JP2005329019A - Indicator sheet for plasma sterilization and package for sterilization - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an indicator sheet for plasma sterilization and a package which allow to detect two processes, that is, a medicine filling process and a plasma generating process, at a glance. <P>SOLUTION: The indicator sheet for plasma sterilization allows to sense both the medicine filling process and the plasma generating process at a glance. Compositions each of which changes its color only on one process are combined and so arranged that the changes of the colors are large and sensible by the eyes. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

 The present invention relates to a plasma sterilization detection indicator and a sterilization packaging bag. More specifically, the present invention relates to a plasma sterilization detection indicator and a sterilization packaging bag using hydrogen peroxide as a medicine.

  Various equipment and instruments used in hospitals, laboratories and the like are used after being sterilized. As this sterilization method, high-pressure steam sterilization, ethylene oxide gas sterilization, plasma sterilization, and the like are known. Among these, the plasma sterilization treatment is advantageous in that plasma is generated in a gas atmosphere such as hydrogen peroxide to sterilize equipment at a low temperature, and toxic gas remains little.

  In this plasma sterilization process, as in other 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 plasma sterilizer to know the atmospheric gas concentration and exposure time in the treatment system, and the concentration and exposure time of active species that contribute to the killing of bacteria.

  As described above, the sterilization process of the plasma sterilizer includes a process in which a drug such as hydrogen peroxide is filled in the apparatus, and a plasma process of the drug by irradiation with high frequency energy and the like thereafter. In order to determine which of the two processes is defective, such as when sterilization failure occurs, there is only a proposal to detect either process for the plasma sterilization indicator. Only the indicator which detects only is in practical use.

  Therefore, it is important for the indicator for plasma sterilization to detect both the drug filling process and the plasma process, and the present invention provides a plasma sterilization indicator sheet and a package that can detect both processes at a glance. The main purpose.

  The present invention is an indicator for plasma sterilization that makes it possible to detect both the drug filling process and the plasma process at a glance, and combines different compositions that change color only in one process, resulting in a large color change in appearance. The problem was solved by arranging so that

  According to the present invention, it is possible to provide a chemical indicator that can judge at a glance whether or not both of the plasma introduction process of the plasma sterilization process and the plasma process of the drug have been normally performed by colors before and after sterilization. it can.

  Various proposals have been made for respective compositions that change color in the course of drug filling or plasma formation, and these can be suitably used in the present invention.

  Examples of compositions that can change color in the course of drug filling when hydrogen peroxide is used include phenolphthalein (see Non-Patent Document 1) and other dyes having a phenolic hydroxyl group (Non-Patent Document 2, 3) is disclosed. In addition, Patent Document 1 or 2 has been proposed as a composition.

  The inventors proposed in Patent Documents 3 and 4 a composition that does not change color only by contact with hydrogen peroxide but does not change color when contacted with plasma hydrogen peroxide.

Kazuo Fujioka, Chemistry and Education 49 (9), 574 (2001) Tamura Takamitsu, Petrochemical 44 (12), 1086 (1995) Tamura Takamitsu, Petrochemical 44 (12), 1093 (1995)

Japanese Patent Laid-Open No. 11-178904 JP 2001-13129 Japanese Patent Laid-Open No. 2001-174449 Japanese Patent Application No. 2004-101035

  An indicator that detects whether or not both processes are correctly performed during the sterilization process is formed on the support by forming a composition layer that changes only in the drug filling process and a composition layer that changes only in the plasma process. Complete. In brief, if both layers are formed in different places on the support, the respective processes can be confirmed on the same support.

  When both layers are formed on the support in an overlapping manner, each process can be detected as two-stage discoloration. For example, a layer that changes from red to yellow when in contact with hydrogen peroxide and a color that changes from blue to colorless when in contact with plasma hydrogen peroxide is purple in an untreated state, after normal sterilization. Becomes yellow. If no hydrogen peroxide plasma is generated after the hydrogen peroxide is filled, the indicator will show green with a mixture of blue and yellow. As a result, the indicator of this configuration changes color in the order of purple-green-yellow when passing through a normal sterilization process. When the indicator after sterilization is yellow, it indicates that the normal sterilization process has been performed. When the indicator is green, it indicates that the hydrogen peroxide plasma was abnormal. Indicates that the filling of sterilizer with hydrogen oxide was abnormal.

  When two layers are formed on a support in an overlapping manner, if the transparency of both layers is insufficient, the color tone often becomes dark due to subtractive color mixing. If a large number of lines are formed next to each other on a straight line, curve, or spot so that the two layers do not overlap each other, the subtractive color mixture will be clear and the color will be clear, making it a more preferable indicator mode in terms of visibility. it can.

  When multiple layers are formed adjacent to each other on a straight line, curve, or spot so that the two layers do not overlap each other, the tone of the indicator varies depending on the thickness of the line or point, or the frequency of formation of multiple layers on one layer. It is also possible to fine-tune to a design with better visibility.

The layer that changes color only in the hydrogen peroxide filling process uses a so-called pH indicator as a pigment as described in the above-mentioned prior art, and is a means for coating, printing, etc. as a composition in which the pH indicator coexists with components capable of becoming an alkaline atmosphere. Can be formed on the support.

The layer that does not change color when contacted with hydrogen peroxide alone, but changes color only when contacted with plasma hydrogen peroxide, contains anthraquinone dyes, methine dyes, and azo dyes in the presence of quaternary ammonium salts. The composition to be a pigment can be formed on a support by means such as coating or printing. The inventors have proposed this as Japanese Patent Application No. 2001-174449 and Japanese Patent Application No. 2004-101035.
Example 1

Preparation of composition A which changes color only in hydrogen peroxide filling process According to Japanese Patent Laid-Open No. 2001-13129, 14.3 g of aurintricarboxylic acid triammonium salt and 66.3 g of a resin binder (“Versamide 756” manufactured by Cognis Japan) 2 A composition A was obtained by stirring and mixing in 120.3 g of propanol.

