JPH0372260A - Indicator composition for detecting formalin sterilization - Google Patents

Abstract

PURPOSE:To accurately detect a sterilizing condition with excellent dicoloration response at relatively low temp. by using a composition containing a disperse dye represented by a specific formula, a hydrazine compound and an org. acid as an indicator. CONSTITUTION:An indicator for detecting formalin sterilization is composed of a composition containing a disperse dye represented by formula (wherein R<1> is an alkoxy group, an alkylsulfonyl group or a nitro group and R<2> and R<3> are a hydrogen atom, an alkyl group or an allyl derivative), a hydrazine compound and an org. acid. This composition is obtained by mixing and dispersing the disperse dye represented by the formula, the hydrazine compound and the org. acid along with vehicle for ink using a dispersing machine such as a ball mill. When the indicator using this composition is together used to treat medical machinery or a sanitary material at the time of formalin sterilization, it can be easily detected whether an object to be sterilized is sterilized under a proper condition by observing the discoloring condition of the indicator.

Description

[Detailed description of the invention]

[Industrial Application Field] The present invention relates to an indicator composition suitable for confirming sterilization conditions in formalin sterilization treatment used for sterilization of medical equipment and the like. [Prior Art] Conventionally, formalin has been used to sterilize silkworm rooms, livestock barns, agricultural and horticultural greenhouses, hospital rooms, beds, pine mattresses, futons, incubators, and operating tables. In recent years, its low toxicity has attracted attention, and its application to sterilization and disinfection of medical instruments is being reconsidered. Specific sterilization and disinfection methods using formalin include:
For example, fumigation is performed by heating formalin to generate formaldehyde gas. Formalin (formaldehyde) is adsorbed on granular plaster and placed in a sealed container together with the object to be sterilized. There is a way to sterilize it underneath. Biochemical and chemical indicators are used to visually check the quality of formalin sterilization. As a biochemical indicator, Bacillus subtilis adhered to filter paper is used. This indicator is sterilized together with the object to be sterilized, and after sterilization is completed, it is cultured to judge the quality of the sterilization process. However, it takes 48 hours for the culture results to be known, so there is no immediate response. Additionally, this indicator is relatively expensive, making it uneconomical and impractical to use every time sterilization is performed. As a chemical indicator, JP-A-56-66260
A disinfection indicator that combines an amino acid and a pH indicator is disclosed in the above publication. This utilizes the PH change that occurs when amino acids are exposed to formaldehyde gas. However, since this indicator is used in an atmosphere of formaldehyde gas generated by heating formalin, the operating temperature range is as high as 73 to 75°C, and it cannot be used to sterilize instruments that are not heat resistant. Therefore, the types of objects to be sterilized are limited. In addition, there are various chemical indicators that indicate bactericidal efficacy by changing color, but they do not store well before use.
It has the disadvantages that it takes a short time to complete the color change, which does not match the sterilization conditions, the color changes after use, and the color change is unclear.

[Problem to be solved by the invention]

The present invention has been made to solve the above problems,
It has discoloration conditions consistent with formalin (formaldehyde gas) sterilization processing conditions at temperatures as low as room temperature,
The object of the present invention is to provide an indicator composition that can accurately detect the sterilization treatment conditions.

[Means to solve the problem]

