Sterilizing cleaning agent, sterilizing cleaning kit, and sterilizing cleaning aid for hemodialysis machines

Abstract

To provide a bactericidal cleaning agent and a bactericidal cleaning kit for hemodialysis machines that meet the dialysis wastewater pH standard (greater than 5.00 and less than 9.00) and have calcium carbonate removal ability and bactericidal effect equivalent to or better than that of strongly acidic peracetic acid preparations. [Solution] The cleaning agent has a composition that includes a peroxide, a specific chelating agent, and optionally a specific alkalizing agent.

Description

[Technical Field]

[0001] The present invention relates to a bactericidal cleaning agent and a bactericidal cleaning kit for cleaning hemodialysis machines containing peracetic acid and acetic acid, as well as an auxiliary agent used in the preparation of the bactericidal cleaning agent. [Background technology]

[0002] A hemodialysis machine is a device that performs hemodialysis by bringing dialysate and blood into contact through a semiosmotic membrane. The dialysate contains bicarbonate ions and glucose, and with repeated dialysis, inorganic substances such as calcium carbonate and organic substances such as proteins accumulate in the piping and semiosmotic membrane of the dialysis machine. Bacteria can proliferate in these deposits, which are a mixture of organic and inorganic substances. For this reason, after use, a cleaning agent and a disinfectant are sent into the dialysate flow path of the dialysis machine, and the disinfectant is retained for a certain period of time to remove inorganic or organic deposits and disinfect the machine.

[0003] Conventionally, for cleaning and sterilizing hemodialysis machines, disinfectant cleaning agents containing peroxides such as peracetic acid and hydrogen peroxide, disinfectant cleaning agents containing peroxides and organic acids, or disinfectant cleaning agents containing peroxides and surfactants have been used either alone or alternately in combination with disinfectant cleaning agents containing chlorine compounds such as sodium hypochlorite, or alkaline solutions that do not contain chlorine compounds such as caustic alkali aqueous solutions (Patent Documents 1 to 10). Such peroxide-containing cleaning agents are particularly effective in removing calcium carbonate scale generated in the dialysate flow path of hemodialysis machines and sterilizing the dialysate flow path. To exhibit both a disinfecting effect and a calcium carbonate scale removal effect, they are usually adjusted to a pH of about 2 to 3.5.

[0004] However, in recent years, damage to sewer pipes caused by acidic wastewater discharged from dialysis medical facilities has become a serious concern. In response, in April 2019, a dialysis medical organization issued "Recommendations Regarding Dialysis Wastewater," which recommended the installation of neutralization treatment facilities to adjust the pH of wastewater to above 5 and below 9, and to conduct daily wastewater monitoring. Therefore, when using conventional cleaning agents containing peroxides such as peracetic acid or hydrogen peroxide, it is necessary to introduce a neutralization treatment facility. However, the installation of a neutralization treatment facility is extremely expensive, which is a significant burden on dialysis medical facilities, and it is even difficult to install such a facility in dialysis medical facilities located in small spaces such as buildings. Therefore, there is an urgent need to develop cleaning agents that meet the dialysis wastewater pH standards (greater than 5 and less than 9) set forth in the "Recommendations on Dialysis Wastewater."

[0005] In response to these demands, a calcium carbonate scale remover has been proposed that uses ammonium salt of EDTA as its main component instead of peroxides such as peracetic acid and hydrogen peroxide, thereby meeting the pH standards for dialysis wastewater (Patent Document 11). However, this calcium carbonate scale remover removes calcium carbonate using chelating agents such as ammonium EDTA, and therefore has low sterilization effect, requiring separate treatment with a disinfectant.

[0006] In contrast, a detergent containing peracetic acid, acetic acid, and hydrogen peroxide, with a pH of 5 or higher, is commercially available (Non-Patent Document 1). However, Non-Patent Document 1 does not specify components other than peracetic acid, acetic acid, and hydrogen peroxide, and it is unclear what composition is used to achieve a pH of 5 or higher. In this regard, according to the inventors' research, simply adding an alkalizing agent to adjust the pH reduces the calcium carbonate removal effect of acetic acid and the bactericidal effect of peroxide (see "Study of a bactericidal cleaning agent by mixing peracetic acid solution and alkalizing agent solution" in the [Examples] section below). [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] Japanese Patent Publication No. 2005-154551 [Patent Document 2] Japanese Patent Publication No. 2000-51350 [Patent Document 3] Japanese Patent Publication No. 2001-70441 [Patent Document 4] Japanese Patent Publication No. 2002-360689 [Patent Document 5] Japanese Patent Publication No. 2001-199811 [Patent Document 6] Japanese Patent Publication No. 2005-245516 [Patent Document 7] Japanese Patent Application Publication No. 8-224299 [Patent Document 8] Publication No. 2006-206535 [Patent Document 9] Japanese Patent Publication No. 2001-72996 [Patent Document 10] Special Publication No. 2005-537355 [Patent Document 11] Patent No. 6807116 [Non-patent literature]

[0008] [Non-Patent Document 1] Paraclear pH5 | ITI Co., Ltd. (Official Website) [https: / / www.iti-e.co.jp / publics / index / 130 / ] Retrieved February 5, 2024 [Overview of the project] [Problems that the invention aims to solve]

[0009] The present invention aims to provide a bactericidal cleaning agent and bactericidal cleaning kit for hemodialysis machines, as well as auxiliary agents used in their preparation, that meet the dialysis wastewater pH standard (greater than 5 and less than 9) while exhibiting excellent calcium carbonate removal ability and bactericidal effect. [Means for solving the problem]

[0010] As a result of intensive studies to solve the above problems, the inventors of the present invention have found that when a composition containing a specific chelating agent and optionally a specific alkalizing agent together with a peroxide is used, it has a calcium carbonate removal ability and a bactericidal effect comparable to or higher than those of a conventional strongly acidic peracetic acid preparation while satisfying the dialysis drainage standard pH (greater than 5 and less than 9), and thus completed the present invention.

[0011] That is, the present invention provides the following bactericidal cleaning agents, bactericidal cleaning kits, bactericidal cleaning aids, and bactericidal cleaning methods for artificial dialysis devices. [1] A bactericidal cleaning agent for an artificial dialysis device, comprising peracetic acid, acetic acid, a chelating agent, and optionally an alkalizing agent, wherein the chelating agent contains at least one selected from citric acid or its salts, succinic acid or its salts, ethylenediaminetetraacetic acid or its salts, and 1-hydroxyethane-1,1-diphosphonic acid or its salts, preferably contains citric acid or its salts, and / or succinic acid or its salts, more preferably contains trisodium citrate, and / or disodium succinate, and the alkalizing agent contains at least one selected from hydroxides of alkali metals, primary alkanolamines, acetates, and phosphates, and has a pH greater than 5.00 and less than 9.00. [2] The bactericidal cleaning agent according to [1], containing 0.010 to 0.050% by mass, preferably 0.020 to 0.050% by mass of peracetic acid and 0.080 to 0.450% by mass, preferably 0.150 to 0.450% by mass of acetic acid. [3] The bactericidal cleaning agent according to [1] or [2], wherein the chelating agent contains trisodium citrate, and / or disodium succinate. [4] The bactericidal cleaning agent according to any one of [1] to [3], wherein the alkalizing agent contains a primary C 1-10 alkanolamine. [5] The bactericidal cleaning agent according to [4], wherein the alkalizing agent contains monoethanolamine. [6] The bactericidal cleaning agent according to any one of [1] to [5], wherein the alkalizing agent comprises sodium hydroxide, potassium hydroxide, or a mixture thereof. [7] The bactericidal cleaning agent according to any one of [1] to [6], wherein the alkalizing agent comprises sodium lactate, sodium acetate, or trisodium phosphate. [8] A disinfectant cleaning agent containing hydrogen peroxide, as described in any one of items [1] to [7]. [9] A bactericidal cleaning agent according to any one of items [1] to [8], wherein the pH is greater than 5.00 and 6.00 or less.

[10] The bactericidal cleaning agent described in [9], wherein the pH is greater than 5.00 and less than or equal to 5.50.

[11] A two-component or three-component bactericidal cleaning kit for a hemodialysis machine, comprising a first liquid containing peracetic acid and acetic acid, a second liquid containing a chelating agent and optionally an alkalizing agent, or a second liquid containing the chelating agent and a third liquid containing the alkalizing agent, The chelating agent comprises at least one selected from citric acid or a salt thereof, succinic acid or a salt thereof, ethylenediaminetetraacetic acid or a salt thereof, and 1-hydroxyethane-1,1-diphosphonic acid or a salt thereof, preferably comprising citric acid or a salt thereof and / or succinic acid or a salt thereof, and optionally ethylenediaminetetraacetic acid or a salt thereof, or 1-hydroxyethane-1,1-diphosphonic acid or a salt thereof. A bactericidal cleaning kit comprising, as the alkalizing agent, at least one selected from alkali metal hydroxides, primary alkanolamines, acetates, and phosphates.

[12] The bactericidal cleaning kit according to

[11] , wherein the first liquid agent and the second liquid agent, or the second liquid agent and the third liquid agent, and optionally a diluent are mixed at the time of use to prepare a bactericidal cleaning agent having a pH greater than 5.00 and less than 9.00.

[13] The bactericidal washing kit according to

[11] or

[12] , wherein the first liquid agent comprises 0.5 to 4.5% by mass, preferably 1.0 to 2.0% by mass, more preferably 1.5 to 1.7% by mass of peracetic acid, and the second liquid agent comprises 0.200 to 30.000% by mass, preferably 8.000 to 30.000% by mass, more preferably 17.000 to 30.000% by mass of a chelating agent.

[14] The bactericidal washing kit according to

[13] , wherein the first liquid agent comprises 1.0 to 2.0% by mass of peracetic acid, and the second liquid agent comprises 8,000 to 30,000% by mass of a chelating agent.

[15] The first liquid preparation comprises 1.5 to 1.7% by mass of peracetic acid, as described in

[13] or

[14] , a bactericidal washing kit.

[16] The second liquid preparation comprises 17,000 to 30,000% by mass of a chelating agent, as described in any one of

[13] to

[15] .

[17] The first liquid preparation comprises hydrogen peroxide, and is a bactericidal cleaning kit as described in any one of

[11] to

[16] .

[18] The bactericidal washing kit according to any one of

[11] to

[17] , wherein the chelating agent comprises trisodium citrate or its hydrate, and / or disodium succinate or its hydrate.

[19] The alkalizing agent is Class 1 C 1-10 A bactericidal washing kit containing an alkanolamine, as described in any one of items

[11] to

[18] .

[20] The bactericidal cleaning kit according to

[19] , comprising monoethanolamine as the alkalizing agent.

[21] The bactericidal cleaning kit according to

[20] , wherein the second or third liquid formulation comprises 0.200 to 17.000% by mass, preferably 8.000 to 16.000% by mass, of the monoethanolamine.

[22] The bactericidal cleaning kit according to any one of

[11] to

[21] , wherein the alkalizing agent comprises sodium hydroxide, potassium hydroxide, or a mixture thereof.

[23] The bactericidal cleaning kit according to

[22] , wherein the alkalizing agent is sodium hydroxide, and the second liquid or the third liquid contains 0.100 to 10.000% by mass, preferably 4.000 to 9.000% by mass, more preferably 4.000 to 8.000% by mass of sodium hydroxide.

[24] The bactericidal cleaning kit according to

[22] , wherein the alkalizing agent is potassium hydroxide, and the second liquid or the third liquid contains 0.100 to 17.000% by mass, preferably 7.000 to 15.000% by mass, of potassium hydroxide.

[25] The bactericidal cleaning kit according to

[22] , wherein the alkalizing agent consists of sodium hydroxide and potassium hydroxide, and the total concentration of both components in the second liquid is 0.100 to 15.000% by mass, preferably 5.000 to 13.000% by mass.

[26] The bactericidal cleaning kit according to any one of

[11] to

[25] , wherein the alkalizing agent comprises sodium lactate, sodium acetate, or trisodium phosphate.

[27] The bactericidal cleaning kit according to

[26] , wherein the alkalizing agent comprises sodium acetate, and the second liquid or the third liquid comprises 0.200 to 15.000% by mass, preferably 5.000 to 13.000% by mass, of sodium acetate.

[28] The bactericidal cleaning kit according to

[26] , wherein the alkalizing agent comprises trisodium phosphate, and the second liquid or the third liquid comprises 0.050 to 6.000% by mass, preferably 2.000 to 4.000% by mass, of trisodium phosphate.

[29] The bactericidal washing kit according to

[26] , wherein the alkalizing agent comprises sodium lactate, and the second liquid or the third liquid comprises 0.100 to 35.000% by mass, preferably 1.000 to 15.000, more preferably 3.000 to 10.000% by mass, and particularly preferably 5.000 to 8.000% by mass of sodium lactate.

[30] The first liquid preparation is a bactericidal washing kit according to any one of

[11] to

[29] , having a pH of 0.8 to 3.0.

[31] The first liquid preparation is a bactericidal washing kit according to

[30] , having a pH of 1.0 to 2.0.

[32] The second liquid preparation having a pH of 11.0 to 15.0, the bactericidal washing kit according to

[30] or

[31] .

[33] The second liquid preparation having a pH of 12.0 to 14.0, the bactericidal washing kit as described in

[32] .

[34] A disinfectant cleaning agent or disinfectant cleaning kit according to any one of

[11] to

[33] , further comprising a diluent.

[35] An auxiliary agent for preparing a bactericidal cleaning agent for hemodialysis machines having a pH greater than 5 and less than 9, which is mixed with a liquid containing peracetic acid and acetic acid, which contains a chelating agent and, optionally, an alkalizing agent. The chelating agent comprises at least one selected from citric acid or a salt thereof, succinic acid or a salt thereof, ethylenediaminetetraacetic acid or a salt thereof, and 1-hydroxyethane-1,1-diphosphonic acid or a salt thereof, preferably comprising citric acid or a salt thereof and / or succinic acid or a salt thereof, and optionally 1-hydroxyethane-1,1-diphosphonic acid or a salt thereof, and the alkalizing agent comprises at least one selected from alkali metal hydroxides, primary alkanolamines, acetates, and phosphates, as an auxiliary agent.

