Peracetic acid composition for cleaning medical equipment and method for producing same
A peracetic acid composition with specific additives and pH control addresses the issue of non-compliant wastewater discharge from medical equipment cleaning, ensuring environmental safety and effective sterilization.
Patent Information
- Application Number
- JP2024114802
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-06-26
- Filing Date
- 2024-07-18
- Publication Date
- 2025-12-16
- Estimated Expiration
- 2040-05-08
AI Technical Summary
Existing peracetic acid compositions for sterilizing and cleaning medical equipment do not meet sewage discharge standards, leading to pipe damage and environmental hazards.
A disinfecting and cleaning composition containing peracetic acid, hydrogen peroxide, acetic acid, and additives such as polyoxyethylene lauryl ether acetic acid, phosphorus-based stabilizers, and carboxylic acid stabilizers, with a pH range of 4.0 to 10.0, ensuring wastewater compliance and improved protein removal.
The composition achieves high peroxide stability and meets sewage discharge standards, allowing wastewater to be discharged without neutralization, while maintaining effective sterilization and cleaning capabilities.
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Abstract
Description
[Technical Field]
[0001] The present invention relates to a peracetic acid composition for sterilization and cleaning suitable for sterilizing and cleaning medical equipment, and a method for producing the same. [Background technology]
[0002] Traditionally, acidic and alkaline chemicals have been used to sterilize and clean medical equipment, including aqueous solutions of peracid. However, the use of acidic and alkaline chemicals has led to numerous cases of wastewater being discharged without meeting sewage discharge standards, resulting in damage to concrete sewer pipes. Damage to sewer pipes not only prevents water from being discharged into the sewer system, but also potentially leads to road collapses, requiring immediate action. Against this backdrop, the Tokyo Metropolitan Government Bureau of Sewerage issued a warning regarding dialysis wastewater and sewer pipes in January 2019. The Bureau requires that the sewage discharge standard for wastewater be a hydrogen ion concentration (pH) between 5 and 9.
[0003] Known peracetic acid compositions for sterilization and cleaning of medical equipment include an acidic aqueous solution of peracetic acid (Patent Document 1), an acidic oxidizing agent-containing composition that inhibits aluminum corrosion (Patent Document 2), and an alkaline disinfectant and cleaning formulation (Patent Document 3). However, these compositions do not necessarily meet the sewage discharge standards for wastewater. Therefore, there is still a need for cleaners that do not damage drainage pipes. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2010-184868 [Patent Document 2] WO2010 / 095231 publication [Patent Document 3] Special Publication No. 2016-532634 Summary of the Invention [Problem to be solved by the invention]
[0005] There is a need for a medical device disinfecting and cleaning composition that has high peroxide stability and whose wastewater meets sewerage standards. [Means for solving the problem]
[0006] As a result of extensive research, the inventors have discovered that by adding an additive, it is possible to provide a composition for sterilizing and cleaning medical equipment, which has high peroxide stability, allows wastewater to meet sewage disposal standards, and has improved protein removal ability.
[0007] That is, the present invention includes the following embodiments.
[0008] <1> containing 0.001 to 15 mass% of peracetic acid, 0.01 to 70 mass% of acetic acid and / or a salt thereof, 0.001 to 25 mass% of hydrogen peroxide, and water, Contains additives, A disinfecting and cleaning composition, the pH value of which is 4.0 to 10.0. <2> the additive is at least one selected from the group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, a carboxylic acid-based stabilizer, and a stannate; <1> The disinfecting and cleaning composition according to claim 1. <3> The additive is polyoxyethylene lauryl ether acetic acid and / or a salt thereof. <1> or <2> The disinfecting and cleaning composition according to claim 1. <4> The additive is a phosphorus-based stabilizer. <1> ~ <3> The disinfecting and cleaning composition according to any one of the preceding claims. <5> The additive is a carboxylic acid-based stabilizer. <1> ~ <4> The disinfecting and cleaning composition according to any one of the preceding claims. <6> The additives are polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, and a carboxylic acid-based stabilizer. <1> or <2> The disinfecting and cleaning composition according to claim 1. <7> the phosphorus-based stabilizer includes 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof, or diethylenetriaminepentamethylenephosphonic acid (DTPP) or a salt thereof; <6> The disinfecting and cleaning composition according to claim 1. <8> the carboxylic acid stabilizer includes ethylenediaminetetraacetic acid (EDTA) or a salt thereof, or diethylenetriaminepentaacetic acid (DTPA) or a salt thereof; <6> The disinfecting and cleaning composition according to claim 1. <9> the phosphorus-based stabilizer is 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof, The carboxylic acid stabilizer is ethylenediaminetetraacetic acid (EDTA) or a salt thereof. <6> The disinfecting and cleaning composition according to claim 1. <10> The polyoxyethylene lauryl ether acetic acid and / or a salt thereof is contained in an amount of 0.001 to 5% by mass. <6> ~ <9> The disinfecting and cleaning composition according to any one of the preceding claims. <11> The phosphorus-based stabilizer is contained in an amount of 0.0001% by mass or more and less than 0.5% by mass, and the carboxylic acid-based stabilizer is contained in an amount of 0.0001% by mass or more and less than 0.5% by mass. <6> ~ <9> The disinfecting and cleaning composition according to any one of the preceding claims. <12> The pH value of the composition is 5.0 to 9.0. <1> ~ <11> The composition according to any one of the preceding claims. <13> It includes a mixing step of mixing at least the following components: <1> ~ <12> 10. A method for producing the composition according to any one of the preceding claims. (i) Additives (ii) Hydrogen peroxide and acetic acid (iii) acetate <14> It includes a mixing step of mixing at least the following components: <1> ~ <12> 10. A method for producing the composition according to any one of the preceding claims. (i) Additives (ii) Hydrogen peroxide and acetic acid (iii) Alkali <15> After mixing the additive, acetic acid, and alkali, hydrogen peroxide water is added at 30 to 50°C. <14> The manufacturing method described in <16> <1> ~ <12> a composition according to any one of the preceding claims, additional water A diluted disinfecting and cleaning composition comprising: <17> containing 0.001 to 1.5 mass% of peracetic acid, 0.01 to 7 mass% of acetic acid and / or a salt thereof, 0.001 to 2.5 mass% of hydrogen peroxide, and water, Contains additives, The pH value of the composition is 4.0 to 10.0. <16> A diluted composition for disinfection and cleaning according to claim 1. <18> <1> ~ <12> or a composition according to any one of <16> or <17> A method for sterilizing and cleaning medical instruments using the diluted composition described above. <19> The method for sterilizing and cleaning the medical instrument is selected from the group consisting of a dipping method, a spraying method, a coating method, a liquid passing method, a circulation method, and an encapsulation method. <20> The sterilization and cleaning method described in <20> The medical device is a dialysis device. <18> or <19> The sterilization and cleaning method described in [Effects of the Invention]
[0009] According to the present invention, by adding an additive, it is possible to provide a composition for sterilizing and cleaning medical instruments, which has high peroxide stability, allows wastewater to meet sewage discharge standards, and has improved protein removal ability. Because the pH value of the composition of the present invention meets sewage discharge standards, the wastewater after use can be discharged without the need for neutralization treatment. DETAILED DESCRIPTION OF THE INVENTION
[0010] 1. Disinfecting and cleaning compositions In one embodiment of the present invention, the disinfecting and cleaning composition comprises peracetic acid, hydrogen peroxide, acetic acid and / or its salts, and water, and additives.
