WO2014161582A1

WO2014161582A1 - Enhanced low odor sporicidal desinfection composition

Info

Publication number: WO2014161582A1
Application number: PCT/EP2013/057148
Authority: WO
Inventors: Katja Teusch; Carola Stingl; Bernhard Meyer; Silke Denzin
Original assignee: Ecolab Inc.
Priority date: 2013-04-04
Filing date: 2013-04-04
Publication date: 2014-10-09

Abstract

The present invention relates to a sporicidal liquid composition, effective in deactivating, inhibiting, disabling, killing, and/or sterilizing bacterial spores, comprising: - phthalimido peroxy alkanoic acid having the general formula I: wherein R is selected from C-4 alkyl and n is an integer of from 1 to 5, - at least one C₂ to C₄ alcohol, - C₂ to C₁₀peroxyorganic acid, and - water.

Description

ENHANCED LOW ODOR SPORICIDAL DES INFECTION COMPOSITION

FIELD OF THE INVENTION

The invention relates to disinfection compositions that are highly effective against bacterial spores and a method of manufacture thereof. The invention further relates to the use of such compositions for disinfection purposes in deactivating, inhibiting, disabling, killing, or otherwise sterilizing bacterial spores.

BACKGROUND

Peroxycarboxylic acids are known for use as antimicrobial agents that can kill or otherwise inhibit the growth or proliferation of microbes including bacteria, bacterial spores, yeasts, viruses and fungi.

Further, a majority of existing peracid compositions, including peroxycarboxylic acids, suffer from unacceptable odors which are an inherent disadvantage of the compositions and limit their use in cleaning applications. Often the peracid compositions exhibit a sharp, annoying, or otherwise unacceptable odor. Such malodors significantly limit the applications suitable for using such peroxycarboxylic acid compositions. It would be undesirable to apply such peroxycarboxylic acid compositions to hard surfaces due to the unpleasant odor.

According to the invention, there is a need for low or no odor antimicrobial peroxycarboxylic acid compositions.

Lowering the peroxycarboxylic acid concentration in overcoming the unpleasant odor leads to a disinfection composition having inherent disadvantage of limited disinfection effect and being not effective in killing bacterial spores. Thus, peroxycarboxylic acids compositions are not effective if low concentrated against spores.

Many commercial and domestic articles include surface metal layers. Such articles are known to those skilled in a variety of occupations or domestic activities, particularly those working in industrial plants, hospitals, maintenance and repair services, manufacturing facilities, kitchens, restaurants and the like. Surgical, medical, and dental instruments after use are typically contaminated with blood and other body matter and potentially with infectious microorganisms. Before being reused in a future procedure these instruments must be washed and disinfected where indicated. A problem with using disinfection composition containing peroxycarboxylic acid in an effective amount for deactivating, inhibiting, disabling, killing, or otherwise sterilizing a microorganism is their potential to corrode and/or discolor hard surfaces such as metal and/or plastic surfaces.

Further, disinfection compositions containing peroxycarboxylic acids in an effective amount for deactivating, inhibiting, disabling, killing, or otherwise sterilizing a

microorganism are skin irritating.

Phthalimidoperoxyhexanoic acid is known for use as disinfectant for deactivating, inhibiting, disabling, killing, or otherwise sterilizing a microorganism including bacteria, yeast, viruses and fungi, except bacterial spores.

It is known that phthalimidoperoxyhexanoic acid has a high foaming performance. Increasing the concentration of phthalimidoperoxyhexanoic acid to improve the antimicrobial activity leads simultaneously to an increase foam formation.

Even more important the solubility of PAP is limited and formulations with high concentrations of PAP leave a high amount of undesirable residues after surface disinfection.

It is an objective of the claimed invention to develop a peracid chemistry composition having a lower odor profile and that kills mycobacteria, most viruses, and bacteria, including bacterial spores.

SUMMARY

In one aspect, the disclosure provides a sporicidal liquid composition comprising: - phthalimido peroxy alkanoic acid having the general formula I:

wherein R is selected from C_1-4 alkyl and n is an integer of from 1 to 5, preferably R = CH₂ and n = 5,

- at least one C₂ to C₄ alcohol,

- C₂ to Cio peroxyorganic acid, preferably peroxyacetic acid, and

- water. In another aspect, the disclosure may provide an embodiment of a sporicidal liquid composition, wherein the ratio of C₂ to C₁₀ peroxyorganic acid, preferably peroxyacetic acid, to phthalimidoperoxyhexanoic acid is about > 0.01 : < 10 to about > 0.5 : < 0.05, preferably about > 0.01 : 5 to about < 0.5 : 0.1, and more preferred about > 0.1 : < 3 to about > 0.2 : < 0.3.

In another aspect, the disclosure provides a method of manufacture of the sporicidal liquid composition, wherein the sporicidal liquid composition is obtained by adding the components comprising:

- hydrogen peroxide,

- phthalimido alkanoic acid having the general formula II:

wherein R is selected from Ci_4 alkyl and n is an integer of from 1 to 5, preferably R = CH₂ and n = 5,

- at least one C₂ to C₄ alcohol

- C₂ to Cio organic acid, preferably acetic acid, and

- water.

In another aspect, the disclosure provides the use of the sporicidal liquid composition for deactivating, inhibiting, disabling, killing and/or sterilizing spores.

Other aspects and embodiments are encompassed by the disclosure and will become apparent in light of the following description.

DETAILED DESCRIPTION

The disclosure provides a liquid composition that is highly effective in deactivating, inhibiting, disabling, killing and/or sterilizing spores. The sporicidal liquid composition is ready-to-use. Such compositions may be useful for deactivating, inhibiting, disabling, killing and/or sterilizing spores on surfaces of articles used in healthcare, food and beverage industry and any other place, where the reduction of microbial burden is desirable.

It has been surprisingly found that the sporicidal liquid composition maybe highly effective in deactivating, inhibiting, disabling, killing and/or sterilizing bacterial spores. In addition the sporicidal liquid composition may be less corrosive, less skin irritating and/or low foaming. Thus, the sporicidal liquid composition may feature high sporicidal activity at short contact times, being less metal corrosive and provides significant malodor reduction. The sporicidal liquid compositions according to the invention provide a shelf life of at least 6 months at storage conditions at about 25° C and a sporicidal efficacy against Bacillus subtilis according to EN 13704.