In order to achieve the above object, the present inventor has conducted intensive research on indicator compositions for detecting formalin sterilization, and has found that colorants of the general formula (wherein R1 is an alkoxy group, an alkylsulfonyl group, or a nitro group, R2 and R3 discovered that a new composition containing a disperse dye represented by a hydrogen atom, an alkyl group, or an alkyl group derivative, a hydrazine compound, and an organic acid is useful as a chemical indicator for formalin sterilization detection, and completed the present invention. I ended up doing it. That is, the indicator composition for detecting formalin sterilization of the present invention contains a disperse dye of the above formula, a hydrazine compound, and an organic acid. R1 in the formula is an alkoxy group, an alkylsulfonyl group or a nitro group. R2 and R3 are a hydrogen atom, an alkyl group or an alkyl group derivative. Examples of the disperse dye represented by the above formula include C,
1, Gisbar's Red 58, C, 1, Gisbar's Red 88, C, 1, Gisbar's Red 110, C, 1, Gisbar's Red 117, C, 1, Gisbar's Red 137
,C,I. Known materials such as Gisbar's Violet 43 can be used. Examples of hydrazine compounds include hydrazine sulfate, hydrazine benzoate, carbazic acid, acetohydrazide,
Benzhydrazide, isonicotinic acid hydrazide, and hydrochloric acid hydrazide can be used. Examples of effective organic acids include maleic acid, benzoic acid, phthalic acid, fumaric acid, citric acid, malonic acid, salicylic acid, gallic acid, succinic acid, malic acid, and various derivatives and metal salts thereof. . If necessary, organic sulfur compounds such as dipentamethylenethiuram tetrasulfide, 2.2°
-Dibenzothiazolyl disulfide, L-cystine, thiourea compounds and various derivatives thereof may be added. In addition to these, various additives such as talc, Carplex (trade name, manufactured by Shionogi & Co., Ltd.), calcium carbonate, etc. may be added. The composition of the present invention is prepared by mixing a disperse dye represented by the above general formula, a hydrazine compound, an organic acid, etc. with a ball mill,
It is obtained by mixing and dispersing in an ink vehicle using a dispersing machine such as a roll mill or a sand mill. The indicator composition thus obtained is usually applied in the form of a printing ink, such as a gravure printing ink, a screen printing ink, or a flexographic printing ink, to a suitable substrate such as paper, synthetic paper, synthetic resin film, etc. It can be printed and used as a detection card, or directly printed on packaging materials for items to be sterilized. Note that the ink vehicle is a resin dissolved in a solvent. The resin component used is one that does not impair the discoloration properties as an indicator, such as methylcellulose, ethylcellulose, nitrocellulose, butyral resin, acrylic ester resin, polyester resin, polyamide resin, maleic acid resin, styrene resin, and synthetic rubber resin. can. As the solvent, for example, a solvent whose main component is water, alcohols, cellosolves, aromatic hydrocarbons, petroleum, esters, or ketones is used depending on the type of resin of the vehicle. Examples of ink vehicles include alcohols,
Commercially available products containing cellosolves, petroleum, esters, ketones, and aromatic hydrocarbons as main solvents may also be used. Further, the surface of the printed indicator composition may be laminated with a synthetic resin film such as a polyester film, polypropylene film, vinyl chloride film, polyacetal film, or vinylidene chloride film using an adhesive. The durability of the indicator composition is improved by imparting water resistance and weather resistance.

[Operation and effects of the invention]

The indicator composition for detecting formalin sterilization of the present invention includes:
Compared to conventional indicator compositions, it has excellent color change responsiveness for detecting the sterilization conditions of formalin sterilization, which is performed at a relatively low temperature around room temperature. Moreover, the color change is consistent with formalin sterilization treatment conditions in the medical field. Therefore, when sterilizing medical equipment, medical tools, sanitary materials, etc. with formalin, if you include an indicator using this composition in the sterilizer, you can check the discoloration of the indicator to determine if the object to be sterilized is properly sterilized. It is possible to easily detect whether sterilization has been achieved under these conditions. This is extremely useful for process control of formalin (formaldehyde gas) sterilization.

