JP2002071570A - Indicator for plasma sterilization and packaging material for sterilization - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an indicator for plasma sterilization, which can precisely judge whether a plasma sterilization treatment to an object to be sterilized has been executed or not, whose light resistance and stability are superior and whose color change speed in a display is fat and to provide a packaging material, for sterilization, on which a display part using the indicator is formed. SOLUTION: A pigment which is composed mainly of an anthraquinone-based compound, an organic amine-based compound and a binder are contained in the indicator for plasma sterilization. The anthraquinone-based compound is preferably selected from between laccaic acid and carminic acid which are indicated by the following structures.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an indicator for sterilization using a chemical indicator useful for hydrogen peroxide plasma sterilization, and an object to be processed for plasma sterilization comprising a display section comprising the sterilization indicator. The present invention relates to a packaging material for sterilization for storage.

[0002]

2. Description of the Related Art Various sterilization means have been used for disposable or reusable medical devices and food containers, and typical examples thereof include ethylene oxide gas (EOG) sterilization, High-pressure high-temperature steam sterilization using an autoclave, plasma sterilization, or the like can be given.
For example, as a sterilization method performed in a hospital or the like, a sterile object such as a scalpel or a syringe is placed in a packaging bag having an area that is at least gas-permeable and does not allow bacteria to pass, and after sealing, The sterilized device is sterilized by the method described above, and the sterilized instrument is stored in this packaging bag until used for surgery or the like, and is opened and used when used for surgery or treatment. In this case, it is useful from the viewpoint of preventing accidents and the like to attach a display for easily determining whether or not the sterilization process has been performed on the device sealed in the packaging material. The display portion is formed using an ink having an indicating function, which changes color irreversibly when sterilization is performed.

[0003] As an example of such an ink, as a coloring material that senses temperature as an indicator of steam sterilization, a coloring material such as a diazonium salt compound used for a heat-sensitive recording material or a heat-sensitive microcapsule is used. When the temperature reaches a predetermined temperature, a coloring material that develops color by impairing the hermeticity of the microcapsules can be mentioned. Commercially available products include, for example, Nescos IC (S) manufactured by I.C.S. -25B, for high-pressure steam sterilization), and inks used for thermolabels and steam integrator cards manufactured by NOF Giken Kogyo. What senses EOG includes, for example, a composition having a disperse dye having an (AN = NB) structure described in JP-A-5-1252.

[0004] Among these sterilization treatments, since there is little concern about affecting medical instruments which are to be sterilized, recently, a hydrogen peroxide plasma sterilization method and an apparatus therefor have been proposed and actually used. Yes (Tokuhei 2-622
Nos. 61 and 7-22693). This sterilization method,
Briefly, the product to be sterilized is exposed to hydrogen peroxide vapor under reduced pressure in an airtight container, and then a hydrogen peroxide plasma is generated. This method is very useful in that not only high sterilization efficiency is obtained, but also hydrogen peroxide is converted into completely harmless water and oxygen. As a display composition suitable for such a plasma sterilization treatment, for example,
JP-A-11-178904, triphenylmethane dyes, cyanine dyes, JP-A-11-3798
No. 8, a technique using a pH indicator as a discoloring dye has been proposed. These display components contain dyes that lose color or change color due to the oxidizing properties of the highly oxidizing gas used for plasma sterilization, but have a low color change rate.
The short-time plasma sterilization treatment causes problems such as insufficient discoloration, insufficient light resistance, and undesired discoloration caused by handling under white light or daylight, which is not practically preferable. Was.

[0005]

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to clearly determine whether or not an object to be sterilized has been subjected to a plasma sterilization treatment. An object of the present invention is to provide an indicator for plasma sterilization having a fast discoloration rate and a packaging material for sterilization comprising a display unit using the indicator for plasma sterilization.

[0006]

As a result of the study, the present inventors have selected an anthraquinone dye having a specific structure from among the anthraquinone dyes known as red dyes, and combined with an organic amine compound as a discoloration aid. Thus, the present inventors have found that the above problems can be solved, and have completed the present invention.

