JP5612423B2 - Hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization detection indicator - Google Patents

Description

  The present invention relates to a hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization detection indicator.

  Various equipment and instruments used in hospitals, laboratories and the like are sterilized for disinfection and sterilization. As this sterilization treatment, for example, hydrogen peroxide (steam) sterilization treatment, hydrogen peroxide plasma sterilization treatment, and the like are known. Among these, the hydrogen peroxide plasma sterilization treatment is advantageous in that it generates plasma in a hydrogen peroxide atmosphere and sterilizes the equipment with low-temperature gas plasma, and can be sterilized at a relatively low temperature.

  In these sterilization processes, it is necessary to install an indicator for confirming whether the sterilization process is completed. Specifically, it is necessary to install an indicator in the sterilizer to know whether hydrogen peroxide or hydrogen peroxide plasma is sufficiently distributed in the treatment system and the exposure time. Patent Documents 1 to 3 describe such an indicator and an ink composition for forming the indicator. Specifically, Patent Documents 1 and 2 describe ink compositions and indicators used for detection of hydrogen peroxide sterilization. Patent Document 3 describes an ink composition and an indicator used for detection of hydrogen peroxide plasma sterilization.

  However, the above prior art indicators have the following problems. That is, the process of evacuating the chamber (sterilization device) during the sterilization process when the object to be processed and the indicator are loaded and sealed in a gas permeable package and subjected to hydrogen peroxide sterilization treatment or hydrogen peroxide plasma sterilization treatment. Therefore, the indicator is in close contact with the gas-permeable packaging body during the vacuum process, and a discoloration failure may occur in the discoloration layer provided on the front surface of the base material. For example, the front surface of the indicator may be in close contact with a transparent window (film surface) provided in a part of the package, and hydrogen peroxide or hydrogen peroxide plasma may not be detected.

  Therefore, it is necessary to develop an indicator that enables accurate detection even when an object to be processed and an indicator are loaded and sealed in a gas-permeable package and hydrogen peroxide sterilization treatment or hydrogen peroxide plasma sterilization treatment is performed. It has been.

JP 2006-078463 A JP 2007-040785 A JP 2005-315828 JP

  The present invention provides an indicator capable of accurate detection even when an object to be processed and an indicator are loaded and sealed in a gas permeable package and hydrogen peroxide sterilization treatment or hydrogen peroxide plasma sterilization treatment is performed. The main purpose is to do.

  As a result of intensive studies to achieve the above object, the present inventor has found that an indicator having a discoloration layer on the back surface of a transparent substrate or a translucent substrate having a specific transmission density can achieve the above object. It came to complete.

That is, the present invention relates to the following hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization detection indicator.
1. A hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization detection indicator having a discoloration layer that changes color in the presence of hydrogen peroxide or hydrogen peroxide plasma on one side of a substrate ,
(1) the substrate is Ri transparent substrate or a translucent substrate der is transmission density was measured with densitometer is 0.1 or less,
(2) The discoloration layer is mirror-character printed (inverted design printing) on one side of the substrate.
An indicator characterized by that.
2. A gas permeable package which is loaded the indicator according to the object to be treated and the claim 1, wherein the inner surface of the gas permeable package, item 1 in a direction wherein the said discoloring layer with an object to be processed in contact A package for hydrogen peroxide or hydrogen peroxide plasma sterilization provided with the indicator according to 1.
3. Item 3. The package according to Item 2, wherein a transparent window is provided in a part of the package so that the indicator can be confirmed from the outside.
4). Item 4. The package according to Item 2 or 3, wherein the gas permeable package is formed of polyethylene fiber.
5. The hydrogen peroxide or hydrogen peroxide plasma sterilization process which has the process of sealing the package in any one of said item 2-4, and placing the said package in a hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization atmosphere Method.
6). Item 6. The method according to Item 5, wherein the package is placed in an atmosphere of hydrogen peroxide or hydrogen peroxide plasma sterilization until the discoloration layer of the indicator changes color.

