JP2003004638A - Sterilization indicator composition - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sterilization indicator composition which can distinguish from a color change by one kind of the sterilization indicator composition whether EOG sterilization and plasma sterilization are completed good or not, facilitate manufacturing sterilization materials and inventory management at a use site, and reduce costs. SOLUTION: The sterilization indicator composition for both EOG sterilization and plasma sterilization contains as components, a disperse dye expressed by a general formula, an organic compound, an acrylic resin, a synthetic resin selected from a urethane/nitrocellulose resin, an acryl/alkyd/nitrocellulose resin, an alkyd resin, a nitrocellulose resin and an acryl/styrene resin, and a chelate compound.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to both an ethylene oxide gas sterilization method and a low temperature gas plasma sterilization method for sterilizing medical equipment performed in a hospital or the like.
The present invention relates to a chemical indicator composition for confirming whether or not sterilization is effectively performed.

[0002]

2. Description of the Related Art Conventionally, as a method for sterilizing medical equipment used in the medical field, etc., autoclave sterilization (hereinafter referred to as AC sterilization) using high-pressure steam and ethylene oxide gas sterilization (hereinafter referred to as E)
OG sterilization) method is used.

As a method of confirming the quality of sterilization completion in these sterilization methods, heat-resistant bacteria (B, stearoth)
ermophilus) and Bacillus subtilis (B, subtili)
s) method for confirming with a biochemical indicator,
There is a method of confirming using a chemical indicator, which causes a color change due to a chemical reaction with high-pressure steam or ethylene oxide gas.

In AC sterilization and EOG sterilization, it is extremely important to determine whether or not the object to be sterilized has undergone the sterilization process, or to detect whether or not the sterilization conditions are appropriate.

The biochemical indicator can confirm the quality of sterilization accurately, but it takes too much time to judge the quality of sterilization because it is necessary to culture the bacteria after sterilization.
Therefore, many chemical indicators that are easy to handle and can confirm the quality of sterilization in real time immediately after the completion of the sterilization process have been put into practical use. Most of the chemical indicators are used in a form in which a chemical substance that changes color by reacting with high-pressure steam or ethylene oxide gas is made into ink and printed on paper or plastic film.

The chemical indicators used for the discrimination means and the detection means can be used only for the respective sterilization methods, and a plurality of chemical indicators corresponding to the sterilization methods are printed as the sterilization methods are diversified. There is a need for a sterilized material that has been prepared and a sterilized material that has a chemical indicator dedicated to a limited sterilization method.

[0007]

[Problems to be Solved by the Invention] Conventionally, EOG sterilization method (sterilization can be performed at a low temperature of 40 ° C to 60 ° C) for sterilization of precision medical devices such as plastic medical instruments and endoscopes that have no heat resistance However, in the EOG sterilization method, highly toxic ethylene oxide gas remains in the sterilized object after sterilization. Therefore, it is necessary to remove ethylene oxide from the object to be sterilized after sterilization, so that there is a drawback that the step of aeration must be performed for a long time.

Recently, as an alternative sterilization method to the EOG sterilization method, hydrogen peroxide low temperature plasma sterilization (hereinafter referred to as plasma sterilization), which uses hydrogen peroxide as plasma at a low temperature and is used as a sterilizing agent, has been developed. And the need for an indicator to use it came out.

Japanese Patent Application No. 10-543743 discloses an indicator composition comprising a combination of a specific PH indicator, for example, bromthymol blue, phenol red, cresol red, etc. and an amine compound.
Japanese Patent No. 178904 discloses an indicator which is a combination of a triphenylmethane dye or a cyanine dye and a compound having a mercapto group.

The disclosed indicator composition is a single indicator that can only be used for plasma sterilization.
For sterilizing material users who have to use multiple types of sterilization methods depending on the object to be sterilized, inventory management of sterilizing materials becomes more complicated than ever, and unnecessary cost burden due to increased inventory of sterilizing materials. Leads to an increase.

