NON-ENZYMATIC CLEANER FOR REPROCESSING SURGICAL INSTRUMENTS AND

FLEXIBLE ENDOSCOPES

Field of the Invention

The disclosure pertains to non-enzymatic compositions useful for cleaning surgical, medical and dental instruments and flexible endoscopes prior to reuse. In particular, the disclosure pertains to liquid concentrate non-enzymatic compositions useful for cleaning such instruments prior to a disinfection process, as well as to methods for use of the non- enzymatic compositions in such treatments.

Background of the Invention

Effective cleaning, sterilization and disinfection of articles are of the upmost importance in many industries, such as healthcare, the food industry, etc. For example, reusable medical instruments, such as surgical instruments or probes, including flexible endoscopes, are typically contaminated with blood and other body matter and potentially with infectious microorganisms during use and require cleaning and sterilization / disinfection after each use to ensure that the risks of cross infection from patient-to-patient as well as from patient-to- health care personnel are minimized.

Surgical instruments including flexible endoscopes are normally pre-cleaned prior to automatic cleaning and disinfection. Manual pre-cleaning with the help of brushing serves to remove macroscopic soil rests and to free any present clogging sites which may not be successfully cleaned in the machine.

A typical cycle for automatic cleaning of medical instruments consists of a number of consecutive stages: pre-wash, wash, rinses (usually two) and drying. The pre-wash stage is primarily used to dissolve blood on the instruments and may be run with a suitable wash solution. The wash part of the cycle is run with a wash solution which typically contains or more surfactants. Both the pre-wash and wash solutions may additionally contain one or more enzymes. Wash time, water temperature, surfactant selection, and wash solution concentration levels can vary depending upon the particular nature of the instrument and/or soil to be cleaned therefrom. The purpose of the rinse stage(s) is primarily to remove soil l dissolved in the pre-wash and /or wash stage(s) as well as to remove any remaining surfactant-containing wash solution.

Medical instruments that are thermally stable, such as scissors, knives or scalpels, may be sterilized by processing at a high temperature.

However, many articles including surgical, medical or dental instruments or probes such as flexible endoscopes are temperature sensitive, particularly at relatively high temperatures, and therefore must be cleaned and disinfected at lower temperatures either manually or in a machine.

The process of cleaning, sterilizing and disinfecting instruments which are temperature sensitive is especially complicated where blood or other matter has been allowed to dry on the instruments. Body fluids, such as blood, lipids and synovial fluids from joints can adhere to the instruments during use in a surgical procedure, and as such fluids dry, the adhesion becomes stronger and the adhered body-fluid based matter becomes harder to dissolve using ordinary cleaning methods. Blood in particular becomes more difficult to remove once it has dried. Therefore, any cleaning composition to be used in these situations must be able to clean a range of body fluids effectively from a variety of different substrate surfaces such as are found on such as surgical instruments or probes, including flexible endoscopes.

In the past it was thought that there was a risk that the instruments having strongly adhered matter could remain soiled after cleaning with conventional detergent-based cleaning compositions. Such soil retention would pose a health risk if the instrument was re-used immediately following cleaning. However, an increased risk is potentially posed if an instrument having retained soil is stored for a period following cleaning because during the storage period bacterial growth is possible, which could affect not only the soiled instrument, but also its surrounding environment. To obviate the risks associated with ineffective removal of adhered body matter, improved cleansing compositions which included one or more enzymes were developed in order to break-down both the chemical structure of the adhered body-fluid based matter, as well as the physical/adhesive bond between matter and the instrument via hydrolysis. Compositions containing one or more enzymes are disclosed in WO 2009/095827A1 are able to deliver effective cleaning at neutral (6.5) pH levels.

Whilst the cleaning power of enzymes is undoubted, their increased use has led to concerns in relation to potential health issues, and issues associated with the spread of enzymes in reprocessing areas. These concerns are of sufficient magnitude that some countries are considering whether enzymes should be incorporated in cleaning compositions in the future. Therefore, there is a need for new non-enzyme based cleaning compositions which are capable of removing strongly adhered matter at levels consistent with those provided by current enzyme-including cleaning compositions.

Currently cleaning compositions which do not contain one or more enzymes are generally formulated at alkaline pH levels. The use of extreme pH levels in cleaning compositions, whether highly acidic or highly alkaline can introduce additional contamination risks in the medical, surgical and dental fields due to material incompatibility effects.

Typical non-enzyme containing cleaning compositions as are known in the art are aggressive and often use moderately or even highly alkaline conditions to provide a high cleaning performance.

As will be readily appreciated many articles including surgical, medical or dental instruments or probes such as flexible endoscopes which require routine re-cleaning prior to re-use comprise metallic components, and even moderately alkaline cleaning compositions such are typical in the art are often highly aggressive towards metals and metal alloys, such as steel, stainless steel, copper, zinc, brass, aluminum, and anodized aluminum, for example. However for aluminum and zinc in particular, exposure to moderate to highly alkaline pH conditions inhibits passivation.

Given the requirement for repeated use, cleaning and re-use of such articles, over time the impact of cleaning using aggressive, alkaline formulations increases the risk of corrosion of the metallic surfaces of such articles, either in whole or in part i.e. localized corrosion concentration such as pitting or cracking. Whilst an impact of metal corrosion is degradation of intrinsic properties such as strength, with associated risk of breakage or fracture, a particular risk for articles for use in the surgical, medical and dental fields is the risk that the surface becomes less impermeable to body fluids. Therefore, there is a need for new nonenzyme based cleaning compositions which are capable of removing strongly adhered matter from metal surfaces and which have desirable material compatibility.

An indication that the surface properties of metal articles, or metal containing articles have been compromised via repeated cleaning with aggressive, alkaline formulations is discoloration of the articles, either in whole or in part. A metal surface which has been compromised, via corrosion or other degradation processes may include cracks or pits which are potential additional sites for bacterial colonies to be established. Once corroded, such articles may require repair to re-establish the integrity of the metal surface, such as via coating processes, or even replacement of the entire instrument. Therefore, there is a need for new non-enzyme based cleaning compositions which are capable of removing strongly adhered matter from metal surfaces and which have reduced risk of post-cleaning soil retention.

During the cleaning process current highly alkaline non-enzyme cleaning compositions can tend to generate levels of foam which either obscure the wash solution in this the articles are immersed, or which cling to the article being cleansed when removed from the solution thereby leading to a longer and less efficient cleaning process. When utilized in manual cleaning of articles, some of these compositions can also provide cloudy or milky solutions in which it is difficult to clearly see the article to be cleansed when immersed in said solution, and therefore to effectively cleanse any adhered soil thereon. Therefore, there is a need for new non-enzyme based cleaning compositions which are capable of removing strongly adhered matter from metal surfaces at neutral or mildly alkaline pH levels and which provide clearer wash solutions and/or reduced levels of foaming during the cleaning process.

Summary of the Invention

Novel non-enzymatic cleaning compositions are provided that are particularly suitable for manual cleaning of articles, and in particular surgical, medical or dental instruments including probes and flexible endoscopes.

The novel liquid concentrate non-enzymatic cleaning compositions provide desirable cleaning performance levels in comparison to neutral enzyme-including compositions. The novel liquid concentrate non-enzymatic cleaning compositions provide desirable cleaning performance levels across a broad range of in use concentrations in comparison to neutral enzyme-including compositions.

The novel liquid concentrate non-enzymatic cleaning compositions have improved material compatibility in comparison to conventional highly alkaline non-enzyme containing compositions.

The novel liquid concentrate non-enzymatic cleaning compositions: are low or no foaming at in use concentration levels; provide low foaming in use (dilute) solutions across a broad range of concentration levels, from 0.2% to 2.0%; provide a cleaning or wash solution which at in use concentration levels is not cloudy at temperatures of up to and including 45°C; are stable across a range of storage conditions in concentrated (undiluted) form; are stable across a range of hardness conditions at in aqueous solutions at in use concentration levels, such as for example up to and including 23 degrees of hardness, on the German hardness scale (°dH DE); demonstrate good material compatibility.

The present liquid concentrate non-enzymatic cleaning compositions include a low foaming surfactant system comprising at least one nonionic surfactant, at least one complexing agent, optionally at least one anti-corrosion agent, and at least one source of alkali and have a moderately alkaline pH level.

The low foaming surfactant system comprising at least one nonionic surfactant may comprise from about 1 to about 15 weight % of at least one nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer.

The at least one complexing agent may comprise one or more super-complexing agents and optionally one or more complexing agents as defined hereinafter. In one aspect the at least one complexing agent comprises one or more small molecule organic super-complexing agents and especially methylglycine diacetic acid (MGDA) and acid or alkali metal salts thereof.

The at least one source of alkalinity may comprise one or more amines. In one aspect the at least one source of alkalinity comprises an alkanolamine independently selected from: triethanolamine (TEA); TEA 99%; monoethanolamine (MEA); diethanolamine (DEA); and combinations or mixtures thereof.

The moderately alkaline pH level may comprise a pH in the range of from 7 to 12; from 8 to 10; from 8.5 to 9.5, about 9.5.

The at least one anti-corrosion agent may comprise one or more phosphoric acid esters, and/or one or more phosphonic acid esters. In one aspect the at least one corrosion inhibitor is a phosphate ester independently selected from phosphoric acid, 2-ethylhexyl ester, commercially available from Clariant as Hordaphos® MDAH, or phosphoric acid, mixed esters with butyl alcohol and ethylene glycol, commercially available as Hordaphos® MDGB.

A non-enzymatic cleaning composition is provided that can comprise a low foaming surfactant system comprising at least one nonionic surfactant, at least one complexing agent, optionally at least one anti-corrosion agent, at least one source of alkali and a moderately alkaline pH level.

Typically, the cleaning composition has a pH of about 9.5.

In some aspects, the low foaming surfactant system comprising at least one nonionic surfactant is present in the cleaning composition in an amount ranging from about 0.1 to 15.0 weight %, the at least one complexing agent is present in an amount ranging from about 0.1 to 10.0 weight %, the at least one source of alkalinity is present in an amount ranging from about 0.1 to 10.0 weight %, optionally, the at least one anti-corrosion agent is present in an amount ranging from about 0 to 5 weight %, and the cleaning composition has a pH of about 9.5.

In certain aspects, the low foaming surfactant system comprising at least one nonionic surfactant is present in the cleaning composition in an amount ranging from about 2.0 to 10.0 weight % the at least one complexing agent is present in an amount ranging from about 2.0 to 8.0 weight %, the at least one source of alkalinity is present in an amount ranging from about 3.0 to 8.0 weight % and the cleaning composition has a pH of: from 8 to 10; from 8.5 to 9.5; or about 9.5.

According to one aspect the non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:

(a) 0.1 to 15.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;

(b) 0.1 to 10.0 weight % of at least one complexing agent;

(c) 0.1 to 10.0 weight % of at least one source of alkalinity;

(d) 0 to 5.0 weight % of at least one anti-corrosion agent;

(d) 60 to 99.7 weight % of an aqueous solvent and wherein the pH of the composition is: between 7 and 12; between 8 and 10; from 8.5 to 9.5; or about 9.5.

According to a further aspect the non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises: (a) 0.1 to 15.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;

(b) 0.1 to 5.0 weight % of at least one complexing agent;

(c) 0.1 to 10.0 weight % of at least one source of alkalinity;

(d) 0 to 5.0 weight % of at least one anti-corrosion agent;

(d) 65 to 99.7 weight % of an aqueous solvent and wherein the pH of the composition is: between 8 and 10; from 8.5 to 9.5; or about 9.5.