[36] The auxiliary agent according to

[35] , wherein, when used, the cleaning auxiliary agent, the liquid agent containing peracetic acid and acetic acid, and optionally a diluent are mixed to prepare a bactericidal cleaning agent containing 0.010 to 0.050% by mass, preferably 0.020 to 0.050% by mass, of peracetic acid and 0.08 to 0.450% by mass, preferably 0.150 to 0.450% by mass, of acetic acid, and having a pH greater than 5.00 and less than 9.00.

[37] The auxiliary agent according to

[35] or

[36] , comprising 0.200 to 30.000% by mass, preferably 8.000 to 30.000% by mass, and more preferably 17.000 to 30.000% by mass of the chelating agent.

[38] The cleaning aid according to

[37] , wherein the auxiliary agent comprises 8,000 to 30,000% by mass of the chelating agent.

[39] The cleaning aid according to

[38] , comprising 17,000 to 30,000% by mass of the chelating agent.

[40] The chelating agent comprises trisodium citrate or its hydrate, and / or disodium succinate or its hydrate, as described in any one of

[35] to

[39] .

[41] The alkalizing agent is Class 1 C 1-10 An adjuvant containing an alkanolamine, as described in any one of items

[35] to

[40] .

[42] The alkalizing agent comprising monoethanolamine, the auxiliary agent according to

[41] .

[43] The auxiliary agent according to

[42] , comprising 0.200 to 17.000% by mass, preferably 8.000 to 16.000% by mass, of the monoethanolamine.

[44] The alkalizing agent is an auxiliary agent according to any one of

[35] to

[43] , comprising sodium hydroxide, potassium hydroxide, or a mixture thereof.

[45] The alkalizing agent is sodium hydroxide, comprising 0.100 to 10.000% by mass, preferably 4.000 to 8.000% by mass of sodium hydroxide, as described in

[44] .

[46] The alkalizing agent is potassium hydroxide, comprising 0.100 to 17.000% by mass, preferably 7.000 to 15.000% by mass, the auxiliary agent according to

[44] .

[47] The alkalizing agent comprises sodium hydroxide and potassium hydroxide, and the total concentration of both components is 0.100 to 15.000% by mass, preferably 5.000 to 13.000% by mass, as described in

[44] .

[48] ​​The alkalizing agent is sodium lactate, sodium acetate, or trisodium phosphate, as described in any one of

[35] to

[47] .

[49] The alkalizing agent is sodium acetate, comprising 0.200 to 15.000% by mass, preferably 5.000 to 13.000% by mass of sodium acetate, as described in

[48] .

[50] The alkalizing agent is trisodium phosphate, and the auxiliary agent according to

[48] comprises 0.050 to 6.000% by mass, preferably 2.000 to 4.000% by mass of trisodium phosphate.

[51] The alkalizing agent comprises sodium lactate, and more preferably contains 0.100 to 35.000% by mass, preferably 1.00 to 15.000%, more preferably 5.0 to 10.000% by mass, and particularly preferably 5.000 to 8.000% by mass of sodium lactate, as described in

[48] .

[52] The auxiliary agent described in

[35] to

[51] , having a pH of 11.0 to 15.0.

[53] The auxiliary agent according to

[52] , having a pH of 12.0 to 14.0.

[54] A method for disinfecting and cleaning an artificial dialysis machine using a disinfectant cleaning agent described in any one of the items [1] to [9]. The method according to

[54] , wherein the bactericidal cleaning agent is prepared by mixing the first liquid agent, the second liquid agent, or the second liquid agent and the third liquid agent, and optionally a diluent, at the time of use, using the bactericidal cleaning kit described in any one of

[10] to

[34] .

[56] The method according to

[54] or

[55] , wherein the bactericidal cleaning agent has a pH greater than 5.00 and less than or equal to 6.00.

[57] The method according to

[56] , wherein the bactericidal cleaning agent has a pH greater than 5.00 and less than or equal to 5.50. [Effects of the Invention]

[0012] The bactericidal cleaning agent for hemodialysis machines according to the present invention meets the dialysis wastewater pH standard (greater than 5 and less than 9), eliminating the need to introduce a neutralization treatment device. Furthermore, the bactericidal cleaning agent for hemodialysis machines according to the present invention has calcium carbonate removal ability and bactericidal effect comparable to or better than conventional strongly acidic peracetic acid preparations. [Modes for carrying out the invention]

[0013] Embodiments of the present invention will be described in detail. However, the present invention should not be understood as being limited to the following embodiments.

[0014] One embodiment of the present invention relates to a bactericidal cleaning agent for hemodialysis machines, comprising peracetic acid, acetic acid, a specific chelating agent, and optionally a specific alkalizing agent, wherein the pH meets the standards for dialysis wastewater, as described above. Another embodiment of the present invention relates to a two- or three-component bactericidal cleaning kit for hemodialysis machines, comprising a first liquid containing peracetic acid and acetic acid, a second liquid containing a specific chelating agent and optionally a specific alkalizing agent, or a second liquid containing a specific chelating agent and optionally a third liquid containing a specific alkalizing agent, as described above. Yet another embodiment of the present invention relates to an auxiliary agent, comprising a specific chelating agent and optionally a specific alkalizing agent, used to prepare a bactericidal cleaning agent for hemodialysis machines, wherein the pH meets the standards for dialysis wastewater, as described above. Yet another embodiment of the present invention relates to a method for disinfecting and cleaning a hemodialysis machine using the bactericidal cleaning agent described above. Each embodiment will be described in detail below.

[0015] 1. Sterilizing cleaning agent for hemodialysis machines A bactericidal cleaning agent for hemodialysis machines according to one embodiment of the present invention comprises peracetic acid and acetic acid, along with a specific chelating agent and optionally a specific alkalizing agent, thereby having excellent calcium carbonate removal ability and bactericidal effect while meeting the pH standards for dialysis wastewater.

[0016] Peracetic acid is the main component that contributes to the bactericidal effect. The concentration of peracetic acid in the bactericidal cleaning agent is adjusted so that the pH of the bactericidal cleaning agent is greater than 5 and less than 9, depending on the concentrations of the chelating agent and the alkalizing agent. However, from the viewpoint of providing a sufficient bactericidal effect while avoiding corrosion of the equipment, the concentration is usually 0.005 to 0.050% by mass, preferably 0.010 to 0.050% by mass, and more preferably 0.020 to 0.050% by mass. Furthermore, acetic acid is the main component that contributes to the removal of calcium carbonate. The concentration of acetic acid in the disinfectant cleaning agent is adjusted so that the pH of the disinfectant cleaning agent is greater than 5 and less than 9, depending on the concentrations of the chelating agent and alkalizing agent. However, in order to provide a sufficient calcium carbonate removal effect while avoiding corrosion of the equipment and maintaining equilibrium with peracetic acid, the concentration is usually set to 0.080 to 0.450% by mass, preferably 0.130 to 0.450% by mass, and more preferably 0.150 to 0.450% by mass.

[0017] Aqueous solutions containing peracetic acid and acetic acid are typically prepared by mixing hydrogen peroxide and acetic acid and reacting them for several days to produce peracetic acid, which is in the following equilibrium state. [ka] Therefore, in disinfectant detergents, hydrogen peroxide is usually present at a predetermined concentration along with peracetic acid and acetic acid, and hydrogen peroxide has protein removal ability. Specifically, hydrogen peroxide is usually present at a concentration of 0.018 to 0.184% by mass, preferably at a concentration of 0.032 to 0.184% by mass, and more preferably at a concentration of 0.064 to 0.184% by mass.

[0018] In this embodiment, the chelating agent is at least one selected from citric acid or its salt, succinic acid or its salt, ethylenediaminetetraacetic acid (EDTA) or its salt, and 1-hydroxyethane-1,1-diphosphonic acid (HEDP, also called etidronic acid) or its salt. These chelating agents work in conjunction with acetic acid to exhibit a synergistic effect in removing calcium carbonate even under the conditions of dialysis wastewater standard pH, resulting in excellent efficacy.

[0019] Examples of citrates include monosodium citrate, disodium citrate, and trisodium citrate. Trisodium citrate is preferred because, being the most basic, it allows for a reduction in the amount of alkalizing agent, thereby suppressing the reduction in acetic acid concentration and enabling an increase in the proportion of water, thus allowing for the addition of more of other components. Furthermore, examples of succinates include sodium succinate and disodium succinate. Disodium succinate is preferred because, being the most basic, it allows for a reduction in the amount of alkalizing agent, thereby suppressing the reduction in acetic acid concentration and enabling an increase in the proportion of water, thus allowing for the addition of more of other components. Another example of a salt of ethylenediaminetetraacetic acid is sodium ethylenediaminetetraacetic acid.

[0020] In this embodiment, trisodium citrate and / or disodium succinate are particularly preferred as chelating agents due to their strong basicity and high safety. These chelating agents can also be combined; for example, a combination of citric acid or its salt and succinic acid or its salt is a preferred combination. HEDP also has the effect of preventing the decomposition of peracetic acid and stabilizing it, and is preferably combined with citric acid or its salt, succinic acid or its salt, or EDTA or its salt.

[0021] In this embodiment, the concentration of the chelating agent varies depending on the type of chelating agent, the presence and type of alkalizing agent used in combination, and its concentration. However, when an alkalizing agent is added, it is important that the alkalizing agent is soluble. In both cases—without an alkalizing agent and with an alkalizing agent—a concentration should be selected that allows the pH of the detergent to exceed 5.00 and achieve the peracetic acid concentration described above. In compositions containing an alkalizing agent, the concentration of the chelating agent is typically 0.2 to 1.5% by mass. This is preferable to 0.2 to 1.2% by mass, more preferably 0.2 to 0.7% by mass, and even more preferably 0.2 to 0.55% by mass, as it allows for a wide range of soluble concentrations of the alkalizing agent and enables the setting of high pH levels, while also achieving the peracetic acid concentration described above. Furthermore, when citric acid or a salt thereof is used as a chelating agent in a composition containing an alkalizing agent, its concentration is typically 0.2 to 1.5% by mass, preferably 0.3 to 1.2% by mass, and more preferably 0.3 to 0.7% by mass. Furthermore, when succinic acid or a salt thereof is used as a chelating agent in a composition containing an alkalizing agent, its concentration is usually 0.2 to 1.5% by mass, preferably 0.2 to 1.0% by mass, more preferably 0.2 to 0.7% by mass, and 0.2 to 0.5% by mass. Furthermore, when EDTA or a salt thereof is used as a chelating agent in a composition containing an alkalizing agent, its concentration is usually 0.01 to 0.10% by mass, preferably 0.01 to 0.02% by mass. Furthermore, when HEDP is used as a chelating agent, its concentration is usually 0.01 to 2.00% by mass, preferably 0.01 to 1.00% by mass.

[0022] When the composition does not contain an alkalizing agent, the concentration of the chelating agent is usually 0.9 to 2.5% by mass, and is preferably 1.0 to 1.8% by mass, as this allows for a wide range of pH settings with a high soluble concentration of the alkalizing agent and the above-mentioned peracetic acid concentration to be obtained. Furthermore, when citric acid or a salt thereof is used as a chelating agent in a composition that does not contain an alkalizing agent, its concentration is usually 0.9 to 2.5% by mass, preferably 1.1 to 2.0% by mass, and more preferably 1.2 to 1.8% by mass. Furthermore, when succinic acid or a salt thereof is used as a chelating agent in a composition that does not contain an alkalizing agent, its concentration is usually 0.95 to 1.8% by mass, preferably 1.0 to 1.9% by mass, and more preferably 1.2 to 1.8% by mass. Furthermore, when EDTA or a salt thereof is used as a chelating agent in a composition that does not contain an alkalizing agent, its concentration is usually 0.05 to 0.50% by mass, preferably 0.05 to 0.10% by mass. Furthermore, when HEDP is used as a chelating agent, its concentration is usually 0.05 to 10.00% by mass, preferably 0.05 to 5.00% by mass. Furthermore, when citric acid or a salt thereof and succinic acid or a salt thereof are used as chelating agents in a composition that does not contain an alkalizing agent, the concentration of citric acid or a salt thereof is usually 0.7 to 1.5% by mass, preferably 0.8 to 1.4% by mass, more preferably 0.85 to 1.35% by mass, and the concentration of succinic acid or a salt thereof is usually 0.2 to 0.6% by mass, preferably 0.25 to 0.5% by mass, more preferably 0.30 to 0.45% by mass.

[0023] In this embodiment, the alkalizing agent is an optional component, and if an alkalizing agent is included, it is selected from alkali metal hydroxides, primary alkanolamines, lactates, acetates, and phosphates. These alkalizing agents have excellent water solubility and, when combined with a chelating agent, peracetic acid, and acetic acid, make it possible to create a detergent with a pH that meets dialysis wastewater standards while maintaining high concentrations of peracetic acid and acetic acid.

[0024] Examples of alkali metal hydroxides include sodium hydroxide, potassium hydroxide, or mixtures thereof. Potassium hydroxide, or a combination of sodium hydroxide and potassium hydroxide, is preferred because it can be incorporated at a wide range of concentrations.

[0025] Furthermore, as primary alkanolamines, primary C 1-10 Alkanolamines are preferred, including monomethanolamine, monoethanolamine, and monopropanolamine. Among these, monoethanolamine is particularly preferred.

