KR100363896B1 - A medical instrument cleaning solution using peracetic acid and the manufacturing method of the above solution - Google Patents

Abstract

The present invention relates to a medical device cleaning agent using peracetic acid and a method for manufacturing the same, and more particularly, by calcium carbonate and magnesium carbonate according to the use of bicarbonate dialysate in medical equipment such as artificial kidneys, peripheral devices and devices related to hemodialysis Removal of the poorly soluble carbonate (scale) produced, peeling and sterilization of the biofilm caused by the growth of bacteria in this scale, eliminating disinfection and endotoxin, as well as medical equipment with a lens such as endoscope and bronchoscope, mass Medical device cleaners using peracetic acid to clean, sterilize and disinfect medical devices such as scissors, tweezers, etc. to remove secondary infection factors of patients by efficient management of medical devices and to prevent secondary environmental pollution It relates to a manufacturing method.

Medical device cleaning agent using peracetic acid of the present invention 0.01 to 10% peracetic acid, 5 to 20% acetic acid, 2 to 6% hydrogen peroxide, 1 to 20% phosphoric acid, 5 to 1% 1,1-diphosphonic acid, reverse osmosis It is characterized by a mixture of 86.99 to 53.00%.

In addition, the present invention comprises the step of mixing the reverse osmosis water 79 ~ 24%, acetic acid 10-30% in a stirrer and mixing evenly for a predetermined time, by mixing 5 to 25% hydrogen peroxide evenly to form peracetic acid, 1 to 20% phosphoric acid is added and mixed evenly to stabilize the peracetic acid produced in the process and to adjust the acidity (pH) of the product, and stabilizer 1,1- to improve the stability and washing efficiency of the overall product. Adding 5% to 1% of diphosphonic acid and mixing the mixture; keeping the mixture at a temperature of 35 to 45 ° C. for 4 to 7 hours to promote the reaction of hydrogen peroxide and acetic acid; and aging at room temperature for 3 days. It is characterized in that it is prepared in a step of lowering the content of hydrogen peroxide to less than 6%.

Description

A medical instrument cleaning solution using peracetic acid and the manufacturing method of the above solution

The present invention relates to a medical device cleaning agent using peracetic acid and a method of manufacturing the same, and more particularly, by calcium carbonate and magnesium carbonate according to the use of bicarbonate dialysate in medical equipment such as artificial kidneys, peripheral devices and devices related to hemodialysis Removal of poorly soluble carbonates (scales) produced, peeling and sterilization of biofilms caused by bacterial growth in this scale, disinfection and endotoxins, as well as medical devices with lenses such as endoscopes and bronchoscopes Clean, sterilize and disinfect medical devices such as mass, scissors, tweezers, etc. (hereinafter referred to as "cleaning") to eliminate secondary infection factors of patients by efficient management of medical devices and prevent secondary environmental pollution. It relates to a medical device cleaning agent (hereinafter referred to as "hemoclean" for convenience) using a peracetic acid and a method for producing the same.

Recently, medical equipment has become more sophisticated and cutting-edge electronic trends in accordance with the development of electronic technology and medical procedures, which has led to many advances in the use of devices and the treatment of patients.In parallel, the correct use of medical equipment and thorough follow-up management As it is directly related to the qualitative management of the level of care, hospitals have their own management and the minimum number of professionals. In addition, the importance of cleaning, disinfection, and disinfection of the machine has become more important in recent years, and in particular, the use of cleaning, disinfection, and disinfectant in which the cleaning, disinfection, and disinfection of the device is directly related to the level of care is essential.

For example, it is very important to clean, sterilize, and disinfect the essential dialysis device of the renal organ for the treatment of chronic renal failure and peripheral devices and devices related to hemodialysis. In particular, artificial kidneys generate poorly soluble scales (carbonates) produced by calcium carbonate and magnesium carbonate due to long-term use of bicarbonate dialysate, and if these scales continue to accumulate, the dialysis apparatus becomes impossible to use. Not only does the problem have to be replaced, but especially when bacteria enter the scale, a biofilm is formed by the microorganisms, and the biofilm is formed. It must be used after sterilization, cleaning and washing as it causes infection.

In addition, medical devices with lenses such as endoscopes and bronchoscopes, and medical devices such as mass, scissors, and tweezers should also be cleaned, sterilized, and disinfected after use to remove secondary infection factors.