[0011] In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be 4.0 to 10.0. In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be, for example, 4.0, 4.5, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, etc., but is not limited to these values. In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be, for example, 4.0 to 10.0, 4.0 to 9.5, 4.0 to 9.0, 4.0 to 8.5, 4.0 to 8.0, 4.0 to 7.5, 4.0 to 7.0, 4.0 to 6.5, or 4.0 to 6.0. In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be 4.5 to 10.0, 4.5 to 9.5, 4.5 to 9.0, 4.5 to 8.5, 4.5 to 8.0, 4.5 to 7.5, 4.5 to 7.0, 4.5 to 6.5, or 4.5 to 6.0. In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be 5.0 to 10.0, 5.0 to 9.5, 5.0 to 9.0, 5.0 to 8.5, 5.0 to 8.0, 5.0 to 7.5, 5.0 to 7.0, 5.0 to 6.5, or 5.0 to 6.0. In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be 5.1 to 10.0, 5.1 to 9.5, 5.1 to 9.0, 5.1 to 8.5, 5.1 to 8.0, 5.1 to 7.5, 5.1 to 7.0, 5.1 to 6.5, or 5.1 to 6.0. In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be 5.2 to 10.0, 5.2 to 9.5, 5.2 to 9.0, 5.2 to 8.5, 5.2 to 8.0, 5.2 to 7.5, 5.2 to 7.0, 5.2 to 6.5, or 5.2 to 6.0. In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be 5.3 to 10.0, 5.3 to 9.5, 5.3 to 9.0, 5.3 to 8.5, 5.3 to 8.0, 5.3 to 7.5, 5.3 to 7.0, 5.3 to 6.5, or 5.3 to 6.0. In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be 5.4 to 10.0, 5.4 to 9.5, 5.4 to 9.0, 5.4 to 8.5, 5.4 to 8.0, 5.4 to 7.5, 5.4 to 7.0, 5.4 to 6.5, or 5.4 to 6.0.In one embodiment of the present invention, the pH value of the sterilizing and cleaning composition may be 5.5 to 10.0, 5.5 to 9.5, 5.5 to 9.0, 5.5 to 8.5, 5.5 to 8.0, 5.5 to 7.5, 5.5 to 7.0, 5.5 to 6.5, or 5.5 to 6.0. In a preferred embodiment of the present invention, the pH value of the sterilizing and cleaning composition is 5.0 to 9.0. In a more preferred embodiment of the present invention, the pH value of the sterilizing and cleaning composition is greater than 5.0. In a more preferred embodiment of the present invention, the pH value of the sterilizing and cleaning composition is greater than 5 and not greater than 10. In another more preferred embodiment of the present invention, the pH value of the sterilizing and cleaning composition is greater than 5 and not greater than 9.
[0012] In one embodiment of the present invention, the disinfecting and cleaning composition comprises 0.001 to 15% by mass of peracetic acid, 0.01 to 70% by mass of acetic acid and / or a salt thereof, 0.001 to 25% by mass of hydrogen peroxide, and water, Contains additives, The pH value of the composition may be 4.0 to 10.0.
[0013] In one embodiment of the present invention, the additive contained in the disinfecting and cleaning composition may be one or more selected from the group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, a carboxylic acid-based stabilizer, and a stannate.
[0014] In one embodiment of the present invention, the disinfecting and cleaning composition may include polyoxyethylene lauryl ether acetic acid and / or salts thereof as an additive.
[0015] In one embodiment of the present invention, the disinfecting and cleaning composition may include a phosphorus-based stabilizer as an additive.
[0016] In one embodiment of the present invention, the disinfecting and cleaning composition may include, as an additive, a carboxylic acid stabilizer.
[0017] In one embodiment of the present invention, the disinfecting and cleaning composition may include stannate as an additive.
[0018] In one embodiment of the present invention, the disinfecting and cleaning composition may include a phosphorus-based stabilizer and a carboxylic acid-based stabilizer as additives. In this embodiment, the disinfecting and cleaning composition may further include a stannate as an additive.
[0019] In one embodiment of the present invention, the disinfecting and cleaning composition may include, as additives, polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, and a carboxylic acid-based stabilizer. In this embodiment, the disinfecting and cleaning composition may further include, as an additive, a stannate salt.
[0020] In one embodiment of the present invention, the disinfecting and cleaning composition may include polyoxyethylene lauryl ether acetic acid and / or a salt thereof and a phosphorus-based stabilizer as additives. In this embodiment, the disinfecting and cleaning composition may further include a stannate as an additive.
[0021] In one embodiment of the present invention, the disinfecting and cleaning composition may include polyoxyethylene lauryl ether acetic acid and / or a salt thereof and a carboxylic acid stabilizer as additives. In this embodiment, the disinfecting and cleaning composition may further include a stannate as an additive.
[0022] In one embodiment of the present invention, the disinfecting and cleaning composition may include polyoxyethylene lauryl ether acetate and / or its salts, and stannate as additives.
[0023] In one embodiment of the present invention, the disinfecting and cleaning composition may contain stannate at a concentration of 0.0001 to 5% by mass.
[0024] In another embodiment of the present invention, the disinfecting and cleaning composition comprises 0.001 to 15% by mass of peracetic acid, 0.01 to 70% by mass of acetic acid and / or a salt thereof, 0.001 to 25% by mass of hydrogen peroxide, and water, Contains stannate as an additive, The pH value of the composition may be 4.0 to 10.0.
[0025] In one embodiment of the present invention, the disinfecting and cleaning composition may further comprise a phosphorus-based stabilizer and a carboxylic acid-based stabilizer. In the disinfecting and cleaning composition of the present invention, the concentration of the phosphorus-based stabilizer may be 0.0001% by weight or more and less than 0.5% by weight, and the concentration of the carboxylic acid-based stabilizer may be 0.0001% by weight or more and less than 0.5% by weight.
[0026] Each component will be described below.
[0027] (1) Additives The sterilizing and cleaning composition of the present invention contains peracetic acid, hydrogen peroxide, acetic acid and / or a salt thereof, and water, and may further contain additives. The addition of these additives improves the stability of hydrogen peroxide and enables the pH value of the sterilizing and cleaning composition to be adjusted to 4.0 to 10.0. Furthermore, by adjusting the pH value of the sterilizing and cleaning composition of the present invention to the above range, it is possible to achieve excellent protein removal. The sterilizing and cleaning composition of the present invention may contain, as an additive, one or more selected from the group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, a carboxylic acid-based stabilizer, and a stannate salt.
