Improved Endoscope Disinfectant

Abstract

To provide a disinfectant operation solution for use in disinfection or sterilization of reusable medical equipment, such as an endoscope.SOLUTION: A disinfectant operation solution includes peracetic acid and at least one kind of surfactant, which is prepared by dilution of either 1 part or 2 parts concentrated liquid. The operation solution shows rapid wetness characterized by dynamic surface tension of 50 mN / m at 250 ms and 46 mN / m at 500 ms.SELECTED DRAWING: Figure 3

Description

Detailed Description of the Invention

[0001]

[0001] [Background]

[0002] Reusable medical devices are devices that can be reprocessed and reused by healthcare providers for multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes, and stethoscopes.

[0002]

[0003] Reusable medical devices can be grouped into one of three categories according to the risk of infection associated with the use of the device: Critical devices (such as surgical forceps) come into contact with blood or normally sterile tissue. Semicritical devices (such as endoscopes) come into contact with mucous membranes. Noncritical devices (such as stethoscopes) come into contact with intact skin.

[0003]

[0004] This classification system was devised by Erwin Spaulding and serves as a guide for the reprocessing of reusable medical devices.

[0004]

[0005] Critical medical devices should ideally be reprocessed by sterilization by moist heat or, if the device is incompatible with moist heat, by other means. Semicritical medical devices should also be sterilized by moist heat if possible, but at a minimum should be sterilized by exposure to a high-level disinfectant.

[0005]

[0006] Chemical sterilants are chemical agents used for the sterilization of critical medical devices. Sterilants kill all microorganisms, resulting in a sterilization assurance level, i.e., the probability of survival of a single microorganism is 10

[0007] , , , -6 or less. High-level disinfectants (HLDs) can be considered a subcategory of sterilants, but the exposure time is shorter than that required for sterilization. HLDs kill all microbial pathogens except for a majority of bacterial endospores when used as recommended by the manufacturer and are the minimum treatment recommended for the reprocessing of semicitical medical devices.

[0006]

[0007] Common types of semi-emergency medical equipment include flexible endoscopes such as colonoscopes and gastroscopes. Due to their complex structure and the use of thermally unstable materials such as polyurethane sheaths, epoxy coatings, fiber optic cables, and optical tips, most flexible endoscopes cannot be sterilized by wet heating and are therefore reprocessed using chemical sterilizers or high-level disinfectants.

[0007]

[0008] A popular choice for both chemical sterilization and advanced disinfection of flexible endoscopes is peracetic acid (PAA).

[0008]

[0009] PAA is typically supplied as an equilibrium mixture of PAA, hydrogen peroxide, and acetic acid. PAA is prepared by mixing aqueous solutions of hydrogen peroxide and acetic acid and allowing the materials to reach equilibrium. Typically, this reaction is carried out without a catalyst, allowing the reactants to reach equilibrium over 10 to 14 days, or it may be catalyzed by adding a strong mineral acid such as 1% w / w concentrated sulfuric acid.

[0009]

[0010] Commercial-grade PAAs are sold with a PAA concentration of 5.0-5.4%. This PAA concentration is generally classified and traded as a Class 5.1 hazardous material. Products with higher concentrations of PAA are classified as Class 5.2 hazardous materials, which negatively impacts transportation costs and storage requirements.

[0010]

[0011] Typically, a 5.0–5.4% w / w PAA equilibrium solution also contains approximately 25–28% w / w hydrogen peroxide and 7–10% w / w acetic acid. In many cases, phosphonic acid chelating agents are added to prevent product degradation due to trace metal contaminants.

[0011]

[0012] PAA is commonly used as a sterilizer or HLD for reprocessing flexible endoscopes using automated endoscope cleaning systems or AERs. Reprocessing of endoscopes in an AER typically involves the following steps: Placement within AER Pre-wash with water Cleaning the phase with a suitable detergent Rinsing the phase using water Sterilization or disinfection Multiple rinses It is required.

[0012]

[0013] AER involves injecting PAA sterilizer or disinfectant into the chamber containing the endoscope and diluting it to a working concentration. For high-level disinfection, a 5% w / w PAA equilibrium solution is typically diluted to 1-2% v / v, while for sterilization, it is diluted to 2-4% v / v. This yields a working concentration of PAA of approximately 650-1000 ppm for high-level disinfection and 1300-2000 ppm for sterilization.

[0013]

[0014] Apart from the PAA concentration, the time required to achieve disinfection is also determined by the temperature of the disinfectant or sterilizer. For flexible endoscopes, a temperature of 25°C to 40°C for 5 minutes is usually used for high-level disinfection, while for sterilization, a temperature of 30°C to 45°C for 7 to 10 minutes of contact time is common.

[0014]

[0015] One problem associated with the use of PAA for disinfection and sterilization of endoscopes is the corrosion of endoscopes and / or AERs by the highly acidic and oxidizing PAA. This is usually mitigated to some extent by adding corrosion inhibitors and pH buffers to the diluted PAA solution. Commonly used corrosion inhibitors include benzotriazole, potassium phosphate, sodium nitrite, sodium nitrate, and molybdenum salts.

[0015]

[0016] Corrosion inhibitors and pH buffers are typically added as separate solutions to the AER disinfection chamber (where concentrated PAA solution is the Part A solution) as Part B solution. This configuration can be called a two-part disinfectant or sterilizer. Other components, such as wetting agents including surfactants, may also be added to the Part B solution. Surfactants are added to adequately wet the surface of the endoscope with the disinfectant and to solubilize any remaining contaminants from the clean phase.

[0016]

[0017] Typically, nonionic surfactants are used in Part B formulations because they typically have low foaming properties. Examples include Pluronic 10R5 (see, e.g., WO2016 / 100818 by Medivators), Pluronic PE85 and PE64 (see, e.g., U.S. Patent No. 20030129254 by Saraya). The use of Pluronic surfactants in Part B formulations is also taught by JP2009155270 from Fujifilm Corporation. Note that there is no teaching regarding the surface tension of disinfectant solutions prepared from these formulations.

[0017]

[0018] The use of amine oxide surfactants in conjunction with other surfactants, particularly when combined with phosphate buffer, has been shown to enhance the bactericidal efficacy of PAA-based disinfectants. This is shown in AU2013359955 (by Saban Ventures). The surfactants tested included cocamidopropylamine oxide. Other nonionic surfactants such as Triton X-100 or Tween-80 were also tested. The cationic surfactants tested included quaternary ammonium compounds such as benzalkonium chloride or hexadecylpyridinium bromide.

[0018]

[0019] The use of amine oxide surfactants, particularly when combined with surfactants having the structure shown in Chemical Formula 1, has also been shown to improve the bactericidal efficacy of PAA-based disinfectants. R1-O-[CH(R2)-CH(R3)-O] n -R4 Formula 1 (In the formula, R1 represents a linear or branched saturated or unsaturated aliphatic group containing 5 to 31 carbon atoms, preferably 10 to 16 carbon atoms; R2 represents a hydrogen atom, a methyl group, or an ethyl group; R3 represents a hydrogen atom, a methyl group, or an ethyl group, and at least one of the two groups R2 and R3 is understood to represent a hydrogen atom; R4 represents a linear or branched alkyl group or a benzyl group containing a hydrogen atom or 1 to 4 carbon atoms; n represents a number from 1 to 50, preferably n is less than 20 (see U.S. Patent No. 6,168,808, U.S. Patent No. 6,444,230, and FR2796285 (all by Sppic)).

[0019]

[0020] One proposed mechanism for improving the bactericidal efficacy of PAA in the presence of surfactants is improved wetting of the disinfectant in the presence of the surfactant system. For example, European Patent No. 0971584 (again by Seppic) suggests that PAA-based disinfectants formulated with amine oxide surfactants can exhibit good wetting properties with respect to dilution, particularly in the presence of a surfactant having the structure shown in Chemical Formula 1, with a static surface tension of approximately 26.5–31.0 mN / m as measured using the Wilhelmie plate method.

[0020]

[0021] Interestingly, measurements of the surface tension of these formulations by regeneration and maximum foam pressure method demonstrate that the example in European Patent No. 0971584 shows that these formulations have slow wetting and, with a surface lifetime of 15,000 ms, have significantly higher surface tension than the static values ​​reported in the document of European Patent No. 0971584 (see Example 9 and Figure 6).

[0021]

[0022] References to literature, laws, materials, equipment, articles, etc., are included herein solely for the purpose of providing the context of the present invention. It is not implied or stated that any or all of these contents existed prior to the priority date of each claim of this application, and therefore formed part of the basis of the prior art or were general knowledge in the art related to the present invention.

[0022]

[0023] [Summary of the Invention]

[0024] According to a first embodiment of the present invention, there is provided a disinfectant working solution for sterilizing or disinfecting medical devices, comprising an aqueous dilution of a disinfectant concentrate containing (a) peracetic acid and (b) at least one surfactant, which exhibits a dynamic surface tension of less than about 50 mN / m at a surface lifetime of 250 ms and less than about 46 mN / m at a surface lifetime of 500 ms when measured by the maximum bubble pressure method at 20 to 25°C.

[0023]

[0025] According to a second embodiment of the present invention, there is provided the disinfectant working solution of the first embodiment, which exhibits a dynamic surface tension of less than about 42.5 mN / m at a surface lifetime of 250 ms and less than about 41.0 mN / m at a surface lifetime of 500 ms at 20 to 25°C when measured by the maximum bubble pressure method.

[0024]

[0026] According to a third embodiment of the present invention, there is provided the disinfectant working solution of the second embodiment, which also exhibits a dynamic surface tension of less than about 40 mN / m at a surface lifetime of 5000 ms when measured by the maximum bubble pressure method. [[ID=​​​​​​​​​​​​A sixth embodiment of the present invention provides a method for disinfecting or sterilizing a medical device, comprising the step of contacting the medical device with a disinfectant working solution comprising (a) peracetic acid and (b) an aqueous dilution of a disinfectant concentrate containing at least one surfactant, wherein the disinfectant working solution exhibits a dynamic surface tension of less than approximately 50 mN / m at a surface lifetime of 250 ms and less than approximately 46 mN / m at a surface lifetime of 500 ms, as measured by the maximum bubble pressure method at 20-25°C.

[0028]

[0030] According to a seventh embodiment of the present invention, a method for disinfecting or sterilizing a medical device is provided, comprising the step of bringing the medical device into contact with a disinfectant working solution according to any one of the first to fifth embodiments.