According to a yet further aspect the non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:

(a) 0.1 to 10.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;

(b) 0.1 to 5.0 weight % of at least one complexing agent;

(c) 0.1 to 10.0 weight % of at least one source of alkalinity;

(d) 0.1 to 5.0 weight % of at least one anti-corrosion agent;

(d) 70 to 99.6 weight % of an aqueous solvent and wherein the pH of the composition is: between 8 and 10; from 8.5 to 9.5; or about 9.5.

Methods of cleaning articles using the novel non-enzymatic cleaning compositions for the delivery of effective cleaning whilst limiting alkaline-pH associated corrosion or degradation of the metallic surfaces of the articles by the cleaning composition are also provided. Typically, the articles to be cleaned are metal articles and the step of cleaning the article with the novel non-enzymatic cleaning composition is carried out manually. The methods can include the steps of providing an article to be cleaned and directly applying an effective amount of the novel non-enzymatic cleaning composition to the article, either in diluted form or as a concentrated solution, and cleaning of the article therewith, followed by at least one rinsing step, and optionally at least one further cleaning and washing cycle. The methods can include the steps of providing an article to be cleaned, providing an effective amount of the novel non-enzymatic cleaning composition in an aqueous solution and cleaning the article with/in the dilute aqueous solution containing the novel non-enzymatic cleaning composition.

Typically, the novel non-enzymatic cleaning composition is at least partially diluted to form a concentrated or a dilute aqueous solution prior to use. In some aspects, the step of cleaning the article with the novel non-enzymatic cleaning composition is carried out automatically.

An effective amount of the novel non-enzymatic cleaning composition is preferably such that desirable foam levels, solution clarity (turbidity), cleaning efficacy (particularly cleaning of blood and/or blood-based soils are provided using the composition after dilution to provide an aqueous solution of the composition prior to use.

In a further aspect an effective amount of the novel non-enzymatic cleaning composition is preferably such that desirable foam levels, solution clarity (turbidity), cleaning efficacy (blood / blood-based soil cleaning), and material compatibility (anti-corrosive effects) are provided using the composition after dilution to provide an aqueous solution of the composition prior to use.

For example, in an embodiment of the invention, an effective amount of the novel non- enzymatic cleaning composition is such that the amount of the low foam surfactant system comprising at least one nonionic surfactant ranges from about 0.1 to 15.0 weight %, the amount of the at least one complexing agent is present in an amount ranging from about 0.1 to 10.0 weight %, and the amount of the at least one source of alkalinity is present in an amount ranging from about 0.1 to 10.0 weight % and the cleaning composition is then diluted with water to between 10% original concentration to 0.1 % original concentration.

For example, for use in cleaning surgical, medical and dental instruments and flexible endoscopes as defined herein prior to their re-use, the concentrated non-enzymatic cleaning composition may be diluted with a suitable aqueous solvent to 10%, 5%, 2%, 1 %, 0.5% or preferably 0.2% of the original composition concentration prior to use i.e. a 10% aqueous solution of the composition. The choice of dilution for any particular in-use aqueous cleaning solution will be dependent upon the level or soil, the type of soil, the time the soil has been left on the surface, as well as the hardness of the water used to dilute the composition.

For the avoidance of doubt, and unless specified to the contrary, where the relative amounts of any particular component in the compositions herein are expressed in terms of % weight this means the amount of the component relative to the total amount of the composition. For example, 6% of a source of alkalinity in a cleaning composition herein means that 100g (100%) of the composition contains 6g (6%) of said source of alkalinity. The foregoing has outlined rather broadly the features and technical advantages of the present disclosure in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the disclosure will be described hereinafter that form the subject of the claims. It should be appreciated by those skilled in the art that the conception and the specific embodiments disclosed may be readily utilized as a basis for modifying or designing other embodiments for carrying out the same purposes of the present disclosure. It should also be realized by those skilled in the art that such equivalent embodiments do not depart from the spirit or scope of the disclosure as set forth in the appended claims.

Detailed Description of Preferred Embodiments

The present disclosure provides non-enzymatic compositions useful for cleaning surgical, medical and dental instruments and flexible endoscopes prior to reuse. In particular, the disclosure provides liquid concentrate non-enzymatic compositions useful for cleaning such instruments prior to disinfection, as well as to methods for use of the non-enzymatic compositions in such cleaning treatments.

For the avoidance of doubt, the liquid concentrate compositions herein may be applied directly to an article to be cleaned without dilution, or may be applied as concentrated solutions to an article to be cleaned, or may be diluted to form aqueous in use solutions into which articles to be cleaned may be immersed and cleaned.

The terms cleaning as used herein in terms of liquid concentrate, or in-use solutions thereof, means suitable for use in cleaning wherein cleaning as defined herein means the removal of soils, marks, stains, dirt or other material from the surface of an item.

The present compositions are formulated to have at least a moderately alkaline pH level both on manufacture of a finished liquid concentrate, and when in-use as a diluted solution. A moderately alkaline pH level as defined herein is a pH of from about pH 7 to about pH 10.5. According to an aspect the non-enzymatic compositions herein have a finished pH of: at least 7.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and about 9.5.

Accordingly non-enzymatic cleaning compositions are provided which additionally are formulated to have a finished pH of: at least 7.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and about 9.5. For the avoidance of doubt, the finished pH of a liquid concentrate composition as detailed herein is the final pH of the composition following pH adjustment with acid or base as necessary to bring the pH into line with the desired levels of from about 7.5 to about 10.5, and preferably about pH 9.5.

As will be readily appreciated the pH of an in-use solution where the liquid concentrate has been diluted with water will substantially correspond to the pH of the original liquid concentrate and ideally be within 0.1 to 1 , or 0.5 to 1 pH unit of the finished pH level. Any suitable form of water may be used to provide an in-use solution, de-ionized (Dl), or tap water. Typically tap water will be used, in which case the water will have a defined hardness level (the degree of hardness).

The cleaning performance of certain aspects is particularly effective in the removal of dried body fluids, and especially of dried blood.

The present compositions provide low, or no foaming use solutions at temperatures of up to and including 45°C. A low foaming or no foaming use solution as defined herein is a solution having an initial foam height of less than about 5cm, and reducing to 0cm between about 10 seconds and 1 minute as measured in accordance with the manual shaking methodology detailed in the Experimental Methods section herein.

The present compositions provide crystal clear use solutions at temperatures of up to and including 45°C and at water hardness levels of up to and including 23 degrees of Hardness (23° dH) on the German water hardness scale. A crystal clear use solution as defined herein is a solution having which is clear to the naked eye both on initial formulation, and after pH finishing.

As demonstrated in the Experimental Results section hereinafter the present compositions provide desirable cleaning performance when compared to enzymatic cleansers. As further demonstrated in the Experimental Results section, the efficacious cleaning abilities of the present compositions are especially effective in the removal of blood based soils.

Surprisingly, the present moderately alkaline non-enzymatic cleaning compositions have been demonstrated to provided material compatibilities consistent with neutral pH multi- enzyme containing cleaning compositions, and improved material compatibility (reduced corrosive potential) versus baseline (standard) alkaline pH non-enzyme containing compositions. These results are especially surprising because it is widely known that increasing the pH in cleaning compositions carries an increased risk of material incompatibility in some metal substrates.

Even more surprisingly the present non-enzymatic cleaning compositions have been demonstrated to provide performance levels, and especially blood soil removal performance levels which are consistent with multi-enzyme containing cleaning compositions. As discussed in the Experimental Results hereinafter the present compositions show faster soil removal performance versus enzyme containing cleaning compositions. These faster cleaning results are particularly surprising because to date, enzymes have been considered to be the "gold-standard" for blood soil removal.

As demonstrated hereinafter the present compositions provide desirable cleaning and anti- corrosive performance levels, and are particularly effective in the removal of dried body fluids, and especially of dried blood and in the inhibition of corrosion of anodized aluminum.

Surfactants

The present invention can be a liquid concentrate composition comprising based on the whole composition from about 0.1 to about 15 wt. %, from about 0.1 to about 10 wt. %, from about 0.1 to about 6 wt. %, from about 0.1 to about 4 wt. %, from about 1 to about 6 wt. %, from about 1 to about 4 wt. % of a low-foam surfactant system comprising at least one nonionic surfactant.

According to an aspect the compositions comprise from 1 to 15% of at least one nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer.

According to a further aspect the composition includes at least two nonionic surfactants selected from one or more PO/EO/PO block copolymers and one or more ethoxylated amine block copolymers.

According to an aspect the compositions comprise from 1 to 15% of at least one nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer, and optionally further surfactants wherein said further surfactants preferably comprise one or more additional non-ionic surfactants. Suitable PO/EO/PO block copolymers for use herein include compounds of general formula A: HO(CH(CH ₃ )CH ₂ 0) _x -(CH ₂ CH ₂ 0) _y -(CH(CH ₃ )CH ₂ 0) _x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60. As will be readily appreciated the corresponding values of x and y will be dependent upon the particular EO : PO range for any particular block copolymer. For example, a PO : EO : PO block copolymer having a weight ratio of total EO to total PO of 40 : 60 and a molecular weight of 2650 will have values of x and y of about 24 for y and about 13 to 14 for x.

Exemplary PO/EO/PO block copolymers of formula suitable for use herein include the Pluronic and reverse Pluronic nonionic surfactant ranges from (BASF), and in particular the Pluronic RPE range including Pluronic® RPE 1720, Pluronic® RPE 1740, Pluronic® RPE 2035, Pluronic® RPE 2520, Pluronic® RPE 2525, Pluronic® RPE 31 10 and mixtures and combinations thereof.

The following Pluronics are suitable for use herein: RPE 1720, having a molecular weight of 2150; RPE 1740 having a molecular weight of 2650; RPE 2035 having a molecular weight of 4100; RPE 2520 having a molecular weight of 3100; RPE 2525 having a molecular weight of 2000; RPE 31 10 having a molecular weight of 3500. For the avoidance of doubt all of these Pluronic RPE materials are considered to be at 100% active.

According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level of from about 0.1 weight % to about 15 weight % and includes at least one PO/EO/PO block copolymer of formula HO(CH(CH ₃ )CH ₂ 0) _x -(CH ₂ CH ₂ 0) _y -(CH(CH ₃ )CH ₂ 0) _x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650.

According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level which is independently selected from : about 0.1 weight % to about 10 weight %; from about 0.1 weight % to about 6%; from about 0.1 weight % to about 4 weight %, and includes at least one PO/EO/PO block copolymer of formula HO(CH(CH ₃ )CH ₂ 0) _x -(CH ₂ CH ₂ 0) _y - (CH(CH ₃ )CH ₂ 0) _X H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650.

The present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level which is independently selected from : about 0.1 weight % to about 10 weight %; from about 0.1 weight % to about 6%; from about 0.1 weight % to about 4 weight %, and is an PO/EO/PO block copolymer of formula HO(CH(CH ₃ )CH ₂ 0) _x -(CH ₂ CH ₂ 0) _y -(CH(CH ₃ )CH ₂ 0) _x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650.

According to a further aspect the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is a PO/EO/PO block copolymer having an EO : PO weight ratio of 40 : 60 and a molecular weight of 2650. An exemplary PO/EO/PO PO block copolymer having an EO : PO weight ratio of 40 :60 and a molecular weight of 2650 is PL1740. Thus in accordance with a further aspect the present invention provides a non-enzymatic liquid concentrate cleaning composition wherein the nonionic surfactant is PL1740.

Suitable ethoxylated amine block copolymers for use herein include alkoxylated ethylene diamines. Exemplary alkoxylated ethylene diamines for use herein are the Synperonic T series which are commercially available from Croda, Genapol ED 3030 and Genapol ED 3060 which are available from Clariant. Particular Synperonics for use herein include: SYNPERONIC T/304, alkoxylated ethylene diamine having a molecular weight of 1650; SYNPERONIC T/701 , alkoxylated ethylene diamine having a molecular weight of 3600; SYNPERONIC T/707, alkoxylated ethylene diamine having a molecular weight of 25000; SYNPERONIC T/904, alkoxylated ethylene diamine having a molecular weight of 7500; and SYNPERONIC T/908, alkoxylated ethylene diamine having a molecular weight of 25000.

