Cleaning and marking composition

Abstract

A cleaning and marking composition for a medical device or a surface comprises an aqueous solution including from 1 wt% to 10 wt% nonionic surfactant selected from the group consisting of: alkyl polyglucosides, alcohol ethoxylates, alcohol ethoxylate propoxylates, and mixtures of two or more thereof, from 1 wt% to 5 wt% organic solvent selected from the group consisting of: glycol ethers, methoxymethyl butanol, propane-1,2-diol, propane-1,3-diol, isopropylideneglycerol, and mixtures thereof, from 0.01 wt% to 3 wt% of a neutral or anionic viscosity modifier, from 0.1 wt% to 5 wt% sodium chloride, and from 0.5 to 5 wt% of a dyestuff, the dyestuff being selected from the group comprising anthocyanin dyestuffs, anthocyanidin dyestuffs, betanin dyestuffs, phycocyanin dyestuffs, and carotene dyestuffs. An applicator wipe for applying the cleaning and marking composition to a medical device or surface, and a method of cleaning and disinfecting a surface carrying a residual aqueous contaminant (ultrasound gel) are also disclosed.

Description

[0001] CLEANING AND MARKING COMPOSITION

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a cleaning and marking composition for cleaning and marking a medical device or a surface, for example as part of a decontamination procedure.

[0004] BACKGROUND TO THE INVENTION

[0005] Within the healthcare market, decontamination procedures are widely used for disinfection and cleaning. Areas of particular importance include the reprocessing of medical devices, such as for example surgical instruments, ultrasound probes, endoscopes and the like. For infection control and patient safety, it is essential that any process used for decontamination or disinfection is effective in practice, taking into account the products used for disinfection, the training and performance of the user, environmental factors, and so on.

[0006] Existing methods for reprocessing such medical devices typically include multiple process steps. For example, a first step may be performed in which the device is cleaned with a cleaning agent, for the removal of gross contaminants (such as ultrasound gel) and soiling from the surface. In a second step, disinfection or sterilization may take place using chemical, thermal, or radiative means. In a third step, a rinsing process may be performed to remove left over chemical residue, particularly where the disinfection step uses a chemical disinfectant. One example of a three-step decontamination system, in which a chlorine dioxide-based disinfecting agent is used, is described in WO 2005 / 107823 A1. Many other disinfectant compositions are also used in the art, including those based on chlorine, peracetic acid, hydrogen peroxide, hypochlorite, quaternary ammonium compounds, tertiary amines and so on. Disinfection may also be achieved for example by exposure to UV radiation, steam or heat.

[0007] P6112PC00 When a pre-disinfection cleaning step is required, failure to adequately clean the device prior to disinfection has the potential to markedly increase the risk of crosscontamination and post-procedure infection. By failing to remove contaminants such as ultrasound gel before disinfection, the performance of the disinfectant can be impaired. For example, the disinfectant may react with the remaining contaminants, reducing the efficacy of the disinfectant on the surface. Also, the contaminants may shield or cover areas of the surface, preventing them from being properly exposed to the disinfecting agent.

[0008] Effective disinfection also relies on the user ensuring that all parts of the surface to be treated are adequately exposed to the disinfecting agent. UK Patent Application Publication No. GB 2618158 A discloses a composition containing a dyestuff that exhibits a distinctive colour change upon exposure to the relevant disinfecting agent and can be applied to a medical device or a work surface before performing a disinfection operation.

[0009] Against that background, it would be desirable to provide a composition that can effectively remove gross contaminants in a pre-disinfection cleaning step whilst also marking the surface to be cleaned to allow a user to verify the effectiveness of a subsequent disinfection step.

[0010] SUMMARY OF THE INVENTION

[0011] Aspects of the invention are specified in the independent claims. Preferred features are specified in the dependent claims.