So that the invention maybe more readily understood, certain terms are defined.

As used herein, "by weight" refers to the total weight of the composition. For example, if a composition has a total weight of 100 grams and comprises 40% (by weight) of an alcohol, the composition comprises 40 grams of alcohol.

It is understood that the total weight percent amount of all components, substances or agents of a composition are selected such that it does not exceed 100 wt.-%.

It is understood that, as used here,„percent",„%", and the like are intended to be synonymous with„weight percent",„wt-%", etc..

The term "disinfection," when used in the context of a sporicidal liquid agent or sporicidal liquid composition, refers to an agent or composition that can kill or otherwise inhibit the growth or proliferation of microbes including, for example, bacteria, viruses, fungi and bacterial spores.

As used herein in the context of a sporicidal liquid agent or sporicidal liquid composition, the term„microorganism" refers to any non-cellular or unicellular (including colonial) organism, including all prokaryotes, bacteria (including cyanobacteria), spores, lichens, fungi, protozoa, virinos, viroids, viruses, phages, and algae.

Similarly, the term "sporicidal activity" as used in the context of a sporicidal liquid agent or sporicidal liquid composition refers to activity that can kill or otherwise inhibit the growth or proliferation of microbes including bacteria, yeasts, viruses, fungi and bacterial spores.

The term "highly effective," when used in the context of a sporicidal liquid

composition, refers to a composition that can kill spores according to EN 13704.

The term "stable" or "stability", as used herein, refers to physical and/or chemical stability. Physical stability refers to retaining an original physical form without undergoing phase change or separation, discoloration, and the like. Chemical stability refers to resistance to impurity generation and degradation of active components.

As used herein, "storage stable" refers to a composition according to the invention, preferably in the form of a Ready to use product, that shows no phase separation at about 40° C for a period of at least 7 days, and preferably the composition shows no phase separation at about 40° C for a period of at least 9 weeks.

As used herein, the term "ready to use" refers to a composition that can be directly applied to a surface to be disinfected without any further dilution.

As used herein, the term„surface" refers to a surface of a medical instrument, a healthcare setting, a tool, a machine, equipment, a structure, a building, or the like that is employed as part of a food processing, preparation, or storage activity. Examples of healthcare settings include hospitals, doctor's offices and long term care facilities. Examples of food processing surfaces include surfaces of food processing or preparation equipment, e.g., slicing, canning, or transport equipment, including flumes, of food processing wares, e.g., utensils, dishware, wash ware, and bar glasses), and of floors, walls, or fixtures of structures in which food processing occurs. Food processing surfaces are found and employed in milking machines, food anti-spoilage air circulation systems, aseptic packaging sanitizing, food refrigeration and cooler cleaners and sanitizers, ware washing sanitizing, blancher cleaning and sanitizing, food packaging materials, cutting board additives, third-sink sanitizing, beverage chillers and warmers, meat chilling or scalding waters, auto dish sanitizers, sanitizing gels, cooling towers, food processing antimicrobial garment sprays, and non-to-low-aqueous food preparation lubricants, oils, and rinse additives.

As used herein, the term„ware" refers to items such as eating and cooking utensils, dishes, and other hard surfaces such as showers, sinks, toilets, bathtubs, countertops, windows, mirrors, transportation vehicles, and floors.

As used herein, the term„about" refers to variation in the numerical quantity that can occur, for example, through typical measuring and liquid handling procedures used for making concentrates or use solutions in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of the ingredients used to make the compositions or carry out the methods; and the like. The term„about" also encompasses amounts that differ due to different equilibrium conditions for a composition resulting from a particular initial mixture. Whether or not modified by the term„about", the claims include equivalents to the quantities.

It should be noted that, as used in this specification and the appended claims, the singular forms„a",„an", and„the" include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a composition containing„a compound" includes a composition having two or more compounds. It should also be noted that the term„or" is generally employed in its sense including „and/or" unless the content clearly dictates otherwise.

As used herein, the phrases„objectionable odor",„offensive odor", or "malodor", refer to a sharp, pungent, or acrid odor or atmospheric environment from which a typical person withdraws if they are able to. Hedonic tone provides a measure of the degree to which an odor is pleasant or unpleasant. An "objectionable odor", "offensive odor", or "malodor" has an hedonic tone rating it as unpleasant as or more unpleasant than a solution of > 5 wt-% acetic acid, propionic acid, butyric acid, or mixtures thereof. However reducing the amount peroxyacetic acid to < 2 wt.-% improves and reducing the amount peroxyacetic acid to < 1 wt.-%, preferably < 0.5 wt.-%, improves significant the reduction of malodor.

The sporicidal liquid composition disclosed herein may be effective for deactivating, inhibiting, disabling, killing, or otherwise sterilizing spores with > 3 log reduction according to EN 13704.

It is specifically understood that any numerical value recited herein (e.g., ranges) includes all values from the lower value to the upper value, i.e., all possible combinations of numerical values between the lowest value and the highest value enumerated are to be considered to be expressly stated in this application. For example, if a concentration range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1% to 3%, etc., are expressly enumerated in this specification. These are only examples of what is specifically intended.

Phthalimido peroxy alkanoic acid

The sporicidal liquid compositions disclosed herein include at least one phthalimido peroxy alkanoic acid having the general formula I:

wherein R is selected from C_1-4 alkyl and n is an integer of from 1 to 5. Most preferred is e- phthalimidoperoxyhexanoic acid (PAP) wherein R is CH₂ and n is 5.

As used herein, phthalimidoperoxyhexanoic acid or e-phthalimido-peroxyhexanoic acid or PAP refer to the compound with CAS Number 128275-31-0, as illustrated below and which is also referred to by other synonyms such as 6-phthalimidoperoxyhexanoic acid, 6- phthalimido hexaneperoxoic acid, e- phthaloylaminoperoxycaproic acid, 3-dihydro-l,3-dioxo- 2H-isoindole-2-hexaneperoxoic acid, and the like.

The sporicidal liquid composition described herein can comprise about > 0.1 wt.- to about < 10 wt.-%, preferably of about > 0.15 wt.- to about < 8 wt.- , further preferred of about > 0,25 wt.-% to about < 6 wt.-%, and more preferred of about > 0,35 wt.-% to about < 4 wt.- phthalimido peroxy alkanoic acid having the general formula I, preferably

phthalimidoperoxyhexanoic acid, based on the total weight of the sporicidal liquid

composition.