Therefore, the use of cleaning and disinfectant for removing the various hemodialysis apparatus and the scale generated inside the pipe and peeling of biofilm, etc. is essential, and the general sodium hypochlorite (aka "Lax" Is often used, and citric acid, formalin, acetic acid, and the like are used once or twice a week.

For example, after dialysis treatment is finished, the dialysis apparatus is washed and disinfected for about 23 minutes using sodium hypochlorite every day, and then rinsed and washed for about 13 minutes with sodium acetate. Disinfection was carried out for about 2 hours 30 minutes using.

However, although sodium hypochlorite and acetic acid have some degree of bactericidal and descaling power, the high concentration of acetic acid used for the purpose of descaling is not only a major cause of instrument corrosion with sodium hypochlorite, but also the frequent failure of the device. This can shorten the life of medical devices. In addition, waste of time, electricity and water, as well as the problem of generating secondary environmental pollution by formalin and sodium hypochlorite.

In addition, there is still a problem that can not remove the scale and biofilm and bacterial spores in the dialysis apparatus pipe, there is a disadvantage that the cleaning, disinfection, sterilization is not completely made.

However, cleaning, disinfection and sterilization using peracetic acid of medical equipment such as artificial kidneys and peripheral devices and devices related to hemodialysis can achieve strong sterilization effect in a short time even in the presence of broad antibacterial spectrum and organic matter. It is excellent in removing soluble carbonate and biofilm, has no deterioration effect on equipment, and has a characteristic of preventing secondary environmental pollution by being rapidly decomposed after washing, and is increasingly used for its use.

The present invention provides a simple method for sterilization and cleaning of medical devices and devices with high sterilization power and short time period, with peracetic acid, acetic acid, hydrogen peroxide, phosphoric acid, and reverse osmosis water ( RO water), 1,1-diphosphonic acid (1,1-diphosphonic acid) provides a medical device cleaning agent as a main component to use a long-term bicarbonate dialysis solution in medical equipment such as artificial kidneys, hemodialysis peripherals and devices It is intended to remove the poorly soluble carbonate (scale) produced by the calcium carbonate and magnesium carbonate due to, and to completely remove the biofilm and endotoxin due to the growth of bacteria in the scale. In addition, it is excellent for cleaning, disinfecting and disinfecting medical devices with lenses such as endoscopes and bronchoscopes and for medical devices such as mass, scissors and tweezers. The technical task is to not only eliminate, but also to prevent secondary environmental pollution.

Medical device cleaning agent using peracetic acid of the present invention 0.01 to 10% peracetic acid, 5 to 20% acetic acid, 2 to 6% hydrogen peroxide, 1 to 20% phosphoric acid, 5 to 1% 1,1-diphosphonic acid, reverse osmosis It is characterized by a mixture of 86.99 to 53.00%.

In addition, the medical device cleaning agent using the peracetic acid of the present invention is a step of evenly mixing the reverse osmosis water 79 ~ 24%, acetic acid 10-30% in a stirrer for a predetermined time, and evenly mixed by adding 5-25% hydrogen peroxide. Forming peracetic acid, mixing 1-20% phosphoric acid evenly to stabilize the peracetic acid produced in the process and adjusting the acidity (pH) of the product, and to improve the stability and washing efficiency of the whole product. Adding 1,1-diphosphonic acid, a stabilizer, 5-1% to make it uniformly mixed, and incubating the mixture at a temperature of 35-45 ° C. for 4-7 hours to promote the reaction between hydrogen peroxide and acetic acid, After the step of aging at room temperature for 3 days is characterized by consisting of a step of lowering the content of hydrogen peroxide to less than 6%.

1 is a manufacturing process of the medical device cleaning agent using peracetic acid according to the present invention.

Figure 2 is antibacterial and antifungal of medical device cleaning agent using peracetic acid according to the present invention

Bacterial Activity Survey Results Table.

Figure 3 before and after treatment of the medical device cleaning agent using peracetic acid according to the present invention

Electron micrograph showing the result of killing bacteria.

Figure 4 is sterilization after treatment of medical device cleaning agent using peracetic acid according to the present invention

Electron micrograph showing the condition.

Figure 5 is a washing state of the medical device cleaning agent using peracetic acid according to the present invention.

Figure 6 Rinse after use of medical device cleaning agent using peracetic acid according to the present invention

Comparative chart of pH change in the process.