Preparation of composition B that changes color upon contact with plasma hydrogen peroxide According to Japanese Patent Laid-Open No. 2001-174449, 0.2 g of anthraquinone dye ("Miketone Fast Violet R" manufactured by Mitsui Toatsu Chemical Co., Ltd.), quaternary 2.0g of ammonium salt ("CA-2150" manufactured by NIKKOL), 7.4g of resin binder ("Etocel 10" manufactured by Dow Chemical Company), and 9.8g of extender ("Aerosil R-972" manufactured by Nippon Aerosil Co., Ltd.) The composition B was stirred, dissolved and dispersed in 80.7 g of ethyl cellosolve.

Example 2
Preparation of an indicator sheet On a white PET sheet, the composition A and the composition B were screen-printed with a 350 mesh plate so as to have the configuration shown in FIGS. 1 to 3, and an indicator C (FIG. 1), an indicator D (FIG. 2), Indicator E (FIG. 3) was produced.

Example 3
Confirmation of degree of discoloration of indicator by exposure to hydrogen peroxide Indicators C, D and E were placed in a 1 liter desiccator, and the following operation was repeated twice. After maintaining the desiccator at 45 ° C. and reducing the pressure to 0.5 torr, 18 μL of 58% hydrogen peroxide was introduced into the desiccator with a microsyringe. After two operations, the degree of discoloration of the indicators C, D and E was observed.

  The above-described processing conditions are in accordance with the conditions of the hydrogen peroxide low temperature plasma sterilizer “STERAD 100S” (manufactured by Johnson & Johnson).

  The color of the indicator before and after treatment was as follows. In the indicator C, only the portion of the composition A that was red changed to yellow, and the portion of the composition B remained purple before and after the treatment. In the indicator D, the overlapping portion of the composition AB, which was dark purple, was changed to a dark engine color. The composition A portion that protruded from the overlapping portion became yellow, and the composition B portion did not change before and after the treatment and was purple. In the indicator E, the portion where the composition AB was applied changed from a bright purple image to the whole, and after the treatment, only the ★ portion of the composition A changed to yellow, and the whole changed to a bright orange image. At this time, the ♦ part of the composition B was purple before and after the treatment.

Example 4
Confirmation of the degree of discoloration by hydrogen peroxide low temperature plasma sterilization treatment of the indicator The indicators C, D, E are placed in the sterilization layer of the hydrogen peroxide low temperature plasma sterilizer “STERAD 100S” (manufactured by Johnson & Johnson). Sterilization was performed once with the setting of the short cycle of the sterilizer.

  The color of the indicator before and after sterilization was as follows. In the indicator C, the portion of the composition A that was red changed to yellow, and the portion of the composition B that was purple changed to almost colorless. In the indicator D, the overlapping portion of the composition AB, which was dark purple, was changed to dark yellow. The part of the composition A that protruded from the overlapping part was yellow, and the part of the composition B was almost colorless. In the indicator E, the part where the composition AB was applied changed from a light purple image to a light yellow image after processing. The ★ part of the composition A changed to yellow, and the ◆ part of the composition B changed to almost colorless.

Example 5
Indicators C, D, and E of untreated, hydrogen peroxide-only treatment (Example 3), and hydrogen peroxide plasma sterilization treatment (Example 4) were arranged, respectively, and visual revisibility was observed. As a result, the indicators C, D, and E showed a difference that could be judged at a glance after untreated, after treatment with only hydrogen peroxide, and after treatment with hydrogen peroxide plasma. In terms of hue, the indicators C and E are preferable because they are easy to judge based on bright colors.

  Therefore, according to the present invention, there is provided a chemical indicator capable of judging at a glance whether or not both of the plasma introduction process of the plasma sterilization process and the plasma process of the drug have been normally performed by colors before and after sterilization. I can do things.

Schematic of a simple example of the chemical indicator of the present invention Schematic diagram when the chemical indicator of the present invention is configured by overcoating Schematic diagram when the chemical indicator of the present invention is composed of spots

Claims (6)

A sterilization processing identification sheet in which at least two layers of a colored layer that changes color in a hydrogen peroxide atmosphere and a colored layer that changes color in a hydrogen peroxide atmosphere in a plasma state are formed on a support. A packaging bag for content sterilization in which at least two layers, a colored layer that changes color in a hydrogen peroxide atmosphere and a colored layer that changes color in a hydrogen peroxide atmosphere in a plasma state, are formed on the packaging bag. 3. The indicator sheet for plasma sterilization and sterilization according to claim 1 and 2, wherein at least two layers of a colored layer that changes color in a hydrogen peroxide atmosphere and a colored layer that changes color in a hydrogen peroxide atmosphere in a plasma state are formed to overlap each other. Packaging bags. 3. A colored layer that changes color in a hydrogen peroxide atmosphere and a colored layer that changes color in a hydrogen peroxide atmosphere in a plasma state are formed so as not to overlap each other in a linear or speckled manner. Plasma sterilization indicator sheet and sterilization packaging bag. 5. The plasma sterilization indicator sheet and sterilization packaging bag according to claim 1, wherein the colored layer that changes color in a hydrogen peroxide atmosphere in a plasma state contains a dye and a quaternary ammonium salt. 6. The indicator for plasma sterilization according to claim 1, wherein the pigment contained in the colored layer that changes color in a hydrogen peroxide atmosphere in a plasma state is an anthraquinone dye and / or a methine dye and / or an azo dye. Sheet and sterilization packaging bag.