disinfectant

A synergistic disinfectant formulation of potassium peroxymonosulfate, organic acids, and surfactants addresses toxicity and stability issues, providing effective pathogen elimination and cost reduction in healthcare settings.

WO2025227137A1PCT designated stage Publication Date: 2025-10-30ASP GLOBAL MFG GMBH +1
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Patent Information

Application Number
PCT/US2025/026543
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-04-25
Filing Date
2025-04-25
Publication Date
2025-10-30

AI Technical Summary

Technical Problem

Existing disinfectants used in healthcare settings are highly toxic, have poor shelf-life, and incur high shipping and storage costs, posing risks and economic burdens, while failing to effectively eliminate pathogens and prevent cross-contamination.

Method used

A disinfectant formulation comprising potassium peroxymonosulfate, organic acids, and surfactants, which synergistically enhance antimicrobial efficacy, reduce toxicity, and improve stability and ease of handling, packaged in forms that maintain separation of reactive ingredients until use.

Benefits of technology

The disinfectant effectively eliminates spores and bacteria with reduced toxicity, extended shelf-life, and lower shipping and storage costs, enhancing patient safety and operational efficiency.

✦ Generated by Eureka AI based on patent content.

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Abstract

Various formulations of a disinfectant are disclosed. The disinfectant includes an amount of potassium peroxymonosulfate, at least one organic acid, and at least one surfactant. The disclosed disinfectant can exist in both powder form and liquid form, and can also be in kit form having a variety of form factors. These disinfectant formulations offer higher efficacy and lower toxicity when compared with disinfectants known in the art, and when compared with potassium peroxymonosulfate alone.
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Description

DISINFECTANTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of the filing date of U.S. Provisional Application No. 63 / 638,542, filed April 25, 2024, entitled “DISINFECTANT”, the disclosure of which is hereby incorporated herein by reference.BACKGROUND

[0002] In settings where patients receive healthcare, there is a need to create a sterile environment, including having sterile instruments within that environment. According to a study by the US Center for Disease Control and Prevention, nearly 1.7 million hospitalized patients acquire some sort of infection while receiving care. Of these patients, more than 1 -in- 17 die from complications resulting from these types of infections, underscoring the need to easily and economically create sterile environments in areas where patients receive such care.

[0003] While healthcare providers are typically well-trained in the techniques needed to sterilize themselves prior to rendering care to patients, ensuring that the equipment used by these providers is sterile, especially in high-traffic environments such as emergency rooms or operating rooms can be a challenge. This challenge is exacerbated by the fact that many disinfectants are highly toxic, rendering them as poor candidates for use in a healthcare setting, as such disinfectants generate additional risks due to accidental or prolonged exposure.

[0004] In addition to the above-mentioned challenges, many of the existing sterilization compounds have poor shelf-life and can be difficult to economically ship and store. Poor shelflife or otherwise low stability can result in healthcare providers needing to dispose of expired disinfectants products prior to them being used, which results in both unnecessary waste and expense. Moreover, for healthcare providers who utilize a large amount of disinfectants,shipping and warehousing costs can be expensive, and such additional costs often get passed to patients receiving care.

[0005] As such, there is a need for a disinfectant which is effective against pathogens while being sufficiently non-toxic to human cells, where such disinfectant is shelf-stable for extended periods of time and is easy and economical to ship to and store. The invention in accordance with the present disclosure meets and exceeds these needs.SUMMARY

[0006] The embodiments of the disinfectant in accordance with the present disclosure provide an effective high-level disinfectant solution for reprocessing medical devices, reducing the risk of infections and cross-contamination, and ensuring patient safety. Other disinfectants known in the art often have a high toxicity profile, issues with material compatibility, antimicrobial resistance, limited effectiveness against a broad range of microorganisms, and challenges related to shipping, handling, and transportation. The disinfectant in accordance with the present invention addresses these limitations by combining active ingredients that work together to unexpectedly enhance antimicrobial efficacy while reducing the overall toxicity, all while improving material compatibility. Additionally, powder forms of the disinfectant in accordance with the present disclosure offer advantages in terms of storage, transportation, and disposal, thereby offering a more practical and environmentally friendly solution for reprocessing medical devices.

[0007] The present disclosure provides for embodiments of a highly effective, high- level disinfectant, preferably for use with one or more medical devices, where use of this disinfectant solution reduces the risk of infections and cross-contamination, and promotes patient safety.

[0008] In particular, an embodiment in accordance with the present disclosure provides for a disinfectant comprising potassium peroxymonosulfate, at least one organic acid, and at least one surfactant. Embodiments exists where the organic acid is water-soluble. In various embodiments, such an organic acid is an organic acid salt. In some of these embodiments, the at least one organic acid being in a salt form is advantageous as disinfectants in powder form have a longer shelf life than disinfectants in a liquid phase. Various organic acids are suitable for use with the disinfectant in accordance with the present disclosure, and in some embodiments these organic acids are selected from the group consisting essentially of glycolic acid, lactic acid, furoic acid, citric acid, salicylic acid, malic acid, and maleic acid.