According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level independently selected from: about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight %, and includes at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650.

The present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level which is independently selected from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %; from about 0.1 weight % to about 4 weight %, and is an alkoxylated ethylene diamine.

According to a further aspect the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is an alkoxylated ethylene diamine having a molecular weight of 1650. An exemplary alkoxylated ethylene diamine having a molecular weight of 1650 is Synperonic T/304, available from Croda. Thus in accordance with a further aspect the present invention provides a non- enzymatic liquid concentrate cleaning composition wherein the nonionic surfactant is Synperonic T/304.

For the avoidance of doubt, where a material is described herein in terms of its general composition i.e. an alkoxylated ethylene diamine, with specific properties i.e. molecular weight of 1650, and an exemplary commercially available form is provided it will be readily appreciated that any alternative commercially available material having the same composition will also be suitable for use herein.

In one embodiment the at least one low foam nonionic comprises Synperonic® T/304.

According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant includes at least one PO/EO/PO block of formula HO(CH(CH ₃ )CH ₂ 0) _x -(CH ₂ CH ₂ 0) _y -(CH(CH ₃ )CH ₂ 0) _x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650, and at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650. In one embodiment the at least one low foam nonionic comprises a combination of a Pluronic RPE and a Synperonic T, and in particular Pluronics® RPE1740 and Synperonic® T/304 wherein the total level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %; from about 0.1 weight % to about 4 weight %.

The present invention is particularly useful for manual and ultrasonic cleaning of surgical instruments and endoscopes where visual inspection is helpful. As detailed hereinafter, compositions according to the invention have been demonstrated to show low foaming at in use concentration and gives a solution which in use concentration is not cloudy at a temperature in the range from 0 to 45°C.

Further, in use liquid compositions according to the present invention have been demonstrated to provide good cleaning efficacy.

Suitable additional nonionic surfactants for use herein include the Dehydol, Lankropol, Genapol and Hoesch ranges of surfactants. Exemplary additional non-ionic surfactants for use herein include: fatty alcohol ethoxylate Cio - Ci ₆ with 1 .2 moles PO and 6.4 moles EO commercially available as Dehydol® 980, from BASF; fatty acid sulphonate commercially available as Lankropol OPA, from AkzoNobel; C12/C15 oxo alcohol PO-EO adduct commercially available from Clariant as Genapol EP 2552; and C12-C14 fatty alcohol alkoxylate 2EO/4PO copolymer commercially available as Hoesch FA 42 LF, from Julius Hoesch; and combinations and mixtures thereof.

According to an aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:

(a) 0.1 to 10.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;

(b) 0.1 to 5.0 weight % of at least one complexing agent;

(c) 0.1 to 10.0 weight % of at least one source of alkalinity;

(d) 0.1 to 5.0 weight % of at least one anti-corrosion agent;

(d) 70 to 99.6 weight % of an aqueous solvent wherein the pH of the composition is: between 8 and 10; from 8.5 to 9.5; or about 9.5, and wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3. According to a further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the surfactant is independently selected from: at least one PO/EO/PO block of formula HO(CH(CH ₃ )CH ₂ 0) _x -(CH ₂ CH ₂ 0) _y -(CH(CH ₃ )CH ₂ 0) _x H wherein the relative weight ratio of EO : PO is from about 10 : 90 to about 90 :10, from about 20 : 80 to about 80 : 20, from about 30 : 70 to about 70 : 30, from about 40 : 60 to from about 60 :40, or about 40 : 60 and wherein the copolymer has a molecular weight in the range of from about 2000 to about 4500, from about 2500 to about 3500, or about 2650; at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650; and mixtures of said PO/EO/PO and ethoxylated amine block copolymers.

According to a further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the surfactant is present at a level of from about 0.1 % to about 10%, from about 2% to about 8%, from about 3 weight % to about 7 weight %, or about 6 weight %, and especially wherein the surfactant is independently selected from: Pluronic 1740 at a level of from about 3 weight % to about 7 weight %, or about 6 weight %; Synperonic T/304 at a level of from about 1 weight % to about 10 weight %.

According to an aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:

(a) 0.1 to 10.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;

(b) 0.1 to 5.0 weight % of at least one complexing agent;

(c) 0.1 to 10.0 weight % of at least one source of alkalinity;

(d) 0.1 to 5.0 weight % of at least one anti-corrosion agent;

(d) 70 to 99.6 weight % of an aqueous solvent wherein the pH of the composition is: between 8 and 10; from 8.5 to 9.5; or about 9.5, and wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6.

According to a yet further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent : anti- corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6.

The invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3.

Complexing Agent

The compositions herein include one or more complexing agents at a level of from 0.1 weight % to about 10 weight %, from about 0.5 weight % to about 8 weight %, from about 1 weight % to about 6 weight %, from about 2 weight % to about 5 weight %.

In general, a complexing agent or a sequestrant, is a molecule capable of coordinating (i.e., binding) the metal ions commonly found in natural water to prevent those metal ions from interfering with the action of other detersive ingredients such as surfactants in a cleaning composition. Some complexing agents can also function as threshold agents when included in an effective amount. For a further discussion of complexing agents, see Kirk-Othmer, Encyclopedia of Chemical Technology, Third Edition, volume 5, pages 339-366 and volume 23, pages 319-320.

The term complexing agent as generally defined herein is one or more agents which are capable of coordinating with metal ions in the wash water, when the compositions are used either as concentrated or diluted aqueous solutions, in order to form stable or transiently stable metal-complexes. Without wishing to be bound to any particular theory, a stable metal complex as defined herein is a complex which binds the metal ions is such a manner that they cannot interfere with the cleaning process, and in some instances such complexes may advantageously precipitate out of solution during the washing process and be simply rinsed away. Advantageously some complexing agents, so-called super complexing agents as particularly defined herein, are not only capable of coordinating with metal ions in natural or wash water as discussed herein but are also capable of binding with metallic components within a body soil to be removed during the cleaning process. Without wishing to be bound to any particular theory it is proposed herein that, for example in relation to blood-based soils, certain complexing agents may additionally be capable of binding to Ca-bridges within the protein-based elements of such soil and by such action enhance soil break-down and removal during the cleaning process.

According to an aspect, the one or more super-complexing agents for use herein includes at least one complexing agents which is capable of coordinating with metal ions in natural or wash water and is capable of binding with metallic components within a body soil to be removed during the cleaning process.

Super-complexing agents for use herein include one or more small molecule organic complexing agents including aminocarboxylic acid type sequestrants. Suitable aminocarboxylic acid type sequestrants include the acids or alkali metal salts thereof, e.g., amino acetates and salts thereof. Some examples include N-hydroxyethylaminodiacetic acid; hydro xyethylenediaminetetraacetic acid, nitrilotriacetic acid (NTA); methylglycine diacetic acid (MGDA); 2-hydroxyethyliminodiacetic acid (HEIDA); ethylenediamine tetraacetic acid (EDTA); N-hydroxyethyl-ethylenediaminetriacetic acid (HEDTA); diethylenetriammepentaacetic acid (DTPA); ethyloenediamine-tetrapropionic acid triethylentetraaminehexaacetic acid (TTHSA), and alanine-N,N-diacetic acid; N,N-diacetic acid (GLDA), methylglycinediacetic acid (MGDA), iminodisuccinate (IDS) and the like; and the respective alkali metal ammonium and substituted ammonium salts thereof; and combinations or mixtures thereof.

Preferred herein as small molecule organic super-complexing agents are materials which when utilised in liquid concentrate compositions provide desirable cleaning performance, particularly versus blood / blood-based soils.

Preferred small molecule organic super-complexing agents for use herein include: methylglycinediacetic acid (MGDA), and salts thereof, and especially the tri-sodium salt, commercially available from BASF as Trilon® M Liquid, and particularly where utilized as a 40% aqueous solution. Other examples of Trilon M grades include: Trilon® M Compactate, Trilon® M Granules SG, Trilon® M Granules, Trilon® M Liquid, Trilon® M Powder In one embodiment the at least one super complexing agent comprises MGDA.

In one embodiment the at least one super complexing agent comprises GLDA. Examples of commercially available sources of GLDA suitable for use herein are: GLDA-Na ₄ , N,N- diacetic acid tetra sodium salts, also known as L-glutamic acid tetra sodium salt of tetra- sodium N,N-bis(carboxymethyl)-L-glutamate, available as Dissolvine GL-47-S (47% liquid), Dissolvine-PD-S (micro-granular) and Dissolvine-38 (38% liquid) from Akzo Nobel.

According to an aspect the liquid concentrate composition herein includes one or more complexing agents wherein at least one complexing agent is a small molecule organic super-complexing agent.

According to an aspect the liquid concentrate composition herein includes one or more complexing agents wherein at least one complexing agent is an aminocarboxylic acid or an acid or alkali metal salt thereof, and particularly wherein at least one complexing agent is methylglycinediacetic acid (MGDA), or an acid or alkali salt thereof.

According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant includes at least one PO/EO/PO block of formula HO(CH(CH ₃ )CH ₂ 0) _x -(CH ₂ CH ₂ 0) _y -(CH(CH ₃ )CH ₂ 0) _x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650, and/or at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650, wherein the total level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight %, and wherein the composition includes one or more complexing agents at a level of from at a level of from 0.1 weight % to about 10 weight %, from about 0.5 weight % to about 8 weight %, from about 1 weight % to about 6 weight %, or from about 2 weight % to about 5 weight % and wherein at least one complexing agent is an aminocarboxylic acid or an acid or alkali metal salt thereof. In one embodiment the at least one low foam nonionic comprises a Pluronic RPE and/or Synperonic T nonionic surfactant, and in particular Pluronics® RPE1740 and/or Synperonic® T/304 wherein the level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight %, and wherein the , and particularly wherein at least one complexing agent is methylglycinediacetic acid (MGDA), or an acid or alkali salt thereof present at a level of from 0.1 weight % to about 10 weight %, from about 0.5 weight % to about 8 weight %, from about 1 weight % to about 6 weight %, or from about 2 weight % to about 5 weight %.

Additional, optional complexing agents for use in addition to the super-complexing agents can be included. Where one or more of such optional additional complexing agents is used the total level of such agents is from 0.01 weight % to about 1 weight %. Suitable additional optional complexing agents for use herein are not limited to organic chelating compounds which sequester metal ions in solution, particularly transition metal ions. A variety of suitable additional optional complexing agents can be used in the liquid concentrate cleaning compositions herein including, for example, organic amino- or hyroxy-polyphosphonic acid complexing agents (either in acid or soluble salt forms), carboxylic acids (e.g. polymeric polycarbonate), hydroxycarboxylic acids, aminocarboxylic acids, or heterocyclic carboxylic acids e.g. , pyridine-2-6-dicarboxylic acid (dipicolinic acid), condensed phosphates, inorganic builders, polymeric polycarboxylates, and the like, and combinations or mixtures thereof. Such complexing agents are commercially available.

Suitable condensed phosphates for use as additional complexing agents herein include sodium and potassium orthophosphate, sodium and potassium pyrophosphate, sodium and potassium tripolyphosphate, sodium hexametaphosphate.

