JP2002360689A - Cleaning method of artificial dialyzer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a disinfecting-cleaning method capable of completely removing and surely sterilizing a stain of a dialyzer and a dialyzing line, and having no fear of generating THM. SOLUTION: Cleaning by an alkaline aqueous solution of pH 9.5 or more including no hypochlorous acid and cleaning by an acid aqueous solution of pH 4.0 or less are applied to this artificial dialyzer and a dialyzing fluid line communicating with this dialyzer.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a dialysis apparatus used for artificial blood dialysis in a medical institution, and a cleaning method for removing and contaminating a dialysate line by sterilization.

[0002]

2. Description of the Related Art In a medical institution equipped with artificial dialysis equipment, it is essential to maintain the dialysis equipment and the dialysate line clean for patient safety. Therefore, it is necessary to carry out daily cleaning and disinfection after dialysis. There is. Thus, dirt generated in the dialysis device and dialysate line after dialysis is mainly organic substances such as proteins and lipids and inorganic substances such as calcium carbonate,
It contains drug components administered to patients and substances other than those derived from living organisms.In addition to simple forms of attachment, dirt components are stacked, inorganic particles are entangled in an organic matrix, calcium and organic materials are not included. Are forming a complex, so that the bacteria that have infiltrated into the interior have a safe growth place and are easily propagated.

On the other hand, early dialysis aims at removing metabolites (mainly low molecular weight nitrogen compounds having a molecular weight of 1000 or less such as urea, creatine, uric acid, guanidine compounds) present in high concentrations in the blood of uremic patients. However, urotoxins, including neurotoxins, are said to be included in the medium-molecular-weight substances having a molecular weight of 3,000 to 5,000, and the cause of dialysis amyloidosis in dialysis patients has recently been molecular weight of 11,800.
Β2-microglobulin has been identified, and it has been pointed out that the symptoms of various other patients may be derived from low-molecular-weight proteins other than β2-microglobulin. It is said that dialysis and removal of all small molecular weight substances leads to patient treatment. However, the pore size of the dialysis membrane increases due to the spread of the object to be removed, and the amount and type of the organic substance to be removed tend to increase accordingly. Has led to complication of the composition and morphology.

Conventionally, two-stage cleaning and disinfection using an aqueous solution of sodium hypochlorite and an aqueous solution of acetic acid has been widely used for disinfecting and cleaning of a dialysis apparatus and a dialysate line. This utilizes the strong sterilization and reactivity of hypochlorous acid generated in the former aqueous solution, disinfects and removes organic dirt, and converts calcium carbonate, which cannot be removed with hypochlorous acid, into acetic acid. To dissolve and remove. In addition, a disinfectant that mixes a sequestering agent and a surfactant with an aqueous sodium hypochlorite solution is also known so that disinfection and disinfection can be performed in one-step washing. However, in order to reliably remove calcium carbonate, a disinfecting agent is used. Due to the limitation of the amount of the agent, periodic cleaning with an aqueous acid such as acetic acid has not been abolished.

Other common disinfectants include aqueous solutions of isocyanurates such as sodium dichloroisocyanurate, electrolytic acidic water obtained by electrolysis of saline, aqueous solutions of peracetic acid and potassium monosulfate, and There is a heated aqueous solution. However, although these disinfectants show the ability to remove calcium carbonate under acidic conditions, they have a very poor ability to remove organic substances and are liable to remain dirt. In particular, as described above, the composition and form of dirt In disinfection and cleaning of dialysis equipment and dialysate lines, which can be complicated, sterilization can be performed superficially, but sterilization power is difficult to reach inside dirt, which may lead to growth of bacteria lurking in and under residual dirt. It is a fatal defect.

[0006]

SUMMARY OF THE INVENTION Under such circumstances,
For the disinfection cleaning of the dialysis device and the dialysate line, two-stage cleaning using an aqueous solution of hypochlorite such as sodium hypochlorite and an aqueous solution of acid such as acetic acid is also suitable.
However, when an aqueous solution of hypochlorite is used, an organic substance is chlorinated by hypochlorous acid having a high reactivity, and trihalomethane (hereinafter abbreviated as THM) is generated. . This THM is generally chloroform, dichlorobromomethane, chlorodibromomethane, bromoform and the like, and is known to be produced by chlorination of tap water, but has carcinogenicity, hepatotoxicity, mutagenicity and the like. Then, the tap water standard is THM
0.1 mg / L or less;
It is regulated to be 6 mg / L or less.

[0007] At present, there is no wastewater standard for THM, but there is a concern that the emission may adversely affect the environment. Therefore, in an artificial dialysis facility, in addition to the generation of THM during disinfection washing with an aqueous solution of sodium hypochlorite, the wastewater after the disinfection washing and the dialysis wastewater containing waste matter from the patient or the wastewater containing other organic substances are discharged. It can be said that the possibility that the liquid comes into contact with the drainage system and THM is generated by the chlorination reaction is very high. Even if other hypochlorite, isocyanurate, chlorine gas, etc. are used as a disinfectant component, generation of THM in the drainage system cannot be avoided because hypochlorous acid is generated in the cleaning solution. Have difficulty. Also, the generated TH
It is possible to remove M by adsorption treatment with activated carbon,
Performing such treatment in a medical institution is impractical because the adsorption capacity of activated carbon is reduced early and the treatment cost is very high in maintaining a constant removal performance.

[0008] Therefore, in a medical institution equipped with a dialysis facility, it is very significant to adopt a disinfecting cleaning method without concern for THM generation. However, if cleaning is insufficient and organic matter remains, Bacteria propagate as a hotbed, which can lead to infections in patients, uptake of pyrogens derived from bacteria, and accidents due to poor operation of the dialysis machine. Must be able to be reliably removed and sterilized.

The present invention has been made in view of the above-mentioned circumstances, and it is possible to completely remove dirt from a dialysis device and a dialysis line and to surely sterilize the dialysis device and the dialysis line.
Moreover, it is an object of the present invention to provide a disinfecting and cleaning method that does not have a concern about THM generation.

[0010]

In order to achieve the above object, a method for disinfecting and cleaning a dialysis device according to the first aspect of the present invention is directed to an artificial dialysis device and a dialysate line communicating therewith. It is characterized in that washing with an alkaline aqueous solution containing no acid and having a pH of 9.5 or more and washing with an acidic aqueous solution having a pH of 4.0 or less are performed. That is, according to this disinfecting and cleaning method, the stains of organic substances are surely removed by the alkaline aqueous solution, and the stains of inorganic substances such as precipitated calcium carbonate are surely removed by the acidic aqueous solution. Since hypochlorous acid is not contained, there is no concern that THM is generated during the disinfecting and cleaning and in the drainage system.

According to the second aspect of the present invention, in the disinfecting and cleaning method of the first aspect, each time the dialysis is completed, the washing with the alkaline aqueous solution and the washing with the acidic aqueous solution are performed. Dirt adhering to the apparatus and the dialysate line can be more reliably removed. According to the third aspect of the present invention, in the disinfecting cleaning method of the first or second aspect, the cleaning with the acidic aqueous solution is performed after the cleaning with the alkaline aqueous solution. Removed, inorganic dirt such as calcium carbonate wrapped in the organic dirt is exposed, and the inorganic dirt is easily removed by the subsequent washing with an acidic aqueous solution, and the organic substance is denatured by the acidic aqueous solution and is hardly removed. There is no concern.

