JP6642017B2 - Biological indicator substrate, biological indicator, biological indicator substrate storage, biological indicator storage, method for manufacturing biological indicator substrate storage, method for manufacturing biological indicator storage, and sterilizing device Sterilization ability evaluation method - Google Patents

Description

  TECHNICAL FIELD The present invention relates to a biological indicator base material that can provide a biological indicator that can easily evaluate the sterilizing ability of a sterilizing device.

  A packaging material used for filling foods or the like may be sterilized in a production line or the like to be in a sterile state from the viewpoint of sanitation. Sterilization equipment used for sterilization of sterilized objects such as packaging materials evaluates sterilization ability using indicator bacteria corresponding to the type of sterilization process in order to confirm whether the sterilized objects can be sufficiently sterilized. Is performed.

As such an evaluation method, generally, a method is used in which an indicator bacterium having a predetermined number of bacteria is directly applied to an object to be sterilized to prepare a measurement sample, and the sterilization ability of the sterilization apparatus is evaluated using the sample ( Hereinafter, it may be referred to as a direct application method.).
In the direct application method, after the measurement sample is sterilized by a sterilizer, the evaluation target site coated with the indicator bacterium is cut out from the measurement sample as an evaluation sample, and the cut out evaluation sample is collected in a culture medium to obtain an index. By culturing the bacteria, the sterilizing ability of the sterilizing apparatus can be evaluated.

Further, as an evaluation method, for example, a method using a biological indicator in which an indicator bacterium is supported on a base material is described in Patent Document 1.
In Patent Literature 1, after the biological indicator is sterilized by a high-pressure sterilizer while being sealed in a bag-like container made of, for example, a plastic film, the biological indicator sealed in the bag-like container is used as an evaluation sample in a culture medium. It is described that the sterilization ability of a sterilization apparatus is evaluated by collecting and culturing the indicator bacteria.

JP-A-4-365499

In recent years, the concept of validation has been incorporated into the production management of foods and the like, and it has been demanded that the sterilization effect of cold spots and the sterilization effect of each part of the packaging material be ascertained also regarding the sterilization treatment of packaging materials.
Therefore, for example, when the object to be sterilized is a packaging material or the like having a three-dimensional shape such as a PET bottle container, it is required to evaluate the sterilization state of various parts of the three-dimensional object to be sterilized. There is.
However, the biological indicator of Patent Literature 1 has a problem that it may be difficult to arrange the biological indicator depending on the evaluation target site. For example, if the evaluation target site is the bottom of the PET bottle container, it can be arranged, but if it is the side of the body, etc., the arrangement may be difficult.
In addition, in the direct application method, since it is usually necessary to form a measurement sample coated with the indicator bacterium for each evaluation target site, the number of measurement samples to be prepared, the number of measurement samples to be processed by a sterilization device, and the like. There is a problem that the number increases. In addition, the direct application method requires a complicated process of disassembling a large number of measurement samples and taking out the evaluation target site on which the indicator bacteria have been applied as an evaluation sample. Takes a long time.

  The present invention has been made in view of the above problems, and has as its main object to provide a biological indicator base material that can provide a biological indicator that can easily evaluate the sterilizing ability of a sterilizing apparatus.

  In order to achieve the above object, the present invention provides a substrate having a bacterial layer forming surface on which an indicator bacterium used for confirmation of a sterilization state is arranged, and a surface of the substrate opposite to the bacterial layer forming surface. And a double-sided pressure-sensitive adhesive layer formed on the substrate.

According to the present invention, for example, a biological layer having a bacterial layer containing an indicator bacterium by easily coating the indicator bacterium solution on the germ layer forming surface of the substrate included in the biological indicator substrate and drying the coating film. You can get an indicator.
In addition, the biological indicator thus obtained has a double-sided adhesive layer formed on the surface of the substrate opposite to the surface on which the bacterium layer is formed. A sample for measurement used for evaluating the sterilization ability of the sample can be easily prepared, and a sample obtained by removing a bacterial layer containing the indicator bacterium from the sample for measurement together with the base material can be used as a sample for evaluation.
Therefore, the biological indicator base material can provide a biological indicator that can easily evaluate the sterilizing ability of the sterilizing apparatus.

  In the present invention, the area in plan view of the base material is preferably smaller than the area in plan view of the double-sided pressure-sensitive adhesive layer. This is because the biological indicator base material can be easily handled by gripping an exposed portion that is not covered by the base material of the double-sided adhesive layer.

  The present invention has a substrate having a fungus layer forming surface on which the indicator bacteria used for confirmation of the sterilization state are arranged, and a double-sided adhesive layer formed on the surface of the base material opposite to the fungus layer forming surface. A microbial layer formed on the microbial layer-forming surface of the substrate, the microbial layer including the indicator bacterium.

According to the present invention, since the double-sided pressure-sensitive adhesive layer is formed on the surface of the substrate opposite to the surface on which the bacteria layer is formed, the biological indicator can be stuck to the object to be sterilized and easily sterilized by the sterilizing device. A measurement sample used for evaluation can be easily prepared, and a sample obtained by taking out a bacterial layer containing the indicator bacterium from the measurement sample together with the base material can be used as the evaluation sample.
Therefore, the biological indicator makes it easy to evaluate the sterilizing ability of the sterilizing device.

  The present invention provides a support unit having a support substrate, an adhesion layer formed on one surface of the support substrate, and a release layer formed on a surface of the adhesion layer opposite to the support substrate; A substrate for a biological indicator disposed on the surface of the, comprising a substrate having a bacterial layer-forming surface on which the indicator bacteria used for confirmation of the sterilization state, the substrate for the biological indicator, A double-sided pressure-sensitive adhesive layer formed on the surface of the substrate opposite to the bacterial layer-forming surface, and the double-sided pressure-sensitive adhesive layer is disposed on the surface of the support portion so as to be in contact with the release layer. A substrate storage for a biological indicator is provided.

According to the present invention, for example, an indicator bacterium solution is applied to the germ layer forming surface of the substrate included in the substrate storage body for a biological indicator, and the germ layer containing the indicator bacterium is easily obtained by drying the coating film. A biological indicator storage can be obtained.
In addition, by having the support portion, the biological indicator base material storage body can obtain a biological indicator storage body from which the biological indicator can be easily taken out.

  The present invention provides a support unit having a support substrate, an adhesion layer formed on one surface of the support substrate, and a release layer formed on a surface of the adhesion layer opposite to the support substrate; A biological indicator disposed on the surface of the, the biological indicator is a substrate having a fungus layer forming surface on which indicator bacteria used for confirmation of the sterilization state is disposed, and the bacteria of the substrate The double-sided pressure-sensitive adhesive layer formed on the surface opposite to the layer-forming surface, and a bacterial layer formed on the bacterial layer-forming surface of the base material and containing the indicator bacterium, wherein the double-sided pressure-sensitive adhesive layer is A biological indicator storage body is provided, which is disposed on a surface of the support section so as to be in contact with a release layer.

  According to the present invention, by having the support portion, the biological indicator storage body can easily take out the biological indicator.

  The present invention provides a support unit having a support substrate, an adhesion layer formed on one surface of the support substrate, and a release layer formed on a surface of the adhesion layer opposite to the support substrate; A first laminate preparation step of preparing a first laminate having a double-sided pressure-sensitive adhesive layer formed on the surface of the release layer included on the side opposite to the adhesion layer, and the first laminate preparation step Sterilization step of sterilizing the first laminate obtained by the above, and a second sterilization step of sterilizing a substrate having a fungus layer forming surface on which the indicator bacteria used for checking the sterilization state are arranged. And a laminating step of disposing the substrate on the surface of the double-sided pressure-sensitive adhesive layer included in the first laminate opposite to the release layer, wherein the laminating step includes the first sterilization. A bio-treatment performed after the treatment step and the second sterilization treatment step To provide a method of manufacturing a radical indicator for substrate storage body.

According to the present invention, by performing the lamination step after the first sterilization step and the second sterilization step, the method for manufacturing a base material storage body for a biological indicator includes, for example, Even if the base material does not transmit the effect of the sterilization treatment from the bacteria layer forming surface to the double-sided adhesive layer side surface of the material, etc., the double-sided adhesive layer side surface of the substrate and the substrate-side surface of the double-sided adhesive layer can be stably formed. Sterilizable.
For this reason, the said manufacturing method can obtain the base material storage body for biological indicators which can form the biological indicator storage body which can evaluate sterilization ability of a sterilization apparatus with high precision.

  The present invention provides a biological indicator base material storage body preparing step of forming a biological indicator base material storage body using the above-described biological indicator base material storage body manufacturing method, and the biological indicator base material. A fungus layer forming step of applying the indicator bacterium solution containing the indicator bacterium to the fungus layer forming surface of the base material included in the storage body to form a germ layer containing the indicator bacterium, The present invention provides a method for producing a biological indicator storage body.

  According to the present invention, by preparing a biological indicator base material storage body by the above-described method for manufacturing a biological indicator base material storage body, the manufacturing method enables highly accurate sterilization ability evaluation of a sterilization apparatus. A biological indicator storage body can be obtained.

  The present invention has a substrate having a fungus layer forming surface on which the indicator bacteria used for confirmation of the sterilization state are arranged, and a double-sided adhesive layer formed on the surface of the base material opposite to the fungus layer forming surface. A biologic indicator formed on the microbial layer-forming surface of the base material and containing the indicator bacterium, and having a biological indicator having a sterilizing device attached thereto, and a sterilizing device after the applying step. A sterilization step of sterilizing the object to be sterilized using, and after the sterilization step, an evaluation step of evaluating the sterilization state of the object to be sterilized by culturing the indicator bacteria contained in the biological indicator. A method for evaluating the sterilizing ability of a sterilizing apparatus is provided.

  According to the present invention, by using the above-described biological indicator, the method for evaluating the sterilizing ability of the sterilizing apparatus can easily evaluate the sterilizing ability of the sterilizing apparatus.

  ADVANTAGE OF THE INVENTION This invention produces the effect that the biological indicator base material which can obtain the biological indicator which can easily evaluate the sterilization ability of a sterilization apparatus can be provided.