[0007] That is, the indicator for plasma sterilization of the present invention is characterized in that it contains a dye mainly composed of an anthraquinone compound, an organic amine compound and a binder. Here, as the anthraquinone-based compound, a compound having at least one carboxy group in the anthraquinone skeleton and selected from laccaic acid and carminic acid is preferable from the viewpoint of stability.

The sterilization packaging material according to the third aspect of the present invention is at least partially composed of gas-permeable paper or nonwoven fabric, and is capable of storing an object to be sterilized for plasma sterilization. A display part comprising a plasma sterilization indicator containing a dye mainly composed of an anthraquinone-based compound, an organic amine-based compound and a binder is formed.

The plasma sterilization indicator of the present invention contains a specific anthraquinone dye stable to heat and light and an organic amine compound which is preferably non-volatile.
There is almost no risk of discoloration during normal white light or daylight handling.
Changes or discoloration in response to the strong oxidizing power of plasma treatment, and the discoloration is irreversible,
It is suitable as a chemical indicator, and even after a certain period of time has passed since hydrogen peroxide plasma sterilization treatment of non-sterile substances such as medical devices and food containers, it is clearly determined whether or not such treatment has been performed. can do. Furthermore, among the specific anthraquinone pigments, particularly preferred laccaic acid and carminic acid are highly safe pigments that can be used for foods, so that the object to be sterilized is used in medical devices, food containers, cooking utensils, and the like. In some cases, there is no concern about toxicity due to the dye, and there is also an advantage of excellent safety.

[0010]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below in detail.
The indicator for plasma sterilization of the present invention contains a dye mainly composed of an anthraquinone compound and an organic amine compound. The dye mainly containing an anthraquinone compound used herein is not particularly limited as long as it is a dye having an anthraquinone skeleton, but from the viewpoint of good stability such as light resistance, a compound having a carboxy group is preferred. Compounds selected from raccaic acid and carminic acid are particularly preferred. The raccaic acid dye suitably used in the present invention is generally a mixture of compounds represented by the following structure, and an aqueous solution of this compound is acidic, exhibits an orange-red-orange color, is neutral, exhibits a red color, and is alkaline, It has a purple-blue color. This compound is also available as a commercial product such as Styrac Red manufactured by Eizen Co., Ltd.

[0011]

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The carminic acid dye suitably used in the present invention is a compound represented by the following structure. An aqueous solution of this compound exhibits an acidic red-orange color, a neutral red color, and an alkaline red-violet color. This compound is, for example,
It is also available as a commercial product such as Echin Co., Cochineal Red.

[0013]

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When any of these compounds is used in the indicator of the present invention, the compound exhibits a reddish purple (maroon) due to the presence of the organic amine compound. At the time of the sterilization treatment, it comes into contact with the hydrogen peroxide vapor and turns yellow. Further sterilization proceeds, and the color is decolorized by the strong oxidizing power of the plasma gas to become colorless. Since these compounds are irreversibly discolored or colorless due to pH change or strong oxidizing power, they have preferable characteristics as indicators, but all are natural red pigments of biological origin, high safety, and food additives. Therefore, in addition to the above-described effects of the present invention, there is also an advantage that it can be safely used without fear of toxicity or the like in foods and medical instruments. These compounds may be used alone or in combination of two or more. The content of the anthraquinone dye is
It is preferably in the range of 0.2 to 20% by weight.
If the amount is less than 2% by weight, the color (color tone) is thin and it is difficult to detect the change in color visually. If the amount is more than 20% by weight, reddish purple remains even after being sterilized by a plasma sterilizer. Absent.

The organic amine compound, which is a color-change aid used together with the dye, is preferably a compound that is stable even in an atmosphere in which plasma sterilization is performed. From the viewpoint of the effect, the organic amine compound is preferably diethanolamine. And triethanolamine. The organic amine compound may be used alone or in combination of two or more.
It is preferable to use a mixture of triethanolamine in a weight ratio of 1/1 to 1/10. The content of the organic amine compound is 2% in the total composition constituting the indicator.
It is preferably in the range of from 40 to 40% by weight, and more preferably in the range of from 10 to 30% by weight. If the addition amount is less than 2% by weight, the reactivity is inferior and the discoloration rate tends to be slow. If the addition amount exceeds 40% by weight, the alkalinity becomes strong and the stability of the dye tends to decrease, so neither is preferred. .