Furthermore, in the disinfecting and cleaning method of the present invention,
The invention according to claim 4, wherein the alkaline aqueous solution contains at least one selected from the group consisting of an alkali metal hydroxide, an alkali metal carbonate, a peroxide alkali metal salt, and a sequestering alkali metal salt. 6. The invention according to claim 5, wherein the aqueous solution is one of an aqueous solution, an acidic peroxide aqueous solution, an acidic ozone water, and a heated aqueous solution of an inorganic acid / organic acid at 60 ° C. or higher. The invention according to claim 6, wherein an activator is blended, the alkaline aqueous solution contains a protease, the alkaline aqueous solution contains a bactericide, the alkaline aqueous solution contains a pH buffer. The invention according to claim 9 containing an agent is a preferred embodiment.

[0013]

BEST MODE FOR CARRYING OUT THE INVENTION The method for disinfecting and cleaning a dialysis device according to the present invention, as described above, has a pH of 9.
The cleaning with an alkaline aqueous solution of 5 or more and the cleaning with an acidic aqueous solution of pH 4.0 or less are performed, so that it is possible to maintain both a clean dialysis environment and environmental consideration in drainage.

That is, the alkaline aqueous solution has an action of removing organic substances such as proteins and lipids and a function of disinfecting and disinfecting the same, and is used to clean the artificial dialysis apparatus and the dialysis line after completion of dialysis. By doing so, even if the adhered dirt is complex in composition and morphology, the organic matter portion is removed so as to effectively peel off, while exhibiting a bactericidal action while eliminating the place where bacteria grow. It exposes inorganic dirt such as calcium carbonate wrapped in organic matter and makes it easy to release from the vessel wall. Since this alkaline aqueous solution does not contain hypochlorous acid, THM is not generated by a reaction with an organic substance unlike the conventional general-purpose sodium hypochlorite aqueous solution. No harmful THM is generated even if the wastewater after disinfection and washing comes into contact with the dialysis wastewater or other organic matter-containing wastewater in the drainage system.

On the other hand, the above-mentioned acidic aqueous solution has a dissolving action on inorganic substances such as calcium carbonate, and cannot be sufficiently removed by the above-mentioned alkaline aqueous solution by washing the artificial dialysis apparatus and the dialysate line using this. Since the inorganic dirt is dissolved and removed and has a strong bactericidal power, it contributes to reliable sterilization in the dialysis system in combination with the sterilizing and disinfecting action of the alkaline aqueous solution.

Although the order of the washing with the alkaline aqueous solution and the washing with the acidic aqueous solution is not particularly limited, generally, dirt on the artificial dialysis apparatus and the dialysate line is quantitatively large in organic components derived from patient wastes and the like. In addition, the organic dirt is usually attached uniformly to the system and covers the inorganic dirt such as calcium carbonate. If the organic dirt is first washed with an alkaline aqueous solution, the organic dirt becomes medium at this stage. Since it can hardly be removed in the acidic region due to its properties, it is difficult to dissolve and remove the inorganic dirt due to being hindered by the organic layer, and there is also a possibility that the organic substance in the dirt is denatured with acid to change to a form that is difficult to remove. Therefore, in a normal case, in order to increase the efficiency of the disinfecting cleaning, cleaning with an alkaline aqueous solution is first performed to remove organic dirt, thereby exposing inorganic dirt such as calcium carbonate, and using the next acidic aqueous solution. An operating procedure of dissolving and removing the inorganic substance by washing is recommended.

Although the ability of the alkaline aqueous solution to wash and remove organic substances is not as high as that of a conventional general-purpose aqueous sodium hypochlorite solution, substances discharged from a patient through a dialysis membrane by artificial dialysis are inherently water-soluble. Since it is hard to be stubborn, it can sufficiently cope with the organic stain. Thus, in order to exhibit the washing and removing power more efficiently, the dialysate may be discharged immediately after dialysis to prevent the accumulation of dirt, and the washing with an alkaline aqueous solution may be performed without a pause. Also, as described below,
By adding a suitable additive to this alkaline aqueous solution, it is possible to improve the removability of organic substances and calcium carbonate, as well as the bactericidal and bactericidal properties.

The alkaline aqueous solution used in the present invention has a pH of 9.5 or more as described above. The higher the pH, the higher the washing and removing properties of organic stains, especially protein stains. Thus, as such an aqueous solution, at least one selected from the group consisting of alkali metal hydroxides, alkali metal carbonates, alkali metal peroxide salts, and alkali metal sequestering agents, from the advantage that it can be easily set to a high pH. Is preferred as an alkalizing agent.

The alkali metal hydroxide is, for example, sodium hydroxide, potassium hydroxide, lithium hydroxide, or the like. The aqueous solution can be set to a high pH with a small amount of use, and its pH buffering power is small. In addition, there is an advantage that the amount of acid required for neutralization in the wastewater treatment of the aqueous solution after washing can be reduced. Examples of the alkali metal carbonate include sodium carbonate, potassium carbonate, and lithium carbonate. Since these alkali metal hydroxides and alkali metal carbonates are both inorganic substances, and their aqueous solutions have a BOD and COD of 0, they only neutralize the waste water after washing and do not impose a load on the environment. Can be discharged.

The alkali metal peroxide is, for example, sodium percarbonate, sodium perborate, or the like. In addition to the function as an alkalizing agent, the alkali metal salt acts as an oxidizing agent by the retained active oxygen. The use of the aqueous solution particularly improves the removability of protein stains. In addition, it has been found that the aqueous solution of the alkali metal peroxide exhibits a higher bactericidal property than the aqueous solution of the alkali metal hydroxide. Although this aqueous solution has no environmental load due to BOD and COD, it goes without saying that the wastewater using sodium perborate must comply with the wastewater standard for boron.

Since the above-described alkali metal salt of the metal sequestering agent has a function of sequestering in addition to the function as the alkalizing agent, the metal in the organic matter is pulled out during the washing with the aqueous solution to remove the stain of the organic matter. In addition to making it easier to work, it also effectively acts to remove and dissolve calcium carbonate, and also acts as a pH buffer to suppress the drop in pH of the aqueous solution.
There is an advantage that the washing and removing power is not easily reduced due to the decrease in pH. Since the sequestering agent alkali metal salt is composed of an organic substance, it is composed of carbon, hydrogen and nitrogen.
There is a D value.