It is a schematic plan view showing an example of the substrate for biological indicators of the present invention. FIG. 2 is a sectional view taken along line AA of FIG. 1. It is a schematic plan view showing an example of the biological indicator of the present invention. FIG. 4 is a sectional view taken along line BB of FIG. 3. It is a schematic plan view showing an example of a substrate storage object for a biological indicator of the present invention. FIG. 6 is a sectional view taken along line CC of FIG. 5. It is a schematic plan view showing an example of a biological indicator storage object of the present invention. FIG. 8 is a sectional view taken along line DD of FIG. 7. It is process drawing which shows an example of the manufacturing method of the base material storage body for biological indicators. It is a flowchart showing an example of a manufacturing method of a biological indicator storage object. It is a flowchart showing an example of a sterilization ability evaluation method of a sterilization device of the present invention. FIG. 3 is an explanatory diagram showing locations of indicator bacteria in Example 1 and Comparative Example 1.

The present invention provides a biological indicator base material and a biological indicator that can be manufactured using the same, a biological indicator base material storage body and a biological indicator storage body that can be manufactured using the same, and a method for manufacturing the same. And a method for evaluating the sterilizing ability of a sterilizing apparatus using a biological indicator.
Hereinafter, a substrate for a biological indicator, a biological indicator, a substrate storage for a biological indicator, a biological indicator storage, a method for manufacturing a substrate for a biological indicator, and a method for manufacturing a biological indicator storage of the present invention The method and the method for evaluating the sterilizing ability of the sterilizing apparatus will be described in detail.

A. First, the substrate for a biological indicator of the present invention will be described.
The substrate for a biological indicator of the present invention, a substrate having a bacterial layer-forming surface on which the indicator bacteria used for confirmation of the sterilization state are arranged, and a surface opposite to the bacterial layer-forming surface of the substrate. And a formed double-sided pressure-sensitive adhesive layer.

Such a base material for a biological indicator of the present invention will be described with reference to the drawings. FIG. 1 is a schematic plan view showing an example of the substrate for a biological indicator of the present invention, and FIG. 2 is a cross-sectional view taken along line AA of FIG.
As illustrated in FIGS. 1 and 2, a biological indicator base material 10 of the present invention includes a base material 1 having a fungus layer forming surface 1a on which an indicator bacterium used for confirming a sterilization state is placed, and And a double-sided pressure-sensitive adhesive layer 2 formed on the surface of the material 1 opposite to the bacterial layer-forming surface 1a.

According to the present invention, for example, a biological layer having a bacterial layer containing an indicator bacterium by easily coating the indicator bacterium solution on the germ layer forming surface of the substrate included in the biological indicator substrate and drying the coating film. You can get an indicator.
In addition, the biological indicator thus obtained has a double-sided adhesive layer formed on the surface of the substrate opposite to the surface on which the bacterium layer is formed. A sample for measurement used for evaluating the sterilization ability of the sample can be easily prepared, and a sample obtained by removing a bacterial layer containing the indicator bacterium from the sample for measurement together with the base material can be used as a sample for evaluation.

Here, as a method for evaluating the sterilization ability when the direct coating method is used, for example, when evaluating the sterilization state of the outer surface of a container such as a film or a PET bottle, microbial contamination occurs in the measurement sample after the sterilization treatment. The sample to be measured is collected, and the portion of the sample for measurement to which the indicator bacteria have been applied is cut out with sterilized scissors or a cutter knife to prepare a sample for evaluation. Thereafter, a sample for evaluation is attached to a petri dish and then overlaid with an agar medium, or the sample for evaluation is collected in a test tube with a screw hole, a conical flask into which a liquid medium is dispensed, and cultured for a predetermined period (evaluation). Method 1) is commonly used.
In addition, as a method of evaluating the sterilization ability when using the direct application method, for example, when evaluating the sterilization state of the inner surface of a container such as a flanged container, use the measurement sample as it is as an evaluation sample, Dispensing the liquid medium or agar medium directly into the sample container, and after dispensing, in order to prevent microbial contamination during culture, the container is sealed with a pre-sterilized lid using a tray sealer or the like, A method of culturing for a predetermined period (evaluation method 2) is generally used.

For this reason, for example, when a total of six evaluation target sites of the sterilization target are set and the sterilization performance is evaluated five times for each evaluation target site, the conventional direct application method disassemble the measurement sample. Since it is necessary to remove the evaluation sample or use the measurement sample itself as the evaluation sample, the sample for measurement is usually prepared by applying the indicator bacteria to only one evaluation target site for one sterilization target. Need to be prepared. Therefore, in the direct application method, it is necessary to prepare a total of 30 measurement samples and to perform a sterilization process (30 times in total) on the 30 measurement samples by a sterilization device.
On the other hand, the biological indicator of the present invention can be easily attached to a sterilization target using a double-sided adhesive layer, so that one sterilization target can be applied to all six evaluation sites at a time. A sample for measurement can be prepared by sticking. Thus, a sample for measurement can be easily prepared by using the biological indicator in the present invention.
In the method of evaluating sterilization ability using a biological indicator in the present invention (hereinafter, may be referred to as the present evaluation method), a total of five measurement samples are prepared, and a total of five measurement samples are prepared using a sterilization apparatus. By sterilizing the sample (total of 5 times), it is possible to evaluate the sterilizing ability in the same number as in the direct application method. Thus, the present evaluation method can reduce the evaluation time.

In addition, in the evaluation method 1 using the direct application method, it is necessary to cut out a portion of the measurement sample to which the indicator bacterium has been applied as an evaluation sample so that contamination does not occur, and a careful operation is required. .
On the other hand, in the present evaluation method, the evaluation sample can be easily prepared only by peeling the bacterial layer containing the indicator bacterium from the collected measurement sample together with the substrate as the evaluation sample. Can be shortened. As a result, the present evaluation method can shorten the evaluation time.

Furthermore, in the evaluation method 2 using the direct application method, it is necessary to prepare a lid material that has been sterilized in advance, and when sealing the lid material on the sample for evaluation, disinfect the trace sealer with alcohol or hypochlorous acid solution. It is necessary to sterilize and seal in a clean environment such as in a clean bench.
In contrast, in this evaluation method, the sterilized measurement sample was collected in a clean environment such as a clean bench, and the bacterial layer containing the indicator bacterium was peeled off from the collected measurement sample together with the substrate as an evaluation sample, The sterilization ability can be evaluated only by collecting the medium. Thus, the present evaluation method can reduce the evaluation time.

  For this reason, this evaluation method can greatly reduce the time required for sterilization ability evaluation and the number of required samples.

In addition, when bacteria and the like adhere to the evaluation target site of the sterilization target, the bacteria may be left without being sterilized even by the sterilization treatment by the sterilization device because the bacteria are covered by the biological indicator. Then, the biological indicator after the sterilization evaluation may be in a state where bacteria and the like adhere to the surface of the double-sided adhesive layer on the side of the sterilization target.
On the other hand, the biological indicator formed using the biological indicator base material of the present invention has a double-sided adhesive layer formed on the surface of the base material opposite to the surface on which the bacterial layer is formed. At the time of checking the state, the double-sided adhesive layer can be easily removed, and the influence of bacteria or the like derived from the surface of the object to be sterilized can be eliminated.

  Therefore, the biological indicator base material can provide a biological indicator that can easily evaluate the sterilizing ability of the sterilizing apparatus.

The substrate for a biological indicator of the present invention has a substrate and a double-sided pressure-sensitive adhesive layer.
Hereinafter, each component of the substrate for a biological indicator of the present invention will be described in detail.

1. Substrate The substrate in the present invention has a bacteria layer-forming surface on which indicator bacteria used for confirming the sterilization state are arranged.

Here, the bacterial layer forming surface on which the indicator bacteria are arranged refers to the surface on the side on which the bacterial layer containing the indicator bacteria is formed when forming the biological indicator.
The confirmation of the sterilization state means that the sterilization apparatus is used to evaluate the sterilization ability of the sterilization apparatus for the object to be sterilized.
The sterilization target is not particularly limited as long as sterilization is required, and examples thereof include food packaging materials, medicine packaging materials, cosmetic packaging materials, and the like. It is preferably a three-dimensional packaging material such as a PET bottle container, a cup container, a tray container, a paper pack, and a pouch with a spout. This is because the effect of the present invention that a biological indicator that can easily evaluate the sterilizing ability of the sterilizing apparatus can be obtained can be more effectively exhibited.

The constituent material of the base material is not particularly limited as long as it can stably support the indicator bacterium. For example, a paper base material, a resin base material, a metal base material, and an inorganic base material can be configured. Paper, resin materials, metal materials and inorganic materials.
As the paper constituting the paper base material, high-quality paper, coated paper, kraft paper, art paper, various types of paperboard, processed paper, synthetic paper, and the like can be used. Further, filter paper may be used as the paper base material.
Examples of the resin material constituting the resin base material include polyethylene terephthalate (PET), polystyrene (PS), polycarbonate (PC), TAC (triacetylcellulose), polyimide (PI), nylon (Ny), and low-density polyethylene ( LDPE), synthetic resin materials such as medium-density polyethylene (MDPE), vinyl chloride, vinylidene chloride, polyphenylene sulfide, polyether sulfone, acrylic materials such as polyethylene naphthalate, polypropylene and urethane acrylate; cellulose, polylactic acid, polyglycol Examples thereof include natural resin materials such as biodegradable polymers such as acids, polycaprolactans, and copolymers thereof.
The metal material constituting the metal substrate may be any material that can be molded into a desired shape, and examples thereof include aluminum and stainless steel. These metal materials are preferred because they are versatile and readily available.
Examples of the inorganic material constituting the inorganic base include glass.

  As the structure of the base material, a plate-shaped plate-shaped base material, a porous base material having a large number of pores, a nonwoven fabric base material obtained by laminating fibrous constituent materials, such as the paper base material, and the like. can do.

  In the present invention, when the indicator bacterium arranged on the base material is black koji mold (Aspergillus niger), the base material is preferably a nonwoven fabric base, and particularly preferably a paper base. Is preferred, and filter paper is preferred. This is because the base material is a nonwoven fabric base material such as a paper base material, so that the base material can stably hold mold, which is an indicator bacterium.