[0012] In a first aspect, the present invention provides a cleaning and marking composition for application to a medical device or a surface. The composition comprises an

[0013] P6112PC00 aqueous solution including:

[0014] from 1 wt% to 10 wt% nonionic surfactant selected from the group consisting of: alkyl polyglucosides, alcohol ethoxylates, alcohol ethoxylate propoxylates, and mixtures of two or more thereof;

[0015] from 1 wt% to 5 wt% organic solvent selected from the group consisting of: glycol ethers, methoxymethyl butanol, propane-1, 2-diol, propane-1, 3-diol, isopropylideneglycerol, and mixtures thereof; and

[0016] from 0.01 wt% to 3 wt% of a neutral or anionic viscosity modifier;

[0017] from 0.1 wt% to 5 wt% sodium chloride;

[0018] and from 0.5 to 5 wt% of a dyestuff, the dyestuff being selected from the group comprising anthocyanin dyestuffs, anthocyanidin dyestuffs, betanin dyestuffs, phycocyanin dyestuffs, and carotene dyestuffs.

[0019] It has been found that the presence of sodium chloride in the composition, alongside the nonionic surfactant, enhances the ability of the composition to break down and remove gross contaminants such as ultrasound gels and protein-based contaminants from a medical device surface.

[0020] The dyestuff may comprise a compound selected from the group comprising anthocyanins, anthocyanidins, betanins, and mixtures thereof. Preferably, the dyestuff is an anthocyanin. In one embodiment, the dyestuff comprises red radish extract. The cleaning and marking composition may comprise from 1 wt% to 3 wt% of the dyestuff.

[0021] In the context of this specification, the term “pigment” is used to refer to a substance that exhibits a colour resulting from selective colour absorption, which may be a single compound or two or more associated compounds (such as pigment-protein complexes). The term “dyestuff” is used to refer to a substance or mixture of substances that includes a pigment. A dyestuff may consist only of the pigment or may include a pigment together with one or more other substances (including additional pigments). Said another way, the dyestuff may comprise up to 100 wt%

[0022] P6112PC00 pigment. In some embodiments, the dyestuff comprises up to 10 wt% pigment, up to 20 wt% pigment, or up to 30 wt% pigment.

[0023] The dyestuff may exhibit a colour change upon exposure to a high-level disinfectant composition. For example, the dyestuff (or the pigment) may be oxidised in the presence of chlorine dioxide so that the initial colour of the dyestuff changes colour (for example to colourless) upon exposure to a chlorine dioxide-based disinfecting agent. Alternatively, the colour change may arise from oxidation of the dyestuff when the disinfecting agent is a different agent, such as chlorine, peracetic acid, hydrogen peroxide, hypochlorite and so on. In further examples, a colour change may arise due to UV-induced or thermal degradation of the dyestuff when the disinfecting agent is UV light or high temperature, respectively.

[0024] The cleaning and marking composition may comprise from 0.5 wt% to 5 wt%, from 0.5 wt% to 4 wt%, from 1 wt% to 4 wt% or from 1 wt% to 3 wt% sodium chloride.

[0025] The nonionic surfactant helps the cleaning and marking composition to wet the surface of medical devices, which are typically smooth and may be hydrophobic. Surfactants typically promote foaming, and in some applications, it is desirable that the cleaning and marking composition is dispensed as a foam, since foams can be easily dispensed onto an applicator (such as a wipe) and spread onto a surface. However, it can be desirable to avoid excessive foaming on the surface to be marked, to avoid non-uniform ity of colour or undesirable light-scattering effects. To that end, when tested using the Ross-Miles method, the nonionic surfactant preferably achieves an initial foam height of 70 mm or less, preferably 50 mm or less, and / or foam collapse of 10% or more, preferably 20% or more after 5 minutes.

[0026] It has been found that a nonionic surfactant mixture comprising one or more alkyl polyglucosides and one or more alcohol ethoxylate propoxylates produces particularly good results, with a suitable balance between wetting and foaming abilities to achieve uniform coverage when applied to a surface.

[0027] P6112PC00 The cleaning and marking composition may comprise a total of from 1 wt% to 5 wt% of the nonionic surfactant(s).

[0028] In addition to the nonionic surfactant, the cleaning and marking composition may comprise a further surfactant, which may be an amphoteric surfactant. The further surfactant may be a fatty acid, in particular a fatty acid amide, such as cocamidopropyl betaine (CAPB). The amount of further surfactant may be up to 5 wt%, or up to 3 wt%, or up to 1 wt% of the composition.

[0029] To control foaming, the composition may include an anti-foaming agent, such as a silicone emulsion. One suitable example is Dowsil FS Antifoam DB-110a (Dow Corning).