Examples of such a sequestering agent alkali metal salt include L-glutamic acid diacetate, L-aspartic acid diacetate, methylglycine diacetate, [S, S] -ethylenediamine-N, N-diacetic acid. Succinic acid, β-alanine diacetate,
Serine diacetate, hydroxyethyliminodiacetic acid, dihydroxyethylglycinic acid, iminodisuccinic acid, hydroxyiminodisuccinic acid, ethylenediaminetetraacetic acid, hydroxyethylenediaminetriacetic acid, hydroxyethylenediaminetriacetic acid, diethylenetriaminepentaacetic acid, triethylenetetraamine Examples thereof include alkali metal salts such as hexaacetic acid, 1,3-propanediaminetetraacetic acid, 1,3-diamino-2-hydroxypropanetetraacetic acid, and nitriloacetic acid. Among these, L-glutamic acid diacetate, L-aspartic acid diacetate, methylglycine diacetate, [S, S] -ethylenediamine-N, N-disuccinic acid, β-alanine diacetate, serine diacetate Alkali metal salts such as hydroxyethyliminodiacetic acid are particularly recommended as environmentally friendly components because of their good biodegradability.

An aqueous solution of an alkali metal hydroxide can be set to a high pH at a low concentration, but has a weak pH buffering property, and its pH is lowered by mixing and contacting with various kinds of dirt. The dirt removability is reduced, but this difficulty can be improved by adding a pH buffering agent. Examples of such a pH buffering agent include an organic acid salt, an organic phosphonate, a phosphate, a borate, an alcoholamine salt, and a bicarbonate, and these may be used in combination of two or more.

Examples of the organic acid salt used in the pH buffering agent include citric acid, gluconic acid, succinic acid, tartaric acid, acetic acid, malic acid, formic acid, fumaric acid, lactic acid, polyacrylic acid, polyacrylic acid-polymaleic acid. Block polymer, polyglyoxylic acid-polyethylene oxide block polymer, polyethylene oxide-polyacrylic acid /
Examples include a sodium salt, a potassium salt, an ammonium salt, and an alcoholamine salt such as a maleic acid graft polymer. Examples of organic phosphonates include aminotri (methylenephosphonic acid), 1-hydroxyethylidene-1,1-diphosphonic acid, 1-hydroxyethylidene-1,1-diphosphonic acid, ethylenediaminetetra (methylenephosphonic acid), diethylenetriaminopenta ( Sodium salts, potassium salts, ammonium salts, and alcoholamine salts such as methylenephosphonic acid) and phosphonobutanetricarboxylic acid. Examples of the phosphate include sodium, potassium, ammonium, and alcoholamine salts such as phosphoric acid, pyrophosphoric acid, tripolyphosphoric acid, tetrapolyphosphoric acid, and hexapolyphosphoric acid. Borates include sodium, potassium and ammonium salts of boric acid. Alcoholamines include monoethanolamine, diethanolamine, and triethanolamine. Bicarbonates include sodium bicarbonate and potassium bicarbonate.

Among these pH buffering agents, organic acid salts, organic phosphonate salts, and polyphosphoric acid hydrochlorides also function as sequestering agents at the same time, and can also contribute to the removal of calcium carbonate. However, it should be noted that ammonium salts increase the ammonia odor as the action time at high pH becomes longer. Although borate has the effect of a pH buffering agent, boron has an emission standard, and it is desirable to avoid it in consideration of the environment.

As a means for further improving the removability of organic substances with an alkaline aqueous solution, an enzyme which is a biocatalyst can be contained in the aqueous solution. Such enzymes include proteolytic enzymes, lipolytic enzymes, carbohydrate degrading enzymes, and the like. Proteolytic enzymes are particularly useful for dealing with contamination of dialysis equipment and dialysate lines. Among them, alkaline protease is generally pH 10-12
Since it has an optimum pH for enzyme activity, it is also one of the enzymes corresponding to the alkaline aqueous solution used in the present invention. Lipase, which is a lipolytic enzyme, is effective in decomposing glycolipids and lipid proteins excreted from the body. In addition, carbohydrate-decomposing enzymes are effective in decomposing and removing carbohydrates, glycolipids, and glycoproteins. In addition, an enzyme having enzyme activity in the presence of peroxide is also useful.

Examples of the alkaline protease include Savinase and Esperase (trade names, manufactured by Novo Corporation).
Alcalase and the like. As lipolytic enzymes,
There is also a brand name lipolase manufactured by Novo. Examples of the carbohydrate-decomposing enzyme include Termamil (trade name) manufactured by Novo, and Clarase (trade name) manufactured by Kyowa Enzyme. An example of an enzyme having an enzyme activity in the presence of a peroxide is Duramil (trade name, manufactured by Novo Corporation).

However, these enzymes have an excellent washing and removing effect on stains, but since they are composed of proteins, they may adversely affect patients if they remain in the dialysis line. They need to be monitored closely. In addition, since the enzyme has a large molecular weight, it cannot be used in an installation line of an endotoxin removal filter (hereinafter abbreviated as ETCF).

The stainless steel used for a part of the liquid contact part of the dialysis machine is generally not easily attacked in an alkaline region, but rust or rust is caused by various ions, sequestering agents, oxidizing agents, and a decrease in pH. May cause corrosion. In the present invention, a metal corrosion inhibitor can be added to the alkaline aqueous solution in order to prevent and suppress such metal corrosion. Examples of the metal corrosion inhibitor include water-soluble silicates such as sodium silicate and potassium silicate, and polysilicates.

The disinfecting action of the alkaline aqueous solution is as follows:
Although it is difficult to say that it alone is sufficient, it is possible to sufficiently sterilize and disinfect the dialyzer and the dialysate line in combination with the sterilizing power of the acidic aqueous solution as described above. Therefore, in order to carry out more reliable sterilization and disinfection, the alkaline aqueous solution is allowed to stay in the artificial dialysis machine and the dialysate line for a long time to reduce the number of bacteria, and is washed in the next stage with an acidic aqueous solution in a sanitary condition. Disinfection should be performed.

Further, in order to improve the disinfecting and bactericidal properties of the alkaline aqueous solution, chlorinated compounds such as chlorine dioxide and chlorite, and oxygen compounds such as hydrogen peroxide and potassium persulfate may be contained in the aqueous solution. A system disinfectant, ozone gas, and a disinfectant can also be contained. Although chlorine dioxide and chlorite are chlorine compounds having residual chlorine, they do not form hypochlorous acid, so they do not chlorinate even when oxidizing organic substances, and there is no concern that THM will be generated. . Hydrogen peroxide quickly generates nascent oxygen in the alkaline region, exerts a more effective bactericidal action, and physically removes the attached dirt by the generated foam, thereby improving the removability of dirt. It also has the effect of increasing. Ozone gas has a strong bactericidal action.

Examples of the above disinfectants include benzalkonium chloride, benzethonium chloride, didecyldimethylammonium chloride, alkyldimethylethylbenzylammonium chloride, polyhexamethyleneguanidine, polyalkylaminoethylglycine and the like. Among these, polyalkylaminoethyl glycine is also a bactericide having detergency. However, benzalkonium chloride and alkyl polyaminoethyl glycine
When used in an ETCF installation line, it is difficult to wash and remove the ETCF, so special care must be taken to ensure that there is no residue. Also, with regard to hydrogen peroxide and dissolved ozone, care must be taken not to leave air bubbles since generated air bubbles may accumulate in the ETCF.