[0028] <Polyoxyethylene lauryl ether acetic acid and / or its salt> The disinfecting and cleaning composition of the present invention may contain polyoxyethylene lauryl ether acetic acid and / or a salt thereof as an additive. The disinfecting and cleaning composition of the present invention may contain polyoxyethylene lauryl ether acetic acid and / or a salt thereof alone as an additive, or may contain it in combination with one or more selected from the group consisting of phosphorus-based stabilizers, carboxylic acid-based stabilizers, and stannate salts. Polyoxyethylene lauryl ether acetic acid and / or a salt thereof that can be used in the disinfecting and cleaning composition of the present invention is represented by the following general formula. Salts of polyoxyethylene lauryl ether acetic acid may be, for example, sodium salts, potassium salts, etc., but are not limited to these. The polyoxyethylene lauryl ether acetic acid and / or a salt thereof is preferably polyoxyethylene lauryl ether acetic acid. R1-(O-R2)nO-R3-COOH (In the formula, R1 is a lauryl group, R2 is an ethylene group, R3 is a methylene group, and n is a number from 1 to 30.)
[0029] In a preferred embodiment, n may be 2 to 20. In a preferred embodiment, n may be, for example, but not limited to, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14, or 15. In a more preferred embodiment, n is 4.5 or 10.
[0030] The molecular weight of the polyoxyethylene lauryl ether acetic acid and / or salts thereof used in the disinfecting and cleaning composition of the present invention may be 300 to 1200. In a preferred embodiment, the molecular weight of the polyoxyethylene lauryl ether acetic acid and / or salts thereof is 400 to 1000.
[0031] In the disinfecting and cleaning composition of the present invention, the concentration of polyoxyethylene lauryl ether acetic acid and / or a salt thereof may be 0.001 to 5% by mass, preferably 0.01 to 2% by mass, and more preferably 0.01 to 1% by mass.
[0032] <Phosphorus-based stabilizer> The disinfectant and cleaning composition of the present invention may contain a phosphorus-based stabilizer as an additive. Any phosphorus-based stabilizer can be used as long as it stabilizes hydrogen peroxide and adjusts the pH value of the disinfectant and cleaning composition within the above range. The disinfectant and cleaning composition of the present invention may contain the phosphorus-based stabilizer alone as an additive, or in combination with one or more selected from the group consisting of polyoxyethylene lauryl ether acetic acid and / or its salt, carboxylic acid stabilizers, and stannate salts. Examples of phosphorus-based stabilizers that can be used in the disinfectant and cleaning composition of the present invention include, but are not limited to, pyrophosphoric acid or a salt thereof, phosphoric acid or a salt thereof, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof, diethylenetriaminepentamethylenephosphonic acid (DTPP) or a salt thereof, nitrilotrismethylenephosphonic acid or a salt thereof, 2-phosphonobutane-1,2,4-tricarboxylic acid or a salt thereof, and ethylenediaminetetramethylenephosphonic acid or a salt thereof. In one embodiment of the present invention, the phosphorus-based stabilizer may be 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof. In another embodiment of the present invention, the phosphorus-based stabilizer may be diethylenetriaminepentamethylenephosphonic acid (DTPP) or a salt thereof. In yet another embodiment of the present invention, the phosphorus-based stabilizer may be pyrophosphoric acid or a salt thereof. In a preferred embodiment of the present invention, the phosphorus-based stabilizer may be 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof.
[0033] In the disinfecting and cleaning composition of the present invention, the concentration of the phosphorus-based stabilizer may be 0.0001% by mass or more and less than 0.5% by mass, preferably 0.0001 to 0.30% by mass, more preferably 0.0001 to 0.20% by mass, and even more preferably 0.0001 to 0.10% by mass.
[0034] <Carboxylic acid stabilizer> The disinfecting and cleaning composition of the present invention may contain a carboxylic acid stabilizer as an additive. Any carboxylic acid stabilizer can be used as long as it stabilizes hydrogen peroxide and can adjust the pH value of the disinfecting and cleaning composition to the above range. The disinfecting and cleaning composition of the present invention may contain the carboxylic acid stabilizer alone as an additive, or may contain it in combination with one or more selected from the group consisting of polyoxyethylene lauryl ether acetic acid and / or its salt, a phosphorus-based stabilizer, and a stannate. Examples of carboxylic acid stabilizers that can be used in the disinfecting and cleaning compositions of the present invention include, but are not limited to, ethylenediaminetetraacetic acid (EDTA) or a salt thereof, diethylenetriaminepentaacetic acid (DTPA) or a salt thereof, picolinic acid or a salt thereof, dipicolinic acid or a salt thereof, nitrilotriacetic acid or a salt thereof, N-(2-hydroxyethyl)ethylenediamine-N,N',N"-triacetic acid or a salt thereof, triethylenetetramine-N,N,N',N",N"',N"'-hexaacetic acid or a salt thereof, 1,3-propanediamine-N,N,N',N'-tetraacetic acid, 1,3-diamino-2-propanol-N,N,N',N'-tetraacetic acid, N-(2-hydroxyethyl)iminodiacetic acid or a salt thereof, N,N-di(2-hydroxyethyl)glycine or a salt thereof, glycol ether diaminetetraacetic acid, and (S,S)-ethylenediamine-N,N'-disuccinic acid or a salt thereof. In one embodiment of the present invention, the carboxylic acid stabilizer may be ethylenediaminetetraacetic acid (EDTA) or a salt thereof. In another embodiment of the present invention, the carboxylic acid stabilizer may be diethylenetriaminepentaacetic acid (DTPA) or a salt thereof. In a preferred embodiment of the present invention, the carboxylic acid stabilizer may be ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
[0035] In the disinfecting and cleaning composition of the present invention, the concentration of the carboxylic acid stabilizer may be 0.0001% by mass or more and less than 0.5% by mass, preferably 0.0001 to 0.30% by mass, more preferably 0.0001 to 0.20% by mass, and even more preferably 0.0001 to 0.10% by mass.
[0036] In one embodiment of the present invention, the disinfecting and cleaning composition comprises: The phosphorus-based stabilizer includes 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof, or diethylenetriaminepentamethylenephosphonic acid (DTPP) or a salt thereof, The carboxylic acid stabilizer may include ethylenediaminetetraacetic acid (EDTA) or a salt thereof, or diethylenetriaminepentaacetic acid (DTPA) or a salt thereof.
[0037] In one embodiment of the present invention, the disinfecting and cleaning composition comprises: The phosphorus-based stabilizer includes 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof, The carboxylic acid stabilizer may include ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
[0038] In one embodiment of the present invention, the disinfecting and cleaning composition may contain 0.0001% by weight or more but less than 0.5% by weight of the phosphorus-based stabilizer and 0.0001% by weight or more but less than 0.5% by weight of the carboxylic acid-based stabilizer.
[0039] In one embodiment of the present invention, the disinfecting and cleaning composition may contain 0.0001 to 0.30% by mass of the phosphorus-based stabilizer and 0.0001 to 0.30% by mass of the carboxylic acid-based stabilizer.