On the other hand, in the sterilization indicator composition of the present application, due to the presence of a specific discoloration aid, the specific dye used as the indicator causes discoloration with different color tones in EOG sterilization treatment and plasma sterilization treatment. It can be used as an indicator for sterilization to be presented, and is disclosed in Japanese Patent Application No. 10-543473 and Japanese Patent Application Laid-Open No. 11-178904.
This is different from the known technique described in the publication. Further, Japanese Patent Publication No. 57-243173 and Japanese Patent Laid-Open No. 2-191462.
Japanese Patent Publication, Japanese Patent Publication No. 05-28273, Japanese Patent Publication No. 52-
Unlike publicly known techniques relating to an indicator for exclusive use of ethylene oxide gas sterilization described in Japanese Patent No. 10043, etc., it can be used for both the EOG sterilization method and the plasma sterilization method.

According to the present invention, in the EOG sterilization method and the plasma sterilization method, the difference between the two sterilization methods and the detection of the completion of sterilization can be confirmed by the difference in the color change color tone which is clear.
It is to provide a sterilization / plasma sterilization dual-purpose sterilization indicator composition.

[0013]

[Means for Solving the Problems] In order to achieve the above-mentioned object, the present inventor has conducted extensive studies and as a result, found that a disperse dye represented by the following general formula

[Chemical 2] It was discovered that a composition comprising an organic acid compound, a synthetic resin, and a chelate compound has the property of discoloring by EOG sterilization treatment and decoloring by plasma sterilization treatment, and EOG sterilization / plasma sterilization. They have found that the composition is a dual-purpose sterilization indicator composition and succeeded in completing the present invention.

That is, the sterilization indicator composition for both EOG sterilization / plasma sterilization of the present invention is a disperse dye represented by the following general formula.

[Chemical 3] [In the formula, R1 is a hydrogen group, a methyl group, an ethyl group, an acylamino group or a phenyl group. R2 is a hydrogen group, a methoxy group, an ethoxy group or a hydroxyl group. R3, R4 and R5 are each a hydrogen group, a hydroxyl group, a nitrate group, an alkyl group] and salicylic acid, benzoic acid, DL tartaric acid, maleic acid, zinc salicylate, calcium salicylate, zinc benzoate, calcium benzoate. At least one organic acid compound selected from among alkyd resin, acrylic resin, urethane / nitrocellulose resin, acrylic / alkyd / nitrocellulose resin, alkyd / nitrocellulose resin, nitrocellulose resin, acrylic / styrene resin At least one synthetic resin selected from the above and at least one chelate compound selected from polyaminocarboxylic acid compounds, oxycarboxylic acid compounds, dimethylglyoxime compounds, dithizone compounds and oxine compounds Is characterized by.

As the disperse dye represented by the above general formula,
C. I. Disperse Red 58, C.I. I Disperse Red 88, C.I. I Disperse Red 110, C.I. I
Disperse Red 117, C.I. I Disperse Red 137, C.I. I Disperse Violet 43 and the like are available, but the disperse dyes having the above general formula are not limited thereto.

Examples of the chelate compound include EDTA metal chelate as a polyaminocarboxylic acid compound. As the chelating metal, Al, Ba, Bi, Ca, Mg, N
The use of metal chelates with i, Pb, Ti, Zn etc. is preferred. In addition to EDTA, there is no problem in using metal chelates of oxycarboxylic acid, dimethylglyoxime, oxine, dithizone and the like.

Other materials may be incorporated into the sterilization indicator composition of the present invention to improve its properties.
For example, as a solvent for forming an ink, ethanol, n-
Preference is given to using propanol, n-butanol, isopropanol, ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, ethyl acetate, butyl acetate, propyl acetate and the like.

Further, in order to stabilize the ink, improve the printability, and adjust the color tone before and after the color change, the constitution of silica, calcium carbonate, basic magnesium carbonate, talc, titanium oxide, zinc oxide, etc. Pigments, metal soaps such as calcium stearate and magnesium stearate, and colored dyes and pigments resistant to ethylene oxide gas and hydrogen peroxide can be added.