Exemplary commercially available additional complexing agents include: phosphonates sold under the trade name DEQUEST® from Thermos or Cublen® from Zschimmer & Schwarz or Briquest® from Rhodia including, for example, 1 -hydroxyethylidine-1 ,1 -diphosphonic acid (CH ₃ C(P0 ₃ H ₂ )20H) (HEDP) DEQUEST® 2010; amino(tri(methylenephosphonic acid)), (NtCHzPOsHds), available as DEQUEST® 2000, or as Cublen® AP5 from Zschimmer & Schwarz, or as Briquest® 301 -50A from Rhodia; ethylenediamine[tetra (methylenephosphonic acid)], available from Thermphos as DEQUEST® 2041 ; diethylene triamine penta(methylene phosphonic acid), available from Thermphos as DEQUEST® 2066, or as Cublen® D 3217S from Zschimmer & Schwarz; 2-phosphonobutane-1 ,2- tricarboxylic acid available from Lanxess as Bayhibit® AM; additional commercially available complexing agents include:; iminodisuccinate sodium salt, available from Lanxess as Baypure® CX 100/34; sodium gluconate (e.g. granular) and sodium triphosphate (available from Innpphos); Versene® 100, Low NTA Versene®, Versene® powder, and Versene® 120 all available from Dow; Dissolvine® D-40 and GL-38 available from Akzo; sodium citrate; and combinations and mixtures thereof.

In view of the increasing complexity of the regulatory requirements relating to the use of phosphates, the present compositions preferably contain 0.5 wt. % or less of phosphate.

According to a further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the complexing agent is independently selected from: methylglycinediacetic acid (MGDA) and/or and salts thereof, and especially the tri- sodium salt; glutamic acid, Ν,Ν-diacetic acid (GLDA) and/or and salts thereof, and especially the tetrasodium salt; and mixtures and combinations thereof.

According to a yet further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6 and wherein the complexing agent is a small molecule organic super-complexing agent as defined herein, and particularly wherein the complexing agent is independently selected from: methylglycinediacetic acid (MGDA) and/or and salts thereof, and especially the tri-sodium salt; glutamic acid, Ν,Ν-diacetic acid (GLDA) and/or and salts thereof, and especially the tetrasodium salt; and mixtures and combinations thereof.

The invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3. The one or more additional complexing agents can include one or more organic phosphonates, such as an organic-phosphonic acid and alkali metal salts thereof. Exemplary suitable organic phosphonates for use herein include: 1-hydroxyethane-1 ,1-diphosphonic acid, CH ₃ C(OH)[PO(OH)2] ₂ ; aminotri(methylenephosphonic acid): N[CH ₂ PO(OH) ₂ ]3; aminotri(methylenephosphonate), sodium salt; 2-hydroxyethyliminobis (methylenephosphonic acid), HOCH2CH2N[CH ₂ PO(OH)2]2; ethylenetriaminepenta(methylene phosphonic acid), (HO) ₂ POCH2N[CH2CH2N[CH2PO(OH)2]2] ₂ ; diethylenetriaminepenta(methylene-phosphonate), sodium salt, C9H(28_x)N ₃ Nax0i ₅ P5 where x=7; hexamethylenediamine(tetramethylene phosphonate), potassium salt, CioH( ₂ 8 _x)N ₂ K _x 0i ₂ P4 where x=6; bis(hexamethylene)triamine (pentamethylenephosphonic acid), (H0 ₂ )POCH2N[CH2)6 N[CH ₂ PO(OH)2]2]2; and phosphorus acid H ₃ P0 ₃ ; and other similar organic phosphonates, and mixtures thereof; 2-hydroxyethyliminobis(methylenephosphonic acid),

HOCH2CH2N[CH ₂ PO(OH)2]2; diethylenetriaminepenta(methylenephosphonic acid), (HO) ₂ POCH2N[CH2CH2N[CH2PO(OH) ₂ ]2]2; diethylenetriaminepenta(methylenephosphonate), sodium salt, C9H(28-x)N ₃ NaxOi ₅ P5 where x=7; hexamethylenediamine(tetramethylenephosphonate), potassium salt, Ci ₀ H( ₂ 8 _x )N ₂ K _x 0i2P4 where x=6; bis(hexamethylene)triamine(pentamethylenephosphonic acid), (HO) ₂ POCH2N[CH2)6N[CH2PO(OH)2]2]2, or salts thereof, such as the alkali metal salts, ammonium salts, or alkyloyl amine salts, such as mono-, di-, or tetra-ethanolamine salts, picolinic acid or di-picolinic acid salts or mixtures thereof.

Anti-Corrosion Agent / Corrosion inhibitor

As used herein, the terms anti-corrosion agent or corrosion inhibitor is intended to refer to at least one of, or any combination of, the disclosed corrosion inhibitors, corrosion inhibitor intermediates, and corrosion inhibitor product formulations. A corrosion inhibitor as defined herein is an agent which either acts with or impacts upon another component in the cleaning composition such that the risk of surface damage (to the article to be cleaned) is reduced.

As used herein, "an effective amount" is intended to refer to an amount by which the referred to component is present to perform its intended function. For example, an effective amount of a corrosion inhibitor is an amount of that component necessary to inhibit corrosion.

It is vital in many industries that the articles or instruments used in those industries are clean and/or sterilized / disinfected. For example, in the healthcare industry, it is crucial that surgical instruments are cleaned and sterilized / disinfected after every use to ensure that the risk of contamination and infection are minimized. Many of these articles are metallic, and these metallic articles may suffer from corrosion if cleaned with an aggressive cleaning composition. As will be readily appreciated, in the surgical field in particular, patient safety is of paramount importance, and as such ensuring articles are cleaned as thoroughly as possible, will generally take precedence over the desire to ensure equipment longevity by reducing or prevention of corrosion. As such, and as referred to in the background herein, it has become a generally accepted trade-off that the need to use higher alkaline pH levels in non-enzymatic cleaning compositions to deliver a high quality of cleaning, brings an increased risk of article corrosion over time.

Therefore, it would be advantageous to provide a non-enzymatic alkaline cleaning composition that inhibits the corrosion of articles to be cleaned without inhibiting the cleaning action of the cleaning composition.

In a further aspect novel liquid concentrate non-enzymatic cleaning compositions for cleaning surgical, medical and dental instruments and flexible endoscopes are provided comprising:

(a) 0.1 to 15.0 weight % of a low-foam surfactant system comprising at least one nonionic surfactant;

(b) 0.1 to 5.0 weight % of at least one complexing agent;

(c) 0.1 to 10.0 weight % of at least one source of alkalinity;

(d) optionally 0.1 to 10.0 weight % of at least one additional surfactant;

(e) 0.1 to 5.0 weight % of at least one anti-corrosion agent;

(d) 55.0 to 99.69 weight % of an aqueous solvent and wherein the pH of the composition is at least 7.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and about 9.5.

According to an aspect there is provided a liquid concentrate non-enzymatic cleaning composition as detailed hereinbefore comprising from 0.1 wt % to 5.0 wt. % of at least one anti-corrosion agent selected from one or more phosphoric acid esters, and/or one or more phosphonic acid esters. Suitable for use herein as anti-corrosion agents are alkyl esters of phosphoric acid, particularly mono or di-alkyl esters, phosphonic acids and esters thereof and combinations and mixtures thereof.

Exemplary phosphate esters for use herein include: Hordaphos® MDAH, phosphoric acid, 2- ethylhexyl ester available from Clariant; Hordaphos® MDGB phosphoric acid, mixed esters with butyl alcohol and ethylene glycol available from Clariant; and combinations and mixtures thereof.

According to a further aspect the non-enzymatic liquid concentrate compositions as defined according to any aspect herein include at least one anti-corrosion agent at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt %. For the avoidance of doubt where one or more anti- corrosion agents are present the total level is within the levels defined hereinbefore and within 0.1 wt % to 5 wt %.

In one embodiment the at least one anti-corrosion agent comprises Hordaphos® MDAH at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt. %.

In one embodiment the at least one anti-corrosion agent comprises Hordaphos® MDGB at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt. %.

According to an aspect the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant includes at least one PO/EO/PO block of formula HO(CH(CH ₃ )CH ₂ 0) _x -(CH ₂ CH ₂ 0) _y -(CH(CH ₃ )CH ₂ 0) _x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650, and at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650 and at least one anti-corrosion agent at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt % and wherein the anti-corrosion agent is an alkyl ester of phosphoric acid, particularly a mono or di-alkyl ester. In one embodiment the at least one low foam nonionic is a Pluronic RPE and/or a Synperonic T, and in particular Pluronics® RPE1740 and/or Synperonic® T/304 wherein the total level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight % and wherein the anti-corrosion agent is independently selected from: Hordaphos® MDGB; Hordaphos® MDAH and mixtures and combinations thereof.

According to a yet further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6 wherein the complexing agent is a small molecule organic super-complexing agent, and wherein the anti- corrosion agent is one or more alkyl esters of phosphoric acid.

The invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3 and wherein the anti-corrosion agent is independently selected from Hordaphos® MDAH; Hordaphos® MDGB.

Suitable optional, additional anti-corrosion agents for use herein include phosphonic acids and phosphonic acid esters also known as phosphonates thereof for use as corrosion inhibitors herein are include organic phosphonates, condensed phosphonates, or the like, and mixtures and combinations thereof.

The at least one phosphonic acid may include a plurality of phosphonic acid or phosphonates including, for example, organic phosphonates, condensed phosphonates, mixtures thereof, or the like. Suitable condensed phosphonates include sodium and potassium orthophosphonates, sodium and potassium pyrophosphonate, sodium and potassium tripolyphosphonate, sodium hexametaphosphonate. Some examples of suitable organic phosphonic acids including their corresponding phosphonates include: Alkyl (C1-C20) phosphonic acid: R[PO(OH) ₂ ], where R is U1-U20; carboxy phosphonic acid: COOH[PO(OH) ₂ ]; 2-carboxyalkyl (C1-C2 ₀ ) phosphonic acid: COOHR[PO(OH) ₂ ], where R is C C ₂₀ ; 1 -hydroxyethane- 1 , 1 -diphosphonic acid: CH ₃ C(OH)[PO(OH)2] ₂ ; aminotri(methylenephosphonic acid) : N[CH ₂ PO(OH) ₂ ]3; aminotri (methylenephosphonate), sodium salt; 2-hydroxyethyliminobis(methylenephosphonic acid), HOCH ₂ CH ₂ N[CH ₂ PO(OH) ₂ ] ₂ ; diethylenetriaminepenta(methylenephosphonic acid), (HO) ₂ POCH ₂ N[CH ₂ CH ₂ N[CH ₂ PO(OH) ₂ ] ₂ ] ₂ ; diethylenetriaminepenta(methylene- phosphonate), sodium salt, C9H( ₂₈ x)N ₃ Nax0i5P5 (x=7); hexamethylenediamine (tetramethylenephosphonate), potassium salt, CioH( ₂₈ -x)N ₂ K _x Oi ₂ P ₄ (x=6); bis(hexamethylene)triamine(pentamethylenephosphonic acid),

(H0 ₂ )POCH ₂ N[CH ₂ ) ₆ N[CH ₂ PO(OH) ₂ ] ₂ ] ₂ ; phosphorus acid H ₃ P0 ₃ ; and other similar organic phosphonates, and mixtures thereof.

Further examples include: 2-hydroxyethyliminobis(methylenephosphonic acid),

HOCH ₂ CH ₂ N[CH ₂ PO(OH) ₂ ] ₂ ; diethylenetriaminepenta(methylenephosphonic acid), (HO) ₂ POCH ₂ N[CH ₂ CH ₂ N[CH ₂ PO(OH) ₂ ] ₂ ] ₂ ; diethylenetriaminepenta(methylene phosphonate), sodium salt, hexamethylenediamine(tetramethylenephosphonate), potassium salt, CioH( ₂₈ . _x )N ₂ K _x Oi ₂ P ₄ (x=6); bis(hexamethylene)triamine(pentamethylenephosphonic acid), (H0 ₂ )POCH ₂ N[(CH ₂ ) ₆ N[CH ₂ PO(OH) ₂ ] ₂ ] ₂ .