The compositions described herein can include phthalimido peroxy alkanoic acid having the general formula I, preferably phthalimidoperoxyhexanoic acid, at concentrations of about 0.3 wt.- to about 8.0 wt.- , for example about 3.0 wt.- to about 5.0 wt.- , or about 3.5 wt.- to about 4.5 wt.- , or about 4.0 wt.- . In embodiments, the liquid sporicidal liquid compositions can comprise at least about 0.3 wt.- , at least about 0.5 wt.- , at least about 0.7 wt.- , at least about 0.8 wt.- , at least about 0.9 wt.- , at least about 1.0 wt.- , at least about 1.5 wt.- , at least about 2.0 wt.- , at least about 2.5 wt.- , at least about 3.0 wt.- , at least about 3.5 wt.- , at least about 4.0 wt.- , at least about 4.5 wt.- , at least about 5.0 wt- , at least about 5.5 wt.- , at least about 6.0 wt.- , at least about 6.5 wt.- , at least about 7.0 wt.- , at least about 7.5 wt.- , at least about 8.0 wt.- , up to about 0.3 wt.- , 0.5 wt.- , up to about 0.7 wt.- , up to about 0.8 wt.- , up to about 0.9 wt.- , up to about 1.0 wt.- , up to about 1.5 wt.- , up to about 2.0 wt.- , up to about 2.5 wt.- , up to about 3.0 wt.- , up to about 3.5 wt.- , up to about 4.0 wt.- , up to about 4.5 wt.- , up to about 5.0 wt.- , up to about 5.5 wt.- , up to about 6.0 wt.- , up to about 6.5 wt.- , up to about 7.0 wt.- , up to about 7.5 wt.- , or up to about 8.0 wt.- phthalimido peroxy alkanoic acid having the general formula I, preferably phthalimidoperoxyhexanoic acid, based on the total weight of the sporicidal liquid composition. In embodiments, the compositions comprise phthalimido peroxy alkanoic acid having the general formula I, preferably phthalimidoperoxyhexanoic acid, at concentrations that are in combination with C₂ to Qo peroxyorganic acid, preferably peroxyacetic acid, adequate for sporicidal activity.

Alcohol

The sporicidal liquid compositions described herein include at least one C₂ to C₄ alcohol. The C₂ to C₄ alcohol can be selected from the group comprising ethanol, n-propanol, iso-propanol, n-butanol, sec-butanol, iso-butanol and/or tert-butanol, wherein iso-propanol may be preferred and n-propanol may be most preferred.

The sporicidal liquid composition may comprises about > 10 wt.-% to about < 80 wt.- %, preferably of about > 20 wt.-% to about < 70 wt.-%, further preferred of about > 25 wt.- to about < 60 wt.-%, and in addition preferred of about > 30 wt.-% to about < 50 wt.- C₂ to C₄ alcohol, wherein n-propanol is preferred, based on the total weight of the sporicidal liquid composition.

C? to Cm peroxyorganic acid

The sporicidal liquid compositions described herein include at least one C₂ to C₁₀ peroxyorganic acid. Examples of suitable C₂to C₁₀ percarboxylic acid include, but are not limited to peroxyacetic acid, peroxypropionic acid, peroxybutanoic acid, peroxypentanoic acid, peroxyhexanoic acid, peroxyheptanoic acid, peroxyoctanoic acid, peroxynonanoic acid, and/or peroxydecanoic acid as well as their branched isomers, for example peroxylactic acid, peroxymaleic acid, peroxyhydroxyacetic acid, peroxyascorbic acid, peroxycitric acid, peroxyneopentanoic acid, peroxyneoheptanoic acid, peroxyneodecanoic acid, peroxyoxalic acid, peroxymalonic acid, peroxysuccinic acid, peroxyglutaric acid, peroxyadipic acid, peroxypimelic acid, and/or peroxysuberic acid, and mixtures thereof.

However, in some embodiments peroxyacetic acid and/or peroxyoctanoic acid may be preferred and peroxyacetic acid may be most preferred,

The sporicidal liquid composition may comprise about > 0.05 wt.-% to about < 5 wt.- %, preferably of about > 0.1 wt.-% to about < 4 wt.-%, further preferred of about > 0.1 wt.- to about < 3 wt.-%, and more preferred of about > 0.1 wt.-% to about < 1 wt.- C₂ to C₁₀ peroxyorganic acid, preferably peroxyacetic acid, based on the total weight of the sporicidal liquid composition.

C? to Cm organic acid

The sporicidal liquid compositions described herein may include at least one C₂ to C₁₀ organic acid. Examples of suitable C₂to C₁₀ percarboxylic acid include, but are not limited to acetic acid, propionic acid, butanoic acid, pentanoic acid, hexanoic acid, heptanoic acid, octanoic acid, nonanoic acid, and/or decanoic acid as well as their branched isomers, for example lactic acid, maleic acid, hydroxyacetic acid, ascorbic acid, citric acid, neopentanoic acid, neoheptanoic acid, neodecanoic acid, oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, pimelic acid, and/or suberic acid, and mixtures thereof. However, in some embodiments acetic acid and/or octanoic acid may be preferred and acetic acid may be most preferred,

The sporicidal liquid composition may comprise about > 0 wt.-% to about < 10 wt.- , preferably of about > 0.01 wt.-% to about < 5 wt.-%, further preferred of about > 0.1 wt.- to about < 5 wt.-%, and more preferred of about > 1 wt.-% to about < 4 wt.- C₂ to C₁₀ organic acid, preferably acetic acid, based on the total weight of the sporicidal liquid composition.

Builder

Builders and builder salts may be inorganic or organic. Examples of builders suitable for use with the methods of the present invention may include, but are not limited to, phosphonic acids and phosphonates, phosphates, aminocarboxylates and their derivatives, pyrophosphates, polyphosphates, ethylenediamene and ethylenetriamene derivatives, hydroxyacids, and mono-, di-, and tri-carboxylates and their corresponding acids. Other builders include aluminosilicates, nitroloacetates and their derivatives, and mixtures thereof. Still other builders include aminocarboxylates, including salts of hydroxyethylenediamine- tetraacetic acid (HEDTA), and diethylenetriaminepentaacetic acid. In some embodiments phosphonic acid may be preferred.