The sterilization indicator of the present invention usually contains a suitable binder in addition to the dye and the color change aid. This is a carrier when the indicator is used as a display unit of the packaging material. The binder is not particularly limited, and for example, a synthetic resin or the like generally used for preparing a printing ink can be appropriately selected and used. Since the indicator of the present invention contains an organic amine, from the viewpoint of the stability of the composition, a polyamide or an ethylcellulose-based binder which is an alkali-resistant polymer material is preferable, but the alkali is adjusted by adjusting other additives. It is not always necessary to be alkali-resistant because damage from components can be prevented. Therefore, in consideration of the discoloration speed and stability of the dye, for example, nitrified cotton can be suitably used as the binder. The kind and amount of binder added are the characteristics as an indicator for sterilization,
It may be appropriately selected according to the material of the packaging material or container to be applied, the required durability, and the like, but the amount of addition is generally about 5 to 30% by weight.

The plasma sterilization indicator of the present invention contains, in addition to the above components, known additives such as a plasticizer, a dispersant, a stabilizer, and a thickener in order to improve durability and handling properties. It can be appropriately contained. In particular, from the viewpoint of improving light resistance, the indicator for plasma sterilization of the present invention preferably contains an ultraviolet absorber. As the ultraviolet absorber, any types can be used as long as they are commonly used in this field, as long as they do not adversely affect the achievement of the object of the present invention. Specifically, for example, triazine-based compounds, benzotriazole-based compounds, hindered amine-based compounds, and the like are preferable. Commercially available products of such compounds having an ultraviolet blocking effect include various compounds known under the trademark Tinuvin from Ciba-Geigy. The ultraviolet absorbers can be used alone or in combination of two or more compounds, but it is also effective to use a plurality of ultraviolet absorbers having different properties.

The indicator for plasma sterilization of the present invention is a composition which is decolorized by plasma sterilization. However, in order to ensure the visibility of the indicator after decolorization, the hue of the pigment main component is not impaired and the sterilization treatment is performed. It is preferable to add a dye or pigment that does not lose color or change color. Since an anthraquinone-based dye, which is a main component of the present invention, usually shows red, it is preferable to use a yellow dye or pigment as such a coloring material.

The plasma sterilization indicator of the present invention comprises:
Each of the above components can be dissolved in a suitable solvent, applied to a region requiring display, dried, and used. The solvent is selected in consideration of the solubility of the anthraquinone-based dye and other components, but in consideration of the solubility of the binder resin, the stability of the dye, and the drying efficiency during printing, ethanol, methanol, propylene Glycol, ethyl acetate, isopropanol, n-propanol, toluene and the like are preferred.

Next, the packaging material for sterilization of the present invention will be described. This packaging material is provided with a region that can be sterilized at least partially composed of gas-permeable paper or nonwoven fabric, and can be arbitrarily selected from known sheet-like materials having a necessary strength. it can. At least one region that can be sterilized, that is, a region made of paper or nonwoven fabric that has a permeability in a range that allows gas (gas) as an active ingredient to pass therethrough and does not allow bacteria to pass during plasma sterilization treatment applied to the present invention. It is necessary to have in the department. All of the packaging material can be made of such a sterilizable material, but from the viewpoint of cost, strength, and visibility of the contents, one uses a gas permeable material such as paper or nonwoven fabric,
On the other hand, it is also a preferred embodiment to use a transparent synthetic resin sheet or the like. For example, a bag formed by combining a gas-permeable paper or nonwoven fabric sheet on one side and a transparent synthetic resin sheet and two sheets on the other side is easy to manufacture, and the contents can be easily viewed. Properties and strength are ensured.

As described above, the packaging material for sterilization of the present invention comprises two sheets, one on the front and the other on the back, and a peelable adhesive portion is provided near both side edges, and at least one of the sheets is provided with a display portion by the indicator. Is formed. This packaging material is supplied after being processed into an arbitrary shape such as a bag shape or a roll shape as desired.

