A bioindicator for monitoring the effectiveness of environmental decontamination

Abstract

This invention provides a biological indicator device for monitoring the effectiveness of environmental decontamination. The device includes a bottle body and an insert. The bottle body contains a reagent chamber with a sealing film inside. The insert includes a bottle cap with a sealing body and a bacterial strip. A microbial barrier and a breathable component are positioned between the bottle cap and the bottle body. In its initial state, the bottle cap, the breathable component, the bottle body, and the sealing film together form a closed cavity, within which the bacterial strip is located. In its closed state, the sealing body is in sealing contact with the opening of the reagent chamber, and the bacterial strip is inserted into the reagent chamber. This invention is simple to operate and prevents external microorganisms from entering the reagent chamber during cultivation, thus improving the reliability of the test results.

Description

Technical Field

[0001] This utility model relates to the technical field of biological indicator devices for sterilization, and in particular to a biological indicator device for monitoring the effectiveness of environmental decontamination. Background Technology

[0002] Monitoring sterilization effectiveness using biological indicators is an important method for evaluating the effectiveness of biocontamination control, and it has been widely used in sterilization validation of healthcare products, aseptic assurance process control, and biosafety risk assessment. When applied to these processes, the traditional method involves placing the biological indicator in the space to be sterilized or within the product. After sterilization, exposure inoculation is performed, i.e., the monitoring biological indicator is transferred to a laboratory and inoculated into sterile culture medium in a controlled clean environment, such as a biosafety cabinet, for further confirmation of sterilization effectiveness. This process requires strict aseptic operation in a laboratory, is cumbersome, and carries a risk of contamination.

[0003] In existing technologies, biological indicator devices typically consist of microbial discs containing specific microorganisms and culture media reagents for culturing and observing the survival of these microorganisms. However, traditional biological indicator devices have the following structural design shortcomings: the microbial discs are susceptible to external environmental influences during storage and transportation, such as humidity and contamination by other microorganisms, leading to changes in microbial activity and affecting detection accuracy; furthermore, in some devices, contact between the microbial discs and the culture medium requires cumbersome manual operation, increasing the risk of contamination; additionally, some biological indicators have poor sealing performance, potentially leading to reagent leakage or intrusion of external contaminants when not in use, while in use, it is difficult to ensure sufficient contact and effective sealing between the microbial discs and the reagents, thus affecting the reliability of the detection results. Summary of the Invention

[0004] The purpose of this invention is to address the shortcomings of existing technologies and provide a biological indicator device for monitoring the effectiveness of environmental decontamination.

[0005] The purpose of this utility model is achieved through the following technical solution: a biological indicator device for monitoring the effect of environmental decontamination, comprising a bottle body and an insert, wherein a reagent chamber is provided inside the bottle body, and a sealing film is provided in the reagent chamber; the insert includes a bottle cap, on which a sealing body and a bacterial strip are provided; and a microbial barrier and a breathable component are provided between the bottle cap and the bottle body; in the initial state, the bottle cap, the microbial barrier and the breathable component, the bottle body, and the sealing film together form a closed cavity, and the bacterial strip is located in the closed cavity; in the closed state, the sealing body is in sealed contact with the opening of the reagent chamber, and the bacterial strip is inserted into the reagent chamber.

[0006] Preferably, the opening of the reagent chamber is provided with a first sealing cone surface, and the outer side of the sealing body is provided with a second sealing cone surface that cooperates with the first sealing cone surface.

[0007] Preferably, the bottle cap is provided with a positioning post, and the bottle body is provided with a guide hole corresponding to the positioning post, with the positioning post slidably connected in the guide hole.

[0008] Preferably, the guide hole includes an upper hole body and a lower hole body, the diameter of the upper hole body is smaller than the diameter of the lower hole body, and a stepped surface is provided between the upper hole body and the lower hole body; an upper annular protrusion is provided on the positioning post; when the biological indicator device is in the closed state, the upper annular protrusion presses against the stepped surface to make the sealing body and the opening of the reagent chamber in close contact.