When the alkaline aqueous solution is an aqueous solution of a peroxide alkali metal salt, the removal of dirt can be improved by adding an activity promoter for enhancing the oxidizing property. Examples of such an activity promoter include tetraacetylglycouryl, tetraacetylethylenediamine, nonanoyloxybenzenesulfonate, lauroyloxybenzenesulfonate, decanoyloxybenzoate and the like. The addition amount of these activity promoters may be close to the molecular weight equivalent to the active oxygen of the peroxide.

Furthermore, as a means for improving the disinfecting and cleaning properties with an alkaline aqueous solution, it is recommended to include a surfactant to increase the permeability to dirt. Examples of the surfactant include anionic surfactants such as alkyl sulfates, polyoxyethylene alkyl ether sulfates, alkyl sulfonates, alkyl diphenyl ether sulfonates, acyl glutamates, meta-xylene sulfonates, and para-toluene sulfonates. Non-ionic interface of activator, polyoxyalkylene alkyl ether, alkyl polyglucoside, polyoxyethylene alkyl ether, polyoxyethylene glyceryl alkyl ether, alkylamine oxide, polyoxyethylene polyoxyethylene block polymer, polyoxypropylene diglyceryl ether, etc. Examples of the surfactant include an amphoteric surfactant such as an activator, alkyl betaine, and imidazolium betaine. These may be used alone or in combination of two or more. However, the surfactant has poor water-washing properties on the ETCF installation line and has a very high possibility of remaining. Therefore, it is desirable to use the surfactant only in the dialysate line in which the ETCF is not installed.

The above-mentioned acidic aqueous solution has a pH as described above.
It is 4.0 or less, and exhibits an action of dissolving and removing inorganic dirt such as calcium carbonate and a disinfecting action. However, the disinfecting action increases as the pH decreases, but it is difficult to obtain sufficient disinfecting properties with a mere aqueous solution of an organic acid or an inorganic acid. It is more preferable to use any of an aqueous solution of a substance, acidic ozone water, and a heated aqueous solution of an inorganic acid / organic acid at 60 ° C. or higher.

The aqueous solution of peracetic acid exhibits an excellent disinfecting and disinfecting action at a concentration of 0.001% or more, and can dissolve calcium carbonate according to the amount of acetic acid contained. As such an aqueous solution of peracetic acid, those containing 0.3 to 9% of peracetic acid, 3 to 10% of hydrogen peroxide, and 3 to 40% of acetic acid are commercially available.

The above-mentioned acidic peroxide aqueous solution is an aqueous solution containing a peroxide and an organic acid and / or an inorganic acid as an acidic substance, and is capable of removing calcium carbonate with an acidic substance and sterilizing with a peroxide. Has a disinfecting effect. The germicidal disinfection effect is based on the effective oxygen content of the aqueous solution of 0.002.
% Or more. The peroxides include sodium, potassium, and ammonium salts such as sulfuric acid peroxide, disulfuric acid peroxide, and phosphoric acid peroxide in addition to hydrogen peroxide, and one or more of these can be used.

The acidic ozone water can be prepared by mixing an ozone water obtained from an ozone water maker with an acidic substance, or by blowing ozone gas into an acidic aqueous solution composed of the acidic substance. Although ozone gas has a strong sterilizing effect, it lacks stability, but can be stably maintained in an aqueous solution in an acidic region, and functions as an active ingredient for sterilization and disinfection.

It is needless to say that the organic acid and the inorganic acid as the acidic substance used in the above-mentioned acidic peroxide aqueous solution and acidic ozone water preferably have a large dissolving power for calcium carbonate. Such organic acids include carboxylic acids such as acetic acid, succinic acid, fumaric acid, maleic acid, sorbic acid, and adipic acid and anhydrides thereof, glycolic acid, lactic acid,
Propionic acid, tartaric acid, malic acid, citric acid, tartaric acid,
Examples include hydroxycarboxylic acids such as gluconic acid. Examples of the inorganic acid include phosphoric acid, sulfamic acid, hydrochloric acid, and nitric acid. Thus, one or more of these acidic substances can be used respectively. When a strong acid such as hydrochloric acid or nitric acid is used, it is desirable to use a metal corrosion inhibitor in combination.

The heated aqueous solution of the organic acid and / or the inorganic acid has improved disinfection and disinfection by a high-temperature disinfection effect. The higher the temperature, the more disinfection and disinfection increase.
It is sufficient that the temperature is at least ° C. It should be noted that although hot water alone exhibits a sufficient bactericidal effect at a high temperature of 80 ° C. or higher, this heated aqueous solution is acidic, so that a higher bactericidal effect can be obtained at a lower temperature. The organic acid and the inorganic acid used in the heated aqueous solution are preferably those having a high dissolving power for calcium carbonate. Such organic acids include acetic acid, succinic acid, fumaric acid, maleic acid, adipic acid, carboxylic acids such as sorbic acid, glycolic acid, lactic acid,
Hydroxycarboxylic acids such as propionic acid, tartaric acid, malic acid, citric acid, gluconic acid and the like can be mentioned. Examples of the inorganic acid include phosphoric acid, sulfamic acid, hydrochloric acid, and nitric acid. Thus, one or more of these acids can be used. When a strong acid such as hydrochloric acid or nitric acid is used in this heated aqueous solution, it is preferable to use a metal corrosion inhibitor in combination.

Incidentally, these acidic aqueous solutions can also contain a surfactant in order to increase the permeability to dirt. As the surfactant, the same anionic surfactant, nonionic surfactant, and amphoteric surfactant as those contained in the above-mentioned alkaline aqueous solution can be used, and nonionic surfactants are particularly preferable. However, it is desirable to use these surfactants only in the dialysate line where no ETCF is installed.

In the washing of the dialysis apparatus and the dialysate line according to the present invention, it is preferable to carry out the two-stage washing with the above-mentioned alkaline aqueous solution and the acidic aqueous solution every time the dialysis is completed. In particular, it is recommended that the washing with the alkaline aqueous solution be carried out first. However, depending on the degree and tendency of the contamination, the type of the washing solution to be used, and the like, the washing is not necessarily limited to the two-step washing each time the dialysis is completed. That is, when the disinfecting and disinfecting properties of the alkaline aqueous solution and the removability of calcium carbonate are enhanced, it is possible to employ a method in which washing with the alkaline aqueous solution is carried out every day and washing with the acidic aqueous solution is used every few days. In addition, when the organic matter tends to be less contaminated, it is possible to employ a method in which washing with an acidic aqueous solution is carried out every day and washing with an alkaline aqueous solution is used every few days.

However, in such a method in which washing with one of an alkaline aqueous solution and an acidic aqueous solution is performed daily and intermittent washing is performed with the other, it is necessary to sufficiently monitor the clean state, and to carry out the cleaning at the end of each dialysis. It is better to make the washing time with each aqueous solution longer than in the case of performing two-step washing with an aqueous solution, but it is necessary to perform washing with the other aqueous solution at least once every 6 to 7 times with one aqueous solution. For example, in a normal dialysis facility, it is common to perform dialysis from Monday to Saturday and stop on Sunday, so from Monday to Saturday, perform daily dialysis and wash with an alkaline aqueous solution, and on weekends on Saturday, Is washed with an acidic aqueous solution after washing with an alkaline aqueous solution, or conversely, washed with an acidic aqueous solution after completion of daily dialysis from Monday to Saturday, and washed with an alkaline aqueous solution on a weekend of Saturday before washing with an acidic aqueous solution What should I do? In the artificial dialysis apparatus and the dialysate line, it is recommended to perform disinfection together with acid cleaning, but it is preferable to perform this disinfection after dirt is surely removed.