For example, the sporicidal liquid composition may comprises about > 0 wt.- to about < 5 wt.-%, preferably of about > 0.1 wt.-% to about < 3 wt.- , further preferred of about > 0.2 wt.-% to about < 2 wt.-%, and in addition preferred of about > 0.3 wt.- to about < 1 wt.- builder, preferably phosphonic acid, and more preferred 1-hydroxy ethylidene-1,1- diphosphonic acid, based on the total weight of the sporicidal liquid composition.

However, the builder can be omitted in the sporicidal liquid compositions.

Surfactants

The sporicidal liquid compositions described herein can be free of surfactants.

Preferably the compositions described herein can be free of anionic surfactants.

However, the sporicidal liquid compositions described herein, not preferred, comprise surfactants including anionic surfactants, amphoteric surfactants, cationic surfactants, zwitterionic surfactants, non-ionic surfactants, and/or combinations thereof.

In one embodiment, less preferred, the sporicidal liquid composition comprises at least one amphoteric surfactant.

Suitable amphoteric surfactants include, for example, betaines, alkylamido betaines, sulfobetaines, N-alkyl betaines, sultaines, amphoacetates, amophodiacetates, imidazoline carboxylates, sarcosinates, acylamphoglycinates, such as cocamphocarboxyglycinates and acylamphopropionates, and combinations thereof. Some non-limiting examples of amphoteric surfactants include cocamidopropyl betaine, lauramidopropyl betaine, meadowfoamamido- propyl betaine, sodium cocoyl sarcosinate, sodium cocamphoacetate, disodium

cocoamphodiacetate, ammonium cocoyl sarcosinate, sodium cocoamphopropionate, and combinations thereof.

In some embodiments amphoteric surfactant such as Ammonyx LO (Laurylamin Oxide) can be most preferred.

The sporicidal liquid composition may comprise at least one surfactant in an amount of about > 0 wt.-% to about < 10 wt.-%, preferably of about > 0.05 wt.-% to about < 5 wt.-%, further preferred of about > 0.1 wt.-% to about < 2 wt.-%, and more preferred of about > 0.25 wt.-% to about < 1.5 wt.-%, wherein the surfactant is preferably an amphoteric surfactant, wherein the amphoteric surfactant is preferably a Laurylamine Oxide, based on the sporicidal liquid composition.

The sporicidal liquid composition may include one surfactant or a combination of multiple surfactants of the same or different type as described above.

Additives

The sporicidal liquid compositions may comprise a thickening agent, which may act to thicken or increase the viscosity of the composition. A thickener may be added to form a viscous liquid or gel. However, it is preferred that the sporicidal liquid compositions described herein is free of a thickening agent.

The composition may also include other additives such as stabilizers, fragrances, dyes, and the like.

Each additive, when present, may be added in amounts about > 0 wt.-% to about < 10% wt.-%, such as about > 0.001 wt.-% to about < 5% wt.-%, or about > 0.01 wt.-% to about < 1% wt.-%, based on the sporicidal liquid composition. However, it is preferred that the sporicidal liquid compositions described herein is free of additives, preferably free of fragrances, and/or dyes.

The balance of the sporicidal liquid composition is typically water, or an aqueous medium. For example a mixed solvent system, buffer, etc., comprising water as the major component, so as to provide 100% by weight of a composition.

Composition pH Composition pH can be adjusted with acid or base, if necessary. Any acid or base compatible with the components of the composition may be used. Exemplary acids include citric acid, phosphoric acid, gluconic acid, lactic acid, acetic acid, and glycolic acid. In some embodiments the acid is citric acid. Exemplary bases include sodium hydroxide, potassium hydroxide, and triethanolamine. In some embodiments an alkylamine can be used to adjust the pH to be less acidic.

In some embodiments the sporicidal liquid composition may comprises about > 0 wt.- % to about < 5 wt.-%, preferably of about > 0.05 wt.-% to about < 2 wt.- , further preferred of about > 0.1 wt.-% to about < 1.0 wt.-%, and more preferred of about > 0.2 wt.-% to about < 0.8 wt.- of an acid and/or base to adjust the pH, preferably alkylamine, further preferred ethanolamine and/or propanolamine, more preferred monoisopropanolamine,

diisopropanolamine and/or triisopropanolamine, and most preferred triisopropanolamine, based on the total weight of the sporicidal liquid composition. ^Λ

Hydro genperoxide

The peroxide components of the sporicidal composition can be synthesized, for example in situ, by adding hydrogen peroxide.

According to one embodiment hydrogen peroxide can be added to the composition in an amount of about > 0 wt.-% to about < 30 wt.-%, preferably of about > 1 wt.-% to about < 20 wt.-%, further preferred of about > 2 wt.-% to about < 10 wt.- , and more preferred of about > 3.0 wt.-% to about < 9.0 wt.- .

The sporicidal liquid compositions may comprises of about > 0 wt.-% to about < 30 wt.-%, preferably of about > 1 wt.-% to about < 20 wt.-%, further preferred of about > 2 wt.- % to about < 10 wt.-%, and more preferred of about > 3.0 wt.-% to about < 9.0 wt.- hydrogen peroxide.

It can be preferred that the hydrogen peroxide has completely reacted with the C₂ to Cio peroxyorganic acid, preferably acetic acid, and the phthalimido peroxy alkanoic acid of formula II to form the corresponding peroxy compounds. However, the hydrogen peroxide may be added in an excess, that means that the sporicidal liquid compositions may comprise > 0 wt.- and < 10 wt.- , preferably > 2 wt.-% and < 8 wt.- hydrogen peroxide, based on the total weight of the sporicidal liquid composition. pH The pH of the sporicidal liquid compositions can affect both stability of the

formulation and the sporicidal activity. For example, lower pH may increase the sporicidal activity. In some embodiments, the sporicidal liquid compositions disclosed herein have a pH that is suitably selected to balance PAP solubility and sporicidal efficacy.

In embodiments the sporicidal liquid composition has a pH in the range of about > 1 pH to about < 8 pH, preferably about > 1.5 pH to about < 7 pH, further preferred of about > 2 pH to about < 6 pH, more preferred of about > 2.5 pH to about < 5 pH, and most preferred of about > 3 pH to about < 4 pH.