[0009] Preferably, the positioning post is provided with a lower annular protrusion, which is located at the upper end of the upper hole when the biological indicator device is in the initial state.

[0010] Preferably, the bacterial flakes have a blade-like structure.

[0011] Preferably, the sealing body is made of rubber or silicone material. Preferably, the antibacterial and breathable element is made of non-woven fabric material.

[0012] Preferably, the antibacterial and breathable component is Tyvek paper.

[0013] Preferably, the sealing film is aluminum foil.

[0014] The beneficial effects of this utility model are: 1. In use, the biological indicator device in its initial state is placed into a sterilizer for sterilization. After sterilization, the biological indicator device is closed by manually pressing the cap, causing the bacterial strip on the cap to puncture the sealing film and insert into the reagent chamber, where it comes into contact with the culture medium. The bacterial strip will then be cultured in the reagent chamber. In the closed state, the sealing body on the insert will be in close contact with the opening of the reagent chamber to achieve a sealed isolation of the reagent chamber, thereby preventing external bacteria from entering the reagent chamber during the culture process and affecting the test results, thus improving the reliability of the test results.

[0015] 2. When not in use (i.e., in the initial state), the sealing film is intact, encapsulating the reagent in the reagent chamber within a sealed space to prevent external contamination. The bacterial strip is located within a closed cavity formed by the bottle cap, the sterile ventilator, the bottle body, and the sealing film. The sterile ventilator has high permeability and sterile isolation function. The bacterial strip is placed in this closed cavity, effectively isolating it from external microbial contamination. Furthermore, the high permeability of the sterile ventilator ensures that sterilizing substances (such as hydrogen peroxide) in the sterilizer can effectively pass through the sterile ventilator and act on the bacterial strip during the testing process.

[0016] 3. This utility model, through the cooperation between the positioning post and the guide hole, plays a good guiding role for the bottle cap when it is pressed, so that the bacterial strip can be accurately inserted into the reagent chamber. At the same time, the positioning post is provided with an annular protrusion to mechanically limit the indicator device in different usage states, ensuring stable connection and sealing.

[0017] 4. This utility model is simple and convenient to operate, and improves testing efficiency. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the external shape of the present invention in its initial state.

[0019] Figure 2 This is a schematic diagram of the external shape of the present invention in the closed state.

[0020] Figure 3 This is a cross-sectional view of the present invention in its initial state.

[0021] Figure 4 This is a cross-sectional view of the present invention in the closed state.

[0022] Figure 5 This is a schematic diagram of the bottle's structure.

[0023] Figure 6 This is a structural schematic diagram of the insert.

[0024] In the figure: 1. Bottle body, 2. Insulating and ventilating component, 3. Reagent chamber, 4. Guide hole, 4a. Lower hole body, 4b. Upper hole body, 5. Sealing film, 6. Bottle cap, 7. Sealing body, 8. Microbial sheet, 9. Positioning post, 9a. Upper annular protrusion, 9b. Lower annular protrusion, 10. First sealing cone surface. Detailed Implementation

[0025] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present utility model are within the protection scope of the present utility model.

[0026] like Figures 1 to 6As shown, a biological indicator device for monitoring the effectiveness of environmental decontamination includes a bottle body 1 and an insert. The bottle body 1 has a reagent chamber 3, and a sealing film 5 is disposed in the reagent chamber 3. The insert includes a bottle cap 6, on which a sealing body 7 and a bacterial strip 8 are disposed. A microbial barrier and a breathable component 2 is disposed between the bottle cap 6 and the bottle body 1. In the initial state, the bottle cap 6, the microbial barrier and the breathable component 2, the bottle body 1, and the sealing film 5 together form a closed cavity, and the bacterial strip 8 is located in the closed cavity. In the closed state, the sealing body 7 is in sealed contact with the opening of the reagent chamber 3, and the bacterial strip 8 is inserted into the reagent chamber 3.