[0030] The choice of organic solvent has been found to be important in stabilising dyestuffs, and affects how the cleaning and marking composition deposits on the surface. Particularly suitable solvents include propanediols such as propane-1, 3-diol, 3-methoxy-3-methyl-1 -butanol and dipropylene glycol n-propyl ether. More generally, the solvent may be a diol, particularly an isoprene diol or branched-chain dialcohol, or a ketal. The cleaning and marking composition may comprise from 2 wt% to 4 wt% of the organic solvent.

[0031] The pH of the cleaning and marking composition may be adjusted to suit the dyestuff selected. For example, the pH may be between 2 and 7. Where the dyestuff is an anthocyanin, a pH range of between 2 and 4 has been found to be suitable. The cleaning and marking composition may comprise a pH modifier (i.e. an acid or base added to adjust the pH to a target value). The pH modifier is preferably selected from the group consisting of: citric acid, sodium hydroxide, sodium carbonate and mixtures thereof.

[0032] The presence of a viscosity modifier (which may also be referred to as a rheology

[0033] P6112PC00 modifier or thickening agent) has a positive effect on the spreading behaviour of the composition. It has been found that suitable viscosity modifiers are neutral or anionic. The viscosity modifier may be selected from the group consisting of natural polysaccharides, polysaccharide derivatives, xanthan gums, guar gums, hydroxyethyl cellulose, cellulose derivatives, polyacrylates and mixtures thereof. The cleaning and marking composition may have a viscosity between 400 cP and 650 cP, and preferably between 500 cP and 600 cP, measured using a Brookfield rotational viscometer with RV spindle 1 at 20 rpm.

[0034] The cleaning and marking composition may further comprise a humectant, for example a triol (such as glycerine / glycerol) or a sugar-based humectant (such as a betaine, sorbitol, or trehalose). The cleaning and marking composition may comprise from 1 wt% to 5 wt%, and preferably from 1 wt% to 3 wt% of the humectant.

[0035] The cleaning and marking composition may further comprise a sequestering agent. Sequestering agents are useful in protecting the pigments, by chelating impurities (particularly metal impurities) that may be introduced during manufacture of the composition or in use. The sequestering agent may for example be selected from the group consisting of: glutamic acid, N,N-diacetic acid, tetrasodium glutamate diacetate and mixtures thereof.

[0036] The cleaning and marking composition may further comprise a preservative, such as a mixture of phenoxyethanol, butylbenzisothiazolone and bis(3-aminopropyl) dodecylamine, commercially available as parmetol BPX (RTM).

[0037] A remainder of the composition may comprise water. The composition may for example include at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80% or at least 85% water.

[0038] In a second aspect, the present invention provides a method of cleaning and

[0039] P6112PC00 disinfecting a surface carrying a residual aqueous contaminant. The method comprises applying to the surface a cleaning and marking composition according to the first aspect of the invention, agitating the cleaning and marking composition on the surface to mix the cleaning and marking composition with the residual aqueous contaminant, and to spread the cleaning and marking composition across a region of the surface to be disinfected, such that said region is marked with a first colour, and applying a disinfection process to the surface, whereby the disinfection process causes a colour change from the first colour.

[0040] The disinfection process may, for example, comprise applying a chlorine dioxide disinfecting composition to the surface. A wipe may be used to apply and / or agitate the cleaning and marking composition.

[0041] The colour change caused by the disinfection process may be from the first colour to colourless.

[0042] The residual aqueous contaminant may comprise an ultrasound gel.

[0043] Preferred and / or optional features of each aspect and embodiment of the invention may also be used, alone or in appropriate combination, in the other aspects and embodiments also.

[0044] BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings in which like reference signs are used for like features, and in which:

[0046] Figure 1 is schematic illustration of steps in a method of decontaminating a surface; and

[0047] P6112PC00 Figure 2 is a flowchart of the method shown in Figure 1.

[0048] DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0049] In this specification, unless the context demands otherwise, the amount of a component in a composition is expressed as wt% (wt / wt% or weight / weight). This corresponds to the mass of each component relative to the total mass of the composition, expressed as a percentage.

[0050] The present invention relates to aqueous cleaning and marking compositions that have surprisingly been found to be effective both for breaking down gross contaminants of the type typically encountered when reprocessing medical devices on a surface, such as ultrasound gel, and for marking the surface uniformly with a distinctive colour prior to a disinfection step. Preferably, the marking colour of the composition changes (for example to become colourless) upon exposure to the disinfecting agent used in the disinfection process, so that the cleaning and marking composition not only helps to remove gross contaminants before disinfection, but also allows the user to verify that the subsequent disinfection process has been applied to all areas of the surface.

