is mixed with the fluid at a certain ratio using the above-described sterilization cartridge and the fluid containing the sterilizing agent is introduced into the sterilizing apparatus, for example, a method widely used for sterilization of a closed space is used. Can be used.

  EXAMPLES Hereinafter, the present invention will be described more specifically with reference to examples, but the present invention is not limited to these examples.

Example 1
After forming a porous body made of alumina having a porosity of 20% with 19 fluid passage holes having a diameter of 30 mm, a length of 80 mm, and a diameter of 4 mm, both ends of the outer diameter portion were sealed with a glaze, Inserted into the stainless steel SUS304 cover together with a sterilizer bag made of polypropylene containing 31% hydrogen peroxide, a shock absorbing member made of two pairs of urethane sponges, a stainless steel SUS304 protruding member having a sharp tip, etc. A sterilization cartridge shown in FIG. 2 was produced. Polyethylene lids were attached to both ends of the sterilization cartridge and dropped onto the floor surface from a height of 1 m, but there was no breakage of the alumina porous body or rupture of the sterilant bag. In addition, the weight of the sterilization cartridge was measured in order to verify that the sterilizing agent described later was completely used for sterilization. Further, a sterilizer was connected to an isolator having a volume of 3 cubic meters, and a sterilization cartridge was attached to the sterilizer. At this point, the sterilization cartridge was not held in the axial direction but only held in the sterilizer. Thereafter, the interior of the isolator was first dehumidified to 10% by a built-in dehumidifier. A clamp that incorporates the sterilization cartridge into the sterilizer is operated to infiltrate the sterilant into the porous body made of alumina, and hot air is sent to the sterilization cartridge by a 180 ° C heater and blower built in the sterilizer to circulate hot air. The test was carried out for 15 minutes, and after the hot air circulation was stopped, the system was kept as it was for 30 minutes. At this time, the concentration of hydrogen peroxide vapor in the isolator was 1.6 mg / liter. Result of confirming that sterilization was performed by a bio-indicator using “Geobacillus stearothermophilus” manufactured by Raven, placed in an isolator, and measuring the weight of the sterilization cartridge and comparing it with the weight before the sterilization operation described above It was confirmed that the total amount of the sterilant enclosed in the sterilant bag was used for sterilization of the isolator by matching the weight of the sterilant injected into the sterilant bag. The verification test described above was performed three times, and similar results were confirmed. In these tests, in order to verify that the sterilant was used in the sterilization operation, the air was not dehumidified / detoxified after the sterilant was evaporated in the isolator. In the actual sterilization operation, after evaporation of the sterilant, the air in the system containing the isolator is passed through the dehumidifier built in the sterilizer and the catalyst made of manganese dioxide by the blower and continuously circulated and remains in the system. Remove water and remove hydrogen peroxide.

  INDUSTRIAL APPLICABILITY The present invention is effectively used in various industrial fields where the closed space needs to be sterilized, for example, the pharmaceutical manufacturing field and the medical field.

FIG. 1A is a cross-sectional view schematically showing one embodiment of the first invention, and FIG. 1A is a state before the sharp tip of the protrusion breaks through the sterilant bag and when the sterilization cartridge is stored FIG. 1 (b) shows the state after the sharp tip of the protrusion breaks through the sterilant bag. FIG. 2A is a cross-sectional view schematically showing an embodiment of the second invention, and FIG. 2A is a state before the sharp tip of the protrusion breaks through the sterilant bag and when the sterilization cartridge is stored 2 (b) shows the cross-sectional shape of the porous body, and FIG. 2 (c) shows the state after the sharp tip of the protrusion breaks through the sterilant bag. FIG. 3A is a cross-sectional view schematically showing an embodiment of the third invention, and FIG. 3A is a state before the sharp tip of the protrusion breaks through the sterilant bag and when the sterilization cartridge is stored. 3 (b) shows the cross-sectional shape of the porous body, and FIG. 3 (c) shows the state after the sharp tip of the protrusion breaks through the sterilant bag. FIG. 4A is a cross-sectional view schematically showing one embodiment of the fourth invention, in which FIG. 4A is a state before the sterilant bag is dissolved and a sterilization cartridge is stored, FIG. b) shows the cross-sectional shape of the porous body, and FIG. 4C shows the state after the sterilant bag is dissolved.

Explanation of symbols

100: Sterilization cartridge 101 of the first invention: Porous body 101a: Channel 102: Sterilizer bag 102a: Sterilizer 103 (103a, 103b): Cover 103c: Projection 103d: Flexible portion 105: Buffer member 106 : Gasket 107: O-ring 108: O-ring 109: Lid 110: Lid 120: Sterilizer flange 121: Sterilizer clamp 200: Sterilization cartridge 201 of the second invention 201: Porous body 201a: Channel 202: Sterilization Agent bag 202a: sterilizing agent 203: cover 203a: braking portion 203b: braking portion 203c: pawl 204: projection member 204a: projection 204b: support member (compression ring)
205 (205a, 205b): buffer member 207: O-ring 208: O-ring 209: lid 210: lid 220: sterilizer flange 221: sterilizer clamp 300: sterilization cartridge 301 of the third invention 301: porous body 301a: channel 302: sterilant bag 302a: sterilant 303: cover 304: projection member 304a: projection 304b: support member 305: buffer member 307: corner packing 308: corner packing 309: lid 310: lid 320: of the sterilizer Flange 321: Sterilizer clamp 330: Squeeze bar 400: Sterilization cartridge 401 of the fourth invention 401: Porous body 401a: Channel 402: Sterilizer bag 402a: Sterilizer 403: Cover 406: Plug 407: Corner packing 408 : Corner packing 409: Lid 410: Lid 420: The filtering apparatus Flange 421: clamping sterilizers F: Fluid X: center axis Y1: glaze coating region of the porous body Y2: glaze coating region of the porous body.