When the sterilization indicator composition according to the present invention is made into an ink, the compounding ratio is (1) general formula, with 100% as a whole. 0.05 to 3% (more preferably 0.15 to 2%) of the disperse dye, and (2) 0.05 to 5% (more preferably 0.2 to 3%) of an organic acid or an organic acid metal salt. ),
(3) Synthetic resin 5 to 50% (more preferably 10 to 35
%), (4) solvent 30 to 90% (more preferably 50 to
75%) and (5) chelate compound 0.01 to 5% (more preferably 0.1 to 2%) as essential components.

When the disperse dye content is less than 0.05%, the color tone of the color change is insufficient and the color difference before and after the color change is small.
If it exceeds 3%, the discoloration rate is affected and discoloration becomes insufficient even under sufficient sterilization conditions. If the organic acid or metal salt of an organic acid is less than 0.05%, the discoloration after sterilization is insufficient, and if it is 5% or more, the color tone before the color change of the printed coating is different from the original color tone of the dye, and the color change speed. Is too fast.
When the content of the synthetic resin is less than 5%, the ink viscosity is low, the printability on the printing material is poor, and the discoloration property during sterilization processing is deteriorated. When the content of the synthetic resin is 50% or more, the viscosity of the ink becomes high, the printability becomes poor, and the coating film printed on the material to be printed becomes brittle. If the amount of the solvent is less than 30%, the synthetic resin cannot be completely dissolved, so that the performance as a printing ink cannot be maintained. The coating film is less likely to be formed. If the chelate compound content is less than 0.01%, discoloration after plasma sterilization will be insufficient, the color difference before and after sterilization will be small, and the sterilization detection performance will be reduced. The color changes, and the performance as an indicator is lost.

In addition, extender pigment and ethylene oxide gas,
The addition of a colored dye or colored pigment resistant to hydrogen peroxide does not have a great influence on the color tone of the indicator composition before it is discolored, and may be appropriately selected as long as the performance as a printing ink is improved.

The indicator composition of the present invention is used in the form of being made into an ink and printed on printing materials made of various materials. The ink composition is optional as long as all components can maintain a uniform dispersed state. It can be manufactured by a method.
For example, the disperse dye, organic acid compound, synthetic resin, organic solvent, chelate compound, extender pigment, and colored pigment, which are the above components, are mixed and stirred in a ball mill to obtain the indicator ink composition of the present invention.

As the synthetic resin used in the present invention, an alkyd resin, an acrylic resin, a urethane / nitrocellulose resin, an acrylic / alkyd / nitrocellulose resin, an alkyd / nitrocellulose resin, a nitrocellulose resin, an acrylic / styrene resin may be used alone or 2 Although two or more species are mixed and used, there is no problem in using a commercially available ink medium containing these resins.

[0024]

EXAMPLES The features of the sterilization indicator composition of the present invention will be described in more detail with reference to specific examples. The percentages in the examples mean percent by weight (%). The formulations of Examples 1 to 4 illustrated in Table 1 were kneaded in a ball mill for about 50 hours to prepare a uniform sterilized indicator ink composition.

A printed material obtained by printing the above-described indicator ink composition on Tyvek (synthetic paper manufactured by DuPont) was used as a test piece. (1) EOG sterilization of test pieces (sterilization conditions: ethylene oxide gas 20%, carbon dioxide gas 80%, gas pressure 1k
g / cm ² , relative humidity 50%, temperature 50 ° C., and sterilization treatment for 2 hours). The test piece was subjected to (2) plasma sterilization (Stellad 100: hydrogen peroxide low temperature plasma sterilizer manufactured by Johnson & Johnson Medical Co., Ltd.) for 75 minutes to visually confirm the discolored state of the indicator. As a result, discoloration as shown in Table 2 was exhibited.