In general, aldehydes, chlorine, and organic acids are mainly used as the disinfectant.

Aldehyde disinfectants include glyoxysal, glutaraldehyde, and formaldehyde, all of which have a broad spectrum of disinfection, but these aldehyde disinfectants exhibit moderate toxicity to human tissues such as skin and eyes, with an irritating odor. It requires a long time and has a disadvantage in that sterilization power is significantly decreased at low temperatures.

Sodium hypochlorite, a representative chlorine disinfectant, has a wide range of bactericidal spectra, but has a low killing effect on Mycobacterium tuberculosis and spore-forming bacteria, and does not destroy bacterial spores and does not remove biofilm on stainless steel surfaces. Has a disadvantage of causing vomiting, high fever and diarrhea due to pollution caused by chlorine disinfectant in Milwaukee, USA, and reacting with formalin to form carcinogens.

Although organic acid disinfectants are recognized as stable additives, there is no synergistic effect of the chemicals when mixed, but only partial addition effect, especially effective sterilization at high temperature (45 ~ 60 ℃) and environmentally friendly because it is not completely decomposed. This has no drawbacks.

Accordingly, the medical device cleaning agent using peracetic acid of the present invention is a cleaning agent mainly composed of peracetic acid as a supplement to the disadvantages of the aldehyde-based, chlorine-based and organic acid-based disinfectants.

The ideal conditions for the dialysis device's disinfecting and cleaning agents include a wide range of bactericidal actions (for bacteria, fungi, spores, etc.), dissolution and adhesion prevention of poorly soluble carbonates, biofilm peeling and Not only should it have anti-adhesion effect, it should be non-toxic to human body and show continuous disinfection effect. Degradation of equipment and piping materials. It is most ideal to fully satisfy various conditions such as low corrosive action, low cost, and no influence on the endotoxin cut filter (the combination of surfactant is non-foamable).

Medical device cleaning agent (hemoclean) using the peracetic acid according to the present invention is prepared as follows that can satisfy all the above conditions.

When 79-24% reverse osmosis water and 10-30% acetic acid are added to the stirrer and mixed evenly for a predetermined time, and then mixed with 5-25% hydrogen peroxide evenly mixed with peracetic acid, the main component of hemoclean, the cleaning agent of the present invention. It is formed at a constant rate.

Then, to stabilize the peracetic acid produced in the process and to adjust the acidity (pH) of the product 1 to 20% of phosphoric acid is added evenly mixed, and then stabilized to improve the efficacy of the overall product stabilization and descaling 1,1-diphosphonic acid is mixed evenly at a ratio of 5 to 1%, and the mixture is kept at a temperature of 35 to 45 ° C. for 4 to 7 hours to promote the reaction of hydrogen peroxide and acetic acid in accordance with the quality standards. By aging at room temperature for 3 days, peracetic acid is rapidly generated to lower the content of hydrogen peroxide to less than 6% to complete the preparation.

That is, because the peracetic acid is formed by the chemical reaction of hydrogen peroxide and acetic acid in the step of warming at 35-45 ° C. for 4 to 7 hours and at room temperature for 3 days to promote the reaction between hydrogen peroxide and acetic acid. The content of hydrogen peroxide is less than 6%, so that it does not violate the domestic toxic substance management law (the content of hydrogen peroxide more than 6%).

Therefore, the overall components and mixing ratio of the hemoclean of the present invention prepared as described above is 0.01 to 10% peracetic acid, 5 to 20% acetic acid, 2 to 6% hydrogen peroxide, 1 to 20% phosphoric acid, stabilizer 1,1-depot It is composed of 5-1% of spongic acid and 86.99-43.00% reverse osmosis water.

The cleaning, sterilization, and disinfection of the medical device cleaning agent using the peracetic acid prepared as described above is performed as follows. After the dialysis is completed, the dialysis apparatus is cleaned and disinfected by rinsing with the reverse osmosis water, the pipes and parts in contact with the dialysis solution in the dialysis solution delivery system portion of the dialysis apparatus, and the safety monitoring device. Rinsing, sterilization, and disinfection are performed through a tube into which the acetate solution has been introduced and a circulation of the cleaning solution takes about 20 minutes. At this time, microbial sterilization and dissolution of poorly soluble carbonate and biofilm are removed. After purifying, all cleaning agents in the pipes and tubes are released and the reverse osmosis water is continuously introduced for about 20-30 minutes to rinse.