[0029]

[0031] Throughout this description and the claims, the word “comprise” and its variations (such as “comprising” and “comprises”) are not intended to exclude other additions, components, integers, or steps. [Brief explanation of the drawing]

[0030] [Figure 1] This shows a Wilhelmie plate apparatus. [Figure 2] This describes the maximum bubble pressure method for determining the dynamic surface tension of a liquid or solution. [Figure 3] The measured dynamic surface tension of the disinfectant of the present invention and a conventional disinfectant for comparison over the surface life range are shown. [Figure 4] Examples 4-7 illustrate the measured dynamic surface tension of various conventional disinfectants across the range of surface life. [Figure 5] Examples 8A–8D illustrate the dynamic surface tension measurements of various conventional disinfectants according to U.S. Patent No. 6,168,808, spanning the range of surface life. [Figure 6] Examples 9A to 9E illustrate the dynamic surface tension measurements of various prior art disinfectants according to European Patent No. 0971584, spanning the range of surface life. [Figure 7] The measured values ​​of the dynamic surface tension in two embodiments of the present invention (Examples 10 and 11) over the surface life range are shown. [Figure 8] The dynamic surface tension measurements of various components of Example 10 over the range of surface life are shown, as described in Example 12. [Figure 9] The measured dynamic surface tension of embodiments of the present invention based on branched alkylalkoxylates (e.g., 13A-13D) over the surface life range is shown. [Figure 10] The measured dynamic surface tension of embodiments of the single-part concentrate of the present invention, based on short-chain fluorinated surfactants (e.g., 14A-14D), over the range of surface life is shown. [Figure 11] The measured dynamic surface tension of embodiments of the single-part concentrate of the present invention based on branched alkylalkoxylates (e.g., 15A-15G) over the surface lifetime range is shown.

[0031]

[0044] [Detailed description of the invention]

[0045] This specification describes PAA-based disinfectant compositions intended for use in the advanced disinfection and / or sterilization of reusable, thermally unstable, complex medical devices such as flexible endoscopes. The compositions described are typically prepared as concentrates and then diluted to a preferred working concentration at the time of use. The diluted disinfectant composition is referred to herein as the disinfectant working solution.

[0032]

[0046] Preferably, the disinfectant working solution of the present invention is used in an automatic cleaning and disinfecting machine, more preferably, an automatic cleaning and disinfecting machine for reprocessing flexible endoscopes.

[0033]

[0047] The disinfectant working solution of the present invention is formed by diluting a concentrated disinfectant solution.

[0034]

[0048] In one embodiment, the disinfectant concentrate consists of two parts. The first part is preferably a PAA concentrate, and the second part is preferably a corrosion inhibitor concentrate containing at least one surfactant. The first part (referred to as part A) contains an equilibrium solution of PAA, hydrogen peroxide, and acetic acid, preferably in combination with a stabilizer and optionally a small amount of strong mineral acid. The second part (referred to as part B) preferably contains at least one corrosion inhibitor and at least one surfactant, and optionally may contain other components such as hydrotropes, pH adjusters, indicators, colorants, and chelating agents. The disinfectant working solution is formed by mixing part A and part B and diluting with water to obtain PAA of the required concentration.

[0035]

[0049] Preferably, Part A is an equilibrium solution containing about 0.1% w / w PAA to about 20% w / w PAA. More preferably, Part A contains about 1% w / w PAA to about 15% PAA. Most preferably, Part A contains about 4% w / w to about 6% w / w PAA.

[0036]

[0050] It should be noted that commercially available PAA equilibrium solutions (such as Proxitane) contain stabilizers (often essentially monopolized). These commercial products may also contain small amounts (typically less than 1%) of mineral acid (especially when manufactured in cold climates).

[0037]

[0051] The second part (hereinafter referred to as Part B) comprises an aqueous solution of at least one surfactant, preferably at least one corrosion inhibitor and / or at least one pH adjuster.

[0038]

[0052] Therefore, the disinfectant working solution of the present invention is produced by combining a portion of the Part A and Part B solutions with water to produce an aqueous disinfectant working solution.

[0039]

[0053] Preferably, the ratio of part A to part B is about 1:10 to about 10:1 in terms of volume. More preferably, the ratio of part A to part B is about 1:5 to about 5:1 in terms of volume. Most preferably, the ratio of part A to part B is about 1:1 in terms of volume.

[0040]

[0054] The disinfectant working solution preferably comprises part A at about 0.1% v / v to about 10% v / v and part B at about 0.1% v / v to about 10% v / v. More preferably, the disinfectant working solution comprises part A at about 0.5% v / v to about 5% v / v and part B at about 0.5% v / v to about 5% v / v for high-level disinfection, and part A at about 1.0% v / v to about 10% v / v and part B at about 1.0% v / v to about 10% v / v for sterilization.

[0041]

[0055] When measured by the maximum foam pressure method, the disinfectant working solution exhibits a dynamic surface tension of less than approximately 50 mN / m at a surface lifetime of 250 ms and less than approximately 46 mN / m at a surface lifetime of 500 ms at 20-25°C.

[0042]

[0056] In a preferred embodiment, the disinfectant working solution exhibits a dynamic surface tension of less than approximately 42.5 mN / m at a surface lifetime of 250 ms and less than approximately 41 mN / m at a surface lifetime of 500 ms at 20-25°C, as measured by the maximum foam pressure method.

[0043]

[0057] In another preferred embodiment, the disinfectant working solution exhibits a dynamic surface tension of less than approximately 42.5 mN / m at a surface lifetime of 250 ms, less than approximately 41 mN / m at a surface lifetime of 500 ms, and less than approximately 40 mN / m at a surface lifetime of 5000 nm, as measured by the maximum foam pressure method, at 20-25°C.

[0044]

[0058] In another embodiment of the present invention, the disinfectant concentrate is provided as a single-part disinfectant composition comprising at least a equilibrium solution of PAA, hydrogen peroxide, and acetic acid, and at least one surfactant, preferably in combination with a stabilizer. Optionally, the single-part disinfectant concentrate may also contain at least one corrosion inhibitor, and other components such as hydrotropes, pH adjusters, indicators, colorants, and chelating agents. During use, the single-part disinfectant concentrate is preferably diluted with water.

[0045]

[0059] The diluted single-part disinfectant concentrate is a disinfectant working solution that, when measured by the maximum foam pressure method, exhibits a dynamic surface tension of less than approximately 50 mN / m at a surface lifetime of 250 ms and less than approximately 46 mN / m at a surface lifetime of 500 ms at 25-25°C.

[0046]

[0060] In a preferred embodiment, this diluted single-part disinfectant concentrate forming the disinfectant working solution of the present invention exhibits a dynamic surface tension of less than approximately 42.5 mN / m at a surface lifetime of 250 ms and less than approximately 41 mN / m at a surface lifetime of 500 ms at 20-25°C, as measured by the maximum foam pressure method.

[0047]

[0061] In another preferred embodiment, the diluted single-part disinfectant concentrate forming the disinfectant working solution exhibits dynamic surface tensions of less than approximately 42.5 mN / m at a surface lifetime of 250 ms, less than approximately 41.0 mN / m at a surface lifetime of 500 ms, and less than approximately 40.0 mN / m at a surface lifetime of 5000 nm at 20-25°C, as measured by the maximum foam pressure method.

[0048]

[0062] While we do not wish to be bound by theory, the improved rapid wetting resulting from low surface tension and low surface lifetime is thought to allow for faster disinfection of endoscopes inside AERs, particularly those using dynamic cleaning processes such as spray arms.

[0049]

[0063] The improved performance of the disinfectant, brought about by the rapid wetting of the disinfectant working solution of the present invention, is at least 6 log compared to conventional PAA-based disinfectant solutions when tested under the same conditions as PAA concentration and temperature, in both bacteria and spores. 10 It provides a faster way to achieve reduction.

[0050]

[0064] Alternatively, or in addition, when tested at lower PAA concentrations, the disinfectant working solution of the present invention exhibits at least 6 log of activity in both bacteria and spores within the same timeframe as conventional PAA-based disinfectant solutions. 10 This provides a reduction in pollution levels. Lower concentrations result in less corrosive disinfectant solutions, while maintaining equivalent bactericidal performance.

[0051]

[0065] Many of the prior art documents describe both single-part and two-part PAA-based disinfectants containing surfactants, and the presence of surfactants can lead to an increase in the bactericidal efficacy of PAA-based disinfectants.

[0052]

[0066] As mentioned above, the presence of surfactants has been suggested to improve surface wetting by disinfectants, and therefore lead to improved disinfectant efficacy. European Patent No. 0971584 describes wetting that shows promise in terms of lower surface tension of disinfectants, which leads to a lower contact angle of the solution to hydrophobic surfaces such as Parafilm. However, in the document, European Patent No. 0971584, the static surface tension of the solution was characterized using the Wilhelmie plate method (see Table 1). Dynamic surface tension data were not reported in the document. [Table 1]

[0053]

[0067] Figure 3 shows a comparison of dynamic surface tensions over the surface life range between several examples of conventional PAA-based disinfectants and exemplary embodiments of the disinfectant working solution of the present invention. As can be clearly seen, all exemplary embodiments exhibit a characteristically rapid realization of a surface tension of less than approximately 42.5 mN / m, compared to conventional examples that reach a surface tension of less than 40 mN / m by 5000 ms.

[0054]

[0068] A Wilhelmie plate typically consists of a thin plate with an area of ​​approximately a few square centimeters (see Figure 1). The plate is often made from filter paper, glass, or platinum, which can be roughened to ensure complete wetting. In fact, experimental results are independent of the material used, as long as the material is wetted by the liquid. The plate is thoroughly cleaned and mounted on a scale with a thin metal wire. The force on the plate due to wetting is measured using a tensile strength meter or microbalance, and this force is expressed by the Wilhelmie formula:

number

[0055]

[0069] One problem with the Wilhelmie plate method is that it represents the static case. When a surfactant is dissolved in water, the surfactant molecules move to the surface of the liquid (either at the air interface or to the walls of the container). Until a certain concentration of surfactant is reached (critical micelle concentration or CMC), all the surfactant molecules move to various surfaces surrounding the solution. Once the CMC is reached, aggregates of surfactant molecules (micelles) are formed in the bulk solution.

[0056]

[0070] The diffusion rate of surfactant molecules from a bulk solution to a surface interface varies depending on the type of surfactant, and this is manifested, for example, in the wetting rate.

[0057]

[0071] When measured by the Wilhelmie plate method (or a similar method such as a DeNoy ring), the solution being measured is not agitated, and the measurement represents the static or equilibrium surface tension, i.e., the surface tension achieved when all available surfactant molecules move to the interface.

[0058]

[0072] The measurements are useful for assessing disinfectants used under static conditions (i.e., when the endoscope is immersed in a static solution of disinfectant), but this is not done in modern AERs, which typically involve continuously pumping the disinfectant solution into the endoscope lumen and spraying the disinfectant onto the outer surface of the endoscope using a spray arm. This creates a highly dynamic environment in which the disinfectant is constantly being mixed. Under these conditions, with slowly diffusing surfactant systems, the actual surface tension is significantly higher than that measured using static methods such as Wilhelmie plates.