  Hereinafter, the indicator of the present invention will be described in detail.

  The indicator of the present invention is a hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization detection indicator having a discoloration layer that changes color in the presence of hydrogen peroxide or hydrogen peroxide plasma on the back surface of the substrate. It is characterized by being a transparent substrate or a semi-transparent substrate having a transmission density measured by a tometer of 0.1 or less.

  The indicator of the present invention having the above characteristics has a discoloration layer on the back surface of the base material, and the base material is a transparent base material or a translucent base material having a transmission density of 0.1 or less. Even if the front surface is in close contact with the packaging material (so-called sterilization pouch), the discoloration layer on the back of the substrate accurately detects the completion of hydrogen peroxide sterilization treatment or hydrogen peroxide plasma sterilization treatment, and the presence or absence of discoloration is transparent Accurate grasp from the front surface of the substrate. In other words, since the conventional indicator has a discoloration layer on the front surface of the substrate, the discoloration layer and the package are in close contact with each other when the package is sealed together with the object to be processed and sterilized. However, since the indicator of the present invention has a discoloration layer on the back surface of the substrate, the discoloration layer and the package do not adhere to each other (the discoloration layer is on the object to be processed side) and can be accurately detected. Moreover, the presence or absence of discoloration can be accurately grasped from the front surface through the transparent substrate or the semi-transparent substrate.

  As the base material of the indicator, a transparent base material or a translucent base material having a transmission density measured by a densitometer of 0.1 or less, preferably a translucent base material having a transmission density of 0.03 or more and 0.04 or less. Is used. The lower limit of the transmission density is not limited as long as it can be confirmed whether or not the color changing layer is discolored from the front surface of the translucent substrate, but is about 0.01. When the transmission density exceeds 0.1, the transparency decreases, and it becomes difficult to grasp the presence or absence of discoloration through the translucent substrate. On the other hand, if it is less than 0.01, it is too transparent and is easily affected by the color of the object to be processed, which may hinder accurate detection. The transmission density in this specification is a measurement value of the optical density measured with a densitometer, and the ratio of the sample (base material) irradiated with a vertically transmitted light beam according to JIS K 7605 and the ratio without the sample. It is a value expressed in log (logarithm).

  In the present invention, a transparent base material or a semi-transparent base material having the above-mentioned transmission density, which can easily form a discoloration layer on the back surface by coating or printing is preferable. For example, glass, plastics (polyethylene terephthalate (PET), polypropylene, nylon, polystyrene, etc.), fibers (nonwoven fabric, woven fabric, other fiber sheets), composite materials of these, and the like can be used. Moreover, synthetic resin fiber paper (synthetic paper) such as polypropylene synthetic paper and polyethylene synthetic paper can also be suitably used.

  The color-changing layer in the present invention includes not only those whose color changes to other colors in the presence of hydrogen peroxide or hydrogen peroxide plasma, but also those whose colors fade or disappear. The discoloration layer can be formed by a printing method such as silk screen printing, gravure printing, offset printing, letterpress printing, flexographic printing, etc., using an ink composition described later. Also, it can be formed by other than printing. For example, the discoloration layer can be formed by immersing the substrate in the ink composition. This method is particularly suitable for a material into which ink penetrates, such as a nonwoven fabric. In the present invention, since the presence or absence of discoloration of the discoloration layer is confirmed from the front surface of the base material, when the discoloration layer imitates characters, symbols, etc., when viewed from the front surface, It is preferable to perform mirror character printing (reversal design printing) on the back surface of the substrate so that correct characters, symbols, and the like are obtained. By performing mirror character printing in this way, it becomes easy to understand in which direction the indicator should be arranged.

