NZ767180A - Compositions for treatment and methods for making and using the same - Google Patents

Abstract

detergent composition, a method of making the detergent composition, and a method of use thereof are provided. The detergent composition comprises at least 0.001% by weight of an antimicrobial agent, based on the total weight of the composition; an enzyme; and at least 0.01% by weight of a hydrotrope, based on the total weight of the composition. ope, based on the total weight of the composition.

Description

TITLE ITIONS FOR TREATMENT AND METHODS FOR MAKING AND USING THE SAME FIELD The t disclosure relates to compositions for treatment and methods of making and using those compositions.

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of US. Provisional Application No. 62/691,224 filed June 28, 2018, which is incorporated herein by reference.

BACKGROUND Various medical devices are employed for procedures in the medical field. One such device is an endoscope that examines the interior of a hollow organ or cavity of the body.

Ensuring reusable medical devices are treated property can inhibit or prevent cross- contamination and the spread of disease. In this regard, treatment solutions such as, for example, cleaning solutions and/or antimicrobial solutions are used on medical s and facility surfaces.

SUMMARY In one aspect, the present disclosure provides a detergent composition. The ent ition comprises at least 0.001% by weight of an crobial agent, based on the total weight of the composition, an enzyme, and at least 0.01% by weight of a hydrotrope, based on the total weight of the composition.

In another aspect, the present disclosure provides a method of making a detergent composition. The method comprises combining, based on the total weight of the composition, at least 0.001% by weight of an antimicrobial agent, at least 0.01% by weight of a hydrotrope, and an enzyme.

W0 2020l003007 In yet r aspect, the present disclosure provides a method for cleaning an object.

The method comprises applying a detergent composition to the object, thereby cleaning the object. The detergent ition comprises, based on the total weight of the composition, at least 0.001% by weight of an antimicrobial agent, at least 0.01% by weight of a hydrotrope, and an enzyme.

It is tood that the inventions described in this specification are not limited to the es provided in this Summary. Various other aspects are described and exemplified BRIEF DESCRIPTION OF THE DRAWINGS The features and advantages of the examples, and the manner of attaining them, will become more apparent and the examples will be better understood by reference to the following description of examples taken in conjunction with the accompanying drawings, wherein: Figure 1 is a depiction of a system for treatment of an object utilizing a detergent composition according to the t disclosure.

Figure 2A-D shows photographs of plastic or ess steel coupons treated with a diluted detergent composition according to the present disclosure, Figure 2A shows a photograph of a stainless steel coupon treated with a diluted detergent composition according to the t disclosure that was supplemented with chlorhexidine gluconate (CHG).

Figure 2B shows a photograph of a plastic coupon treated with a diluted detergent ition according to the present disclosure that was supplemented with CHG.

Figure 2C shows a photograph of a stainless steel coupon treated with a diluted detergent composition according to the present disclosure that was not supplemented with CHG.

Figure 2D shows a photograph of a plastic coupon treated with a diluted detergent ition according to the present sure that was not supplemented with CHG.

Figure 3A-D shows photographs of plastic or stainless steel coupons treated with a diluted detergent composition, C1.

Figure 3A shows a photograph of a stainless steel coupon treated with a diluted detergent composition, C1, which was supplemented with CHG.

Figure 3B shows a photograph of a plastic coupon treated with a diluted detergent composition, C1, which was supplemented with CHG.

Figure 3C shows a photograph of a stainless steel coupon treated with a diluted detergent composition, C1, which was not supplemented with CHG.

Figure 3D shows a photograph of a plastic coupon treated with a diluted detergent composition, C1, which was not supplemented with CHG.

Figure 4A-D shows photographs, when available, of plastic or stainless steel s treated with a diluted detergent composition, C2.

Figure 4A indicates that CHG was insoluble in a diluted detergent ition, C2.

Figure 4B indicates that CHG was insoluble in a diluted ent composition, C2.

Figure 4C shows a photograph of a stainless steel coupon d with a diluted detergent composition, C2, which was not supplemented with CHG.

Figure 4D shows a photograph of a plastic coupon treated with a diluted detergent composition, C2, which was not supplemented with CHG, Figure SA-D shows raphs, when available, of plastic or stainless steel s d with a d detergent composition, C3.

Figure 5A indicates that CHG was insoluble in a diluted detergent composition, C3.

Figure 5B indicates that CHG was insoluble in a diluted ent composition, C3.

Figure 5C shows a photograph of a stainless steel coupon treated with a diluted detergent composition, C3, which was not supplemented with CHG.

Figure 5D shows a photograph of a plastic coupon treated with a diluted detergent composition, C3, which was not supplemented with CHG.

W0 2020l003007 Figure 6A-D shows photographs of plastic or stainless steel s d with a diluted detergent composition, C4.

Figure 6A shows a raph of a stainless steel coupon treated with a diluted detergent composition, C4, which was supplemented with CHG.

Figure 6B shows a photograph of a plastic coupon treated with a diluted detergent composition, C4, which was supplemented with CHG.

Figure 6C shows a raph of a stainless steel coupon treated with a diluted detergent composition, C4, which was not mented with CHG.

Figure 6D shows a photograph of a plastic coupon treated with a diluted detergent composition, C4, which was not supplemented with CHG.

Figure 7A-D shows photographs of plastic or stainless steel coupons treated with a diluted detergent composition, C5.

Figure 7A shows a photograph of a stainless steel coupon treated with a diluted detergent composition, C5, which was supplemented with CHG.

Figure 7B shows a photograph of a plastic coupon d with a diluted detergent composition, C5, which was supplemented with CHG.

Figure 7C shows a photograph of a stainless steel coupon d with a diluted detergent composition, C5, which was not supplemented with CHG.

Figure 7D shows a photograph of a plastic coupon treated with a diluted detergent ition, C5, which was not supplemented with CHG.

Figure 8A-D shows photographs, when available, of plastic or stainless steel coupons treated with a diluted detergent composition, C6.

Figure 8A indicates that CHG was insoluble in a diluted detergent composition, C6.

Figure 8B indicates that CHG was insoluble in a diluted ent composition, C6.

Figure 8C shows a photograph of a stainless steel coupon treated with a diluted detergent composition, C6, which was not supplemented with CHG.

W0 2020l003007 Figure 8D shows a photograph of a plastic coupon treated with a diluted detergent composition, C6, which was not supplemented with CHG.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate n examples, in one form, and such exemplifications are not to be ued as limiting the scope of the examples in any manner.

DETAILED DESCRIPTION Certain exemplary aspects of the present disclosure will now be described to provide an overall understanding of the principles of the composition, function, manufacture, and use of the compositions and methods sed herein. One or more examples of these aspects are illustrated in the accompanying drawing. Those of ordinary skill in the art will understand that the compositions and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects and that the scope of the s examples of the present invention is defined solely by the claims. The features illustrated or described in connection with one ary aspect may be ed with the features of other aspects.

Such modifications and variations are intended to be included within the scope of the present invention. nce throughout the specification to “various examples,77 (4 77 5‘ some examples, one e,” or “an e”, or the like, means that a particular feature, ure, or characteristic described in connection with the example is included in at least one example.

Thus, appearances of the phrases “in various es,” “in some examples,” “in one example”, or “in an example”, or the like, in places throughout the specification are not necessarily all referring to the same example. Furthermore, the particular es, structures, or characteristics may be combined in any suitable manner in one or more examples. Thus, the particular features, structures, or characteristics illustrated or described in connection with one e may be combined, in whole or in part, with the features structures, or characteristics of one or more other examples t limitation. Such modifications and variations are intended to be included within the scope of the present examples.

In this specification, unless otherwise indicated, all numerical parameters are to be tood as being prefaced and modified in all instances by the term "about", in which the numerical parameters possess the inherent variability characteristic of the underlying measurement techniques used to ine the numerical value of the parameter. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter described herein should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

Also, any numerical range recited herein includes all sub-ranges subsumed within the d range. For example, a range of "l to 10" includes all sub-ranges between (and including) the recited minimum value of l and the recited m value of 10, that is, having a minimum value equal to or r than 1 and a m value equal to or less than 10. Any maximum numerical limitation recited in this specification is intended to e all lower numerical limitations subsumed therein and any m numerical limitation recited in this specification is intended to include all higher numerical tions subsumed therein. ingly, Applicant reserves the right to amend this specification, including the claims, to expressly recite any sub-range subsumed within the ranges expressly recited. All such ranges are inherently described in this cation such that amending to expressly recite any such nges would comply with the requirements of35 U.S.C. § 112 and 35 U.S.C. § 132(a).

The present disclosure relates to compositions for treatment and methods of making and using those compositions. Objects of the present disclosure can undergo a treatment process as set forth herein to prevent cross-contamination and the spread of disease. As used herein, a “treatment process” may be a ng process, a disinfecting process, the like, and combinations thereof. A treatment process may be either , ted, or some combination thereof, and may utilize a treatment agent. As used herein, a “treatment agent” can comprise at least one of a cleaning agent and an antimicrobial agent. As used herein a ing process” means a treatment process employing a cleaning agent that removes and/or eliminates debris such as, for example, a body fluid (e.g., blood, urine, saliva) a dirt, a dust, a particle, an oil, a protein, a carbohydrate, and the like. As used herein, a “cleaning agent” means a type of treatment agent that removes and/or eliminates debris during a cleaning process such as, for example, a surfactant and/or a detergent.