As in the above embodiment, the hemoclean of the present invention, which is mixed at a ratio of peracetic acid, acetic acid, hydrogen peroxide, phosphoric acid, 1,1-diphosphonic acid, and reverse osmosis water, has a wide range of bactericidal spectrum even at low temperatures and low concentrations. It is excellent for the removal of spores and biofilm, and finally decomposed into carbon dioxide and water after cleaning and disinfection.

The medical device cleaning agent of the present invention prepared as described above will be described in terms of chemical properties, physical properties, and environmental friendliness.

First, in terms of chemical properties, peracetic acid is made by acetic acid and hydrogen peroxide, and each component is mixed in a constant ratio in the stock solution to maintain chemical parallelism as shown in Scheme 1 below.

(Scheme 1) CH ₃ COOH + H ₂ O ₂ CH ₃ COOOH + H ₂ O

In addition, peracetic acid and hydrogen peroxide are peroxides (-OO-), and by contacting with an organic substance to generate atomic oxygen (generator oxygen: O) as shown in Scheme 2 below, and exhibit a sterilizing effect by oxidation. Acetic acid has a sterilizing effect in a short time, and hydrogen peroxide has a long time sterilizing effect and at the same time exfoliates organic matter.

(Scheme 2) CH ₃ COOOH + H ₂ O CH ₃ COOH + 1/20 ₂

It is a colorless transparent liquid in terms of physical properties, maintains a typical acetic acid smell, non-flammable, non-flammable, easy to mix with water, easy to rinse after sterilization, acidity (pH), density, freezing point is shown in Table 1 below It was.

Table 1

PH (pH) density Freezing point Hemoclean 0.8 to 0.9 1.08 -10 ℃ (Can be used after freezing)

On the environment-friendly surface, microorganisms and dialysis metabolites are oxidized to generator oxygen, and the remaining generator oxygen becomes stable oxygen (O ₂ ) as in Scheme 3 below.

(Scheme 3) CH ₃ COOOH CH ₃ COOH + 1/20 ₂

In the above process, peracetic acid is changed to acetic acid and oxygen, hydrogen peroxide to water and oxygen, as shown in Scheme 4 below.

(Scheme 4) H ₂ O ₂ H ₂ O + _1/2 0 ₂

The acetic acid remaining from the acetic acid and peracetic acid is used to dissolve and remove the carbonate, and then oxidized by the generator oxygen of peracetic acid and hydrogen peroxide to be finally decomposed into water and carbon dioxide as shown in Scheme 5 below.

(Scheme 5) CH ₃ COOH + 2O ₂ 2CO ₂ + 2H ₂ O

Therefore, it is effective for disinfection and cleaning of medical devices by effective removal and prevention of contamination by microorganisms and biofilms that may occur during dialysis treatment and scale generated by dialysis solution. It can be seen that it does not occur.

Next will be described microbial sterilization power by the hemoclean treatment of the present invention.

The microorganisms for measuring bactericidal power were various, but the bactericidal power was tested against general bacteria and fungi, especially bacterial spores resistant to fungicides, and the strains used were 10 listed in Table 2, which was distributed by the Korean spawn association. Eggplant strains were used and applied to each titration medium listed in Table 3, and then used for the experiment while incubated for 24 hours and stored at 4 ℃.

Table 2 Strains Used to Measure Microbial Sterilization

Strain A: (Escherichia coli) ATCC 2592B: (Salmonella typhimurium) ATCC 14028C: (Staphylococcus aureus) ATCC 6538D: (Klebsiella pneumoniae) ATCC 10051E: (Candida albicans) ATTC 10251F: (Proteus mirabilis) ATCC 21C10 sub21 : (Pseudomonas aeruginosa) ATCC 9027I: (Bacillus cereus) wildJ: (Bacillus cereus) wildK: (Staphylococcus aureus) ATCC 10051L: (Bacillus subtilis) ATCC 9027

Table 3 Medium used for microbial bactericidal power measurement

badge Nutrient broth Nutrient agar Casein- peptone soymeal-peptone broth Casein-peptone soymeal-peptone agar Sabouraud broth Sabouraud agar

That is, the bactericidal power was measured in the antibacterial and antifungal vitality measurement according to the cleaning agent treatment of the present invention, and the spore bactericidal power, and observed by electron microscopy to observe the damage of the cells.