[0051] A method of cleaning and marking a surface using a cleaning and marking composition according to the invention, and then disinfecting the surface, will now be described with reference to Figures 1 and 2. In this example, the cleaning and marking composition (referred to also as a “cleaner / marker”) is applied to a surface of a medical device using a wipe.

[0052] As shown in Figure 1(a), a cleaning and marking system 10 comprises a cleaning and marking composition 12, together with an applicator wipe 14. The marking composition 12 is an aqueous composition that is contained in a pump container 16 with a pump dispenser head 18 that is operable to dispense a quantity of the cleaning and marking composition 12, optionally as a foam. As will be described

[0053] P6112PC00 below, the cleaning and marking composition 12 in this example includes a red radish extract dyestuff, which gives the composition a distinctive red colour.

[0054] In step 101 (Figure 2) of the method, the cleaning and marking composition is dispensed from the container 16 onto the wipe 14, as shown in Figure 1(a). The wipe 14 may then be folded and scrunched to distribute the cleaning and marking composition evenly on the wipe 12.

[0055] Then, the wipe 14 is used to apply the cleaning and marking composition 12 to the surface of the device 20 (Figure 1(b), step 102 in Figure 2). It is desirable that the whole of the surface to be decontaminated is covered by a uniform, continuous coating of the cleaning and marking composition 12.

[0056] Residual aqueous contaminants, such as ultrasound gel, may be present on the surface of the device 20 at the time of application of the cleaning and marking composition 12. The presence of ultrasound gel may be revealed by a change in colour of the cleaning and marking composition 12, which results from a change in pH. In this example, the cleaning and marking composition 12 has a pH of between 2 and 4, while ultrasound gel typically has a pH of around 5.5 to 6.5. As a result, the the cleaning and marking composition changes shade and appears pink in the regions of contamination. As shown in Figure 1 (c), the position of such contaminants on the surface of the device 20 may therefore be observable by the user as regions 22 of different colour and can provide an indication that further cleaning is required to remove the contaminant from the surface. It will be understood that, in some cases, no discernible colour change occurs upon contact with contaminants.

[0057] To remove the contaminant, the user may agitate the cleaning and marking composition 12 on the surface with the wipe 14 (Figure 1(d), step 103 in Figure 2). This continued wiping mixes the cleaning and marking composition with the contaminant, and the cleaning and marking composition helps to break down the contaminant. The agitation process manually removes the contaminant by

[0058] P6112PC00 transferring it to the wipe 14, and re-applies the cleaning and marking composition 12 to the surface. Wiping continues until the surface appears with a uniform coating of the second colour (Figure 1(e), step 104 in Figure 3).

[0059] The device 20 is then subjected to a disinfecting step (step 105 in Figure 2). In such cases, a suitable disinfecting agent, such as chlorine dioxide, may be applied to the surface of the device 20 with a suitable applicator. In this example, a two-part chlorine dioxide disinfectant system is shown, in which first and second parts of the disinfectant system are contained in a two-chamber container 30 and dispensed as foams onto a wipe 32, where they are mixed to produce a chlorine dioxide disinfectant 34 in-situ on the wipe (Figure 1(f)). The wipe 32 is then used to apply the disinfectant 34 to the device 20 (Figure 1(g)). A suitable chlorine dioxide disinfectant system is described in European Patent No. 1843765 B1.

[0060] The dyestuff of the cleaning and marking composition, in this example, undergoes a colour change in the presence of chlorine dioxide, from coloured to colourless. This colour change allows the user to visually validate that the areas marked by the cleaning and marking composition 12 have changed colour, and therefore that these areas have been exposed to chlorine dioxide during the disinfection process. After successful disinfection, no residual colour can be seen on the device 20 (Figure 1(h)).