[0009] It is beneficial to include at least one surfactant as part of the disinfectant in accordance with the present disclosure. Preferably, this surfactant or these surfactants are selected from the group consisting essentially of CieCis fatty alcohol ethoxylate, fatty alcohol ethylene oxide / propylene oxide copolymer derivative, polyoxyethylene -polyoxypropylene block copolymer, capryleth-6 carboxylic acid, capryleth-4 carboxylic acid, capryleth-9 carboxylic acid, Akypo® LF1, Akypo® LF2, Akypo® EF4, Pluronic® 10R5, and other surfactants commonly known in the field. Embodiments exist where two or more surfactants are included in the disinfectant in accordance with the present disclosure. Embodiments of the disinfectant in accordance with the present disclosure can also include at least one hydrotrope, such as sodium xylene sulfonate.

[0010] Various concentrations of potassium peroxymonosulfate can be used in various embodiments of the disinfectant in accordance with the present disclosure. In some embodiments, the potassium peroxymonosulfate has a concentration in the range of 0.1% to 5%, while in other embodiments, the potassium peroxymonosulfate has a concentration in the range of 1% to 1.2%. The desired concentration of potassium peroxymonosulfate can depend on the intended use of the instant disinfectant, as well as intended contact time, ambienttemperature during use, and whether the disinfectant is in powder or liquid form. Embodiments exist where the at least one organic acid is glycolic acid and the at least one surfactant is Akypo® LF1. In such embodiments, the glycolic acid can be 1% of the disinfectant in accordance with the present disclosure and Akypo® LF1 can be 0.3% of the disinfectant. Preferably, the disinfectant in accordance with the present disclosure will be non-toxic to human cells when in contact with such cells for at least 48 hours.

[0011] Embodiments exist where the disinfectant in accordance with the present disclosure also include at least one stabilizer. In some embodiments, this stabilizer is Dequest® 2010EC, although other stabilizers are also suitable for use as part of the disinfectant in accordance with the present disclosure. When the disinfectant in accordance with the present disclosure is a liquid, it also includes a solvent. In some embodiments, this solvent is water, and can be 200 ppm hard water. Various embodiments exist where the disinfectant in accordance with the present disclosure also includes sodium salicylate, sodium formate, and / or sodium xylene sulfonate. In some embodiments, sodium salicylate can have a concentration of 0.15% of the total disinfectant and in other embodiments the sodium xylene sulfonate can have a concentration of 0.3% of the total disinfectant.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1 shows the results of an efficacy test run on a disinfectant which does not display the synergistic effects of the disinfectant in accordance with the present disclosure.

[0013] FIGS. 2A-2F show results of efficacy tests run on various embodiments of the disinfectant in accordance with the present disclosure, showing the unexpectedly synergistic effects of the combination of its components.

[0014] FIG. 3 shows a representative illustration of a kit for making a disinfectant containing a first tablet and a second tablet in accordance with the present disclosure.

[0015] FIG. 4 shows a representative illustration of a dual-chambered water-soluble pod in accordance with the present disclosure.

[0016] FIG. 5 shows a representative illustration of a triple-chambered water-soluble pod in accordance with the present disclosure.

[0017] FIG. 6 shows a representative illustration of a layered tablet in accordance with the present disclosure.

[0018] FIG. 7 shows a representative illustration of a dual-chambered stick pack in accordance with the present disclosure.DETAILED DESCRIPTION

[0019] The present disclosure provides for multiple embodiments of a high-level disinfectant. Embodiments exist where disinfectant in accordance with the present disclosure is a powder disinfectant formulation which demonstrates synergistic effects towards the elimination of spores and bacteria. Preferably, in these embodiments the formulation comprises potassium peroxymonosulfate, at least one organic acids, and one or more surfactants. Here, the potassium peroxymonosulfate serves as an oxidizing agent. However, potassium peroxymonosulfate is not known to be a strong disinfectant, adding criticality to the synergistic interaction with the other components of the formulation to eliminate unwanted spores or bacteria. Embodiments exist where this potassium peroxymonosulfate is added to the disinfectant formulation as part of a triple salt. Preferably, this triple salt is a combination of potassium peroxymonosulfate, potassium hydrogen sulfate, and potassium sulfate. For the purposes of this disclosure, it should be understood that when this disclosure states that potassium peroxymonosulfate is used, the triple salt thereof can be used interchangeably. In some embodiments, this triple salt has a formula of 2KHSO5 KHSO4 K2SO4. While the exact concentration of potassium peroxymonosulfate will vary based on intended use of thedisinfectant, a suitable range is 0.1%-5% of the total formulation. Embodiments exist of the powder formulation in accordance with the present disclosure which include potassium peroxymonosulfate in concentrations of 10-60% w / w. Embodiments also exist of the liquid disinfectant solution in accordance with the present disclosure that contain potassium peroxymonosulfate in concentrations of 0.1-5% w / w, Moreover, embodiments of the disinfectant in accordance with present disclosure can be used as a cleaning and disinfecting product, in addition to being used as a high-level disinfectant. In some of these embodiments, when in a liquid solution, potassium peroxymonosulfate is present in concentrations of 0.1-2% w / w.