First, in order to investigate the antibacterial and antifungal activity according to the hemoclean treatment of the present invention in suspension, 12 pathogenic microorganisms, which are problematic for cleaning and disinfection, were tested using the suspension culture method (DLG method).

10 ml of the sample diluted in the above-described hemoclean prepared in the above-described examples and 0.1 ml of the co-culture medium were shaken and then reacted for a predetermined time, and then 1 ml of the reaction solution was immediately added to a test tube containing a neutralizing agent. After being diluted to physiological saline, the solution was properly diluted and plated on a plate medium to calculate the number of viable bacteria.

The neutralizing agent used above is 4.26% sodium phosphate, dibasic, 3% tween, 0.5% sodium thiosulfat-e, pentahydrate, 0.3% elalpha Lecithin (L-α-lecithin (Sigma)) and 0.1% L-histidine were used.

As a result, the control of all the microorganisms used as shown in Figure 2 was maintained at 10 ⁷ ~ 10 ⁸ or more, but all of the hemoclean 5 minutes treatment of the present invention showed a very strong disinfection power.

Next, in order to measure the spore disinfecting power of the hemoclean of the present invention, a strain was cultured for 24 hours to form spores, and after confirming the formation of spores through spore staining, each sample of the hemoclean of the present invention diluted 34: 1 to 10 After shaking and mixing the ㎖ and 0.1ml of the co-culture medium was reacted for a predetermined time (5 minutes).

After 1 ml of the reaction solution was diluted with physiological saline and plated, the number of cells displayed after 48 hours of incubation in each appropriate medium was measured. As a result, the spore control group produced by heat treatment showed 10 ⁴ to 10 ⁵ levels. The hemoclean treatment, the cleaning agent of the invention, was shown to be completely killed, and the bactericidal power against spores was also very high.

In addition, in order to observe the damage of the cells by the hemoclean treatment of the present invention was observed by transmission and scanning electron microscope. That is, the strain cultured for 24 hours was centrifuged to collect only the cells and fixed with 2.5% glutaraldehyde at 4 ° C. for 2 hours, and then fixed in 0.5% osmium tetoxide solution for 1 hour. Blocks were prepared with 2% agar and subsequently dehydrated with alcohol, embedded in resin, and the block samples were then observed with a microtome section and transmission electron microscope. Scanning electron microscope observation was carried out by centrifugation of the strain cultured for 24 hours to collect only the cells, washed with phosphate buffer, fixed dehydration and then coated and observed the samples.

As a result of observing the damage of the cells by the hemoclean treatment of the present invention by electron microscopy (SEMTEM), as shown in Figure 3 hemoclean treated cells are swollen and the cell wall is crushed does not have a constant shape, or the cell wall is deformed As the contents leaked, the microorganisms were eventually killed and showed excellent disinfection.

Next, the removal power of the biofilm (Biofilm = Adherent micro colony) in the hemoclean of the present invention was measured. Biofilm means a membrane formed of microorganisms immobilized on or inside the particle surface or surrounded by extracellular polymer substance (EPS). It will serve as a shield to receive. Adherent microcolony is a cell that survives on stainless steel that contains very little nutrients from microorganisms attached to the surface of the machine, and forms capsule-type microcolon via a substance such as polysaccharide. As a result, these cells soon form a biofilm on the machine surface.

Therefore, any Adherent microcolonies were prepared to measure the removal power of these biofilms. That is, Adherent microcolon preparation was prepared by injecting the washed stainless steel slide (stainless steel slide) in a test tube containing 500 ml of medium and inoculated with a strain cultured in a test tube for 24 hours after autoclaving. The test tube was incubated at 21 ° C. for 2 days, transferred to a test tube containing fresh medium, and further cultured for 8 days in a repeat culture method at 21 ° C. for 2 days to prepare Adherent microcolonies of feeder cells.

After culturing for 8 days, stainless steel slides with Adherent microcolon formed were removed with sterile phosphate buffer, and then placed in a test tube containing 500 ml of phosphate buffer. Adherent microcolonies of deficient cells, ie biofilms, were prepared.