In the present invention, when the sterilization treatment of the sterilization apparatus to be evaluated is a chemical sterilization treatment using a hydrogen peroxide solution or the like, the base is preferably a metal base, an aluminum base or stainless steel. Preferably, it is a substrate. Since the base material is a metal base material, the base material is less adsorbed by the drug during the sterilization treatment by the sterilizer. For this reason, the biological indicator base material can provide a biological indicator with little effect on the indicator bacterium due to the drug remaining on the base material.
Therefore, the biological indicator base material can provide a biological indicator that enables highly accurate evaluation of the sterilization ability of the sterilizer.

  The thickness of the base material is not particularly limited as long as it can stably support the indicator bacterium, and can be, for example, in the range of 5 μm to 100 μm, and particularly, in the range of 7 μm to 20 μm. It is preferred that This is because when the thickness is within the above range, the substrate can be easily peeled off from the double-sided pressure-sensitive adhesive layer.

The shape of the base material in plan view is not particularly limited as long as it can stably support the indicator bacterium, and may be triangular, polygonal such as square, circular, elliptical, or the like. .
The area of the base material in plan view is not particularly limited as long as it can stably support the indicator bacterium, and is appropriately set according to the size of the object to be sterilized.
The plan view area, if sterilized object is a PET bottle, for ^example, may be in the range of 1 mm 2 100 mm ^2.
In the present invention, it is particularly preferable that the area in plan view of the base material is smaller than the area in plan view of the double-sided pressure-sensitive adhesive layer. The base material can be arranged so as to be included in the double-sided pressure-sensitive adhesive layer in plan view, and the biological indicator base material can be handled by grasping an exposed portion that is not covered by the base material of the double-sided pressure-sensitive adhesive layer. This is because it becomes easy.
Further, when a biological indicator storage body described later is formed using the biological indicator base material, a biological indicator storage body that allows easy removal of the biological indicator can be obtained.
1 and 2 already described, the substrate 1 is arranged such that the area in plan view is smaller than the area of the double-sided adhesive layer 2 in plan view, and the substrate is included in the double-sided adhesive layer 2 in plan view. This is an example.

2. Double-sided pressure-sensitive adhesive layer The double-sided pressure-sensitive adhesive layer in the present invention is formed on the surface of the substrate opposite to the surface on which the bacteria layer is formed.
The double-sided pressure-sensitive adhesive layer is capable of adhering the biological indicator to an object to be sterilized and removably adhering to a substrate.
Here, the term “formed on the surface” is not limited to the mode formed so as to be in direct contact with the surface, and includes the mode formed via another layer. It is formed so as to be in direct contact with.

Such a double-sided pressure-sensitive adhesive layer may have a single-layer structure consisting of only a pressure-sensitive adhesive layer. However, usually, as in a general double-sided pressure-sensitive adhesive tape, a support and two layers disposed on both sides of the support are used. A laminated structure having a layer of a pressure-sensitive adhesive layer is used.
FIG. 2 described above shows an example in which the double-sided pressure-sensitive adhesive layer 2 has a laminated structure having a support 2a and two pressure-sensitive adhesive layers (2b1 and 2b2) arranged on both sides of the support 2a. It is shown.

The constituent material and structure of the support are not particularly limited as long as they can be stably bonded to the pressure-sensitive adhesive layer, and are the same as, for example, the contents of the base material described in the section “1. be able to.
In the present invention, when the sterilization treatment of the sterilization apparatus to be evaluated is a chemical sterilization treatment using a hydrogen peroxide solution or the like, the support is preferably a nonwoven fabric substrate, among which a paper substrate It is preferred that When the support is a non-woven fabric base such as a paper base, the support can easily adsorb the drug during sterilization by a sterilizer. For this reason, even when the double-sided adhesive layer comes into contact with fungi adhered to the surface of the object to be sterilized, the fungi can be sterilized and eliminated. As a result, when evaluating the sterilization state, even if the indicator bacteria are cultured in a state in which the double-sided adhesive layer is included in the evaluation sample, the double-sided adhesive layer is affected by bacteria and the like derived from the surface of the object to be sterilized. Can be eliminated.

  The thickness of the support is not particularly limited as long as it can be stably bonded to the pressure-sensitive adhesive layer. .

The pressure-sensitive adhesive constituting the pressure-sensitive adhesive layer is a pressure-sensitive adhesive that can form a pressure-sensitive adhesive layer on which a biological indicator can be attached to an object to be sterilized and that can be removably adhered to a substrate. It is not particularly limited.
Examples of the pressure-sensitive adhesive include a rubber-based pressure-sensitive adhesive mainly containing a synthetic rubber such as natural rubber, butadiene-styrene rubber, and acrylic rubber; an acrylic pressure-sensitive adhesive mainly containing acrylic acid and butyl acrylate; General adhesives such as fluorine-based adhesives can be used.
The pressure-sensitive adhesive may contain additives such as a tackifier, a softener, and an antioxidant, if necessary.
When the double-sided pressure-sensitive adhesive layer has a laminated structure, the pressure-sensitive adhesive may be the same as the pressure-sensitive adhesive layer on the base material side and may be the same as the pressure-sensitive adhesive layer on the sterilization target side.

The thickness of the pressure-sensitive adhesive layer is not particularly limited as long as the desired double-sided adhesiveness can be exhibited.
When the double-sided pressure-sensitive adhesive layer has a laminated structure, the thickness can be in the range of 1 μm to 500 μm for each of the pressure-sensitive adhesive layers on the substrate side and the sterilization target side.
When the double-sided pressure-sensitive adhesive layer has a laminated structure, the thickness may be the same for the pressure-sensitive adhesive layer on the substrate side and the pressure-sensitive adhesive layer on the sterilization target side, or may be different.

The degree of adhesion of the pressure-sensitive adhesive layer to the base material can be appropriately adjusted from the viewpoint of the ease of adhesion of the biological indicator to the object to be sterilized, the removability from the base material, and the like.
The adhesiveness of the pressure-sensitive adhesive layer to the substrate can be made weakly adhesive to the substrate, for example, from the viewpoint of ease of re-peeling. On the other hand, the adhesiveness is, for example, from the viewpoint of preventing the base material from falling off from the adhesive layer of the base material when the sterilization treatment by the sterilizing device is a high-temperature hot air treatment, for example, even if the base material has strong adhesiveness. Good.
When the double-sided pressure-sensitive adhesive layer has a laminated structure, the pressure-sensitive adhesive properties of the pressure-sensitive adhesive layer on the base material side and the pressure-sensitive adhesive layer on the sterilization target side may be the same or different.

The method for forming the pressure-sensitive adhesive layer may be any method capable of forming a pressure-sensitive adhesive layer having a desired thickness, for example, by applying a pressure-sensitive adhesive coating liquid obtained by dispersing or dissolving a pressure-sensitive adhesive in a solvent. And a method of drying and removing a solvent from the obtained coating film.
As the coating method, for example, a known coating method such as a blade coating method or a gravure coating method can be used.

  As the double-sided pressure-sensitive adhesive layer having a laminated structure, a commercially available double-sided pressure-sensitive adhesive tape can be used. Examples of the double-sided pressure-sensitive adhesive tape that can be used as the double-sided pressure-sensitive adhesive layer include Nystank Rimuka (registered trademark) manufactured by Nichiban and Scotch (registered trademark) manufactured by 3M.

The plan view shape of the double-sided pressure-sensitive adhesive layer may be any shape that can stably support the base material, and may be the same as the plan view shape of the base material described in the above section “1. it can.
The area in plan view of the double-sided pressure-sensitive adhesive layer is not particularly limited as long as it can stably support the base material, and is appropriately set according to the size of the object to be sterilized.
The plan view area, if sterilized object is a PET bottle, for ^example, may be in the range of 10 mm 2 100 mm ^2.

3. Substrate for Biological Indicator The substrate for a biological indicator of the present invention has the above-mentioned substrate and the above-mentioned double-sided pressure-sensitive adhesive layer, but may have another configuration as necessary.

As the adhesion state of the bacteria of each component of the biological indicator substrate, the double-sided adhesive layer side surface of the substrate and the substrate-side surface of the double-sided adhesive layer are preferably in an aseptic state, among which the double-sided adhesive layer It is preferable that the surface of the object to be sterilized is also in a sterile state, and it is particularly preferable that all surfaces of all components of the biological indicator substrate are in a sterile state. These surfaces may be covered surfaces that are covered by another configuration when the measurement sample is formed, and may be exposed surfaces that are not covered by the other configuration when the evaluation sample is formed. For this reason, there is a possibility that bacteria adhering to the surface serving as the coating surface during the formation of the measurement sample will remain unsterilized even if they are subjected to a sterilization treatment by a sterilizer. When the surface in which such bacteria remain becomes an exposed surface when the surface becomes an evaluation sample, due to the influence of the bacteria on the exposed surface, it is not possible to accurately evaluate the sterilizing ability of the sterilizer. Because there is.
In addition, regarding the state of adherence of bacteria, for example, the surface to be checked for the state of adherence of bacteria is scraped off from each component, and as a sample for confirmation, when cultured for a predetermined period, the occurrence of bacteria in the culture medium is visually observed. When it is not seen, it is aseptic and it can be determined that it is sterilized.
As a determination of the aseptic state, for example, the above-described sample for confirmation was collected in a tryptic soy broth liquid medium, and cultured at 37 ° C. for 7 days under visual conditions. When no occurrence is observed, it can be determined that the condition is aseptic.
As the tryptic soy broth medium, those commonly used for cell culture can be used, and for example, those manufactured by Eiken Chemical Co., Ltd. can be used.