The formation of the display section is usually carried out by dissolving at least the indicator composition for plasma sterilization in a suitable solvent on a sheet constituting a packaging material, coating and drying. The indicator formed in this way may be provided with a surface protective layer for protecting the indicator. The surface protective layer is transparent or translucent so that the hydrogen peroxide vapor used in the plasma sterilization process or the plasma derived from the hydrogen peroxide can be transmitted and the color change of the dye can be seen. It can also be formed from various components. Among them, from the viewpoint of affinity with the display unit, the binder constituting the composition forming the indicator unit is included as a film-forming component, and an ultraviolet absorber, a water-repellent component for imparting water resistance, and abrasion resistance. It is preferably formed from a composition containing an acidic component, specifically, a wax component such as polyethylene wax. Such a surface protective layer of the display unit can be also implemented by dissolving in a solvent and applying the same as in the formation of the display unit.

The display portion of the sterile packaging material is usually formed on the surface of a gas-permeable paper or nonwoven sheet constituting a part of the packaging material. When the other constituent material of the packaging material is a transparent sheet through which the inside can be seen, the indicator layer is formed inside a gas-permeable paper or nonwoven fabric sheet or inside a transparent resin sheet (that is, when the packaging material is formed). On the inside of the bag body).

The composition constituting the indicator is homogeneously mixed by using a known kneading method such as that used for preparing a printing ink, and then the mixture is placed on a sheet material constituting a packaging material. To form an indicator. Examples of the application method include a method according to a known printing method, for example, offset printing, flexographic printing, gravure printing, or the like. The same method can be used for forming a surface protective layer on the display unit. There is no particular limitation on the coating amount of the display unit can be selected arbitrarily as long as the display is visible, in general, 0.2 to 20 g / m ²
And preferably in the range of 1 to 10 g / m ² . If the coating amount is too small, the visibility after the sterilization treatment is poor,
If the amount is too large, the scratch resistance during transportation and storage tends to decrease. The coating amount of the optional surface protective layer is preferably in the range of 1 to 10 g / m ² .

[0025]

The present invention will be described below in detail with reference to specific examples, but the present invention is not limited to these examples. In the following examples, “%” indicates “% by weight” unless otherwise specified.

(Examples 1 and 2) The components shown in Table 1 below which constitute the indicator for plasma sterilization were mixed and kneaded by a roll mill until the composition became homogeneous, thereby preparing a composition for forming the indicator.

[0027]

[Table 1]

The indicator composition was applied to the sheet surface of a high-density polyethylene nonwoven fabric by a gravure method using a gravure roll so that the coating amount after drying was 10 g / m ² to form a display portion. The hue of the display was reddish purple.

(Evaluation of Indicator for Plasma Sterilization) Light resistance The nonwoven fabric sheet was placed, and left for 1 day and 3 days in a state where three black lights were irradiated, and a change in hue of the display portion was observed. The results are shown in Table 2 below. When discoloration could not be detected by visual observation, it was evaluated as ○, when slight discoloration was observed, as Δ, and when completely discolored, as X. 2. Display Performance The nonwoven fabric sheet is treated with a low-temperature plasma sterilization system [STE
RRAD-100 (trade name, manufactured by Johnson & Johnson Medical Co., Ltd.)], and subjected to a sterilization treatment for 75 minutes. The results are shown in Table 2 below. 3. Discoloration speed Immediately after the display portion is formed on the nonwoven fabric sheet, it is placed in a low-temperature plasma sterilization system (STERRAD-100 (trademark), manufactured by Johnson & Johnson Medical Co., Ltd.) and treated for 1 minute after hydrogen peroxide is injected. The operation was stopped, and the change in hue of the display portion was visually observed. A sample that completely discolored was evaluated as ○, and a sample whose coloration was not detected visually was evaluated as x. Further, after the display portion was formed, the display was allowed to stand at normal temperature for one week, and the same test was performed to evaluate the discoloration speed after lapse of time. 4. Sterilization performance and display performance of sterile packaging material The nonwoven fabric sheet was used on one side, and a transparent polyester / low-density polyethylene laminated film was used on the other side. A biological indicator (BI) is put in the sterilization bag and sealed, and a low-temperature plasma sterilization system [STERRAD-100 (registered trademark) Johnson & Johnson Medical Co., Ltd.]
And then sterilized for 75 minutes. A change in the hue of the display section after sterilization was observed. The results are shown in Table 2 below.
Also, the biological indicator was aseptically removed, inoculated in a sterilized TSB medium, and cultured at 35 ° C. for 7 days.
The presence or absence of the growth of the bacteria was visually confirmed. The results are shown in Table 2 below.
Shown in