A disinfecting process can remove and/or eliminate a bioburden from an object. A bioburden may be, for example, a bacterium (e.g., mycobacterium, bacterial spores), an archaeon, a eukaryote, a virus, a , and/or other forms of biological agents. Bacterial spores (e.g., endospores) are a form of bacteria which are dormant and highly resistive to physical and chemical degradation. As used , a “disinfecting process” means a treatment process that substantially s a bioburden. As used herein, “substantially remove” means W0 03007 that at least 99% of the den has been removed from the object such as, for example, at least 99.9% of the bioburden, at least 99.99% of the bioburden, at least 99.999% of the bioburden, or at least 99.9999% of the bioburden has been removed from the object. The disinfection process may include, for example, the on of heat, an antimicrobial agent, irradiation, re, and combinations thereof. The antimicrobial agent may comprise a chemical capable of disinfection.

As used herein, a nent” of the detergent composition of the present disclosure is meant to mean any chemical substance that can be added and/or can be a part of the ent composition. For example, a component of the detergent ition can be water, an alcohol, an antimicrobial agent, a hydrotrope, a surfactant, a buffer, a t, an enzyme, a chelating agent, a salt, the like, and combinations thereof.

Detergent compositions comprising an enzyme can aid in cleaning an object. The enzyme can remove and/or eliminate . However, the enzyme, by itself, may not provide a sufficient reduction of bioburden to ect an obj ect. Thus, an additional disinfecting process employing an antimicrobial agent can be performed simultaneously with or subsequent to the first cleaning step to prepare the object for subsequent use.

However, it was previously believed by those of ordinary skill in the art that an antimicrobial agent reduces the enzymatic activity of the enzyme of the detergent composition, possibly via denaturation of the enzyme’s three-dimensional structure, thereby adversely affecting and diminishing the ability of the enzyme to remove and/or eliminate debris and/or bioburden. onally, the antimicrobial agent was thought to similarly denature elements of debris and/or bioburden making them less likely to be removed during a treatment process.

Thus, previously, it was believed that an antimicrobial agent was incompatible with a detergent sing an enzyme. singly, it has been found that the addition of an antimicrobial agent to a detergent composition in combinations and/or amounts provided herein can enable a detergent composition already used for cleaning to also be used for disinfection processes. Thus, it has been found that the cleaning and disinfecting processes can be combined, and the efficiency of treating s can be increased. The cleaning and disinfecting can be combined.

Accordingly, provided herein are detergent compositions comprising an antimicrobial agent and an enzyme, methods of making the detergent compositions, and methods of using the detergent compositions. The detergent compositions of the t disclosure can comprise a cleaning agent and an antimicrobial agent. The ent itions of the present disclosure can comprise an enzyme that can effectively remove and/or eliminate debris and/or bioburden from an object in the presence of an antimicrobial agent that can disinfect the object. The detergent compositions set forth herein can clean and disinfect the obj ect.

In one example, the present disclosure provides a detergent composition comprising an antimicrobial agent, an enzyme, and a hydrotrope.

The antimicrobial agent can se at least one of a biguanide compound and a quaternary ammonium compound. Quaternary ammonium compounds comprise a nitrogen atom covalently bonded to four R-groups. For example, quaternary ammonium compounds can comprise Formula 1 below.

Formula 1 where R14 are each an alkyl or aryl group, and R14 may each be the same or different.

As used herein a “biguanide nd” means at least one of a bisbiguanide compound, a biguanide compound, and a polybiguanide nd. Polybiguanide compounds can se Formula 2 below.

//III//////////////////////////,i \.\\\ ‘33: x:1: 353w.i III/I ‘l/I/////lll////////I1 3:3 21:3 3:2 S § . where R5 is an alkyl or an aryl, R5 may be halogen substituted; and n is in a range of 1 to 50.

For example, when n is 2, the polybiguanide compounds can comprise Formula 3 below. $335 33 where R6 and Rs are each an alkyl or an aryl, R6 and Rs may be halogen substituted, and R6 and Rs may be the same or different; and R7 is an alkyl comprising 3 to 10 carbon atoms.

The antimicrobial agent in the detergent compositions of the present disclosure can remove and/or eliminate bioburden. The antimicrobial agent can disinfect an object (e.g., Via disruption of biological membranes or denaturation of proteins). The antimicrobial agent can be present in the detergent compositions of the present disclosure in any effective amount. For example, the detergent composition can se at least 0.001% antimicrobial agent by weight based on the total weight of the detergent ition such as, for example, at least 0.01% antimicrobial agent by , at least 0.1% antimicrobial agent by weight, at least 0.5% antimicrobial agent by weight, at least 1% antimicrobial agent by weight, at least 2% antimicrobial agent by weight, at least 3% antimicrobial agent by weight, at least 4% antimicrobial agent by weight, at least 5% antimicrobial agent by weight, at least 10% antimicrobial agent by weight, or at least 15% antimicrobial agent by weight. The detergent ition can se 20% or less antimicrobial agent by weight based on the total weight of the detergent composition such as, for example, 15% or less antimicrobial agent by , % or less antimicrobial agent by weight, 5% or less antimicrobial agent by weight, 4% or less antimicrobial agent by weight, 3% or less antimicrobial agent by weight, 2% or less antimicrobial agent by weight, 1% or less antimicrobial agent by weight, 0.5% or less antimicrobial agent by weight, 0.1% or less antimicrobial agent by weight, or 0.01% or less antimicrobial agent by weight. The detergent composition can comprise 0.001% to 20% antimicrobial agent by weight based on the total weight of the detergent composition such as, for e, 0.001% to 5% antimicrobial agent by weight, 0.01% to 5% antimicrobial agent by weight, 0.1% to 5% antimicrobial agent by weight, 1% to 5% antimicrobial agent by weight, 1% to 10% antimicrobial agent by weight, 5% to 15% crobial agent by weight, or 1% to 20% antimicrobial agent by weight.

The biguanide nd, if present, can comprise at least one of chlorhexidine (e.g, N,N””1,6-Hexanediylbis[N'-(4-chlorophenyl)(imidodicarbonimidic diamide)]), alexidine (e.g., 1,1’-(l,6-Hexanediyl)bis{2-[N’-(2-ethylhexy1)carbamimidoyl]guanidine}), octenidine, (e.g, N- octyl-l-[10-(4—octyliminopyridinyl)decyl]pyridinimine), a polybiguanide such as Polyhexanide (polyhexamethylene biguanide), and a salt of any thereof.

The quaternary ammonium compound, if present, can comprise, for example, at least one of l dimethyl benzyl ammonium chloride, didecyl dimethyl um chloride, and n- alkyl yl ethylbenzyl ammonium chloride, and various other suitable quaternary ammonium compounds as known in the art. The quaternary ammonium compound can comprise n-alkyl dimethyl benzyl ammonium de and didecyl dimethyl ammonium chloride. The quaternary ammonium compound may be BTC 1210 ®, available from Stepan Company, Northfield, Illinois. BTC 1210 ® can comprise l yl benzyl ammonium chloride and l dimethyl ammonium chloride.

The detergent composition can further comprise a hydrotrope. A hydrotrope is a substance that can solubilize hydrophobic substances while in aqueous solution. ropes lly do not form micelles as readily as surfactants because the hydrophobic moieties of WO 03007 hydrotropes are too small to do so. The hydrotrope can be, for example, an anionic, cationic, or ic hydrotrope. The hydrotrope can be inorganic or organic and can se tant activity. Organic solvents can be sulfonated to create a sulfonic acid, which can then be neutralized to create a rope salt. The hydrotrope can comprise at least one of an alkanoic acid (e.g., sulfonic acid, carboxylic acid), an aromatic sulfonic acid, an aromatic ylic acid, and a salt of any thereof. The salt of the alkanoic acid can be, for example, a sodium alkanoate salt. The hydrotrope can comprise a toluenesulfonyl functional group. The hydrotrope can comprise at least one of urea, enesulfonic acid (e.g., 4—methylbenzene—1-sulfonic acid), xylene ic acid (e.g., 2,5-dimethylbenzenesulfonic acid), cumene sulfonic acid (e.g., 2(or 4)-(isopropyl)benzenesulphonic acid), and a salt of any thereof. If an anionic hydrotrope is employed, the hydrotrope can comprise at least one of Cola®Trope INC, Cola®Trope OD, and Cola®Trope CA. All three Cola®Trope substances are available from Colonial Chemical, Inc., South Pittsburg, Tennessee, USA. All three Cola®Trope substances se sodium alkanoate.