Claims (12)

A porous body made of a porous material into which a sterilizing agent can permeate and having a fluid flow path in the central axis direction, and an outer peripheral surface of the porous body in which the sterilizing agent is sealed are disposed so as to surround the porous body. A sterilizer bag, and a cover disposed so as to cover an outer surface of the porous body and the sterilant bag,
The cover is movable on the inner surface facing the outer surface of the sterilant bag so that its sharp tip faces in a direction substantially perpendicular to the outer surface of the sterilant bag and is movable in the central axis direction. Having protrusions arranged,
By flowing a fluid through the flow path of the porous body and moving the projection in the direction of the central axis, the sharp tip of the projection breaks through the sterilant bag, and the sterilizing agent enclosed inside is porous. It is possible to infiltrate inward from the outer surface of the material, evaporate by the fluid flowing through the flow channel on the surface of the flow channel, and mix the sterilizing agent with the fluid at a certain ratio. Sterilization cartridge.   The shape of the sterilant bag is a flat floating bag shape penetrating the center part by the porous body, and the shape corresponding to the shape of the sterilant bag is opposed to the outer surface of the sterilant bag of the cover. The portion to be formed is composed of a portion having flexibility (flexible portion), and the flexible portion of the cover is bent, so that the protrusion disposed on the flexible portion of the cover The sterilization cartridge according to claim 1, wherein a sharp tip can move in the direction of the central axis to break through the sterilant bag. A porous body made of a porous material into which a sterilizing agent can permeate and having a fluid flow path in the central axis direction, and an outer peripheral surface of the porous body in which the sterilizing agent is sealed are disposed so as to surround the porous body. A sterilizer bag, and a cover disposed so as to cover an outer surface of the porous body and the sterilant bag,
Between the cover and the sterilant bag, a sharp protrusion has a protrusion disposed so as to face a direction substantially perpendicular to the outer surface of the sterilant bag and is movable in the central axis direction And further including a protruding member arranged as follows:
The fluid is passed through the flow path of the porous body and the projecting member is moved in the central axis direction so that the sharp projecting end of the projecting member breaks through the sterilant bag and is sealed inside. The agent permeates inward from the outer surface of the porous body, evaporates by the fluid flowing through the channel on the surface of the channel, and the sterilizing agent can be mixed with the fluid at a certain ratio. A sterilization cartridge characterized by.   The portion of the cover facing the outer surface of the sterilant bag having a shape corresponding to the shape of the sterilant bag, the shape of the sterilant bag being a cylindrical shape penetrating the central portion by the porous body Has a braking portion that restricts movement of the protrusion in the central axis direction, and supports the protruding member between the braking portion and the protruding member and is movable in the central axis direction. A member having a member, and by applying a force to the support member from the outside in the direction of the central axis, the sharp end of the protrusion of the protrusion member moves in the direction of the central axis and breaks through the sterilant bag. The sterilization cartridge according to claim 3, which can be used. A porous body made of a porous material into which a sterilant can permeate and having a fluid flow path in the central axis direction; and a sterilant bag disposed inside the porous body in which the sterilant is sealed. A cover disposed so as to cover the outer surface of the porous body,
In the vicinity of the sterilant bag, there is a protrusion disposed so that its sharp tip faces in a direction substantially perpendicular to the outer surface of the sterilant bag, and is disposed so as to be movable in the central axis direction. Further comprising a projected member,
The fluid is passed through the flow path of the porous body and the projecting member is moved in the central axis direction so that the sharp projecting end of the projecting member breaks through the sterilant bag and is sealed inside. The agent permeates from the center of the porous body toward the outer surface, evaporates by the fluid flowing through the flow channel on the surface of the flow channel, and the sterilizing agent can be mixed with the fluid at a certain ratio. The cartridge for sterilization characterized by the above-mentioned.   The sterilant bag has a cylindrical shape, and has a support member that supports the protrusion member in the vicinity of the protrusion member and is movable in the central axis direction, and is external to the support member. The sterilization cartridge according to claim 5, wherein by applying a force in the direction of the central axis, the sharp protruding end of the protrusion of the protruding member can move in the direction of the central axis to break through the sterilant bag.   The sterilization cartridge according to any one of claims 1 to 6, wherein a buffer member is disposed between the sharp protruding end of the protrusion and the sterilizing agent bag. A porous body made of a porous material into which a sterilant can permeate and having a fluid flow path in the central axis direction; and a sterilant bag disposed inside the porous body in which the sterilant is sealed. A cover disposed so as to cover the outer surface of the porous body,
The sterilizer bag is made of a material that dissolves by contact with a hot fluid;
By flowing a high-temperature fluid through the flow path of the porous body, the sterilant bag is dissolved, and the sterilizing agent sealed inside penetrates from the center of the porous body toward the outer surface, and A sterilization cartridge characterized by evaporating with a fluid flowing through the flow path on the surface of the flow path and allowing the sterilizing agent to be mixed with the fluid at a constant rate.   The sterilizing cartridge according to any one of claims 1 to 8, wherein the sterilizing agent is hydrogen peroxide or chlorine dioxide.   The sterilization cartridge according to any one of claims 1 to 9, wherein the porous body is at least one selected from the group consisting of alumina, cordierite, mullite, and sintered metal.   The sterilizing cartridge according to any one of claims 1 to 10, wherein the sterilizing bag is made of resin or glass.   A sterilization method comprising mixing a sterilant with a fluid at a constant rate using the sterilization cartridge according to any one of claims 1 to 11.

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