As a method for producing the base material for a biological indicator of the present invention, any method can be used as long as the above-described components can be accurately laminated, and a known lamination method can be used. Examples of the production method include a method of preparing a double-sided pressure-sensitive adhesive layer and then laminating the substrate on the double-sided pressure-sensitive adhesive layer using a gripping means such as tweezers.
The above-mentioned manufacturing method may have a sterilization treatment step for making the surface of each component of the biological indicator base material aseptic as required.
As the sterilization treatment in the sterilization treatment step, known sterilization treatments can be used, for example, radiation sterilization treatments such as γ-ray irradiation treatment, ultraviolet irradiation treatment, electron beam treatment; ethylene oxide gas treatment, hydrogen peroxide treatment, etc. Heat sterilization such as dry heat sterilization and steam sterilization;
As the hydrogen peroxide treatment, a treatment of dipping in a hydrogen peroxide solution, a treatment of spraying a hydrogen peroxide gas, and a treatment of spraying a hydrogen peroxide solution can be used.
The above-mentioned chemical sterilization treatment may include a drying treatment such as hot-air drying if necessary.
In addition, as a sterilization method in the sterilization process, any method can be used as long as the number of bacteria adhering to the surface can be reduced and a sterile state can be obtained. Each component such as may be a method of sterilizing treatment before forming the biological indicator base material, in a state where the biological indicator base material is formed, that is, sterilizing treatment in a state in which the above-described components are stacked. It may be a method.

  The use of the biological indicator base material is used for a biological indicator used to evaluate the sterilizing effect of a sterilizing device on a sterilization target, among others, evaluation of the sterilizing ability of a sterilizing device for a three-dimensional packaging material It is preferably used for.

B. Next, the biological indicator of the present invention will be described.
The biological indicator of the present invention has a substrate having a fungus layer forming surface on which indicator bacteria used for confirmation of a sterilization state are arranged, and is formed on the surface of the above substrate opposite to the fungus layer forming surface. It is characterized by having a double-sided adhesive layer and a bacterial layer formed on the bacterial layer-forming surface of the substrate and containing the indicator bacteria.

Such a biological indicator of the present invention will be described with reference to the drawings. FIG. 3 is a schematic plan view showing an example of the biological indicator of the present invention, and FIG. 4 is a sectional view taken along line BB of FIG.
As illustrated in FIGS. 3 and 4, the biological indicator 20 of the present invention includes a substrate 1 having a fungus layer forming surface on which an indicator bacterium used for confirming a sterilization state is disposed, It has a double-sided adhesive layer 2 formed on the surface opposite to the bacteria layer forming surface 1a, and a bacteria layer 3 formed on the bacteria layer forming surface 1a of the substrate 1 and containing the indicator bacteria. is there.

According to the present invention, since the double-sided pressure-sensitive adhesive layer is formed on the surface of the substrate opposite to the surface on which the bacteria layer is formed, the biological indicator can be stuck to the object to be sterilized and easily sterilized by the sterilizing device. A measurement sample used for evaluation can be easily prepared, and a sample obtained by taking out a bacterial layer containing the indicator bacterium from the measurement sample together with the base material can be used as the evaluation sample.
Therefore, the biological indicator makes it easy to evaluate the sterilizing ability of the sterilizing device.

The biological indicator of the present invention has a base material, a double-sided adhesive layer, and a bacterial layer.
Hereinafter, each component of the biological indicator of the present invention will be described in detail.
The base material and the double-sided pressure-sensitive adhesive layer can be the same as those described in the section “A. Base Material for Biological Indicators”, and thus the description thereof is omitted.

1. Bacterial layer The bacterial layer in the present invention is formed on the surface of the substrate on which the bacterial layer is formed, and contains an indicator bacterium used for confirming the sterilization state.
Here, being formed on the fungal layer forming surface of the base material is not limited to an embodiment formed so as to be in direct contact with the fungal layer forming surface, and other layers may be provided between the fungal layer forming surface and the fungal layer. Although it includes an embodiment formed via a substrate, it is usually formed so as to be in direct contact with the bacterial layer-forming surface of the substrate.
The bacterial layer is usually formed so as to be exposed on the outermost surface of the biological indicator.

The indicator bacterium is used for confirming the sterilization state, and can be appropriately selected according to the type of sterilization treatment of the sterilization apparatus to be evaluated, the use of the sterilization target, and the like. As the indicator bacteria, for example, spores such as Bacillus and Clostridium, and fungi such as mold can be used.
More specifically, when the sterilization treatment is a heat sterilization treatment such as a dry heat sterilization treatment, Geobacillus stearothermophilus, Bacillus atrophaeus, or the like can be used as an indicator spore bacterium.
When the sterilization treatment is a chemical sterilization treatment using a hydrogen peroxide solution or the like, as the spore bacterium as the indicator bacterium, Geobacillus stearothermophilus, Bacillus atrophaeus, or the like can be used.
Further, when the sterilization treatment is a radiation sterilization treatment, Bacillus pumilus or the like can be used as the spore bacterium as the indicator bacterium.

  The bacterial layer contains the indicator bacterium, but may also contain other saccharides, skim milk, sodium glutamate, serum, dextrin, and other dry protective agents, if necessary.

The method for forming the bacterial layer may be any method capable of forming a bacterial layer containing the indicator bacterium in a predetermined amount, for example, preparing an indicator germ solution containing the indicator bacterium, and then applying the indicator germ solution. A method of forming a bacterial layer containing the indicator bacterium can be exemplified.
Examples of the method for preparing the indicator bacterial solution include a method of culturing the indicator bacteria, collecting the bacteria, and then suspending the dispersion in a dispersion medium such as water to which a dry protective agent has been added, if necessary, to prepare an indicator bacterial solution. be able to.
As a method of applying the indicator bacterial solution to form a bacterial layer, the above-described bacterial layer forming surface of the base material is coated with the indicator bacterial solution to form a coating of the indicator bacterial solution, and then the coating is dried. Methods can be mentioned.
As an application method of the indicator bacterium solution, there can be mentioned a method in which an indicator germ solution of an amount containing a predetermined number of bacteria is dropped on a base material using a dropper or the like.
Examples of the drying method include drying under normal temperature and normal pressure and freeze drying.

2. Biological Indicator The biological indicator of the present invention has a base material, a double-sided adhesive layer, and a bacterial layer, but may have another configuration as necessary.
Such other configurations can be the same as the biological indicator base material described in the section “A. Biological Indicator Base Material” above.

The attached state of the bacteria of each component other than the bacterial layer of the biological indicator can be the same as the content described in the above section “A. Substrate for biological indicator”.
The adhesion state of the bacteria on the surface of the substrate on which the bacteria layer is formed does not include the adhesion of the bacteria derived from the bacteria layer.

The method for producing the biological indicator of the present invention is not particularly limited as long as the above-described components can be laminated with high accuracy. For example, the substrate for a biological indicator described in the section “A. And then a method of forming a bacterial layer on the bacterial layer-forming surface of the substrate included in the biological indicator substrate can be used.
The above-mentioned production method may have a sterilization treatment step for making the surface of each component other than the above-mentioned bacterial layer aseptic, if necessary. The disinfection treatment and disinfection method in such a disinfection treatment step can be the same as those described in the above section “A. Substrate for biological indicator”.

C. Next, the base material storage body for a biological indicator of the present invention will be described.
The substrate storage body for a biological indicator of the present invention includes a support substrate, an adhesion layer formed on one surface of the support substrate, and a release layer formed on a surface of the adhesion layer opposite to the support substrate. And a biological indicator base material disposed on the surface of the support portion, wherein the biological indicator base material is a bacterium on which an indicator bacterium used for confirmation of a sterilization state is disposed. A substrate having a layer-forming surface and a double-sided pressure-sensitive adhesive layer formed on the surface of the substrate opposite to the bacterial layer-forming surface, so that the double-sided pressure-sensitive adhesive layer is in contact with the release layer. It is characterized by being arranged on the surface of the support.

Such a base material storage body for a biological indicator of the present invention will be described with reference to the drawings. FIG. 5 is a schematic plan view showing one example of the substrate storage body for a biological indicator of the present invention, and FIG. 6 is a cross-sectional view taken along line CC of FIG. As illustrated in FIGS. 5 and 6, the base material storage body 30 for a biological indicator of the present invention includes a support substrate 31a, an adhesion layer 31b formed on one surface of the support substrate 31a, and an adhesion layer 31b. A support portion 31 having a release layer 31c formed on a surface opposite to the support substrate 31a, and a biological indicator base material 10 disposed on a surface of the support portion 31; The base material 10 for a logical indicator includes a base material 1 having a fungus layer forming surface 1a on which an indicator bacterium used for checking a sterilization state is arranged, and a surface of the base material 1 opposite to the fungus layer forming surface 1a. And a double-sided pressure-sensitive adhesive layer 2 formed on the support portion 31 so that the double-sided pressure-sensitive adhesive layer 2 is in contact with the release layer 31c.
Further, in this example, an example is shown in which the biological indicator base material storage body 30 has a lid portion 32 formed so as to cover the entire surface of the biological indicator base material 10. FIG. 5 omits the illustration of the lid 32 for ease of explanation.

  According to the present invention, by having the support portion, the biological indicator base material storage body can obtain a biological indicator storage body from which the biological indicator can be easily taken out.

The biological indicator base material storage body of the present invention has a support portion and a biological indicator base material.
Hereinafter, each configuration of the base material storage body for a biological indicator of the present invention will be described in detail.

1. Substrate for biological indicator The substrate for biological indicator in the present invention, a substrate having a bacteria layer forming surface on which the indicator bacteria used for confirmation of the sterilization state are arranged, and the bacteria layer forming surface of the substrate Has a double-sided pressure-sensitive adhesive layer formed on the opposite surface.
In addition, the base material for a biological indicator is disposed on the surface of the support portion such that the double-sided pressure-sensitive adhesive layer is in contact with the release layer.
The base material for the biological indicator can be the same as the content described in the above section “A. Base Material for Biological Indicator”, and the description is omitted here.

The number of the biological indicator substrates disposed on the support portion may be one or more, and is preferably two or more.
5 and 6 already described show examples in which the number of arrangements is two or more.