Alkaline Source

The source of alkalinity can be any source of alkalinity that is compatible with the other components of the liquid concentrate non-enzymatic cleaning composition. Exemplary sources of alkalinity include alkali metal hydroxides, alkali metal salts, phosphates, amines, and mixtures thereof.

The alkalinity of a liquid concentrate composition as defined herein can be adjusted to provide a finished liquid concentrate composition having a desirable pH by adding the source of alkalinity until a pH-value of: at least 7.5; from about 7.5 to about 12; from about 7.5 to about 10.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and especially about 9.5 is achieved.

According to an aspect the source of alkalinity is one or more amines. Exemplary amines include alkanolamines selected from the group comprising triethanolamine (TEA), TEA 99%, monoethanolamine (MEA), diethanolamine (DEA), and mixtures thereof. TEA is a preferred amine for use herein. Exemplary alkali metal hydroxides include sodium hydroxide, potassium hydroxide, and lithium hydroxide. Alkali metal hydroxides are commercially available as pellets or beads having a mix of particle sizes ranging from 12-100 U.S. mesh, or as an aqueous solution, such as for example, as an about 45 wt.%, as an about 50 wt.%, or as an about 73 wt.% solution. A preferred form of sodium hydroxide is a 50% aqueous solution (caustic soda).

Exemplary alkali metal salts include sodium carbonate, trisodium phosphate, potassium carbonate, and mixtures thereof. Exemplary phosphates include sodium pyrophosphate, potassium pyrophosphate, and mixtures thereof.

According to a yet further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6 wherein the complexing agent is a small molecule organic super-complexing agent, wherein the anti- corrosion agent is one or more alkyl esters of phosphoric acid, and wherein the source of alkalinity is one or more amines, and especially one or more alkanolamines.

The invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3 and wherein the source of alkalinity is an alkanolamine, particularly TEA.

The source of alkalinity, particularly the one or more amines, may be added to the composition in a variety of forms, including for example in the form of liquids (for amines), or as solid beads, dissolved in an aqueous solution or as a combination thereof (for alkali metal hydroxides).

The source of alkalinity may comprises one or more different sources of alkalinity with the provision that the total level of the source of alkalinity in the present composition is form about 1 wt. % to about 10 wt. %, from about 2 wt. % to about 8 wt. %, from about 3 wt. % to about 6 wt. %, about 5 wt. % of the liquid concentrate non-enzymatic cleaning composition. Hydrotrope Component

The liquid detergent concentrate composition may optionally additionally include from 1 weight % to 20 weight % in total of one or more hydrotrope components. It is anticipated, that where present, the one or more hydrotrope components will provide added stability to the liquid concentrate cleaning compositions, primarily by stabilizing the nonionic surfactant component.

Examples of the hydrotropes include the sodium, potassium, ammonium and alkanol ammonium salts of xylene, toluene, ethylbenzoate, isopropylbenzene, naphthalene, alkyl naphthalene sulfonates, phosphate esters of alkoxylated alkyl phenols, phosphate esters of alkoxylated alcohols, short chain (C8 or less) alkyl polyglycoside, sodium, potassium and ammonium salts of the allcyl sarcosinates, salts of cumene sulfonates, amino propionates, diphenyl oxides, and disulfonates.

According to an aspect one or more hydrotropes are present in the liquid concentrate cleaning compositions wherein the total level of hydrotrope is provided in an amount of about 1 weight % to about 20 weight %, preferably about 3 weight % to about 15 weight %, further preferred about 5 weight % to about 15 weight %, based on the weight of the liquid concentrate cleaning composition.

According to an aspect the hydrotrope is a 40% aqueous solution of sodium cumene sulfonate (SCS). According to an aspect the hydrotrope is a 40% aqueous solution of sodium cumene sulfonate (SCS) present at a level of from 5 weight % to about 15 weight %, and preferably about 10 weight %.

Additional components

The non-enzymatic cleaning compositions may include such additional ingredients or forms of ingredients such as are typically found in manual cleaning compositions such as one or more additional surfactants, one or more dyes, one or more perfumes or odorants, one or more preservatives or antimicrobial agents, one or more hydrotropes, one or more pH adjusting agents, one or more corrosion inhibitors, one or more anti-foaming agents, one or more viscosity adjusting or formulation stabilising agents such as thickening agents.

Additional Surfactant

The liquid concentrate non-enzymatic cleaning compositions herein may comprise additional surfactants such as one or more cationic surfactants, one or more anionic surfactants, e.g., phosphate ester, alkyl amine oxide, one or more amphoteric so-called zwitterionic surfactants and combinations and mixtures thereof. Where present the total level of additional surfactants is from 0.1 to 10 weight %.

According to an aspect the non-enzymatic cleaning compositions herein are free of cationic surfactants. According to another aspect the non-enzymatic cleaning compositions herein are free of both cationic surfactants and amphoteric surfactants. According to one aspect the non-enzymatic liquid concentrate cleaning compositions additionally comprise from 1 to 10 weight % of one or more anionic surfactants, and optionally from 0.1 to 2 weight % of one or more anti-foaming agents.

Anionic Surfactants

As discussed hereinbefore, the non-enzymatic liquid concentrate cleaning composition can include from 1 to 10 weight % of one or more anionic surfactants, and optionally from 0.1 to 2 weight % of one or more anti-foaming agents. Exemplary anionic surfactants that can be used include organic carboxylates, organic sulfonates, organic sulfates, organic phosphates and the like, particularly linear alkylaryl sulfonates, such as alkylarylcarboxylates, alkylarylsulfonates, alkylarylphosphates, and the like. These classes of anionic surfactants are known within the surfactant art as linear alkyl benzyl sulfonates (LABS), alpha olefin sulfonates (AOS), alkyl sulfates, and secondary alkane sulfonates.

The anionic surfactants can be provided in the composition in an amount of from: 0 to about 10 weight%; from about 1 weight % to about 10 weight %; from about 2 weight % to about 9 weight %; from about 3 weight % to about 8 weight %; or about 5 weight %, based on the weight of the total non-enzymatic liquid concentrate cleaning composition, as defined hereinbefore.

Cationic Surfactants

The non-enzymatic liquid concentrate cleaning compositions herein can include from 0.1 to 1 weight % of one or more cationic surfactants. Where the composition includes one or more anionic surfactants no cationic surfactant is present.

Suitable cationic surfactants include quaternary ammonium compounds having the formula of RR'R"R"N ⁺ X ^" , where R, R, R" and R'" are each a Ci-C ₂₄ alkyl, aryl or arylalkyl group that can optionally contain one or more P, O, S or N heteroatoms, and X is F, CI, Br, I or an alkyl sulfate. Each of R, R, R" and R'" can independently include, individually or in combination, substituents including 6 to 24 carbon atoms, preferably 14 to 24 carbon atoms, and more preferably, 16 to 24 carbon atoms. Each of R, R', R" and R'" can independently be linear, cyclic, branched, saturated, or unsaturated, and can include heteroatoms such as oxygen, phosphorous, sulfur, or nitrogen. Any two of R, R, R" and R'" can form a cyclic group. Any one of three of R, R, R" and R'" can independently be hydrogen. X is preferably a counter ion and preferably a non- fluoride counter ion. Exemplary counter ions include chloride, bromide, methosulfate, ethosulfate, sulfate, and phosphate.

The quaternary ammonium compound includes alkyl ethoxylated and/or propoxylated quaternary ammonium salts (or amines).

Preferred alkyl groups contain between about 6 and about 22 carbon atoms and can be saturated and/or unsaturated. The degree of ethoxylation is preferably between about 2 and about 20, and/or the degree of propoxylation is preferably between about 0 and about 30. In an embodiment, the quaternary ammonium compound includes an alkyl group with about 6 to about 22 carbon atoms and a degree of ethoxylation between about 2 and about 20. An exemplary cationic surfactant is commercially available under the name Berol 563 from Akzo-Nobel.

Additional cationic surfactants suitable for use include ethoxylated and/or propoxylated alkyl amines, diamines, or triamines.

Amphoteric Surfactants

The non-enzymatic liquid concentrate cleaning compositions herein can include from 0.1 to 5 weight % of one or more amphoteric surfactants. Examples of suitable amphoteric surfactants include capryloamphopropionate, disodium lauryl B-iminodipropionate, cocoamphocarboxypropionate, and disodium octylimino dipropionate.

The amphoteric surfactants can be provided in the composition in an amount of about 0 weight % to about 5 weight %; from 0.1 to 5 weight %, 1 to 5 weight %; 2 to 5 weight %, based on the weight of the total liquid concentrate composition.

pH Adjusting Agent

The pH value of the non-enzymatic liquid concentrate cleaning composition herein can be adjusted by adding an acidic or basic pH adjusting agent. The selection of any particular agent will be dependent upon the starting pH of the liquid concentrate cleaning composition, or in use solution to be adjusted, and desired pH to be achieved. Typically, the pH adjusting agent is provided as part of the liquid concentrate cleaning composition.

The pH adjusting agent can be provided in a form that allows it to take effect at a certain point in time during the manual or automatic washing process i.e. during use. For example, the pH adjusting agent can be coated in a manner that provides for release of the pH adjusting agent after a length of time. In addition, the pH-adjusting agent can be a component that is generated as a result of a reaction.

Accordingly, the pH-adjusting agent can provide the desired pH shift to a second pH after the composition has been provided at the first pH for a desired length of time.

When the pH adjusting agent is used to increase the pH, it can be referred to as an alkaline agent. Exemplary alkaline agents that can be used has been already mentioned above and referred to as "source of alkalinity". Triethylamine (TEA) and particularly 99% TEA is a preferred source of alkalinity herein.

When the pH adjusting agent is used to lower the pH, it can be referred to as an acidifying agent. Exemplary acidifying agents include inorganic acids, organic acids, and mixtures of inorganic acids and organic acids. Exemplary inorganic acids that can be used include mineral acids such as sulphuric acid, nitric acid, hydrochloric acid, and phosphoric acid. Exemplary organic acids that can be used include carboxylic acids including monocarboxylic acids and polycarboxylic acids such as dicarboxylic acids. Exemplary carboxylic acids include aliphatic and aromatic carboxylic acids. Exemplary aliphatic carboxylic acids include acetic acid, formic acid, halogen-containing carboxylic acids such as chloroacetic carboxylic acid, and modified carboxylic acids containing side groups such - OH, - R, - OR, -(EO) _x , - (PO) _x , - NH ₂ , and- N0 ₂ wherein R is a Ci to C ₁₀ alkyl group. Exemplary aromatic carboxylic acids include benzoic carboxylic acid, salicylic carboxylic acid, and aromatic carboxylic acid modified to include as a side group at least one of halogen, - OH, - R, - OR, -(EO) _x , - (PO) _x , - NH ₂ , and- N0 ₂ wherein R is a Ci to C ₁₀ alkyl group. Additional exemplary organic acids include oxalic acid, phthlaic acid, sebacic acid, adipic acid, citric acid, maleic acid, and modified forms thereof containing side groups including halogen, - OH, - R, - OR, -(EO) _x , - (PO) _x , - NH ₂ , and- N0 ₂ wherein R is a Ci to C ₁₀ alkyl group. It should be understood that the subscript X refers to repeating units. Additional exemplary organic acids include fatty acids such as aliphatic fatty acids and aromatic fatty acids. Exemplary aliphatic fatty acids include oleic acid, palmitic acid, stearic acid, and C ₃ -C ₂₆ fatty acids that may be saturated or unsaturated, and sulfonated forms of fatty acids. An exemplary aromatic fatty acid includes phenylstearic acid. Additional acids that can be used include peroxycarboxylic acid such as peroxyacetic acid, and phthalimidopercarboxylic acids. Additional acidic pH adjusting agents include carbon dioxide and ozone.

According to an aspect the pH adjusting agent is an acidifying agent, more particularly an organic acid, and especially citric acid.