[0040] In one embodiment of the present invention, the disinfecting and cleaning composition may contain 0.0001 to 0.20% by mass of the phosphorus-based stabilizer and 0.0001 to 0.20% by mass of the carboxylic acid-based stabilizer.
[0041] In one embodiment of the present invention, the disinfecting and cleaning composition may contain 0.0001 to 0.10 mass % of the phosphorus-based stabilizer and 0.0001 to 0.10 mass % of the carboxylic acid-based stabilizer.
[0042] <Stannate> The sterilizing and cleaning composition of the present invention contains peracetic acid, hydrogen peroxide, acetic acid and / or a salt thereof, and water, and may contain a stannate as an additive. The addition of a stannate improves the stability of hydrogen peroxide and adjusts the pH value of the sterilizing and cleaning composition to 4.0 to 10.0. The sterilizing and cleaning composition of the present invention may contain a stannate as an additive alone or in combination with one or more additives selected from the group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, and a carboxylic acid-based stabilizer. In the present invention, the stannate may be, for example, sodium stannate, potassium stannate, strontium stannate, etc., but is not limited to these. In a preferred embodiment of the present invention, the stannate may be sodium stannate.
[0043] In the disinfecting and cleaning composition of the present invention, the concentration of the stannate may be 0.0001 to 5 mass%, preferably 0.0001 to 1 mass%, more preferably 0.0001 to 0.5 mass%, and even more preferably 0.0001 to 0.2 mass%.
[0044] (2) Other ingredients <Hydrogen peroxide> The sterilizing and cleaning composition of the present invention contains hydrogen peroxide. Because hydrogen peroxide itself has sterilizing and cleaning properties, it not only contributes to enhancing the sterilizing and cleaning effects of the entire composition, but also contributes to the production and maintenance (stability in aqueous solution) of a sufficient amount of peracetic acid through an equilibrium reaction with acetic acid. Therefore, the combination of acetic acid and hydrogen peroxide can further enhance the sterilizing and cleaning effects of the composition of the present invention.
[0045] The concentration of hydrogen peroxide in the sterilizing and cleaning composition of the present invention may be 0.001 to 25% by mass, preferably 0.005 to 20% by mass, more preferably 0.01 to 15% by mass, and even more preferably 0.02 to 10% by mass. If the hydrogen peroxide concentration is too low, the amount of peracetic acid produced by the equilibrium reaction with acetic acid may be insufficient, and the sterilizing and cleaning effects of the present invention may not be fully exerted. On the other hand, if the hydrogen peroxide concentration is too high, the effects will not be enhanced and may even pose safety concerns.
[0046] <Acetic acid and / or its salts> The acetic acid used in the disinfecting and cleaning composition of the present invention may be any acetic acid commonly used in the art. The acetic acid salt is not particularly limited as long as it is an acetate salt that is alkaline when dissolved in water, and examples thereof include sodium acetate, potassium acetate, lithium acetate, beryllium acetate, magnesium acetate, aluminum acetate, calcium acetate, rubidium acetate, strontium acetate, cesium acetate, barium acetate, and ammonium acetate.
[0047] The concentration of acetic acid and / or a salt thereof in the sterilizing and cleaning composition of the present invention may be 0.01 to 70% by mass, preferably 0.05 to 60% by mass, more preferably 0.1 to 55% by mass, and even more preferably 0.2 to 50% by mass.
[0048] In the sterilizing and cleaning composition of the present invention, the concentration of acetic acid and / or a salt thereof may be 3.5 to 250 times the concentration of peracetic acid. In one embodiment of the present invention, the concentration of acetic acid and / or a salt thereof may be 3.5 to 250 times, 3.5 to 150 times, 3.5 to 100 times, 5 to 250 times, 5 to 150 times, 5 to 100 times, 10 to 250 times, 10 to 150 times, 10 to 100 times, or the like, the concentration of peracetic acid. In a preferred embodiment of the present invention, the concentration of acetic acid and / or a salt thereof may be 10 to 250 times, 10 to 150 times, or 10 to 100 times the concentration of peracetic acid. When the concentration of acetic acid and / or a salt thereof is within the above range, calcium scale such as calcium carbonate adhering to objects to be sterilized and cleaned can be sufficiently removed.
[0049] <Peracetic acid> The peracetic acid used in the disinfecting and cleaning composition of the present invention may be any peracetic acid commonly used in the art.
[0050] The concentration of peracetic acid in the sterilizing and cleaning composition of the present invention may be 0.001 to 15% by mass. In one embodiment of the present invention, the concentration of peracetic acid in the sterilizing and cleaning composition may be, for example, but is not limited to, 0.001% by mass, 0.005% by mass, 0.01% by mass, 0.1% by mass, 0.3% by mass, 0.4% by mass, 0.5% by mass, 0.6% by mass, 1.0% by mass, 3.0% by mass, 4.0% by mass, 5.0% by mass, 10% by mass, or 15% by mass. In one embodiment of the present invention, the concentration of peracetic acid in the disinfecting and cleaning composition is, for example, 0.001 to 15% by mass, 0.001 to 10% by mass, 0.001 to 5% by mass, 0.001 to 3% by mass, 0.005 to 15% by mass, 0.005 to 10% by mass, 0.005 to 5% by mass, 0.005 to 3% by mass, 0.01 to 15% by mass, 0.01 to 10% by mass, 0.01 to 5% by mass, 0.01 to 3% by mass, 0.1 to 15% by mass, 0.1 to 10% by mass, 0.1 to 5% by mass, 0. The concentration of peracetic acid in the sterilizing and cleaning composition may be 1 to 3 mass%, 0.3 to 15 mass%, 0.3 to 10 mass%, 0.3 to 5 mass%, 0.3 to 3 mass%, 0.4 to 15 mass%, 0.4 to 10 mass%, 0.4 to 5 mass%, 0.4 to 3 mass%, 0.5 to 15 mass%, 0.5 to 10 mass%, 0.5 to 5 mass%, 0.5 to 3 mass%, 0.6 to 15 mass%, 0.6 to 10 mass%, 0.6 to 5 mass%, 0.6 to 3 mass%, 1.0 to 15 mass%, 1.0 to 10 mass%, 1.0 to 5 mass%, 1.0 to 3 mass%, etc. In one embodiment of the present invention, the concentration of peracetic acid in the sterilizing and cleaning composition may be preferably 0.001 to 10 mass%, more preferably 0.005 to 5 mass%, and even more preferably 0.01 to 3 mass%.
[0051] <Other ingredients> The disinfecting and cleaning composition of the present invention may further contain, as necessary, additives used in general disinfecting and cleaning agents, such as surfactants, thickeners, fragrances, colorants, hydrolases, etc. The remainder of the disinfecting and cleaning composition of the present invention, other than hydrogen peroxide, acetic acid and / or its salts, peracetic acid, and stabilizers and other additives added as needed, is mainly water.