The hydrotrope can be present in the ent compositions of the present disclosure in any effective amount. For example, the detergent compositions of the present disclosure can comprise at least 0.01% hydrotrope by weight based on the total weight of the detergent composition such as, for example, at least 0.1% hydrotrope by weight, at least 1% hydrotrope by , at least 5% hydrotrope by weight, at least 10% rope by weight, at least 15% hydrotrope by weight, at least 20% hydrotrope by weight, or at least 25% hydrotrope by weight.

The detergent composition can comprise 30% or less hydrotrope by weight based on the total weight of the detergent composition such as, for example, 25% or less hydrotrope by weight, % or less hydrotrope by weight, 15% or less hydrotrope by weight, 10% or less hydrotrope by weight, 5% or less hydrotrope by weight, 1% or less hydrotrope by weight, or 0.1% or less hydrotrope by weight. The detergent composition can comprise 0.01% to 30% rope by weight based on the total weight of the detergent composition such as, for example, 0.1% to % hydrotrope by weight, 1% to 30% hydrotrope by weight, 5% to 20% hydrotrope by weight, % to 15% hydrotrope by weight, 10% to 20% hydrotrope by weight, or 10% to 15% hydrotrope by weight.

The detergent composition can further comprise an enzyme component. The enzyme ent can be in the form of a liquid enzyme solution or a dry, powdered ent (e.g., lyophilized). The enzyme can remove and/or eliminate debris via enzymatic digestion (e.g., decomposition) of the . The enzyme can comprise a hydrolase enzyme. The hydrolase enzyme can break chemical bonds in the debris and/or bioburden, by the addition of a water molecule (e.g., ysis). For example, the hydrolase enzyme can remove and/or eliminate lipids, carbohydrates, proteins, peptides, and c acids from an object. The hydrolase enzyme can comprise at least one of a lipase, a protease, a peptidase, an amylase, a idase, a cellulase, a DNAse, and a se. The enzyme can be selected based on a pH of a detergent composition and/or effectiveness on removing and/or eliminating a select debris and/or bioburden.

The enzyme can be present in the detergent compositions of the present disclosure in any effective amount. For e, the enzyme can comprise at least 0.001% active enzyme protein by weight based on the total dry weight of the enzyme such as, for example, at least .01% active enzyme protein, at least 0.1% active enzyme protein, at least 1% active enzyme protein, at least % active enzyme protein, at least 10% active enzyme protein, or at least 15% active enzyme protein. The enzyme can comprise 20% or less active enzyme n by weight based on the total dry weight of the enzyme such as, for example, 15% or less active enzyme protein, 10% or less active enzyme protein, 5% or less active enzyme protein, 1% or less active enzyme protein, 0.1% or less active enzyme protein, or .01% or less active enzyme protein. The enzyme can comprise 0.001 % to 20 % active enzyme protein by weight based on the total dry weight of the enzyme such as, for example, 0.01% to 20% active enzyme protein, 0.1% to 20% active enzyme protein, 0.1% to 10% active enzyme protein, 1% to 10% active enzyme protein, or 1% to 5% active enzyme protein.

The pH the detergent composition can be adjusted based on the enzyme such that the enzyme has an tic activity suitable to remove and/or ate debris and/or bioburden.

For example, the detergent ition can have a pH of at least 6.0 such as, for example, at least 6.5, at least 7.0, at least 7.5, at least 8.0, at least 9, at least 10, or at least 11. The detergent composition can have a pH of less than 12 such as, for example, less than 11, less than 10, less than 9.0, less than 8, less than 7.5, less than 7.0, or less than 6.5. The detergent composition can have a pH in a range of6 to 12 such as, for example, 6 to 8, 7 to 10, 7 to 9, or 8 to 11.

The pH of the detergent composition can be adjusted by adding a pH adjusting agent.

The pH adjusting agent can be, for example, at least one of an acid and a base. The pH adjusting agent can comprise, for example, at least one of sodium hydroxide, potassium hydroxide, monoethanolamine, diethanolamine, and triethanolamine. The detergent composition can comprise any effective amount of pH adjusting agent to e the d pH. For example, the detergent composition can comprise 2% or less of a pH adjusting agent based on the total weight of the detergent composition such as, for e, 1% or less of a pH adjusting agent, 0.5% or less ofa pH adjusting agent, 0.1% or less ofa pH adjusting agent, 0.01% or less ofa pH adjusting agent, 0.001% or less of a pH adjusting agent The detergent composition can comprise at least 0.0001% of a pH adjusting agent based on the total weight of the detergent composition such as, for example, at least 0.001% of a pH adjusting agent, at least 0.01% of a pH adjusting agent, at least 0.1% of a pH adjusting agent, at least 0.5% of a pH adjusting agent, or at least 1% of a pH adjusting agent. The detergent composition can se 0.0001% to 2% of a pH adjusting agent based on the total weight of the detergent composition such as, for example, 0.1% to 2% of a pH adjusting agent, 0.01% to 2% of a pH adjusting agent, or 0.001% to 1% of a pH adjusting agent.

Detergent compositions of the present disclosure can further comprise a boron- containing nd such as, for example, boric acid (e.g., H3BO3), borax (e.g., mineral salts of boric acid, including commercially provided, lly dehydrated salts), and other similar boron-containing compounds. These boron-containing compounds can improve the pH ing, cleaning performance, and enzyme stability of a detergent composition. Surprisingly, however, it has been found that examples of the detergent compositions of the present disclosure do not require boron-containing compounds for aspects of their performance such as, for example, enzyme stability, pH buffering, and/or cleaning performance. Thus, it may be advantageous for the detergent compositions of the present disclosure to se a limited amount of a boron-containing compound, only incidental (116., trace) amounts of a boron- ning compound, no measurable boron—containing compound at all, or no intentionally added boron-containing compound. For example, detergent compositions of the present disclosure can comprise 0.1% or less by weight of a boron-containing compound based on the total weight of the ent composition such as, for example, 0.01% or less by weight of a boron—containing compound, 0.001% or less by weight of a boron-containing compound, 0.0001% or less by weight of a containing compound, or no able boron-containing compound, The detergent composition of the present disclosure can further comprise a buffer component. The buffer can stabilize the pH of the detergent composition and can maintain a chemical environment that can be compatible with other components of the detergent composition such as, for example, the enzyme. The buffer can comprise, for example, a conjugate acid/base pair. The conjugate acid/base pair can comprise a zwitterion compound.

The zwitterion compound can accept and donate hydrogen ions in response to pH changes, thereby ining a consistent pH. The zwitterion compound can comprise an amino acid, such as, for example, glycine. The ate acid/conjugate base pair can comprise, for example, at least one of tris(hydroxymethyl)aminomethane, a carbonate buffer, and a phosphate buffer. If present, the buffer may be present in the detergent compositions of the present sure in any effective amount. For e, the detergent composition can comprise 10% or less by weight of buffer based on the total weight of the detergent composition such as, for example, 5% or less buffer by weight, 3% or less buffer by weight, 1% or less buffer by weight, 0.5% or less buffer by weight, 0.1% or less buffer by weight, 0.01% or less buffer by weight, or 0.001% or less buffer by weight. The detergent compositions of the present disclosure can comprise at least 0.0001% by weight of buffer based on the total weight of the ent composition such as, for example, at least 0.001% by weight of buffer, at least 0.01% by weight of buffer, at least 0.1% by weight of buffer, at least 0.5% by weight of buffer, at least 1% by weight of buffer, at least 3% buffer by weight, or at least 5% by weight of buffer. The detergent compositions of the present disclosure can comprise 0.0001% to 10% by weight of buffer based on the total weight of the detergent ition such as, for example, 0.001% to 5% by weight of buffer, 0.01% to 5% by weight of buffer, 0.1% to 5% by weight of buffer, 0.5% to 3% by weight of buffer, or 0.5% to 2% by weight of buffer.

The detergent composition of the present disclosure can r comprise a solvent. The solvent can assist in removing and/or eliminating debris from the obj ect. The solvent can enhance solubility of the components of the detergent composition and/or the solubility of the debris and/or bioburden. Enhancing the solubility of the debris and/or bioburden can facilitate removal and/or ation of the debris and/or bioburden. The solvent can comprise, for example, at least one of a glycol ether, propylene glycol, ne glycol, methanol, ethanol, isopropanol, and anol. The glycol ether can comprise, for e, at least one of 2— ethoxyethanol, 2-butoxyethanol, methyl ether, and propylene glycol l ether. If present, the t may be present in the detergent compositions of the present disclosure in any effective amount. For e, the detergent composition can comprise at least .01% solvent by weight based on the total weight of the detergent composition such as, for example, at least 0.1% solvent by weight, at least 1% t by weight, at least 5% solvent by weight, at least 10% solvent by weight, at least 11% solvent by weight, at least 12% solvent by weight, at least 13% solvent by weight, at least 14% solvent by weight, at least 15% solvent by weight, at least 20% solvent by weight, at least 30% solvent by weight, or at least 40% t by weight. The ent ition can comprise 50% or less solvent by weight based on the total weight of the detergent composition such as, for example, 40% or less t by weight, 30% or less solvent by , 20% or less solvent by weight, 15% or less solvent by weight, 14% or less solvent by weight, 13% or less solvent by weight, 12% or less solvent by weight, 11% or less solvent by weight, 10% or less solvent by weight, 5% or less solvent by weight, 1% or less solvent by weight, or 0.1% or less solvent by . The ent composition can comprise 0.01% to 50% solvent by weight based on the total weight of the detergent ition such as, for example, 0.1% to 5% solvent by weight, 5% to 20% t by weight, 10% to 20% solvent by weight, or 10% to 15% solvent by weight.