[0059]

[0073] [Dynamic surface tension measurement]

[0074] One method for measuring dynamic surface tension is the maximum bubble pressure method. Due to the internal gravitational force of the liquid, bubbles in the liquid are compressed. As the bubble radius decreases, the resulting pressure (bubble pressure) increases. The bubble pressure method uses this bubble pressure, which is higher than that of the surrounding environment (water). The airflow is pumped into a capillary immersed in the fluid. The bubbles formed at the tip of the capillary continue to grow in size across the surface area.

[0060]

[0075] The pressure rises to its maximum level. At this point, the bubble reaches its minimum radius (capillary radius) and forms a hemisphere. Beyond this point, the bubble size increases rapidly and immediately bursts, detaching from the capillary, thereby creating a new bubble at the capillary tip. During this process, a characteristic pressure pattern is established (see Figure 2), and the determination of the surface tension is evaluated.

[0061]

[0076] As the foam formation rate varies, the surface tension can be determined over a range of surface life, and the surface tension can be measured over a longer surface life that approaches the value measured under static conditions.

[0062]

[0077] Therefore, the use of the maximum foam pressure method allows for the determination of surface tension under dynamic conditions (such as those encountered in modern AERs).

[0063]

[0078] [Disinfectant components]

[0079] (Peracetic acid solution)

[0080] In a preferred embodiment, the disinfectant concentrate of the present invention is prepared using an equilibrium solution containing PAA containing about 0.1 to about 20% w / w of PAA, hydrogen peroxide, acetic acid, and water. In a more preferred embodiment, the PAA solution preferably contains about 1% to 15% w / w of PAA, more preferably about 4% w / w to about 6% w / w.

[0064]

[0081] Typically, PAA solutions are supplied as equilibrium solutions. These solutions are prepared by reacting hydrogen peroxide with acetic acid, as shown in Equation 2. CH3COOH+H2O2⇔CH3COOOH+H2O Formula 2

[0065]

[0082] The reaction mixture preferably also includes a stabilizer, which is typically a chelating agent that complexes heavy metal ions, in order to prevent the catalytic action of heavy metal ions on the decomposition of peroxy species.

[0066]

[0083] The reaction to form PAA may be left uncatalyzed, in which case it may take 10 to 15 days to reach equilibrium, or catalysis may be provided by adding a small amount (about 1% w / w) of strong acid (such as sulfuric acid). At equilibrium, the final solution consists of a mixture containing both the reactants and the products (i.e., a mixture containing PAA, water, hydrogen peroxide, and acetic acid). The equilibrium solution can be prepared using known methods (e.g., FP Greenspan, "The Convenient Preparation of Per-acids," J.Am.Chem.Soc. 1946, 68, 5, 907-907).

[0067]

[0084] The degree of the reaction is determined by the equilibrium constant k, which is the molar concentration ratio of the product to the reactants, i.e.,

number

number

[0068]

[0085] At room temperature, the equilibrium constant is approximately 2.7 (see, for example, Zhao et al., "Preparation of Peracetic Acid from Acetic Acid and Hydrogen Peroxide: Experimentation and Modelling," The Chinese Journal of Process Engineering, 8(1), 35-41, (2008)).

[0069]

[0086] As can be seen in Equation 4, the molar concentration of PAA in a solution is directly proportional to the product of the molar concentrations of hydrogen peroxide and acetic acid, and inversely proportional to the molar concentration of water. Therefore, as long as the product of the molar concentrations of hydrogen peroxide and acetic acid remains constant, an equilibrium solution containing a given concentration of PAA may contain different concentrations of hydrogen peroxide and acetic acid.

[0070]

[0087] The PAA composition may also contain other components such as stabilizers and mineral acids. The stabilizer can be selected from the group consisting of phosphonic acid derivatives, such as aminotri(methylenephosphonic acid), 1-hydroxyethylidene-1,1-diphosphonic acid, quinoline-8-ol, 2,6-pyridinedicarbon(dipicoline) acid, aspartic acid, diethoxy succinate, quinoline-2-carboxylic acid, citric acid, isocitric acid, aconitic acid, propane-1,2,3-tricarboxylic acid, and mixtures thereof. The mineral acid can be selected from the group consisting of sulfuric acid, nitric acid, methanesulfonic acid, trifluoromethanesulfonic acid, and mixtures thereof.

[0071]

[0088] In yet another embodiment, a composition comprising the PAA of the present invention may be formed by a reaction between a hydrogen peroxide solution and an acylating agent such as tetraacetylethylenediamine (TAED), N-acetylcaprolactam, N-acetylsuccinimide, N-acetylphthalimide, N-acetylmaleimide, pentaacetylglucose, octaacetylsucrose, acetylsalicylic acid, tetraacetylglycoluryl, and combinations thereof.

[0072]

[0089] When diluted for use, the concentration of PAA in the disinfectant working solution is preferably about 0.01% w / v to about 1.0% w / v (about 100 ppm to about 10,000 ppm), more preferably about 0.02% w / v to about 0.5% w / v (200 ppm to about 5,000 ppm).

[0073]

[0090] As those skilled in the art will recognize, other peracids may be used together with or in place of peracetic acid. Other peracids include, but are not limited to, percitric acid, perlactic acid, performic acid, perpropionic acid, perhexanoic acid, perheptanoic acid, peroctanoic acid, perbenzoic acid, and mixtures thereof.

[0074]

[0091] (Corrosion inhibitor)

[0092] Preferably, the disinfectant compositions of the present invention include, but are not limited to, benzotriazole, alkali metal phosphate, alkali metal nitrate, alkali metal nitrite, 2-phosphonobutane-1,2,4-tricarboxylate, metal molybdate, and combinations thereof as corrosion inhibitors.

[0075]

[0093] The corrosion inhibitor reduces corrosion caused by the disinfectant composition of the present invention in both endoscopes and endoscope cleaning and disinfection devices. Preferably, the corrosion inhibitor is present in the disinfectant concentrate at an amount of about 0.1% w / v to about 2% w / v, or in the diluted standard disinfectant solution at an amount of about 500 ppm to about 5000 ppm.

[0076]

[0094] In one embodiment, the corrosion inhibitor is contained in part B of a two-part disinfectant concentrate. In another embodiment, the corrosion inhibitor is contained in a peracetic acid solution of a single-part concentrate.

[0077]

[0095] (Surfactants)

[0096] Suitable surfactants for use in the disinfectant working solution of the present invention include ionic, nonionic, amphoteric, and amphoteric surfactants, or mixtures thereof. Preferably, the surfactant or surfactant mixture has low foaming properties and also functions as a wetting agent.

[0078]

[0097] It is preferable that the surfactant(s) are present in the disinfectant solution in an amount of approximately 0.005% w / v to 0.5% w / v.

[0079]

[0098] Preferably, the surfactant(s) are present in the disinfectant solution in an amount of approximately 0.01% w / v to 0.4% w / v.

[0080]

[0099] In the concentrated disinfectant solution of Part 2, the surfactant(s) are preferably present in an amount of about 0.05% to about 15% w / w, more preferably about 0.1% to about 10% w / w of the Part B composition.

[0081]

[0100] In a concentrated single-part disinfectant solution, surfactants (or multiple surfactants) are preferably present in an amount of about 0.05% to about 15% w / w, more preferably about 0.1% to about 10% w / w.

[0082]

[0101] Ideally, the surfactant(s) also enable rapid wetting of the surface. In a preferred embodiment, the surfactant(s) are selected to produce a disinfectant working solution having a Draves wetting time of less than 40 seconds.

[0083]

[0102] In a preferred embodiment, the surfactant is selected to produce a disinfectant working solution having a dynamic surface tension of less than approximately 42.5 mN / m at a surface lifetime of 250 ms and less than approximately 41 mN / m at a surface lifetime of 500 ms, as measured by the maximum foam pressure method.

[0084]

[0103] More preferably, the surfactant is selected to produce a disinfectant working solution having a dynamic surface tension of less than approximately 42.5 mN / m at a surface lifetime of 250 ms, less than approximately 41 mN / m at a surface lifetime of 500 ms, and less than approximately 40 mN / m at a surface lifetime of 5000 ms, as measured by the maximum foam pressure method, at 25-25°C.

[0085]

[0104] Examples of suitable surfactants that may be used in the compositions of the present invention include, but are not limited to, block copolymers of polyethylene oxide and polypropylene oxide, fatty alcohol alkoxylates, long-chain alkyl alkoxylates, N-alkylpyrrolidones, branched short-chain perfluorosurfactants, branched short-chain polysiloxane-functionalized polyglycols, and combinations thereof.

[0086]

[0105] (Hydrotrope)

[0106] Hydrotropes are compounds that solubilize hydrophobic compounds in aqueous solutions by means other than micelle solubilization. Typically, hydrotropes consist of a hydrophilic part and a hydrophobic part (similar to surfactants), but the hydrophobic part is generally too small to undergo spontaneous self-association.

[0087]

[0107] Hydrotropes can be used in the disinfectant compositions of the present invention to enable the solubilization of other insoluble components, such as low-foaming nonionic surfactants.

[0088]

[0108] Suitable hydrotropes include, but are not limited to, potassium xylenesulfonate, potassium naphthalenesulfonate, potassium cumenesulfonate, potassium cresyl phosphate, potassium octyliminodipropionate, sodium xylenesulfonate, sodium naphthalenesulfonate, sodium cumenesulfonate, sodium cresyl phosphate, sodium octyliminodipropionate, pentyl glucoside, hexyl glucoside, octyl glucoside, isooctyl glucoside, and mixtures thereof.

[0089]

[0109] In a preferred embodiment, the hydrotrope is present in an amount of about 0.1% to about 15% w / w, more preferably about 0.5% to about 10% w / w, of Part B of the two-part disinfectant concentrate.

[0090]

[0110] In a second preferred embodiment, the hydrotrope is present in an amount of about 0.1% to about 15% w / w, more preferably about 0.5% to about 10% w / w, of the equilibrium peracetic acid concentrate of the single-part disinfectant concentrate.

[0091]

[0111] (pH adjuster)

[0112] The disinfectant working solution and disinfectant concentrate of the present invention may also contain a pH adjuster to control the pH of the final disinfectant composition. These pH adjusters are selected from the group consisting of alkali metal hydroxides, alkali metal carbonates, and alkali metal salts of polyhydric acids, such as alkali metal salts of citric acid, boric acid, phosphoric acid, oxalic acid, maleic acid, and fumaric acid.

[0092]

[0113] pH adjusters may be used to control the pH of Part B of the disinfectant concentrate itself, allowing the use of surfactants that may be unstable to acids or bases. The pH of the Part B disinfectant concentrate is preferably in the range of about 6.0 to about 13, more preferably about 7.0 to about 13.