When the number of the biological indicator base materials arranged on the support portion is two or more, the adjacent biological indicator base materials may be arranged so as to be in contact with each other, and are arranged apart from each other. May be used.
Further, when the adjacent biological indicator base materials are arranged so as to be in contact with each other, the adjacent biological indicator base materials may be continuously connected and integrally formed. However, it is preferable that both are formed as separate bodies separated by forming a cut portion between them. The reason is that the biological indicator base material storage body can easily take out each of the biological indicator base materials one by one.
Note that FIGS. 5 and 6 described above show an example in which the number of arrangements is two or more, and the notch 33 is formed between the adjacent biological indicator base materials 10 so that both of them are formed. It shows an example formed as a separate body.

2. Supporting part The supporting part in the present invention includes a supporting substrate, an adhesive layer formed on one surface of the supporting substrate, and a release layer formed on a surface of the adhesive layer opposite to the supporting substrate. is there.

(1) Support substrate The support substrate supports the base material for a biological indicator.

As a constituent material of such a support substrate, a support substrate having a desired strength can be formed, and examples thereof include a resin material and an inorganic material.
The resin material and the inorganic material can be the same as those described in the section “A. Base Material for Biological Indicators”, and thus description thereof is omitted.
In addition, the structure of the support substrate may be any shape as long as a support substrate having a desired strength can be formed. For example, the structure of the support substrate may be the same as the structure of the base material described in the section “A. Base Material for Biological Indicator”. Therefore, the description is omitted here.

  The thickness of the support substrate may be any thickness as long as it can stably support the biological indicator base material, and may be in the range of 100 μm to 3000 μm.

The shape of the support substrate in plan view may be any shape as long as it can stably support the base material for a biological indicator, and may be, for example, a square shape, a circular shape, or the like.
FIG. 5 described above shows an example in which the planar shape of the support substrate 31a is a quadrangle.

The shape of the support substrate may be a flat plate shape, a container shape having a bottom surface and side surfaces, and the like.
5 and 6 already described show an example in which the shape of the support substrate 31a is a container shape having a bottom surface and side surfaces.

  As the support substrate, a round or square petri dish used for cell culture or the like of a commercial product may be used. Further, a lid attached to the petri dish may be used as a lid described later.

(2) Adhesion layer The adhesion layer is formed on one surface of the support substrate.
The adhesion layer makes the support substrate and the release layer adhere to each other, and maintains the state in which the support substrate and the release layer are in close contact with each other when the biological indicator is separated from the support portion and taken out. That is, the adhesion layer generally has higher adhesion to the support substrate and the release layer than the adhesion of the double-sided adhesive layer included in the biological indicator base material to the release layer.
The adhesion layer is usually formed so as to be in direct contact with both the support substrate and the release layer.

The adhesion layer can be a pressure-sensitive adhesive layer or an adhesive layer, and can be appropriately selected according to the material of a release layer described below.
The pressure-sensitive adhesive constituting the pressure-sensitive adhesive layer may be, for example, the same as the pressure-sensitive adhesive described in the section “2. Double-sided pressure-sensitive adhesive layer” in the above-mentioned “A.
Examples of the adhesive constituting the adhesive layer include a heat-sensitive adhesive which melts or softens when heated and exhibits an adhesive effect.
In addition, as the adhesive, a known adhesive such as a two-component curable adhesive such as a two-component curable urethane-based adhesive, an ultraviolet curable adhesive, and a thermosetting adhesive can be used.
Examples of the heat-sensitive adhesive include polyethylene, ethylene-α-olefin copolymer, polypropylene, polybutene, polyisobutene, polyisobutylene, polybutadiene, polyisoprene, ethylene-methacrylic acid copolymer, and ethylene-acrylic acid copolymer. A thermoplastic resin such as a copolymer of ethylene and an unsaturated carboxylic acid, or an acid-modified polyolefin-based resin obtained by modifying them, an ethylene-ethyl acrylate copolymer, an ionomer resin, and an ethylene-vinyl acetate copolymer. Can be used.

More specifically, when the release layer contains a fluorine-based resin such as ethylene tetrafluoride resin (PTFE), an adhesive layer can be used as the adhesive layer.
The pressure-sensitive adhesive constituting the pressure-sensitive adhesive layer can be the same as the pressure-sensitive adhesive used for a commercially available fluorine-based resin tape using a support containing a fluorine-based resin. Specific examples of the pressure-sensitive adhesive include a silicon-based pressure-sensitive adhesive and a rubber-based pressure-sensitive adhesive.

The thickness of the adhesion layer is not particularly limited as long as desired adhesion can be obtained, and is appropriately set according to the types of the release layer and the support substrate.
Specifically, the thickness can be the same as the thickness of the pressure-sensitive adhesive layer described in the section “2. Double-sided pressure-sensitive adhesive layer” in the above-mentioned “A.

The method for forming the adhesion layer may be any method that can form an adhesion layer that can stably adhere the release layer and the support substrate.
The method for forming the pressure-sensitive adhesive layer may be the same as the method for forming the pressure-sensitive adhesive layer described in the section “A. Base Material for Biological Indicator”.

As the adhesion layer, a commercially available release adhesive tape may be used as a laminate laminated on the surface of the release layer.
Examples of the release adhesive tape that can be used as a laminate in which the adhesion layer and the release layer are laminated include, for example, NITOFLON (registered trademark) manufactured by Nitto Denko Corporation and Chuko Flow (registered trademark) manufactured by Chuko Kasei Kogyo Co., Ltd. Can be mentioned.

(3) Release Layer The release layer is formed on the surface of the adhesion layer opposite to the support substrate.
The release layer has easy releasability from the double-sided adhesive layer included in the biological indicator when removing the biological indicator from the biological indicator storage body. That is, the release layer usually has lower adhesion to the double-sided pressure-sensitive adhesive layer than the substrate included in the biological indicator substrate.

As a constituent material of such a release layer, a material containing a conventionally known resin material having excellent releasability can be used.
Examples of the resin material include waxes; silicone resins such as silicone wax, silicone resin, and silicone-modified resin; fluorine-based resins such as fluororesin and fluorine-modified resin; polyvinyl alcohol, acrylic resin, and acryl-styrene-based resin; Thermally crosslinkable epoxy-amino resins and thermally crosslinkable alkyd-amino resins, and the like. These resin materials can be used alone or as a mixture.
In the present invention, the resin material is preferably a fluororesin. This is because a fluorine-based resin can easily form a release layer having excellent release properties.

  The constituent material may include additives such as a filler, a cross-linking agent, and a catalyst as necessary, in addition to the resin material.

The thickness of the release layer is not particularly limited as long as a desired release property can be obtained from the double-sided pressure-sensitive adhesive layer, and is appropriately set according to the type of the double-sided pressure-sensitive adhesive layer.
As the thickness, for example, it may be about in the range of 0.5g ^{/ m 2} ~5g ^/ m 2 as a weight per unit area of the dry basis.
The area of the release layer in plan view may be any area as long as it overlaps at least the entire surface of the double-sided pressure-sensitive adhesive layer in plan view, and is appropriately set according to the shape of the double-sided pressure-sensitive adhesive layer in plan view.

  The method for forming the release layer may be any method capable of forming a release layer having a desired thickness. For example, the method for forming a pressure-sensitive adhesive layer described in the above section “A. Base for biological indicator”. Can be the same as

(4) Support Section The support section has a support substrate, an adhesion layer, and a release layer, but may have another configuration as necessary.

3. Biological Indicator Substrate Storage Body The biological indicator base material storage body of the present invention has a support portion and a biological indicator base material, but has another configuration as necessary. Is also good.
As another configuration described above, a lid portion formed so as to cover the base material for a biological indicator can be mentioned. By having the lid, the biological indicator base material storage body can prevent contamination.

As the shape of the lid, any shape may be used as long as it can cover the upper surface of the biological indicator base material and can be reclosed, but the support portion and the lid surround the entire periphery of the biological indicator base material. It is preferably a shape that can be used. The shape may be, for example, a flat plate shape, a cap shape having an upper surface and side surfaces, and the like.
In FIG. 6, which has already been described, the shape of the lid 32 is a cap shape, and the shape of the lid 32 surrounds the entire periphery of the biological indicator base material 10 with the support 31 and the lid 32. It shows an example of a possible shape.
The constituent material, structure and thickness of the lid can be the same as those of the support substrate.

The state of adhesion of the bacteria to the biological indicator base material storage body can be the same as the content described in the above section “A. Biological Indicator Base Material”.
In the present invention, it is particularly preferable that all surfaces of all components of the biological indicator base material storage body are in a sterile state.
In addition, about the manufacturing method of such a base material storage body for biological indicators, the below-mentioned "E. Manufacturing method of the base material storage body for biological indicators" can be preferably used.

D. Biological Indicator Storage Next, the biological indicator storage of the present invention will be described.
The biological indicator storage body of the present invention is a support having a support substrate, an adhesion layer formed on one surface of the support substrate, and a release layer formed on a surface of the adhesion layer opposite to the support substrate. Part, having a biological indicator disposed on the surface of the support portion, the biological indicator, a substrate having a fungus layer forming surface on which indicator bacteria used for confirmation of the sterilization state is disposed, A double-sided pressure-sensitive adhesive layer formed on the surface opposite to the bacterial layer-forming surface of the substrate, and a bacterial layer formed on the bacterial layer-forming surface of the substrate and containing the indicator bacterium, The double-sided pressure-sensitive adhesive layer is disposed on the surface of the support portion so as to be in contact with the release layer.

  Such a biological indicator storage body of the present invention will be described with reference to the drawings. FIG. 7 is a schematic sectional view showing an example of the biological indicator storage body of the present invention, and FIG. 8 is a sectional view taken along line DD of FIG. As illustrated in FIGS. 7 and 8, the biological indicator storage body 40 of the present invention includes a support substrate 31a, an adhesion layer 31b formed on one surface of the support substrate 31a, and the support substrate 31a of the adhesion layer 31b. A support portion 31 having a release layer 31c formed on the surface on the side opposite to the support portion, and a biological indicator 20 disposed on the surface of the support portion 31. The biological indicator 20 is in a sterilized state. A substrate 1 having a bacterial layer forming surface 1a on which an indicator bacterium to be used for confirmation is placed, and a double-sided adhesive layer 2 formed on a surface of the substrate 1 opposite to the bacterial layer forming surface 1a; A microbial layer 3 formed on the microbial layer forming surface 1a of the base material 1 and containing the indicator bacterium, and the surface of the support portion 31 such that the double-sided adhesive layer 2 is in contact with the release layer 31c. Placed in Is shall.