【Example】

Examples of the present invention will be described in detail below. The ink vehicle is Unigloss 800 Medium (trade name, manufactured by Jujo Kako Co., Ltd.) made of acrylic acid ester resin.
, Q Set 200 Medium (trade name, manufactured by Jujo Kako Co., Ltd.) made of synthetic rubber resin is used. Ethocel (trade name, ethyl cellulose manufactured by Dow Chemical Company) was used as the resin component of the ink vehicle. Example 1 C, L Discharge Red 110 (manufactured by Mitsui Toatsu Dye Co., Ltd., Miketon Discharge Red RN) 0.3 parts Hydrazine sulfate 7 parts Maleic acid 3 parts Propyl gallate 3 parts Talc
Part 2 Unigloss 800 Medium
40 parts of the above formulation was placed in a ball mill and kneaded for 72 hours to prepare an ink-like indicator composition for detecting formalin sterilization. The resulting composition was screen printed on high quality paper and further laminated with a polypropylene film to produce an indicator card. 11.5 g of the granular formaldehyde preparation Evgen (trade name, manufactured by Tateyama Chemical Co., Ltd.) and the indicator obtained above were placed in a 404 acrylic resin container and left at room temperature to perform a color change test. At this time, the concentration of formaldehyde gas generated from Evgen corresponds to a maximum of about 3%. During the test, a biochemical indicator for ethylene oxide gas, A-Test (trade name, manufactured by 3M), was included as an indicator bacteria, and the consistency between the time of death of the indicator bacteria and the discoloration of the indicator card was confirmed. did. Test results first
Shown in the table. Table 1 As shown in Table 1, in this indicator card for formalin sterilization detection, the difference in color change depending on the processing time can be clearly distinguished, and the color change condition is consistent with the results of the biochemical indicator. Example 2 13 g of Ethocel was added to 87 g of butyl cellosolve and thoroughly stirred to completely dissolve, thereby preparing an Ethocel solution. In parallel with the preparation of Ethocel solution, add 6 parts of sulfuric acid hydrazide, 1.6 parts of maleic acid, and 1.6 parts of talc.
Two parts were placed in a ball mill and ground for 5 hours. Then, in a ball mill, C.1, Gisbar's Red 110 0.3
3 parts of propyl particulate ester solution and 45 parts of Ethcel solution were added and kneaded for 48 hours to form an ink, thereby preparing an indicator composition for detecting formalin sterilization. Using this composition, an indicator card was prepared in the same manner as in Example 1, and a color change test was conducted. Results similar to those shown in Table 1 were obtained. The results show that this composition is suitable as an indicator for detecting formalin sterilization. Example 3 C,1, Gisbar's Red 58 (manufactured by Mitsui Toatsu Dye Co., Ltd., Miketone First Pink PR) 0.3 parts Hydrazine sulfate 6 parts Talc
2 parts benzoic acid
2 parts propyl gallate
3 parts dipentamethylenethiuram tetrasulfide 2 parts Ethocel solution 45 parts An ink having the above formulation was prepared in the same manner as in Example 2, and an indicator card was produced. When a discoloration test was conducted in the same manner as in Example 1, results similar to those shown in Table 1 were obtained. Example 4 C,! , Jisbar's Red 110 0.3
7 parts hydrazine sulfate 7 parts malonic acid 4 parts propyl gallate 3 parts dipentamethylenethiuram tetrasulfide 2 parts Uniglos 800 medium 40 parts Ink with the above formulation was prepared in the same manner as in Example 1 to make an indicator card, and color change was performed. I conducted a test. The test results are shown in Table 2. ) Table 12 Dipentamethylenethiuram tetrasulfide 2 parts Uniglos 800 Medium 50 parts Ink having the above formulation was prepared in the same manner as in Example 1 to prepare an indicator card, and a color change test was conducted. The test results are shown in Table 3. Table 3 Example 5 c, r, Gisbar's Red 137 (manufactured by Mitsui Toatsu Dye Co., Ltd., Miketone Discharge Red BB) Hydrazine sulfate 1 Narichylic acid Propyl talc gallate 0.3 parts 6 parts 2.5 parts 3 parts 2 parts Example 6 C, 1, Gisbar's Red 110 Hydrazine sulfate Maleate Gallic acid Propyl dipentamethylene thiuram tetrasulfide Q set 200 Medium 03 parts 6 parts 1.8 parts 2 parts 1.5 parts 50 parts of the above formulation An indicator card was prepared by preparing the ink in the same manner as in Example 1, and a color change test was conducted. Results similar to those shown in Table 1 were obtained. Example 7 c, r, Gisbar's Red 110 0.3
Part sulfuric acid hydrazide 6 parts maleic acid 2 parts Turku
2 parts Propyl gallate 3 parts 2.2'-dibenzothiazolyl disulfide 1.5 parts Ethocel solution
50 parts of the above-mentioned ink was prepared in the same manner as in Example 2 to prepare an indicator card,
A discoloration test similar to that in Example 1 was conducted. Table 4 shows the results. In Table 4, the difference in color change with the passage of processing time can be clearly distinguished, and it is particularly suitable as an indicator for detecting formalin sterilization. Comparative Example 1 An ink having the same formulation as in Example 1 was prepared except that hydrazine sulfate, which is a hydrazine compound, was not added, and a printed matter was produced and a color change test was conducted. However, the hue of the printed matter remained red and no color change occurred. Comparative Example 2 An ink with the same formulation as in Example (except that the organic acids maleic acid and propyl gallate were not added) was prepared, and printed matter was produced and a color change test was conducted. However, the hue of the printed matter remained red. No color change occurred.

Claims (1)

[Claims] 1. General formula ▲ Numerical formula, chemical formula, table, etc. or an alkyl group derivative), a hydrazine compound, and an organic acid.