[Reactivity Test of Alkaline Aqueous Solution and Artificial Dialysis Effluent] To 4 parts by volume of artificial dialysis effluent from a patient obtained in a dialysis facility, sodium hypochlorite (NaClO), One part by volume of an aqueous solution of each of sodium isocyanurate (SDCI), sodium chlorite (Na chlorite), and chlorine dioxide was mixed, and the change over time in the residual chlorine amount was examined. The results are shown in Table 1 below. The pH of these aqueous solutions was adjusted using a sodium hydroxide aqueous solution and a phosphoric acid aqueous solution. In the following, sodium is represented by Na, potassium by K, sodium hydroxide by NaOH, and potassium hydroxide by KOH.

[0045]

[Table 1]

From the results in the above table, the aqueous solutions of sodium hypochlorite (Nos. 1 to 3) and the aqueous solutions of sodium dichloroisocyanurate (Nos. 4 and 5), which produce hypochlorous acid, were mixed with the dialysis wastewater. As a result, the residual chlorine is rapidly reduced, and it can be seen from the strength of their reactivity that they react with the substances in the dialysate. On the other hand, an aqueous solution of chlorine dioxide (No. 6, 7) and an aqueous solution of sodium chlorite (No. 8,
Item 9) shows a slight decrease in residual chlorine even when mixed with the dialysis effluent, suggesting that there is almost no reactivity.

[THM Production by Mixing of Alkaline Aqueous Solution and Artificial Dialysis Effluent] To 4 parts by volume of artificial dialysis effluent from a patient obtained in a dialysis facility, the above Nos. 1, 3, 5 to 9
And 1 part by volume of each aqueous solution.
H, 0.01% aqueous solution of H, 1% aqueous solution of ethylenediaminetetraacetic acid 4Na salt (EDTA), L-glutamic acid diacetate 2
0.4% aqueous solution of sodium salt (GLDA), 0.5% of sodium percarbonate
The amount of THM generated was measured at predetermined time intervals when 1 volume part of each aqueous solution was mixed. The results are shown in Table 2 below. The amount of THM produced was measured by head space gas chromatography / mass spectrometry, and excess residual chlorine was neutralized with Na thiosulfate during the measurement.

[0048]

[Table 2]

From the results shown in Table 2, the aqueous solutions of sodium hypochlorite (Nos. 1 and 3) and sodium dichloroisocyanurate (No. 5), which produce hypochlorous acid, were mixed with the dialysis effluent to obtain THM. Is generated, and the generation amount increases with time. The comparison between Tables 1 and 2 for the aqueous solutions (Nos. 1, 3, and 5) that produce hypochlorous acid also suggests that the decrease in residual chlorine and the increase in THM production are correlated. Is done. In contrast, aqueous solutions of chlorine dioxide (Nos. 5, 6), aqueous solutions of sodium chlorite (Nos. 8, 9),
NaOH aqueous solution (No.10), ethylenediaminetetraacetic acid 4
Na salt aqueous solution (No.11), L-glutamic acid diacetate 2N
a salt aqueous solution (No. 12) and Na percarbonate aqueous solution (No. 13)
Neither generated THM. Therefore, it is understood that the alkaline aqueous solution containing no hypochlorous acid does not generate THM and does not adversely affect the environment. Further, as shown in Table 1, the pH of the mixed solution of the alkaline aqueous solution and the dialysis waste liquid is 9 or less of the effluent standard. It is clear that the pH range can be set easily by mixing with the above.

[Mock washing test] Soil of organic matter (protein, lipid) and inorganic matter (CaCO ₃ ... Calcium carbonate) corresponding to the stain of the dialysis device and the dialysis line was attached to the test piece, and the test piece was subjected to various tests at 25 ° C. It was immersed in the cleaning solution for a required time, and the degree of dirt removal was examined. The results are shown in Tables 3A to 3D below together with the active ingredient concentration (%) and the pH of each washing solution. In addition, the test piece of each dirt, evaluation of cleanability, and the breakdown of active ingredients are as follows.

<Test piece> Protein stain: 10 μl of a 10% aqueous solution of human serum was dropped on a slide glass and left indoors at room temperature for 18 hours. Lipid stain: 10 μl of soybean oil dropped on a slide glass and left indoors at room temperature for 18 hours. CaCO ₃ stain: 10 μl of dialysate (Kindery 2p manufactured by Fuso Chemicals Co., Ltd.) in which the concentration of sodium bicarbonate was doubled so as to easily precipitate CaCO ₃ was dropped into a silicon tube, and room temperature was kept at room temperature for 48 hours or more. What was left.

<Evaluation of Detergency> Protein: Using an Amido Black 10B color test solution, the color of the sample before immersion was set to 10 at maximum, and 0 was set to 0 for no color.
The degree of coloration, that is, the degree of residual protein, was represented by a number from 0 to 0. A colorless value of 0 means that no protein remains, and a washability of 5 or less after 2 hours of washing indicates good cleaning. Lipid: Evaluated by the time until oil droplets disappear from the slide glass, ◎ disappears within 10 minutes, ○ disappears within 30 minutes, burns off within 60 minutes, □ disappears within 120 minutes Δ, x: no disappearance even after 120 minutes. CaCO ₃ ··· Orthophthalein complexane (O
According to the calcium coloration by the CPC) method, な し indicates no color after 10 minutes of immersion washing, □ indicates no color after 60 minutes, Δ indicates no color after 2 hours, and × indicates coloration after 2 hours.

<Sequestering Agent Alkali Metal Salt> Neutral EDTA ··· Ethylenediaminetetraacetic acid 3Na salt EDTA ··· Ethylenediaminetetraacetic acid 4Na salt EDTA # 1 ··· Ethylenediaminetetraacetic acid 4Na salt containing 0.4% as 4Na salt PH adjustment with 3N salt and GLDA ... 40% L-glutamic acid diacetate 2Na salt
Containing 50% of Cyles CMG-40 ASDA ... L-aspartic diacetate 2Na salt
% Cre-Wat Bi-HDS MGDA manufactured by Teikoku Chemical Industry Co., Ltd. Trilon M EDDS manufactured by BASF containing 40% methylglycine diacetate 2Na salt [S, S-] Ethylenediamine-N, N
-Octel Quest E-30 EDDS # 2 containing 37% of disodium 3Na salt, EDDS # 2 ... 1% aqueous solution of EDDS is pH-adjusted with NaOH. HIDS ... Chillest E-25 DHEG containing 25% hydroxyethyliminodiacetic acid 2Na salt. DHEG ... Chillest G-50 DPTA ... Diethylene containing 50% dihydroxyethylglycinic acid 1Na salt. Kyrest P HEDTA containing 40% of tetraamine pentaacetic acid 5Na salt manufactured by Kyrest Co., Ltd. hydroxyethylenediamine triacetic acid 3
Cherest H TTHA containing 35% of Na salt. Triethylenetetraamine hexaacetic acid 6Na
KIRESTO Q-NTA containing 33% salt 3N salt of nitrilotriacetic acid