  According to the present invention, by having the support portion, the biological indicator storage body can easily take out the biological indicator.

  The biological indicator base material storage body of the present invention has a support portion and a biological indicator base material.

The biological indicator according to the present invention can be the same as the content described in the above section “B. Biological Indicator”, and the description thereof is omitted here.
Regarding the number of notches and the number of cuts on the surface of the support portion of the biological indicator, the contents described in the section “1. Base Material for Biological Indicator” in “C. Can be the same as

  The support portion in the present invention can be the same as the content described in the section of “C. Substrate storage body for biological indicator”, and thus the description thereof is omitted.

In addition, the base material storage body for a biological indicator has a support part and a base material for a biological indicator, but may have another configuration as necessary.
Such other configurations can be the same as the contents described in the section of “C. Substrate storage body for biological indicator”, and thus description thereof will be omitted.

The attached state of the bacteria of each component other than the bacterial layer of the biological indicator storage body can be the same as the content described in the above section “C. Biological indicator substrate storage body”.
In the present invention, it is particularly preferable that all surfaces of all components other than the bacterial layer of the biological indicator storage body are in a sterile state.
In addition, about the manufacturing method of such a biological indicator storage body, the below-mentioned "F. Manufacturing method of a biological indicator storage body" can be preferably used.

E. FIG. Next, a method of manufacturing the base material storage body for a biological indicator of the present invention will be described.
The method for manufacturing a substrate storage body for a biological indicator of the present invention includes a support substrate, an adhesion layer formed on one surface of the support substrate, and an adhesion layer formed on a surface of the adhesion layer opposite to the support substrate. First lamination for preparing a first laminate having a support having a release layer and a double-sided pressure-sensitive adhesive layer formed on a surface of the release layer included in the support opposite to the adhesive layer A body preparation step, a first sterilization treatment step of sterilizing the first laminate obtained in the first laminate preparation step, and a fungus layer forming surface on which the indicator bacteria used for checking the sterilization state are arranged. A second disinfection treatment step of disinfecting the base material having, and a lamination step of disposing the base material on the surface of the double-sided adhesive layer included in the first laminate opposite to the release layer, And the laminating step includes the first sterilizing step and the It is characterized in that performed after 2 sterilization process.

The method for manufacturing the base material storage body for a biological indicator of the present invention will be described with reference to the drawings. FIG. 9 is a process chart showing an example of a method for producing a base material storage body for a biological indicator of the present invention. As illustrated in FIG. 9, the method for manufacturing a base material storage body for a biological indicator of the present invention includes a support substrate 31 a, an adhesion layer 31 b formed on one surface of the support substrate 31 a, A support portion 31 having a release layer 31c formed on the surface opposite to the support substrate 31a, and both surfaces formed on the surface of the support portion 31 opposite to the adhesion layer 31b of the release layer 31c. A first laminate having an adhesive layer 2 is prepared (FIG. 9 (a)), and the first laminate is sterilized (FIG. 9 (b)), and an indicator bacterium used for confirming the sterilization state is arranged. The base material 1 having the fungus layer forming surface to be sterilized is treated (FIG. 9C), and the base material 1 is opposite to the release layer 31c of the double-sided adhesive layer 2 included in the first laminate. It is a method of arranging it on the side surface.
9A to 9D show a first laminated body preparing step, a first sterilizing step, a second sterilizing step, and a laminating step, respectively.
In this example, the sterilization process in the first sterilization process and the second sterilization process is an example of hydrogen peroxide sterilization that supplies ethylene oxide gas g to the first laminate and the substrate 1. .

According to the present invention, by performing the lamination step after the first sterilization step and the second sterilization step, the method for manufacturing a base material storage body for a biological indicator includes, for example, Even if the base material does not transmit the effect of the sterilization treatment from the bacteria layer forming surface to the double-sided adhesive layer side surface of the material, etc., the double-sided adhesive layer side surface of the substrate and the substrate-side surface of the double-sided adhesive layer can be stably formed. Sterilizable.
For this reason, the said manufacturing method can obtain the base material storage body for biological indicators which can form the biological indicator storage body which can evaluate sterilization ability of a sterilization apparatus with high precision.

The method for producing a base material storage body for a biological indicator of the present invention includes a first laminate preparation step, a first sterilization treatment step, a second sterilization treatment step, and a lamination step.
Hereinafter, each step of the method for producing a substrate storage body for a biological indicator of the present invention will be described in detail.

1. First Laminate Preparing Step The first laminating body preparing step in the present invention is formed on a support substrate, an adhesion layer formed on one surface of the support substrate, and a surface of the adhesion layer opposite to the support substrate. A step of preparing a first laminate having a support having a release layer, and a double-sided adhesive layer formed on a surface of the release layer included in the support opposite to the adhesive layer. is there.

  As a method of laminating the support portion and the double-sided pressure-sensitive adhesive layer in this step, any method may be used as long as both can be laminated in a desired positional relationship.First, the support portion is prepared, and then, on the surface of the release layer of the support portion, A method of laminating a separately prepared double-sided pressure-sensitive adhesive layer can be used.

  Since the support portion and the double-sided pressure-sensitive adhesive layer used in this step can be the same as those described in the above section “C. Substrate storage body for biological indicator”, description thereof will be omitted.

2. First sterilization step and second sterilization step The first sterilization step in the present invention is a step of sterilizing the first laminate obtained in the first laminate preparation step.
The second sterilization step is a step of sterilizing a substrate having a bacterial layer-forming surface on which indicator bacteria used for checking the sterilization state are arranged.
As such a sterilization treatment for the first laminate and the base material, a known sterilization treatment can be used. As the sterilization treatment, for example, the sterilization treatment described in the above section “A. Substrate for biological indicator” can be used.
In this step, it is particularly preferable that the sterilization treatment is a radiation sterilization treatment or a chemical sterilization treatment. These sterilization treatments are treatments in which the effect of the sterilization treatment is hardly transmitted from the surface on which the bacterial layer is formed to the surface on the double-sided adhesive layer side when the substrate is a metal substrate or the like. Therefore, the effects of the present invention can be more effectively exhibited.

The base material used in this step can be the same as the content described in the above section “A. Base Material for Biological Indicator”.
In this step, among others, the base is preferably a metal base or an inorganic base, and more preferably a metal base. When these substrates are laminated on the surface of the first laminate, the sterilization treatment hardly permeates to the first laminate side surface of the substrate. Therefore, the above-mentioned substrate can more effectively exhibit the effect of the present invention that the surface of the substrate on both sides of the double-sided adhesive layer and the surface of the double-sided adhesive layer on the side of the substrate can be stably sterilized.

3. Laminating Step The laminating step in the present invention is a step of arranging the base material on the surface of the double-sided pressure-sensitive adhesive layer included in the first laminate opposite to the release layer.
The laminating step is performed after the first sterilizing step and the second sterilizing step.

  The method of arranging the base material in this step on the surface of the double-sided pressure-sensitive adhesive layer included in the first laminate opposite to the surface of the release layer may be such that both can be laminated in a desired positional relationship. It is sufficient that a first laminate is prepared first, and then the above-mentioned base material is laminated on the surface of the double-sided pressure-sensitive adhesive layer of the first laminate.

4. Manufacturing method of base material storage body for biological indicator The manufacturing method of the base material storage body for biological indicator of the present invention includes a first laminate preparation step, a first sterilization treatment step, a second sterilization treatment step, and a lamination step. However, it may have other steps as necessary.
As other steps, for example, there can be mentioned a step of preparing other components of the biological indicator base material storage body, performing a sterilization treatment, and arranging the other components in the biological indicator base material storage body.
More specifically, as other steps, a lid preparation step of preparing a lid formed to cover the biological indicator base material, a lid sterilization processing step of sterilizing the lid, a lamination step and After the lid sterilization step, a lid arranging step of arranging the lid so as to cover the biological indicator base material and the like can be mentioned.

  The biological indicator base material storage body manufactured by the method for producing a biological indicator base material storage body of the present invention is the same as the content described in the above section “C. Biological indicator base material storage body”. Therefore, the description is omitted here.

5. Other Embodiments The present invention has a first laminate preparation step, a first sterilization treatment step, a second sterilization treatment step and a lamination step, and performs the first sterilization treatment step and the second sterilization treatment step after the lamination step. It is possible to provide a method for producing a base material storage body for a biological indicator, which is performed at the same time.

According to the present invention, the base material is a paper base material, a resin base material, etc., the sterilization treatment penetrates the base material, and the base material side surface of the double-sided adhesive layer and the double-sided adhesive layer of the base material When it can be reached, the first sterilization step and the second sterilization step are performed simultaneously after the lamination step, so that the number of times of performing the sterilization step can be reduced.
Except that the first sterilization process and the second sterilization process are performed at the same time after the lamination process, the details of each process and other matters are the same as those described above, and thus description thereof is omitted. .
In the present invention, it is particularly preferable that the base is a paper base or a resin base. Even when these substrates are laminated on the surface of the first laminate, the effect of the sterilization treatment is easily transmitted to the first laminate side surface of the substrate. Therefore, even when the first sterilization process and the second sterilization process are performed simultaneously after the lamination process, the base material stabilizes the double-sided adhesive layer side surface of the base material and the substrate-side surface of the double-sided adhesive layer. This is because it can be sterilized.

F. Method for Producing Biological Indicator Storage Next, a method for producing the biological indicator storage of the present invention will be described.
The method for manufacturing a biological indicator storage body of the present invention includes a biological indicator base material storage body preparing step of forming a biological indicator base material storage body using the above-described biological indicator base material storage body manufacturing method. And coating the indicator layer solution containing the indicator bacteria on the bacterial layer forming surface of the substrate included in the biological indicator substrate storage body, and forming a bacterial layer forming the indicator layer containing the indicator bacteria. And a step.