[0027] The bacterial strip 8 contains microbial spores, and the reagent chamber 3 contains culture medium reagents for culturing microorganisms. When the biological indicator is not in use (i.e., in its initial state), the sealing film 5 is intact, encapsulating the reagent in the reagent chamber 3 in a sealed space to prevent external contamination. The bacterial strip 8 is located in a closed cavity formed by the bottle cap 6, the sterile ventilator 2, the bottle body 1, and the sealing film 5. The sterile ventilator 2 has high air permeability and sterile isolation function. The bacterial strip 8 is placed in this closed cavity, which can effectively isolate external microbial contamination. Furthermore, the high air permeability of the sterile ventilator 2 ensures that sterilizing substances (such as hydrogen peroxide) in the sterilizer can effectively pass through the sterile ventilator 2 and act on the bacterial strip 8 during the detection process.

[0028] In use, the biological indicator device in its initial state is placed into the sterilizer for sterilization. After sterilization, the biological indicator device is closed by manually pressing the cap 6, causing the bacterial strip 8 on the cap 6 to puncture the sealing film 5 and insert into the reagent chamber 3, coming into contact with the culture medium reagent. The bacterial strip 8 will then be cultured in the reagent chamber 3. In the closed state, the sealing body 7 on the insert will be in close contact with the opening of the reagent chamber 3 to achieve a sealed isolation of the reagent chamber 3, thereby preventing external bacteria from entering the reagent chamber 3 during the culture process and affecting the test results, while also preventing reagent spillage.

[0029] In this invention, during the process of pressing the insert to insert the bacterial strip 8 into the reagent chamber 3, the entire movement process is carried out in a fully enclosed state, which improves the reliability of the test results; while traditional biological indicator devices are easily affected by the environment and are easily contaminated during the movement process, and the test results are prone to false positives.

[0030] A first sealing cone surface 10 is provided at the opening of the reagent chamber 3, and a second sealing cone surface that mates with the first sealing cone surface 10 is provided on the outer side of the sealing body 7. When the biological indicator is in the closed state, the second sealing cone surface on the sealing body 7 fits tightly with the first sealing cone surface 10 at the opening of the reagent chamber 3. The sealing effect can be effectively improved through the cooperation between the two sealing cone surfaces.

[0031] Furthermore, a positioning post 9 is provided on the bottle cap 6, and a guide hole 4 corresponding to the positioning post 9 is provided on the bottle body 1. The positioning post 9 is slidably connected in the guide hole 4. Through the cooperation between the positioning post 9 and the guide hole 4, the bottle cap 6 is well guided when pressed, so that the bacterial tablet 8 can be accurately inserted into the reagent chamber 3.

[0032] The guide hole 4 includes an upper hole 4b and a lower hole 4a. The diameter of the upper hole 4b is smaller than that of the lower hole 4a. A stepped surface is provided between the upper hole 4b and the lower hole 4a. The positioning post 9 is provided with an upper annular protrusion 9a. When the biological indicator device is in the closed state, the upper annular protrusion 9a presses against the stepped surface to make the sealing body 7 in close contact with the opening of the reagent chamber 3. When the biological indicator device is in the closed state, the positioning post 9 on the insert moves down along the guide hole 4, and the upper annular protrusion 9a finally presses against the stepped surface between the upper hole 4b and the lower hole 4a of the guide hole 4. This structural design, with the help of the upper annular protrusion 9a forming a mechanical limit, forces the sealing body 7 to form a stable and tight contact with the opening of the reagent chamber 3, ensuring the sealing of the internal environment of the reagent chamber 3 and preventing external contaminants from entering the reagent chamber 3 or the reagent inside the reagent chamber 3 from leaking outward.