The detergent compositions of the present disclosure can further comprise a salt. The salt can increase removal and/or elimination of debris by the enzyme. The salt can act as an enzyme stabilizer. The salt can be c or inorganic and can comprise, for example, at least one of calcium chloride, potassium chloride, sodium chloride, sodium citrate, and magnesium chloride. If present, the salt may be present in the detergent compositions of the present sure in any effective amount. For example, the ent composition can se 10% or less of salt by weight, based on the total weight of the detergent composition such as, for example, 5% or less salt by weight, 4% or less salt by weight, 3% or less salt by weight, 2% or less salt by weight, 1% or less salt by weight, 0.5% or less salt by weight, 0.1% or less salt by weight, or 0.01% or less salt by weight. The detergent composition can comprise at least 0.001% of salt by weight, based on the total weight of the detergent composition such as, for example, at least 0.01% of salt by weight, at least 0.1% of salt by weight, at least 0.5% of salt by weight, at least 1% of salt by weight, at least 2% of salt by weight, at least 3% of salt by weight, at least 4% of salt by weight, or at least 5% of salt by weight. The detergent ition can comprise 0.001% to 10% of salt by weight, based on the total weight of the detergent composition such as, for example, 0.1% to 5% of salt by weight or 0.001% to 0.1%.

The detergent composition of the present disclosure can further comprise a chelating agent. The chelating agent can increase cleaning by the detergent composition. For example, the chelating agent can chelate a metal ion and/or chelate at the pH of the detergent composition.

The ing agent can be a non-phosphate chelator and/or can be biodegradable. The chelating agent can comprise, for example, at least one of, methylglycindiacetic acid, N,N— 2019/000845 bis(carboxymethyl)-L-glutamic acid, citric acid, a gluconic acid, N—(l,2-dicarboxyethyl)aspartic acid, ethylenediamine-N, N'-disuccinic acid, and a salt of any f. The chelating agent can comprise Trilon M®, available from BASF, SE, Ludwigshafen, Germany. Trilon M® can comprise trisodium salt of methylglycindiacetic acid. The chelating agent can comprise Dissolvine® GLS, available from Akzo Nobel N.V., Amsterdam, Netherlands. vine® GLS can comprise Tetrasodium N,N—bis(carboxymethyl)-L-glutamate. The chelating agent can comprise Baypure® CX100, available from Lanxess AG, e, Germany. Baypure® CX100 can comprise N—(l,2-dicarboxyethyl)aspartic acid as a sodium salt (e.g., Tetrasodium iminodisuccinate).

If present, the chelating agent may be present in the detergent compositions of the present disclosure in any ive amount. For example, the detergent composition can se 5% or less of chelating agent by weight based on the total weight of the detergent composition such as, for example, 4% or less of chelating agent by weight, 3% or less of chelating agent by weight, 2% or less of chelating agent by weight, 1% or less of chelating agent by weight, 0.1% or less of chelating agent by weight, or 0.01% or less of chelating agent by weight. The detergent composition can comprise at least 0.005% of chelating agent by weight based on the total weight of the detergent composition such as, for example, at least 0.01% of chelating agent by weight, at least 0.1% of chelating agent by weight, at least 1% of chelating agent by weight, at least 2% of chelating agent by weight, at least 3% of chelating agent by weight, or at least 4% of chelating agent by weight. The detergent composition can se 0.005% to 5% of ing agent by weight based on the total weight of the detergent composition such as, for example, 0.005% to 0.1% of ing agent by weight, 0.5% to 3% of chelating agent by weight, 1% to 3% of chelating agent by weight.

The ent composition of the present disclosure can se surfactants in addition to the hydrotrope, such as, for example, a non—ionic surfactant. The non-ionic surfactant can increase the solubility of debris and/or bioburden, and aid in the removal of the debris and/or bioburden from the object. The non-ionic tant can be low g. Non-ionic tants can se, for example, at least one of a fatty alcohol ethylene oxide/propylene oxide copolymer derivative, a polyoxyethylene-polyoxypropylene block copolymer, and various other non-ionic surfactants as known in the art. The non-ionic surfactant may be Dehypon ® LS 54 available from BASF SE, Ludwigshafen, Germany. Dehypon ® LS 54 can comprise a C12-15 fatty alcohol ethylene oxide/propylene oxide copolymer derivative. The non—ionic surfactant may be Dehypon ® LS 36 available from BASF SE, Ludwigshafen, Germany. Dehypon ® LS 36 can comprise a C12-14 fatty l ethylene propylene oxide copolymer derivative.

The non-ionic surfactant may be Pluronic® L62 ble from BASF SE, Ludwigshafen, Germany. Pluronic® L62 can se a polyoxyethylene-polyoxypropylene block copolymer.

If present, the non-ionic surfactant may be present in the detergent compositions of the t disclosure in any effective amount. For example, the detergent composition can comprise at least 0.005% of non-ionic surfactant by weight based on the total weight of the detergent composition such as, for example, at least 0.01% of non-ionic surfactant by weight, at least 0.1% of non-ionic surfactant by weight, at least 1% of non-ionic surfactant by weight, at least 2% of non-ionic surfactant by weight, at least 3% of non-ionic surfactant by weight, at least 4% of non-ionic tant by weight, at least 5% of non-ionic surfactant by weight, at least 6% of non-ionic surfactant by weight, or at least 7% of non-ionic surfactant by weight. The detergent ition can se 10% or less of non-ionic surfactant by weight based on the total weight of the detergent composition such as, for example, 7% or less of non-ionic surfactant by weight, 6% or less of non—ionic surfactant by weight, 5% or less of non-ionic surfactant by , 4% or less of nic tant by weight, 3% or less of nic surfactant by weight, 2% or less of non-ionic surfactant by weight, 1% or less of non-ionic surfactant by , 0.1% or less of non-ionic surfactant by weight, or 0.01% or less of non- ionic surfactant by weight. The detergent ition can comprise 0.005% to 10% of non- ionic surfactant by weight based on the total weight of the detergent composition such as, for example, 0.01% to 1% of non-ionic surfactant by weight, 0.5% to 7% of non-ionic surfactant by weight, 0.5% to 6% of non-ionic surfactant by weight, 1% to 6% of non-ionic surfactant by weight, or 2% to 6% of non-ionic surfactant by weight.

The detergent compositions of the present disclosure can further comprise at least 10% by weight of water based on the total weight of the detergent composition such as, for example, at least 25% water by weight, at least 35% water by weight, at least 40% water by weight, at least 45% water by weight, at least 50% water by weight, at least 55% water by weight, or at least 60% water by weight. The water content of the detergent composition can be in a range of % to 60% by weight based on the total weight of the detergent composition such as, for example, 25% to 55% by weight, 30% to 55% by weight, or 34% to 50% water by . The water employed can be any suitable type of water known in the art such as, for example, at least one of de-ionized water, distilled water, reverse osmosis treated water, filtered water, sterile water, tap water, and the like.

It is understood that a detergent composition of the present disclosure can be made in a concentrated or diluted form. Accordingly, the present disclosure provides examples wherein the percentage by , based on the total weight of the composition, of various components of the detergent composition are at relatively high values, and es wherein the percentage by , based on the total weight of the composition, of various components of the detergent composition are at relatively low values. Compositions of relatively high and relatively low concentrations are contemplated herein and may serve n intended purposes.

The detergent itions of the present disclosure can be stored for a period of time before use in a cleaning and/or disinfecting. After storage, the detergent itions can maintain an enzymatic ty of an enzyme le for removing and/or eliminating debris and/or bioburden. For example, the detergent compositions of the present sure can comprise a four week storage stability at 40 degrees Celsius suitable to in the enzymatic activity of the enzyme of at least 40% of an initial enzymatic activity of the enzyme prior to storage such as, for example, at least 50% of the initial enzymatic activity, at least 60% of the initial enzymatic activity, at least 70% of the initial enzymatic activity, at least 80% of the initial enzymatic ty, at least 90% of the initial enzymatic activity, or at least 95% of the initial enzymatic activity prior to storage. The detergent compositions of the present disclosure can comprise a four week storage stability at 30 degrees Celsius suitable to maintain an enzymatic activity of the enzyme of at least 40% of an initial enzymatic activity of the enzyme prior to storage such as, for example, at least 50% of the initial enzymatic ty, at least 60% of the initial enzymatic activity, at least 70% of the initial enzymatic ty, at least 80% of the initial enzymatic activity, at least 90% of the initial enzymatic activity, or at least 95% of the l enzymatic activity. The detergent compositions of the present disclosure can comprise a four week storage stability at 25 degrees s suitable to maintain an enzymatic activity of the enzyme of at least 40% of an initial enzymatic activity of the enzyme in the enzyme prior to e such as, for example, at least 50% of the initial tic activity, at least 60% of the initial enzymatic activity, at least 70% of the initial enzymatic activity, at least 80% of the initial enzymatic activity, at least 90% of the initial enzymatic activity, or at least 95% of the initial enzymatic activity.