In some embodiments the pH may be about > 2.5 to about < 4.5. Accordingly, the pH may be from about > 3.0 to about < 4.5, from about > 4.0 to about < 4.5, from about > 3.0 to about < 4.0, from about > 3.5 to about < 3.8, from about > 3.6 to about < 3.7, about > 3.5, about > 3.6, about > 3.7 or about > 3.8. In embodiments, a composition may have a pH of up to about 2.5, up to about 3.0, up to about 3.5, up to about 3.6, up to about 3.7, up to about 3.8, up to about 3.9, up to about 4.0, up to about 4.5, at least about 2.5, at least about 3.0, at least about 3.5, at least about 3.6, at least about 3.7, at least about 3.8, at least about 3.9, or at least about 4.0.

In one embodiment the sporicidal liquid composition may comprise:

- about > 0.1 wt.- to about < 10 wt.-%, preferably of about > 0.15 wt.-% to about < 8 wt.- %, further preferred of about > 0,25 wt.-% to about < 6 wt.- , and more preferred of about > 0,35 wt.-% to about < 4 wt.- phthalimidoperoxyhexanoic acid;

- about > 10 wt.-% to about < 80 wt.-%, preferably of about > 20 wt.-% to about < 70 wt.- , further preferred of about > 25 wt.-% to about < 60 wt.- , and in addition preferred of about > 30 wt.-% to about < 50 wt.- C₂ to C₄ alcohol, preferably n-propanol, based on the total weight of the sporicidal liquid composition;

- about > 0.05 wt.-% to about < 5 wt.-%, preferably of about > 0.1 wt.-% to about < 4 wt.- , further preferred of about > 0.2 wt.-% to about < 3 wt.-%, and more preferred of about > 0.3 wt.-% to about < 1 wt.- C₂ to Qo peroxyorganic acid, preferably peroxyacetic acid;

- about > 0 wt.-% to about < 5 wt.-%, preferably of about > 0.1 wt.-% to about < 3 wt.- , further preferred of about > 0.2 wt.-% to about < 2 wt.- , and in addition preferred of about > 0.3 wt.-% to about < 1.0 wt.- builder, preferably phosphonic acid, and more preferred 1 -hydroxy ethylidene-l,l-diphosphonic acid;

- about > 0 wt.-% to about < 10 wt.-%, preferably of about > 0.05 wt.-% to about < 5 wt.- , further preferred of about > 0.1 wt.-% to about < 2 wt.- , and more preferred of about > 0.25 wt.-% to about < 1.5 wt.- , surfactant, wherein the amphoteric surfactant is preferably a Amine Oxide, preferably a Laurylamine Oxide

- about > 0 wt.-% to about < 30 wt.-%, preferably of about > 1 wt.-% to about < 20 wt.- , further preferred of about > 2 wt.-% to about < 10 wt.-%, and more preferred of about > 3.0 wt.-% to about < 9.0 wt.- hydrogen peroxide;

- about > 0 wt.-% to about < 5 wt.-%, preferably of about > 0.05 wt.-% to about < 2 wt.- , further preferred of about > 0.1 wt.-% to about < 1.0 wt.-%, and more preferred of about > 0.2 wt.-% to about < 0.8 wt.- of an acid and/or base to adjust the pH, preferably alkylamine, further preferred ethanolamine and/or propanolamine, more preferred monoisopropanolamine, diisopropanolamine and/or triisopropanolamine, and most preferred triisopropanolamine;

- add. Water to 100 wt.- ; wherein the wt.- are calculated on the total weight of the sporicidal liquid composition; wherein

the composition has a pH in the range of about > 1 pH to about < 8 pH, preferably about > 1.5 pH to about < 7 pH, further preferred of about > 2 pH to about < 6 pH, more preferred of about > 2.5 pH to about < 5 pH, and most preferred of about > 2.5 pH to about < 4 pH.

Use of the sporicidal liquid composition

The sporicidal liquid composition maybe used for disinfection, preferably for deactivating, inhibiting, disabling, killing, and/or sterilizing bacterial spores.

The sporicidal liquid composition maybe used for example for deactivating, inhibiting, disabling, killing and/or sterilizing spores from surgical, medical, and dental instruments, including endoscopes and any kind of equipment or building surface in healthcare settings, like hospitals, doctor's offices and long-term care facilities.

Method of preparation

The sporicidal liquid compositions may be generally prepared by any appropriate manufacturing processes and using any appropriate manufacturing equipment such as are known in the art. In an exemplary process, the various formulation components are sequentially added to water, with stirring between each addition to ensure dissolution and/or dispersion of the previous component. For example, a formulation may be prepared by first adding hydrogen peroxide to water with stirring. This may be followed by addition of one or more of the other components sequentially or simultaneously.

In embodiments, the compositions may be prepared at ambient temperature. A method of manufacture of the sporicidal liquid composition include, adding the components comprising:

hydrogen peroxide,

phthalimido alkanoic acid of formula (II),

wherein R is selected from C_1-4 alkyl and n is an integer of from 1 to 5, preferably R =

CH₂ and n = 5 (= phthalimidohexanoic acid),

at least one C₂ to C₄ alcohol,

C₂ to Cio organic acid, preferably acetic acid, and

water.

According to one embodiment the sporicidal liquid composition is obtained by adding the components comprising:

about > 0 wt.-% to about < 30 wt.-%, preferably of about > 1 wt.-% to about < 20 wt- %, further preferred of about > 2 wt.-% to about < 10 wt.- , and more preferred of about > 3.0 wt.-% to about < 9.0 wt.- hydrogen peroxide;

about > 0.1 wt.-% to about < 10 wt.-%, preferably of about > 0.15 wt.-% to about < 8 wt.- , further preferred of about > 0,25 wt.-% to about < 6 wt.- , and more preferred of about > 0,35 wt.-% to about < 4 wt.- phthalimido alkanoic acid of formula (II), preferably R = CH₂ and n = 5 (= phthalimido-hexanoic acid);

about > 10 wt.-% to about < 80 wt.- , preferably of about > 20 wt.-% to about < 70 wt.-%, further preferred of about > 30 wt.-% to about < 60 wt.- , and in addition preferred of about > 30 wt.-% to about < 50 wt.- C₂ to C₄ alcohol, preferably n- propanol, based on the total weight of the sporicidal liquid composition;