[0052] The sterilizing and cleaning composition of the present invention can be used as is without dilution, or can be diluted to any concentration to form a diluted sterilizing and cleaning composition. Water is usually used as a diluent. Examples of water used as a diluent include pure water, ultrapure water, distilled water, purified water, water for injection, and tap water. The dilution ratio is not particularly limited as long as it is a dilution ratio that allows the diluted sterilizing and cleaning composition to have a sterilizing and cleaning effect, but is preferably 1 to 10,000 times, and more preferably 1 to 1,000 times.
[0053] 3. Diluted compositions for disinfection and cleaning The diluted disinfecting and cleaning composition of the present invention contains peracetic acid, acetic acid and / or a salt thereof, hydrogen peroxide, water, and additives, and further contains additional water as a diluent. Each component is as described above.
[0054] In one embodiment of the present invention, a diluted disinfecting and cleaning composition comprises the disinfecting and cleaning composition described above and additional water.
[0055] The diluted sterilizing and cleaning composition of the present invention can be prepared by diluting the above-mentioned sterilizing and cleaning composition with water. As described above, the dilution ratio is not particularly limited as long as it is a dilution ratio that can achieve a concentration that allows the diluted sterilizing and cleaning composition to exhibit sterilizing and cleaning effects, but is preferably 1 to 10,000 times, more preferably 1 to 1,000 times.
[0056] In one embodiment of the present invention, the diluted composition for sterilization and cleaning may have a peracetic acid concentration of 0.001 to 1.5 mass%, preferably 0.001 to 1.0 mass%, more preferably 0.005 to 0.5 mass%, and even more preferably 0.005 to 0.3 mass%.
[0057] In one embodiment of the present invention, the diluted composition for sterilization and cleaning may have a concentration of acetic acid and / or a salt thereof of 0.01 to 7 mass%, preferably 0.05 to 6 mass%, more preferably 0.1 to 5.5 mass%, and even more preferably 0.2 to 5 mass%.
[0058] In one embodiment of the present invention, the diluted composition for sterilization and cleaning may have a hydrogen peroxide concentration of 0.001 to 2.5% by mass, preferably 0.005 to 2% by mass, more preferably 0.01 to 1.5% by mass, and even more preferably 0.02 to 1.0% by mass.
[0059] In one embodiment of the present invention, the diluted composition for sterilization and cleaning contains 0.001 to 1.5 mass% peracetic acid, 0.01 to 7 mass% acetic acid and / or a salt thereof, 0.001 to 2.5 mass% hydrogen peroxide, and water, Contains additives, The pH value of the composition may be 4.0 to 10.0.
[0060] In one embodiment of the present invention, the diluted disinfectant and cleaning composition may contain, as an additive, one or more selected from the group consisting of polyoxyethylene lauryl ether acetic acid and / or a salt thereof, a phosphorus-based stabilizer, a carboxylic acid-based stabilizer, and a stannate.
[0061] In one embodiment of the present invention, the concentration of polyoxyethylene lauryl ether acetic acid and / or a salt thereof that can be contained in the diluted composition for sterilization and cleaning may be 0.00001 to 0.1% by mass, preferably 0.00005 to 0.05% by mass, more preferably 0.0001 to 0.03% by mass, and even more preferably 0.0001 to 0.01% by mass.
[0062] In one embodiment of the present invention, the concentration of the phosphorus-based stabilizer contained in the diluted composition for sterilization and cleaning may be 0.0001 to 0.05% by mass, preferably 0.0001 to 0.03% by mass, more preferably 0.0001 to 0.02% by mass, and even more preferably 0.0001 to 0.01% by mass.
[0063] In one embodiment of the present invention, the concentration of the carboxylic acid stabilizer contained in the diluted composition for disinfection and cleaning may be 0.0001 to 0.05% by mass, preferably 0.0001 to 0.03% by mass, more preferably 0.0001 to 0.02% by mass, and even more preferably 0.0001 to 0.01% by mass.
[0064] In one embodiment of the present invention, the concentration of stannate contained in the diluted composition for disinfection and cleaning may be 0.0001 to 0.5% by mass, preferably 0.0001 to 0.1% by mass, more preferably 0.0001 to 0.05% by mass, and even more preferably 0.0001 to 0.02% by mass.
[0065] 4. Method for producing disinfectant and cleaning composition and diluted disinfectant and cleaning composition In one embodiment of the present invention, a method for preparing a disinfecting and cleaning composition comprises mixing at least the following ingredients: (i) Additives (ii) Hydrogen peroxide and acetic acid (iii) acetate The method may include a mixing step of mixing the above ingredients. This manufacturing method does not generate heat of neutralization and is easy to work with. When the aqueous solution reaches an equilibrium state, peracetic acid will also be present in the aqueous solution, and peracetic acid may be added in the mixing step. The components are as described above. The order in which the components are mixed may be arbitrary, and in the sterilizing and cleaning composition of the present invention, the mixed components are in an equilibrium state.
[0066] The acetate may be any acetate that is alkaline when dissolved in an aqueous solution, including, but not limited to, sodium acetate, potassium acetate, lithium acetate, beryllium acetate, magnesium acetate, aluminum acetate, calcium acetate, rubidium acetate, strontium acetate, cesium acetate, barium acetate, and ammonium acetate. In one embodiment of the present invention, the acetate may be sodium acetate. In another embodiment of the present invention, the acetate may be potassium acetate.
[0067] In one embodiment of the present invention, a method for preparing a disinfecting and cleaning composition comprises mixing at least the following ingredients: (i) Additives (ii) Hydrogen peroxide and acetic acid (iii) Alkali The method may include a mixing step of mixing the components. In this manufacturing method, neutralization heat is generated, which increases the parallel movement rate and accelerates the reaction. When the aqueous solution reaches an equilibrium state, peracetic acid will also be present in the aqueous solution, and peracetic acid may be added in the mixing step. Each component is as described above. The components may be mixed in any order, and in the sterilizing and cleaning composition of the present invention, the mixed components are in an equilibrium state.
[0068] Examples of the alkali that can be used include, but are not limited to, sodium hydroxide, potassium hydroxide, lithium hydroxide, beryllium hydroxide, magnesium hydroxide, aluminum hydroxide, calcium hydroxide, rubidium hydroxide, strontium hydroxide, cesium hydroxide, barium hydroxide, and ammonia. In one embodiment of the present invention, the alkali may be sodium hydroxide. In another embodiment of the present invention, the alkali may be potassium hydroxide.
[0069] The above-mentioned production method using an alkali may include a step of mixing an additive, acetic acid, and an alkali, and then mixing the resulting mixture with aqueous hydrogen peroxide at 30 to 50° C. In this production method, heat of neutralization is generated, and the heat of neutralization generated by mixing the additive, acetic acid, and alkali can be utilized to mix the aqueous hydrogen peroxide at 30 to 50° C., thereby increasing the translation speed and accelerating the reaction.