The method for manufacturing such a biological indicator storage body of the present invention will be described with reference to the drawings. FIG. 10 is a process chart showing an example of the method for producing a biological indicator storage body of the present invention. As illustrated in FIG. 10, in the method for manufacturing a biological indicator storage body of the present invention, a biological indicator base material storage body 30 is formed using the above-described method for manufacturing a biological indicator base material storage body ( (FIG. 10 (a)) Then, the indicator bacterial solution 3a containing the indicator bacteria is applied to the bacterial layer forming surface 1a of the substrate 1 included in the biological indicator substrate storage body 30 (FIG. 10A). 10 (b)), a method of forming a bacterial layer 3 containing the indicator bacteria by drying the coating film of the indicator bacteria solution (FIG. 10 (c)).
FIG. 10A is a step of preparing a substrate storage body for a biological indicator, and FIGS. 10B and 10C are steps of forming a bacterial layer.

  According to the present invention, by preparing a biological indicator base material storage body by the above-described method for manufacturing a biological indicator base material storage body, the manufacturing method enables highly accurate sterilization ability evaluation of a sterilization apparatus. A biological indicator storage body can be obtained.

The method for producing a biological indicator storage body of the present invention includes a biological indicator base material storage body preparing step and a fungus layer forming step.
Hereinafter, each step of the method for producing a biological indicator storage body of the present invention will be described in detail.
In addition, since the preparation process of the base material storage body for a biological indicator can be the same as the content described in the section of “E. Method for producing a base material storage body for a biological indicator”, the description here will be omitted. Omitted.

1. Bacterial layer forming step The bacterial layer forming step in the present invention comprises applying the indicator bacterial solution containing the indicator bacteria to the bacterial layer forming surface of the substrate contained in the biological indicator substrate storage body, This is a step of forming a bacterial layer containing bacteria.

  The method of preparing the indicator bacterial solution and the method of forming the bacterial layer in this step can be the same as those described in the above section “B. Biological Indicator”, and thus description thereof will be omitted.

2. Method for manufacturing biological indicator storage body The method for manufacturing a biological indicator storage body of the present invention includes a biological indicator base material storage body preparation step and a fungus layer forming step, and other steps as necessary. May be provided.

  The biological indicator storage body manufactured by the method for manufacturing a biological indicator storage body of the present invention can be the same as the content described in the above section “D. Biological indicator storage body”. Is omitted.

G. FIG. Next, a method for evaluating the sterilizing ability of the sterilizing apparatus of the present invention will be described.
The method for evaluating the sterilizing ability of the sterilizing apparatus of the present invention includes a substrate having a bacterial layer-forming surface on which an indicator bacterium used for confirming a sterilizing state is disposed, and a surface of the substrate opposite to the bacterial layer-forming surface. A double-sided pressure-sensitive adhesive layer, formed on the fungus layer-forming surface of the substrate, a fungus layer containing the indicator bacteria, a biological indicator having a biological indicator, and affixing step of sticking to the sterilization target, After the pasting step, a sterilization step of sterilizing the object to be sterilized using a sterilizer, and after the sterilization step, the sterilization state of the object to be sterilized by culturing the indicator bacteria contained in the biological indicator. And an evaluation step of evaluating.

Such a method for evaluating the sterilizing ability of the sterilizing apparatus of the present invention will be described with reference to the drawings. FIG. 11 is a process chart showing an example of the method for evaluating the sterilizing ability of the sterilizing apparatus of the present invention. As exemplified in FIG. 11, the method for evaluating the sterilizing ability of the sterilizing apparatus of the present invention comprises a substrate having a bacterial layer forming surface on which an indicator bacterium used for confirming a sterilizing state is arranged, and the bacterial layer of the substrate. A biological indicator 20 having a double-sided adhesive layer formed on the surface opposite to the forming surface and a bacterial layer formed on the bacterial layer-forming surface of the substrate and containing the indicator bacterium, 11 (FIG. 11 (a)), the sterilizing object 11 is sterilized using the sterilizing apparatus 50 (FIG. 11 (b)), and the sterilized object 11 after the sterilizing process is sterilized. Removed from the device, the base material included in the biological indicator is gripped by a gripping means such as tweezers, and is pulled with a predetermined pulling force against the double-sided adhesive layer, thereby separating the double-sided adhesive layer and the base material c. , To sterilize the double-sided adhesive layer 2 11, the laminate 10 a including the substrate and the bacterial layer is collected as a sample for evaluation in a test tube 61 which is a culture container containing a culture medium 62 (FIG. 11C). Is sealed with a stopper 63, and the indicator bacteria contained in the bacterial layer collected together with the base material as a sample for evaluation are cultured in a medium 62 in a test tube 61, so that the sterilization state of the object to be sterilized is reduced. This is an evaluation method (FIG. 11D).
FIG. 11A shows an attaching step, FIG. 11B shows a sterilizing step, and FIGS. 11C and 11D show an evaluating step.
Further, in this example, the sterilization apparatus 50 has a hydrogen peroxide gas supply unit 51 as a sterilization treatment apparatus, and supplies hydrogen peroxide gas g1 and g2 to the inside and the outer surface of the container to be sterilized, respectively. It is sterilized with hydrogen peroxide. In addition, the sterilization device 50 supplies a conveying device 53 such as a belt conveyor that conveys the sterilization target 11 and a hydrogen peroxide gas (g1 and g2) to the sterilization target 11, and then supplies the sterilization target 11 And a drying device 52 that supplies the heated dry air h to the sterilizing target 11.

  According to the present invention, by using the above-described biological indicator, the method for evaluating the sterilizing ability of the sterilizing apparatus can easily evaluate the sterilizing ability of the sterilizing apparatus.

The method for evaluating the sterilizing ability of a sterilizing apparatus according to the present invention includes an attaching step, a sterilizing step, and an evaluating step.
Hereinafter, each step of the method for evaluating the sterilizing ability of the sterilizing apparatus of the present invention will be described in detail.

1. Sticking step The sticking step in the present invention, a substrate having a bacteria layer forming surface on which the indicator bacteria used for confirmation of the sterilization state are arranged, and the surface of the substrate opposite to the bacteria layer forming surface on the opposite side This is a step of attaching a biological indicator having the formed double-sided pressure-sensitive adhesive layer and the bacterial layer formed on the bacterial layer-forming surface of the base material and containing the indicator bacterium to an object to be sterilized.

In this step, as a method of attaching the biological indicator to the object to be sterilized, the biological indicator may be attached to a site to be evaluated of the object to be sterilized, and may be any method capable of producing a measurement sample, using a gripping means such as tweezers. A method of attaching a biological indicator to a site to be evaluated can be used.
In addition, this step is generally performed under aseptic conditions such as a clean bench.

  In this step, the number of biological indicators to be attached to the sterilization target and the evaluation target site to which the biological indicator is attached, according to the sterilization device and the sterilization target that is the evaluation target of the sterilization ability evaluation method of the present invention. It is set appropriately.

  The sterilization target and the biological indicator can be the same as those described in the sections of “A. Biological indicator base material” and “B. Biological indicator”, respectively. Description is omitted.

2. Sterilization Step The sterilization step in the present invention is a step of sterilizing the object to be sterilized using a sterilizer after the attaching step.

The sterilization treatment using the sterilization apparatus in this step is appropriately set according to the type of the sterilization target and the like, and is the same as the content described in the above section “A. Substrate for biological indicator”. It can be.
Further, the sterilizing apparatus is an object to be evaluated by the sterilizing ability evaluation method of the present invention, and sterilizes an object to be sterilized. Such a sterilizing device may include at least a sterilizing device installed according to the type of the sterilizing process, and if necessary, a transport device for transporting the sterilizing object, and drying the sterilizing object. One having a drying device or the like can be used.

3. Evaluation step The evaluation step in the present invention is a step of evaluating the sterilization state of the object to be sterilized by culturing the indicator bacterium contained in the biological indicator after the sterilization step.

  The method of culturing the indicator bacteria in this step may be any method that can accurately evaluate the sterilization state of the sterilization target, such as a method of collecting the indicator bacteria in the medium and culturing the indicator bacteria in the medium. it can.

The method for collecting the indicator bacteria into the culture medium may be any method that can collect at least a bacterial layer containing the indicator bacteria from the biological indicator attached to the sterilization target. A method of collecting a laminate containing both as a sample for evaluation in a culture medium can be given.
In this step, in the above-mentioned collection method, the evaluation sample may include a double-sided pressure-sensitive adhesive layer, but preferably does not include a double-sided pressure-sensitive adhesive layer. This is because the evaluation method of the present invention can eliminate the influence of bacteria and the like derived from the surface of the sterilization target.
As a preparation method of the evaluation sample containing no double-sided adhesive layer, for example, by gripping the base material of the biological indicator attached to the object to be sterilized with a gripping means such as tweezers and pulling the double-sided adhesive layer A method of peeling between the double-sided pressure-sensitive adhesive layer and the substrate, leaving the double-sided pressure-sensitive adhesive layer on the object to be sterilized, including the substrate and the bacterial layer, and preparing a sample for evaluation not including the double-sided pressure-sensitive adhesive layer can be mentioned. .

The medium in which the indicator bacteria are collected and cultured, the culturing conditions when culturing the collected indicator bacteria in the medium, the culturing period, and the like should be the same as those used for a general method for confirming the sterilization state. Can be set as appropriate according to the type of indicator bacteria and the like.
As a culture vessel for cultivating the indicator bacterium while holding the above-mentioned medium, any culture vessel capable of culturing the indicator bacterium may be used, and a general culture vessel such as a test tube or a petri dish can be used.

As a method for evaluating the sterilization state of the object to be sterilized in this step, the indicator bacteria are cultured for a predetermined period, the presence or absence of the indicator bacteria growing by culture is checked, and the indicator bacteria are growing. If is observed, it is determined that the sterilization state of the sterilization state of the object to be sterilized by the sterilization device was insufficient, and if the indicator bacteria do not occur, the sterilization state of the sterilization state confirmation area is sufficient. It can be a judgment method.
As a method for confirming whether or not the indicator bacterium proliferates by culturing, for example, a method for visually confirming can be used.
As a method of evaluating the sterilization state, for example, a method of evaluating the number of remaining bacteria and the bactericidal effect by the most probable number (MPN method) based on the result of culturing the indicator bacteria in a liquid medium is used. Can also.