[0026] Furthermore, sodium lactate is preferred as the lactate, sodium acetate is preferred as the acetate, and trisodium phosphate is preferred as the phosphate. The bactericidal detergent and the acetates and phosphates or their ions in the second liquid may be derived from their hydrates (for example, sodium acetate trihydrate, sodium phosphate dodecahydrate).

[0027] In this embodiment, the alkalizing agent is preferably one selected from primary alkanolamines (especially monoethanolamine), potassium hydroxide, and sodium hydroxide, or a combination of two or more of these, or a combination of at least one of these with lactate (especially sodium lactate), acetate (especially sodium acetate), and / or phosphate (especially trisodium phosphate), as it has excellent water solubility and can be blended over a wide range of concentrations, thus allowing for pH adjustment over a wide range. A combination of primary alkanolamine (especially monoethanolamine) and lactate (especially sodium lactate), acetate (especially sodium acetate), and / or phosphate (especially trisodium phosphate) is particularly preferred. In this embodiment, the concentration of the alkalizing agent varies depending on the type of alkalizing agent, the type and concentration of the chelating agent used in combination, and the concentrations of peracetic acid and acetic acid. However, it is sufficient to select an alkalizing agent concentration that results in a pH of the detergent exceeding 5.00 and the aforementioned concentrations of peracetic acid and acetic acid in the detergent. Specifically, when the alkalizing agent is sodium hydroxide, its concentration is usually selected from the range of 0.10 to 0.22% by mass, preferably from the range of 0.11 to 0.18% by mass, more preferably from the range of 0.12 to 0.16% by mass, and particularly preferably from the range of 0.13 to 0.14% by mass. When the alkalizing agent is potassium hydroxide, its concentration is usually selected from the range of 0.13 to 0.33% by mass, preferably from the range of 0.16 to 0.30% by mass, and more preferably from the range of 0.20 to 0.26% by mass. When the alkalizing agent is a combination of sodium hydroxide and potassium hydroxide, the individual concentrations are within the ranges described above, and the combined concentration of the two may vary depending on the mixing ratio, but is usually selected from the range of 0.12 to 0.26 mass%, preferably from the range of 0.14 to 0.20 mass%, and more preferably from the range of 0.17 to 0.19 mass%. When the alkalizing agent is a primary alkanolamine (especially monoethanolamine), its concentration is usually selected from the range of 0.19% to 0.34% by mass, preferably from the range of 0.20% to 0.32% by mass, and more preferably from the range of 0.22% to 0.23% by mass.

[0028] When the alkalizing agent is a combination of a primary alkanolamine (particularly monoethanolamine) and sodium hydroxide and / or potassium hydroxide, the individual concentrations are within the ranges described above, and the combined concentration may vary depending on the mixing ratio of the two, but is usually selected from the range of 0.12 to 0.30 mass%, preferably from the range of 0.14 to 0.28 mass%, and more preferably from the range of 0.15 to 0.22 mass%.

[0029] When the alkalizing agent is an acetate (particularly sodium acetate), its concentration is usually selected from the range of 0.28% to 0.60% by mass, preferably from the range of 0.30% to 0.50% by mass. In this specification, in the case of hydrated acetates, the molecular weight is calculated excluding water molecules. When the alkalizing agent is a phosphate (particularly trisodium phosphate), its concentration is usually selected from the range of 0.08 to 0.15% by mass, preferably from the range of 0.09 to 0.13% by mass. In this specification, the molecular weight of the phosphate refers to the converted value excluding water molecules in the case of a hydrated phosphate.

[0030] When the alkalizing agent is a combination of a primary alkanolamine (especially monoethanolamine) and lactic acid (especially sodium lactate), acetate (especially sodium acetate), and / or phosphate (especially trisodium phosphate), the individual concentrations and the combined concentration may vary depending on the mixing ratio of the two. When the alkalizing agent is a combination of a primary alkanolamine (especially monoethanolamine) and acetate (especially sodium acetate), the concentration of the acetate (especially sodium acetate) is usually selected from the range of 0.05% to 0.50% by mass, preferably from the range of 0.07% to 0.30% by mass, and preferably from the range of 0.08% to 0.15% by mass. When the alkalizing agent is a combination of a primary alkanolamine (especially monoethanolamine) and a phosphate (especially trisodium phosphate), the concentration of the phosphate (especially trisodium phosphate) is usually selected from the range of 0.20% to 0.80% by mass, preferably from the range of 0.30% to 0.70% by mass, and more preferably from the range of 0.45% to 0.65% by mass. When the alkalizing agent is a combination of a primary alkanolamine (especially monoethanolamine) and a lactate (especially sodium lactate), the concentration of the lactate (especially sodium lactate) is usually selected from the range of 0.05% to 0.35% by mass, preferably from the range of 0.10% to 0.20% by mass, and more preferably from the range of 0.12% to 0.17% by mass. Furthermore, the combined concentration of both may vary depending on the mixing ratio of the two, but is usually selected from the range of 0.20% by mass to 1.0% by mass, preferably from the range of 0.30% by mass to 0.90% by mass, and more preferably from the range of 0.32% by mass to 0.76% by mass.

[0031] Peracetic acid, acetic acid, chelating agents, and alkalizing agents are all involved in the solubility range of the alkalizing agent, the pH range of the detergent, the calcium carbonate removal ability, and the bactericidal effect, and it is preferable to set the proportions of these components from such multifaceted viewpoints. In this regard, in detergents that do not contain alkalizing agents, it is preferable that peracetic acid, acetic acid, and chelating agents are present in the detergent in a molar ratio (peracetic acid:acetic acid:chelating agent) of 1:15.5 to 17.5:10.5 to 20.5, more preferably 1:16.5 to 17.5:11.0 to 20.0, and particularly preferably 1:17.0 to 17.5:11.5 to 19.5. Furthermore, when the chelating agent is trisodium citrate, peracetic acid, acetic acid, and the chelating agent are preferably present in the detergent in a molar ratio (peracetic acid:acetic acid:chelating agent) of 1:15.5 to 17.5:10.5 to 18.5, more preferably in a ratio of 1:16.5 to 17.5:11.0 to 17.5, and particularly preferably in a ratio of 1:17.0 to 17.5:11.5 to 16.5. Furthermore, when the chelating agent is disodium succinate, peracetic acid, acetic acid, and the chelating agent are preferably present in the detergent in a molar ratio (peracetic acid:acetic acid:chelating agent) of 1:15.5 to 17.5:12.5 to 20.5, more preferably in a ratio of 1:16.5 to 17.5:13.5 to 20.0, and particularly preferably in a ratio of 1:17.0 to 17.5:14.5 to 19.5. Furthermore, when the chelating agent is trisodium citrate and disodium succinate, peracetic acid, acetic acid, and the chelating agent are preferably present in the detergent in a molar ratio (peracetic acid:acetic acid:chelating agent) of 1:15.5 to 17.5:10.5 to 20.5, more preferably in a ratio of 1:16.5 to 17.5:11.0 to 20.0, and particularly preferably in a ratio of 1:17.0 to 17.5:11.5 to 19.5. Similarly, in detergents containing an alkalizing agent, peracetic acid, acetic acid, chelating agent, and alkalizing agent are preferably present in the detergent in a molar ratio (peracetic acid:acetic acid:chelating agent:alkalizing agent) of 1:15.5 to 17.5:2.0 to 10.0:1 to 15, more preferably in a ratio of 1:16.5 to 17.5:2.0 to 7.5:5.0 to 14.0, and particularly preferably in a ratio of 1:17.0 to 17.5:2.0 to 5.5:6.0 to 13.0. Furthermore, when the chelating agent is trisodium citrate, peracetic acid, acetic acid, the chelating agent, and the alkalizing agent are preferably present in the detergent in a molar ratio (peracetic acid:acetic acid:chelating agent:alkalizing agent) of 1:15.5 to 17.5:2.0 to 10.0:1 to 15, more preferably in a ratio of 1:16.5 to 17.5:2.0 to 7.5:5.0 to 14.0, and particularly preferably in a ratio of 1:17.0 to 17.5:2.0 to 5.0:6.0 to 13.0. Furthermore, when the chelating agent is disodium succinate, peracetic acid, acetic acid, the chelating agent, and the alkalizing agent are preferably present in the detergent in a molar ratio (peracetic acid:acetic acid:chelating agent:alkalizing agent) of 1:15.5~17.5:2.0~6.5:5.5~14.0, more preferably in a ratio of 1:16.5~17.5:2.5~6.0:6.0~13.5, and particularly preferably in a ratio of 1:17.0~17.5:3.0~5.5:6.5~13.0.

[0032] The disinfectant cleaning agent in this embodiment typically contains the above-mentioned components in an aqueous medium. Examples of this aqueous medium include water such as distilled water, RO water, and deionized water, with RO water and deionized water being preferred.

[0033] The bactericidal cleaning agent in this embodiment satisfies the dialysis wastewater pH standard. That is, the pH is greater than 5 and less than 9. This makes it possible to discharge the wastewater without a neutralization treatment facility. From the viewpoint of calcium carbonate removal ability and bactericidal effect, the pH is preferably greater than 5.00 and 7.00 or less, more preferably greater than 5.00 and 6.00 or less, even more preferably greater than 5.00 and 5.50 or less, even more preferably between 5.10 and 5.30, and particularly preferably between 5.10 and 5.20.

[0034] 2. Sterilizing cleaning kit for hemodialysis machines Another embodiment of the present invention relates to a two- or three-component bactericidal cleaning kit for hemodialysis machines, comprising a first liquid containing peracetic acid, a second liquid containing a specific chelating agent and optionally a specific alkalizing agent, or a third liquid containing a second liquid containing a specific chelating agent and a specific alkalizing agent. With this kit, when cleaning the hemodialysis machine, the first liquid, the second liquid, or the second and third liquids, and a diluent as needed can be mixed to prepare the bactericidal cleaning agent described above. The kit of this embodiment is a two- or three-component type, and the first liquid, the second liquid, or the second and third liquids are stored separately and mixed at the time of use, so that even if the kit is stored for a long period of time, a bactericidal cleaning agent that exhibits the desired calcium carbonate removal ability and bactericidal effect can be obtained.

[0035] The first liquid formulation contains peracetic acid and is configured such that, when mixed with the second liquid formulation, or the second and third liquid formulations, and optionally a diluent, it forms a disinfectant cleaning agent with a pH greater than 5 and less than 9. Therefore, the peracetic acid concentration and acetic acid concentration in the first liquid agent vary depending on whether or not a diluent is used, the dilution ratio, the type and concentration of the chelating agent in the second or third liquid agent to be combined, and the presence, type and concentration of the alkalizing agent. However, from the viewpoint of being able to prepare a bactericidal cleaning agent that satisfies the dialysis wastewater pH standard while exhibiting the desired calcium carbonate removal effect and bactericidal effect without particular difficulty, the first liquid agent usually contains 0.5 to 4.5% by mass of peracetic acid, preferably 0.8 to 3.5% by mass, more preferably 1.0 to 2.0% by mass, and particularly preferably 1.5 to 1.7% by mass. From a similar viewpoint, the concentration of acetic acid in the first liquid agent is usually 5.00 to 40.00% by mass, preferably 10.00 to 30.00% by mass, and more preferably 15.00 to 25.00% by mass. Furthermore, although it varies depending on whether or not dilution water is used, the dilution ratio, the type and concentration of the chelating agent in the second liquid agent to be combined, and the presence, type and concentration of the alkalizing agent, the first liquid agent usually has a pH of 0.8 to 3.0, preferably 1.0 to 2.0, and more preferably 1.2 to 1.5, from the same viewpoint as the peracetic acid concentration mentioned above. Examples of media include water such as distilled water, reverse osmosis (RO) water, and ion-exchanged water, with reverse osmosis (RO) water and ion-exchanged water being preferred. Also, as mentioned above, aqueous solutions containing peracetic acid and acetic acid are usually prepared by mixing hydrogen peroxide and acetic acid, and peracetic acid, hydrogen peroxide, and acetic acid are in equilibrium, so the first liquid agent contains hydrogen peroxide at a predetermined concentration along with peracetic acid and acetic acid.

[0036] The concentration of acetic acid in the first liquid agent may fluctuate in accordance with the change in peracetic acid concentration in order to maintain the equilibrium relationship described above. However, in a stable state (usually, equilibrium is reached within a few days after the change in peracetic acid concentration), the concentration is typically 5.00 to 40.00% by mass, preferably 5.00 to 30.00% by mass, and more preferably 5.00 to 20.00% by mass. The concentration of hydrogen peroxide in the first liquid agent is typically 4.00 to 20.00% by mass, preferably 4.00 to 10.00% by mass, and more preferably 4.00 to 6.00% by mass.

[0037] When preparing a disinfectant cleaning agent by diluting the first liquid and then mixing it with the second liquid, the kit may contain dilution water. Examples of dilution water include distilled water, reverse osmosis (RO) water, and deionized water, with reverse osmosis (RO) water and deionized water being preferred. When diluting the first liquid, the dilution ratio must be such that the pH of the final disinfectant detergent is greater than 5 and less than 9. The dilution ratio must be determined according to the concentration of peracetic acid in the first liquid, the type and concentration of the chelating agent in the second or third liquid, and the presence, type, and concentration of alkalized substances. However, the first liquid can usually be diluted by mass ratio with dilution water up to about 500 times, and in many cases it is diluted up to about 50 times, preferably 20 to 30 times, and typically 25 times.

[0038] In a two-component kit, the second liquid contains a chelating agent and optionally an alkalizing agent. In a three-component kit, the second liquid contains a chelating agent and the third liquid contains an alkalizing agent. These are configured such that when mixed with the first liquid and optionally a diluent, the pH is greater than 5 and less than 9.