[0070] In one embodiment of the present invention, a method for producing a disinfectant and cleaning composition includes the following steps (A) and (B): Step (A) At least (i) an additive, (ii) hydrogen peroxide and acetic acid, and (iii) an acetate or alkali and mixing the above components; Step (B) A step of leaving the aqueous solution (a) obtained in step (A) standing for one day or more. The aqueous solution (a) obtained in step (A) is allowed to stand in step (B), whereby the aqueous solution reaches an equilibrium state. In an embodiment using an acetate, the temperature at which the solution is allowed to stand in step (B) is preferably 20 to 60°C, more preferably 20 to 50°C. The time period for which the solution is allowed to stand in step (B) is preferably 1 day or more, and may be, for example, 2 days or more, 3 days or more, 5 days or more, 10 days or more, or 30 days or more. In an embodiment using an alkali, the reaction can be accelerated by the generation of heat of neutralization, as described above.
[0071] In yet another embodiment of the present invention, a method for producing a disinfectant and cleaning composition includes the following steps (C) to (E): Step (C) mixing at least (ii) hydrogen peroxide solution and acetic acid, and (i) an additive; Step (D) is a step of leaving the aqueous solution (c) obtained in Step (C) to stand for one day or more; Step (E) A step of mixing the aqueous solution (d) obtained in step (D), (iii) an acetate salt or an alkali, and water. The aqueous solution (c) obtained in step (C) is allowed to stand, thereby allowing the aqueous solution to reach an equilibrium state. The temperature at which the solution is allowed to stand in step (D) is preferably 20 to 60°C, more preferably 20 to 50°C. The time period for allowing the solution to stand in step (D) is preferably one day or more, and may be, for example, two days or more, three days or more, five days or more, 10 days or more, or 30 days or more. Thereafter, an acetate or an alkali, and water are mixed with the aqueous solution (d) that has reached an equilibrium state.
[0072] In one embodiment of the present invention, a method for preparing a diluted disinfecting and cleaning composition comprises mixing at least the following components: (i) Additives (ii) Hydrogen peroxide and acetic acid (iii) Acetate or alkali a mixing step of mixing the above ingredients; A dilution step of diluting the obtained mixture The aqueous solution may contain peracetic acid. When the aqueous solution reaches equilibrium, peracetic acid will also be present in the aqueous solution, and peracetic acid may be added in the mixing step. The components are as described above. In the method for producing a diluted composition for sterilization and cleaning of the present invention, the dilution step may include mixing the mixture obtained in the mixing step with water. The water used as a diluent may be, for example, pure water, ultrapure water, distilled water, purified water, water for injection, tap water, etc.
[0073] 5. Sterilization and cleaning method using the sterilization and cleaning composition The sterilizing and cleaning composition or the diluted sterilizing and cleaning composition of the present invention can be used as is without dilution, or diluted to any desired concentration and used for sterilizing and cleaning, for example, medical instruments, food and beverage containers, industrial wastewater, cooling water for air conditioning equipment, clothing, cooking utensils, tableware, bathrooms, kitchens, washing machines, bath heaters, furniture, and pets.
[0074] In one embodiment of the present invention, there is provided a method for sterilizing and cleaning medical instruments using the sterilizing and cleaning composition or the diluted sterilizing and cleaning composition. In the sterilization and cleaning method of the present invention, the sterilization and cleaning method for medical instruments may be selected from the group consisting of immersion, spraying, coating, liquid passing, circulation, and encapsulation. In the method for sterilizing and cleaning medical instruments of the present invention, the amount of the sterilizing and cleaning composition or diluted sterilizing and cleaning composition used and the sterilization and cleaning time can be appropriately selected depending on the type and amount of microorganisms, the concentration of the cleaning composition or diluted sterilizing and cleaning composition, etc.
[0075] In the sterilization and cleaning method of the present invention, the medical instrument includes, but is not limited to, dialysis instruments, endoscopic instruments, surgical instruments, obstetric and urological instruments, anesthesia equipment, artificial respiration equipment, dental instruments, syringe needles, etc. In the sterilization and cleaning method of the present invention, the medical instrument is preferably dialysis instruments. [Example]
[0076] Examples of the present invention are shown below. However, these examples are merely illustrative of embodiments of the present invention and are not intended to limit the scope of the present invention.
[0077] <Method for measuring hydrogen peroxide concentration in disinfecting and cleaning compositions> In the present invention, the hydrogen peroxide concentration of the sterilizing and cleaning composition (peracetic acid composition) was measured by oxidation-reduction titration. Specifically, approximately 0.1 g of sample was precisely weighed and placed in a 250 mL Erlenmeyer flask, and 100 mL of pure water and 10 mL of 1.8 mol / L sulfuric acid were added to prepare a test solution. A few drops of ferroin test solution were added to this test solution, and the solution was titrated with 0.1 mol / L cerium (IV) sulfate solution to calculate the hydrogen peroxide concentration.
[0078] <Method for measuring acetic acid and peracetic acid concentrations in disinfecting and cleaning compositions> In the present invention, the acetic acid concentration and peracetic acid concentration of the sterilizing and cleaning composition (peracetic acid composition) were measured by neutralization titration. Specifically, approximately 0.1 g of a sample of the sterilizing and cleaning composition was precisely weighed and placed in a 100 mL beaker, and approximately 50 mL of pure water was added to prepare a test solution. This test solution was titrated with 0.1 mol / L sodium hydroxide solution, and the acetic acid concentration was calculated from the amount added at the first inflection point, and the peracetic acid concentration was calculated from the amount added from the first inflection point to the second inflection point.
[0079] <Total Peroxide Concentration (TPO) in Disinfecting and Cleaning Compositions> In the present invention, the total peroxide concentration of the sterilization and cleaning composition (peracetic acid composition) was measured by iodometric titration. Specifically, approximately 0.1 g of sample was precisely weighed and placed in a 250 mL Erlenmeyer flask. 100 mL of pure water and 10 mL of 1.8 mol / L sulfuric acid were added, followed by 10 mL of 10% by weight potassium iodide solution and a few drops of 1% by weight ammonium molybdate solution to prepare a test solution. A 0.1 mol / L sodium thiosulfate solution was added dropwise to this test solution, and the liberated iodine was quantified using starch as an indicator, with the end point being when the blue-purple color of the solution disappeared and became colorless. The total peroxide concentration was calculated in terms of hydrogen peroxide from the amount of iodine.
[0080] <Stability of the composition for sterilization and cleaning> The stability of the composition for sterilization and cleaning (peracetic acid composition) of the present invention was calculated based on the ratio of the total peroxide concentration at the time of measurement with the total peroxide concentration (TPO) at the time of charging being 100.
[0081] <pH measurement> The pH of the cleaning composition and the diluted solution of the cleaning composition was measured using a pH meter (LAQUA, D-71S, manufactured by Horiba, Ltd.).
[0082] <Preparation of spore suspension> The standard strain of Bacillus cereus (manufactured by Microbiologics, product name: Bacillus cereus ATCC10876) was spread on MYP agar (manufactured by AZONE Corporation, product name: Sanispec raw culture medium) and cultured at 35°C for 7 days. Sterilized distilled water was added to this agar medium, and the cells were scraped off with a Conrage rod and collected, and then washed with sterilized distilled water by centrifugation. The surviving bacteria after heating at 80°C for 10 minutes to obtain only spore forms were used as the spore suspension.