The present disclosure also provides methods of making a detergent ition. The components of the detergent composition set forth herein can be combined in any suitable manner and in the various amounts set forth herein. For example, the antimicrobial agent, the hydrotrope, and the enzyme can be combined in any manner in the s set forth herein to form the detergent compositions of the present disclosure. For e, based on the total weight of the detergent composition, at least 10% by weight of water, at least 0.001% by weight of the antimicrobial agent, at least 0.01% by weight of the hydrotrope, and the enzyme can be combined to form the detergent composition. The components of the ent compositions of the present disclosure can be combined in any order. For example, combining the water, antimicrobial agent, and the hydrotrope can occur prior to adding the enzyme. Also, optional components provided herein can be added to the detergent compositions of the present disclosure. For example, at least one of the buffer, the chelating agent, the solvent, the non—ionic surfactant, and the salt described herein can be added to the detergent compositions of the present disclosure. The pH of the detergent composition can be adjusted to a pH suitable to in enzymatic activity of an enzyme. The pH can be adjusted prior to adding the enzyme.

When a dry, powdered detergent composition is d, dry, powered components can be mixed together to form a powdered mixture and then surfactants can be mixed with, such as sprayed onto (e.g., in a liquid form), the powdered mixture. The powdered mixture can be mixed until a desired homogeneity is achieved.

The components of the detergent itions of the present disclosure can be combined in various . For example, the components of the detergent composition can be combined by adding each component one at a time, adding multiple components in a single step, or adding a portion of a component at multiple addition stages. For e, based on the total weight of the detergent composition, at least 10% by weight of water can be combined with at least 0.001% by weight of the antimicrobial agent, followed by at least 0.01% by weight of the hydrotrope. The buffer, if present, can then be added, ed by the addition of the enzyme.

Thereafter, the pH can be adjusted to a level riate for the enzyme to retain enzymatic activity. Alternatively, the enzyme can be added after the pH of the detergent composition has been adjusted.

The water, the antimicrobial agent, the rope, the non-ionic surfactant, and the buffer can each be added in a single n or in multiple ns. For example, a first portion of the buffer can be added to the water to form a first composition, the solvent can be added to the first composition to form a second composition, and the remaining portion of the buffer can be added to the second composition to form a third composition. Then, the third composition can be combined with the antimicrobial agent, the hydrotrope, and the enzyme, in a single step, in series, or in some other ation, to form the detergent composition of the present disclosure. The enzyme can be the final component added.

A method for cleaning all or a portion of an object is also provided herein. For example, the object can be a reusable medical device such as, for example, an endoscope, and the detergent composition can be used to clean and disinfect the endoscope. The detergent composition of the present disclosure can clean and/or disinfect the object by removing debris and/or bioburden, from the object. The method for ng the object can se applying the detergent composition of the present sure to the object. As used herein, “applying” is meant to include all or a n of the object, ing one or more surfaces of the object, whether the surface of the object is an exterior surface, an interior surface, or a cavity of the . As set forth above, the detergent composition can comprise the various components and amounts set forth herein. For e, based on the total weight of the detergent composition, the detergent composition can comprise at least 0.001% by weight of the antimicrobial agent, at least 0.01% by weight of the hydrotrope, and the enzyme. Application of the detergent composition of the present disclosure thereby cleans the obj ect. The detergent composition can be applied to the object by any suitable means. For example, ng the detergent composition of the present disclosure to the object can comprise at least one of depositing, scrubbing, spraying, rolling, submerging, and/or agitating the detergent composition over, onto, or inside the obj ect.

Before or during applying the detergent composition of the present disclosure to the object, the detergent composition can be diluted, if necessary, to a lower tration. The dilution can be by a factor of at least 5—fold, at least lO—fold, at least 20-fold, at least 50-fold, at least 100-fold, at least 200-fold, or any factor appropriate to achieve treatment of the object and/or ve the detergent composition. The diluting can be automated or manual. The diluent can comprise or consist of, for example, water in any type as y described herein.

The detergent composition can be applied to the object manually or automatically (e.g., mechanically) to clean and/or disinfect the . After application, the ent composition can be immediately removed from, or be allowed to remain on, the object for a period of time.

W0 2020l003007 The detergent composition and any remaining debris or bioburden can be removed from the object by wiping, rinsing, drying, or combinations thereof.

The ng and/or ecting can occur in a treatment system such as, for example, an automated endoscope re-processor. Referring to Figure 1, the treatment system 100 can comprise a chamber 102 ing a basin 104 in fluid ication with a reservoir 106.

The chamber 102 may be any suitable size and configuration to receive the object (not , and can be suitable to perform a treatment process on the object. The chamber 102 can be at least one of a cleaning chamber and/or a disinfection chamber. The object can comprise an endoscope. The treatment system 100 can se an automated endoscope re-processor.

The reservoir 106 can be any suitable size and configuration to receive the detergent composition of the present disclosure and can store the detergent ition until the detergent composition can be output into the basin 104. The basin 104 can be in fluid communication with the reservoir 106 via a treatment line 108 and can receive detergent composition from the reservoir 106. The treatment line 108 can receive the detergent composition from the reservoir 106 and transport the ent composition to the basin 104. The treatment line 108 can include at least one of a tube, a valve, and a pump. The ent line 108 can l the amount of detergent ition provided to the basin 104. For example, the detergent composition can be metered into the basin 104 by the treatment line 108 until a select amount of detergent composition has been provided to the basin 104. The basin 104 can be in fluid communication with a drain line 110 to remove detergent composition from the basin.

An object to be treated can be provided to the r 102 and subjected to the treatment process therein. The treatment process can comprise providing the detergent composition to the basin 104 and/or applying the detergent composition to the obj ect. For example, the detergent composition can be sprayed and/or deposited on the object by a spray arm (not shown) in the chamber 102. Thereafter, the object can be optionally wiped, rinsed, and/or dried and removed from the chamber 102.

Applying the detergent composition to the object can occur at an operating temperature in a range of 15°C to 60°C such as, for example, 15°C to 50°C, 30°C to 50°C, or 43°C to 48°C.

The operating temperature can be achieved through automation, such as in an automated endoscope cessor, a similar machine, or by heating the detergent composition independent of an ted endoscope re-processor.

Examples The present sure will be more fully understood by reference to the following examples, which provide illustrative, non-limiting aspects of the invention. The examples describe the making of detergent compositions and use thereof in cleaning and/or disinfecting.

Example 1 Detergent compositions F1-F6*, ed below, were manufactured as shown in Table 1. Glycine and calcium chloride were obtained from VWR International, Randor, Pennsylvania.

Sodium hydroxide and 2-ethoxyethanol were obtained from Sigma-Aldrich, St. Louis, Missouri.

Propylene glycol was obtained from Ward’s Science, ter, New York. Savinase ® everis, Stainzyme ® plus, and Lipex ® everis were obtained from mes A/S, Denmark. Savinase ® everis ses an alkaline protease having an active enzyme protein of 2.5 % to 5 % by weight of the Savinase ® solution. Stainzyme ® plus comprises an amylase having active enzyme protein of 1 % to 2.5 % by weight of the Stainzyme ® solution. Lipex ® everis comprises a lipase. Savinase ® everis, Stainzyme ® plus, and Lipex ® everis were obtained in solution. BTC 1210 ® was obtained from Stepan Company, Northfield, Illinois. Trilon M® was obtained from BASF, SE, Ludwigshafen, Germany. Dehypon ® LS 54 was obtained from BASF SE, Ludwigshafen, Germany. 1.6 kilograms of each ent composition F1-F6* was prepared. For the ation of each detergent compositions F1-F6*, glycine was added to de-ionized water and then sodium hydroxide and Trilon M ® were added in order respectively. The pH of the detergent composition was adjusted and/or maintained by addition of the glycine and the sodium ide to the detergent composition. If used (e.g., detergent itions F1, F3, F4*, and F6*), 2-ethoxyethanol was added after the addition of the Trilon M ®. rly, if used (detergent compositions F2, F3, F5*, and F6*), propylene glycol was added after the addition of the Trilon M ® and the optional addition of the 2-ethoxyethanol. Then, for detergent compositions F4*-F6*, BTC ® 1210 was added. Thereafter, for detergent compositions Fl-F6*, Dehypon ® LS 54 and Calcium chloride were added in order respectively. The enzyme solutions, Savinase ® everis, Stainzyme ® plus, and Lipex ® everis were added last.

As shown in Table 1, detergent compositions F 1 and F4* are similar except that F4* ses BTC ® 1210. ent compositions F2 and F5* are similar except that F5* W0 2020l003007 comprises BTC ® 1210. Detergent compositions F3 and F6* are similar except that F6* comprises BTC ® 1210.