As described above, after adhering to the adventitious microcolon by using a stainless steel slide, the microbial solution was immersed in the hemoclean solution of the present invention for 5 minutes. The viable cell count on the surface was washed with stainless steel slides in sterile and phosphate buffer, dried and wiped the surface with calcium alginates wab using a stainless steel ring of 2 cm diameter. The wiped swab tip was placed in a screw cap test tube, thoroughly stirred using a rotary stirrer, and counted after incubation for 48 hours to measure the number of cells. Adherent micro colony control formed by 5-minute treatment of hemoclean, the cleaning agent of the present invention, showed a level of 104-105, but hemocrine treatment, the cleaning agent of the present invention, was shown to be completely killed. .

In addition, an Adherent microcolon prepared in the same manner as described above using a stainless steel slide was observed with a scanning electron microscope. Hemoclean, a cleaning and disinfecting agent of the present invention, was prepared by cutting and sterilizing stainless steel into 1 cm × 1 cm sized pieces, and then preparing an adhering microcolon with sterilized pieces. As a result, as shown in Figure 4 it can be seen that such a biofilm is removed very effectively.

In the following description of the hemocrine toxicity of the present invention, LD50, which is acutely toxic of products having the same composition as the hemocrine of the present invention, is reported as 3400 mg / kg (mouse, oral), which is compared with general disinfectant and disinfectant. This is a relatively low range. According to the data of the "Hazardous Substances Data Bank (HSDB)", it was determined that the hemocrine 5% dilution of the present invention had no toxicity at all in animal experiments at a concentration of 18 / m ³ . The% solution is the limit that does not affect human skin. In addition, sodium hypochlorite, which represents a chlorine disinfectant, was defined by OSHA as a toxic chemical.

Next, to test the hemoclean safety of the present invention, the corrosion resistance was observed under the following conditions using the metal, synthetic resins, and components inside the apparatus used in the dialysis apparatus.

(Condition 1) Based on KS-D0222, the entire surface area of the specimen was taken to 10 to 30 cm ^2, and when scale was attached to the specimen, it was removed by cutting or grinding.

(Condition 2) Each specimen was left at 25 ° C. for 5 days in the hemoclean stock solution, 20 times, and 35 times diluted solution of the present invention, and the results were measured by gravimetric method.

As a result of the stability test under the conditions 1 and 2, as shown in Table 4 below, the corrosion resistance of the metal, the synthetic resin, and the components inside the apparatus used in the dialysis apparatus was not shown at all, and the safety was very excellent.

Table 4

material 3% 5% Aluminum 99.5 0.00 g / 100 ml 0.00 g / 100 ml Stainless steel 0.00 g / 100 ml 0.00 g / 100 ml Remark 0.00 g / 100 ml 0.00 g / 100 ml Galvanized steel sheet 0.00 g / 100 ml 0.00 g / 100 ml 5PVC 0.00 g / 100 ml 0.00 g / 100 ml Phi Phi (PP) 0.00 g / 100 ml 0.00 g / 100 ml PE 0.00 g / 100 ml 0.00 g / 100 ml silicon 0.00 g / 100 ml 0.00 g / 100 ml Polyurethane 0.00 g / 100 ml 0.00 g / 100 ml Synthetic resin 0.00 g / 100 ml 0.00 g / 100 ml L-tube 0.00 g / 100 ml 0.00 g / 100 ml O-ring 0.00 g / 100 ml 0.00 g / 100 ml Spring 0.00 g / 100 ml 0.00 g / 100 ml pipe 0.00 g / 100 ml 0.00 g / 100 ml Connecting tube 0.00 g / 100 ml 0.00 g / 100 ml Nipple 0.00 g / 100 ml 0.00 g / 100 ml

Next, the scale and contaminated connection tube formed in the artificial stretcher pipe used for a long time to measure the hemoclean washing power of the present invention was used.

X-ray diffraction analysis of the samples taken from the apparatus and pipes to determine the scale phenomenon in the artificial kidney used for a long time, the main components of the scale was determined to be calcium carbonate and calcium sulfate. Calcium carbonate powder prepared artificially to measure the scale-removing power of the hemoclean of the present invention was measured at room temperature for the solubility of the hemoclean stock solution, 10-fold, and 35-fold dilutions of the present invention. In the case of the hemoclean stock solution of the present invention, a foaming phenomenon of dissolving calcium carbonate occurred and 2 g of calcium carbonate was dissolved in a few minutes. In addition, continuous foaming was observed after 3 days, showing excellent scale removal ability. As shown in Table 5 below, hemoclean was more than twice the scale removal power compared to foreign products (S company D product) dissolving 1.00g of calcium carbonate.