<Alkali metal peroxide> Na percarbonate: SPC-G manufactured by Nippon Peroxide Co. Na perborate: Na perborate tetrahydrate

<PH buffer> Na citrate: pH-adjusted 0.4% aqueous solution of 3Na citrate with NaOH HEDP: CHILEST containing 60% of 1-hydroxyethylidene-1,1-diphosphonic acid MASKOR P-2
Use 10 and adjust pH with KOH

<Disinfectant> Na chlorite: Chlorous acid N having a residual chlorine amount of 500 ppm
a pH adjustment of the aqueous solution with NaOH Chlorine dioxide: pH adjustment of a chlorine dioxide aqueous solution with a residual chlorine content of 500 ppm with NaOH Alkaline ozone water: Obtained with an ozone water production machine (OW1020 manufactured by Mitsubishi Electric Corporation, containing 20 mg / L of ozone gas) PH of dissolved ozone gas dissolved water is adjusted with NaOH Amphoteric disinfectant: alkyl polyaminoethyl glycine
Nissan Anon LG manufactured by NOF Corporation containing 30%.

<Surfactant> S1 ... polyoxyethylene alkyl sulfate N
a soft oil containing 25% a manufactured by NOF CORPORATION EF S2: polyoxyalkylene alkyl ether (Leox 2008C manufactured by Lion) S3: 36% of alkyldimethylaminoacetic acid betaine
Contained Levon LD-36 S4: Polyoxyethylene alkyl ether (Naroacti N-95 manufactured by Sanyo Chemical) S5: Polyoxyethylene alkyl ether (ADEKATOL SO-135 manufactured by Asahi Denka)

<Enzyme> Proteolytic enzyme: Sabinase manufactured by Novo.

<Aqueous Aqueous Solution> 0.01% peracetic acid containing 0.01% peracetic acid, 0.15% acetic acid, and 0.05% hydrogen peroxide. 0.02% peracetic acid: Contains 0.02% of peracetic acid, 0.3% of acetic acid, and 0.1% of hydrogen peroxide. Peroxysulfate: Mono-potassium sulfate compound (Oxone manufactured by DuPont, available oxygen amount: about 5%). Disulfuric acid salt: sodium disulfate peroxide (manufactured by MGC,
Effective oxygen amount about 5%). Acidic ozone water: A solution obtained by dissolving 0.2% of acetic acid in ozone water produced by the above ozone producing machine.

[0060]

[Table 3A]

[0061]

[Table 3B]

[0062]

[Table 3C]

[0063]

[Table 3D]

From the results shown in Tables 3A to 3D, even when the neutral aqueous solution contains an alkali metal salt, a sequestering agent, a peroxide, etc., almost no organic dirt can be removed. In aqueous solutions, the removability increases as the pH increases. Thus, the sequestering agent aqueous alkali metal salt solution and the aqueous peroxide alkali metal salt solution are both
It has better detergency for proteins than an aqueous solution of an alkali metal hydroxide alone having the same pH. The detergency against proteins is improved by the inclusion of hydrogen peroxide, which is an oxygen-based bactericide, and a pH buffering agent, and is particularly remarkably improved when a protease is added. Furthermore, the addition of a surfactant dramatically improves the detergency of lipids and also slightly improves the protein removal properties. In particular, anionic surfactants and nonionic surfactants are effective. On the other hand, with respect to the detergency of calcium carbonate, an acidic aqueous solution shows a quick effect, and even an alkaline aqueous solution is improved by the inclusion of a sequestering agent and a pH buffering agent having sequestering power. 80
C. hot water removes only a certain amount of lipids, but hardly removes proteins and calcium carbonate.

[Metal Corrosion Test] A SUS-410 plate (20 × 50 × 1 mm, about 7.5 g) was immersed in an alkaline aqueous solution maintained at 37 ° C. for 7 days, and its state change and weight change were examined. Table 4 shows the results. As the alkaline aqueous solution, No. a8 and No. a26 in Tables 3A and 3B, and those obtained by adding potassium silicate to these were used.

[0066]

[Table 4]

From the results shown in Table 4, it can be seen that the addition of a silicate is effective in preventing metal corrosion by an alkaline aqueous solution.

[Bactericidal Effect Test 1] A bactericidal effect of an alkaline aqueous solution and an acidic aqueous solution on mesitiline-resistant Staphylococcus aureus (MRSA) was tested. Table 5 shows the results. In the test, 0.1 ml of 10 ⁷ cells / ml test bacterial solution was inoculated to 10 ml of the test solution, stored at 20 ° C. for 5 minutes, and 1 ml thereof was added to 9 ml of SCDLP agar medium (manufactured by Nippon Pharmaceutical Co., Ltd.). After culturing at 35 ° C. for 2 days, the number of viable cells was measured. The number of each test liquid corresponds to the test liquids shown in Tables 3A to 3D.

[0069]

[Table 5]

As is clear from the results in Table 5, MRSA
In contrast, in an alkaline aqueous solution, the higher the pH, the greater the disinfection effect, the better the disinfection effect due to the presence of percarbonate, ozone, and hydrogen peroxide, and a solution of hypochlorite-free aqueous chlorite or dioxide. Chlorine aqueous solution is slow-acting, but can sterilize 100%, and an alkaline aqueous solution containing benzalkonium chloride or alkyl polyaminoethylglycine, which is a germicidal disinfectant, achieves 100% sterilization after 60 minutes. On the other hand, in the case of the acidic aqueous solution, 100% sterilizing effect can be obtained in a short time.

[Bactericidal Effect Test 2] An aqueous solution of peracetic acid (peracetic acid: acetic acid: hydrogen peroxide = 1: 15:
5) Aqueous solution of sulfuric acid peroxide (potassium monosulfate = Oxone manufactured by DuPont), aqueous solution of hydrogen peroxide-citric acid, acidic ozone water, citric acid heating water, and 0.25% organic acid (succinic acid, apple (Acid, citric acid) aqueous solution, and a 60 ° C. hot aqueous solution were used as a reference, and each was contacted with Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa at a rate of 10 ⁶ / ml, respectively, to examine the bactericidal effect. Table 6 shows the results. The test liquids with No. correspond to the test liquids shown in Tables 3C and 3D.

[0072]

[Table 6]

As is clear from the results in Table 6, in the case of the aqueous solution of peracetic acid, the growth of Pseudomonas aeruginosa was observed in 5 minutes of contact at a peracetic acid concentration of 0.002%. No growth of all the bacteria was observed. In the case of acidic aqueous solutions of sulfate and hydrogen peroxide, the effective oxygen content is 0.002% and
An excellent sterilizing effect was obtained at 0.005%, and it can be seen that acidic ozone water and an acidic heating aqueous solution can surely sterilize and disinfect. However, simple aqueous solutions of organic and inorganic acids or 60
Sufficient bactericidal effects have not been obtained with warm water at about ° C.