Table 1: Weight percentage (wt. %) of each component of the detergent compositions F1-F6* based on the total weight of the composition.

Deter ~ ent Com 1 osition De-ionized Water wt. % 49.84 44.842 49.842 44.842 39.842 34.842 m—————2 WtHydroxide 0098 --0 098 0 098 0. 098 0. 098 0.098 —-l—_—__ 1 n——---25 25 _-----wt% 25 25 10 10 _— 5 _—----wt% 2 2 2 2 _mmmmmwt% 0.06 _nn---wt% 10 10 10 10 _-—---wt% 5 5 5 5 —--———-5 8.85 *These ent compositions contain a quaternary ammonium compound.

Example 2 To determine the s of quaternary ammonium compound presence on enzymatic activity, the detergent compositions F1-F6* were stored at 25 degrees Celsius, 30 degrees Celsius, 40 degrees Celsius, and 50 degrees Celsius in ate for 4 weeks. At two weeks and four weeks, aliquots of the stored detergent compositions F1-F6* were sampled and tested for the enzymatic activity against a rd substrate. Enzyme activities of each aliquot were compared to initial activities of the detergent compositions F1-F6* before storage. singly, as illustrated in Tables 2-7 and described herein, the detergent compositions *maintained an amount of enzymatic activity suitable to remove and/or eliminate debris and/or bioburden from an object after storage.

W0 2020l003007 Results for Savinase ® everis are shown in Table 2 which shows enzymatic activity data after 2 weeks of storage and Table 3 which shows enzymatic activity data after 4 weeks of storage. Detergent compositions F4*—F6* ined an amount of Savinase ® enzyme activity suitable to clean and/or disinfect an object at after storage for 4 weeks at 25 degrees Celsius, 30 degrees Celsius, and 40 degrees Celsius. Detergent composition F5* had an enhanced Savinase ® storage stability compared to detergent composition F2 after storage for 4 weeks at 25 degrees Celsius, 30 degrees Celsius, and 40 degrees Celsius.

Table 2: Savinase ® tic ty as a percentage of initial enzymatic activity after 2 weeks of storage Deter_ent Com osition Storage Tem o e F 1 F4* F2 F5* F3 F6* “mm“ Table 3: Savinase ® enzymatic ty as a percentage of initial enzymatic activity after 4 weeks of storage Deter;ent Com osition Tem o erature F6* -ii 90 °C -33 21 40°C Results for Stainzyme ® Plus are shown in Table 4 which shows enzymatic activity data after 2 weeks of storage and Table 5 which shows enzymatic activity data after 4 weeks of storage. Detergent compositions F4*—F6* maintained an amount of yme ® Plus enzymatic activity le to clean and/or disinfect an object after 4 weeks of storage at 25 degrees Celsius, 30 degrees Celsius, and 40 degrees Celsius. Detergent composition F5* had an enhanced Stainzyme ® Plus storage stability compared to detergent composition F2 after 4 W0 2020l003007 weeks of storage at 40 degrees Celsius. Detergent composition F6* had an enhanced Stainzyme ® Plus storage ity compared to detergent composition F3 after 4 weeks of storage at 25 degrees Celsius, and 30 degrees s, 40 degrees Celsius.

Table 4: Stainzyme ® Plus enzymatic ty as a percentage of initial tic activity at 2 weeks Deter ent Com osition Table 5: Stainzyme ® Plus enzymatic activity as a percentage of initial enzymatic activity at 4 weeks Example 3 Detergent compositions Al-A4, provided below, were manufactured as shown in Table 6. Glycine and calcium chloride were ed from VWR International, Randor, Pennsylvania.

Sodium ide was obtained from Sigma—Aldrich, St. Louis, Missouri. Propylene glycol was obtained from Ward’s Science, Rochester, New York. Ethylene glycol was obtained from VWR International, Randor, Pennsylvania. Colatrope ® OD was obtained from Colonial Chemical, Inc., South Pittsburg, Tennessee, USA. Dehypon ® LS 54, Dehypon ® LS 36, ic® L62, and Trilon M® were ed from BASF SE, Ludwigshafen, Germany.

Baypure® CXlOO was obtained from Lanxess AG, Cologne, Germany. DissolVine® GLS 47 was obtained from Akzo Nobel N.V., Amsterdam, lands. l am of each detergent composition Al-A4 was prepared.

Table 6: Weight percentage (wt. %) of each component of the detergent compositions Al-A4 based on the total weight of the composition Detergent Compositions Component Component Type A0 A1 A2 A3 A4 Qs to Qs to Qs to Qs to Qs to De-ionized water 8°”th 100 100 100 100 100 Propylene glycol Solvent 20 10 12 -n Ethylene glycol Solvent I.- p—l U‘I Sodium xylene Hydrotrope p—l N sulfonate Sodium cumene Hydrotrope sulfonate Colatrope ® OD rope Calcium chloride Enzyme stabilizer .

Sodium citrate Enzyme stabilizer Sodium gluconate Chelating agent O \1 Trilon® M Chelating agent Baypure® CXlOO Chelating agent DissolVine® GLS 47 ing agent p—a Dehypon® LS 54 Nonionic surfactant Dehypon® LS 36 Nonionic tant Pluronic® L62 Nonionic surfactant 0 U1 Glycine pH buffer Amplify lOOL Amylase enzyme Everis DUO lOOL Protease enzyme p—l U‘l Chlorohexidine (20% w/w solution in Antimicrobial agent W0 2020l003007 Up to Up to Up to Up to pH=8 pH=9 pH=10 pH=11 Example 4 To determine the cleaning efficacy of detergent compositions of the present disclosure, formulation AO according to the present disclosure and as bed in Example 3, was compared to commercially available detergent compositions, C1-C6, which are not according to the present disclosure. Each detergent composition (A0 and C1-C6) was tested with and t addition of an antimicrobial agent to control for the presence of an antimicrobial agent, which is not necessarily present in the commercially available detergent compositions. For all detergent compositions the antimicrobial agent was 5% by weight chlorhexidine gluconate (abbreviated as CHG), based on the total weight of the composition.

Detergent composition C1 is a commercially available l detergent composition comprising ic surfactants and triethanolamine. Detergent composition C2 is a commercially available enzymatic detergent composition comprising protease, amylase, and lipase enzymes. Detergent composition C3 is a commercially available enzymatic detergent composition comprising subtilisin se. Detergent composition C4 is a commercially available detergent composition comprising an antimicrobial agent (a biguanide). Detergent composition C5 is a commercially available enzymatic detergent comprising subtilisins (protease enzyme). Detergent ition C6 is a commercially available dual enzymatic detergent comprising proteinase subtilisin and subtilisin (protease ).

Cleaning efficacy was tested using ess steel and plastic s. The stainless steel coupons were Tosi® coupons available from Healthmark Industries Company, Inc., Fraser an, USA. Each Tosi® coupon comprises a stainless steel plate treated with simulated blood test soil to create a surface appropriate to test for cleaning activity. The ted blood comprises blood proteins in a sodium chloride and calcium chloride on. The plastic coupons were Verify® All Clean coupons available from STERIS ation Mentor, Ohio, USA. Each Verify® All Clean coupon comprises a plastic plate d with a test soil comprising proteins, lipids, and polysacchaIides. Thus, testing was conducted for cleaning of both metal and plastic surfaces, with and t antimicrobial agent.

The following procedure was used to perform the cleaning tests. First, each detergent composition was diluted with 200 PPM hard water to the recommended concentration in a first beaker. For detergent composition A0, the dilution factor was 1:100. Then, the resulting diluted detergent composition was heated to 45°C. Then, a plastic and stainless steel coupon were ed in the beaker for 10 min. After 10 min, each coupon was removed, and rinsed with de-ionized water. Then, each coupon was dried at room temperature overnight and examined and photographed for cleaning efficacy. s are shown in Figures 2-8. Generally, each Figure has a panel A, B, C, and D, with one raph in each panel. Panel A of each Figure shows a stainless steel coupon d with a d detergent composition to which 5% CHG was added. Panel B of each Figure shows a plastic coupon treated with a diluted detergent composition to which 5% CHG was added. Panel C of each Figure shows a stainless steel coupon treated with a diluted detergent composition to which no CHG was added. Panel D of each Figure shows a plastic coupon treated with a diluted detergent composition to which no CHG was added.

Figure 2 shows photographs of stainless steel and plastic coupons that were treated with diluted detergent composition A0. Panel 2A shows a stainless steel coupon treated with diluted detergent composition A0 to which 5% CHG was added. Panel 2B shows a plastic coupon treated with diluted detergent composition A0 to which 5% CHG was added. Panel 2C shows a stainless steel coupon treated with diluted detergent composition A0 to which no CHG was added. Panel 2D shows a c coupon treated with diluted detergent composition A0 to which no CHG was added.