According to an aspect the pH adjusting agent is an acidifying agent, more particularly an organic acid, and especially citric acid and the source of alkalinity is an amine, more particularly triethylamine (TEA).

The pH can be adjusted by adding the pH adjusting agent and/or by allowing the pH adjusting agent to cause a pH shift. For example, the pH adjusting agent can be formed in situ by reaction and/or the pH adjusting agent can be coated and, once the coating is degraded, the pH adjusting agent can become exposed to the liquid concentrate cleaning composition.

Preservative

One or more preservatives also known as antimicrobial agents or biocides are typically included in the non-enzymatic liquid concentrate cleaning compositions herein at a total preservative level of from 0.01 weight % to 2 weight %.

Any suitable preservative can be used. Exemplary preservatives for use include: phenoxyethanol, and 1 ,2-Benzisothiazol-3(2H)-on (BIT) commercially available within the Nuosept® product range from Ashland.

According to an aspect the non-enzymatic liquid concentrate cleaning compositions include one or more preservatives at a total level of from 0.05 weight % to 1 .0 weight %, from 0.1 weight % to 1 weight %.

Dyes/Odorants

Various dyes, odorants including perfumes, and other aesthetic enhancing agents may also be included in the composition. Dyes may be included to alter the appearance of the composition, as for example, Patent Blue V, 4-[4,4',-Bis-diethylamino-a-hydroxy-benzhydryl]- 6-hydroxy-benzol-1 ,3-disulfoacid, also known as iso-sulphan blue available from Sigma- Aldrich, Direct Blue 86 (Miles), Fastusol Blue (Mobay Chemical Corp.), Acid Orange 7 (American Cyanamid), Basic Violet 10 (Sandoz), Acid Yellow 23 (GAF), Acid Yellow 17 (Sigma Chemical), Sap Green (Keyston Analine and Chemical), Metanil Yellow (Keystone Analine and Chemical), Acid Blue 9 (Hilton Davis), Sandolan Blue/ Acid Blue 182 (Sandoz), Hisol Fast Red (Capitol Color and Chemical), Fluorescein (Capitol Color and Chemical), Acid Green 25 (Ciba-Geigy), and the like.

Fragrances or perfumes that may be included in the compositions include, for example, terpenoids such as citronellol, aldehydes such as amyl cinnamaldehyde, a jasmine such as CIS-jasmine or jasmal, vanillin, and the like.

For liquid concentrate cleaning compositions the total level at which one or more dyes, or one or more perfumes or odorants may be independently included is from about 0.0001 to about 0.2 weight %.

As will be readily appreciated the novel non-enzymatic cleaning compositions provided herein are suitable for cleaning a wide variety of articles including: surgical, medical or dental instruments; surgical probes including flexible endoscopes; ware including food plates or platters, food containers or cutlery; beverage containers including bottles, glasses, jugs, cups or mugs.

Such cleaning can be carried out manually or automatically in accordance with the methods detailed herein wherein the selection of the cleaning route will be dependent upon the nature of the article to be cleansed. As previously described and as exemplified hereinafter surgical, medical or dental instruments; surgical probes including flexible endoscopes are preferably cleansed using manual methods.

As detailed hereinbefore, cleaning solutions comprising the novel non-enzymatic compositions herein are substantially non-corrosive to metals such as stainless steel, anodized aluminium, aluminium, copper and brass which are often at risk of damages when soaked in previously available alkaline cleaning products.

The cleaning solution provided by the invention can be used for any suitable purpose.

Preferably, it is employed as a soak cleaner for medical and surgical instruments, dental hand piece, and the like, for both human and veterinary practice. When used as a soak cleaner, it is applied before the instruments are disinfected. It can also be readily used as a concentrate to be added to ultrasonic baths and to automatic washers, for cleaning more elaborate medical equipment.

As detailed previously herein, when employed in automatic washing systems, it is important that the surfactant, or detergent, component has low foam characteristics to avoid machine malfunction due to excessive foam formation. The cleaning and detergent solutions comprising an aqueous solution of the non-enzymatic cleaning compositions as defined herein are readily employed at elevated temperatures, as high as about 45°C.

Foreign matter to be cleaned or removed includes, for example, biological substances, e.g., tissue and blood. Foreign matter also includes other materials such as lubricant, diagnostic and therapeutic compositions, materials for pathology testing, medical or veterinary research, and the like, remaining on instruments after these are employed for their intended use. Foreign matter also includes pathogens including bacteria, viruses, and prions. For the avoidance of doubt, the term " instrument" as used herein is intended to be defined broadly, to include any articles, items, objects, implements or devices for which the gentle removal of organic or biological substances, such as protein, fats, carbohydrates and similar material is desirable. Simply by way of example and without limitation, instruments are implements employed in patient or client contact (human or veterinary) during the practice of surgery, medicine, dentistry, podiatry, pathology for e.g., therapeutic, diagnostic and/ or research purposes. Examples include, surgical instruments, e.g., scalpels, probes, clamps, etc., endoscopes, operating room or dental hand-pieces, ventilation tubes, and the like. Surgical instruments and equipment inevitably pick up amounts of bio-burden on them after being employed in operations on humans or animals.

Surgical instruments include for example rigid and flexible probes and scopes, and specifically including flexible endoscopes, laparoscopic instruments, trays and anything that gets soiled with body fluids which result in them having varying amounts of bio-burden on them after being so used.

Other articles that may be cleansed with solutions of the novel non-enzymatic compositions as detailed herein also include miscellaneous other instruments and/or implements employed in cosmetic and beauty applications. These applications include hair cutting, nail care, body art, skin piercing, collection of body fluids, e.g., blood, and blood separation and fractionation equipment, and similar such applications, that are too numerous to mention. The novel non-enzymatic compositions are also contemplated for use in cleaning implements and items employed in the food processing and pharmaceutical industries.

Experimental Methods

Method of Preparation of Cleaning Compositions Cleaning compositions as defined hereinbefore can be made in accordance with the following method.

Method of Preparation of a Use Solution

A use solution of a test composition is prepared by diluting the composition with water at room temperature (RT). For the avoidance of doubt, and unless specifically defined to the contrary, RT as defined herein is a temperature in the range of from 20°C to about 23°C, and especially about 20°C. The concentration of the test composition in water, the so-called "use solution" can be varied according to the nature of the particular assessment to be undertaken. Typically use solutions having test composition aqueous concentration levels of 10%, 5%, 1 %, 0.5%, 0.3% or 0.2% can be tested using in the methods detailed herein.

Test for Efficacy of Cleaning Compositions fBlood Cleaning Efficacyl

The purpose of this test is to enable to measurement of the efficiency of blood cleaning performance of different cleaning compositions. To ensure consistency in the trends in cleaning efficacy observed between different test compositions, and different test runs it is important to ensure that the test compositions are exposed to blood coupons for the same contact time. In the present test methodologies as detailed in the results section herein contact times of 5 minutes and 2 minutes have been used, although shorter or longer contact time periods may be used depending upon the nature of the substrate (metal coupon) or soil (blood etc) being tested. Furthermore, it is recommended that where it is intended to make comparisons between the results obtained for different test compositions against a particular soil on a particular coupon, that soiled coupons from a common batch are used for each test compositions in order to minimize batch-to-batch inconsistencies.

A batch of coupons is prepared as follows: Stainless steel coupons (5x5x0.1 cm) are cleaned and degreased with acetone for preparation. The coupons were dried prior to soiling by placing them on a bench for 30min. Typically 3 coupons were tested for each concentration of a particular formula. The combined weight of all the coupons is then measured and recorded. 0.2 g of reactivated sheep blood (commercially available from for example from Fiebig-Nahrstofftechnik) is weighed out and delivered onto each coupon and spread across the coupon surface. For ease of handling and to avoid contamination of the test area it can be useful to leave a small frame, typically around 3mm around the outside of each coupon thereby providing a soil-free (clean) handling area. The soiled coupons are then dried in a drying cabinet for 1 hour at 45°C. After cooling down to room temperature the combined weight of all the dried, soiled coupons is measured and recorded. 400ml of an aqueous use solution of a test Composition at the desired aqueous concentration level of: 0.2%, 0.5% and/or 1 % is prepared in the required water (de-ionised, tap / 14°C dH DE, or Hard / 23°C dH DE as detailed hereinbefore, but at a temperature of 20°C to 23°C and added into a standard 500ml beaker. The test coupons (one coupon per beaker, 3 coupons per formula) were immersed in the test solution and left for 5 minutes without agitation, in an environment where the external temperature is from 20°C to 23°C RT. At the end of this 5 minute test solution contact time, the coupons were removed and immersed in clean water for rinsing. Then the test coupons were dried at ambient temperature (20 to 23°C) overnight.

The level of soil removal is evaluated both visually and gravimetrically. The total starting weight of the coupons with dried blood (i.e. the pre-immersion weight) minus the total weight of the clean coupons (i.e. the pre-soiling weight) is equal to the blood load. The total weight of the cleaned coupons (i.e. the post-immersion and drying weight) minus the weight of the clean coupons (i.e. the pre-soiling weight) is equal to the blood load after cleaning, namely the remaining blood load.

Using this approach the cleaning efficacy can be calculated. The result in form of the cleaning efficacy is given in percent. The tests were repeated a minimum of three times and average results (in percent) are reported.

Test for Foam Performance oam Height - manual tilting/shaking method!

A use solution of a composition to be tested in water is prepared at room temperature (RT). For the avoidance of doubt, and unless specifically defined to the contrary, RT as defined herein is a temperature in the range of from 20°C to about 23°C. The concentration of test composition in water can be varied according to the nature of the particular assessment to be undertaken. Typically use solutions having test composition aqueous concentration levels of 10%, 5%, 1 % or 0.5% are tested using this method.

A sample of the use solution to be tested (100 ml) is poured, placed or otherwise filled into a 250 ml measuring cylinder (height: 30.5cm, width: 3.7cm). The cylinder is closed with a polyethylene (PE) plug. Any suitable PE plug which effectively seals the cylinder and prevents or substantially limits the escape of test solution can be used. The so-closed cylinder is then tilted 20 times from a substantially upright position to a substantially upended / upside down position. The resultant foam height in the cylinder is measured as soon as practicably possible following the removal of the plug. This measurement provides a baseline, 0 minute foam height. The foam height is then measured at further pre-defined time points, of 1 and 5 minutes thereafter. The foam height in the measuring cylinder is measured with a ruler and documented in millimetres (mm).

This test is repeated minimum three times.

Before the test the measuring cylinder is cleaned and rinsed with ethanol for degreasing; followed by rinsing with demineralized water.

Test for Cleaning Solution Clarity TTurbidity / Cloud point!

As defined hereinbefore the cloud point is the temperature where a liquid product becomes cloudy. To determine the cloud point of a test composition a use solution is prepared and an assessment of its clarity is made using the naked eye. As detailed hereinbefore a use solution is a solution of a composition to be tested in water. The concentration of the use solution of a test composition can be varied according to the nature of the particular assessment to be undertaken. Typically use solutions having test composition aqueous concentration levels of 10%, 5%, 1 %, 0.5%, 0.3% or 0.2% can be tested using this method. For the avoidance of doubt where a solution is described as being "clear" in the results section herein this means that to the naked eye the solution is crystal clear, whilst a solution which is described as "turbid" is non-clear or cloudy.

The relative stability of test compositions in different water conditions can be measured by recording the cloud points of use solutions prepared from water of different degrees of (°dH).

The use solution at the desired concentration level is filled into a 150 ml beaker at room temperature (RT). The temperature is raised slowly and monitored with a thermometer. To ensure consistency between the results for different test samples, the means for increasing the temperature includes any suitable graduated heating method which can be pre-set or pre-programmed. The temperature at which the test composition use solution shows the first signs of cloudiness, as observed by the naked eye, during heating is documented. The heating is stopped and the solution is allowed to cool naturally. Both the solution and the temperature are observed during this cooling period. The temperature is documented when the solution first becomes clear again.