[0074]

EXAMPLES Examples of the present invention will be specifically described below in comparison with comparative examples. The alkaline aqueous solution and the acidic aqueous solution used in these Examples and Comparative Examples are shown in Table 3.
This corresponds to the test liquids of Nos. A to 3D.

Examples 1 to 46 Simulated dirt after dialysis in a dialysis apparatus and a dialysate line, a test piece having a mixture of organic matter and inorganic matter was subjected to a predetermined concentration of sodium bicarbonate so that CaCO ₃ was easily deposited. Double volume dialysate (Kindally 2p, manufactured by Fuso Chemicals)
1 volume part of human serum was mixed and dissolved in 9 volume parts, and
l was dropped on a slide glass and left for 24 hours at room temperature. Then, this test piece was used in Table 7 below.
Immersed in an alkaline aqueous solution described in 1) at a liquid temperature of 25 ° C. for 1 hour, washed with water, and then placed in an acidic aqueous solution described in the same table at a liquid temperature of 2 ° C.
It was immersed in 5 ° C. (excluding heated water), washed with water and examined for dirt removal. The results are shown in Table 7 below. "Real" in the table means an example. In addition, the washing | cleaning property with respect to the stain | pollution | contamination of an organic matter was determined by the evaluation method based on the coloration using the amide black 10B test solution mentioned above about what was immersed in the acidic aqueous solution for 1 hour, and washed with water, and determined the residual degree of the protein.
In addition, the cleaning property against inorganic dirt is 1
For the thing immersed in water for 0 minutes and washed,
The determination and evaluation were performed in the same manner as described above by the calcium coloration by the method.

Comparative Examples 1 to 4 Test pieces similar to those used in Examples 1 to 46 were prepared as shown in Table 7 below.
Was immersed in each of an alkaline aqueous solution, an acidic aqueous solution and warm water for 2 hours at a liquid temperature of 25 ° C., washed with water and examined for dirt removal properties in the same manner as described above. The results are shown in Table 7 below. "Ratio" in the table means a comparative example.

[0077]

[Table 7]

From Table 7, it can be seen that by performing two-step washing with an alkaline aqueous solution and an acidic aqueous solution according to the present invention, the washing performance of organic substances is improved more than the washing performance of the alkaline aqueous solution alone, and the inorganic substances are washed. It can be seen that the detergency with respect to water was also improved compared to the detergency with the acidic aqueous solution alone. Such a difference is caused by the fact that the dirt attached to the test piece is in a complex state of organic and inorganic substances, so that washing of the alkaline aqueous solution alone does not easily remove protein stains to be removed, and the acidic aqueous solution alone Calcium carbonate, which should be removed by washing, is difficult to fall off due to organic matter, whereas in the two-step washing of the present invention, calcium carbonate stains were exposed even if some amount of protein etc. remained after washing with an alkaline aqueous solution. It is presumed that calcium carbonate is easily dissolved and removed by the next washing with an acidic aqueous solution, and the remaining proteins and the like are also released and removed simultaneously with the dissolution and removal.

Examples 47 to 57 Test pieces similar to those used in Examples 1 to 46 were placed in an acidic aqueous solution described in Table 8 below at a liquid temperature of 25 ° C. After immersion in water (excluding warm water) for 1 hour, rinsing with water, and then immersion in an alkaline aqueous solution shown in the same table at a liquid temperature of 25 ° C. for 1 hour, and examining the dirt removal property after rinsing with water. The results are shown in Table 8 below. "Real" in the table means an example.

[0080]

[Table 8]

As can be seen from Table 8, even in the two-stage washing in which the washing with the alkaline aqueous solution is performed first after the washing with the acidic aqueous solution, if the immersion in both the aqueous solutions is as long as one hour, the cleaning property against the stains of the organic substances is obtained. It can be seen that the cleaning properties for the soil and the inorganic substance are both good.

Examples 58 to 68 In a medical institution having an artificial dialysis facility, after completion of dialysis, RO (reverse osmosis) water is supplied for 15 minutes to a dialyzer and a dialysate line in which artificial dialysis is performed once a day. Then, washing for a required time with an alkaline aqueous solution described in Table 9 below, washing with RO water for 90 minutes, washing with an acidic aqueous solution shown in the same table for a required time, and washing with RO water for 90 minutes are sequentially performed for 6 days. After continuing, the cleanliness was checked. Table 9 shows the results. In Examples 58 to 65,
An alkaline aqueous solution and an acidic aqueous solution were passed through a patient monitor (DBB-22B manufactured by Nikkiso Co., Ltd.) in which ETCF (EF-01 manufactured by Nikkiso Co., Ltd.) was installed. In Examples 66 to 68, a patient monitoring device without an ETCF (Toray T
R-230) was passed through an alkaline aqueous solution and an acidic aqueous solution. The supply rate of each aqueous solution is 500 ml / min.

The degree of cleanliness is determined by the number of viable bacteria and endotoxin value (E
T value), the presence or absence of protein-based stain, and the presence or absence of calcium carbonate were examined. Table 8 shows the results. For the viable cell count and endotoxin level, a sample for measurement was taken from a position immediately before the supply of the dialysis membrane. The presence or absence of protein-based stain was determined by using the above-described amide black 10B test solution for coloration in the silicon tube immediately after drainage from the dialysis membrane. For the presence of calcium carbonate,
Regarding the silicone tube at the position immediately before supply to the patient monitoring device and the position immediately after drainage from the patient monitoring device, the already described OC
It was examined by the PC method.

[0084]

[Table 9]

As shown in Table 9, in the dialysis apparatus and the dialysate line to which the washing methods of Examples 58 to 68 were applied, the number of bacteria was 0 and the endotoxin value was 1 EU / L or less.
No residue of protein-based soil and calcium carbonate was observed,
It is clear that it is kept very clean.

Examples 69 to 74 After completion of dialysis, RO water was supplied to the dialysis apparatus and the dialysate line in which artificial dialysis was performed once a day as in Examples 58 to 68 for 15 minutes. Washing for a required time with an acidic aqueous solution described in 10 above, washing with RO water for 90 minutes, washing for a required time with an alkaline aqueous solution described in the table, and washing with RO water for 90 minutes were sequentially performed for 6 days. The cleanliness was checked. Table 10 shows the results. In Examples 69 to 73, a patient monitoring device (DBB-22 manufactured by Nikkiso Co., Ltd.) equipped with an ETCF (same as above) was used.
An acidic aqueous solution and an alkaline aqueous solution were passed through B). In Example 74, an alkaline aqueous solution and an acidic aqueous solution were passed through a patient monitoring device (TR-230, manufactured by Toray Industries, Inc.) in which no ETCF was installed. The supply rate of each aqueous solution is 500 ml / min.