[0030]

[Table 2]

As is clear from Table 2, it was confirmed that the indicator for plasma sterilization of the present invention rapidly changed its color by the plasma sterilization treatment, had a high discoloration speed, and exhibited an excellent display function. Further, fading and discoloration due to the irradiation of the ultraviolet rays hardly caused a problem. It was also confirmed that there was no problem in the display function and no problem in the effect of the plasma sterilization treatment even when the sterilized packaging material was used.
In Example 2, in which the indicator for plasma sterilization contains a yellow pigment, the display portion remains yellow after discoloration.
The visibility was excellent.

(Examples 3 and 4) A surface protective layer containing the following components was coated on the display section of Examples 1 and 2 at an application amount of 10 g / m 2.
The nonwoven fabric sheets and the sterile packaging materials of Examples 3 and 4 were obtained in the same manner as in Examples 1 and ² , except for the formation in Example 2, and the same evaluation as in Example 1 was performed. The results are shown in Table 2 above. From the evaluation results, it was found that similar display performance, light resistance, and sterilization performance were obtained even when the surface protective layer was provided.

(Comparative Example 1) In the composition for a display unit of Example 1, diethanolamine as a discoloration aid,
A nonwoven fabric sheet and a sterile packaging material of Comparative Example 1 were obtained in the same manner as in Example 1 except that triethanolamine was not added, and the same evaluation as in Example 1 was performed. The results are shown in Table 2 above. As a result of the evaluation, it was found that when no discoloration aid was added, no discoloration was caused by the sterilization treatment, and this was unsuitable as an indicator. Therefore, subsequent evaluations were not performed.

(Comparative Example 2) In the composition for a display section of Example 1, the dye was changed to scratch red,
A nonwoven fabric sheet and a sterile packaging material of Comparative Example 2 were obtained in the same manner as in Example 1 except that the carbinol base of fuchsin, which is a triphenylmethane-based dye, was added, and the same evaluation as in Example 1 was performed. As shown in Table 2, when the dye containing the anthraquinone-based compound of the present invention as a main component was not used as the dye, the light resistance was low even when used in combination with an organic amine-based discoloration aid, which was not suitable for practical use. I understand.
Therefore, subsequent evaluations were not performed.

[0035]

According to the present invention, it is possible to clearly determine whether or not the object to be sterilized has been subjected to the plasma sterilization treatment, to have excellent stability including light fastness, and to achieve a fast discoloration speed for display. Indicator may be provided.
Moreover, since the sterilization packaging material of the present invention is formed with a display unit using the plasma sterilization indicator, the display unit has excellent stability, and it is clear whether or not the object to be sterilized has been subjected to plasma sterilization. Can be determined.

 ────────────────────────────────────────────────── ─── Continued on the front page (72) Inventor Kazuhiro Ikeda 1-4-16 Nihombashi Bakurocho, Chuo-ku, Tokyo Fujimori Industry Co., Ltd. F-term (reference) 2G054 AA10 AB10 BB08 BB20 CA20 EA06 FA29 FA50 GB04 JA04 3E067 AA11 AB83 AB99 BB01A BB06A BB22A CA03 EE32 EE47 4C058 AA01 BB06 DD15 EE12 EE13 EE16 KK06 4H056 AA01 AB04 AC04 AC05 AD02B AD04C AD09B AD09C AD34B AD34C AD38C FA08

Claims (3)

[Claims] 1. An indicator for plasma sterilization comprising a dye mainly composed of an anthraquinone compound, an organic amine compound and a binder. 2. The indicator for plasma sterilization according to claim 1, wherein the anthraquinone compound as a main component of the dye is selected from laccaic acid and carminic acid. 3. A sterilizing packaging material at least partially composed of gas-permeable paper or nonwoven fabric and capable of storing an object to be sterilized for plasma sterilization, wherein the dye is mainly composed of an anthraquinone compound. A sterilization packaging material, comprising: a display section comprising a plasma sterilization indicator containing an organic amine compound and a binder.