[0039] The chelating agent is as described above in the section on disinfectant cleaning agents. The concentration of the chelating agent in the second liquid can be determined by the water solubility of the chelating agent used, and may vary depending on the type of chelating agent, the presence, type, and concentration of the alkalizing agent used in combination. However, in order to easily prepare a bactericidal cleaning agent that dissolves in the liquid and works in cooperation with the alkalizing agent to bring the liquid to a pH that meets the dialysis wastewater standards, while working in cooperation with peracetic acid and acetic acid to exert the desired effect, the concentration of the chelating agent in the second liquid is usually in the range of 0.200 to 30.000% by mass, preferably 8.000 to 30.000% by mass, and more preferably 17.000 to 30.000% by mass. Similarly, the concentration of the chelating agent in the second liquid is usually in the range of 0.008 to 1.163 mol / L, preferably 0.310 to 1.163 mol / L, and more preferably 0.659 to 1.163 mol / L. When citric acid or its salt is used as a chelating agent, its concentration is usually in the range of 0.200 to 30.000% by mass, preferably 8.000 to 30.000% by mass, and more preferably 17.000 to 30.000% by mass. When succinic acid or its salt is used as a chelating agent, its concentration is usually in the range of 0.200 to 30.000% by mass, preferably 5.000 to 20.000% by mass, more preferably 7.000 to 20.000% by mass, and particularly preferably 11.000 to 20.000% by mass. When EDTA or its salt is used as a chelating agent, its concentration is usually 0.01 to 0.10% by mass, preferably 0.01 to 0.02% by mass. Furthermore, when HEDP is used as a chelating agent, its concentration is usually 0.01 to 0.10% by mass, and preferably 0.01 to 0.02% by mass.

[0040] When the second liquid preparation contains citric acid or a salt thereof and succinic acid or a salt thereof as chelating agents, the individual concentrations are within the ranges described above, and the combined concentration of both may vary depending on the mixing ratio of the two, but is usually 15.00 to 35.00% by mass, preferably 18.00 to 33.00% by mass, more preferably 20.00 to 32.00% by mass, and particularly preferably 21.00 to 31.00% by mass.

[0041] If the second liquid formulation contains citric acid or a salt thereof, and / or succinic acid or a salt thereof, along with at least one chelating agent such as EDTA or a salt thereof and HEDP, the second liquid formulation preferably contains 0.014 to 1.020 mol / L of chelating agent, more preferably 0.340 to 1.020 mol / L of chelating agent, and particularly preferably 0.680 to 1.020 mol / L of chelating agent, due to the synergistic effect with acetic acid regarding calcium carbonate removal.

[0042] The alkalizing agent in this embodiment is the same as described in the description of the bactericidal cleaning agent according to the first embodiment above. The concentration of the alkalizing agent in the second or third liquid formulation is preferably in the range of up to 17.000% by mass from the viewpoint of water solubility. Furthermore, the concentration should be such that a bactericidal cleaning agent that satisfies the pH standard of dialysis wastewater can be prepared, depending on whether or not a diluent is used, the dilution ratio, and the concentrations of peracetic acid and acetic acid in the first liquid formulation to be combined. However, the concentration of the alkalizing agent in the second or third liquid formulation is preferably 0.100 to 17.000% by mass, and more preferably 4.000 to 17.000% by mass, because pH adjustment is easy. Furthermore, the alkalizing agent is a primary alkanolamine, preferably a primary C 1-10 In the case of alkanolamines, particularly monoethanolamine, the concentration of the primary alkanolamine in the second or third liquid formulation is preferably in the range of up to 17.000% by mass from the viewpoint of solubility, and is preferably 0.200 to 17.000% by mass, and more preferably 8.000 to 17.000% by mass, as this facilitates the preparation of a bactericidal cleaning agent that meets the pH standards for dialysis wastewater. Similarly, the concentration of the primary alkanolamine in the second or third liquid formulation is preferably 0.033 to 2.783 mol / L, and more preferably 1.310 to 2.783 mol / L. Furthermore, when the alkalizing agent is sodium hydroxide, the concentration of sodium hydroxide in the second or third liquid is preferably in the range of up to 10,000% by mass from the viewpoint of solubility, and is preferably 0.100 to 10,000% by mass, more preferably 2,000 to 10,000% by mass, even more preferably 4,000 to 10,000% by mass, even more preferably 4,000 to 9,000% by mass, and particularly preferably 4,000 to 8,000% by mass, as this facilitates the preparation of a bactericidal cleaning agent that meets the pH standards for dialysis wastewater. Similarly, the concentration of sodium hydroxide in the second or third liquid is preferably 0.026 to 2,500 mol / L, more preferably 0.500 to 2,500 mol / L, and particularly preferably 1,000 to 2,500 mol / L. Furthermore, when the alkalizing agent is potassium hydroxide, the concentration of potassium hydroxide in the second or third liquid is preferably in the range of up to 17.000% by mass from the viewpoint of solubility, and is preferably in the range of 0.100 to 17.000% by mass, more preferably 2.000 to 17.000% by mass, and particularly preferably 7.000 to 17.000% by mass, as it facilitates the preparation of a bactericidal cleaning agent that meets the pH standards for dialysis wastewater. Similarly, the concentration of potassium hydroxide in the second or third liquid is preferably 0.018 to 3.030 mol / L, more preferably 0.356 to 3.030 mol / L, and particularly preferably 1.247 to 3.030 mol / L.

[0043] Furthermore, when the alkalizing agents are sodium hydroxide and potassium hydroxide, the individual concentrations in the second or third liquid preparation are within the above-mentioned ranges, and the total concentration of both components may vary depending on the ratio of the two components, but from the viewpoint of water solubility, it is preferable to set it in the range of up to 15.000% by mass, and more preferably in the range of 0.100 to 15.000% by mass, 2.000 to 15.000% by mass, and more preferably 5.000 to 15.000% by mass, as it facilitates the preparation of a bactericidal cleaning agent that satisfies the pH standards of dialysis wastewater. Similarly, from the same viewpoint, the total concentration of sodium hydroxide and potassium hydroxide in the second or third liquid preparation is preferably 0.021 to 3.212 mol / L, more preferably 0.428 to 3.212 mol / L, and particularly preferably 1.071 to 3.212 mol / L.

[0044] Furthermore, the alkalizing agent is a primary alkanolamine, preferably a primary C 1-10In the case of a combination of alkanolamine, particularly monoethanolamine, and sodium hydroxide and / or potassium hydroxide, the individual concentrations are within the ranges described above, and the total concentration of both may vary depending on the ratio of the two components, but from the viewpoint of water solubility, it is preferable to set it in the range of up to 15.000% by mass, and it is easier to prepare a bactericidal cleaning agent that satisfies the pH standards of dialysis wastewater, so 0.100 to 15.000% by mass is preferred, 2.000 to 15.000% by mass is preferred, 5.000 to 15.000% by mass is more preferred, and 7.000 to 15.000% by mass is even more preferred. Similarly, the total concentration of the primary alkanolamine in the second or third liquid preparation and sodium hydroxide and / or potassium hydroxide is preferably 0.022 to 2.950 mol / L, more preferably 0.44 to 2.950 mol / L, even more preferably 1.10 to 2.950 mol / L, and particularly preferably 1.54 to 2.950 mol / L.

[0045] Furthermore, when the alkalizing agent is sodium acetate, the concentration of sodium acetate in the second or third liquid formulation is preferably in the range of up to 15.000% by mass from the viewpoint of solubility, and is preferably in the range of 0.200 to 15.000% by mass, more preferably 1.000 to 15.000% by mass, even more preferably 3.000 to 15.000% by mass, even more preferably 7.000 to 15.000% by mass, and particularly preferably 5.000 to 13.000% by mass. Similarly, the concentration of sodium acetate in the second or third liquid is preferably 0.024 to 1.829 mol / L, more preferably 0.122 to 1.829 mol / L, even more preferably 0.366 to 1.829 mol / L, even more preferably 0.610 to 1.829 mol / L, and particularly preferably 0.853 to 1.829 mol / L. Furthermore, when the alkalizing agent is trisodium phosphate, the concentration of trisodium phosphate in the second or third liquid formulation is preferably in the range of up to 6.000% by mass from the viewpoint of solubility, and is preferably in the range of 0.050 to 6.000% by mass, more preferably 0.300 to 6.000% by mass, even more preferably 1.200 to 6.000% by mass, and particularly preferably 2.000 to 4.000% by mass, as this facilitates the preparation of a bactericidal cleaning agent that meets the pH standards for dialysis wastewater. Similarly, the concentration of trisodium phosphate in the second or third liquid formulation is preferably 0.003 to 0.366 mol / L, more preferably 0.018 to 0.366 mol / L, even more preferably 0.072 to 0.366 mol / L, and particularly preferably 0.122 to 0.366 mol / L.

[0046] Furthermore, the alkalizing agent is a primary alkanolamine, preferably a primary C 1-10 In the case of a combination of an alkanolamine, particularly monoethanolamine, with an acetate (particularly sodium acetate) or phosphate (particularly trisodium phosphate), the total concentration of both components may vary depending on the ratio of the two components, but from the viewpoint of water solubility, it is preferable to keep it in the range of up to 22.000% by mass, and since it is easy to prepare a bactericidal cleaning agent that satisfies the pH standards of dialysis wastewater, a range of 0.200 to 22.000% by mass is preferred, 5.000 to 20.000% by mass is more preferred, 7.000 to 16.000% by mass is even more preferred, and 9.000 to 13.000% by mass is particularly preferred. Similarly, the total concentration of the primary alkanolamine and acetate and / or phosphate in the second or third liquid formulation is preferably 0.028 to 2.970 mol / L, more preferably 0.70 to 2.70 mol / L, even more preferably 0.98 to 2.16 mol / L, and particularly preferably 1.26 to 1.755 mol / L. Furthermore, the alkalizing agent is a primary alkanolamine, preferably a primary C 1-10In the case of a combination of an alkanolamine, particularly monoethanolamine, and a lactate (particularly sodium lactate), the concentration of the lactate (particularly sodium lactate) may vary depending on the ratio of the two components, but from the viewpoint of water solubility, it is preferable to keep it in the range of up to 35.000% by mass, and it is also preferable to prepare a bactericidal cleaning agent that satisfies the pH standards of dialysis wastewater, so a range of 0.100 to 15.000% by mass is preferable, 3.000 to 10.000% by mass is more preferable, and 5.000 to 8.000% by mass is particularly preferable. Furthermore, while the total concentration of both components may vary depending on the ratio of the two components, it is preferable to keep it in the range of up to 22.000% by mass from the standpoint of water solubility. Since it is easy to prepare a bactericidal cleaning agent that satisfies the pH standards for dialysis wastewater, a range of 0.200 to 22.000% by mass is preferred, 5.000 to 20.000% by mass is more preferred, 7.000 to 16.000% by mass is even more preferred, and 9.000 to 13.000% by mass is particularly preferred.

[0047] The pH of the second and third liquids may vary depending on whether or not dilution water is used, the dilution ratio, the pH of the first liquid combined with it, and the concentrations of peracetic acid and acetic acid in the first liquid. However, to easily obtain a bactericidal cleaning agent that meets the pH standards for dialysis wastewater, the pH is usually set to 11.0 to 15.0, preferably 12.0 to 14.0.

[0048] The second and third liquid preparations are usually prepared as aqueous solutions, and the medium can be water such as distilled water, RO water, or ion-exchanged water, with RO water and ion-exchanged water being preferred.

[0049] When diluting the second and third solutions, the dilution ratio must be such that the pH of the final disinfectant detergent is greater than 5 and less than 9. The dilution ratio must be determined according to the concentrations of peracetic acid, acetic acid, hydrogen peroxide, and etidronic acid in the first solution, and the type and concentration of the chelating agent and alkalizing agent in the second solution. However, the second and third solutions can usually be diluted by mass ratio with dilution water up to about 500 times, and in many cases diluted up to about 50 times, preferably 20 to 30 times, and typically 25 times.

[0050] In a preferred embodiment, the first liquid agent contains peracetic acid at 0.5 to 4.5% by mass, preferably 1.0 to 2.0% by mass, more preferably 1.5 to 1.7% by mass, and acetic acid at 5.00 to 40.00% by mass, preferably 10.00 to 30.00% by mass, more preferably 15.00 to 25.00% by mass. The second liquid agent contains a chelating agent at 0.200 to 30.000% by mass, preferably 8.000 to 30.000% by mass, more preferably 17.000 to 27.000% by mass. The second liquid agent or the third liquid agent contains at least one alkalizing agent selected from primary alkanolamines, particularly monoethanolamine, sodium hydroxide, and potassium hydroxide, at 0.100 to 17.000% by mass, preferably 7.000 to 15.000% by mass. Further, in a preferred embodiment, the first liquid agent contains hydrogen peroxide together with peracetic acid and acetic acid, the chelating agent contains trisodium citrate, and the alkalizing agent is a primary C 1-10 alkanolamine, particularly monoethanolamine. Also, in a preferred embodiment, the first liquid agent has a pH of 0.8 to 3.0, preferably 1.0 to 2.0, the second liquid agent has a pH of 11.0 to 15.0, preferably 12.0 to 14.0, and the kit further contains a diluent.

[0051] The diluent that may optionally be included in the kit of this embodiment typically includes water such as distilled water, RO water, and ion-exchanged water, with RO water and ion-exchanged water being preferred. However, additives such as surfactants may be included as necessary.