[0026]

[Comparative Example 1] Salicylic acid and EDT in the formulation of Example 1
The composition prepared by removing the titanium chelate A and adding sodium carbonate as an alternative substance was made into an ink by the same method as in the example and printed on Tyvek (synthetic paper manufactured by DuPont) to give a test piece. When this was subjected to EOG sterilization treatment and plasma sterilization treatment under the same conditions as in the examples, no discoloration was observed in any sterilization treatment.

[0027]

COMPARATIVE EXAMPLE 2 The composition of Example 2 excluding the acrylic / alkyd / nitrocellulose resin and EDTA titanium chelate was made into ink in the same manner as in Example and printed on Tyvek to give a test piece. When this was subjected to EOG sterilization treatment under the same conditions as in the example, it turned blue. When the same test piece was plasma sterilized, no discoloration was observed.

[0028]

[Comparative Example 3] Of the formulations of Example 3, C.I. I. Instead of the disperse dye having the above general formula except for Disperse Red 137, a formulation using a basic dye, Rhodamine B, was inked in the same manner as in Example and printed on Tyvek to give a test piece. When this was subjected to EOG sterilization and plasma sterilization treatment under the same conditions as in the examples, no discoloration was observed in any sterilization treatment.

[0029]

Comparative Example 4 Salicylic acid and EDT in the formulation of Example 4
A composition obtained by removing the titanium chelate A and adding barbituric acid and ethylenediamine hydrochloride as an alternative substance was made into ink by the same method as in the example and printed on Tyvek to give a test piece. When this was subjected to EOG sterilization and plasma sterilization treatment under the same conditions as in the examples, no discoloration was observed in any sterilization treatment.

[0030]

The sterilization indicator composition of the present invention is E
In the OG sterilization as well as the plasma sterilization process, it is possible to clearly identify whether or not the sterilization is completed. Further, since the discoloration differs between EOG sterilization and plasma sterilization, a plurality of indicators corresponding to the sterilization method are not required. Therefore, it is an indicator composition effective for manufacturing sterilizing materials, simplifying production management and inventory management at medical sites using sterilizing materials such as hospitals.

Front page continuation (51) Int.Cl. ⁷ Identification code FI theme code (reference) G01N 31/22 121 G01N 31/22 121C 122 122 // A61L 2/26 A61L 2/26 C

Claims (4)

[Claims] 1. A disperse dye represented by the following general formula: [In the formula, R1 is a hydrogen group, a methyl group, an ethyl group, an acylamino group, a phenyl group or a hydroxyl group. R2 is a hydrogen group, a methoxy group, an ethoxy group or a hydroxyl group. R3, R4 and R5 are hydrogen groups,
Hydroxyl group, nitrate group, alkyl group], at least one organic acid or organic acid metal salt, synthetic resin,
A sterilization indicator composition for both ethylene oxide gas sterilization / plasma sterilization, which contains at least one chelate compound as an essential component. 2. The organic acid or organic acid metal salt contains at least one selected from salicylic acid, benzoic acid, DL / tartaric acid, maleic acid, zinc salicylate, calcium salicylate, zinc benzoate, and calcium benzoate. It is characterized by doing. The dual-purpose indicator composition for ethylene oxide gas sterilization / plasma sterilization according to claim 1. 3. The synthetic resin is at least one or more of alkyd resin, acrylic resin, urethane / nitrocellulose resin, acrylic / alkyd / nitrocellulose resin, alkyd / nitrocellulose resin, nitrocellulose resin, and acrylic / styrene resin. The indicator composition for dual use of ethylene oxide gas sterilization / plasma sterilization according to claim 1, which contains. 4. The chelate compound contains at least one or more selected from polyaminocarboxylic acid compounds, oxycarboxylic acid compounds, dimethylglyoxime compounds, dithizone compounds and oxine compounds. Item 2. An indicator composition for both ethylene oxide gas sterilization / plasma sterilization according to items 1, 2 and 3.