[0033] The positioning post 9 is also provided with a lower annular protrusion 9b. When the biological indicator device is in the initial state, the lower annular protrusion 9b is located at the upper end of the upper hole 4a, forming a mechanical limit on the initial state, so as to prevent the cover from being accidentally pressed by the insert when no force is applied.

[0034] In some embodiments of this application, the mycelium sheet 8 has a blade-shaped structure. Blade-shaped mycelium sheets 8 are easier to manufacture and can be mass-produced by stamping or by laser cutting, resulting in lower production costs.

[0035] In some embodiments of this application, the sealing body 7 is made of rubber or silicone material.

[0036] In some embodiments of this application, the antibacterial and breathable component 2 is made of non-woven fabric or Tyvek paper. Tyvek paper is made of 100% high-density polyethylene fiber, which is chemically inert to most acids, alkalis, and salts, providing good liquid barrier protection. It is also waterproof and breathable. The dense fibers prevent liquid water and oil from easily penetrating, while allowing gas and water vapor to pass through, giving it good breathability and antibacterial properties.

[0037] In some embodiments of this application, the sealing film 5 is aluminum foil.

[0038] This utility model is not limited to the above-described preferred embodiments. Anyone can derive other forms of products under the guidance of this utility model. However, regardless of any changes made in their shape or structure, any technical solution that is the same as or similar to this application falls within the protection scope of this utility model.

Claims

1. A biological indicator device for monitoring the effectiveness of environmental decontamination, characterized in that, It includes a bottle body and an insert. The bottle body has a reagent chamber, and the reagent chamber has a sealing film. The insert includes a bottle cap, which has a sealing body and a bacterial sheet. An antibacterial and breathable component is provided between the bottle cap and the bottle body. In the initial state, the cap, the sterile ventilator, the bottle body, and the sealing film together form a closed cavity, and the bacterial strip is located in the closed cavity. In the closed state, the biological indicator device is in sealed contact with the opening of the reagent cavity, and the bacterial strip is inserted into the reagent cavity.

2. The biological indicator device for monitoring the environmental decontamination effect according to claim 1, characterized in that, The reagent chamber has a first sealing cone surface at its opening, and the outer side of the sealing body has a second sealing cone surface that mates with the first sealing cone surface.

3. The biological indicator device for monitoring the environmental decontamination effect according to claim 1, characterized in that, The bottle cap is provided with a positioning post, and the bottle body is provided with a guide hole corresponding to the positioning post. The positioning post is slidably connected in the guide hole.

4. A biological indicator device for monitoring the effectiveness of environmental decontamination according to claim 3, characterized in that, The guide hole includes an upper hole body and a lower hole body. The diameter of the upper hole body is smaller than that of the lower hole body. A stepped surface is provided between the upper hole body and the lower hole body. An upper annular protrusion is provided on the positioning post. When the biological indicator is in the closed state, the upper annular protrusion presses against the stepped surface to ensure that the seal is in close contact with the opening of the reagent chamber.

5. A biological indicator device for monitoring the effectiveness of environmental decontamination according to claim 4, characterized in that, The positioning post is provided with a lower annular protrusion. When the biological indicator device is in the initial state, the lower annular protrusion is located at the upper end of the upper hole.

6. A biological indicator device for monitoring the effectiveness of environmental decontamination according to claim 1, characterized in that, The bacterial flakes have a blade-like structure.

7. A biological indicator device for monitoring the environmental decontamination effect according to claim 1, characterized in that, The sealing body is made of rubber or silicone material.

8. A biological indicator device for monitoring the effectiveness of environmental decontamination according to claim 1, characterized in that, The antibacterial and breathable component is made of non-woven fabric.

9. A biological indicator device for monitoring the environmental decontamination effect according to claim 1, characterized in that, The antibacterial and breathable component is made of Tyvek paper.

10. A biological indicator device for monitoring the environmental decontamination effect according to claim 1, characterized in that, The sealing film is aluminum foil.

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