about > 0.0 wt.-% to about < 10 wt.-%, preferably of about > 0.01 wt.-% to about < 5 wt.-%, further preferred of about > 0.1 wt.-% to about < 5 wt.- , and more preferred of about > 1 wt.-% to about < 4 wt.- C₂ to C₁₀ organic acid, preferably acetic acid; about > 0 wt.-% to about < 5 wt.-%, preferably of about > 0.1 wt.-% to about < 3 wt.- %, further preferred of about > 0.2 wt.-% to about < 2 wt.- , and in addition preferred of about > 0.3 wt.-% to about < 1 wt.-% builder, preferably phosphonic acid, and more preferred 1 -hydroxy ethylidene-l,l-diphosphonic acid;

about > 0 wt.-% to about < 10 wt.-%, preferably of about > 0.05 wt.-% to about < 5 wt.-%, further preferred of about > 0.1 wt.-% to about < 2 wt.-%, and more preferred of about > 0.25 wt.-% to about < 1.5 wt.-% surfactant, preferably amphoteric surfactant, wherein the amphoteric surfactant is preferably amine oxide, preferably laurylamine oxide;

about > 0 wt.-% to about < 5 wt.-%, preferably of about > 0.05 wt.-% to about < 2 wt- %, further preferred of about > 0.1 wt.-% to about < 1.0 wt.-%, and more preferred of about > 0.2 wt.-% to about < 0.8 wt.-% of an acid and/or base to adjust the pH, preferably alkylamine, further preferred ethanolamine and/or propanolamine, more preferred monoisopropanolamine, diisopropanolamine and/or triisopropanolamine, and most preferred triisopropanolamine;

add. 100 wt.-% water; wherein the wt.-% is calculated on the total weight of the liquid composition.

Determination of sporicidal efficacy

The following example was carried out to illustrate the sporicidal efficacy of the disinfectant according to the invention.

The sporicidal efficacy of the examples was investigated against a spore suspension of Bacillus subtilis spores (DSM 347). The investigations were performed according to the procedure of the quantitative suspension test according to European norm DIN EN 13704 (2002) . The chosen neutralisation method was in each case the membrane filtration method according to EN 13704. The test concentration was 80%, which is the maximum possible test concentration in this test, i.e. the test samples were used undiluted in the test. The contact time was 2, 5, 15, 30 and 60 minutes (El to E3 and CI to C6) and the test temperature was room temperature of 20° C. The tests were performed with an interfering substance of 0.3 g/1 bovine albumin (simulated clean conditions following EN 13704). The incubation

temperature of all cultures was 30°C.

The non-toxicity of the chosen neutraliser solution and the sufficient neutralisation of the test substance by the neutralisation process were proven beforehand. It was proven as well the selected experimental conditions had no adverse effect on the test organisms. Based upon the provisions of the European norm DIN 13704 (2002), sporicidal efficacy for a disinfectant is shown by demonstrating a reduction of the spores within a contact time of 60 minutes by a factor of 10 (3 log).

Table 1 shows the components used and the initial concentrations of the starting substances for preparing the compositions. The compositions were prepared by adding the components to water and mixing at room temperature. The samples El to E3 are examples according to the invention and the sample CI to C6 are comparative examples.

Table 1

Compositions according to the invention El, E2 and E3 and reference compositions CI to C6 for comparison:

The components of table 1 are mixed, whereby due to H₂0₂ the peroxy compounds phthalimido-perhexanoic acid and peracetic acid are synthesized in situ.

The following table 2 shows the results of the examples of table 1 for a contact time of 2, 5, 15, 30 and 60 minutes at room temperature 20° C with an interfering substance of 0.3 g/1 bovine albumin.

Table 2

Reduction of spores:

contact time / E 1 E 2 E 3 CI C2 C3 C4 C5 C6 log reduction 2 min. 2.4 2.6 2.69 0.4 - 0.75 - 0.1 1.76

5 min. > 3.1 > 3.1 > 3.15 0.5 1.07 1.82 - 0.1 2.02

15 min. > 3.1 > 3.1 > 3.15 2.3 2.37 >3.2 1.26 0.3 2.51

30 min. > 3.1 > 3.1 > 3.15 2.2 >3.2 >3.2 3.2 0.4 3

60 min. > 3.1 > 3.1 > 3.15 3.1 >3.2 >3.2 3.25 1.3 3.24

It can be seen in table 2 that for the samples El to E3 according to the invention the required spore reduction of at least 1x10 could be demonstrated at about 5 minutes of contact time, whereas the respective reference CI to C6 did not show sufficient reduction in spores. Further, the samples El to E3 according to the invention provides a spore reduction of at least 1x10 at about 2 minutes contact time, whereas the respective reference CI to C6 did not show significant reduction in spores at about 2 minutes. This shows that the formulations according to the invention had adequate sporicidal efficacy against Bacillus subtilis in the quantitative suspension test according to European norm DIN EN 13704 (2002) at a contact time of 5 min, when tested undiluted.

Material Compatibility Test

This test method provides a basis to assess the enhanced metal- surface- safeness of the sporicidal liquid composition of the invention with respect to corrosion.

Corrosion testing equipment

350 ml wide-necked screw cap flasks for each test condition

Acetone

Steel V2A, Steel V4A, Copper, Brass and Aluminum test plates of 100 mm x 50 mm x 1.5 mm

(The Steel V2A, Steel V4A, Copper, Brass and Aluminum test plates are cleaned with acetone before use)

Clean paper toweling

Stop watch

Drying oven

Analytical balance capable of weighing to the 0.0001 place.

Test method The sporicidal liquid composition El to E3 and comparative examples CI to C6 were used as obtained according to table 1. The weights of Steel V2A, Steel V4A, Copper, Brass and Aluminum test plates of 100 mm x 50 mm x 1.5 mm were recorded and then placed in the center area of the bottom of a 350 ml wide-necked screw cap flask each. The Steel V2A, Steel V4A, Copper, Brass and Aluminum test plates were completely submerged. Subsequently, each wide-necked screw cap flask was filed to the top with the compositions of El to E3 and comparative examples CI to C6 having a temperature of 23° C. The wide-necked screw cap flasks were closed with the cap and allow staying for 21 days at a temperature of 23° C.