Using this method cloud points are determined with an accuracy of 0.5°C. Typically the test is repeated at least twice to ensure consistency of results.

Test for Material Compatibility ln-use solutions of the compositions to be tested at the desired concentration level are prepared as indicated hereinbefore. The test solutions can be prepared in de-ionised (Dl) or tap water as desired. Tap water is a more likely real-life scenario, whilst Dl water provides a worst-case, stress test scenario. The metal materials to be assessed for compatibility with the test composition solutions are provided as metal plates, such as for example Steel or Aluminium plates. Whilst the size of the plates can vary it is important that the same size and material of plates are used for each test solution within any group of tests. Typically plates of (12cm by 6cm by 0.1 cm) are used.

The weight of each plate is measured in its dry state prior to testing, and again post- immersion. In each case, the testing is carried out at room temperature and each test plate is fully immersed an in-use solution of 500ml of the test composition at the desired aqueous concentration, for example 0.5%, in a suitable container, such as for example in a beaker (600ml).

After one week each of the test plates was rinsed off with Dl water, dried and the weight was re-measured. On the following day the plates were immersed again (in freshly prepared test solutions) and the procedure was repeated twice more. The results obtained from this test can be provided either as raw data set or as an average data set of the average % weight loss.

All of the compositions and methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. The present disclosure is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. In addition, unless expressly stated to the contrary, use of the term "a" is intended to include "at least one" or "one or more." For example, "a nonionic surfactant" is intended to include "at least one nonionic surfactant" or "one or more nonionic surfactant."

Any ranges given either in absolute terms or in approximate terms are intended to encompass both, and any definitions used herein are intended to be clarifying and not limiting. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all sub ranges (including all fractional and whole values) subsumed therein. Furthermore, the invention encompasses any and all possible combinations of some or all of the various embodiments described herein. It should also be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

The following experimental results are based on various compositions. The function, chemical and trade names of the components used in these compositions are as follows:

(BIT)

Preservative Phenoxyethanol Protectol PE

Alkalinity Triethanolamine 99% Triethanolamine 99%

Wetting agent Propan-1 ,2,3-triol Glycerin

pH adjust Citric acid monohydrate Citric Acid monohydrate pH adjust Sodium hydroxide, 50% solution Sodium Hydroxide 50%

Nonionic surfactant Alcohols, C10-16, ethoxylated, Dehydol 980

propoxylated

Anti-corrosion agent / Phosphoric acid ester Hordaphos MDGB corrosion inhibitor

Nonionic Surfactant Alkoxylated ethylene diamine Synperonic T/304

Anti-corrosion agent /c Phosphoric acid, 2-ethylhexyl ester Hordaphos MDAH corrosion Inhibitor

Super-complexing Methylglycine Trilon M Liquid

agent diacetic acid, tri sodium salt, , 40%

solution (MGDA)

Dye 4-[4,4'-bis-diethylamino-a-hydroxy- Patentblue 85 E 131 ; Food benzhydryl]-6-hydroxy-benzol-1 ,3- Blue 5 CI 42051 DRM disulfoacid

Experimental Results

1. Foam Height pH and Clarity of Compositions

The purpose of this experiment was to determine whether a series of test formulations, Compositions E, F, G which contained varying levels of at least PL1740 as a nonionic surfactant and 10% GLDA as a super-complexing agent could provide desirable foam heights in combination with clarity across conditions and retain elevated (alkaline) pH. The foam height, clarity and pH retention of Compositions E, F, G were compared to an enzyme containing formulation, Sekusept Multienzyme, Composition J, and two further comparator formulations, Compositions H and I based on alternative nonionic surfactants at a total level of 4%, and each containing GLDA at 10%, and again formulated at elevated pH.

The formulation details of Compositions E to J as well as physical properties (pH and visual appearance) of formulations E to I and multi-enzyme formulation J is also provided in Table 1 . The relative composition of the components in formulations E to I are shown as weight percentages, wt. %, out of a total composition level of 100.00. Table 1 additionally provides data relating to foam height, as well as clarity and pH data for each formulation, at the point of manufacture, after 24 hours (at room temperature), and in 1 % use solutions in de-ionised water and in tap water (14°dH DE).

As can be seen from the results in Table 1 , test Composition E which contained PL1740- alone was clear at the point of manufacture but became cloudy after 24 hours. Test Compositions F and G provided desirable clarity under all conditions and demonstrated improved foam height results both initially and after 1 minute in 1 % solutions in both de- ionised and tap water.

Again, the initial pH and pH in de-ionised water were maintained at desirable elevated levels, whilst in tap water solution the pH level fell below the pH 9.5 target.

The foam heights were determined using the methodology as detailed in the Experimental Methods section herein. For the avoidance of doubt, the faster the foam dissipates the more desirable the foam performance.

None of the text or comparator formulations was able to provide foam performance at the levels provided by the multi-enzyme formulation I.

TABLE 1

pH adjust Citric Acid 0.35 0.35 0.35 0.35 0.35 N/A monohydrate

TOTAL 100.0 100.0 100.0 100.0 100.0 N/A

Appearance clear clear clear clear clear clear, blue

Appearance > 24 turbid clear clear clear clear clear, hours blue pH 10.8/ 10.3/ 10.0/ 10.0/ 10.1 / 8.6

9.5 9.5 9.5 9.5 9.5 pH in deionised 10.10 10.00 10.00 10.00 9.90 8.3

Appearance in 1% clear clear clear clear clear, (deionised bluish solution )

pH 1% in Tap 8.60 8.60 8.60 8.60 7.90 water (14°dH DE)

Appearance in 1% clear clear clear clear clear, Tap water solution bluish

Foam test / Tap 0/5 0/5 0/7 0/7 0/2 water (min. / cm) 110 1 / 1 1 /5 1 /6.5 10sec/

0

Foam test / de0/5 0/6 0/6 0/8 0/2 ionised water 110.7 1 /3 1 /5 117 10sec/ (min. / cm) 0

As can be seen from the results in Table 1, test Compositions F and G provide desirable clarity under all conditions.

2.1 Core Stability, Foam Height pH and Clarity of Compositions

A series of experiments was designed to explore the stability of the core system: the nonionic, the super-complexing agent and the source of alkalinity. Two test formulations were prepared, Composition K and Composition L, and the cores for stability were assessed via selective removal of one or more elements and observation of whether a stable formulation could be prepared. For the avoidance of doubt a stable formulation is an emulsified formulation and an unstable formulation is a formulation which separates. The relative composition of the components in formulations K and L are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 2.

Table 2 additionally provides information as to the method of preparation of test Compositions K and L.

TABLE 2

The results obtained from examination of the stability of a series of sub-formulations based on Compositions K and L confirmed that for Composition K, only the dye and citric acid could be removed without a detrimental impact on stability, whilst for Composition L, the dye, citric acid, preservative and corrosion inhibitor can all be removed without detrimental effect to the stability of the core of the emulsion composition.

2.2 Core Stability, Foam Height pH and Clarity of Compositions

A series of experiments was designed to explore the impact of varying the MGDA level in further test formulations similar to Composition L as discussed herein before. Three test formulations were prepared, Compositions M, N, and O. Surprisingly all three compositions provided excellent foam height data as well as desirable emulsion clarity in tap water-based and hard-water based, in use solutions. This is unexpected because normally increased levels of stabilizing agents would be required to provide these levels of emulsion stability (clarity) in very hard water conditions.

The relative composition of the components in formulations M, N and O are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 3.

Table 3 additionally provides information as to the method of preparation of test Compositions M, N and O.

TABLE 3

2.3 Core Stability, Foam Height pH and Clarity of Compositions A further series of five formulations, Compositions P, Q, R, S, T was prepared which included combination of a super complexing agent, MGDA with TEA as the source of alkalinity (at the same level in each formulation) in combination with either T304 or PL1740 (nonionics), and either Hordaphos MDAH or MDGB (corrosion inhibitors). The results presented in Table 4 illustrate the impact of varying the nonionic/corrosion inhibitor combinations.

Comparisons between P and Q show that reducing the pH leads to initially turbid concentrates, whilst comparing R, S and T shows that increasing the pH (to 12.1 ) does not affect initial clarity. The final pHs of the concentrates were all -9.5. The foam test results indicate that PL1740 is a better nonionic for the provision of low foaming, than T304.

These results also confirm, in the T304-based compositions, that varying the type or level of the corrosion inhibitors does not adversely impact upon the stability of the formulations.

Formulation Q was prepared at a below target pH level (pH 8.62), and was found to be turbid on initial formulation, this confirms the value of maintaining the target pH level of pH 9.5 or above.

Surprisingly the results demonstrate that compositions according to the invention, Compositions R, S and T provide clear compositions with acceptable foam performance (although not as low as for P or Q) in the absence of propylene glycol.

The relative composition of the components in formulations P to T are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 4. Table 4 additionally provides information as to the order of addition for preparation.

TABLE 4

Function Trade Name P Q R S T Order solvent Aqua purificata 59.90 59.30 82.5 81.5 81.8 1 , 9 solvent Propylene Glycol 10.00 10.00 - - - -

Nonionic Synperonic T/304 - - 6.00 6.00 6.00 2 surfactant

Nonionic Pluronic RPE 1740 6.00 6.00 - - - 2 surfactant

hydrotrope 10.00 10.00

Na cumene

sulphonate

(min. / cm)

2.4 Core Stability. Foam Height pH and Clarity of Compositions

Test formulations, Compositions U and V, were prepared which were similar to compositions P and Q in Table 4, but with different water contents and without propylene glycol. The purpose of this experiment was to confirm that desirable clarity and foam performance could be provided by PL1740 nonionic formulations without PG.

The results presented in Table 5 show that desirable clarity and foam performance are provided by PL1740 / Trilon M / TEA core formulations having differing corrosion inhibitors and no PG. In particular the foam test results demonstrate that formulation U had significantly improved foam reduction time.

The relative composition of the components in formulations U and V are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 5. Table 5 additionally provides information as to the order of addition for preparation as well as formulation W, which was tested versus compositions Ua for cleaning efficacy as discussed hereinafter.

TABLE 5 Nonionic Synperonic T/304 10.00

surfactant

Nonionic Pluronic RPE 1740 6.00 6.00 2 6.00 2 surfactant

hydrotrope Na cumene 10.00 10.00 3 10.00 3 sulphonate

Complexing Trilon M Liquid 5.00 5.00 3 5.00 5.00 4 agent

Alkalinity 5.00 5.00 4 5.00 5.00 5

Triethanolamine

99%

pH-adjuster NaOH 50% 0.46 0.20 8 - 0.46 10 pH-adjuster Citric Acid 0.53 10 monohydrate

preservative Nuosept BM 22 0.2 0.2 7 0.2 0.2 8

Corrosion Hordaphos MDAH 1 .0 6 1 .0 1 .0 6 inhibitor

Corrosion Hordaphos MDGB 1 .0 6

inhibitor

preservative Protectol PE 0.5 0.5 5 0.5 0.5 7 dye Patent blue V - - - 0.0015 0.0015 9

TOTAL 100 100 100 100

pH (< adjustment) 9.64 9.02 9.83 9.71

Finished pH 9.5 9.49 9.51 9.5

Appearance, on Clear Clear Clear Clear

preparation initially

2.4 Core Stability, pH and Clarity of Compositions

Composition L2 which corresponds to Composition L (see Table 2), but with a lower level of MDAH was prepared. The purpose of this experiment was to determine the impact of MDAH level and whether use of a pre-mix of water / TEA / MDAH impacted on the initial formulation stability.