[0093]

[0114] The pH adjuster in Part B can achieve a preferred pH for the disinfectant working solution and allows for the presence of acidic species that may be present in the starting Part A (PAA) solution. The pH of the disinfectant working solution of the present invention is preferably in the range of about 2.0 to about 8, more preferably about 3.0 to about 6.0.

[0094]

[0115] [2-part concentrated disinfectant solution]

[0116] In a two-part disinfectant concentrate, the disinfectant concentrate is supplied as two parts (referred to as "Part A" and "Part B" for clarity), typically as two solutions. Part A typically contains an aqueous equilibrium solution of PAA, hydrogen peroxide, and acetic acid. Part A may also contain small amounts of other components, such as stabilizers or strong acids. Stabilizers can be selected from the group consisting of, but are not limited to, aminotri(methylenephosphonic acid), 1-hydroxyethylidene-1,1-diphosphonic acid, quinoline-8-ol, 2,6-pyridinedicarbon(dipicoline) acid, aspartate diethoxysuccinate, quinoline-2-carboxylic acid, citric acid, isocitric acid, aconitic acid, propane-1,2,3-tricarboxylic acid, and mixtures thereof.

[0095]

[0117] A strong acid may be used as a catalyst for forming PAA. The strong acids that can be used in the present invention are not limited to these, but can be selected from sulfuric acid, nitric acid, methanesulfonic acid, trifluoromethanesulfonic acid, and mixtures thereof.

[0096]

[0118] Furthermore, the use of commercially available PAA equilibrium solutions is also anticipated. It has been found that commercial-grade PAA contains stabilizers and optional strong acids.

[0097]

[0119] In a preferred embodiment, part B of the disinfectant concentrate contains about 0.05% w / w to about 15% w / w of surfactant. In a more preferred embodiment, the single-part disinfectant concentrate contains about 0.1% w / w to about 10% w / w of surfactant. In a very preferred embodiment, the disinfectant concentrate contains about 1% to about 9% w / w of surfactant.

[0098]

[0120] Part B of the disinfectant concentrate may also contain other components such as corrosion inhibitors, pH adjusters, surfactants, colorants, and indicators. Part B may also contain hydrotropes that help solubilize various components of the solution.

[0099]

[0121] In a preferred embodiment, the disinfectant working solution of the present invention is produced by combining a portion of the Part A and Part B solutions with water to produce an aqueous disinfectant working solution. Preferably, the ratio of Part A to Part B solutions is about 1:10 to about 10:1 by volume. More preferably, the ratio of Part A to Part B solutions is about 1:5 to about 5:1 by volume. Most preferably, the ratio of Part A to Part B solutions is about 1:1 by volume.

[0100]

[0122] The resulting diluted or disinfectant working solution preferably contains about 0.01% w / v to about 1.0% w / v (100 ppm to 10,000 ppm) of PAA, more preferably about 0.02% w / v to about 0.5% w / v (200 ppm to 5,000 ppm) of PAA.

[0101]

[0123] Those skilled in the art will find that the concentration of the active ingredient in a disinfectant (in this case, PAA) is determined by a combination of factors such as the contact time for disinfection, the disinfection temperature suitable for microbiological testing, and the desired microbiological performance (e.g., high disinfection or sterilization).

[0102]

[0124] Other factors, such as material compatibility, can also determine the PAA concentration. For example, the corrosiveness of a disinfectant working solution can be reduced by decreasing the PAA concentration while increasing the contact time and / or disinfection temperature. Similarly, if the equipment being disinfected is relatively resistant to corrosion by the disinfectant, faster disinfection can be achieved by using higher concentrations and / or higher temperatures and shorter disinfection contact times.

[0103]

[0125] Single-part disinfectant concentrates offer a certain degree of convenience to the end user, while two-part disinfectant concentrates offer production flexibility in that they do not require the components of Part B to exhibit long-term stability against oxidation by peracids, etc.

[0104]

[0126] [Concentrated single-part disinfectant solution]

[0127] In a single-part disinfectant concentrate, all components are preferably supplied as a single concentrate, which are then preferably diluted with water before use to obtain a disinfectant working solution. In another embodiment, the single-part disinfectant can be used without dilution (i.e., a ready-to-use solution). The resulting disinfectant working solution preferably contains about 0.01% w / v to about 1.0% w / v (100 ppm to 10,000 ppm) of PAA, more preferably about 0.02% w / v to about 0.5% w / v (200 ppm to 5,000 ppm) of PAA.

[0105]

[0128] Those skilled in the art will find that the concentration of the active ingredient in a disinfectant (in this case, PAA) is determined by a combination of factors such as the contact time for disinfection, the disinfection temperature suitable for microbiological testing, and the desired microbiological performance (e.g., high disinfection or sterilization).

[0106]

[0129] Other factors, such as material compatibility, can also determine the PAA concentration. For example, the corrosiveness of a disinfectant working solution can be reduced by decreasing the PAA concentration while increasing the contact time and / or disinfection temperature. Similarly, if the equipment being disinfected is relatively resistant to corrosion by the disinfectant, faster disinfection can be achieved by using a higher concentration and / or higher temperature and a shorter disinfection contact time.

[0107]

[0130] The single-part disinfectant concentrate contains PAA, hydrogen peroxide, and acetic acid. The single-part disinfectant concentrate also contains at least one surfactant, and an optional corrosion inhibitor, hydrotrope and / or pH buffer, as well as a stabilizer.

[0108]

[0131] In a preferred embodiment, the single-part disinfectant concentrate contains about 0.1% w / w to 20% w / w of peracetic acid.

[0109]

[0132] In a more preferred embodiment, the single-part disinfectant concentrate contains about 1% w / w to 15% w / w of peracetic acid.

[0110]

[0133] In a very preferred embodiment, the single-part disinfectant concentrate contains about 4% w / w to 6% w / w of peracetic acid.

[0111]

[0134] The stabilizers are not limited to these, but can be selected from the group consisting of aminotri(methylenephosphonic acid), 1-hydroxyethylidene-1,1-diphosphonic acid, quinoline-8-ol, 2,6-pyridinedicarbon(dipicoline) acid, aspartate diethoxysuccinate, quinoline-2-carboxylic acid, citric acid, isocitric acid, aconitic acid, and propane-1,2,3-tricarboxylic acid.

[0112]

[0135] Typically, stabilizers are present in the single-part disinfectant concentrate at concentrations of approximately 0.1% w / w to approximately 1% w / w.

[0113]

[0136] The single-part disinfectant concentrate may optionally contain a strong acid selected from, but is not limited to, sulfuric acid, nitric acid, methanesulfonic acid, trifluoromethanesulfonic acid, and mixtures thereof. As can be seen by those skilled in the art, the strong acid can be added and act as a catalyst while the PAA solution is being formed.

[0114]

[0137] Typically, acids are present in single-part disinfectant concentrates at concentrations of approximately 0.1% w / w to 1% w / w.

[0115]

[0138] A single-part disinfectant concentrate can be produced by mixing hydrogen peroxide, acetic acid, water, a stabilizer, at least one surfactant, and an optional corrosion inhibitor, hydrotrope, and / or pH buffer.

[0116]

[0139] The reaction for producing PAA may be uncatalyzed, by which the PAA will form within a few days, or it may be catalyzed by adding a strong acid selected from, but not limited to, sulfuric acid, nitric acid, methanesulfonic acid, trifluoromethanesulfonic acid, and mixtures thereof. Typically, the acid is present at a concentration of about 0.1% w / w to about 1% w / w of the single-part disinfectant concentrate.

[0117]

[0140] In the second embodiment, a single-part disinfectant concentrate is produced by adding at least one surfactant and an optional corrosion inhibitor, hydrotrope, and / or pH buffer to a pre-formed PAA solution. This pre-formed solution may be commercially available. Commercial-grade PAA is known to contain stabilizers and optionally strong acids.

[0118]

[0141] In a preferred embodiment, the single-part disinfectant concentrate contains about 0.05% w / w to about 15% w / w of surfactant. In a more preferred embodiment, the single-part disinfectant concentrate contains about 0.1% w / w to about 10% w / w of surfactant. In a very preferred embodiment, the disinfectant concentrate contains about 1% w / w to about 9% w / w of surfactant.

[0119]

[0142] Those skilled in the art will understand that all components in a single-part disinfectant concentrate should be stable against oxidation by peroxy species.

[0120]

[0143] [Disinfectant work solution]

[0144] In this specification, a disinfectant working solution is defined as a disinfectant solution formed by diluting a disinfectant concentrate and used to disinfect reusable, heat-unstable medical devices such as flexible endoscopes.

[0121]

[0145] In the case of a single-part disinfectant concentrate, the disinfectant working solution is produced by diluting the single-part disinfectant concentrate.

[0122]

[0146] In the case of a two-part disinfectant concentrate, the disinfectant working solution is formed by diluting a mixture of the two parts (parts A and B). Typically, the disinfectant working solution is formed by adding parts A and B to the required amount of water, avoiding any adverse reactions that may arise from mixing the undiluted concentrate together.

[0123]

[0147] In a preferred embodiment, the disinfectant working solution of the present invention is produced by combining a portion of the Part A and Part B solutions with water to produce an aqueous disinfectant working solution. Preferably, the ratio of Part A to Part B solutions is about 1:10 to about 10:1 by volume. More preferably, the ratio of Part A to Part B solutions is about 1:5 to about 5:1 by volume. Most preferably, the ratio of Part A to Part B solutions is about 1:1 by volume.

[0124]

[0148] The concentration of PAA in the disinfectant working solution is preferably 0.01% w / v to about 1.0% w / v (100 ppm to 10,000 ppm) of PAA, and more preferably about 0.02% w / v to about 0.5% w / v (200 ppm to 5,000 ppm) of PAA in the disinfectant working solution.

[0125]

[0149] In many cases, it is recognized that more concentrated disinfectants are used for sterilization rather than advanced disinfection.

[0126]

[0150] When used for advanced disinfection, the concentration of PAA in the disinfectant working solution is preferably 0.01% w / v to about 0.5% w / v (100 ppm to 5,000 ppm) of PAA, more preferably about 0.02% w / v to about 0.25% w / v (200 ppm to 2,500 ppm) of PAA in the disinfectant working solution.

[0127]

[0151] When used as a sterilizing agent, the concentration of PAA in the disinfectant working solution is preferably 0.02% w / v to about 1.0% w / v (200 ppm to 10,000 ppm) of PAA, more preferably about 0.04% w / v to about 0.5% w / v (400 ppm to 5,000 ppm) of PAA in the disinfectant working solution.

[0128]

[0152] As is recognized by those skilled in the art, the minimum concentration of PAA is determined by microbiological testing according to national regulations, and is also determined by the disinfection and / or sterilization temperature, as well as the contact time for disinfection and / or sterilization.