Thereafter, the Steel V2A, Steel V4A, Copper, Brass and Aluminum test plates were removed, rinsed with deionized water, placed on a clean paper towel and allowed to dry for 24 hours at a temperature of 23° C. The Steel V2A, Steel V4A, Copper, Brass and Aluminum test plates were then weighted and the weight was taken to the fourth place. Three tests were run for each experiment and the average weight loss was determined. The average weight loss for each Steel V2A, Steel V4A, Copper, Brass and Aluminum test plates after treatment with said sporicidal liquid composition can be taken from table 3 and table 4.

Table 3

Material Compatibility Test El to E3:

Product

Material identification El E2 E3

St. Steel

V2A Weight loss [%] -0,0020 -0,0130 -0,0051

St. Steel

V4A Weight loss [%] 0,0000 0,0000 0,0000

Copper Weight loss [%] -0,1010 -0,5000 -0,2043

Brass Weight loss [%] -5,5320 -9,6998 -7,1617

Aluminium Weight loss [%] -0,5030 -1,2007 -1,0934 Table 4

Material Compatibility Test CI to C3:

It can be clearly taken from tables 3 and 4 that the material corrosive effect of peracetic acid can be surprisingly reduced in the presence of phthalimido perhexanoic acid for compositions of El to E3.

The compositions CI to C3 are free of phthalimido perhexanoic acid but contain peracetic acid. It can be taken from tables 3 and 4 that the material corrosive effect of CI to C3 is significant higher compared to El to E3.

As used herein, the term "about" refers to variation in the numerical quantity that can occur, for example, through typical measuring and liquid handling procedures used for making concentrates or use solutions in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of the ingredients used to make the compositions or carry out the methods; and the like. The term "about" also encompasses amounts that differ due to different equilibrium conditions for a composition resulting from a particular initial mixture. Whether or not modified by the term "about", the claims include equivalents to the quantities.

It should be noted that, as used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a composition containing "a compound" includes a mixture of two or more compounds. It should also be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. The invention has been described to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention.

Claims

1. A sporicidal liquid composition comprising:

- phthalimido peroxy alkanoic acid having the general formula I:

wherein R is selected from C_1-4 alkyl and n is an integer of from 1 to 5,

- at least one C₂ to C₄ alcohol,

- C₂ to Cio peroxyorganic acid, and

- water.

2. The sporicidal liquid composition of claim 1, wherein the ratio of C₂ to C₁₀

peroxyorganic acid, preferably peroxyacetic acid, to phthalimidoperoxyhexanoic acid is about > 0.01 : < 10 to about > 0.5 : < 0.05, preferably about > 0.01 : 5 to about < 0.5 : 0.1, and more preferred about > 0.1 : < 3 to about > 0.2 : < 0.3.

3. The sporicidal liquid composition of claim 1 or 2, wherein the sporicidal liquid

composition comprises of about > 0.1 wt.-% to about < 10 wt.-%, preferably of about > 0.15 wt.-% to about < 8 wt.-%, further preferred of about > 0,25 wt.-% to about < 6 wt.- %, and more preferred of about > 0,35 wt.-% to about < 4 wt.- phthalimido peroxy alkanoic acid having the general formula I, preferably phthalimidoperoxyhexanoic acid, based on the total weight of the sporicidal liquid composition.

4. The sporicidal liquid composition of claims 1 to 3, wherein the phthalimido peroxy

alkanoic acid of general formula I is phthalimidoperoxyhexanoic acid (PAP).

5. The sporicidal liquid composition of claims 1 to 4, wherein the C₂ to C₄ alcohol is

selected from the group comprising ethanol, n-propanol, iso-propanol, n-butanol, sec- butanol, iso-butanol and/or tert-butanol, preferably iso-propanol and most preferred n- propanol.

6. The sporicidal liquid composition of claims 1 to 5, wherein the composition comprises about > 10 wt.-% to about < 80 wt.-%, preferably of about > 20 wt.-% to about < 70 wt.- %, further preferred of about > 25 wt.-% to about < 60 wt.- , and in addition preferred of about > 30 wt.-% to about < 50 wt.- C₂ to C₄ alcohol, preferably n-propanol, based on the total weight of the sporicidal liquid composition.

7. The sporicidal liquid composition of claims 1 to 6, wherein the composition comprises about > 0.05 wt.-% to about < 5 wt.-%, preferably of about > 0.1 wt.-% to about < 4 wt.- %, further preferred of about > 0.2 wt.-% to about < 3 wt.- , and more preferred of about

> 0.3 wt.-% to about < 1 wt.- C₂ to C₁₀ peroxyorganic acid, preferably peroxyacetic acid, based on the total weight of the sporicidal liquid composition.

8. The sporicidal liquid composition of claims 1 to 7, wherein the composition comprises about > 0 wt.-% to about < 5 wt.- , preferably of about > 0.1 wt.-% to about < 3 wt.- , further preferred of about > 0.2 wt.-% to about < 2 wt.- , and in addition preferred of about > 0.3 wt.-% to about < 1.0 wt.- builder, preferably phosphonic acid, and more preferred 1 -hydroxy ethylidene-l,l-diphosphonic acid, based on the total weight of the sporicidal liquid composition.

9. The sporicidal liquid composition of claims 1 to 8, wherein the composition comprises a surfactant, preferably an amphoteric surfactant, wherein the amphoteric surfactant is preferably a Laurylamine Oxide.

10. The sporicidal liquid composition of claims 1 to 9, wherein the composition comprises about > 0 wt.-% to about < 5 wt.-%, preferably of about > 0.05 wt.-% to about < 2 wt.- , further preferred of about > 0.1 wt.-% to about < 1.0 wt.- , and more preferred of about

> 0.2 wt.-% to about < 0.8 wt.- of an acid and/or base to adjust the pH, preferably alkylamine, further preferred ethanolamine and/or propanolamine, more preferred monoisopropanolamine, diisopropanolamine and/or triisopropanolamine, and most preferred triisopropanolamine, based on the total weight of the sporicidal liquid composition.

11. The sporicidal liquid composition of claims 1 to 11, wherein the sporicidal liquid

composition has a pH in the range of about > 1 pH to about < 8 pH, preferably about >

1.5 pH to about < 7 pH, further preferred of about > 2 pH to about < 6 pH, more preferred of about > 2.5 pH to about < 5 pH, and most preferred of about > 2.5 pH to about < 4 pH.