[0020] The present disclosure contemplates the use of one or more organic acids as part of the disinfectant. As some embodiments of the disinfectant in accordance with the present disclosure are in powder form while other embodiments are in liquid form, use of organic acid salts as well as organic acids in their liquid form are both contemplated. In an embodiment, the powder disinfectant in accordance with the present disclosure is to be dissolved in a solvent by the end user, selecting organic acids that are soluble in the desired solvent is a relevant consideration. Suitable solvents include distilled water, non-distilled soft water, and hard water, although use of other solvents is contemplated by the present disclosure. For embodiments where the desired solvent is some sort of water, the one or more organic acids used in the disinfectant in accordance with the present disclosure are water-soluble.

[0021] Exemplary embodiments of the disinfectant in accordance with the present disclosure use one or more of the following organic acids: glycolic acid, lactic acid, furoic acid, citric acid, salicylic acid, malic acid, and maleic acid. These acids are particularly suitable for use due to their high commercial availability, low toxicity, and lack of a noticeable odor. In particular, the low toxicity of these organic acids is beneficial as having low toxicity components will assists with the final formulation also having low toxicity. The lack ofnoticeable odor of these organic acids is beneficial to patients, as a disinfectant that is substantially odor-free creates a more pleasant experience for the patient. Other embodiments of the powder form of the disinfectant formulation in accordance with the present disclosure include an organic acid in the concentrations of 10-60% w / w. Embodiments of the liquid form of the disinfectant in accordance with the present disclosure can include an organic acid in the concentrations of 0.1-5% w / w. As noted above, the disinfectant in accordance with the present disclosure can

[0022] In addition to potassium peroxymonosulfate and an organic acid, the disinfectant in accordance with the present disclosure will include one or more surfactants. Generally, nonionic surfactants, anionic surfactants, and cationic surfactants are all suitable for use with the disinfectant in accordance with the present disclosure. Preferably, this surfactant will be low-foaming. The commercial availability of this surfactant is relevant, but not a critical consideration in selecting a given surfactant or surfactants. Preferably, one or more of the following surfactants will be used as part of the disinfectant in accordance with the present disclosure: CieCis fatty alcohol ethoxylate, capryleth-9 carboxylic acid, Akypo® LF1, Akypo® LF2, Akypo® EF4, and Pluronic® 10R5. In a highly preferred embodiment, Akypo® EFl is the lone surfactant used as part of this disinfectant. Other embodiments of the powder form of the disinfectant formulation in accordance with the present disclosure include a surfactant in the concentrations of 5-30% w / w. Embodiments of the liquid form of the disinfectant in accordance with the present disclosure can include an organic acid in the concentrations of 0.2-3% w / w. In various embodiments, alcohol ethyoxylate surfactants of any type can be used in the disinfectant in accordance with the present disclosure.

[0023] The present disclosure contemplates a number of embodiments of the disclosed disinfectant. Such embodiments include formulations where the disinfectant serves as a high- level disinfectant, in both power and liquid form. In such embodiments, the pH can range from1.5-5. The present disclosure also contemplates further embodiments of the disclosed disinfectant for use in a cleaning product, also in both powder form and liquid form. In such embodiment, the pH of the disinfectant can range from 2-8. Embodiments of the disinfectant in accordance with the present disclosure, when formulated for use as a cleaning product, and when in powder form can include potassium peroxymonosulfate in concentrations of 10-60% w / w, an organic acid in concentrations of 10-60% w / w, and a surfactant in the concentrations of 5-30% w / w. In other embodiments, the disinfectant in accordance with the present disclosure, when formulated for use as a cleaning product, and when in powder form can include potassium peroxymonosulfate in concentrations of 30-50% w / w, an organic acid in concentrations of 30-50% w / w, and a surfactant in the concentrations of 5-20% w / w.

[0024] Embodiments of the disinfectant in accordance with the present disclosure, when formulated for use as a cleaning product, and when in liquid form can include potassium peroxymonosulfate in concentrations of 0.1-5% w / w, an organic acid in concentrations of 0.1- 5% w / w, and a surfactant in the concentrations of 0.01-3% w / w. In other embodiments, the disinfectant in accordance with the present disclosure, when formulated for use as a cleaning product, and when in liquid form can include potassium peroxymonosulfate in concentrations of 1-2% w / w, an organic acid in concentrations of 1-2% w / w, and a surfactant in the concentrations of 0.3-0.5% w / w. In various embodiments, such cleaning products can include disinfecting wipes and disinfecting spray products. Embodiments of the disinfectant in accordance with the present disclosure exist where a hydrotrope is included. In such embodiments the hydrotrope can be sodium xylene sulfonate.