[0052] In the kit of this embodiment, the first liquid agent, the second liquid agent, or the second and third liquid agents, and optionally a diluent are mixed at the time of use to prepare a disinfectant cleaning agent with a pH greater than 5 and less than 9. For disinfectant cleaning agents with such a pH range that do not contain an alkalizing agent, the first liquid agent, the second liquid agent, or the second and third liquid agents are usually mixed in a molar ratio (peracetic acid:acetic acid:chelating agent) of 1:15.5~17.5:10.5~20.5, more preferably 1:16.5~17.5:11.0~20.0, and particularly preferably 1:17.0~17.5:11.5~19.5. In the case of a disinfectant cleaning agent containing an alkalizing agent, a cleaning agent in such a pH range should be prepared by mixing the first liquid agent with the second liquid agent, or the second liquid agent with the third liquid agent, such that the molar ratio (peracetic acid:acetic acid:chelating agent:alkalizing agent) of peracetic acid, acetic acid, chelating agent, and alkalizing agent is typically 1:15.5~17.5:2.0~10.0:1.0~15.0, more preferably 1:16.5~17.5:2.0~7.5:5.0~14.0, and particularly preferably 1:17.0~17.5:2.0~5.5:6.0~13.0. Therefore, depending on the peracetic acid concentration, acetic acid concentration, and the type and concentration of the chelating agent and alkalizing agent, for example, in the case of a two-component type, the first liquid agent or a diluted solution of the first liquid agent and the second liquid agent or a diluted solution of the second liquid agent may be mixed in a mass ratio in the range of 49:1 to 1:49 (first:second), preferably in a mass ratio of 10:1 to 1:10 (first:second), more preferably in a mass ratio of 3:1 to 1:3 (first:second), even more preferably in a mass ratio of 2:1 to 1:2 (first:second), and particularly preferably in a mass ratio of 1:1 to 1:1.4 (first:second). In the case of a three-component type, the first liquid agent or a diluted version of the first liquid agent, the second liquid agent or a diluted version of the second liquid agent, and the third liquid agent or a diluted version of the third liquid agent should be mixed in a mass ratio within the range of 49:0.5:0.5 to 1:24.5:24.5 (first:second:third), preferably in a mass ratio of 10:0.5:0.5 to 1:5:5 (first:second:third), more preferably in a mass ratio of 3:0.5:0.5 to 1:1.5:1.5 (first:second:third), even more preferably in a mass ratio of 2:0.5:0.5 to 1:1:1 (first:second:third), and particularly preferably in a mass ratio of 1:0.5:0.5 to 1:0.7:0.7 (first:second:third).

[0053] 3. Auxiliary agents In the two-component or three-component kits described above, each liquid can be manufactured and sold individually. For example, the second and third liquids can be manufactured and sold separately as auxiliary agents for a disinfectant cleaning agent containing peracetic acid and acetic acid. Therefore, yet another embodiment of the present invention relates to an auxiliary agent used in combination with a liquid or disinfectant cleaning agent containing peracetic acid and acetic acid, comprising a specific chelating agent and a specific alkalizing agent. By mixing this auxiliary agent with a liquid containing peracetic acid and acetic acid, including existing disinfectant cleaning agents containing peracetic acid and acetic acid, it is possible to prepare a disinfectant cleaning agent that satisfies the dialysis wastewater pH standard (greater than 5 and less than 9) while exhibiting calcium carbonate removal ability and disinfectant effect equivalent to or better than conventional strong acid peracetic acid cleaning agents.

[0054] The chelating agent and alkalizing agent contained in the auxiliary agent according to this embodiment are as described in the description of the bactericidal cleaning agent above. Furthermore, the concentrations and pH of the chelating agent and alkalizing agent are as described in the second and third liquid formulations of the kit described above.

[0055] In the preferred embodiment of the auxiliary agent, the chelating agent comprises trisodium citrate or disodium succinate, and the alkalizing agent comprises sodium hydroxide, potassium hydroxide, and primary carbon. 1-10 It contains at least one selected from alkanolamines (particularly monoethanolamine). In a preferred embodiment, the auxiliary agent contains 0.200 to 30.000% by mass, preferably 8.000 to 30.000% by mass, and more preferably 17.000 to 27.000% by mass of a chelating agent.

[0056] In a preferred embodiment, the auxiliary agent typically contains monoethanolamine in an amount of 0.200 to 17.000% by mass, preferably 8.000 to 16.000% by mass, when the alkalizing agent is monoethanolamine. The auxiliary agent typically contains sodium hydroxide in an amount of 0.100 to 10.000% by mass, preferably 2.000 to 10.000% by mass, more preferably 4.000 to 10.000% by mass, even more preferably 4.000 to 9.000% by mass, and even more preferably 4.000 to 8.000% by mass, when the alkalizing agent is potassium hydroxide. The auxiliary agent typically contains potassium hydroxide in an amount of 0.100 to 17.000% by mass, preferably 2.000 to 17.000% by mass, and particularly preferably 7.000 to 15.000% by mass, when the alkalizing agent is potassium hydroxide. When the alkalizing agent consists of sodium hydroxide and potassium hydroxide, the auxiliary agent typically contains sodium hydroxide and potassium hydroxide in an amount of 0.100 to 15.000% by mass, preferably 2.000 to 15.000% by mass, and more preferably 5.000 to 13.000% by mass.

[0057] Furthermore, the auxiliary agent is an alkalizing agent, preferably a primary alkanolamine, and more preferably a primary C 1-10When the mixture consists of an alkanolamine, particularly monoethanolamine, and sodium hydroxide and / or potassium hydroxide, these are typically present in amounts of 0.100 to 15.000% by mass, preferably 2.000 to 15.000% by mass, more preferably 5.000 to 15.000% by mass, and even more preferably 7.000 to 15.000% by mass.

[0058] Furthermore, when the alkalizing agent is sodium acetate, the mixture typically contains 0.200 to 15.000% by mass of sodium acetate, preferably 1.000 to 15.000% by mass, more preferably 3.000 to 15.000% by mass, even more preferably 5.000 to 15.000% by mass, and particularly preferably 7.000 to 15.000% by mass. Furthermore, when the alkalizing agent is trisodium phosphate, the mixture typically contains 0.050 to 6.000% by mass of trisodium phosphate, preferably 0.300 to 6.000% by mass, more preferably 1.200 to 6.000% by mass, and particularly preferably 2.000 to 6.000% by mass.

[0059] Furthermore, the alkalizing agent is a primary alkanolamine, preferably a primary C 1-10 In the case of a combination of an alkanolamine, particularly monoethanolamine, with an acetate (particularly sodium acetate) or phosphate (particularly trisodium phosphate), the total concentration of both is usually 0.200 to 22.000% by mass, preferably 5.000 to 22.000% by mass, more preferably 7.000 to 20.000% by mass, and particularly preferably 9.000 to 21.000% by mass. Furthermore, the alkalizing agent is a primary alkanolamine, preferably a primary C 1-10In the case of a combination of an alkanolamine, particularly monoethanolamine, and a lactate (particularly sodium lactate), the lactate (particularly sodium lactate) is preferably contained in a range of up to 30,000% by mass from the viewpoint of solubility, and it is easy to prepare a bactericidal cleaning agent that satisfies the pH standard for dialysis wastewater. Therefore, it is preferably contained in a range of 0.100 to 35,000% by mass, more preferably 1.00 to 15,000%, even more preferably 5.0 to 10,000% by mass, and particularly preferably 5,000 to 8,000% by mass. The total concentration of both is usually 0.200 to 25,000% by mass, preferably 5,000 to 22,000% by mass, more preferably 10,000 to 21,000% by mass, and particularly preferably 15,000 to 20,000% by mass.

[0060] In a preferred embodiment, the auxiliary agent has a pH of 11.0 to 15.0, and more preferably a pH of 12.0 to 14.0.

[0061] 4. Method for disinfecting and cleaning hemodialysis machines Another embodiment of the present invention relates to a method for disinfecting and cleaning an artificial dialysis machine using the above-described bactericidal cleaning agent. In carrying out this method, typically, the above-described bactericidal cleaning kit is used to prepare a bactericidal cleaning agent having a pH greater than 5.00 and less than 9.00, preferably greater than 5.00 and 7.80 or less, more preferably greater than 5.00 and 5.50 or less, and particularly preferably 5.10 or more and 5.30 or less. The disinfection and cleaning process can be the same as the process carried out with conventional peroxide-based cleaning agents. For example, after rinsing the dialysate flow path with water, the prepared disinfectant cleaning agent is sent into the flow path, stored for a certain period of time, and then rinsed with water to completely remove the disinfectant cleaning agent. Alternatively, such a process may be carried out alternately (for example, every other day) in combination with cleaning using a disinfectant cleaning agent containing a chlorine-based compound such as sodium hypochlorite, or an alkaline solution such as a caustic alkali aqueous solution. Such a combination is effective in removing organic matter such as proteins, thereby effectively preventing bacteria from remaining and multiplying in deposits formed from organic and inorganic matter. [Examples]

[0062] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

[0063] 1. Examination of chelating agents (Preparation Examples 1-5) Trisodium citrate, used as a chelating agent, was added to RO water at different concentrations of 8.77 g / 100 g, 17.55 g / 100 g, 35.10 g / 100 g, 43.87 g / 100 g, and 52.65 g / 100 g, and its solubility and pH were evaluated. The evaluation method and results are shown below.

[0064] (1) Solubility After adding the chelating agent to RO water, the sample was stirred for 30 minutes, and then the presence or absence of insoluble matter was visually checked. Complete dissolution (no insoluble matter) was marked with ○, and poor dissolution (insoluble matter present) was marked with ×. (2) pH The pH was measured using a pH meter (product name: pH meter HM-50G, manufactured by Toa DKK Co., Ltd.). The pH criteria were as follows: 5.01 to 8.99 was marked as "○" (good), and anything else was marked as "×" (bad).

[0065] (3) Evaluation results The evaluation results are summarized in the table below. [Table 1]

[0066] When trisodium citrate was added to RO water at concentrations of 8.77g / 100g, 17.55g / 100g, and 35.10g / 100g, the pH became 7.75-7.88, indicating complete dissolution. However, when trisodium citrate was added to RO water at concentrations of 43.87g / 100g and 52.65g / 100g, it did not dissolve.

[0067] 2. Investigation of disinfectant cleaning agents prepared by mixing peracetic acid solution and chelating agent solution (Preparation Examples 6-8) 270 g of 80% acetic acid and 131.1 g of 45% hydrogen peroxide solution were dissolved in 585.6 g of RO water. Furthermore, 13.3 g of etidronic acid was added as a stabilizer for the resulting equilibrium peracetic acid, and the mixture was reacted at room temperature for 1 to 2 days to prepare a first solution containing 1.61% by mass of peracetic acid, 20.11% by mass of acetic acid, and 5.40% by mass of hydrogen peroxide solution (the methods for measuring the peracetic acid concentration, acetic acid concentration, and hydrogen peroxide concentration are described later). The obtained first solution was diluted 25 times with RO water to prepare a diluted solution of the first solution containing 0.064% by mass (8.42 mmol / L) of peracetic acid, 0.800% by mass of acetic acid, and 0.216% by mass of hydrogen peroxide solution. Furthermore, the trisodium citrate solutions from Preparation Examples 1 to 3 were used as second liquid preparations. These were diluted 25 times (by mass) with RO water to prepare trisodium citrate solutions of 0.351 g / 100 g, 0.702 g / 100 g, and 1.404 g / 100 g. The two diluted solutions were then mixed in a 1:1 ratio to prepare a disinfectant cleaning agent. The pH of the obtained disinfectant cleaning agent was measured using a pH meter (product name: pH meter HM50G, manufactured by Toa DKK Co., Ltd.). The results are summarized in Table 2 below. [Table 2] All solutions had a pH of 4.01 to 4.68, which was outside the standard pH range for dialysis wastewater (greater than 5 and less than 9).

[0068] 3. Examination of alkalizing agents (Preparation Examples 9-16) Monoethanolamine (MEA), diethanolamine (DEA), triethanolamine (TEA), 50% sodium lactate solution, sodium acetate, sodium hydroxide, potassium hydroxide, and trisodium phosphate dodecahydrate were added to RO water in amounts corresponding to 16.0 g / 100 g of MEA, 27.5 g / 100 g of DEA, 40.5 g / 100 g of TEA, 50.0 g / 100 g of sodium lactate, 30.0 g / 100 g of sodium acetate, 10.1 g / 100 g of sodium hydroxide, 15.0 g / 100 g of potassium hydroxide, and 3.235 g / 100 g of trisodium phosphate, respectively. Solubility and pH were evaluated according to the procedure described in "1. Examination of Chelating Agents". The evaluation results are shown in Table 3 below.

[0069] [Table 3] As described above, all of them dissolved.

[0070] 3. Investigation of a disinfectant cleaning agent prepared by mixing peracetic acid solution and alkalizing agent solution. (1) Preparation of bactericidal cleaning agents (Comparative Examples 1-8) Diluted solutions of the first liquid preparation (containing 0.064% by mass of peracetic acid, 0.800% by mass of acetic acid, and 0.216% by mass of hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6 to 8. The alkalizing agent solutions of Preparation Examples 9 to 16 were used as the second liquid preparations, and these were diluted 25 times with RO water to prepare alkalizing agent solutions containing 0.64 g / 100 g of MEA, 1.10 g / 100 g of DEA, 1.62 g / 100 g of TEA, 2.00 g / 100 g of sodium lactate, 1.20 g / 100 g of sodium acetate, 0.404 g / 100 g of sodium hydroxide, 0.60 g / 100 g of potassium hydroxide, and 0.129 g / 100 g of trisodium phosphate, respectively. The two diluted solutions were then mixed in a 1:1 ratio to prepare a bactericidal cleaning agent.

[0071] (2) Evaluation of bactericidal and cleansing properties The obtained bactericidal cleaning agent was compared with a commercially available strong acidic peracetic acid preparation (product name: StellaCare, manufactured by Osaka Sasaki Chemical Co., Ltd., composition: 0.99% peracetic acid, 10.5% acetic acid, 5.9% hydrogen peroxide, pH: 3.2) using the procedure described below to evaluate pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration.

[0072] A. pH The pH was measured using a pH meter (product name: pH meter HM-50G, manufactured by Toa DKK Co., Ltd.). The pH criteria were as follows: 5.01 to 8.99 was marked as "○" (good), and anything else was marked as "×" (bad).