[0083] <Sterilization test> The cleaning composition was appropriately diluted with sterilized distilled water to prepare a sample solution. To 4.5 mL of each sample solution, 0.5 mL of a 1% by mass albumin solution and 50 μL of the spore suspension were added, and the mixture was allowed to act at 25°C for 120 minutes. After the action, it was diluted 10-fold with a 0.1 mol / L sterilized sodium thiosulfate solution, and cultured at 35°C for 48 hours using a culture medium for detecting Bacillus cereus (manufactured by Nissui Pharmaceutical Co., Ltd., product name: Compact Dry X-BC) to measure the viable cell count. Also, the viable cell count of the spore suspension was measured and used as the initial viable cell count.
[0084] <Protein removal test> The cleaning composition was appropriately diluted with purified water to prepare 50 g of sample solution. A cleaning evaluation indicator (Nescos IC W·I, manufactured by Sakura Color Products Corporation) was immersed in each sample solution for 60 minutes, then washed with 10 mL of purified water and dried at room temperature. The color difference (ΔEab) from the unsoiled white area of the cleaning evaluation indicator was measured using a handheld spectrophotometer (NF555, manufactured by Nippon Denshoku Industries Co., Ltd.) set to a C light source and a 2° field of view. The protein removal rate was calculated as the ratio of the color difference after washing to the color difference of the unwashed cleaning evaluation indicator, which was set to 100.
[0085] <Calcium carbonate dissolution test> The cleaning composition was appropriately diluted with pure water to prepare 50 g of sample solutions. A small amount of calcium carbonate (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) was added to each sample solution, and the dissolved weight was taken as the dissolved amount of calcium carbonate.
[0086] Example 1 22.0 g of purified water, 0.17 g of 60% by weight 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, Italmatch Japan Co., Ltd., product name: Dayquest 2010), 0.11 g of disodium ethylenediaminetetraacetate dihydrate (EDTA 2Na 2HO, MP Biomedicals, Inc.), 18.0 g of glacial acetic acid (Showa Denko K.K., product name: 99% Pure Acetic Acid), 45.6 g of sodium acetate trihydrate (Fujifilm Wako Pure Chemical Industries, Ltd.), and 14.2 g of 45% by weight hydrogen peroxide solution (Mitsubishi Gas Chemical Company, Inc., product name: SER45) were mixed in a PE container. The total peroxide concentration at the time of mixing was 6.1%. After preparation, the mixture was aged at 25°C for 7 days to obtain a peracetic acid composition for use in cleaning dialysis equipment, containing 5.6% by mass of hydrogen peroxide, 17.1% by mass of acetic acid, 1.1% by mass of peracetic acid, 0.1% by mass of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), 0.1% by mass of disodium ethylenediaminetetraacetate (EDTA·2Na), and a pH of 5.1. The total peroxide concentration (TPO) of the resulting peracetic acid composition was measured 14 days after preparation at 25°C, and its stability was calculated. The results are shown in Table 1.
[0087] <Examples 2 to 14 and Comparative Examples 1 to 6> A disinfectant and cleaning composition having the concentration shown in Table 1 was obtained in the same manner as in Example 1, except that the additives listed in Table 1 were used. The total peroxide concentration (TPO) of each disinfectant and cleaning composition was measured, and the stability was calculated. The results are shown in Table 1. The following DTPP, sodium stannate 3H2O, and DTPA were used as the additives shown in the table. Diethylenetriaminepentamethylenephosphonic acid (DTPP, purified product manufactured by Mitsubishi Gas Chemical Company, Inc.) Sodium stannate trihydrate (Na stannate·3H2O, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) Diethylenetriaminepentaacetic acid (DTPA, manufactured by Dojindo Laboratories, Ltd.)
[0088] <Examples 15 to 20> A disinfectant and cleaning composition having the concentration shown in Table 2 was obtained in the same manner as in Example 1, except that the formulation was as shown in Table 2 and the composition was aged for one day at 50°C. The total peroxide concentration (TPO) of the disinfectant and cleaning composition was measured after preparation, aging for one day at 50°C, and aging for 20 days at 25°C, and the stability was calculated. The results are shown in Table 2.
[0089] <Examples 21 to 22, Comparative Examples 7 to 12> A disinfectant and cleaning composition having the concentration shown in Table 3 was obtained in the same manner as in Example 1, except that the formulation was as shown in Table 3 and the composition was aged at 25°C for 21 days. The total peroxide concentration (TPO) of the disinfectant and cleaning composition was measured 21 days after preparation at 25°C, and the stability was calculated. The results are shown in Table 3. The 50% phytic acid and NaOH used in the table were as follows: 50% by mass phytic acid solution (50% phytic acid, Fujifilm Wako Pure Chemical Industries, Ltd.) Sodium hydroxide (NaOH, Fujifilm Wako Pure Chemical Industries, Ltd.)
[0090] <Examples 23 to 25, Comparative Examples 13 to 14> A disinfectant and cleaning composition having the concentration shown in Table 4 was obtained in the same manner as in Example 21, except that the formulation was as shown in Table 4. The disinfectant and cleaning composition was measured for total peroxide concentration (TPO) 21 days after preparation at 25°C, and the stability was calculated. The results are shown in Table 4. The pyrophosphates shown in the table were as follows: Pyrophosphate (manufactured by Junsei Chemical Co., Ltd., product name: diphosphate)
[0091] <Comparative Examples 15 to 21> A disinfectant and cleaning composition having the concentration shown in Table 5 was obtained in the same manner as in Example 21, except that the formulation was as shown in Table 5 and the composition was aged at 25°C for 11 days. The total peroxide concentration (TPO) of the disinfectant and cleaning composition was measured 21 days after preparation at 25°C, and the stability was calculated. The results are shown in Table 5. The dipicolinic acid and EDTMP shown in the table were as follows: Dipicolinic acid (Fujifilm Wako Pure Chemical Industries, Ltd.) Ethylenediaminetetramethylenephosphonic acid (EDTMP, manufactured by Tokyo Chemical Industry Co., Ltd.)
[0092] [Table 1]
[0093] [Table 2-1]
[0094] [Table 2-2]
[0095] [Table 3-1]
[0096] [Table 3-2]
[0097] [Table 4]
[0098] [Table 5]
[0099] <Examples 26 to 29> The results of investigating the method for producing the disinfectant and cleaning composition of the present invention are shown below as examples. In Examples 26 and 28, which used alkali, an increase in reaction rate due to heat of neutralization was observed compared to Examples 27 and 29, which used acetate.