[0129]

[0153] For example, the two-part disinfectant Rapicide PA (Medivators Inc., Minneapolis, MN, USA) has a recommended minimum concentration of PAA of 850 ppm for high-level disinfection with a contact time of 5 minutes at 30°C, and a recommended minimum concentration of PAA of 1700 ppm for sterilization with a contact time of 10 minutes at 40°C. These concentrations are achieved by diluting Rapicide A and B solutions to 1.7–1.9% v / v for high-level disinfection and 3.4–3.8% v / v for sterilization. In this case, the same volume of Part A and B solutions is used.

[0130]

[0154] The disinfectant working solution also contains at least one surfactant in an amount of approximately 0.05% w / v to approximately 0.5% w / v.

[0131]

[0155] Suitable surfactants for use in the disinfectant working solution of the present invention include ionic, nonionic, amphoteric, and amphoteric surfactants, or mixtures thereof. Preferably, the surfactant or surfactant mixture has low foaming properties and also acts as a wetting agent.

[0132]

[0156] Examples of suitable surfactants that can be used in the compositions of the present invention include, but are not limited to, block copolymers of polyethylene oxide and polypropylene oxide, fatty alcohol alkoxylates, long-chain alkyl alkoxylates, N-alkylpyrrolidones, branched short-chain perfluorosurfactants, branched short-chain polysiloxane-functionalized polyglycols, and combinations thereof.

[0133]

[0157] In addition, the mixture may optionally include at least one corrosion inhibitor in an amount of approximately 0.01 to 0.1% and up to 0.2% hydrotrope.

[0134]

[0158] Suitable corrosion inhibitors may include, but are not limited to, benzotriazoles, alkali metal phosphates, alkali metal nitrates, alkali metal nitrites, 2-phosphonobutane-1,2,4-tricarboxylates, metal molybdates, and combinations thereof.

[0135]

[0159] Suitable hydrotropes include, but are not limited to, potassium xylenesulfonate, potassium naphthalenesulfonate, potassium cumenesulfonate, potassium cresyl phosphate, potassium octyliminodipropionate, sodium xylenesulfonate, sodium naphthalenesulfonate, sodium cumenesulfonate, sodium cresyl phosphate, sodium octyliminodipropionate, pentyl glucoside, hexyl glucoside, octyl glucoside, isooctyl glucoside, and mixtures thereof.

[0136]

[0160] Other optional components in the disinfectant working solution include pH adjusters, indicators, colorants, and fragrances. [Item 1] a. Peracetic acid and b. At least one surfactant A disinfectant working solution for sterilizing or disinfecting medical devices, comprising an aqueous dilution of a concentrated disinfectant solution containing [a specific substance], wherein the disinfectant working solution exhibits a dynamic surface tension of less than approximately 50 mN / m at a surface lifetime of 250 ms and less than approximately 46 mN / m at a surface lifetime of 500 ms, when measured by the maximum bubble pressure method at 20-25°C. [Item 2] The disinfectant working solution described in item 1 exhibits a dynamic surface tension of less than approximately 42.5 mN / m at a surface lifetime of 250 ms and less than approximately 41.0 mN / m at a surface lifetime of 500 ms at 20-25°C, as measured by the maximum foam pressure method. [Item 3] The disinfectant working solution described in item 2 exhibits a dynamic surface tension of less than approximately 42.5 mN / m at a surface lifetime of 250 ms, less than approximately 41 mN / m at a surface lifetime of 500 ms, and less than approximately 40 mN / m at a surface lifetime of 5000 nm, as measured by the maximum foam pressure method, at 20-25°C. [Item 4] A disinfectant working solution according to any one of items 1 to 3, wherein the concentration of peracetic acid is 0.01% w / v to about 1.0% w / v (about 100 ppm to about 10,000 ppm) of the disinfectant working solution. [Item 5] The disinfectant working solution according to any one of items 1 to 3, wherein the concentration of peracetic acid is approximately 0.02% w / v to approximately 0.5% w / v (approximately 200 ppm to approximately 5000 ppm) of the disinfectant working solution. [Item 6] The disinfectant working solution according to item 5, wherein the concentration of the surfactant is approximately 0.05% w / v to approximately 0.5% w / v of the disinfectant working solution. [Item 7] The disinfectant working solution according to any one of items 1 to 3, wherein the disinfectant concentrate is provided as a single-part disinfectant concentrate. [Item 8] The disinfectant working solution according to any one of items 1 to 3, wherein the disinfectant concentrate is provided as a two-part disinfectant concentrate having a first part and a second part. [Item 9] The disinfectant working solution according to item 7, wherein the single-part disinfectant concentrate contains approximately 0.1% w / w to approximately 20% w / w of peracetic acid in the disinfectant concentrate. [Item 10] The disinfectant working solution according to item 9, wherein the single-part disinfectant concentrate contains approximately 1% w / w to approximately 15% w / w of peracetic acid in the disinfectant concentrate. [Item 11] The disinfectant working solution according to item 10, wherein the single-part disinfectant concentrate contains approximately 4% w / w to approximately 6% w / w of peracetic acid in the disinfectant concentrate. [Item 12] The disinfectant working solution according to any one of items 1 to 11, wherein the at least one surfactant is selected from the group consisting of ionic, nonionic, amphoteric, and amphoteric surfactants, and mixtures thereof. [Item 13] The disinfectant working solution according to item 12, wherein the surfactant is selected from the group consisting of a block copolymer of polyethylene oxide and polypropylene oxide, fatty alcohol alkoxylate, long-chain alkyl alkoxylate, N-alkylpyrrolidone, branched short-chain perfluorosurfactant, branched short-chain polysiloxane-functionalized polyglycol, and combinations thereof. [Item 14] The disinfectant working solution according to item 7, wherein the single-part disinfectant concentrate contains approximately 0.05% w / w to approximately 15% w / w of surfactant in the disinfectant concentrate. [Item 15] The disinfectant working solution according to item 14, wherein the single-part disinfectant concentrate contains approximately 0.1% w / w to approximately 10% w / w of surfactant in the disinfectant concentrate. [Item 16] The disinfectant working solution according to item 15, wherein the single-part disinfectant concentrate contains about 1% to about 9% w / w of surfactant in the disinfectant concentrate. [Item 17] The disinfectant working solution according to item 7, wherein the single-part disinfectant concentrate further comprises a corrosion inhibitor and / or hydrotrope. [Item 18] The disinfectant working solution according to item 17, wherein the corrosion inhibitor is selected from the group consisting of benzotriazole, alkali metal phosphate, alkali metal nitrate, alkali metal nitrite, 2-phosphonobutane-1,2,4-tricarboxylate, metal molybdate, and combinations thereof. [Item 19] The disinfectant working solution according to item 17 or item 18, wherein the single-part disinfectant concentrate contains approximately 0.1% w / v to approximately 2% w / v of a corrosion inhibitor in the disinfectant concentrate. [Item 20] The disinfectant working solution according to item 17, wherein the hydrotrope is selected from the group consisting of potassium xylenesulfonate, potassium naphthalenesulfonate, potassium cumenesulfonate, potassium cresyl phosphate, potassium octyliminodipropionate, sodium xylenesulfonate, sodium naphthalenesulfonate, sodium cumenesulfonate, sodium cresyl phosphate, sodium octyliminodipropionate, pentyl glucoside, hexyl glucoside, octyl glucoside, isooctyl glucoside, and mixtures thereof. [Item 21] The disinfectant working solution according to item 20, wherein the single-part disinfectant concentrate contains approximately 0.1% to approximately 15% w / w of hydrotrope in the disinfectant concentrate. [Item 22] The disinfectant working solution according to item 8, wherein the first part of the two-part disinfectant concentrate comprises an equilibrium solution of peracetic acid, hydrogen peroxide, acetic acid, and water. [Item 23] The disinfectant working solution according to item 22, wherein the first part contains peracetic acid in an amount of approximately 0.1% w / w to approximately 20% w / w of the first part. [Item 24] The disinfectant working solution described in item 23, wherein the first part contains peracetic acid in an amount of approximately 1% w / w to approximately 15% w / w of the first part. [Item 25] The disinfectant working solution described in item 24, wherein the first part contains approximately 4% w / w to approximately 6% w / w of peracetic acid in the first part. [Item 26] The disinfectant working solution according to any one of items 22 to 25, wherein the second part of the two-part disinfectant concentrate comprises at least one surfactant. [Item 27] The disinfectant working solution according to item 26, wherein the surfactant is selected from the group consisting of ionic, nonionic, amphoteric, and amphoteric surfactants, and mixtures thereof. [Item 28] The disinfectant working solution according to item 27, wherein the surfactant is selected from the group consisting of a block copolymer of polyethylene oxide and polypropylene oxide, fatty alcohol alkoxylate, long-chain alkyl alkoxylate, N-alkylpyrrolidone, branched short-chain perfluorosurfactant, branched short-chain polysiloxane-functionalized polyglycol, and combinations thereof. [Item 29] A disinfectant working solution according to any one of items 26 to 28, wherein the surfactant constitutes approximately 0.05% w / w to approximately 15% w / w of the second part. [Item 30] The disinfectant working solution described in item 29, wherein the surfactant constitutes approximately 0.1% w / w to approximately 10% w / w of the second part. [Item 31] The disinfectant working solution described in item 30, wherein the surfactant constitutes approximately 1% w / w to approximately 9% w / w of the second part. [Item 32] The disinfectant working solution according to item 26, wherein the second part of the two-part disinfectant concentrate further comprises a corrosion inhibitor and / or hydrotrope. [Item 33] The disinfectant working solution according to item 32, wherein the corrosion inhibitor is selected from the group consisting of benzotriazole, alkali metal phosphate, alkali metal nitrate, alkali metal nitrite, 2-phosphonobutane-1,2,4-tricarboxylate, metal molybdate, and combinations thereof. [Item 34] The disinfectant working solution according to item 32 or 33, wherein the corrosion inhibitor is present in the two-part disinfectant concentrate at a concentration of approximately 0.1% w / v to approximately 2% w / v. [Item 35] The disinfectant working solution according to item 32, wherein the hydrotrope is selected from the group consisting of potassium xylenesulfonate, potassium naphthalenesulfonate, potassium cumenesulfonate, potassium cresyl phosphate, potassium octyliminodipropionate, sodium xylenesulfonate, sodium naphthalenesulfonate, sodium cumenesulfonate, sodium cresyl phosphate, sodium octyliminodipropionate, pentyl glucoside, hexyl glucoside, octyl glucoside, isooctyl glucoside, and mixtures thereof. [Item 36] The disinfectant working solution according to item 35, wherein the hydrotrope is present in an amount of about 0.1% to about 15% w / w of the second part of the two-part disinfectant concentrate. [Item 37] Medical devices, a. Peracetic acid and b. At least one surfactant A method for disinfecting or sterilizing a medical device, comprising the step of contacting the device with a disinfectant working solution containing an aqueous dilution of a concentrated disinfectant solution, wherein the disinfectant working solution exhibits a dynamic surface tension of less than approximately 50 mN / m at a surface lifetime of 250 ms and less than approximately 46 mN / m at a surface lifetime of 500 ms, as measured by the maximum bubble pressure method at 20-25°C. [Item 38] A method for disinfecting or sterilizing a medical device, comprising the step of bringing the medical device into contact with a disinfectant working solution described in any one of items 1 to 36.