[0073] B. Calcium carbonate removal effect 1) Preparation of calcium suspension Solution A was prepared by adding 12 g of calcium chloride dihydrate to 600 mL of RO water and stirring. Solution B was prepared by adding 36 g of sodium bicarbonate to 600 mL of RO water and stirring. Solution A and Solution B were mixed during the test to prepare a calcium suspension. 2) Preparation of a silicon plate coated with calcium carbonate A silicon plate (2 x 7 cm) is dried in air at 60°C for 40 minutes, then allowed to cool at room temperature, and its mass (W1) is measured. Next, it is immersed in a calcium suspension and left for 3 days, then dried under the same conditions (air, 60°C, 40 minutes). After immersing it in a beaker of water for 2 minutes to remove water-soluble components from the adhering material, it is dried under the same conditions (air, 60°C, 40 minutes). The mass (W2) of the silicon plate after drying is measured, and the mass difference from before immersion (W2-W1) is calculated, and the total surface area (28 cm²) of the silicon plate is measured. 2 This is the amount of calcium carbonate attached to the surface. 3) Calcium carbonate removal test Add 110 mL of disinfectant detergent to a 200 mL beaker, and immerse the silicone plate with the calcium carbonate attached for 6 hours. After removing the plate, immerse it in a beaker filled with water for 2 minutes, and dry it in the air at 60°C for 40 minutes. Measure the mass of the dried silicone plate (W3), calculate the mass difference from before immersion (W2-W3), and determine the amount of calcium carbonate removed by immersion in the detergent solution. The removal rate was calculated from the ratio of the amount of calcium carbonate removed after immersion in the detergent solution (W2-W3) to the amount of calcium carbonate attached before immersion in the detergent solution (W2-W1). Calcium carbonate removal rate (%) = (W2-W3) / (W2-W1) × 100 We rated products as follows: ◎ if the calcium carbonate removal rate (%) was 50% or higher than that of commercially available products, ○ if it was less than 50% but higher than that of commercially available products, and × if it was lower than that of commercially available products.

[0074] C. Acetic acid is essential. The measurement was performed by neutralization titration with a 0.1 mol / L sodium hydroxide solution.

[0075] D. Hydrogen peroxide concentration The measurement was performed by titration with 0.02 mol / L potassium permanganate solution.

[0076] E. Sterilizing effect (1) Test bacteria S. aureus and C. albicans were obtained from the ATCC (American Type Culture Collection) and used as representative microorganisms of bacteria and yeast-like fungi, respectively. (2) Test culture medium Soybean casein digest (SCD) agar medium was used for bacteria (S. aureus), and malt extract agar medium (3% malt extract, 0.3% polypeptone, 1.5% agar) was used for yeast-like fungi (C. albicans). (3) Preparation of bacterial suspension The bacterial cells cultured on each of the above agar plates are suspended in tryptone-added physiological saline (0.1% tryptone, 0.85% sodium chloride) to obtain a bacterial suspension (the bacteria number approximately 10 9 CFU / mL, approximately 10 yeast-like fungi 8A solution (CFU / mL) was prepared. (4) Test Procedure 50 μL of bacterial suspension was mixed with 4.95 mL of the drug, and then samples were taken at 15, 30, and 60 seconds. The reaction was stopped by diluting the samples 100-fold with a neutralizing solution (1% peptone, 0.1% sodium thiosulfate, 1.4% potassium dihydrogen phosphate, 300 units / mL catalase). The neutralizing solution was then mixed with agar plates and cultured. The bactericidal effect was determined by the logarithmic decrease in viable cell count (LRV) relative to the number of viable cells before action. The shortest action time that resulted in an LRV of 5 or higher for bacteria and 4 or higher for yeast-like fungi was defined as the bactericidal time. If the sterilization time against bacteria and yeast-like fungi is shorter than that of commercially available products, it is marked with a circle (○), and if it is longer, it is marked with a cross (×).

[0077] F. Peracetic acid concentration The measurement was performed by titration with 0.02 mol / L sodium thiosulfate solution.

[0078] (3) Evaluation results The results, along with those for commercially available products, are summarized in Table 4 below. [Table 4]

[0079] In Comparative Examples 2 and 3, the peracetic acid content decreased significantly, resulting in a lower bactericidal effect compared to commercially available products. Furthermore, the cleaning agents in Comparative Examples 3, 4, 5, and 8 failed to maintain a pH above the dialysis wastewater standard of 5.00. While the cleaning agents in Comparative Examples 1, 6, and 7 met the dialysis wastewater standard of 5.00 and showed no significant decrease in peracetic acid content, their calcium carbonate removal power was not higher than that of commercially available products.

[0080] 4. Examination of mixed formulations of chelating agents and alkalizing agents (Preparation Examples 17-40) Trisodium citrate was added as a chelating agent, and monoethanolamine (MEA), diethanolamine (DEA), triethanolamine (TEA), 50% sodium lactate, sodium acetate, sodium hydroxide, potassium hydroxide, or trisodium phosphate dodecahydrate were added as alkalizing agents in various amounts to RO water to prepare various mixtures of chelating and alkalizing agents, and their solubility and pH were evaluated. The composition and evaluation results of each preparation are summarized in Tables 5 and 6 below. [Table 5]

[0081] [Table 6] As described above, the mixed formulations of chelating agents and alkalizing agents in Preparation Examples 20 to 25 were insoluble, but the mixed formulations of chelating agents and alkalizing agents in Preparation Examples 17 to 19 and Preparation Examples 26 to 40 were soluble.

[0082] 5. Investigation of bactericidal cleaning agents prepared by mixing peracetic acid solution, alkalizing agent solution, and chelating agent (Reference Example 1, Examples 1-14, and Comparative Examples 9-17) Diluted solutions of the first liquid preparation (containing 0.064% by mass of peracetic acid, 0.800% by mass of acetic acid, and 0.216% by mass of hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6 to 8. Mixed solutions of the chelating agent and alkalizing agent from Preparation Examples 17 to 19 and 26 to 40 were used as the second liquid preparation. The mixed solutions from Preparation Examples 17 to 19 and 26 to 40 were diluted 25 times with RO water, and the mixed solutions from Preparation Examples 29 to 31 and 38 to 40 were diluted 12.5 times with RO water to prepare diluted solutions of the second liquid preparation containing various alkalizing agents and trisodium citrate at various concentrations. The diluted solutions of the first liquid preparation and the diluted solutions of the second liquid preparation were mixed in a 1:1 ratio to prepare a bactericidal cleaning agent. The obtained bactericidal cleaning agents were evaluated for pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration using the procedure described in "3. Examination of bactericidal cleaning agents obtained by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Tables 7-9 below. [Table 7] [Table 8] [Table 9]

[0083] The bactericidal cleaning agents of Examples 1 and 2, which contained 0.44% by mass of trisodium citrate and 0.22-0.23% by mass of monoethanolamine, with a peracetic acid concentration of 310-330 ppm and an acetic acid concentration of 1642-1910 ppm, were found to meet the dialysis wastewater pH standard and exhibit superior calcium carbonate removal and bactericidal effects compared to commercially available products. The bactericidal cleaning agents of Examples 3 to 5, which contained 0.35 to 0.53% by mass of trisodium citrate and 0.12 to 0.14% by mass of sodium hydroxide, with a peracetic acid concentration of 327 to 342 ppm and an acetic acid concentration of 1880 to 2052 ppm, also met the dialysis wastewater pH standards and were found to exhibit superior calcium carbonate removal and bactericidal effects compared to commercially available products. The bactericidal cleaning agents of Examples 6 to 8, which contained 0.35 to 0.53% by mass of trisodium citrate and 0.16 to 0.21% by mass of potassium hydroxide, with a peracetic acid concentration of 330 to 334 ppm and an acetic acid concentration of 1696 to 2129 ppm, also met the dialysis wastewater pH standards and were found to exhibit superior calcium carbonate removal and bactericidal effects compared to commercially available products. The bactericidal cleaning agents of Examples 9-11, which contained 0.70-1.06% by mass of trisodium citrate and 0.30-0.50% by mass of sodium acetate, with a peracetic acid concentration of 340-345 ppm and an acetic acid concentration of 4316-4348 ppm, also met the dialysis wastewater pH standards and were estimated to exhibit superior calcium carbonate removal and bactericidal effects compared to commercially available products. Furthermore, the bactericidal cleaning agents of Examples 12 to 14, which contained 0.70 to 1.06% by mass of trisodium citrate and 0.09 to 0.13% by mass of trisodium phosphate, with a peracetic acid concentration of 338 to 346 ppm and an acetic acid concentration of 3754 to 4032 ppm, also met the dialysis wastewater pH standards and were estimated to exhibit superior calcium carbonate removal and bactericidal effects compared to commercially available products. On the other hand, the bactericidal cleaning agents of Comparative Examples 9 to 11, which contain 0.35 to 0.53% by mass of trisodium citrate and 0.40 to 0.60% by mass of sodium lactate, the bactericidal cleaning agents of Comparative Examples 12 to 14, which contain 0.35 to 0.53% by mass of trisodium citrate and 0.15 to 0.25% by mass of sodium acetate, and the bactericidal cleaning agents of Comparative Examples 15 to 17, which contain 0.35 to 0.53% by mass of trisodium citrate and 0.043 to 0.065% by mass of trisodium phosphate, were unable to ensure a pH above 5.00, which is the standard for dialysis wastewater.

[0084] 6. Examination of monoethanolamine concentration (Preparation Examples 41-46, Reference Example 2, and Examples 15-19) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater pH standard, trisodium citrate and monoethanolamine (MEA) were added to RO water at various concentrations to prepare the second liquid agent (alkalizing agent / chelating agent mixed solution), and the pH and solubility were confirmed according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 10 below.

[0085] [Table 10] As shown in Table 10, solubility was observed in the second liquid preparations (alkalizing agent / chelating agent mixture) of Preparation Examples 41-46, which contained 21.94% by mass of trisodium citrate and 9.00, 10.80, 11.60, 13.00, 13.50, or 15.20% by mass of monoethanolamine.

[0086] Diluted solutions of the first liquid preparation (0.064% by mass (8.42 mmol / L) peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6 to 8. The second liquid preparation (alkalizing agent / chelating agent mixture) from Preparation Examples 41 to 46 was diluted 25 times with RO water to prepare diluted solutions of the second liquid preparation containing 0.878% by mass (34.02 mmol / L) trisodium citrate solution and monoethanolamine of various concentrations. The two diluted solutions were mixed in a 1:1 ratio to prepare a bactericidal cleaning agent. The obtained bactericidal cleaning agent was evaluated for pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration using the procedure described in "3. Examination of bactericidal cleaning agents obtained by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 11 below.

[0087] [Table 11]

[0088] As shown in Table 11, the bactericidal cleaning agents of Examples 15-19, each containing 0.44% by mass of trisodium citrate and 0.22-0.30% by mass of monoethanolamine, all had a pH of 5.08-5.48, meeting the standards for dialysis wastewater. Furthermore, it was confirmed or estimated that the bactericidal cleaning agents of Examples 15-19 exhibited higher calcium carbonate removal and bactericidal effects than commercially available products.

[0089] 7. Examination of sodium hydroxide concentration (Preparation Examples 47-54, Reference Example 3, and Examples 20-27) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with peracetic acid solution met the dialysis wastewater pH standard, trisodium citrate and sodium hydroxide were added to RO water at various concentrations to prepare a second solution (alkalizing agent / chelating agent mixed solution), and the pH and solubility were confirmed according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 12 below. [Table 12] As shown in Table 12, the second liquid preparations (alkalizing agent / chelating agent mixture) of Preparation Examples 47-54, which contained 17.55-26.32% by mass of trisodium citrate solution and 5.20-7.90% by mass of sodium hydroxide, all showed solubility.

[0090] Diluted solutions of the first liquid agent (containing 0.064% by mass of peracetic acid, 0.800% by mass of acetic acid, and 0.2160% by mass of hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6 to 8. The second liquid agent (a mixed solution of alkalizing agent and chelating agent) from Preparation Examples 47 to 54 was diluted 25 times with RO water to prepare diluted solutions of the second liquid agent containing trisodium citrate and sodium hydroxide at various concentrations. The two diluted solutions were mixed in a 1:1 ratio to prepare a disinfectant cleaning agent. In addition, the second liquid agent from Preparation Example 54 and RO water were mixed in a 1.5:23.5 ratio to prepare a diluted solution of the second liquid agent. The diluted solution of the first liquid agent (25-fold diluted solution) and the diluted solution of the second liquid agent were mixed in a 1:1 ratio to prepare a disinfectant cleaning agent. The obtained bactericidal cleaning agents were evaluated for pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration using the procedure described in "3. Examination of bactericidal cleaning agents obtained by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 13 below.

[0091] [Table 13]

[0092] As shown in Table 13, the bactericidal cleaning agents of Examples 20 to 27 all had a pH of 5.01 to 5.82, meeting the standards for dialysis wastewater. Furthermore, it was confirmed or inferred that the bactericidal cleaning agents of Examples 20 to 27 all exhibited higher calcium carbonate removal and bactericidal effects than commercially available products.

[0093] 8. Examination of potassium hydroxide concentration (Preparation Examples 55-67, Reference Examples 4 and 5, and Examples 28-38) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater standards, trisodium citrate and potassium hydroxide were added to RO water at various concentrations to prepare the second liquid agent (alkalizing agent / chelating agent mixed solution). The pH and solubility were then confirmed according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 14 below. [Table 14] As shown in Table 14, the second liquid preparations (alkalizing agent / chelating agent mixture) of Preparation Examples 55 to 67, which contained 17.55 to 26.32% by mass of trisodium citrate and 6.60 to 16.05% by mass of potassium hydroxide, all showed solubility.