[0025] Disinfectants in accordance with the present disclosure can be prepared using the following steps, and for clarity preparation details pertaining to one specific embodiment of said disinfectant will be used. However, a person having ordinary skill in the art would understand that these steps can be followed using different quantities or using an acceptablesubstitution of a given component as disclosed as being appropriate herein. For this given embodiment, preparation thereof begins by taking 1g of potassium peroxymonosulfate and adding that powder to 97.7g of water inside of a suitably sized beaker, which is mixed via a magnetic stir plate and stir bar until the powder is fully dissolved. After the powder is fully dissolved, 1g of glycolic acid is added to the mixture, while continuously being stirred by the magnetic stir plate and stir bar combination. Then 0.3g of Akypo® LF1 is added to the mixture while stirring continues until all components are fully dissolved.

[0026] For elements of the disinfectant formulation in accordance with the present disclosure that are not chemically or physically compatible, such elements may be separated via multi-compartment packaging, which can include dual chamber pods, twin sachet stick packs, multiplayer capsules, and separated mini tablets, all of which can keep reactive ingredients separated until the moment of use.

[0027] For embodiments of the disinfectant in accordance with the present disclosure which are in powder form, an end user may utilize this powder to create a liquid form of said disinfectant. In such embodiments, an end user may achieve this by first opening a package containing a powder form of the disinfectant in accordance with the present disclosure. The contents of the package, whether pure powder or powder encapsulated in a pod or tablet are deposited into an appropriate vessel, which can include items such as a washer disinfector, or automated endoscope reprocessing device. A desired amount of water, depending on the desired concentration of the end user, is then placed within the vessel and is subsequently mixed until the powder is fully dissolved or uniformly suspended, thereby producing a homogenous, ready-to-use solution or dispersion.

[0028] The various embodiments of the powder form of the in accordance with the present disclosure can be packaged into a variety of different form factors. One such form factor is an all-in-one form factor where the potassium peroxymonosulfate, organic acid, andsurfactant are all mixed until a uniform mixture is created, which is then dispensed into either a unit dose or a bulk container and subsequently sealed to safeguard against exposure to moisture and oxygen. In one such embodiment of this form factor, the mixture contains 40% w / w potassium peroxymonosulfate, 40% w / w malic acid, and, 20% w / w of DelONIC LF-EP- 61.

[0029] Other form factors of these embodiments are also contemplated by the present disclosure and include a dual tablet form factor, wherein the potassium peroxymonosulfate and the organic acid are mixed and pressed into a first tablet, and the surfactant is pressed into a second tablet which is packaged with, but separately from the first tablet. In one embodiment of this form factor, potassium peroxymonosulfate and malic acid are each present in 43% w / w of the total composition, and Akypo® LF1 is used to make the second tablet. An illustration of this form factor is shown in FIG. 3, illustrating the first tablet 102, the second tablet 104, and the packaging 106 thereof.

[0030] Another form factor contemplated by the present disclosure is a dual-chambered water-soluble pod. Such a pod has two separate compartments, one filled with a mixture of potassium peroxymonosulfate and an organic acid, and the other filled with a surfactant. In an embodiment, a mixture of potassium peroxymonosulfate and malic acid is added to a primary compartment of the water-soluble pod. Then, Akypo® LF1 is loaded into a second compartment which is isolated from the first compartment. The two compartments are then separated by a water-soluble film and then a top layer of water-soluble film is sealed over the compartments, forming a sealed pod with two distinct zones. In this embodiment, the potassium peroxymonosulfate is present in a concentration of 50% w / w, the malic acid is present in a concentration of 40% w / w, and the Akypo® LF1 is present in a concentration of 10% w / w. An illustration of this form factor is shown in FIG. 4, illustrating the first chamber 202, the second chamber 204, and the water-soluble film 208.

[0031] Yet another form factor contemplated by the present disclosure is a triplechambered water-soluble pod. This form factor is similar to the dual-chambered water-soluble pod disclosed above, however there are three distinct compartments separated by a water- soluble film. In an embodiment of this form factor, potassium peroxymonosulfate is in one of the compartment, glycolic acid is in another compartment, and Akypo® LF1 is in the final compartment. Once loaded, a top layer of water-soluble film is sealed over each compartment, thereby forming a sealed pod with three distinct zones. In this embodiment, the potassium peroxymonosulfate is present in a concentration of 50% w / w, the glycolic acid is present in a concentration of 40% w / w, and the Akypo® LF1 is present in a concentration of 10% w / w. An illustration of this form factor is shown in FIG. 5, illustrating the first chamber 202, the second chamber 204, the third chamber 206, and the water-soluble film 208.