[0061] Log entries may be made at each step of the above method such that an audit trail is produced, for regulatory, training, or monitoring purposes. For example, a log entry may be made once the cleaning and marking composition is applied to the surface of the device, with the outcome recorded in the log. Outcomes may include whether a uniform colour was provided on the surface, or whether and where any colour change was observed, indicative of the presence of pH-modifying contaminants. A subsequent log entry may be made once further wiping of the surface has occurred to provide a uniform colour on the surface, corresponding to removal of the contaminant from the surface, and the subsequent disinfecting steps

[0062] P6112PC00 may also be logged.

[0063] Further details of the cleaning and marking composition will now be described.

[0064] The cleaning and marking composition is an aqueous solution, comprising one or more nonionic surfactants, one or more organic solvents and one or more viscosity modifiers, and sodium chloride. Optionally, the cleaning and marking composition may also include one or more humectants, one or more sequestering agents, one or more preservatives, one or more pH modifiers and / or one or more fragrances.

[0065] The surfactant contributes to the ability of the cleaning and marking composition to wet the surface of the medical device or the work surface. Good wetting ability is important, since medical device surfaces are often designed to resist wetting (i.e. they may have hydrophobic properties and a smooth texture).

[0066] Testing revealed that suitable nonionic surfactants are alkyl polyglucosides, alcohol ethoxylates, alcohol ethoxylate propoxylates, and mixtures of two or more thereof. Alcohol ethoxylate propoxylates with chain lengths of C6 to C15 with between 6 and 8 moles of ethoxylation and 4 moles of propoxylation may be particularly suitable.

[0067] It has been determined that a blend of two commercially-available nonionic surfactants, namely SugaDet D (RTM, Colonial Chemical), a decyl glucoside, and Berol (RTM) 185 (alcohol ethoxylate propylate, available from Nouryon), provides the desired wetting properties without excessive foaming and without causing degradation of the dyestuff. As an alternative to SugaDet D, AG 6210 (a blend of alkyl polyglucosides, in particular decyl glucoside and caprylyl glucoside and available from Nouryon), may be used in this blend.

[0068] Other suitable tested nonionic surfactants include Genapol EP 2424 and Genapol EP 2484 (RTMs, Clariant), and decyl glucoside.

[0069] P6112PC00 The cleaning and marking composition may comprise from 1 wt% to 10 wt% of the nonionic surfactant (i.e. the total amount of nonionic surfactant, whether a single compound or a mixture of two or more compounds). Preferably, the cleaning and marking composition comprises a total of from 1 wt% to 8 wt%, from 1 wt% to 7 wt%, from 1 wt% to 6 wt%, from 1 wt% to 5 wt%, from 2 wt% to 8 wt%, from 2 wt% to 7 wt%, from 2 wt% to 6 wt%, from 2 wt% to 5 wt%, from 2 wt% to 4 wt%, from 3 wt% to 8 wt%, from 3 wt% to 7 wt%, or from 3 wt% to 6 wt%, of nonionic surfactant.

[0070] In some cases, the cleaning and marking composition includes a further surfactant, in addition to the nonionic surfactant. The further surfactant may, for example, comprise an amphoteric surfactant. Suitable amphoteric surfactants include fatty acid amides, such as cocamidopropyl betaine (CAPB, available as Surfac B4 (RTM), Surfachem Group Ltd.). In one example, the nonionic surfactant is alcohol ethoxylate propylate (Berol 185) and the further surfactant is CAPB.

[0071] When a further surfactant is present, the cleaning and marking composition may comprise up to 5 wt% of the further surfactant, and preferably up to 3 wt% of the further surfactant.

[0072] The solvent is a water-soluble organic solvent. It is desirable that the solvent is low toxicity, has a high flash point (to reduce flammability), is biodegradable and has a suitable evaporation rate to allow for spreading and even drying of the cleaning and marking composition after application to the surface. Simple solvents such as ethanol and isopropyl alcohol are therefore not preferred for one or more of these reasons. Suitable tested solvents include glycol ethers such as dipropylene glycol n-propyl ether (available as Dowanol DPnP, Dow Chemicals), 3-methoxy-3-methyl-1-butanol, propane-1, 2-diol, propane-1, 3-diol (available as Zemea (RTM) propanediol) and isopropylideneglycerol. More generally, the solvent may be a diol, particularly an isoprene diol or branched-chain dialcohol, or a ketal.

[0073] The cleaning and marking composition may comprise from 1 wt% to 5 wt% of the

[0074] P6112PC00 solvent. Preferably, the cleaning and marking composition comprises from 1 wt% to 4 wt% of the solvent, and more preferably from 1.5 wt% to 3.5 wt% of the solvent.