[0094] Diluted solutions of the first liquid preparation (0.064% by mass peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6-8. The second liquid preparation (a mixed solution of alkalizing agent and chelating agent) from Preparation Examples 55-67 was diluted 25 times with RO water to prepare diluted solutions of the second liquid preparation containing trisodium citrate and potassium hydroxide at various concentrations. The two diluted solutions were mixed in a 1:1 ratio to prepare a disinfectant cleaning agent. The obtained disinfectant cleaning agent was evaluated for pH, calcium carbonate removal effect, acetic acid concentration, disinfectant effect, and peracetic acid concentration using the procedure described in "3. Examination of disinfectant cleaning agents prepared by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 15 below. [Table 15]

[0095] As shown in Table 15, the bactericidal cleaning agents of Examples 28-38 all had a pH of 5.01-5.42, meeting the standards for dialysis wastewater. Furthermore, it was confirmed or estimated that the bactericidal cleaning agents of Examples 28-38 all exhibited higher calcium carbonate removal and bactericidal effects than commercially available products.

[0096] 9. Investigation of alkalizing agents prepared by mixing sodium hydroxide and potassium hydroxide (Preparation Examples 68-78, Examples 39-49) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater standards, trisodium citrate and alkalizing agents containing sodium hydroxide and potassium hydroxide were added to RO water at various concentrations to prepare the second liquid agent (alkalizing agent / chelating agent mixed solution). The pH and solubility of the obtained alkalizing agent / chelating agent mixed solution were checked according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 16 below. [Table 16] As shown in Table 16, the second liquid preparations (alkalizing agent / chelating agent mixture) of Preparation Examples 68-78, which contained 3.40-6.35% by mass of sodium hydroxide and 3.60-6.30% by mass of potassium hydroxide, dissolved together with trisodium citrate.

[0097] Diluted solutions of the first liquid preparation (0.064% by mass peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6 to 8. The second liquid preparation (a mixed solution of alkalizing agent and chelating agent) from Preparation Examples 68 to 78 was diluted 25 times with RO water to prepare diluted solutions of the second liquid preparation containing trisodium citrate and potassium hydroxide at various concentrations. The two diluted solutions were mixed in a 1:1 ratio to prepare a disinfectant cleaning agent. The obtained disinfectant cleaning agent was evaluated for pH, calcium carbonate removal effect, acetic acid concentration, disinfectant effect, and peracetic acid concentration using the procedure described in "3. Examination of disinfectant cleaning agents prepared by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 17 below.

[0098] [Table 17]

[0099] As shown in Table 17, the bactericidal cleaning agents of Examples 39 to 49 all had a pH of 5.02 to 5.57, meeting the standards for dialysis wastewater. Furthermore, it was confirmed or estimated that the bactericidal cleaning agents of Examples 39 to 49 all exhibited higher calcium carbonate removal and bactericidal effects than commercially available products.

[0100] 10. Investigation of bactericidal cleaning agents with compositions that do not contain alkalizing agents (Preparation Example 79, Comparative Examples 18 and 19, and Examples 50 and 51) Trisodium citrate, used as a chelating agent, was added to RO water at a concentration of 21.94 g / 100 g, and its solubility and pH were evaluated according to the procedure described in "1. Examination of Chelating Agents". The evaluation results are shown below. [Table 18]

[0101] A diluted solution of the first liquid preparation (containing 0.064% by mass of peracetic acid, 0.800% by mass of acetic acid, and 0.216% by mass of hydrogen peroxide solution) was prepared in the same manner as in Preparation Examples 6 to 8. Furthermore, the second liquid agent from Preparation Example 79 was mixed with RO water in ratios of 1:24, 2:23, 3:22, and 4:21 to prepare various diluted solutions of the second liquid agent. These diluted solutions of the second liquid agent were then mixed in a 1:1 ratio with the diluted solution of the first liquid agent (25-fold dilution) to prepare a bactericidal cleaning agent. The obtained bactericidal cleaning agents were evaluated for pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, peracetic acid concentration, and hydrogen peroxide concentration using the procedure described in "3. Examination of bactericidal cleaning agents mixed with peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 19 below. [Table 19]

[0102] The solutions of Comparative Examples 18 and 19 had a pH of 4.44 to 4.81, which deviated from the dialysis wastewater pH standard (greater than 5 and less than 9). However, the solutions of Examples 50 and 51 had a pH of 5.07 to 5.24, which met the dialysis wastewater pH standard (greater than 5 and less than 9). Furthermore, the acetic acid concentrations were 4159 and 4215 ppm, and the peracetic acid concentrations were 339 and 345 ppm, suggesting that they exhibited higher calcium carbonate removal and bactericidal effects than commercially available products.

[0103] 11. Investigation of alkalizing agents prepared by mixing sodium hydroxide and monoethanolamine (Preparation Examples 80-84, Examples 52-56) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater standards, an alkalizing agent containing sodium hydroxide and monoethanolamine was added to RO water at various concentrations, together with trisodium citrate, to prepare a second liquid agent (alkalizing agent / chelating agent mixed solution). The pH and solubility of the obtained alkalizing agent / chelating agent mixed solution were checked according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 20 below. [Table 20] As shown in Table 20, the second liquid preparations (alkalizing agent / chelating agent mixture) of Preparation Examples 80-84, which contained 4.90% by mass of sodium hydroxide and 1.00-7.00% by mass of monoethanolamine as alkalizing agents along with trisodium citrate, all dissolved.

[0104] Diluted solutions of the first liquid preparation (0.064% by mass peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6-8. The second liquid preparation (a mixed solution of alkalizing agent and chelating agent) from Preparation Examples 80-84 was diluted 25 times with RO water to prepare diluted solutions of the second liquid preparation containing trisodium citrate, sodium hydroxide, and monoethanolamine at various concentrations. The two diluted solutions were mixed in a 1:1 ratio to prepare a bactericidal cleaning agent. The pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration of the obtained bactericidal cleaning agent were evaluated using the procedure described in "3. Examination of bactericidal cleaning agents prepared by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 21 below.

[0105] [Table 21]

[0106] 12. Investigation of alkalizing agents prepared by mixing potassium hydroxide and monoethanolamine (Preparation Examples 85-89, Examples 57-61) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater standards, an alkalizing agent containing potassium hydroxide and monoethanolamine was added to RO water at various concentrations along with trisodium citrate to prepare a second liquid agent (alkalizing agent / chelating agent mixed solution). The pH and solubility of the obtained alkalizing agent / chelating agent mixed solution were checked according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 22 below. [Table 22] As shown in Table 22, the second liquid preparations (alkalizing agent / chelating agent mixture) of Preparation Examples 85-89, which contained trisodium citrate, 4.90% by mass of potassium hydroxide, and 3.00-10.00% by mass of monoethanolamine, all dissolved.

[0107] Diluted solutions of the first liquid preparation (0.064% by mass peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6-8. The second liquid preparation (a mixed solution of alkalizing agent and chelating agent) from Preparation Examples 85-89 was diluted 25 times with RO water to prepare diluted solutions of the second liquid preparation containing trisodium citrate, potassium hydroxide, and monoethanolamine at various concentrations. The two diluted solutions were mixed in a 1:1 ratio to prepare a bactericidal cleaning agent. The pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration of the obtained bactericidal cleaning agent were evaluated using the procedure described in "3. Examination of bactericidal cleaning agents prepared by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 23 below.

[0108] [Table 23]

[0109] 13. Investigation of alkalizing agents prepared by mixing sodium hydroxide, potassium hydroxide, and monoethanolamine (Preparation Example 90, Example 62) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater standards, an alkalizing agent containing sodium hydroxide, potassium hydroxide, and monoethanolamine was added to RO water along with trisodium citrate to prepare the second liquid agent (alkalizing agent / chelating agent mixed solution). The pH and solubility of the obtained alkalizing agent / chelating agent mixed solution were checked according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 24 below. [Table 24] As shown in Table 24, the second liquid preparation (alkalizing agent / chelating agent mixture) of Preparation Example 90, which contained 4.90% by mass of sodium hydroxide, 4.90% by mass of potassium hydroxide, and 4.50% by mass of monoethanolamine, dissolved together with trisodium citrate.

[0110] Diluted solutions of the first liquid preparation (0.064% by mass peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6 to 8. The second liquid preparation (a mixed solution of alkalizing agent and chelating agent) from Preparation Example 90 was diluted 25 times with RO water to prepare a diluted solution of the second liquid preparation, and the two diluted solutions were mixed in a 1:1 ratio to prepare a bactericidal cleaning agent. The pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration of the obtained bactericidal cleaning agent were evaluated using the procedure described in "3. Examination of bactericidal cleaning agents prepared by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 25 below.

[0111] [Table 25]

[0112] 14. Investigation of alkalizing agents prepared by mixing sodium lactate, sodium acetate, or trisodium phosphate with monoethanolamine (Preparation Examples 91-93, Examples 63-65) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater standards, an alkalizing agent containing sodium lactate, sodium acetate, or trisodium phosphate and monoethanolamine was added to RO water along with trisodium citrate to prepare the second liquid agent (alkalizing agent / chelating agent mixed solution). The pH and solubility of the obtained alkalizing agent / chelating agent mixed solution were checked according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 26 below. [Table 26] As shown in Table 26, the second liquid preparations (alkalizing agent / chelating agent mixtures) of Preparation Examples 91-93, which contained 13.16% by mass of trisodium citrate along with 7.5% by mass of sodium lactate, 5.00% by mass of sodium acetate, or 2.80% by mass of trisodium phosphate and 10.00-12.00% by mass of monoethanolamine, all dissolved.

[0113] Diluted solutions of the first liquid preparation (0.064% by mass peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6-8. The second liquid preparation (a mixed solution of alkalizing agent and chelating agent) from Preparation Examples 91-93 was diluted 25 times with RO water to prepare a diluted solution of the second liquid preparation, and the two diluted solutions were mixed in a 1:1 ratio to prepare a bactericidal cleaning agent. The obtained bactericidal cleaning agent was evaluated for pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration using the procedure described in "3. Examination of bactericidal cleaning agents prepared by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 27 below.

[0114] [Table 27]

[0115] 15. Investigation of disodium succinate as a chelating agent (Preparation Example 94, Comparative Examples 20 and 21, and Examples 66 and 67) Disodium succinate, used as a chelating agent, was added to RO water at a concentration of 9.00 g / 100 g, and its solubility and pH were evaluated according to the procedure described in "1. Examination of Chelating Agents". The evaluation results are shown in Table 28 below. [Table 28] As shown in Table 28, the second liquid preparation (alkalizing agent / chelating agent mixture) of Preparation Example 94, which contained 9.00% by mass of disodium succinate, dissolved.

[0116] A diluted solution of the first liquid preparation (containing 0.064% by mass of peracetic acid, 0.800% by mass of acetic acid, and 0.216% by mass of hydrogen peroxide solution) was prepared in the same manner as in Preparation Examples 6 to 8. Furthermore, the second liquid agent from Preparation Example 94 was mixed with RO water in a ratio of 1:24, 1:4, 6:19, or 7:18 to prepare various diluted solutions of the second liquid agent. These diluted solutions of the first liquid agent and the diluted solutions of the second liquid agents were then mixed in a 1:1 ratio to prepare disinfectant cleaning agents. The obtained disinfectant cleaning agents were evaluated for pH, calcium carbonate removal effect, acetic acid concentration, disinfectant effect, peracetic acid concentration, and hydrogen peroxide concentration using the procedure described in "3. Examination of disinfectant cleaning agents prepared by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 29 below. [Table 29]

[0117] The solutions of Comparative Examples 20 and 21 had a pH of 4.13 to 4.94, which deviated from the dialysis wastewater pH standard (greater than 5 and less than 9). However, the solutions of Examples 66 and 67 had a pH of 5.02 to 5.11, which met the dialysis wastewater pH standard (greater than 5 and less than 9). Furthermore, the acetic acid concentrations were 4393 and 4189 ppm, and the peracetic acid concentrations were 344.5 and 328.2 ppm, suggesting that they exhibited higher calcium carbonate removal and bactericidal effects than commercially available products.

[0118] 15. Investigation of the combination of disodium succinate and trisodium citrate as chelating agents (Preparation Example 95, and Examples 68-69) Disodium succinate and trisodium citrate, used as chelating agents, were added to RO water at concentrations of 7.50 g / 100 g and 21.94 g / 100 g, respectively, and their solubility and pH were evaluated according to the procedure described in "1. Examination of Chelating Agents". The evaluation results are shown in Table 30 below. [Table 30] As shown in Table 30, the second liquid preparation (alkalizing agent / chelating agent mixture) of Preparation Example 94, which contained 7.50% by mass of disodium succinate and 21.94% by mass of trisodium citrate, dissolved.

[0119] A diluted solution of the first liquid preparation (containing 0.064% by mass of peracetic acid, 0.800% by mass of acetic acid, and 0.216% by mass of hydrogen peroxide solution) was prepared in the same manner as in Preparation Examples 6 to 8. Next, the second liquid agent from Preparation Example 95 and RO water were mixed in a 2:23 or 3:22 ratio to prepare each diluted solution of the second liquid agent. These diluted solutions of the first liquid agent and the diluted solutions of the second liquid agents were then mixed in a 1:1 ratio to prepare a bactericidal cleaning agent. The obtained bactericidal cleaning agents were evaluated for pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, peracetic acid concentration, and hydrogen peroxide concentration using the procedure described in "3. Examination of bactericidal cleaning agents mixed with peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 31 below. [Table 31]

[0120] The solutions in Examples 68 and 69 had a pH of 5.04 to 5.11, which met the dialysis wastewater pH standard (greater than 5 and less than 9). Furthermore, the acetic acid concentrations were 4277 and 4155 ppm, and the peracetic acid concentrations were 342 and 330 ppm, suggesting a higher calcium carbonate removal and bactericidal effect than commercially available products.