Figure 3 shows photographs of stainless steel and plastic coupons that were d with diluted detergent ition C1. Panel 3A shows a stainless steel coupon treated with d detergent ition C1 to which 5% CHG was added. Panel 3B shows a plastic coupon treated with diluted detergent composition C1 to which 5% CHG was added. Panel 3C shows a stainless steel coupon treated with diluted detergent composition C1 to which no CHG was added. Panel 3D shows a plastic coupon treated with diluted detergent composition C1 to which no CHG was added. For all panels A-D of Figure 3, comparison to the corresponding panels of Figure 2 shows that cleaning y is increased in detergent compositions of the present disclosure, based on increased removal of test soil in Figure 2.

W0 2020l003007 Figure 4 shows photographs of stainless steel and plastic coupons that were treated with diluted detergent composition C2. Data for panels 4A and B was not obtainable because the 5% CHG that was added to detergent composition C2 was ble. Panel 4C shows a stainless steel coupon treated with diluted detergent composition C2 to which no CHG was added. Panel 4D shows a plastic coupon treated with diluted detergent composition C2 to which no CHG was added. For panels C and D of Figure 4, comparison to the corresponding panels of Figure 2 shows that cleaning efficacy is increased in detergent compositions of the present disclosure, based on increased removal of test soil in Figure 2.

Figure 5 shows photographs of stainless steel and plastic coupons that were treated with diluted ent composition C3. Data for panels 5A and B was not obtainable because the 5% CHG that was added to detergent composition C3 was insoluble. Panel 5C shows a ess steel coupon treated with diluted detergent composition C3 to which no CHG was added. Panel 5D shows a plastic coupon treated with diluted detergent composition C3 to which no CHG was added. For panels C and D of Figure 5, comparison to the ponding panels of Figure 2 shows that cleaning efficacy is increased in detergent compositions of the present disclosure, based on increased removal of test soil in Figure 2.

Figure 6 shows photographs of stainless steel and plastic coupons that were treated with diluted detergent composition C4. Panel 6A shows a stainless steel coupon treated with diluted detergent composition C4 to which 5% CHG was added. Panel 6B shows a plastic coupon d with diluted detergent composition C4 to which 5% CHG was added. Panel 6C shows a ess steel coupon treated with diluted detergent composition C4 to which no CHG was added. Panel 6D shows a plastic coupon treated with d detergent composition C4 to which no CHG was added. For all panels A—D of Figure 6, comparison to the corresponding panels of Figure 2 shows that cleaning efficacy is sed in detergent compositions of the present disclosure, based on increased removal of test soil in Figure 2.

Figure 7 shows photographs of stainless steel and plastic coupons that were treated with diluted detergent composition C5. Panel 7A shows a stainless steel coupon treated with diluted detergent composition C5 to which 5% CHG was added. Panel 7B shows a plastic coupon treated with d detergent composition C5 to which 5% CHG was added. Panel 7C shows a stainless steel coupon treated with d detergent composition C5 to which no CHG was added. Panel 7D shows a plastic coupon treated with diluted ent composition C5 to which no CHG was added. For all panels A-D of Figure 7, comparison to the corresponding panels of W0 2020l003007 Figure 2 shows that cleaning efficacy is increased in detergent compositions of the present sure, based on increased removal of test soil in Figure 2.

Figure 8 shows raphs of stainless steel and plastic coupons that were treated with diluted detergent composition C6. Data for panels 8A and B was not obtainable because the 5% CHG that was added to detergent ition C6 was ble. Panel 8C shows a stainless steel coupon treated with d detergent composition C6 to which no CHG was added. Panel 8D shows a plastic coupon treated with diluted detergent composition C6 to which no CHG was added. For panels C and D of Figure 8, comparison to the corresponding panels of Figure 2 shows that cleaning efficacy is sed in detergent compositions of the present disclosure, based on increased removal of test soil in Figure 2.

Example 5 To determine the cleaning and disinfection efficacy of detergent compositions of the t disclosure, formulation A0, according to the present disclosure and as described in Example 3, was compared to commercially available detergent composition C2 which is not according to the present disclosure. Each detergent composition (A0 and C2) was tested for the ability to remove bacterial biofilms. This was measured, first, based on the ability of treatment with the detergent composition to reduce bacterial presence and, second, based on the ability of treatment with the ent composition to reduce protein content of the biofilm.

Biofilms comprising Pseudomonas aeruginosa were grown in the lumen of a test object according to the ISO/TS 15883-5 Annex F . 8 test objects comprising P. aeruginosa biofilm were treated using an ted endoscope reprocessor. The treatments were performed in an automated endoscope repressor at 45°C and at an re time of 8 min. In 4 of the treatments a test object was treated with diluted detergent composition AX, at a dilution factor of 1:100. In the other 4 treatments, a test object was treated with d detergent composition C2, at a dilution factor of 0.8: 100, as recommended by the manufacturer. uent to the treatment, test objects were analyzed for colony forming units (CFUs) and for total protein utilizing a BCA protein assay. These values were ed to those obtained for an untreated test object comprising the biofilm to determine fold-reduction of bacteria and percent reduction of total n.

Results for reduction of bacteria are displayed in Table 7. In Replicate 1, treatment of a test object with diluted detergent composition A0 resulted in a Logio-fold reduction of bacteria W0 2020l003007 of 6.98 (e.g., a reduction of 106‘98-fold). In ate 1, treatment of a test object with diluted detergent composition C2 resulted in a Logio-fold reduction of bacteria of 2.64 (e.g, a reduction of 102'64-fold). In Replicate 2, treatment of a test object with diluted detergent composition A0 resulted in a Logio-fold reduction of bacteria of 6.85 (e. g., a reduction of -fold). In ate 2, treatment of a test object with diluted detergent composition C2 resulted in a Logio- fold reduction of bacteria of 4.89 (e.g, a reduction of 1 04‘89-fold). In Replicate 3, treatment of a test object with diluted ent composition A0 resulted in a LOgIO-fOld reduction of bacteria of 6.02 (e.g., a reduction of 106‘02-fold). In ate 3, treatment of a test object with diluted detergent composition C2 resulted in a LOgIO-fOld ion of bacteria of 1.38 (e.g, a reduction of 101'38-fold). In Replicate 4, treatment of a test object with diluted detergent composition A0 resulted in a Logio-fold ion of bacteria of 6.22 (e.g., a reduction of loan-fold). In Replicate 4, treatment of a test object with diluted detergent composition C2 resulted in a L0g10- fold reduction of bacteria of 3.56 (e.g, a reduction of 103‘56-fold).

These results te that cleaning and disinfecting efficacy is increased in ent compositions of the present disclosure, based on the sed removal of bacteria demonstrated by d detergent composition A0 in Table 7, compared to diluted detergent composition C2.

Table 7 LOgIO-fOld reduction of bacteria.

Diluted detergent Diluted detergent composition A0 (Logio-fold composition C2 (Logio-fold Results for reduction of total protein are displayed in Table 8. In Replicate 1, treatment of a test object with diluted detergent composition A0 resulted in a ion of total protein on the test object of 95.5%. In Replicate 1, ent of a test object with diluted detergent composition C2 resulted in a reduction of total protein on the test object of 72.3%. In Replicate 2, treatment of a test object with diluted detergent composition A0 resulted in a reduction of total protein on the test object of 99.2%. In Replicate 2, treatment of a test object with diluted detergent composition C2 resulted in a reduction of total protein on the test object of 86.2%. In Replicate 3, treatment of a test object with diluted ent composition A0 ed in a reduction of total protein on the test object of 98.8%. In Replicate 3, treatment of a test object W0 2020l003007 with diluted detergent composition C2 resulted in a reduction of total n on the test object of 95.8%. In Replicate 4, treatment of a test object with diluted detergent ition A0 resulted in a ion of total protein on the test object of 92.4%, In Replicate 4, treatment of a test object with diluted detergent composition C2 resulted in a reduction of total protein on the test object of 81.2%.

In each replicate shown in Table 8, cleaning and ecting y was increased in detergent compositions of the present disclosure, based on the increased removal of total protein demonstrated by diluted detergent composition A0, compared to diluted detergent composition Table 8 Percent reduction of protein. com-osition A0 com oosition C2 ate 1 te 2 Relicate 3 Relicate 4 The grammatical articles "a", "an", and "the", as used herein, are intended to include "at least one" or "one or more", unless otherwise indicated, even if “at least one” or “one or more” is sly used in certain instances. Thus, the articles are used herein to refer to one or more than one (i.e., to "at least one") of the grammatical objects of the article. Further, the use of a singular noun includes the plural, and the use of a plural noun includes the singular, unless the context of the usage es otherwise.

One skilled in the art will recognize that the herein described compositions, methods, and the discussion accompanying them are used as examples for the sake of conceptual clarity and that various configuration modifications are plated. Consequently, as used herein, the specific exemplars set forth and the accompanying discussion are intended to be representative of their more general classes. In general, use of any ic exemplar is intended to be representative of its class, and the non-inclusion of specific ents (e.g., operations), devices, and objects should not be taken limiting.