[0075] The viscosity modifier (also known as a viscosity modifying agent) is provided to stabilise the dispersion of the dyestuff solid phase and to thicken the composition for optimum spreadability on the surface. Suitable tested viscosity modifiers include xanthan gum, hydroxyethyl cellulose, nonionic guar gums, and polyacrylates.

[0076] The cleaning and marking composition preferably comprises from 0.01 wt% to 3 wt% of the viscosity modifier. Preferably, the cleaning and marking composition comprises from 0.1 wt% to 1 wt% of the viscosity modifier.

[0077] It has been found that the addition of sodium chloride substantially enhances the cleaning ability of the cleaning and marking composition, without impacting the performance of the composition as a marker. Without wishing to be bound by theory, it is believed that the presence of electrolytes such as sodium chloride assists in the breakdown of long-chain molecules, such as acrylic acid polymers, in viscous aqueous contaminants such as ultrasound gel.

[0078] The cleaning and marking composition may comprise from 0.1 wt% to 5 wt%, from 0.5 wt% to 5 wt% sodium chloride, from 0.5 wt% to 4 wt%, from 0.5 wt% to 3 wt%, from 1 wt% to 3 wt%, or about 2 wt% sodium chloride.

[0079] As an alternative to sodium chloride, other alkali metal salts or alkaline earth metal salts may be suitable. Examples include potassium chloride, calcium chloride, magnesium chloride and magnesium sulfate.

[0080] The cleaning and marking composition may include a humectant to help disperse the viscosity modifier. It has also been found that humectants can help stabilise the dyestuff. Triols (in particular glycerol) or sugar-based humectants (such as sorbitol) are suitable. When present, the humectant may comprise from 0.5 wt% to 5 wt%, or

[0081] P6112PC00 from 1 wt% to 3 wt%, or from 1 wt% to 2 wt% of the composition.

[0082] The cleaning and marking composition may include a sequestering agent or chelating agent. When present, a sequestering agent can chelate impurities, in particular heavy metals, which might otherwise cause degradation of pigments. A sequestering agent may therefore improve the shelf-life of the cleaning and marking composition and increase tolerance to impurities introduced during manufacturing or in use. Suitable sequestering agents include tetrasodium glutamate diacetate (an aminopolycarboxylate-based chelating agent), available as Dissolvine (RTM) GL38 (Glutamic acid, N,N-diacetic acid, tetrasodium salt, Nouryon), trisodium ethylenediamine disuccinate, disodium EDTA and tetrasodium EDTA.

[0083] The cleaning and marking composition may for example comprise from 0.01 wt% to 5 wt% of the sequestering agent. Preferably, the cleaning and marking composition comprises from 0.1 wt% to 1 wt% of the sequestering agent.

[0084] The cleaning and marking composition may include a preservative, such as parmetol BPX (Vink Chemicals). The composition may include up to 2 wt%, and preferably from 0.1 wt% to 1.5 wt % of the preservative.

[0085] The cleaning and marking composition may include a fragrance additive, such as a citrus fragrance. The composition may comprise up to 1 wt%, or up to 0.5 wt% of fragrance additive.

[0086] In some examples, the first and / or second parts of the marking system may include a UV filter, such as Surfacare (Registered Trade Mark of Surfachem) PCE 567, or benzophenone-3 (also known as oxybenzone).

[0087] The dyestuff is most preferably a natural dyestuff that is soluble or substantially soluble in water. Examples of suitable dyestuffs may include anthocyanins, anthocyanidins, betanins, phycocyanins, and carotenes (in particular beta-

[0088] P6112PC00 carotenes).

[0089] Anthocyanin dyestuffs have been found to be particularly suitable. Table 1 shows a range of tested anthocyanin dyestuffs, and records the colour exhibited by the dyestuff when in a cleaning and marking composition with a pH range of 2 to 4.

[0090] It was found that all of the dyestuffs were oxidised by chlorine dioxide when in the cleaning and marking composition, inducing a colour change from coloured to colourless.

[0091] Table 1

[0092]

[0093] Other tested dyestuffs included spirulina (phycocyanin), which was blue, and Natpure col Red LC313 (beta-carotene), which was pink.