[0121] 16. Investigation of a second liquid formulation containing disodium succinate and monoethanolamine (Preparation Examples 96-100, and Examples 70-73) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater pH standard, disodium succinate and monoethanolamine (MEA) were added to RO water at various concentrations to prepare the second liquid agent (alkalizing agent / chelating agent mixed solution), and the pH and solubility were confirmed according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 32 below.

[0122] [Table 32] As shown in Table 32, solubility was observed in the second liquid preparation (alkalizing agent / chelating agent mixture) of Preparation Examples 96-99, which contained 12.00-17.99% by mass of disodium succinate and 8.80-15.90% by mass of monoethanolamine, with the two together making up 23.00-30.89% by mass.

[0123] Diluted solutions of the first liquid preparation (0.064% by mass peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6 to 8. The second liquid preparation (alkalizing agent / chelating agent mixture) from Preparation Examples 96 to 99 was diluted 25 times with RO water to prepare diluted solutions of the second liquid preparation containing trisodium citrate solution and monoethanolamine at various concentrations. The two diluted solutions were mixed in a 1:1 ratio to prepare a bactericidal cleaning agent. The obtained bactericidal cleaning agent was evaluated for pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration using the procedure described in "3. Examination of bactericidal cleaning agents obtained by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 33 below.

[0124] [Table 33]

[0125] As shown in Table 33, the bactericidal cleaning agents of Examples 70-73, each containing 0.24-0.36% by mass of disodium succinate and 0.176-0.318% by mass of monoethanolamine, with a combined total of 0.46-0.62% by mass, and a disodium succinate / monoethanolamine ratio of 0.943-2.045, all had a pH of 5.02-5.45, meeting the dialysis wastewater standards. Furthermore, it was estimated that the bactericidal cleaning agents of Examples 70-73 exhibited higher calcium carbonate removal and bactericidal effects than commercially available products.

[0126] 17. Investigation of a second liquid preparation containing disodium succinate and sodium hydroxide (Preparation Examples 101-103, and Examples 74-76) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater pH standard, disodium succinate and sodium hydroxide were added to RO water at various concentrations to prepare the second liquid agent (alkalizing agent / chelating agent mixed solution), and the pH and solubility were confirmed according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 34 below.

[0127] [Table 34] As shown in Table 34, solubility was observed in the second liquid preparations (alkalizing agent / chelating agent mixture) of Preparation Examples 101-103, which contained 14.99% by mass of disodium succinate and 7.00-9.00% by mass of sodium hydroxide.

[0128] Diluted solutions of the first liquid preparation (0.064% by mass peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6 to 8. The second liquid preparation (alkalizing agent / chelating agent mixture) from Preparation Examples 101 to 103 was diluted 25 times with RO water to prepare diluted solutions of the second liquid preparation containing disodium succinate and sodium hydroxide at various concentrations. The two diluted solutions were mixed in a 1:1 ratio to prepare a disinfectant cleaning agent. The obtained bactericidal cleaning agent was evaluated for pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration using the procedure described in "3. Examination of bactericidal cleaning agents obtained by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 35 below.

[0129] [Table 35]

[0130] As shown in Table 35, the bactericidal cleaning agents of Examples 74-76, each containing 0.300% by mass of disodium succinate and 0.140-0.180% by mass of sodium hydroxide, all had a pH of 5.01-5.27, meeting the dialysis wastewater standards. Furthermore, it was estimated that the bactericidal cleaning agents of Examples 74-76 exhibited higher calcium carbonate removal and bactericidal effects than commercially available products.

[0131] 17. Investigation of a second liquid preparation containing disodium succinate and potassium hydroxide (Preparation Examples 104-105, and Examples 77-78) To ensure that the pH of the bactericidal cleaning agent obtained when mixed with the first liquid agent, peracetic acid solution, met the dialysis wastewater pH standard, disodium succinate and potassium hydroxide were added to RO water at various concentrations to prepare the second liquid agent (alkalizing agent / chelating agent mixed solution), and the pH and solubility were confirmed according to the procedure described in "1. Examination of Chelating Agents". The results are summarized in Table 36 below.

[0132] [Table 36] As shown in Table 36, solubility was observed in the second liquid preparations (alkalizing agent / chelating agent mixture) of Preparation Examples 104 and 105, which contained 14.99% by mass of disodium succinate and 10.75-14.70% by mass of potassium hydroxide.

[0133] Diluted solutions of the first liquid preparation (0.064% by mass (8.42 mmol / L) peracetic acid, 0.800% by mass acetic acid, and 0.216% by mass hydrogen peroxide solution) were prepared in the same manner as in Preparation Examples 6 to 8. The second liquid preparation (alkalizing agent / chelating agent mixture) from Preparation Examples 104 and 105 was diluted 25 times with RO water to prepare diluted solutions of the second liquid preparation containing disodium succinate and potassium hydroxide at various concentrations. The two diluted solutions were mixed in a 1:1 ratio to prepare a bactericidal cleaning agent. The obtained bactericidal cleaning agent was evaluated for pH, calcium carbonate removal effect, acetic acid concentration, bactericidal effect, and peracetic acid concentration using the procedure described in "3. Examination of bactericidal cleaning agents obtained by mixing peracetic acid solution and alkalizing agent solution". The test results are summarized in Table 37 below.

[0134] [Table 37]

[0135] As shown in Table 37, the bactericidal cleaning agents of Examples 77 and 78, which contained 0.300% by mass of disodium succinate and 0.210-0.294% by mass of potassium hydroxide, both had a pH of 5.02-5.28 and met the dialysis wastewater standards. Furthermore, it was estimated that the bactericidal cleaning agents of Examples 77 and 78 exhibited higher calcium carbonate removal and bactericidal effects than commercially available products.

Claims

1. A bactericidal cleaning agent for an artificial dialysis machine comprising peracetic acid, acetic acid, a chelating agent, and optionally an alkalizing agent, wherein the chelating agent comprises at least one selected from citric acid or a salt thereof, succinic acid or a salt thereof, ethylenediaminetetraacetic acid or a salt thereof, and 1-hydroxyethane-1,1-diphosphonic acid or a salt thereof, preferably comprising citric acid or a salt thereof and / or succinic acid or a salt thereof, more preferably trisodium citrate and / or disodium succinate, and the alkalizing agent comprises at least one selected from alkali metal hydroxides, primary alkanolamines, acetates, and phosphates, and has a pH greater than 5.00 and less than 9.

00.

2. The bactericidal cleaning agent according to claim 1, comprising 0.010 to 0.050% by mass of peracetic acid and 0.08 to 0.450% by mass of acetic acid.

3. The alkalizing agent is Class 1 C １－１０ A bactericidal cleaning agent according to claim 1, comprising an alkanolamine, preferably a monoethanolamine.

4. The bactericidal cleaning agent according to claim 1, wherein the alkalizing agent comprises sodium hydroxide, potassium hydroxide, or a mixture thereof.

5. The bactericidal cleaning agent according to claim 1, wherein the pH is greater than 5.00 and 6.00 or less, preferably greater than 5.00 and 5.50 or less.

6. The bactericidal cleaning agent according to claim 1, wherein the alkalizing agent comprises sodium lactate, sodium acetate, or trisodium phosphate.

7. A first liquid preparation containing peracetic acid and acetic acid, A second liquid preparation containing a chelating agent and optionally an alkalizing agent, or a second liquid preparation containing the chelating agent and a third liquid preparation containing the alkalizing agent A two-component or three-component sterilizing cleaning kit for hemodialysis machines, including, The chelating agent comprises at least one selected from citric acid or a salt thereof, succinic acid or a salt thereof, ethylenediaminetetraacetic acid or a salt thereof, and 1-hydroxyethane-1,1-diphosphonic acid or a salt thereof, preferably citric acid or a salt thereof and / or succinic acid or a salt thereof, more preferably trisodium citrate and / or disodium succinate, and optionally ethylenediaminetetraacetic acid or a salt thereof, or 1-hydroxyethane-1,1-diphosphonic acid or a salt thereof. A bactericidal cleaning kit comprising, as the alkalizing agent, at least one selected from alkali metal hydroxides, primary alkanolamines, acetates, and phosphates.

8. The bactericidal cleaning kit according to claim 7, wherein at the time of use, the first liquid agent, the second liquid agent, or the second liquid agent and the third liquid agent, and optionally a diluent are mixed to prepare a bactericidal cleaning agent having a pH greater than 5.00 and less than 9.

00.

9. The bactericidal cleaning kit according to claim 7, wherein the first liquid agent comprises 0.5 to 4.5% by mass, preferably 1.0 to 2.0% by mass, and more preferably 1.5 to 1.7% by mass of peracetic acid, and the second liquid agent comprises 0.200 to 30.000% by mass, preferably 8.000 to 30.000% by mass, and more preferably 17.000 to 30.000% by mass of a chelating agent.

10. The alkalizing agent is Class 1 C １－１０ The bactericidal cleaning kit according to claim 7, comprising an alkanolamine, preferably monoethanolamine.

11. The bactericidal cleaning kit according to claim 10, wherein the second or third liquid formulation contains 0.200 to 17.000% by mass, preferably 8.000 to 16.000% by mass, of the monoethanolamine.

12. The bactericidal cleaning kit according to claim 7, wherein the alkalizing agent comprises sodium hydroxide, potassium hydroxide, or a mixture thereof.

13. When the alkalizing agent is sodium hydroxide, the second liquid or the third liquid contains 0.100 to 10.000% by mass, preferably 4.000 to 9.000% by mass, more preferably 4.000 to 8.000% by mass of sodium hydroxide. When the alkalizing agent is potassium hydroxide, the second liquid or the third liquid contains 0.100 to 17.000% by mass, preferably 7.000 to 15.000% by mass, potassium hydroxide. The bactericidal cleaning kit according to claim 12, wherein the alkalizing agent consists of sodium hydroxide and potassium hydroxide, and the total concentration of both components in the second liquid is 0.100 to 15.000% by mass, preferably 5.000 to 13.000% by mass.

14. The bactericidal cleaning kit according to claim 7, wherein the alkalizing agent comprises sodium lactate, sodium acetate, or trisodium phosphate.

15. The bactericidal washing kit according to claim 7, wherein the first liquid agent has a pH of 0.8 to 3.0, preferably 1.0 to 2.

0.

16. The bactericidal washing kit according to claim 15, wherein the second liquid agent has a pH of 11.0 to 15.0, preferably 12.0 to 14.

0.

17. An auxiliary agent for preparing a disinfectant cleaning agent for hemodialysis machines having a pH greater than 5.00 and less than 9.00, which is mixed with a liquid containing peracetic acid and acetic acid, which contains a chelating agent and, optionally, an alkalizing agent. The chelating agent comprises at least one selected from citric acid or a salt thereof, succinic acid or a salt thereof, ethylenediaminetetraacetic acid or a salt thereof, and 1-hydroxyethane-1,1-diphosphonic acid or a salt thereof, preferably comprising citric acid or a salt thereof and / or succinic acid or a salt thereof, and optionally 1-hydroxyethane-1,1-diphosphonic acid or a salt thereof. The alkalizing agent is an auxiliary agent comprising at least one selected from alkali metal hydroxides, primary alkanolamines, acetates, and phosphates.

18. The auxiliary agent according to claim 17, wherein, when used, the auxiliary agent, the liquid agent containing the peracetic acid and acetic acid, and optionally diluting water are mixed to prepare a bactericidal cleaning agent containing 0.010 to 0.050% by mass, preferably 0.020 to 0.050% by mass, of peracetic acid and 0.08 to 0.45% by mass, preferably 0.15 to 0.45% by mass, of acetic acid, and having a pH greater than 5.00 and less than 9.

00.

19. The auxiliary agent according to claim 17, wherein the auxiliary agent comprises 0.200 to 30.000% by mass, preferably 8.000 to 30.000% by mass, and more preferably 17.000 to 30.000% by mass of the chelating agent.

20. The auxiliary agent according to claim 17, wherein the chelating agent comprises trisodium citrate or its hydrate, and / or disodium succinate or its hydrate.

21. The alkalizing agent is Class 1 C １－１０ The auxiliary agent according to claim 17, comprising an alkanolamine, preferably a monoethanolamine.

22. The auxiliary agent according to claim 21, comprising 0.200 to 17.000% by mass, preferably 8.000 to 16.000% by mass, of the monoethanolamine.

23. The auxiliary agent according to claim 17, wherein the alkalizing agent comprises sodium hydroxide, potassium hydroxide, or a mixture thereof.

24. If the alkalizing agent is sodium hydroxide, it contains 0.100 to 10.000% by mass, preferably 4.000 to 8.000% by mass of sodium hydroxide. If the alkalizing agent is potassium hydroxide, it contains 0.100 to 17.000% by mass, preferably 7.000 to 15.000% by mass of potassium hydroxide. The auxiliary agent according to claim 23, wherein the alkalizing agent consists of sodium hydroxide and potassium hydroxide, and the total concentration of both components is 0.100 to 15.000% by mass, preferably 5.000 to 13.000% by mass.

25. The auxiliary agent according to claim 17, wherein the alkalizing agent comprises sodium lactate, sodium acetate, or trisodium phosphate.

26. The auxiliary agent according to claim 17, having a pH of 11.0 to 15.0, preferably 12.0 to 14.

0.

27. A method for disinfecting and cleaning an artificial dialysis machine using a bactericidal cleaning agent according to any one of claims 1 to 6.

28. A method for preparing a bactericidal cleaning agent by using the bactericidal cleaning kit described in any one of claims 7 to 16, and mixing the first liquid agent with the second liquid agent, or the second liquid agent and the third liquid agent, and optionally a diluent, at the time of use.

29. The method according to claim 28, wherein the bactericidal cleaning agent has a pH greater than 5.00 and less than or equal to 6.00, preferably greater than 5.00 and less than or equal to 5.50.

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