[0032] Another form factor is also contemplated by the present disclosure, which is a dual-chambered stick pack. In this form factor, the potassium peroxymonosulfate is mixed with an organic acid and then filled into one of the chambers of the stick pack, and the surfactant is filled into the second chamber of the same stick pack. These chambers are formed from a heat- sealable laminate film, and are sealed from the top to form a unit-dose package with two distinct chambers. This form factor provides for the separation of certain ingredients during storage and allows both chambers to be simultaneously dispensed at the point of use. FIG. 7 shows an illustration of this form factor, illustrating first stick chamber 402, second stick chamber 404, and the heat-sealable laminate 406.

[0033] The present disclosure also contemplates a layered tablet equipped with a barrier coat as an additional form factor. In this form factor, the potassium peroxymonosulfate is blended with an organic acid such as malic acid to form a homogenous mixture. This mixture is then compressed to form a first layer of the tablet. An inert powder is then added on top of this first layer and then is also compressed. If a surfactant which is a liquid or viscous liquid isused in the disinfectant, then that liquid is mixed with an inert powder and that mixture is compressed on top of the second layer, completing the formation of the tablet. In this embodiment, the potassium peroxymonosulfate is present in a concentration of 50% w / w, the malic acid is present in a concentration of 40% w / w, and the Akypo® LF1 is present in a concentration of 10% w / w. An illustration of this form factor is shown in FIG. 6, where the first layer 302, the second layer 304, and the third layer 306 are shown.

[0034] Various disinfectants in accordance with the present disclosure were tested both for efficacy against both Mycobacterium bovis (M. bovis) and Geobacillus stearothermophilus (G. stearothermophilus) and for toxicity.

[0035] To determine efficacy, a quantitative tuberculocidal suspension test, which is a modification of the United States Environmental Protection Agency’s guidelines for the quantitative tuberculocidal procedure for liquid chemical sterilant and high level disinfectants, was performed. At its core, this test involves exposing a spore of a pathogen to one or more of the embodiments of the disinfectant in accordance with the present disclosure. In these tests, the test organism was prepared by first transferring a stock test organism to a 250mL-300mL flask containing a lOOmL growth medium. This mixture was then incubated at a temperature in the range of 35-37 °C, where the flask was spun at a rate of 250 revolutions per minute, for a period ranging from 7 to 21 days. On the day of testing this mixture is harvested from this flask and homogenized using a sterile tissue grinder.

[0036] With the specimen prepared, the sample was then exposed to the test disinfectant under the following conditions. First, the experimental test tubes were filled with 9mL of the test disinfectant and was brought to testing temperature for a period greater than 10 minutes. Once at testing temperature, ImL of the homogenized test organism was added to the text tube and then vortexed to initiate exposure. After the predetermined exposure time has lapsed, the suspension was then mixed again and removed from the test tube in ImL aliquots.These aliquots were added to 9mL of neutralizer. From there, the resulting solution was diluted ten-fold using a 0.85% saline solution.

[0037] Next, filter units ranging from 0.2-0.45 pm filter units were pre-wet with lOmL of 0.85% saline solution. For each needed exposure time, excluding the longest, 5mL of the neutralized sample and ImL of the 10'2and 10'4dilutions were transferred to the filter membranes and then washed with sterile saline. For the longest exposure time, the entire contents of the neutralized solution were transferred to the filter membrane and then washed with sterile saline solution. The filters were then transferred to a recovery agar. Then, the agar plates were incubated for 15-25 days at a temperature of 35-37°C. After incubation, any survivors of the test organism were enumerated, and positive subcultures are stained using an AFB fluorescent stain to confirm the identity of the organism. In these tests, a comprehensive set of controls were implemented to validate the accuracy of the results. These controls include assessments for purity, organic soil sterility, neutralizer sterility, initial suspension population, and neutralization confirmation.

[0038] To evaluate the toxicity of the various embodiments in accordance with the present disclosure, a quantitative suspension test was also performed, using the protocol as follows.

[0039] To start, the embodiment of the disinfectant to be tested is dissolved in 200 ppm hard water. Once dissolved, a 20mL aliquot of the working solution is deposited into a lOOmL beaker. The solution is then stirred at a rate in the range of 140 revolutions per minute to 160 revolutions per minutes while being heating to a predetermined temperature, preferably using a stir plate / hot plate combination equipped with a temperature probe which is placed in the solution for accurate temperature measurement. Either while this solution is being heated and mixed or immediately thereafter, a spore crop is vortexed for a period of 3 minutes. After inoculation, the heated and mixed solution is continued to be mixed, however at an increasedrate of 250 revolutions per minute and then is subsequently inoculated with 60 pm of the spore crop. A ImL portion of the inoculated mixture is immediately drawn and placed into one or more centrifuge tubes pre-filled with a DEB solution. The moment of these test tubes are filled with the inoculated mixture represents 0 in the timepoint scale and serves as the positive control. From here, a timer is started for the next timepoint collection and the neutralized solution is vortexed for an additional 30 seconds. The prior steps of drawing a ImL portion of the inoculated mixture to place in a pre-fill test tube, starting the timer, and vortexing the neutralized solution are repeated for each subsequent timepoint. Between each time point, serial dilutions of the neutralized collection sample are performed.