12. The sporicidal liquid composition of claims 1 to 12, wherein the composition comprises:

- about > 0.1 wt.-% to about < 10 wt.-%, preferably of about > 0.15 wt.-% to about < 8 wt.-%, further preferred of about > 0,25 wt.-% to about < 6 wt.- , and more preferred of about > 0,35 wt.-% to about < 4 wt.- phthalimidoperoxyhexanoic acid;

- about > 10 wt.-% to about < 80 wt.-%, preferably of about > 20 wt.-% to about < 70 wt.-%, further preferred of about > 25 wt.-% to about < 60 wt.- , and in addition preferred of about > 40 wt.-% to about < 50 wt.- C₂ to C₄ alcohol, preferably n- propanol, based on the total weight of the sporicidal liquid composition;

- about > 0.05 wt.-% to about < 5 wt.-%, preferably of about > 0.1 wt.-% to about < 4 wt.- , further preferred of about > 0.2 wt.-% to about < 3 wt.- , and more preferred of about > 0.3 wt.-% to about < 1 wt.- C₂ to C₁₀ peroxyorganic acid, preferably peroxyacetic acid;

- about > 0 wt.-% to about < 5 wt.-%, preferably of about > 0.1 wt.-% to about < 3 wt- %, further preferred of about > 0.2 wt.-% to about < 2 wt.- , and in addition preferred of about > 0.3 wt.-% to about < 1.0 wt.- builder, preferably phosphonic acid, and more preferred 1 -hydroxy ethylidene-l,l-diphosphonic acid;

- > 0 wt.- to about < 10 wt.-%, preferably of about > 0.05 wt.-% to about < 5 wt.- , further preferred of about > 0.1 wt.-% to about < 2 wt.- , and more preferred of about > 0.25 wt.-% to about < 1.5 wt.- , wherein the surfactant is preferably an amphoteric surfactant, wherein the amphoteric surfactant is preferably a laurylamine oxide;

- about > 0 wt.-% to about < 30 wt.-%, preferably of about > 1 wt.-% to about < 20 wt.- %, further preferred of about > 2 wt.-% to about < 10 wt.- , and more preferred of about > 3.0 wt.-% to about < 9.0 wt.- hydrogen peroxide;

- about > 0 wt.-% to about < 5 wt.-%, preferably of about > 0.05 wt.-% to about < 2 wt.- %, further preferred of about > 0.1 wt.-% to about < 1.0 wt.- , and more preferred of about > 0.2 wt.-% to about < 0.8 wt.- of an acid and/or base to adjust the pH, preferably alkylamine, further preferred ethanolamine and/or propanolamine, more preferred monoisopropanolamine, diisopropanolamine and/or triisopropanolamine, and most preferred triisopropanolamine;

- add. 100 wt.- water; wherein the wt.- are calculated on the total weight of the sporicidal liquid composition; wherein the composition has a pH in the range of about > 1 pH to about < 8 pH, preferably about > 1.5 pH to about < 7 pH, further preferred of about > 2 pH to about < 6 pH, more preferred of about > 2.5 pH to about < 5 pH, and most preferred of about > 2.5 pH to about < 4 pH.

13. The method of manufacture of the sporicidal liquid composition of claims 1 to 12,

wherein the sporicidal liquid composition is obtained by adding the components comprising:

- hydrogen peroxide,

- phthalimido alkanoic acid of formula (II),

- at least one C₂ to C₄ alcohol,

- C₂ to C₄ organic acid, preferably acetic acid, and

- water.

14. The method of manufacture of the sporicidal liquid composition of claim 13, wherein the sporicidal liquid composition is obtained by adding the components comprising:

- about > 0.1 wt.-% to about < 10 wt.- , preferably of about > 0.15 wt.-% to about < 8 wt.-%, further preferred of about > 0,25 wt.-% to about < 6 wt.- , and more preferred of about > 0,35 wt.-% to about < 4 wt.- phthalimido alkanoic acid of formula (II), preferably R = CH₂ and n = 5;

- about > 10 wt.-% to about < 80 wt.-%, preferably of about > 20 wt.-% to about < 70 wt.-%, further preferred of about > 30 wt.-% to about < 60 wt.- , and in addition preferred of about > 30 wt.-% to about < 50 wt.- C₂ to C₄ alcohol, preferably n- propanol, based on the total weight of the sporicidal liquid composition;

- about > 0.0 wt.-% to about < 10 wt.-%, preferably of about > 0.01 wt.-% to about < 5 wt.-%, further preferred of about > 0.1 wt.-% to about < 5 wt.- , and more preferred of about > 1 wt.- to about < 4 wt.- C₂ to C₁₀ organic acid, preferably acetic acid;

- about > 0 wt.-% to about < 5 wt.-%, preferably of about > 0.1 wt.-% to about < 3 wt.- %, further preferred of about > 0.2 wt.-% to about < 2 wt.- , and in addition preferred of about > 0.3 wt.- to about < 1 wt.- builder, preferably phosphonic acid, and more preferred 1 -hydroxy ethylidene-l,l-diphosphonic acid;

- about > 0 wt.-% to about < 10 wt.-%, preferably of about > 0.05 wt.-% to about < 5 wt.-%, further preferred of about > 0.1 wt.- to about < 2 wt.- , and more preferred of about > 0.25 wt.-% to about < 1.5 wt.- surfactant, preferably amphoteric surfactant, wherein the amphoteric surfactant is preferably amine oxide, preferably laurylamine oxide;

- about > 0 wt.-% to about < 5 wt.- , preferably of about > 0.05 wt.-% to about < 2 wt.- %, further preferred of about > 0.1 wt.-% to about < 1.0 wt.- , and more preferred of about > 0.2 wt.-% to about < 0.8 wt.- of an acid and/or base to adjust the pH, preferably alkylamine, further preferred ethanolamine and/or propanolamine, more preferred monoisopropanolamine, diisopropanolamine and/or triisopropanolamine, and most preferred triisopropanolamine;

- add. 100 wt.- water; wherein the wt.- is calculated on the total weight of the liquid composition.

15. Use of a sporicidal liquid composition of claims 1 to 12 for disinfection, preferably for deactivating, inhibiting, disabling, killing, and/or sterilizing bacterial spores.