[0100] [Table 6]
[0101] <Example 101> 28.2 g of purified water, 0.02 g of 60% by weight 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, Italmatch Japan Co., Ltd., product name: Dequest 2010), 0.01 g of disodium ethylenediaminetetraacetate dihydrate (EDTA·2Na·2HO, MP Biomedicals, Inc.), 0.01 g of polyoxyethylene (4.5) lauryl ether acetate (Kao Corporation, product name: Kao Akipo RLM-45), 8.0 g of 99% by weight acetic acid (Showa Denko K.K., product name: 99% Pure Acetic Acid), 14.2 g of 45% by weight hydrogen peroxide (Mitsubishi Gas Chemical Company, Inc., product name: SER45), and 49.6 g of sodium acetate trihydrate (Fujifilm Wako Pure Chemical Corporation) were mixed in a PE container. After mixing, the mixture was aged at 25°C for 7 days to obtain a cleaning composition containing 5.8% by mass of hydrogen peroxide, 7.6% by mass of acetic acid, 0.4% by mass of peracetic acid, 29.9% by mass of sodium acetate, 0.01% by mass of 1-hydroxyethylidene-1,1-diphosphonic acid, 0.01% by mass of disodium ethylenediaminetetraacetate, and 0.01% by mass of polyoxyethylene (4.5) lauryl ether acetate. The total peroxide concentration of the resulting cleaning composition was measured 14 days after preparation, and the stability was calculated. pH measurement, sterilization test, protein removal test, and calcium carbonate dissolution test were performed, and the bacterial count, protein removal rate, and calcium carbonate dissolution amount after 120 minutes were calculated. The results are shown in Tables 7 and 8. The stability shown in Table 7 was evaluated as follows. A: 95% or more B: 80% or more C: Less than 80%
[0102] <Example 102, Comparative Example 101> A disinfecting and cleaning composition having the concentration shown in Table 7 was obtained in the same manner as in Example 101, except that the formulation was as shown in Table 7. The total peroxide concentration of the obtained cleaning composition was measured 14 days after preparation, and the stability was calculated. pH measurement, disinfection test, protein removal test, and calcium carbonate dissolution test were performed, and the number of bacteria, protein removal rate, and calcium carbonate dissolution amount after 120 minutes were calculated. The results are shown in Tables 7 and 8. The stability shown in Table 7 was evaluated in the same manner as in Example 101. The pyrophosphates shown in the table were as follows: Pyrophosphate (manufactured by Junsei Chemical Co., Ltd., product name: diphosphate)
[0103] [Table 7]
[0104] [Table 8]
[0105] As described above, the present invention has shown that by adding an additive, it is possible to provide a composition for sterilizing and cleaning medical instruments, which has high peroxide stability, allows wastewater to meet sewage disposal standards, and has improved protein removal ability.
Claims
1. A disinfecting and cleaning composition comprising 0.01 to 30% by mass of peracetic acid, 1 to 60% by mass of acetic acid and / or a salt thereof, 0.1 to 30% by mass of hydrogen peroxide, 0.01 to 5% by mass of polyoxyethylene lauryl ether acetic acid or a salt thereof as an additive, and water, The disinfectant and cleaning composition has a pH value of 4.0 to 7.
0.
2. 10. The disinfecting and cleaning composition of claim 1, further comprising a phosphorus-based stabilizer as an additive.
3. 10. The disinfecting and cleaning composition of claim 1, further comprising a carboxylic acid stabilizer as an additive.
4. 2. The disinfecting and cleaning composition of claim 1, further comprising a phosphorus-based stabilizer and a carboxylic acid-based stabilizer as additives.
5. 5. The disinfecting and cleaning composition according to claim 2 or 4, wherein the phosphorus-based stabilizer comprises 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof, or diethylenetriaminepentamethylenephosphonic acid (DTPP) or a salt thereof.
6. 5. The disinfecting and cleaning composition of claim 3, wherein the carboxylic acid stabilizer comprises either ethylenediaminetetraacetic acid (EDTA) or a salt thereof, or diethylenetriaminepentaacetic acid (DTPA) or a salt thereof.
7. the phosphorus-based stabilizer is 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) or a salt thereof; 5. The disinfecting and cleaning composition of claim 4, wherein the carboxylic acid stabilizer is ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
8. The disinfecting and cleaning composition according to claim 4 or 7, comprising 0.0001% by mass or more and less than 0.5% by mass of the phosphorus-based stabilizer and 0.0001% by mass or more and less than 0.5% by mass of the carboxylic acid-based stabilizer.
9. The composition according to any one of claims 1 to 8, wherein the pH value of the composition is from 5.0 to 7.
0.
10. A method for producing the composition according to any one of claims 1 to 9, comprising a mixing step of mixing at least the following components: (i) Additives (ii) Hydrogen peroxide and acetic acid (iii) acetate
11. A method for producing the composition according to any one of claims 1 to 9, comprising the following steps (A) and (B): Step (A) A step of mixing at least acetic acid, an aqueous hydrogen peroxide solution, and polyoxyethylene lauryl ether acetic acid or a salt thereof. Step (B): A step of leaving the aqueous solution (a) obtained in step (A) at 20 to 60°C for one day or more.
12. The method for producing a composition according to claim 11, wherein the step (A) further comprises mixing one or more selected from a phosphorus-based stabilizer and a carboxylic acid-based stabilizer.
13. A method for producing the composition according to any one of claims 1 to 9, comprising the following steps (C) to (E): Step (C) A step of mixing at least acetic acid and an aqueous hydrogen peroxide solution Step (D): A step of leaving the aqueous solution (c) obtained in step (C) at 20 to 60°C for one day or more. Step (E): A step of mixing the aqueous solution (d) obtained in Step (D), polyoxyethylene lauryl ether acetic acid or a salt thereof, and water.
14. The method for producing a composition according to claim 13, wherein in the step (E), one or more stabilizers selected from a phosphorus-based stabilizer and a carboxylic acid-based stabilizer are further mixed.
15. The composition according to any one of claims 1 to 9, additional water A diluted disinfecting and cleaning composition comprising:
16. The composition contains 0.005 to 0.1 mass% of peracetic acid, 0.05 to 0.5 mass% of acetic acid and / or a salt thereof, 0.01 to 1 mass% of hydrogen peroxide, 0.001 to 0.1 mass% of polyoxyethylene lauryl ether acetic acid or a salt thereof as an additive, and water, 16. The diluted disinfectant and cleaning composition according to claim 15, wherein the pH value is 4.0 to 7.
0.
17. a mixing step of mixing at least the following components: A dilution step of diluting the obtained mixture A method for producing the diluted composition according to claim 15 or 16, comprising: (i) Hydrogen peroxide solution (ii) acetic acid (iii) Polyoxyethylene lauryl ether acetic acid or a salt thereof
18. A method for sterilizing and cleaning medical instruments, which uses the composition according to any one of claims 1 to 9 or the diluted composition according to claim 15 or 16.
19. 19. The sterilization and cleaning method according to claim 18, wherein the method for sterilizing and cleaning the medical instrument is selected from the group consisting of a dipping method, a spraying method, a coating method, a liquid passing method, a circulation method, and an encapsulation method.
20. 20. The sterilization and cleaning method according to claim 18 or 19, wherein the medical instrument is a dialysis instrument.
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