Testing of Composition L2 demonstrated that at this reduced MDAH level (0.1 %), versus 0.95% in Composition L, the formulation became cloudy (turbid) during manufacture as soon as the corrosion inhibitor was introduced. Additionally this could not be revised by modified addition of the MDAH in combination with the TEA and the water components. This confirms that to ensure desirable concentrate clarity and Composition stability, a level of corrosion inhibitor of greater than about 0.1 % is required.

Formulation L2 did achieve a target finished (adjusted) pH level of 9.5.

The relative composition of the components in formulations L and L2 are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 6. Table 6 additionally provides information as to the order of addition for preparation as well as pH and clarity data. For the avoidance of doubt the data for Composition L is extracted from Table 2 hereinbefore.

TABLE 6

3.1.1 Cleaning Efficacy f Blood Removall of Compositions after 2 minutes

The cleaning efficacy of compositions in accordance with the invention was tested versus a number of commercially available enzyme-containing compositions. These tests confirmed the desirable performance levels of present compositions versus these commercial compositions at both 2 and 5 minute soak times. A number of these results are illustrated and discussed hereinafter.

Test solutions of compositions K and L (from Table 3) were prepared and diluted solutions thereof at 0.5%, in deionised (Dl) water were assessed for cleaning efficacy against blood soil for 2 minutes soak time versus correspondingly diluted solutions of a commercial multi- enzyme comparator formulations Endozyme AW Plus (from Ruhof), and a commercial multi- enzymatic comparator formulation Aniosyme DD1 (from Anios).

The testing was carried out in accordance with the method described hereinbefore and three sets of results were obtained for each composition. In each instance the plates were weighed before soiling, after soiling (with blood) and after cleaning. The percentage removal was calculated for each, as well as the average percentage removal.

empty plate after %

plate blood cleaning removal

Test product K, 0.5% 15.5387 15.5730 15.5396 97.3761

2 Min Dl-Water 15.5884 15.6274 15.5904 94.8718

15.7839 15.8330 15.7866 94.5010

Test product L, 0.5% 15.5692 15.6161 15.5700 98.2942

2 Min Dl-Water 15.5263 15.5573 15.5272 97.0968

15.7335 15.7667 15.7345 96.9880

Aniosyme DD1 , 0.5% 15.5134 15.5460 15.5149 95.3988 2 Min Dl-Water 15.5983 15.6341 15.6044 82.9609

15.8322 15.8718 15.8348 93.4343

Endozyme AW Plus, 0.5% 15.7974 15.8342 15.8033 83.9674 2 Min Dl-Water 15.4351 15.4783 15.4373 94.9074

15.4866 15.5330 15.4905 91.5948

% blood

removed

Test product K, 0.5%, 2 Min Dl water 95.5830 Test product L, 0.5%, 2 Min Dl water 97.4597

Aniosyme DD1 , 0.5%, 2 Min Dl water | 90.5980

Endozyme AW Plus, 0.5%, 2 Min Dl water | 90.1565

The average results obtained from these three tests clearly illustrates that compositions K and L of the present invention deliver superior cleaning performance in terms of percentage blood removal after 2 minutes versus enzymatic comparator compositions. These results are very surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.

Compositions of the invention have been demonstrated to deliver improved soil removal after 2 minutes versus comparator compositions.

3.1.2 Cleaning Efficacy fBlood Removall of Compositions after 5 minutes

The tests of 3.1.1 were repeated but with a 5 minute soak time. The average results obtained from these three tests clearly illustrates that compositions K and L of the present invention deliver superior cleaning performance in terms of percentage blood removal after 2 minutes versus both enzymatic comparator compositions. These results are very surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.

Compositions of the invention have been demonstrated to deliver improved soil removal after 2 minutes versus comparator compositions. empty plate after %

plate blood cleaning removal

Test product K, 0.5% 15.5259 15.5599 15.5292 90.2941

5 Min Dl-Water 15.4183 15.4601 15.4205 94.7368

15.7329 15.7768 15.7340 97.4943

Test product L, 0.5% 15.5685 15.605 15.5783 73.1507

5 Min Dl-Water 15.7972 15.8376 15.8026 86.6337

15.8296 15.8743 15.8331 92.1700 Aniosyme DD1 , 0.5% 15.5384 15.5738 15.5403 94.6328

5 Min Dl-Water 15.5978 15.6415 15.5997 95.6522

15.8317 15.8805 15.8351 93.0328

Endozyme AW Plus, 0.5% 15.7838 15.8422 15.7854 97.2603

5 Min Dl-Water 15.4397 15.4846 15.4407 97.7728

15.5126 15.5470 15.5145 94.4767

% blood

removed

Test product K, 0.5%, 5 Min Dl water 94.1751

Test product L, 0.5%, 5 Min Dl water 83.9848

Aniosyme DD1 , 0.5%, 5 Min Dl water 94.4392

Endozyme AW Plus, 0.5%, 5 Min Dl water 96.5033

3.2 Cleaning Efficacy fBlood Removall of Compositions

Test solutions of compositions A1 , A2, A3 and A1 -a (illustrated in Table 7) were prepared and diluted solutions thereof at 0.5%, 1 %, in deionised (Dl) water were assessed for cleaning efficacy versus correspondingly diluted solutions of a commercial multi-enzyme comparator formulation Sekusept from Ecolab.

TABLE 7

The test was carried out in accordance with the method described hereinbefore and three sets of results were obtained for each composition. In each instance the plates were weighed before soiling, after soiling (with blood) and after cleaning. The percentage removal was calculated for each.

empty plate after

plate blood cleaning % removal

Sekusept

Multienzyme 0.5% 15.2616 15.2921 15.2667 83.2787

2 Min in Dl-H ₂ 0 15.5983 15.6384 15.6049 83.541 1

15.7780 15.8164 15.7814 91.1458

A1 0.5% 15.7979 15.8275 15.8065 70.9459

2 Min in DI-H2O 15.7929 15.8368 15.7982 87.9271

15.8334 15.8617 15.8359 91.1661

A2 0.5% 15.8028 15.8314 15.8074 83.9161

2 Min in DI-H2O 15.8302 15.8652 15.8361 83.1429

15.7676 15.8071 15.7707 92.1519

A3 0.5% 15.5263 15.5670 15.5287 94.1032

2 Min in DI-H ₂ 0 15.4881 15.5189 15.4926 85.3896

15.5948 15.6285 15.5985 89.0208

A1 -a 0.5% 15.7339 15.7792 15.7431 79.6909

2 Min in DI-H ₂ 0 15.8266 15.8620 15.8299 90.6780

15.8328 15.8632 15.8361 89.1447

Surprisingly the average results obtained from these three tests clearly illustrate that compositions of the present invention deliver cleaning performance at similar levels to that of the comparator enzyme containing composition. These results are surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance. % blood

removed

Enzymatic Cleaner, 2 Min Dl-H ₂ 0 85.9886

A1 , 2 Min Dl-H ₂ 0 83.3464

A2, 2 Min Dl-H ₂ 0 86.4036

A3, 2 Min Dl-H ₂ 0 89.5045

A1 -a, 2 Min Dl-H ₂ 0 86.5046

4.3 Cleaning Efficacy fBlood Removall of Compositions

Test solutions of compositions B1 , B2, B3 and B1 -a (from Table 8 were prepared and diluted solutions thereof at 0.5%, 1 %, in Dl water were assessed for cleaning efficacy versus correspondingly diluted solutions of a commercial multi-enzyme comparator formulation (Sekusept) and a non-enzymatic commercially available formulation Aniosyme DDL The test was carried out in accordance with the method described hereinbefore and three sets of results were obtained for each composition. In each instance the plates were weighed before soiling, after soiling (with blood) and after cleaning. The percentage removal was calculated for each. empty plate after

plate blood cleaning % removal

Sekusept

Multienzyme 0.5% 15.7705 15.8044 15.7752 86.1357

2 Min in Dl-H ₂ 0 15.6371 15.6720 15.6416 87.1060

15.8033 15.8438 15.8078 88.8889

B1 0.5% 15.4515 15.4864 15.4555 88.5387

2 Min in Dl-H ₂ 0 15.5054 15.5434 15.5101 87.6316

15.5486 15.5846 15.5536 86.1 1 1 1

B2 0.5% 15.8099 15.8376 15.8102 98.9170

2 Min in Dl-H ₂ 0 15.6575 15.8585 15.6644 96.5672

15.7038 15.7446 15.709 87.2549

B3 0.5% 15.7446 15.7807 15.7489 88.0886

2 Min in Dl-H ₂ 0 15.7665 15.7983 15.7709 86.1635 15.7749 15.8095 15.7783 90.1734

B1 -a 0.5% 15.7337 15.7722 15.7376 89.8701

2 Min in Dl-H ₂ 0 15.7965 15.8296 15.8008 87.0091

15.7265 15.7596 15.7306 87.6133

Aniosyme DD1

0.5% 15.8023 15.843 15.8091 83.2924

2 Min in Dl-H ₂ 0 15.7506 15.7892 15.7572 82.9016

15.6780 15.706 15.6813 88.2143

As clearly illustrated the average results obtained from these three tests clearly illustrate that compositions of the present invention deliver cleaning performance at similar levels to that of the comparator enzyme containing composition, and that composition B2 delivers improved cleaning. All of the test compositions and the enzyme comparator formulation outperformed the non-enzymatic comparator formulation. These results are surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.

% blood

removed

Sekusept Multienzyme, 2 Min Dl-

H ₂ 0 87.3769

B1 , 2 Min Dl-H ₂ 0 87.4271

B2, 2 Min Dl-H ₂ 0 94.2463

B3, 2 Min Dl-H ₂ 0 88.1419

B1 -a, 2 Min Dl-H ₂ 0 88.1642

Aniosyme DD1 , 2 Min Dl-H ₂ 0 84.8027

5.1. Material Compatibility

Material compatibility testing was carried out for compositions A1 to B1 -a as illustrated in Table 8 and also for a comparator enzymatic composition (Sekusept Multienzyme). The method was carried out in accordance with the procedure detailed hereinbefore, and in each test case, the plates were immersed an in-use solution of the test composition at 0,5% aqueous concentration in deionised (Dl) water, in a beaker (600ml).

After a week the plates were rinsed off with Dl water, dried and the weight was measured. On the following day the plates were immersed again (in freshly prepared test solutions) and the whole procedure was repeated twice more.

The results are illustrated in Table 8.

These results illustrate that even when tested in Dl water, there was substantially no weight loss shown for compositions of the invention when tested against Steel for up to 3 weeks. As it is known that alkaline compositions can have a negative impact on compatibility with Steel these results are unprecedented.

In addition the results demonstrate very low weight losses in Dl water for a range of metals at up to 3 weeks of immersion. Whilst not wishing to be bound to any particular theory it is proposed herein that the increased weight losses observed for the present compositions with blue and red Al, versus Al-alone are pigment-associated effects.

Given that, in reality surgical instruments are only likely to be soaked for a matter of minutes at a time, and in tap water, as opposed to the weeks of immersion in Dl water in these stress condition tests, these results indicate that the present compositions are likely to compare favourably to enzymatic compositions during use.

TABLE 8

4.2. Material Compatibility

Material compatibility testing was carried out for compositions K and L (as illustrated in Table 2). The method was carried out in accordance with the procedure detailed hereinbefore, and in each test case, the Anodized Aluminium plates were immersed an in-use solution of the test composition at 0.5% aqueous concentration in TAP water (water hardness 14 °dH), in a beaker (600ml). The results for Composition K are shown in Table 9 and the results for Composition L are shown in Table 10.

TABLE 9

TABLE 10

These results demonstrate that both compositions K and L show negligible weight losses in these stress test conditions. Compositions of the invention have been demonstrated to show highly desirable material compatibility when tested with both red and blue Anodized Aluminum.