Table 5

Stock solution 10-fold dilution 35-fold dilution 2.95 g / 100 ml 1.06g / 100ml 0.46 g / 100 ml

In addition, the cleaning power for the contaminated connecting tube was measured by cutting the contaminated artificial kidney connecting tube, which is disinfected and washed with lax and citric acid in the actual artificial kidney, to an appropriate length. Elution analysis of the contaminants with the hemoclean stock solution of the present invention, and observed the color change of the tube at room temperature according to the dilution ratio of hemoclean and S company, the cleaning agent of the present invention, but there is no way to quantitatively determine the experimental results, The washing powers were compared based on the tubes that were not.

As a result of the above cleaning power, the main pollutant in the tube was found to be iron (29.4 ppm (n = 7)) and urea (295.4 ppm (n = 7)), and the present invention was based on an uncontaminated tube as shown in FIG. Was found to be much higher than S's D product.

Next, to check the residualness of the detergent of the present invention in the artificial kidney after washing, the water discharged during washing for 30 minutes was collected every 2 minutes, and the acidity (pH) was measured. As shown in FIG. After washing, the acidity of the artificial kidney water discharged was the same as the distilled water (pH 5.40), and the pH of the sewage discharge was 5 ~ 9, which meets the Japanese standard and falls within the range that does not cause environmental pollution.

In addition, after analyzing the cations and anions remaining in the artificial kidney by using ion chromatography, water released 6 minutes before washing was finished. As shown in Table 6, acetate and phosphate ions were not detected. Sulfate ions were detected significantly lower. This shows the safety of hemoclean as a result showing that no chemicals remain in the device when the dialysis apparatus is sterilized, disinfected, washed and rinsed with hemoclean consisting of peracetic acid, hydrogen peroxide, acetic acid and phosphoric acid.

Table 6

Acetate Nitrate Ion Phosphate ions Sulfate ion Hemoclean Not detected 2.825 (ppm) Not detected 3.670 (ppm)

As described above, the medical device cleaning agent using peracetic acid according to the present invention contains calcium acetate and magnesium carbonate due to prolonged use of bicarbonate dialysis fluid in peripheral devices and devices related to artificial kidneys and hemodialysis, with peracetic acid, acetic acid, and hydrogen peroxide as main ingredients. In addition to the removal and adhesion prevention of poorly soluble carbonates (scales) produced by the treatment, there is an effect of thorough follow-up management of medical devices, and rapid removal and disinfection effect in the removal of biofilm and endotoxin due to the growth of bacteria in the scale. You can expect

In addition, the present invention has the effect of preventing secondary environmental pollution due to the nature of the environmentally-friendly nature of decomposed into carbon dioxide and water when drained after using the medical device cleaning agent using peracetic acid, and additionally in accordance with the existing waste water purification It is expected to reduce the effects, and it is effective to remove the secondary infection factors of patients through efficient management of medical devices by cleaning, disinfecting and disinfecting medical equipment with lens such as endoscope and bronchoscope and mass, scissors and tweezers. And prevention is expected, and the quality of care is also very good.

In addition, the medical device cleaning agent using the peracetic acid of the present invention is less than 6% of the content of hydrogen peroxide, so that it does not violate the domestic toxic substance management law will not interfere with use or distribution at all.

Claims (2)

0.01 to 10% peracetic acid, 5 to 20% acetic acid, 2 to 6% hydrogen peroxide, 1 to 20% phosphoric acid, 5 to 1% 1,1-diphosphonic acid as a stabilizer, and 86.99 to 53.00% reverse osmosis water Medical device cleaners. Mixing reverse osmosis water 79-24% and acetic acid 10-30% in a stirrer, Adding 5-25% hydrogen peroxide and mixing to form peracetic acid, Adding and mixing 1-20% of phosphoric acid to stabilize the produced peracetic acid and to adjust the acidity (pH) of the product, Adding and mixing 5-1% of 1,1-diphosphonic acid as a stabilizer to improve the stabilization and washing efficiency of the product, Incubating the mixture at a temperature of 35-45 ° C. for 4-7 hours to promote the reaction of hydrogen peroxide with acetic acid, and Method of manufacturing a medical device cleaning agent comprising the step of aging at room temperature for 3 days to reduce the content of hydrogen peroxide to less than 6%.