[0040] This serial dilution is performed as follows. First, the neutralized collection sample is vortexed for approximately 30 seconds prior to the initial dilution. Then, a ImL portion of the fully concentrated neutralized solution is pipetted into a 10-1 test tube. This is performed in triplicate using a fresh pipet tip for each transfer. From there, 3 separate 10-fold series dilutions are performed for each sample, into test tubes 10-2 to 10-4. Then, a ImL solution of the 10-1 dilution is pipetted into the 10-2 test tubes along with sterile water, which is repeated for all triplicate samples. A ImL sampling of the 10-2 dilution is pipetted into the 10-3 test tubes, again repeating in triplicate. Finally, a ImL sampling of the 10-3 dilution is pipetted into the 10-4 test tubes, using a fresh pipet tip for each transfer.

[0041] In this test, plating of the sample is done by first vortexing the sample for approximately 10 seconds prior to plating. After this vortexing, a pipette is filled with ImL of solution and is deposited onto fresh sterile petri dishes. A negative control is then prepared by pipetting ImL of sterile water onto a sterile petri dish to serve as a water negative control, and a TSA medium is poured onto a sterile petri dish to serve as the media negative control. Gloves are then disinfected and a TSA medium is poured into the plates and mixed well, using a figure- 8 motion. The media is then allowed to solidify and to cool to room temperature. The platesare then stacked and inverted, where the sides are secured with tape and the entire stack is wrapped with aluminum foil. The wrapped plates are then incubated for a period of 48-72 hours at a temperature in the range of 55-60°C. After this incubation period, the plates are examined for any growth, any colonies are counted, and these results are recorded.

[0042] In developing this disinfectant in accordance with the present disclosure, Applicant performed tests to determine any synergistic effects of various organic acids with potassium peroxymonosulfate. Tests were performed with a 2% concentration of potassium peroxymonosulfate, as part of the aforementioned triple salt, in connection with various organic acids as well as without any organic acids as a control.

[0043] These tests were performed at a set temperature and for a set period of time; the results of one such test are reproduced below:After witnessing the synergistic effects of potassium peroxymonosulfate and these organic acids, further research was conducted to assess how these synergistic effects can be exploited while also incorporating one or more surfactants. The results of some of these efficacy tests are shown in FIGS. 1 and 2. Table 1, below, shows a comparison of the efficacy of an embodiment of the disinfectant in accordance with the present disclosure again a known disinfectant.Table 1

[0044] In addition to the efficacy tests that were performed, tests to evaluate the toxicity of embodiments in accordance with the present disclosure were also performed. The toxicity criteria are in conformance with ISO 10993-5, and the below results show multiple embodiments each of which have lower toxicity than peracetic acid, a disinfectant known in the art.Table 2Table 3Table 4Table 5

[0045] Examples exist where the disinfectant in accordance with the present disclosure also includes a stabilizer such as a scale inhibitor. In these examples, the use of a scale inhibitor provides the benefit of stabilizing the disinfectant such that long-term stability while the disinfectant is in liquid form can be achieved. However, for examples of the disinfectant in accordance with the present disclosure which are in powder form, the use of a scale inhibitor is not required. For examples that do contain a scale inhibitor, Dequest® 2010LC is suitable for use, although other scale inhibitors are contemplated by the present disclosure. For the purposes of this disclosure, unless explicitly specified, a listed concentration can be preferring to either percent weight by volume or percent weight by weight.

[0046] Examples exist where the disinfectant in accordance with the present disclosure includes one or more enzymes. Such enzymes can include lipase, protease, peptidase, amylase,glycosidase, cellulase, and nuclease which aid in the disinfectants ability to clean. These enzymes may be present, either individual or collectively, in concentrations of 1% w / w to 10% w / w. It should be noted that the novel combination of components of the disinfectant in accordance with the present disclosure can prevent against soil fixation. Examples which contain lower amounts of potassium peroxymonosulfate can exhibit improved properties in this regard.

[0047] The present disclosure also contemplates a disinfectant where the potassium peroxymonosulfate being present in a concentration of 1% to 1.2%. In some examples, the organic acid used in the disinfectant in accordance with the present disclosure of is a water- soluble organic acid salt. In various examples, the at least one organic acid is selected from the group consisting essentially of: glycolic acid, lactic acid, furoic acid, citric acid, salicylic acid, malic acid, and maleic acid.