[0137]

[0161] [How it was used]

[0162] [Example 1: Determination of hydrogen peroxide and PAA]

[0163] The hydrogen peroxide and PAA content of the PAA solution was determined using a two-step redox titration with a Mettler Toledo T70 automatic titrator. The automatic titrator consisted of two burettes and a drive unit, a platinum ring redox sensor, and a peristaltic pump for dispensing auxiliary solutions. One burette was filled with 0.02 M potassium permanganate solution, and the second with 0.1 M sodium thiosulfate solution. Both titrants were standardized before use.

[0138]

[0164] A known weight of sample was placed in a titration beaker with 20 ml of 0.5 M sulfuric acid solution. The beaker was placed in an automatic titrator, and hydrogen peroxide was determined by titration against potassium permanganate solution. After identifying the endpoint, 10 ml of 10% potassium iodide solution was added via a peristaltic pump (under the control of a T70 automatic titrator), and then free iodine was titrated using sodium thiosulfate solution. The concentrations of hydrogen peroxide and PAA were then calculated using the automatic titrator, taking into account the excess potassium permanganate added after the endpoint.

[0139]

[0165] [Example 2: Determination of Acetic Acid]

[0166] The acetic acid content of the PAA solution was determined by acid-base titration using a Mettler Toledo T70 automated titrator equipped with a single burette filled with 0.1 M sodium hydroxide solution and a pH sensor.

[0140]

[0167] A known weight of PAA solution was placed in a titration beaker, and approximately 30 ml of deionized water was added. The beaker was then placed in an automatic titrator, and the sample was titrated against a 0.1 M sodium hydroxide solution.

[0141]

[0168] [Example 3: Measurement of dynamic surface tension]

[0169] The dynamic surface tension of various disinfectant solutions was determined over the range of surface lifetime (typically 14 ms to 5000 ms) using a Kruss BP50 bubble tenosynovometer (Kruss GMBH, Hamburg, Germany). A new capillary tip was fixed to the BP50 after each set of measurements, and the instrument was recalibrated using HPLC water each time the capillary tip was changed.

[0142]

[0170] The data from BP50 was obtained using the Laboratory Desktop software package version 3.2.2.3064, supplied by Kruss.

[0143]

[0171] The surface tension for a specific surface lifetime was calculated by interpolating the data points on both sides of that lifetime. For example, the surface tension at 500 ms can be calculated from the surface tension values ​​of 29.1 mN / m and 28.0 mN / m for surface lifetimes of 440 ms and 555 ms, respectively. This is done by assuming linearity between these two points and determining the slope and intercept of the line between them. In the above example, the surface tension at 500 ms can be calculated as 28.5 mN / m.

[0144]

[0172] [Examples of conventional technologies]

[0173] Figure 3 shows a comparison of dynamic surface tensions over the surface life range between several prior art examples of PAA-based disinfectants and exemplary embodiments of the disinfectant working solution of the present invention. As can be clearly seen, all exemplary embodiments reach a surface tension of less than approximately 42.5 mN / m characteristically faster than the prior art examples, and reach a surface tension of less than 40 mN / m by 5000 ms.

[0145]

[0174] Examples 4-6 represent commercially available PAA-based high-grade disinfectants intended for use in automated endoscope cleaning devices.

[0146]

[0175] [Example 4]

[0176] 1.9 ml of 5% w / w PAA solution supplied by Proxy P (Whiteley Corporation, Tomago, NSW, Australia) was pipetted into a 100 ml volumetric flask containing approximately 80 ml of tap water. Then, 1.9 ml of Proxy A (concentrated corrosion inhibitor) was added by pipette, and the solution was diluted with additional tap water to form a disinfectant working solution.

[0147]

[0177] Next, the surface tension of the obtained disinfectant working solution was measured over the surface life range (14 ms to 5000 ms) according to the procedure outlined in Example 3. As can be seen in Figure 4 and Table 2, there was no substantial decrease in the surface tension of the disinfectant (the surface tension of pure water is 72 mN / m, and there was no significant change in surface tension due to surface life). [Table 2]

[0148]

[0178] [Example 5]

[0179] 1.9 ml of Soluscope P (Soluscope SAS, a 5% w / w PAA solution supplied from France) was pipetted into a 100 ml volumetric flask containing approximately 80 ml of tap water. Then, 1.9 ml of Soluscope A (concentrated corrosion inhibitor) was added by pipette, and the solution was diluted to make up with additional tap water.

[0149]

[0180] Next, the surface tension of the obtained disinfectant working solution was measured over the surface life range (14 ms to 5000 ms) as described in Example 3. As can be seen in Figure 4 and Table 3, there was no substantial decrease in the surface tension of the disinfectant compared to the surface tension of water (i.e., 72 mN / m). [Table 3]

[0150]

[0181] [Example 6]

[0182] 1.9 ml of Rapicide PA Part A (a 5% w / w PAA solution supplied by Medivators Inc., MN, Minneapolis, USA) was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of tap water. Then, 1.9 ml of Rapicide PA Part B (a concentrated corrosion inhibitor) was added by pipette, and the solution was diluted to make up with additional tap water.

[0151]

[0183] The dynamic surface tension of the obtained disinfectant working solution was measured over a range of 14 ms to 5000 ms. As can be seen in Figure 4 and Table 4, even with a long surface lifetime (i.e., over 5000 ms), the surface tension remained above 50 mN / m, although there was an initial sharp decrease in surface tension to approximately 52 mN / m. [Table 4]

[0152]

[0184] [Example 7]

[0185] In this example, a single-part disinfectant concentrate described in WO2016100818 was prepared. A 50% solution of hydrogen peroxide (560.02 g) was added to 250 ml of HPLC-grade water (Sigma Aldrich), followed by the addition of 160.00 g of glacial acetic acid, 10.00 g of Dequest 2010 (IMCD, Mulgrave, VIC, Australia), and 20 g of Pluronic 10R5 (Sigma Aldrich, Castle Hill, NSW, Australia). The mixture was then allowed to stand for at least two weeks to form PAA.

[0153]

[0186] After two weeks, the hydrogen peroxide and PAA content was determined using the method of Example 1, and the acetic acid content was determined using the method of Example 2. The composition of the obtained disinfectant concentrate is shown in Table 5. [Table 5]

[0154]

[0187] Next, 2 ml of this preparation was pipetteed into a 100 ml volumetric flask and diluted with tap water. The dynamic surface tension of the resulting disinfectant working solution was then measured according to the method in Example 3. [Table 6]

[0155]

[0188] As can be seen in Figure 4 and Table 6, despite the relatively rapid initial decrease in surface tension to a value of 54.5 at a surface lifetime of 500 ms, the surface tension effectively maintains a stable state with only a small difference in surface tension between 500 and 5000 ms.

[0156]

[0189] [Example 8]

[0190] The following example represents a prior art example described in U.S. Patent No. 6,168,808. Four formulations were prepared according to Table 7. [Table 7]

[0157]

[0191] The PAA solution used is an equilibrium solution supplied by Solvay Interox Pty Ltd. (Banksmeadow, NSW, Australia). This PAA solution contains 5% PAA, 27% hydrogen peroxide, and 7.5% acetic acid.

[0158]

[0192] In these examples, Genapol EP2564 (Clariant Pty Ltd., Lara, VIC, Australia) was used. This surfactant was formerly known by the trade name Genapol 2908D. Ammonyx LO is a cocodimethylamine oxide supplied by Ixom Operations Pty Ltd., East Melbourne, (VIC, Australia).

[0159]

[0193] Two ml of each solution was pipetteed into a 100 ml volumetric flask and diluted with tap water to make up the required volume.

[0160]

[0194] The dynamic surface tension of each diluted solution was assessed according to the method in Example 3. The dynamic surface tension plots for these examples are shown in Figure 5, and the surface tensions at 250 ms, 500 ms, and 5000 ms are listed in Table 8. As can be seen, the decrease in surface tension for each formulation is slow up to the first 500 ms. Even up to 5000 ms, the surface tension of each formulation remains above 45 mN / m. [Table 8]

[0161]

[0195] [Example 9]

[0196] The following examples were implemented from European Patent No. 0971584. Since each example described in European Patent No. 0971584 was prepared from PAA solutions of different compositions, various PAA solutions were prepared as shown below.

[0162]

[0197] (Preparation of PAA sample)

[0198] The series of PAA solutions were prepared by mixing deionized water, a 50% hydrogen peroxide solution, and glacial acetic acid. 1-Hydroxyethylidene-1,1-diphosphonic acid (HEDP) was added to each formulation as a stabilizer (see Table 9 for the amount). [Table 9]

[0163]

[0199] The solutions were allowed to stand at room temperature for 2-3 weeks to reach equilibrium. Then, each sample was analyzed for PAA and hydrogen peroxide using the method described in Example 1. The acetic acid content of the samples was determined using the method described in Example 2.

[0164]

[0200] The composition of each PAA sample is shown in Table 10. [Table 10]

[0165]

[0201] Next, compositions 1-5 shown in Table A of European Patent No. 0971584 were regenerated using the PAA solution (see Table 11). [Table 11] Note: Genapol EP2564 is currently supplied by Clariant (Australia) Pty Ltd. (Lara, VIC, Australia) and was formerly known as Genapol 2908D. Genapol EP2584 is currently supplied by Clariant (Australia) Pty Ltd. (Lara, VIC, Australia) and was formerly known as Genapol 2909.

[0166]

[0202] In accordance with European Patent No. 0971584, sample 9A (1.25 ml) was diluted with 100 ml of tap water to obtain an 80-fold disinfectant working solution (1 part). Similarly, in accordance with European Patent No. 0971584, 2.5 ml each of samples 9B to 9E was diluted with 100 ml of tap water to obtain a 40-fold disinfectant working solution (1 part).

[0167]

[0203] Next, the dynamic surface tension of the obtained diluted solution was measured as described in Example 3.

[0168]

[0204] As can be seen in Figure 6 and Table 12, the surface tension of various disinfectant working solutions 9A to 9E reaches low values ​​(less than 45 mN / m), but this is only achieved over long surface lifespans (over 15,000 ms). [Table 12]

[0169]

[0205] Interestingly, as shown in Table 1, the surface tension measured and observed using the maximum bubble pressure method is significantly higher than the surface tension reported in European Patent No. 0971584 for the same formulation when measured using the static method (Wilhelmie plate method).