The herein described subject matter sometimes illustrates different components contained within, or connected with, different other components. It is to be understood that such depicted architectures are merely exemplary, and that in fact many other architectures may be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved. Hence, any two components herein combined to e a particular functionality can be seen as “associated with” each other such that the desired functionality is achieved, irrespective of architectures or intermedial components. Likewise, any two components so associated can also be viewed as being “operably connected,” or bly coupled,” to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being “operably couplable,” to each other to achieve the desired functionality. Specific examples of operably couplable include but are not limited to physically mateable and/or physically interacting ents, and/or ssly ctable, and/or wirelessly interacting components, and/or logically interacting, and/or logically interactable components.

With respect to the appended claims, those skilled in the art will appreciate that recited operations therein may generally be performed in any order. Also, although s operational flows are presented in a ce(s), it should be understood that the various operations may be med in other orders than those which are illustrated, or may be med concurrently.

Examples of such alternate orderings may include overlapping, interleaved, interrupted, reordered, ental, preparatory, supplemental, aneous, reverse, or other variant orderings, unless context dictates otherwise. Furthermore, terms like “responsive to, 77 (L related to,” or other past-tense adjectives are generally not intended to exclude such variants, unless context dictates otherwise.

Although vaiious examples have been described , many modifications, variations, substitutions, changes, and equivalents to those examples may be implemented and will occur to those skilled in the art. Also, where materials are disclosed for certain components, other materials may be used. It is ore to be understood that the foregoing description and the ed claims are intended to cover all such modifications and variations as g within the scope of the disclosed examples. The following claims are intended to cover all such ation and variations.

Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion f, that is said to be incorporated by reference herein, but which conflicts with existing deflnitions, ents, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

Various aspects of the invention according to the present disclosure include, but are not limited to, the aspects listed in the following numbered clauses. l. A detergent composition comprising: at least 0.001% by weight of an antimicrobial agent, based on the total weight of the composition, an enzyme, and at least 0.01% a hydrotrope, based on the total weight of the composition. 2. The composition of clause 1, wherein the hydrotrope comprises an anionic hydrotrope. 3. The composition of clause 2, wherein the anionic rope comprises at least one of an alkanoic acid, an aromatic sulfonic acid, an aromatic carboxylic acid, and a salt of any thereof. 4. The composition of clause 3, wherein the aromatic sulfonic acid is at least one of xylene sulfonic acid, cumene sulfonic acid, and a salt of any thereof.

. The ition of any one of clauses 1-4, sing 0.1% or less by weight of a boron-containing compound, based on the total weight of the composition. 6. The composition of any one of s 1-5, sing either no boron-containing compound or only an incidental amount. 7. The composition of any one of clauses 1-6, wherein the antimicrobial agent comprises at least one of a biguanide nd and a quaternary ammonium compound. 8. The ition of clause 7, wherein the ide compound comprises at least one of chlorhexidine and a salt thereof.

The composition of any one of clauses 1-8, wherein the enzyme comprises at least one of a lipase, a protease, a peptidase, an amylase, a idase, a cellulase, DNAse and a nuclease.

. The composition of any one of clauses 1-9, wherein the composition has a pH in a range of6toll. ll. The composition of any one of clauses l-lO, further comprising at least one of at least 0.0001% by weight of a , based on the total weight of the composition, and at least 0.0001% by weight of a pH adjusting agent, based on the total weight of the composition. 12. The composition of any one of clauses l-l 1, further comprising at least 0.01% by weight of a solvent, based on the total weight of the composition. l3. The composition of clause 12, wherein the solvent comprises at least one of a glycol ether, propylene , ethylene glycol, methanol, ethanol, isopropanol, and n-propanol. 14. The composition of any one of clauses l-l3, r comprising at least one of a chelating agent and a salt.

. The composition of any one of clauses 1-14, r sing at least 10% by weight of water, based on the total weight of the composition. l6. The ition of any one of clauses l-15, further comprising at least 0.005% by weight of a non-ionic surfactant, based on the total weight of the composition. 17. The composition of clause 16, wherein the non-ionic surfactant is low foam. 18. A method of making a detergent composition, the method comprising: combining, based on the total weight of the composition, at least 0.001% by weight of an antimicrobial agent, at least 0.01% by weight of a hydrotrope, and an enzyme. 2019/000845 19. The method of clause 18, further comprising adjusting a pH of the detergent composition prior to the adding the enzyme.

. The method of any one of clauses 18-19, further comprising adding at least one of a buffer, a chelating agent, a solvent, water, a non-ionic surfactant, and a salt. 21. A method for cleaning an object, comprising: applying a detergent ition to the object, the ition comprising, based on the total weight of the composition: at least 0.001% by weight of an antimicrobial agent, at least 0.01% by weight of a hydrotrope, and an enzyme thereby cleaning the object. 22. The method of clause 21, wherein the object comprises an endoscope. 23. The method of any one of clauses 21-22, further comprising disinfecting the obj ect. 24. The method of any one of clauses 21—23, wherein the applying the composition comprises ing an automated endoscope re-processor.

. The method of any one of clauses 21-24, n an ing ature is from 15°C to 60°C.

In summary, numerous benefits have been described which result from employing the ts described herein. The foregoing description of the one or more examples has been ted for purposes of illustration and description. It is not intended to be exhaustive or limiting to the precise form disclosed. Modifications or variations are possible in light of the above ngs. The one or more examples were chosen and described in order to illustrate principles and practical application to thereby enable one of ordinary skill in the art to utilize the various examples and with various modifications as are suited to the particular use contemplated. It is intended that the claims submitted herewith define the overall scope.

While the present disclosure provides descriptions of various specific aspects for the purpose of illustrating various aspects of the present disclosure and/or its potential applications, it is understood that ions and modifications will occur to those skilled in the art.

W0 2020l003007 Accordingly, the invention or inventions described herein should be tood to be at least as broad as they are claimed, and not as more narrowly defined by particular illustrative aspects provided herein.

Claims (25)

WHAT IS CLAIMED IS:

1. A ent composition comprising: at least 0.001% by weight of an antimicrobial agent, based on the total weight of the composition; an enzyme; and at least 001% a hydrotrope, based on the total weight of the composition.

The composition of claim 1, wherein the hydrotrope comprises an anionic hydrotrope.

The composition of claim 2, wherein the c rope compnses at least one of an alkanoic acid, an ic sulfonic acid, an aromatic carboxylic acid, and a salt of any thereof.

The composition of claim 3, wherein the aromatic sulfonic acid is at least one of xylene sulfonic acid, cumene sulfonic acid, and a salt of any thereof.

The composition of any one of claims 1-4, comprising 0.1% or less by weight of a boron—containing compound, based on the total weight of the composition.

The composition of any one of claims 1-5, comprising either no boron-containing compound or only an incidental amount.

The composition of any one of claims 1-6, wherein the antimicrobial agent comprises at least one of a biguanide compound and a quaternary ammonium compound.

The composition of claim 7, wherein the biguanide compound comprises at least one of exidine and a salt thereof.

The composition of any one of claims 1-8, wherein the enzyme comprises at least one of a , a protease, a peptidase, an amylase, a glycosidase, a cellulase, DNAse and a nuclease.

10. The composition of any one of claims 1-9, wherein the ition has a pH in a range of6toll.

11. The composition of any one of claims 1-10, further comprising at least one of: at least 0.0001% by weight of a buffer, based on the total weight of the ition, and at least 0.0001% by weight of a pH ing agent, based on the total weight of the composition.

12. The composition of any one of claims 1-11, further comprising at least 0.01% by weight of a solvent, based on the total weight of the composition.

13. The composition of claim 12, wherein the solvent comprises at least one of a glycol ether, propylene glycol, ethylene glycol, methanol, ethanol, isopropanol, and n-propanol.

14. The composition of any one of claims 1-13, further sing at least one of a chelating agent and a salt.

15. The composition of any one of claims 1-14, further comprising at least 10% by weight of water, based on the total weight of the composition.

16. The composition of any one of claims 1-15, further comprising at least 0.005% by weight of a non-ionic surfactant, based on the total weight of the composition.

17. The composition of claim 16, wherein the non-ionic tant is low foam.

18. A method of making a detergent composition, the method comprising: combining, based on the total weight of the composition, at least 0.001% by weight of an antimicrobial agent, at least 0.01% by weight of a hydrotrope; and an enzyme.

19. The method of claim 18, further comprising adjusting a pH of the ent composition prior to the adding the enzyme.

20. The method of any one of claims 18-19, further sing adding at least one of a buffer, a chelating agent, a solvent, water, a non-ionic surfactant, and a salt.

21. A method for cleaning an object, comprising: applying a detergent composition to the , the composition comprising, based on the total weight of the composition: at least 0.001% by weight of an antimicrobial agent, at least 0.01% by weight of a hydrotrope, and an enzyme thereby cleaning the object.

22. The method of claim 21, wherein the object comprises an endoscope.

23. The method of any one of claims 21-22, further sing disinfecting the obj ect.

24. The method of any one of claims 21-23, wherein the applying the composition comprises utilizing an automated endoscope re-processor.

25. The method of any one of claims 21-24, n an operating temperature is from 15°C to 60°C.