[0048] In other examples, at least one surfactant is selected from the group consisting essentially of: CieCis fatty alcohol ethoxylate, fatty alcohol ethylene oxide / propylene oxide copolymer derivative, polyoxyethylene-polyoxypropylene block copolymer, capryleth-6 carboxylic acid, capryleth-4 carboxylic acid, capryleth-9 carboxylic acid, Akypo® LF1, Akypo® LF2, Akypo® EF4, and Pluronic® 10R5. Examples exist where the at least one water- soluble organic acid being glycolic acid and the at least one surfactant being Akypo® EFl. In at least one embodiment 1% of the disinfectant is glycolic acid and 0.3% of the disinfectant is Akypo® LF1. In an embodiment the disinfectant is configured to be non-cytotoxic for up to at least 48 hours of upon contact. Examples exist where the disinfectant further comprises at least one stabilizer, and in some examples that stabilizer is Dequest® 2010LC. Examples exist where the disinfectant further comprises sodium salicylate, and sodium xylene sulfonate. In examples, 0.15% of the disinfectant is sodium salicylate. In other examples 0.3% of the disinfectant is sodium xylene sulfonate.

[0049] One example of a disinfectant in accordance with the present disclosure is in the form of a kit. In such an example, this kit comprises a first tablet and a second tablet, where the first tablet is a pressed mixture of potassium peroxymonosulfate and organic acid, and where the second tablet is a pressed surfactant, where the first tablet and the second tablet are packaged separately. Another example of a disinfectant in accordance with the present disclosure is a dual-chambered water-soluble pod having a first compartment constructed out of a water-soluble material and filled with a mixture of potassium peroxymonosulfate and an organic acid, and a second compartment constructed out of a water-soluble material and filled with a surfactant. The compartments may be distinct components or may be joined via a water- soluble membrane. Yet another example of the disinfectant in accordance with the present disclosure a triple-chambered water-soluble pod having a first chamber constructed out of a water soluble material filled with potassium peroxymonosulfate, a second chamber constructed out of a water-soluble material filled with an organic acid such as glycolic acid, and a third chamber constructed out of a water soluble material filled with a surfactant such as Akypo® LF1. These chambers may be distinct chambers or may be separated by a water-soluble membrane. All of these chambers may be sealed by a top layer of water-soluble film. Another example of a disinfectant in accordance with the present disclosure is a dual chambered stick pack comprising a first chamber constructed out of a heat- sealable laminate film filled with a mixture of potassium peroxymonosulfate and an organic acid, and the second chamber constructed out of a heat- sealable laminate film filled with one or more surfactants. Yet another example of a disinfectant in accordance with the present disclosure is a layered tablet comprising a first layer of a compressed homogenous mixture of potassium peroxymonosulfate and an organic acid such as malic acid a second layer abutting against the first layer comprising an inert powder, and a third layer abutting against the second layer comprising a mixture of a surfactant and the inert powder used in the second layer or optionally a different inert powder.

[0050] Other examples of the disinfectant in accordance with the present disclosure include a cleaning wipe imbued with a mixture of at least potassium peroxymonosulfate, an organic acid, and at least one surfactant. Yet another example of the disinfectant in accordance with the present disclosure is a cleaning spray comprising potassium peroxymonosulfate, an organic acid, and at least one surfactant.

[0051] The present disclosure contemplates a kit for preparing a disinfectant in accordance with the present disclosure comprising potassium peroxymonosulfate, an organic acid, and a surfactant. In one example of this kit, the potassium peroxymonosulfate is in powder form, the organic acid is in powder or viscous liquid form, or the surfactant is in powder or viscous liquid form. In another example of this kit, the potassium peroxymonosulfate is present in a concentration of 10% w / w to 80% w / w, the organic acid is present in a concentration of 10% w / w to 80% w / w, and the surfactant is present in a concentration of 5% w / w to 30% w / w;. In another example, the potassium peroxymonosulfate is present in a concentration of 30% w / w to 50% w / w, the organic acid is present in a concentration of 30% w / w to 50% w / w, and the surfactant is present in a concentration of 5% w / w to 20% w / w. In another example, the kit further comprises an enzyme in a concentration of 1% w / w to 10% w / w.

[0052] In yet another example, this kit is configured to be dissolved to become a ready - to-use disinfectant solution with a pH in a range of 1.5-5 for high-level disinfection purposes. In another example, the disinfectant prepared by the kit in accordance with the present disclosure can have a pH in a range of 2-8, which is suitable for cleaning or disinfecting purposes. In a further example of said kit, the kit includes a first tablet having the potassium peroxymonosulfate and the organic acid, and a second tablet having the surfactant; wherein the first tablet and the second tablet are separately packed. In another example, the kit includes a first tablet having the potassium peroxymonosulfate, a second tablet having the organic acid, and a third tablet having the surfactant. In another example of this kit, the kit includes a water-soluble pod having chambers, the potassium peroxymonosulfate and the organic acid being contained within a first chamber, the surfactant being contained within a second chamber, the first chamber and the second chamber being separated by a water-soluble divider.