[0170]

[0206] [Example of the present invention]

[0207] The following examples represent non-limiting embodiments of the present invention. These examples are representative examples of two-part disinfectants intended to be mixed with PAA solution to form a functional disinfectant.

[0171]

[0208] [Example 10]

[0209] The compositions shown in Table 13 (100 ml each) were prepared.

[0172]

[0210] Triton H66 (a solution of potassium cresyl phosphate) was obtained from Dow Chemicals. Pluronic PE6400 (a triblock copolymer of polyethylene oxide and polypropylene oxide) was obtained from BASF. Makon NF12 is a low-foaming C10-C12 alcohol alkoxylate supplied by Stepan Company (Northfield, IL, USA), and Surfadone LP100 is a low-foaming nonionic fast wetting agent containing N-octyl-2-pyrrolidone without a critical micelle concentration, supplied by Ashland Global Holdings (Covington, KY, USA). The formulation has a pH of 11.93. [Table 13]

[0173]

[0211] 2 mL of the formulation of Example 10 was pipetted into a 100 mL volumetric flask containing approximately 80 mL of tap water. To this was added 2 mL of Rapicide PA Part A, a 5% w / w PAA solution obtained from Cantel Australia (Heatherton, VIC, Australia). The resulting solution was then made up to volume with additional tap water to produce a disinfectant working solution. The pH of the dilution solution was 4.04.

[0174]

[0212] The disinfectant working solution contained 0.025% corrosion inhibitors (benzotriazole and sodium molybdate), 0.14% surfactants (Pluronic PE6400, Makon NF12 and Surfadone LP100), 0.05% hydrotrope (Triton H66), together with 2% Proxitane (i.e., 0.1% PAA).

[0175]

[0213] The dynamic surface tension of the disinfectant working solution was then measured as described in Example 3. Figure 7 shows a plot of surface tension (mN / m) versus surface lifetime (milliseconds), and Table 14 shows the surface tensions for selected surface lifetimes.

Table 14

[0176]

[0214] [Example 11]

[0215] The following example demonstrates the use of a branched short-chain nonionic surfactant commonly referred to as a “super-spreader”. Due to the acid-labile nature of the silicone-based hydrophobic moiety, a concentrate was formulated to obtain a pH-neutral solution.

[0177]

[0216] The following formulation (100 mL) was prepared.

Table 15

[0178]

[0217] FC-41 is a low-foaming isooctyl glucoside obtained from Interchem Pty Ltd. (Abbotsford, VIC, Australia). Orthowet H-408, obtained from Ortho Chemicals (Kensington Victoria, Australia), is a solution of 3-(polyoxyethylene)propylheptamethyltrisiloxane. This surfactant is an example of a class of silicone-based surfactants known as super-spreaders due to its ability to impart rapid wetting and low surface tension to aqueous solutions. Acticide B20 is a glycol-based benzoisothiazolinone preservative solution manufactured by Thor Specialties Pty Limited (Wetherill Park, NSW, Australia).

[0179]

[0218] To prevent hydrolysis of Orthowet H-408 during storage, the pH of the stock solution was set to 7.32.

[0180]

[0219] Two ml of the formulation shown in Table 15 was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of tap water. Two ml of Proxitane (5% w / w PAA solution) was then added. The resulting solution was then diluted with additional tap water to prepare a disinfectant working solution. The pH of the diluted solution was 2.98.

[0181]

[0220] Disinfectant working solutions were prepared in the same manner using the 0.5%, 1.0%, and 1.5% formulations shown in Table 15 (containing 0.5%, 1.0%, and 1.5% Proxitane, respectively). The concentrations of each functional component (corrosion inhibitor, surfactant, hydrotrope, and PAA) are shown in Table 16. [Table 16]

[0182]

[0221] Next, the dynamic surface tension of the disinfectant working solution was measured as described in Example 3. Figure 7 shows a plot of surface tension (mN / m) versus surface lifetime (milliseconds) for the 2% solution, and Table 17 shows the surface tension of the selected surface lifetime for each concentration. [Table 17]

[0183]

[0222] Next, the dynamic surface tension of the disinfectant working solution was measured using a Kruss BP50 bubble tenometer, as described in Example 3. Figure 7 shows a plot of surface tension (mN / m) versus surface lifetime (milliseconds) for the 2% solution, and Table 16 shows the surface tension of the selected surface lifetime for each concentration.

[0184]

[0223] [Example 12]

[0224] In this example, we examined the effects of various components in Example 10.

[0185]

[0225] A basal solution was prepared containing 907.77 g of deionized water, 46.22 g of anhydrous dipotassium hydrogen phosphate, 30.98 g of 48% w / w potassium hydroxide solution, and 10.36 g of benzotriazole.

[0186]

[0226] Next, various formulations shown in Table 18 were prepared using the basal solution. Where possible, formulations containing only one additional component selected from Triton H66, Pluronic PE6400, Surfadone LP100, and Makon NF12 were also prepared.

[0187]

[0227] In the case of Surfadone LP100 and Makon NF12, these surfactants are insoluble in the base formulation and were therefore solubilized using the hydrotrope Triton H66 (see formulations 12-D and 12-F). [Table 18]

[0188]

[0228] As described in Example 10, from each of these solutions, a dilution solution containing 2% v / v of various formulations together with 2% v / v of Rapicide PA Part A was prepared. According to Example 3, the surface tension of the various surface lives of each disinfectant working solution was measured.

[0189]

[0229] As can be seen in FIG. 8 and Table 19, the addition of Triton H66 to the base solution has only a very slight effect on the dynamic surface tension.

[0190]

[0230] The addition of Pluronic H66 (see Formulation 12-C) results in a sharp drop in surface tension to 45.4 mN / m with a surface life of 500 ms, and subsequently this value is substantially maintained, giving a surface tension of 43.9 mN / m at 5000 ms.

[0191]

[0231] The addition of Surfadone LP100 appears to act synergistically with these various formulations, resulting in a sharp drop in surface tension to values substantially lower than those observed with, for example, Pluronic PE6400 alone. For example, the addition of Surfadone LP100 to Formulation 12-C reduces the surface tension from 46 mN / m to 38 mN / m with a surface life of 250 ms.

Table 19

[0192]

[0232] [Example 13]

[0233] In these examples, while using Triton H66 as a hydrotrope, the fast wetting surfactant Ecosurf LFE-635, a branched alcohol alkoxylate (Dow Chemicals Co., Ltd.) is used to provide rapid wetting.

[0193]

[0234] As shown in Table 20, various concentrations of Ecosurf LFE-635 in the range of 2.5% w / v to 5% w / v were prepared.

Table 20

[0194]

[0235] Next, 2 ml of the formulation was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of tap water. Then, 2 ml of Proxitane was added, and the solution was made up with additional tap water to form a disinfectant working solution. Table 21 shows the functional components of the disinfectant working solution. [Table 21]

[0195]

[0236] Next, the dynamic surface tension of the disinfectant working solution was measured as described in Example 3.

[0196]

[0237] Figure 9 shows a plot of surface tension (mN / m) versus surface life (milliseconds), and Table 22 shows the surface tension for selected surface lives. As can be seen, these formulations result in a sharp drop in surface tension with a very short surface life. [Table 22]

[0197]

[0238] [Single-part disinfectant]

[0239] The following embodiments of the present invention demonstrate a single-part formulation comprising a single solution based on a 5% PAA solution. The PAA solution used was Proxitane.

[0198]

[0240] [Example 14]

[0241] The following examples of single-part disinfectants are based on the use of Bayhibit AM as a corrosion inhibitor and Pluronic PE6400 as a solubilizing surfactant. A branched short-chain anionic perfluorosurfactant (Tivida FL2200, Merck Pty Ltd., Bayswater, VIC, Australia) was used as a fast wetting agent. A series of formulations shown in Table 23 were prepared. Each formulation was observed to be colorless and transparent without apparent haze. [Table 23]

[0199]

[0242] Two ml of each formulation was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of tap water. The solution was then diluted with additional tap water to form a disinfectant working solution. The approximate functional composition of the disinfectant working solution is shown in Table 24. [Table 24]

[0200]

[0243] Next, the dynamic surface tension of the disinfectant working solution was measured as described in Example 3.

[0201]

[0244] Figure 10 shows a plot of surface tension (mN / m) versus surface life (milliseconds), and Table 25 shows the surface tension for selected surface lives. As can be seen, these formulations result in a sharp drop in surface tension with a very short surface life. [Table 25]

[0202]

[0245] [Example 15]

[0246] The following example of a single-part disinfectant concentrate is based on the use of Bayhibit AM as a corrosion inhibitor, along with Ecosurf LFE-635 as a fast-wetting surfactant.

[0203]

[0247] The formulations shown in Table 26 were prepared using either Triton H66 or Pluronic PE6400 as a solubilizing agent. [Table 26]

[0204]

[0248] Two ml of each formulation was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of tap water. The solution was then diluted with additional tap water to form a disinfectant working solution. The approximate functional composition of the disinfectant working solution is shown in Table 27. [Table 27]

[0205]

[0249] Next, the dynamic surface tension of the disinfectant working solution was measured as described in Example 3.

[0206]

[0250] Figure 11 shows a plot of surface tension (mN / m) versus surface life (milliseconds), and Table 28 shows the surface tension for the selected surface life. Here again, these formulations result in a sharp drop in surface tension with a very short surface life. [Table 28]

[0207]

[0251] Of particular note is that formulations containing only Proxitane and Pluronic PE6400 (Example 15C) show a sharp drop in surface tension initially, but the decrease is only slight, from 43.7 mN / m at 500 ms to 42.4 mN / m at 5000 ms. The addition of the branched alkyl alkoxylate Ecosurf LFE-635 demonstrates a significant improvement in the reduction of surface tension, especially when present in the formulation concentrate at levels higher than 1.85% w / w. As can be seen in Table 28, all formulations containing Ecosurf LFE-635 above 1.85% w / w showed surface tensions of less than 40 mN / m with a surface lifetime exceeding 250 ms.

[0208]

[0252] [Example 17: Microbiological effectiveness]

[0253] The following disinfectant working solutions were prepared as follows:

[0254] (Test disinfectant 1)

[0255] 2 ml of Example 10 was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of artificial hard water (as 340 mg / L CaCO3) along with 2 ml of 5% PAA solution (Rapicide PA Part A). The solution was then made up with additional hard water. The resulting disinfectant working solution was then titrated to determine its PAA content, and subsequently further diluted with hard water to obtain a final PAA content of 857 ppm PAA and 3901 ppm hydrogen peroxide.

