JP4557282B2 - Ink composition for indicator for plasma sterilization, sheet and packaging bag for sterilization - Google Patents

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 for detecting 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 for making it possible to detect both the drug filling process and the plasma process at a glance, and each different dye that changes color only in one process is mixed in the same composition. . The application layer of this composition solved the problem by making the color change in two stages in both the drug filling process and the plasma process.

  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 the respective dyes 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 Documents 1 and 2 have been proposed as the composition.

  As in these prior documents, so-called pH indicators can be suitably used because a composition in which components capable of forming an alkaline atmosphere coexist changes color upon contact with hydrogen peroxide.

  The inventors proposed in Patent Documents 3 and 4 a dye and a composition that do not change color only by contact with hydrogen peroxide but do not change color when contacted with plasma hydrogen peroxide. Anthraquinone dyes, methine dyes, and azo dyes are suitable as pigments for this application.

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

  If these dyes that change color only in the drug filling process and dyes that change only in the plasma process have the same composition and are formed on the support by coating, etc., both processes are performed correctly during the sterilization operation. The indicator that detects whether or not it is completed.

  Although it is not easy to introduce two kinds of dyes into one composition and exhibit their independent functions without interaction, in the composition of the present invention, an organic amine, an organic ammonium salt, or both It was found that the two functions are exhibited separately by adding. Organic amines and organic ammonium salts keep the composition or its coating layer alkaline, which helps discolor the pH indicator when contacted with hydrogen peroxide. In particular, the quaternary ammonium salt has a catalytic function of increasing the decoloring speed of anthraquinone dyes, methine dyes, and azo dyes by hydrogen peroxide plasma. For this reason, by using a composition to which an organic amine or organic ammonium salt is added, the two functions of discoloration due to contact with hydrogen peroxide and discoloration due to contact with hydrogen peroxide plasma can be exhibited separately. It has become possible.

  The organic amine is not particularly limited, and may be mono, di, or triamine of methyl, isopropyl, octylamine, cetyl, methanol, or ethanol, or di or triamine having functional groups that are different from each other. In addition to alkyl groups, alkenyl, alkynyl, aromatic, cyclic and heterocyclic functional groups may be used, and aromatic groups such as pyridine may be used.

  The organic ammonium salt is not particularly limited, and mono-, di-, tri-, and tetra-ammonium salts of methyl, isopropyl, octylamine, cetyl, methanol, and ethanol, and mono- and di-functional groups each having a different alkyl group. , Tri and tetraammonium salts may be used. Further, not only an alkyl group but also an alkenyl, alkynyl, aromatic, cyclic or heterocyclic functional group may be used, and an aromatic group such as a cetylpyridinium salt may be used. In particular, a quaternary ammonium salt is particularly preferable because it becomes a decoloring catalyst for a specific dye by hydrogen peroxide plasma as described above.

  As the ammonium salt, a chlorine salt is generally used and can be preferably used, but is not particularly limited, and may be bromine, iodine salt and the like.

The composition of the present invention can be used as an indicator sheet in which a layer is formed by coating, printing or the like, or an indicator packaging bag. The support used for coating and printing is not particularly limited, and paper, wood, synthetic resin sheet, glass plate, cloth, nonwoven fabric, and the like are preferably used. The use of a polyethylene terephthalate (PET) sheet or a polyethylene or polypropylene non-woven fabric for sterilization bags as a support is more preferable because the drug is not adsorbed by the indicator.
Example

Example 1
Preparation of ink composition 10 g of pH indicator (aurintricarboxylic acid triammonium salt), 1 g of anthraquinone dye (“Miketone Fast Violet R” manufactured by Mitsui Toatsu Chemical Co., Ltd.), quaternary ammonium salt (“CA-2150”, NIKKOL) 2.0 g, 10 g of resin binder (“Versamide 756” manufactured by Cognis) and 10 g of extender (“Aerosil R-972” manufactured by Nippon Aerosil Co., Ltd.) in 150 g of ethyl cellosolve, dissolved and dispersed. It was set as thing A.

Example 2
Preparation of Indicator Sheet On a white PET sheet, the composition A was screen-printed with a 1 cmφ circle with a 350 mesh plate and dried. Thereby, an indicator B having a purple printed layer on a white background was obtained.

Example 3
Confirmation of degree of discoloration of indicator by exposure to hydrogen peroxide Indicator B was 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 indicator B 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).

  Before and after the treatment, the indicator changed from purple to green. pH indicator (aurintricarboxylic acid triammonium salt) changes from red to yellow when contacted with hydrogen peroxide, and anthraquinone dye ("Miketone Fast Violet R" manufactured by Mitsui Toatsu Chemicals) contacts hydrogen peroxide plasma. In this example, only the pH indicator is changed to show an orange color mixed with yellow and purple.

Example 4
Confirmation of degree of discoloration by hydrogen peroxide low temperature plasma sterilization treatment of indicator The indicator B is placed in the sterilization layer of the hydrogen peroxide low temperature plasma sterilizer “STERAD 100S” (manufactured by Johnson & Johnson) and the sterilizer is short-circuited. Sterilization was performed once at the cycle setting.

  Before and after treatment, the indicator changed from purple to yellow. Both the pH indicator and the anthraquinone dye have changed color, indicating a mixed color of yellow and colorless.

Example 5
The indicators B of untreated, hydrogen peroxide-only treatment (Example 3), and hydrogen peroxide plasma sterilization treatment (Example 4) were arranged, and re-visibility was visually observed. As a result, the difference which can be judged at a glance after untreated, treatment with only hydrogen peroxide and after treatment with hydrogen peroxide plasma was recognized.

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.

Claims (3)

Including a pigment of a PH indicator and a pigment of a pigment that changes color with plasma hydrogen peroxide selected from anthraquinone dyes and / or methine dyes and / or azo dyes, and the two pigments have different discoloration colors, An indicator composition for plasma sterilization comprising an organic amine and / or an organic ammonium salt. A sterilization identification sheet comprising at least one layer formed on a support, comprising the indicator composition for plasma sterilization according to claim 1. A packaging bag for identifying sterilization treatment, wherein at least one layer formed on the packaging bag comprises the plasma sterilization indicator composition according to claim 1.