[0087]

[Table 10]

As shown in Table 10, in the dialysis apparatus and the dialysate line to which the washing methods of Examples 69 to 74 were applied, the number of bacteria was 0, the endotoxin value was 1 EU / L or less, and protein-based soil and calcium carbonate were used. No residue was observed, and it is clear that the residue was kept extremely clean.
However, in these examples, the supply and residence time of each cleaning liquid are set to be longer in order to perform cleaning with an alkaline aqueous solution after cleaning with an acidic aqueous solution.

Examples 75 to 77 After completion of dialysis, RO water was supplied for 15 minutes to the dialyser and the dialysate line in which artificial dialysis was performed once a day in the same manner as in Examples 58 to 74. The washing with the alkaline aqueous solution described in 11 for a required time and the washing with RO water for 90 minutes were performed for 6 days. After washing with an alkaline aqueous solution and water washing on the sixth day, washing was performed for a required time with an acidic aqueous solution shown in the same table, and then washing with RO water was performed for 90 minutes, and then the cleanliness was examined.
Table 11 shows the results. The supply amount of each aqueous solution was 500 m
At 1 / min, the solution was passed through a patient monitoring device (DBB-22B manufactured by Nikkiso Co., Ltd.) in which an ETCF (same as above) was installed.

Examples 78 and 79 After completion of the dialysis, RO water was supplied for 15 minutes to the dialysis apparatus and dialysate line in which artificial dialysis was performed once a day in the same manner as in Examples 58 to 77. Washing with an acidic aqueous solution described in 12 for a required time and washing with RO water for 90 minutes were performed for 5 days. After completion of the dialysis on the sixth day, the membrane is washed with RO water for 15 minutes, then washed with an alkaline aqueous solution described in the same table for a required time, washed with RO water for 90 minutes, and further required with an acidic aqueous solution described in the same table. After washing for an hour, and washing with RO water for 90 minutes, the cleanliness was examined. Table 12 shows the results. The supply rate of each aqueous solution was 500 ml / min, and a patient monitor (DBB-2 manufactured by Nikkiso Co., Ltd.) equipped with an ETCF (same as above) was used.
2B).

[0091]

[Table 11]

[0092]

[Table 12]

As shown in Tables 11 and 12, Examples 75 to
Even in the method of performing daily washing with one of an alkaline aqueous solution and an acidic aqueous solution and washing with the other once a week as in 79, the supply and residence time of each aqueous solution are set to be sufficiently long. This clearly shows that the dialyzer and the dialysate line can be kept extremely clean.

[0094]

According to the first aspect of the present invention, the artificial dialysis apparatus and the dialysate line communicating therewith are washed with an alkaline aqueous solution containing no hypochlorous acid and having a pH of 9.5 or more, and having a pH of 4.0 or less. Cleaning with an acidic aqueous solution ensures that organic dirt such as proteins and lipids and inorganic dirt such as calcium carbonate can be reliably removed and the inside of the system can be kept clean. Trihalomethane is not produced.

According to the second aspect of the present invention, in the above-mentioned washing method, the washing with the alkaline aqueous solution and the washing with the acidic aqueous solution are performed each time the dialysis is completed. Can be removed.

According to the third aspect of the present invention, in the above-described cleaning method, since washing with an acidic aqueous solution is performed after washing with an alkaline aqueous solution, generally, a large amount of organic dirt is removed first, and this organic dirt is removed. An inorganic substance such as calcium carbonate, which has been wrapped, is exposed, and the inorganic substance is easily removed by the next washing with an acidic aqueous solution, and there is no fear that the organic substance is denatured by the acidic aqueous solution to make it difficult to remove.

According to the fourth aspect of the present invention, in the above-mentioned cleaning method, since the alkaline aqueous solution to be used contains a specific alkalizing agent, there is an advantage that the aqueous solution can be easily set to a high pH.

According to the fifth aspect of the present invention, since a specific acidic aqueous solution is used in the cleaning method, there is an advantage that the artificial dialysis device and the dialysate line can be surely sterilized and disinfected.

According to the sixth aspect of the present invention, in the above-mentioned cleaning method, since a surfactant is blended in one or both of the alkaline aqueous solution and the acidic aqueous solution, there is an advantage that the cleaning property by the aqueous solution is further improved. is there.

According to the invention of claim 7, in the above-mentioned washing method, the alkaline aqueous solution contains an enzyme.
There is an advantage that the removability of organic dirt is further improved.

According to the eighth aspect of the present invention, in the above-described cleaning method, since the alkaline aqueous solution contains a bactericide, there is an advantage that the artificial dialyzer and the dialysate line can be more reliably sterilized and disinfected.

According to the ninth aspect of the present invention, in the above-mentioned cleaning method, since the alkaline aqueous solution contains a pH buffer, there is an advantage that excellent removability of organic dirt can be continuously exhibited.

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI theme coat ゛ (Reference) A61L 2/20 A61L 2/20 J C11D 3/48 C11D 3/48 7/06 7/06 7/08 7 / 08 7/10 7/10 7/12 7/12 7/18 7/18 17/08 17/08 F term (reference) 4C058 AA17 BB07 CC01 CC06 JJ07 JJ08 JJ14 JJ21 4C077 AA05 BB01 CC08 EE03 GG02 GG04 GG13 JJ04 JJ12 KK09 PP21 PP28 4H003 DA20 EA02 EA16 EA20 EA21 EB07 EB13 EB15 EB16 FA28 FA29 FA34 4H011 AA02 BA06 BB06 BB18 DD01

Claims (9)

[Claims] An artificial dialysis apparatus and a dialysate line communicating therewith are subjected to washing with an alkaline aqueous solution not containing hypochlorous acid and having a pH of 9.5 or more and washing with an acidic aqueous solution having a pH of 4.0 or less. How to clean the dialysis machine. 2. The method for cleaning an artificial dialysis device according to claim 1, wherein the washing with the alkaline aqueous solution and the washing with the acidic aqueous solution are performed every time the dialysis is completed. 3. The method for cleaning an artificial dialysis device according to claim 1, wherein the washing with the acidic aqueous solution is performed after the washing with the alkaline aqueous solution. 4. The alkaline aqueous solution according to claim 1, wherein the alkaline aqueous solution contains at least one selected from the group consisting of an alkali metal hydroxide, an alkali metal carbonate, a peroxide alkali metal salt, and a sequestering agent alkali metal salt. 3. The method for cleaning an artificial dialysis device according to item 1. 5. The acidic aqueous solution is one of an aqueous solution of peracetic acid, an aqueous solution of an acidic peroxide, an acidic ozone water, and a heated aqueous solution of an inorganic acid and / or an organic acid at 60 ° C. or higher.
5. The method for cleaning an artificial dialysis device according to any one of items 4 to 4. 6. A surfactant is added to one or both of the alkaline aqueous solution and the acidic aqueous solution.
The method for cleaning an artificial dialysis device according to any one of claims 1 to 5. 7. The method according to claim 1, wherein the alkaline aqueous solution contains a protease. 8. The method according to claim 1, wherein the alkaline aqueous solution contains a bactericide. 9. The method according to claim 1, wherein the alkaline aqueous solution contains a pH buffer.