  In the present invention, known components can be used as components that change color in the presence of hydrogen peroxide or hydrogen peroxide plasma contained in the ink composition. For example, as an ink composition for detecting hydrogen peroxide sterilization, an ink composition containing at least one of an azo dye, a methine dye, a triarylmethane dye, and a thiazine dye (see JP-A-2006-78463). As described above), 1) at least one styrene acrylic resin and styrene maleic acid resin, and 2) an ink composition containing a methine dye (described in JP-A-2007-40785) can be used. The ink composition for detecting hydrogen peroxide plasma sterilization contains 1) at least one anthraquinone dye, azo dye, and methine dye, 2) a nitrogen-containing polymer, and 3) a cationic surfactant. An ink composition (described in JP-A-2005-315828) can be preferably used. These ink compositions will be briefly described below.

Ink composition for detecting hydrogen peroxide sterilization An ink composition containing at least one of an azo dye, a methine dye, a triarylmethane dye and a thiazine dye (described in JP-A-2006-78463) Can be mentioned.

  The azo dye is not limited as long as it has an azo group —N═N— as a chromophore. Examples thereof include monoazo dyes, polyazo dyes, metal complex azo dyes, stilbene azo dyes, thiazole azo dyes, and the like. More specifically, the dye numbers indicate CIDisperse Red 13, CIDisperse Red 52, CIDisperse Violet 24, CIDisperse Blue, 44, CIDisperse Red 58, CIDisperse Red 88, CIDisperse Yellow 23, CIDisperse Orange 1, CIdisperse Orange 5, CISolvent Red 1, CISolvent Red 3, CISolvent Red 23, and the like. These can be used alone or in combination of two or more.

  The methine dye may be a dye having a methine group. Therefore, in the present invention, polymethine dyes, cyanine dyes and the like are also included in the methine dyes. These can be appropriately selected from known or commercially available methine dyes. Specifically, CIBasic Red 12, CIBasic Red 13, CIBasic Red 14, CIBasic Red 15, CIBasic Red 27, CIBasic Red 35, CIBasic Red 36, CIBasic Red 37, CIBasic Red 45, CIBasic Red 48, CIBasic Yellow 11, CIBasic Yellow 12, CIBasic Yellow 13, CIBasic Yellow 14, CIBasic Yellow 21, CIBasic Yellow 22, CIBasic Yellow 23, CIBasic Yellow 24, CIBasic Violet 7, CIBasic Violet 15, CIBasic Violet 16, CIBasic Violet 20, CIBasic Violet 21, CIBasic Violet 39, CIBasic Blue 62, CIBasic Blue 63, and the like. These can be used alone or in combination of two or more.

  The triarylmethane dye is not limited, and known or commercially available dyes can be used. For example, CIBasic Blue 1, CIBasic Blue 26, CIBasic Blue 5, CIBasic Blue 8, CIBasic Green 1, CIBasic Red 9, CIBasic Violet 12, CIBasic Violet 14, CIBasic Violet 3, CISolvent Green 15, CISolvent Violet 8, etc. These can be used alone or in combination of two or more. Among these triarylmethane dyes, C.I.Solvent Violet 8, C.I.Basic Green 1, C.I.Basic Red 9, C.I.Basic Blue 1, and the like can be suitably used.

  The thiazine dye is not particularly limited and can be selected from known or commercially available ones. Examples thereof include C.I.Basic Blue 9, C.I.Basic Blue 25, C.I.Basic Blue 24, C.I.Basic Blue 17, C.I.Basic Green 5, C.I.Solvent Blue 8, and the like. These can be used alone or in combination of two or more. Among these thiazine dyes, C.I.Basic Blue 9 and the like can be suitably used.

  The content of these dyes varies depending on the type of dye used, desired detection characteristics, etc., but is 0.01 to 10% by weight, preferably 0.05 to 5% by weight, more preferably 0.00% in the ink composition. It may be 1 to 2% by weight.

  In addition, an ink composition (described in Japanese Patent Application Laid-Open No. 2007-40785) containing 1) at least one of styrene acrylic resin and styrene maleic acid resin and 2) a methine dye.

  The methine dye may be a dye having a methine group. Therefore, in the present invention, polymethine dyes, cyanine dyes and the like are also included in the methine dyes. These can be appropriately selected from known or commercially available methine dyes. Specifically, CIBasic Red 12, CIBasic Red 13, CIBasic Red 14, CIBasic Red 15, CIBasic Red 27, CIBasic Red 35, CIBasic Red 36, CIBasic Red 37, CIBasic Red 45, CIBasic Red 48, CIBasic Yellow 11, CIBasic Yellow 12, CIBasic Yellow 13, CIBasic Yellow 14, CIBasic Yellow 21, CIBasic Yellow 22, CIBasic Yellow 23, CIBasic Yellow 24, CIBasic Violet 7, CIBasic Violet 15, CIBasic Violet 16, CIBasic Violet 20, CIBasic Violet 21, CIBasic Violet 39, CIBasic Blue 62, CIBasic Blue 63, and the like. These can be used alone or in combination of two or more.

  The content of the dye can be appropriately determined according to the desired hue and the like, but is generally about 0.05 to 5% by weight, particularly 0.1 to 1% by weight in the ink composition.

  The types and properties of the styrene acrylic resin and styrene maleic acid resin are not limited, and known or commercially available ones can be used. The content of the styrene acrylic resin and styrene maleic acid resin can be appropriately determined according to the type of the colorant used, but is generally about 50% by weight or less, particularly 1 to 35% by weight in the ink composition. Is desirable.

Ink composition for hydrogen peroxide plasma sterilization detection 1) Ink composition containing at least one of anthraquinone dye, azo dye and methine dye, 2) nitrogen-containing polymer and 3) cationic surfactant No. 2005-315828).

  The anthraquinone dye is not limited as long as it has anthraquinone as a basic skeleton, and a known anthraquinone disperse dye or the like can also be used. An anthraquinone dye having an amino group is particularly preferable. More preferred is an anthraquinone dye having at least one amino group of a primary amino group and a secondary amino group. In this case, each amino group may have two or more, and these may be the same or different from each other.

  More specifically, for example, 1,4-diaminoanthraquinone (CIDisperse Violet 1), 1-amino-4-hydroxy-2-methylaminoanthraquinone (CIDisperse Red 4), 1-amino-4-methylaminoanthraquinone ( CIDisperse Violet 4), 1,4-diamino-2-methoxyanthraquinone (CIDisperse Red 11), 1-amino-2-methylanthraquinone (CIDisperse Orange 11), 1-amino-4-hydroxyanthraquinone (CIDisperse Red) 15), 1,4,5,8-tetraaminoanthraquinone (CIDisperse Blue 1), 1,4-diamino-5-nitroanthraquinone (CIDisperse Violet 8), etc. (the dye number in parentheses) . CISolvent Blue 14, CISolvent Blue 35, CISolvent Blue 63, CISolvent Violet 13, CISolvent Violet 14, CISolvent Red 52, CISolvent Red 114, CIVat Blue 21, CIVat Blue 30, CIVat Violet 15, CIVat Violet 17, CIVat Red 19, CIVat Red 28, CIAcid Blue 23, CIAcid Blue 80, CIAcid Violet 43, CIAcid Violet 48, CIAcid Red 81, CIAcid Red 83, CIReactive Dyes known as Blue 4, CI Reactive Blue 19, CI Disperse Blue 7, etc. can also be used. These anthraquinone dyes can be used alone or in combination of two or more. Among these anthraquinone dyes, C.I Disperse Blue 7, C.I Disperse Violet 1 and the like are preferable. In the present invention, the detection sensitivity can be controlled by changing the type (molecular structure, etc.) of these anthraquinone dyes.

  The azo dye is not limited as long as it has an azo group —N═N— as a chromophore. Examples thereof include monoazo dyes, polyazo dyes, metal complex azo dyes, stilbene azo dyes, thiazole azo dyes, and the like. More specifically, the dye numbers are CISolvent Red 1, CISolvent Red 3, CISolvent Red 23, CIDisperse Red 13, CIDisperse Red 52, CIDisperse Violet 24, CIDisperse Blue 44, CIDisperse Red 58 CIDisperse Red 88, CIDisperse Yellow 23, CIDisperse Orange 1, CIDisperse Orange 5, and the like. These can be used alone or in combination of two or more.

  The methine dye may be a dye having a methine group. Therefore, in the present invention, polymethine dyes, cyanine dyes and the like are also included in the methine dyes. These can be appropriately selected from known or commercially available methine dyes. Specifically, CIBasic Red 12, CIBasic Red 13, CIBasic Red 14, CIBasic Red 15, CIBasic Red 27, CIBasic Red 35, CIBasic Red 36, CIBasic Red 37, CIBasic Red 45, CIBasic Red 48, CIBasic Yellow 11, CIBasic Yellow 12, CIBasic Yellow 13, CIBasic Yellow 14, CIBasic Yellow 21, CIBasic Yellow 22, CIBasic Yellow 23, CIBasic Yellow 24, CIBasic Violet 7, CIBasic Violet 15, CIBasic Violet 16, CIBasic Violet 20, CIBasic Violet 21, CIBasic Violet 39, CIBasic Blue 62, CIBasic Blue 63, and the like. These can be used alone or in combination of two or more.

  The content of the dye can be appropriately determined according to the kind of dye, desired hue, and the like, but is generally about 0.05 to 5% by weight, particularly 0.1 to 1% by weight in the ink composition. It is desirable.

  As the nitrogen-containing polymer, for example, a synthetic resin such as polyamide resin, polyimide resin, polyacrylonitrile resin, amino resin, polyacrylamide, polyvinyl pyrrolidone, polyvinyl imidazole, or polyethyleneimine can be suitably used. These can be used alone or in combination of two or more. In the ink composition, the nitrogen-containing polymer serves as a sensitivity enhancer. That is, by using a sensitivity enhancer, the accuracy (sensitivity) of hydrogen peroxide plasma sterilization detection can be further increased. Thus, the color is surely changed even in the package for hydrogen peroxide plasma sterilization.

  From this viewpoint, it is particularly preferable to use a polyamide resin in the present invention. The kind of polyamide resin, molecular weight, etc. are not specifically limited, A well-known or commercially available polyamide resin can be used. Among these, a polyamide resin which is a reaction product (long chain linear polymer) of a dimer of linoleic acid and di- or polyamine can be preferably used. The polyamide resin is a thermoplastic resin having a molecular weight of 4000 to 7000. A commercially available product can also be used for such a resin.

  The content of the nitrogen-containing polymer can be appropriately determined according to the type of the polymer, the type of colorant used, and the like, but is generally about 0.1 to 50% by weight, particularly 1 to 20% in the ink composition. It is desirable to set the weight%.

  The cationic surfactant is not particularly limited, but at least one of alkyl ammonium salt, isoquinolinium salt, imidazolinium salt and pyridinium salt is preferably used. These may be known or commercially available products. In the present invention, a superior detection sensitivity can be obtained by using these cationic surfactants in combination with the above dyes.

  Of the alkylammonium salts, alkyltrimethylammonium salts and dialkyldimethylammonium salts are preferred. Specifically, palm alkyltrimethylammonium chloride, tallow alkyltrimethylammonium chloride, behenyltrimethylammonium chloride, hexadecyltrimethylammonium chloride, lauryltrimethylammonium chloride, octadecyltrimethylammonium chloride, dioctyldimethylammonium chloride, distearyldimethylammonium chloride, chloride Examples thereof include alkylbenzyldimethylammonium. In particular, coconut alkyltrimethylammonium chloride and lauryltrimethylammonium chloride are preferable.

  Examples of the isoquinolinium salt include lauryl isoquinolinium bromide, cetyl isoquinolinium bromide, cetyl isoquinolinium chloride, lauryl isoquinolinium chloride and the like. Among these, lauryl isoquinolinium bromide is particularly preferable.

  Examples of the imidazolinium salt include 1-hydroxyethyl-2-oleylimidazolinium chloride and 2-chloro-1,3-dimethylimidazolinium chloride. Among these, 2-chloro-1,3-dimethylimidazolinium chloride is particularly preferable.

  Examples of the pyridinium salt include pyridinium chloride, 1-ethylpyridinium bromide, hexadecylpyridinium chloride, cetylpyridinium chloride, 1-butylpyridinium chloride, Nn-butylpyridinium chloride, hexadecylpyridinium bromide, N-hexadecylpyridinium bromide, 1-dodecylpyridinium chloride, 3-methylhexylpyridinium chloride, 4-methylhexylpyridinium chloride, 3-methyloctylpyridinium chloride, 2-chloro-1-methylpyridinium iodide, 3,4-dimethylbutylpyridinium chloride, pyridinium-n -Hexadecyl chloride-hydrate, N- (cyanomethyl) pyridinium chloride, N-acetonyl pyridi Umbromide, 1- (aminoformylmethyl) pyridinium chloride, 2-amidinopyridinium chloride, 2-aminopyridinium chloride, N-aminopyridinium iodide, 1-aminopyridinium iodide, 1-acetonylpyridinium chloride, N-acetonyl Examples include pyridinium bromide. Among these, hexadecylpyridinium chloride is particularly preferable.

  The content of the cationic surfactant can be appropriately determined according to the type of the surfactant, the type of the dye to be used, etc., but is generally about 0.2 to 10% by weight in the ink composition. It is desirable to set it as 5 to 5 weight%.

  In addition, the ink composition may be appropriately blended with components used in known inks such as a resin binder, a filler, a solvent, a leveling agent, an antifoaming agent, an ultraviolet absorber, and a surface conditioner, as necessary. Can do. What is necessary is just to follow a conventional method about content of these components.

  The indicator of the present invention can be applied to any sterilization treatment performed in a hydrogen peroxide or hydrogen peroxide plasma atmosphere. Therefore, it is useful as an indicator in a sterilization apparatus (specifically, an apparatus that performs sterilization with hydrogen peroxide or hydrogen peroxide plasma). For example, when using the indicator, the indicator of the present invention may be placed in a commercially available sterilization apparatus and exposed to a sterilization atmosphere together with equipment to be sterilized. In this case, it is possible to detect that a predetermined plasma sterilization process has been performed by changing the color of an indicator placed in the apparatus.

  In the present invention, sterilization can be suitably performed using a package for hydrogen peroxide or hydrogen peroxide plasma sterilization in which an indicator is provided on the inner surface of the gas permeable package.

  The gas permeable packaging body is preferably a packaging body that can be sterilized while the object to be processed is sealed therein. As this, a known or commercially available product used as a sterilization package (sterile pouch) can be used. For example, a package formed of polyethylene fibers (polyethylene synthetic paper) can be suitably used. After putting an object to be processed into this package and sealing the opening by heat sealing or the like, the entire package can be sterilized in a sterilization apparatus.

  Conventional indicators are generally arranged in a manner (orientation) in which the object to be processed and the discolored layer do not contact the inner surface of the package, but in the present invention, the object is not covered between the object to be processed and the film of the package. An indicator is arrange | positioned in the aspect (direction) which a processed material and a discoloration layer contact.

  In the present invention, it is desirable that a transparent window is provided in a part of the package so that the indicator can be confirmed from the outside. For example, the package may be made of a transparent sheet and the polyethylene synthetic paper, and the indicator may be arranged on the inner surface of the package at a position where it can be visually recognized through the transparent sheet.

  When sterilization is performed using the package, for example, a process of loading an object to be processed into the package, a process of sealing the package loaded with the object to be processed, and hydrogen peroxide or hydrogen peroxide plasma A method having a step of placing in a sterile atmosphere may be used. More specifically, after an object to be processed (medical instrument, food, etc.) is put in a package, it is sealed according to a known method such as heat sealing. Next, the entire package is placed in a sterile atmosphere. For example, it is placed in a sterilization chamber of a known or commercially available sterilizer and sterilized. After the sterilization process is completed, the whole package can be taken out and stored in the package until it is used. In this case, the sterilization is preferably performed by placing the package in a sterilizing atmosphere until the discoloration layer of the indicator changes color.

  The indicator of the present invention has a discoloration layer on the back surface of the base material, and the base material is a transparent base material or a translucent base material having a transmission density of 0.1 or less. Even if it is in close contact with the packaging material (so-called sterilization pouch), the discoloration layer on the back of the substrate accurately detects the completion of the hydrogen peroxide sterilization treatment or hydrogen peroxide plasma sterilization treatment, and the presence or absence of discoloration is detected on the transparent substrate. Accurate grasp from the front. In other words, since the conventional indicator has a discoloration layer on the front surface of the substrate, the discoloration layer and the package are in close contact with each other when the package is sealed together with the object to be processed and sterilized. However, since the indicator of the present invention has a discoloration layer on the back surface of the substrate, the discoloration layer and the package do not adhere to each other (the discoloration layer is on the object to be processed side) and can be accurately detected. Moreover, the presence or absence of discoloration can be accurately grasped from the front surface through the transparent substrate or the semi-transparent substrate.

  Hereinafter, the present invention will be specifically described with reference to Examples and Comparative Examples. However, the present invention is not limited to the examples.

Examples 1 to 5 and Comparative Example 1
An ink composition that changes color by hydrogen peroxide plasma sterilization was prepared.

  The ink composition was screen-printed on the back surface of each substrate shown in Table 1 using a 250 mesh plate to form a discoloration layer. After natural drying for 30 minutes, forced drying was performed at 70 ° C. for 5 minutes. This produced six types of indicators.

  Next, each indicator and 5 m × 2 PVC electric wires were placed in a package (sterilized pouch, product name “Sterad Sterilized Pouch Regular”). At this time, the discoloration layer of the indicator and the polyvinyl chloride electric wire were put in an aspect (direction) in contact. The package with the opening sealed by heat-sealing is placed in a plasma sterilizer device (hydrogen peroxide low temperature gas plasma sterilization system “STERRAD 50” manufactured by Johnson & Johnson Medical) and sterilized under standard conditions programmed in advance by the manufacturer. Processing was performed, and the presence of discoloration was confirmed from the front surface of the indicator. The results are shown in Table 1.

Claims (6)

A hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization detection indicator having a discoloration layer that changes color in the presence of hydrogen peroxide or hydrogen peroxide plasma on one side of a substrate ,
(1) the substrate is Ri transparent substrate or a translucent substrate der is transmission density was measured with densitometer is 0.1 or less,
(2) The discoloration layer is mirror-character printed (inverted design printing) on one side of the substrate.
An indicator characterized by that. A gas permeable package which is loaded the indicator according to the object to be processed and in the claims 1, to the inner surface of the gas permeable package, according to claim 1 in the orientation wherein the said discoloring layer with an object to be processed in contact A package for hydrogen peroxide or hydrogen peroxide plasma sterilization provided with the indicator according to 1.   The package according to claim 2, wherein a transparent window is provided in a part of the package so that the indicator can be confirmed from the outside.   The package according to claim 2 or 3, wherein the gas permeable package is formed of polyethylene fibers. A hydrogen peroxide or hydrogen peroxide plasma sterilization treatment comprising a step of sealing the package according to any one of claims 2 to 4, and a step of placing the package in a hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization atmosphere. Method.   The method according to claim 5, wherein the package is placed in a hydrogen peroxide or hydrogen peroxide plasma sterilized atmosphere until the color changing layer of the indicator changes color.