[0053] One example of this kit can include a multi-chambered pod, wherein the potassium peroxymonosulfate is contained within a first chamber, wherein the organic acid is contained within a second chamber, wherein the surfactant is contained within a third chamber, the first chamber, the second chamber, and the third chamber all being separated by respective dividers. Another example of this kit can include a multi-chambered pack having a first chamber and a second chamber, separated by a heat-sealable laminate, the first chamber containing a mixture of the potassium peroxymonosulfate and the organic acid, the second chamber containing the surfactant. In yet another example of this kit, the kit has a layered form fact, where a first layer comprises a compressed blend of the potassium peroxymonosulfate and the organic acid, a second layer comprises an inert powder, and a third layer comprises the surfactant or a compressed blend of a mixture of the inert powder and the surfactant. In another example of this kit, the first layer comprises a compressed blend of the potassium peroxymonosulfate and the organic acid, and a second layer comprises the surfactant or a compressed blend of a mixture of an inert powder and the surfactant, wherein the first layer and the second layer are separated by a divider. In various examples, this kit is configured to be shelf-stable for greater than six months, greater than twelve months, greater than eighteen months, or greater than twenty-four months.

[0054] An example of the process preparing a disinfectant through the use of one such kit in accordance with the present disclosure comprises the steps of kit dispensing powders of potassium peroxymonosulfate and an organic acid into a first compartment of the disinfectant kit, dispensing a surfactant into a second compartment of the disinfectant kit. In other examples,this process further comprises a step of sealing the first and second compartments to protect chemicals in the first and second compartments from exposure to moisture or oxygen.

[0055] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

Claims

CLAIMS1. A disinfectant, comprising: potassium peroxymonosulfate; at least one organic acid; and at least one surfactant, wherein the disinfectant is a powder.

2. The disinfectant of claim 1, the potassium peroxymonosulfate being present in a concentration of 10% w / w to 60% w / w, the organic acid being present in a concentration of 10% w / w to 60% w / w, and the surfactant being present in a concentration of 5% w / w to 30% w / w.

3. The disinfectant of claim 1, the potassium peroxymonosulfate being present in a concentration of 30% w / w to 50% w / w, the organic acid being present in a concentration of 30% w / w to 50% w / w, and the surfactant being present in a concentration of 5% w / w to 20% w / w.

4. The disinfectant of claim 3, further comprising water.

5. The disinfectant of claim 3, wherein the disinfectant is sealed within a container configured to protect the disinfectant from moisture and oxygen.

6. The disinfectant of claim 3, the disinfectant being part of a dual tablet kit, wherein the potassium peroxymonosulfate and organic acid are contained within a first tablet, wherein the surfactant is contained within a second tablet, the first tablet and the second tablet being separately packed and sealed.

7. The disinfectant of claim 3, the disinfectant being part of a dual-chambered water-soluble pod, wherein the potassium peroxymonosulfate and the organic acid are contained within a first chamber, wherein the surfactant is contained within a second chamber, the first chamber and the second chamber being separated by a water-soluble film, wherein the first chamber and the second chamber are sealed by a water-soluble film.

8. The disinfectant of claim 3, the disinfectant being part of a triple-chambered water-soluble pod, wherein the potassium peroxymonosulfate is contained within a first chamber, wherein the organic acid is contained within a second chamber, wherein the surfactant is contained within a third chamber, the first chamber, the second chamber, and the third chamber all being separated by a water-soluble film, wherein the first chamber, the second chamber, and the third chamber are all sealed by a water-soluble film.

9. The disinfectant of claim 3, the disinfectant being part of a layered tablet having a first layer, a second layer, and a third layer, wherein the first layer comprises a compressed blend of the potassium peroxymonosulfate and the organic acid, the second layer comprises an inert powder, and the third layer comprises a compressed blend of a mixture of the inert powder and the surfactant.

10. The disinfectant of claim 3, the disinfectant being part of a dual-chambered stick pack having a first chamber and a second chamber, the first chamber comprising a heat-sealable laminate, the first chamber containing a mixture of the potassium peroxymonosulfate and the organic acid, the second chamber comprising a heat- sealable laminate, the second chamber containing the surfactant.

11. The disinfectant of claim 3, further comprising an enzyme in a concentration of 1% w / w to10% w / w.

12. The disinfectant of claim 3, wherein the disinfectant has a pH in the range of 1.5-5.

13. The disinfectant of claim 3, wherein the disinfectant has a pH in the range of 2-8.

14. The disinfectant of claim 3, further comprising a wipe configured to be imbued with the disinfectant.

15. A kit for preparing a disinfectant, comprising: a first chamber containing potassium peroxymonosulfate and an organic acid; a second chamber containing a surfactant; a first water-soluble film disposed between the first chamber and the second chamber; and a second water-soluble film configured to seal the first chamber and the second chamber.

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