[0256] (Test disinfectant 2 (control formulation))

[0257] 2 ml of Rapicide PA Part B was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of artificial hard water (as 340 mg / L CaCO3) along with 2 ml of 5% PAA solution (Rapicide PA Part A). The solution was then made up with additional hard water. The resulting disinfectant working solution was then titrated to determine its PAA content, and subsequently diluted further with hard water to obtain a final PAA content of 857 ppm PAA and 3929 ppm hydrogen peroxide.

[0209]

[0258] Next, the spore-killing efficacy of both disinfectant working solutions was evaluated in a time-based sterilization test using a suspension of Bacillus subtilis spores (ATCC 19659) containing 1.8 × 10⁸ CFU / ml with 5% horse serum added as organic soil.

[0210]

[0259] The tests were conducted at 40°C using five replicas at each time point, employing various contact time ranges (5 seconds, 60 seconds, 120 seconds, 180 seconds, and 240 seconds). After the required contact time, the disinfectant was neutralized and viable spores were counted.

[0211]

[0260] As can be seen in Table 29, test solution 1 prepared using the formulation of Example 10 was 6 log 10 A decrease was demonstrated. [Table 29]

[0212]

[0261] [Example 16: Microbiological efficacy: Spore carrier test]

[0262] In this study, a screening carrier test based on the AOAC spore-icidal activity test was conducted, using four carriers for each of the two concentrations of the test substance.

[0213]

[0263] (Test disinfectant 1)

[0264] Two ml of the formulation from Example 10 was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of artificial hard water (as 340 mg / L CaCO3) along with two ml of 5% PAA solution (Rapicide PA Part A). The solution was then made up with additional hard water. The resulting disinfectant working solution was then titrated to determine its PAA content, and subsequently diluted further with hard water to obtain a final PAA content of 856 ppm PAA and 3840 ppm hydrogen peroxide (HP).

[0214]

[0265] Next, four porcelain penicylans inoculated with Bacillus subtilis spores under contaminated conditions (5% horse serum) were treated with a disinfectant working solution at 40°C at various time points (60 seconds, 120 seconds, 180 seconds, and 240 seconds). The disinfectant was neutralized with 10 ml of T6 neutralizing agent, and the samples were incubated to assess growth / non-growth and determine any remaining viable spores.

[0215]

[0266] (Test disinfectant 2 (control))

[0267] 2 ml of Rapicide PA Part B was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of artificial hard water (as 340 mg / L CaCO3) along with 2 ml of 5% PAA solution (Rapicide PA Part A). The solution was then made up with additional hard water. The resulting disinfectant working solution was then titrated to determine its PAA content, and subsequently diluted further with hard water to obtain a final PAA content of 868 ppm PAA and 4000 ppm hydrogen peroxide.

[0216]

[0268] Next, four porcelain penicylans inoculated with Bacillus subtilis spores under contaminated conditions (5% horse serum) were treated with disinfectant solution at 40°C at various time points (60 seconds, 120 seconds, 180 seconds, and 240 seconds). The disinfectant was neutralized with 10 ml of T6 neutralizing agent, and the samples were incubated to assess growth / non-growth and determine any remaining viable spores.

[0217]

[0269] After incubation, the following results were obtained. As can be seen in Table 30, the test substance (Example 10) showed no growth at all time points, while the control sample (Example 6, Rapicide PA) showed no viable spores at 60 seconds and 120 seconds. Note that this PAA concentration was used for high-level disinfection with Rapicide PA, while the temperature was specified for sterilization with Rapicide PA (even though the sterilization time was typically 10 minutes). [Table 30]

[0218]

[0270] [Example 17: Microbiological efficacy: Spore carrier test (higher PAA concentration).]

[0271] In this study, a screening carrier test based on the AOAC spore-icitating activity test was also conducted, using four carriers for each of the two concentrations of the test substance.

[0219]

[0272] (Test disinfectant 1)

[0273] Two ml of the formulation from Example 10 was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of artificial hard water (as 340 mg / L CaCO3) along with two ml of 5% PAA solution (Rapicide PA Part A). The solution was then made up with additional hard water. The resulting disinfectant working solution was then titrated to determine its PAA content, and subsequently diluted further with hard water to obtain a final PAA content of 1700 ppm PAA and 7821 ppm hydrogen peroxide.

[0220]

[0274] Next, four porcelain penicylans inoculated with Bacillus subtilis spores under contaminated conditions (5% horse serum) were treated with a disinfectant working solution at 40°C at various time points (60 seconds, 120 seconds, 180 seconds, and 240 seconds). The disinfectant was neutralized with 10 ml of T6 neutralizing agent, and the samples were incubated to assess growth / non-growth and determine any remaining viable spores.

[0221]

[0275] (Test disinfectant 2 (control))

[0276] 2 ml of Rapicide PA Part B was pipetteed into a 100 ml volumetric flask containing approximately 80 ml of artificial hard water (as 340 mg / L CaCO3) along with 2 ml of 5% PAA solution (Rapicide PA Part A). The solution was then made up with additional hard water. The resulting disinfectant working solution was then titrated to determine its PAA content, and subsequently diluted further with hard water to obtain a final PAA content of 1706 ppm PAA and 8019 ppm hydrogen peroxide.

[0222]

[0277] Next, four porcelain penicylans inoculated with Bacillus subtilis spores under contaminated conditions (5% horse serum) were treated with a disinfectant working solution at 40°C at various time points (60 seconds, 120 seconds, 180 seconds, and 240 seconds). The disinfectant was neutralized, the samples were incubated, and growth / non-growth was assessed to determine any remaining viable spores.

[0223]

[0278] After incubation, the following results were obtained. As can be seen in Table 31, the test substance (Example 10) showed no growth at all time points, while the control sample (Example 6, Rapicide PA) did not show any viable spores at 60 seconds. [Table 31]

Claims

1. a. Peracetic acid, b. At least one surfactant selected from the group consisting of a block copolymer of polyethylene oxide and polypropylene oxide, branched-chain alkyl alkoxylates, N-alkylpyrrolidone, 3-(polyoxyethylene)propylheptamethyltrisiloxane, and combinations thereof. c. At least one corrosion inhibitor, and d. At least one hydrotrope selected from the group consisting of potassium cresyl phosphate, potassium octyliminodipropionate, sodium cresyl phosphate, sodium octyliminodipropionate, pentyl glucoside, hexyl glucoside, octyl glucoside, isooctyl glucoside, and mixtures thereof. It contains an aqueous dilution of a concentrated disinfectant solution containing, A highly effective disinfectant solution exhibiting a dynamic surface tension of less than 42.5 mN / m at a surface life of 250 ms and less than 41 mN / m at a surface life of 500 ms, as measured by the maximum foam pressure method at 20–25°C.

2. The highly effective disinfectant solution according to claim 1, which, when measured by the maximum foam pressure method, exhibits a dynamic surface tension of less than 42.5 mN / m at a surface life of 250 ms, less than 41 mN / m at a surface life of 500 ms, and less than 40 mN / m at a surface life of 5000 ms at 20 to 25°C.

3. The highly disinfectant solution according to claim 1 or 2, wherein the concentration of peracetic acid is 0.01% w / v to 1.0% w / v (100 ppm to 10,000 ppm) of the highly disinfectant solution.

4. The highly disinfectant solution according to claim 3, wherein the concentration of peracetic acid is 0.02% w / v to 0.5% w / v (200 ppm to 5000 ppm) of the highly disinfectant solution.

5. The advanced disinfectant solution according to claim 4, wherein the concentration of the surfactant is 0.05% w / v to 0.5% w / v (500 ppm to 5000 ppm) of the advanced disinfectant solution.

6. The highly effective disinfectant solution according to claim 1, wherein the disinfectant concentrate is provided as a single-part disinfectant concentrate or as a two-part disinfectant concentrate having a first part and a second part.

7. The highly effective disinfectant solution according to claim 6, wherein the single-part disinfectant concentrate contains 0.1% w / w to 20% w / w of peracetic acid in the disinfectant concentrate.

8. The highly effective disinfectant solution according to claim 7, wherein the single-part disinfectant concentrate contains 1% w / w to 15% w / w of peracetic acid in the disinfectant concentrate.

9. The highly effective disinfectant solution according to claim 8, wherein the single-part disinfectant concentrate contains 4% w / w to 6% w / w of peracetic acid in the disinfectant concentrate.

10. The advanced disinfectant solution according to claim 6, wherein the first part of the two-part disinfectant concentrate comprises an equilibrium solution of peracetic acid, hydrogen peroxide, acetic acid, and water.

11. The highly disinfectant solution according to claim 10, comprising 1% w / w to 15% w / w peracetic acid of the first part.

12. The highly disinfectant solution according to claim 11, comprising 4% w / w to 6% w / w of peracetic acid in the first part.

13. The highly effective disinfectant solution according to claim 6, wherein the single-part disinfectant concentrate contains 1% to 9% w / w of surfactant in the disinfectant concentrate.

14. The highly effective disinfectant solution according to claim 6, wherein the second part of the two-part concentrated disinfectant solution contains 0.1% w / w to 10% w / w of surfactant in the second part.

15. The highly disinfectant solution according to claim 14, comprising 1% to 9% w / w of the surfactant of the second part.

16. The advanced disinfectant solution according to any one of claims 1 to 15, wherein the corrosion inhibitor is selected from the group consisting of benzotriazole, alkali metal phosphate, alkali metal nitrate, alkali metal nitrite, 2-phosphonobutane-1,2,4-tricarboxylate, metal molybdate, and combinations thereof.

17. At least 6 log in both bacteria and spores １０ A method for disinfecting or sterilizing medical devices that provides a reduction, Medical devices, a. Peracetic acid, b. At least one surfactant selected from the group consisting of a block copolymer of polyethylene oxide and polypropylene oxide, branched-chain alkyl alkoxylates, N-alkylpyrrolidone, 3-(polyoxyethylene)propylheptamethyltrisiloxane, and combinations thereof. c. At least one corrosion inhibitor, and d. At least one hydrotrope selected from the group consisting of potassium cresyl phosphate, potassium octyliminodipropionate, sodium cresyl phosphate, sodium octyliminodipropionate, pentyl glucoside, hexyl glucoside, octyl glucoside, isooctyl glucoside, and mixtures thereof. The step includes contacting with a highly disinfectant solution containing an aqueous dilution of a concentrated disinfectant solution containing a disinfectant, A method wherein the aforementioned high-grade disinfectant solution exhibits a dynamic surface tension of less than 42.5 mN / m at a surface life of 250 ms and less than 41 mN / m at a surface life of 500 ms, when measured by the maximum foam pressure method at 20-25°C.

18. At least 6 log in both bacteria and spores １０ A method for disinfecting or sterilizing medical devices that provides a reduction, A method comprising the step of bringing a medical device into contact with a highly disinfectant solution according to any one of claims 1 to 16.

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