4. Sterilization ability evaluation method of sterilization apparatus The sterilization ability evaluation method of the sterilization apparatus of the present invention has an attaching step, a sterilization step and an evaluation step, but may have other steps as necessary. .
As other steps, for example, when the biological indicator is in a state included in the biological indicator storage body, peeling between the release layer of the double-sided adhesive layer and the support portion of the biological indicator, the biological indicator A removing step of removing the biological indicator from the storage body can be included.
As a method of taking out the biological indicator from the biological indicator storage body, a method of gripping the double-sided adhesive layer of the biological indicator with a gripping means such as tweezers and pulling the biological indicator toward the supporting portion can be exemplified.

  Note that the present invention is not limited to the above embodiment. The above-described embodiment is an exemplification, and has substantially the same configuration as the technical idea described in the claims of the present invention, and any device having the same function and effect can be realized by the present invention. It is included in the technical scope of the invention.

  Hereinafter, the present invention will be specifically described with reference to Examples and Comparative Examples.

[Example 1]
The biological indicator of the present invention was produced by the following procedure.
(1) A fluororesin-based tape (NITTOFLON (registered trademark) manufactured by Nitto Denko Corporation) having a width of about 60 mm and a length of about 130 mm as an adhesion layer and a release layer was attached to a square petri dish prepared as a support substrate, and supported. Part was produced.
(2) Next, a 15 mm-wide easily peelable double-sided tape (Nystack (registered trademark) manufactured by Nichiban Co., Ltd.) was applied as a double-sided pressure-sensitive adhesive layer on the fluororesin base material (release layer) of the support portion to form a first layer. A laminate was produced.
(3) Next, a cut was made in the double-sided tape so as to have a square shape of about 7 mm × 7 mm square.
(4) A 7 μm-thick aluminum foil was cut into a square shape of about 3 mm to 5 mm square to prepare a base material, which was collected in a petri dish.
(5) The petri dish from which the first laminate and the cut aluminum foil as the base material were collected was sterilized using ethylene oxide gas (EOG).
(6) After the EOG sterilization treatment, an aluminum foil as a base material was stuck on the double-sided tape of the first laminate using tweezers in a clean bench. Thus, a substrate storage body for a biological indicator of the present invention was produced.
(7) The indicator bacteria and sterilized water were prepared as the indicator bacteria solution, and a suspension was prepared by suspending the indicator bacteria in sterilized water.
Next, a coating film was formed by applying 1 μL of the indicator bacterium solution on an aluminum foil, and the coating film was air-dried to form a bacterial layer, thereby producing a biological indicator storage body.
The number of indicator bacteria was 2.0 × 10 ⁵ to 3.0 × 10 ⁵ per aluminum foil as a base material.
The indicator bacteria were Bacillus. atrophaeus ATCC 9372 was used.

(Evaluation)
The biological indicator was taken out of the obtained biological indicator storage body and, as shown in FIG. 12, was attached to the upper portion of the inner surface of the in-mold molding cup, which was the object to be sterilized, to obtain a measurement sample.
Next, as a sterilizing device, one having a hydrogen peroxide gas supply unit and a drying device as shown in FIG. 11 already described is prepared, a measurement sample is placed in the sterilizing device, and the hydrogen peroxide supply amount is 3 g. / Min, 5 g / min and 7 g / min, a sterilization treatment in which gasified hydrogen peroxide is sprayed on the inner surface of the cup as a measurement sample for 1 second, and then dry air at 150 ° C. is applied to the cup for 1 second. The spray drying process was performed four times at one second intervals.
After the drying treatment, leaving the double-sided adhesive layer on the measurement sample, take out the laminate containing the base material aluminum foil and the bacterial layer as an evaluation sample, collect it in a tryptic soy broth medium in a test tube, and seal with a tight stopper. did. Then, the cells were cultured under culture conditions at 37 ° C. for 7 days (culturing period), and the presence or absence of turbidity after the culture was visually checked to confirm the sterilization of the bacteria.
The evaluation was performed with n = 5. That is, five measurement samples in which a biological indicator was attached to the same evaluation target site were prepared, and five evaluation samples were prepared from the five measurement samples, and evaluation was performed.
In addition, the numerical value of the bactericidal effect in Table 1 represents LRV (Log Reduction Value: log reduction value).
The number of bacteria generated in Table 1 indicates the number of measurement samples in which no bacteria were observed among the five measurement samples.

[Comparative Example 1]
Without preparing a biological indicator storage body, an indicator germ solution containing an indicator bacterium was prepared for preparing a measurement sample by a conventional direct application method.

(Evaluation)
1 μL of the same indicator bacterium solution as in Example 1 was applied to the upper part of the inner surface of the in-mold molding cup, which is the object to be sterilized, to form a coating film. A measurement sample was prepared.
Next, evaluation was performed in the same manner as in Example 1 except that the measurement sample was disassembled after the sterilization treatment, and the portion where the bacterial layer was formed was cut out as an evaluation sample. The results are shown in Table 1 below.

From Table 1, similar bactericidal effects were observed with the direct application method of Comparative Example 1 and the present evaluation method of Example 1.
Therefore, it was confirmed that the evaluation of the sterilizing ability of the sterilizing apparatus using the biological indicator of the present invention can obtain the same evaluation result as the evaluation of the sterilizing ability of the conventional sterilizing apparatus.

DESCRIPTION OF SYMBOLS 1 ... Base material 1a ... Bacterial layer forming surface 2 ... Double-sided adhesive layer 2a ... Supports 2b1, 2b2 ... Adhesive layer 3 ... Bacterial layer 10 ... Biological indicator base material 20 ... Biological indicator 30 ... Biological indicator base Material storage 31 ... Support 31a ... Support substrate 31b ... Adhesion layer 31c ... Release layer 40 ... Biological indicator storage 50 ... Sterilizer

Claims (8)

A substrate having a bacterial layer-forming surface on which indicator bacteria used for confirmation of the sterilization state are arranged,
A double-sided pressure-sensitive adhesive layer formed on the surface of the substrate opposite to the bacteria layer-forming surface,
A base material for a biological indicator, comprising:   The base material for a biological indicator according to claim 1, wherein a plan view area of the base material is smaller than a plan view area of the double-sided pressure-sensitive adhesive layer. A substrate having a bacterial layer-forming surface on which indicator bacteria used for confirmation of the sterilization state are arranged,
A double-sided pressure-sensitive adhesive layer formed on the surface of the substrate opposite to the bacteria layer-forming surface,
A bacterial layer formed on the bacterial layer forming surface of the base material and containing the indicator bacterium,
A biological indicator comprising: A support portion having a support substrate, a release layer formed on a surface of the support substrate opposite to the support substrate of the adhesion layer and the adhesion layer formed on one surface of the support substrate,
A biological indicator base material arranged on the surface of the support portion,
Has,
The biological indicator substrate,
A substrate having a bacterial layer-forming surface on which indicator bacteria used for confirmation of the sterilization state are arranged,
A double-sided pressure-sensitive adhesive layer formed on the surface of the substrate opposite to the bacteria layer-forming surface,
Has,
The substrate storage body for a biological indicator, wherein the double-sided pressure-sensitive adhesive layer is disposed on a surface of the support portion so as to be in contact with the release layer. A support portion having a support substrate, a release layer formed on a surface of the support substrate opposite to the support substrate of the adhesion layer and the adhesion layer formed on one surface of the support substrate,
A biological indicator arranged on the surface of the support,
Has,
The biological indicator includes:
A substrate having a bacterial layer-forming surface on which indicator bacteria used for confirmation of the sterilization state are arranged,
A double-sided pressure-sensitive adhesive layer formed on the surface of the substrate opposite to the bacteria layer-forming surface,
A bacterial layer formed on the bacterial layer forming surface of the base material and containing the indicator bacterium,
Has,
The biological indicator storage body, wherein the double-sided pressure-sensitive adhesive layer is disposed on a surface of the support portion so as to be in contact with the release layer. A support part having a release layer formed on a surface of the support substrate, the adhesion layer formed on one surface of the support substrate and the surface of the adhesion layer opposite to the support substrate, and the support part being included in the support part. A first laminate preparing step of preparing a first laminate having a double-sided pressure-sensitive adhesive layer formed on the surface of the release layer opposite to the adhesive layer;
A first sterilization treatment step of sterilizing the first laminate obtained in the first laminate preparation step,
A second sterilization process for sterilizing a substrate having a bacterial layer-forming surface on which the indicator bacteria used for confirmation of the sterilization state are arranged,
A laminating step of disposing the base material on the surface of the double-sided pressure-sensitive adhesive layer included in the first laminate opposite to the release layer,
Has,
The method of manufacturing a substrate storage body for a biological indicator, wherein the laminating step is performed after the first sterilizing step and the second sterilizing step. A biological indicator base material storage body preparing step of forming a biological indicator base material storage body using the method for manufacturing a biological indicator base material storage body according to claim 6,
A fungus layer forming step of applying an indicator bacterium solution containing the indicator bacterium to the fungus layer forming surface of the base material included in the biological indicator base material storage body to form a germ layer containing the indicator bacterium. ,
A method for producing a biological indicator storage body, comprising: A substrate having a bacterial layer-forming surface on which indicator bacteria used for confirmation of the sterilization state are arranged,
A double-sided pressure-sensitive adhesive layer formed on the surface of the substrate opposite to the bacteria layer-forming surface,
A bacterial layer formed on the bacterial layer forming surface of the base material and containing the indicator bacterium,
A biological indicator having a paste step of sticking to the sterilization target,
After the pasting step, a sterilization step of sterilizing the object to be sterilized using a sterilizer,
After the sterilization step, an evaluation step of evaluating the sterilization state of the sterilization target by culturing the indicator bacteria included in the biological indicator,
A method for evaluating the sterilizing ability of a sterilizing apparatus, comprising: