WO2012043722A1 - Indicateur pour la détection de la stérilisation au peroxyde d'hydrogène ou de la stérilisation au plasma de peroxyde d'hydrogène - Google Patents

Indicateur pour la détection de la stérilisation au peroxyde d'hydrogène ou de la stérilisation au plasma de peroxyde d'hydrogène Download PDF

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Publication number
WO2012043722A1
WO2012043722A1 PCT/JP2011/072381 JP2011072381W WO2012043722A1 WO 2012043722 A1 WO2012043722 A1 WO 2012043722A1 JP 2011072381 W JP2011072381 W JP 2011072381W WO 2012043722 A1 WO2012043722 A1 WO 2012043722A1
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Prior art keywords
hydrogen peroxide
indicator
sterilization
package
dye
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PCT/JP2011/072381
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English (en)
Japanese (ja)
Inventor
盛作 大城
藤澤　俊樹
美帆 岡田
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株式会社サクラクレパス
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Publication of WO2012043722A1 publication Critical patent/WO2012043722A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
    • G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
    • G01N31/226—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators for investigating the degree of sterilisation

Definitions

  • the present invention relates to a hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization detection indicator.
  • 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.
  • 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.
  • 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 may be in close contact with the gas permeable package during the vacuum process, resulting in a discoloration defect. For example, 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.
  • the indicator does not adhere to the gas permeable package. Therefore, the development of an indicator that can be detected accurately is required.
  • the indicator adheres to the gas permeable package.
  • the main objective is to provide an indicator that can be detected accurately.
  • the present invention relates to the following hydrogen peroxide sterilization or hydrogen peroxide plasma sterilization detection indicator.
  • 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 a substrate, wherein the surface roughness Ra of the discoloration layer is 2.5.
  • Indicator characterized by being in the range of ⁇ 15.0 ⁇ m.
  • Item 2 The indicator according to Item 1, wherein an opening of 0.2 to 20% of the substrate area is provided on the substrate. 3. Item 2.
  • the indicator according to Item 1 wherein at least one selected from the group consisting of embossed grooves, slits (linear holes), and perforations (dashed holes) is provided on the substrate. 4).
  • Item 5. The ink composition according to Item 4, wherein the particles are at least one of a polymer compound and an inorganic compound. 6). Item 6.
  • a package for hydrogen peroxide or hydrogen peroxide plasma sterilization wherein the indicator according to any one of Items 1 to 3 is provided on the inner surface of the gas permeable package. 10.
  • Item 10 The package according to Item 9, wherein a transparent window is provided on a part of the package so that the indicator can be confirmed from the outside. 11.
  • Item 11 The package according to Item 9 or 10, wherein the gas permeable package is formed of polyethylene fiber. 12
  • the step of loading the object to be processed in any of the above items 9 to 11 the step of sealing the package in which the object to be processed is loaded, and the package is sterilized with hydrogen peroxide or hydrogen peroxide plasma
  • a hydrogen peroxide or hydrogen peroxide plasma sterilization treatment method comprising a step of placing in a sterilizing atmosphere.
  • Item 13 The method according to Item 12, wherein the package is placed in an atmosphere of hydrogen peroxide or a hydrogen peroxide plasma sterilization until the color changing layer of the indicator changes color.
  • 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 a substrate, the surface roughness of the discoloration layer.
  • the thickness Ra is in the range of 2.5 to 15.0 ⁇ m.
  • the indicator of the present invention having the above-described features is particularly suitable for loading and sealing the object to be treated and the indicator on the gas permeable package by having the surface roughness Ra of the discoloration layer in the range of 2.5 to 15.0 ⁇ m. Even when the hydrogen peroxide sterilization process or the hydrogen peroxide plasma sterilization process is performed, the indicator does not adhere to the gas-permeable package, and accurate detection is possible.
  • the indicator of the present invention can have the same configuration as the conventionally known indicator as long as the discoloration layer has the surface roughness Ra and changes color in the presence of hydrogen peroxide or hydrogen peroxide plasma.
  • the indicator it is preferable to more reliably prevent the indicator from adhering to the gas permeable package by providing an opening of 0.2 to 20% of the substrate area on the substrate.
  • One or two or more openings may be provided on the substrate (including a portion where the color-changing layer is formed), and preferably two or more openings are provided in the portion where the color-changing layer is formed.
  • the shape of the opening is not particularly limited, and various shapes such as a circle, a square, and a triangle can be adopted.
  • the opening include, for example, a mode in which circular holes having a diameter of 2 mm to 4 mm are provided on both sides of the color changing layer, a mode in which the central portion of the color changing layer is provided, and a part on which the color changing layer is formed And the like provided randomly.
  • the total area of the openings is preferably within the range of 0.3 to 13% of the substrate area.
  • the indicator is gas permeable by providing at least one selected from the group consisting of embossed grooves, slits (linear holes) and perforations (dashed holes) on the substrate. It is preferable to more reliably prevent adhesion to the adhesive package.
  • the embossed grooves can be provided with vertical stripes, horizontal stripes or the like alone or in combination so as to cross the opposite sides of the indicator.
  • Such an embossing groove can be provided by a known embossing machine.
  • the depth of the groove is preferably set to about 25 to 35 ⁇ m.
  • the direction in which the embossing grooves are formed is not particularly limited, and the surface having the discoloration layer may be provided as a concave portion or may be provided as a convex portion.
  • a slit it is preferable to provide one or more on the color changing layer as shown in Example 3 of FIG.
  • the slit can be replaced with a perforation (not shown) in consideration of the strength of the indicator.
  • the indicator it is preferable to fold and use the indicator to more reliably prevent the indicator from sticking to the gas permeable packaging.
  • the shape of the indicator is a rectangle
  • the bending may be performed so as to bend across the opposite side, or bend the end of the indicator into a triangle. Specific examples of such bending are shown in a-1 to b-1 in FIG.
  • the direction of folding is not particularly limited, and the surface having the discoloration layer may be mountain-folded or valley-folded.
  • the base material of the indicator those which can form a discoloration layer by coating or printing are good, for example, metal or alloy, ceramics, glass, concrete, plastics (polyethylene terephthalate (PET), polypropylene, nylon, polystyrene, etc.), fiber (Nonwoven fabric, woven fabric, other fiber sheets), composite materials of these, and the like can be used.
  • synthetic resin fiber paper synthetic paper
  • synthetic paper such as polypropylene synthetic paper and polyethylene synthetic paper can also be suitably used.
  • the discoloration 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.
  • 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.
  • the ink composition for forming the color changing layer preferably contains particles having an average particle size of 1 to 30 ⁇ m in addition to the component that changes color in the presence of hydrogen peroxide or hydrogen peroxide plasma.
  • the surface roughness Ra of the discoloration layer can be easily set to 2.5 to 15.0 ⁇ m (preferably 2.5 to 5.0 ⁇ m).
  • surface roughness Ra in this specification is Ra prescribed
  • a mechanical method for example, roughening by sandpaper or sandblasting, color changing layer by silk screen printing
  • the average particle size of the particles is preferably 1 to 30 ⁇ m, more preferably 5 to 15 ⁇ m.
  • the material of the particles is not limited, but is preferably at least one of a polymer compound and an inorganic compound that does not react with or adsorb hydrogen peroxide or hydrogen peroxide plasma.
  • polymer compound examples include polyethylene, polypropylene, acrylic copolymer, polyester, polyamide, polyurethane, phenol resin, and melamine resin.
  • the polymer compound may be not only resin spheres but also hollow resin spheres, microcapsules, and the like. Moreover, it does not need to be colorless and may be colored with dyes or pigments.
  • low molecular weight polyethylene resin spheres are preferable.
  • commercially available Chemipearl W308 average particle size 6 ⁇ m, softening point 132 ° C.
  • Chemipearl W200 average particle size 6 ⁇ m, softening point 113 ° C.
  • Chemipearl W310 Average particle size 9.5 ⁇ m, softening point 132 ° C., 40% aqueous dispersion manufactured by Mitsui Chemicals) and the like are preferable.
  • inorganic compounds include calcium carbonate and glass.
  • the inorganic compound is not limited to a spherical shape, but may be a plate-like material (flake-like material), a needle-like material, or the like, if necessary.
  • particles, plates, and needles are collectively referred to as “particles”.
  • the color change layer can be used in combination so that the surface roughness Ra falls within the range of 2.5 to 5.0 ⁇ m.
  • the diameter is preferably 1 to 30 ⁇ m in terms of a sphere equivalent diameter measured by a laser diffraction method.
  • the content of the particles and the like in the ink composition is not limited, but it is preferably 1 to 50 parts by weight, more preferably 5 to 20 parts by weight, based on 100 parts by weight of the ink excluding the particles and the like. .
  • the content of the particles and the like in the ink composition is not limited, but it is preferably 1 to 50 parts by weight, more preferably 5 to 20 parts by weight, based on 100 parts by weight of the ink excluding the particles and the like. .
  • 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.
  • 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).
  • 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 hydrogen peroxide sterilization detection 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 are CIDisperse Red 13, CIDisperse Red 52, CIDisperse Violet 24, CIDisperse Blue, 44, CIDisperse Red 58, CIDisperse Red 88, CIDisperse Yellow 23, CIDisperse Orange 1, CIsisperse 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.
  • methine dye any dye having a methine group may be used. 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.
  • 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 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 a known or commercially available dye can be used.
  • 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, CISRol Green 15, CISolvent Violet 8 etc. can be used alone or in combination of two or more.
  • 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 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.
  • methine dye any dye having a methine group may be used. 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.
  • 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 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 the styrene maleic acid resin can be appropriately determined according to the type of the colorant used and the like, 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 kind 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.
  • 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) and the like (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, CIReactive Blue 19, CIdisperse Blue 7 etc. can also be used.
  • These anthraquinone dyes can be used alone or in combination of two or more.
  • 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.
  • methine dye any dye having a methine group may be used. 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.
  • 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 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 type of dye, desired hue, etc., but is generally about 0.05 to 5% by weight, particularly 0.1 to 1% by weight in the ink composition. It is desirable.
  • 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.
  • 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. Thereby, since the color is surely changed even in the package for hydrogen peroxide plasma sterilization, it is very advantageous as an indicator used for the package.
  • 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.
  • 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, etc., 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 it is particularly desirable to use at least one of an alkyl ammonium salt, an isoquinolinium salt, an imidazolinium salt, and a pyridinium salt. 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.
  • alkylammonium salts alkyltrimethylammonium salts, dialkyldimethylammonium salts and the like are preferable.
  • palm alkyltrimethylammonium chloride tallow alkyltrimethylammonium chloride, behenyltrimethylammonium chloride, hexadecyltrimethylammonium chloride, lauryltrimethylammonium chloride, octadecyltrimethylammonium chloride, dioctyldimethylammonium chloride, distearyldimethylammonium chloride, chloride
  • alkylbenzyldimethylammonium alkylbenzyldimethylammonium.
  • coconut alkyltrimethylammonium chloride and lauryltrimethylammonium chloride are preferable.
  • isoquinolinium salt examples include lauryl isoquinolinium bromide, cetyl isoquinolinium bromide, cetyl isoquinolinium chloride, lauryl isoquinolinium chloride and the like. Among these, lauryl isoquinolinium bromide is particularly preferable.
  • imidazolinium salt examples include 1-hydroxyethyl-2-oleylimidazolinium chloride, 2-chloro-1,3-dimethylimidazolinium chloride, and the like. Of these, 2-chloro-1,3-dimethylimidazolinium chloride is particularly preferable.
  • pyridinium salt examples 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 pyri Nitrobromide, 1- (amino
  • 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, and the like, but is generally about 0.2 to 10% by weight in the ink composition, particularly about 0. It is desirable that the content be 5 to 5% by weight.
  • 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).
  • a sterilization apparatus specifically, an apparatus that performs sterilization with hydrogen peroxide or hydrogen peroxide plasma.
  • 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.
  • 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 treated is sealed therein.
  • a known or commercially available product used as a sterilization package can be used.
  • 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.
  • the indicator may be disposed on the inner surface of the package.
  • the arrangement method is not limited, and the indicator can also be constituted by applying or printing the ink composition directly on the inner surface of the package, in addition to a method using an adhesive, heat sealing, or the like.
  • an indicator can be formed at the manufacturing stage of the package.
  • 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.
  • 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 surface roughness Ra of the discolored layer is in the range of 2.5 to 5.0 ⁇ m. Even when the treatment or the hydrogen peroxide plasma sterilization treatment is performed, the indicator is not in close contact with the gas permeable package, and accurate detection is possible.
  • Examples 1 to 3 and Comparative Example 1 Each component shown in Table 1 was uniformly mixed with a stirrer to prepare an ink composition. Specifically, components other than particles (Chemical) were sufficiently stirred first, then Chemipearl was added and stirred for 30 minutes.
  • Each ink composition was screen-printed on a PET sheet (Toyobo's Crisper K2323: 125 ⁇ m) using a 250 mesh plate to form a discolored layer. After natural drying for 30 minutes, forced drying was performed at 70 ° C. for 5 minutes. This produced the indicator.
  • each indicator and 5m x 2 PVC electric wires are placed in a package (sterilized pouch, product name "Sterad Sterilized Pouch Regular"), and the opening is sealed by heat sealing.
  • the sample was placed in a hydrogen oxide low temperature gas plasma sterilization system “STERRAD 50” manufactured by Johnson & Johnson Medical Co., Ltd.) and sterilized under standard conditions programmed in advance by the manufacturer, and examined for the presence or absence of discoloration. The results are shown in Table 1.

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Abstract

L'invention concerne un indicateur grâce auquel il devient possible d'empêcher l'adhérence de l'indicateur à un matériau d'emballage perméable aux gaz et il devient également possible d'atteindre une détection précise même lorsqu'un matériau auquel on s'intéresse et l'indicateur sont emballés/scellés dans un matériau d'emballage perméable aux gaz et qu'un traitement de stérilisation au peroxyde d'hydrogène ou un traitement de stérilisation au plasma de peroxyde d'hydrogène est réalisé en utilisant le matériau d'emballage. L'indicateur est un indicateur de détection de stérilisation au peroxyde d'hydrogène ou de stérilisation au plasma de peroxyde d'hydrogène, qui comprend une base et une couche changeant de couleur formée sur la base, la couleur, de la couche changeant de couleur, changeant en présence de peroxyde d'hydrogène ou de plasma de peroxyde d'hydrogène, et l'indicateur étant caractérisé en ce que la couche changeant de couleur présente une rugosité de surface (Ra) de 2,5-15,0 μm.
PCT/JP2011/072381 2010-10-01 2011-09-29 Indicateur pour la détection de la stérilisation au peroxyde d'hydrogène ou de la stérilisation au plasma de peroxyde d'hydrogène WO2012043722A1 (fr)

Applications Claiming Priority (2)

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CN107078053B (zh) * 2014-12-02 2021-02-26 株式会社樱花彩色笔 使用有金属氧化物微粒作为变色层的等离子体处理检测指示器

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