[0094] In a preferred embodiment, the dyestuff is a red radish dye, commercially available for example as NatPure XFINE Red Radish.

[0095] It has been observed that adjusting the pH of the cleaning and marking composition

[0096] P6112PC00 to within a target range can optimise stability, colour depth and hue of the dyestuff. To this end, the composition may include a pH modifier, such as citric acid, sodium hydroxide and / or sodium carbonate. The behaviour of commercial dyestuffs with respect to pH is typically well-documented and a target pH range can be determined accordingly. For example, a pH range of from 4 to 7, preferably from 5 to 6, and most preferably from 5.5 to 6 has been found to be appropriate for dyestuffs based on blue spirulina extract. A pH range of 2 to 4, preferably from 3 to 4, has been found to be appropriate for anthocyanin-based dyestuffs.

[0097] The total amount of dyestuff in solution in the cleaning and marking composition may be, for example, up to 8 wt%, up to 5 wt%, up to 4 wt%, up to 3 wt%, or up to 2 wt%. In some embodiments, the amount of dissolved dyestuff may be from 0.5 wt% to 3 wt%, and is preferably from 1 wt% to 2 wt%.

[0098] The cleaning and marking composition may be supplied as a liquid composition in any suitable container or dispenser. For example, the cleaning and marking composition may be supplied in a bottle, a foam dispenser, a spray bottle, a pump bottle and so on. Conveniently, the cleaning and marking composition can be dispensed onto a suitable applicator, such as a wipe or sponge, for application to a medical device or a surface. Alternatively, the cleaning and marking composition could be sprayed, poured or otherwise directly applied to the surface to be marked. In the case of a medical device, the device may be dipped into a vat of the cleaning and marking composition.

[0099] It is also possible for the cleaning and marking composition to be pre-applied to an applicator wipe, for example a wipe with a polypropylene substrate. It has been found through testing that the cleaning and marking composition remains stable when impregnated into or carried on such wipes. After application of the cleaning and marking composition to the wipes, each wipe can be sealed in an individual sachet for storage.

[0100] P6112PC00 The cleaning and marking composition described herein can be applied to substantially any surface to be decontaminated. It is particularly useful where the surface is the surface of a medical device, for example an invasive or non-invasive ultrasound probe, an endoscope, nasendoscope, transvaginal probe, or any other similar device. The surface to be decontaminated may be substantially the whole surface of the medical device or only a part of the medical device. The composition and corresponding method can also be applied to other surfaces, such as counter tops, room surfaces such as floors and walls, furniture and so on.

[0101] The disinfection step described above could be substituted for other disinfection processes, for example by using a different disinfectant composition such as chlorine, chlorine dioxide, peracetic acid, hydrogen peroxide, hypochlorite and so on. In further examples, disinfection may be performed using UV light or high temperature (in which cases the cleaning and marking composition may lose colour due to UV or thermal degradation of the dyestuff).

[0102] The invention will be further disclosed with reference to the following examples.

[0103] Example 1 - cleaning and marking composition

[0104] 1 kg of a cleaning and marking composition was prepared as follows. First, 12.5 g of propane-1, 3-diol (Zemea Propanediol; organic solvent) was mixed with 3.0 g of xanthan gum (Keltrol Advanced Performance; viscosity modifier) and then added to 866 g of water and mixed to form an agueous solution. The following constituents were then added and mixed:

[0105] P6112PC00 Table 2

[0106] Glutamic acid, N,N-diacetic acid, tetrasodium Sequestering

[0107] 3.0 g salt (Dissolvine GL38) agent

[0108] Sodium Chloride Cleaning

[0109] 20.0 g agent

[0110] Decyl glucoside 62% (Suga Det D) Nonionic

[0111] 27.5 g surfactant

[0112] After mixing, the following additional constituents were added, first by pre-mixing the propane-1, 3-diol, benzophenone-3 and fragrance and adding the pre-mix to the solution resulting from the previous step, and then by adding the remaining constituents:

[0113] Table 3

[0114] Alcohol ethoxylate / propoxylate 90% Nonionic

[0115] 22.5 g (Berol 185, Nouryon) surfactant phenoxyethanol, butylbenzisothiazolone and

[0116] bis(3-aminopropyl)dodecylamine Preservative 10 g (parmetol BPX, Vink Chemicals)

[0117] Citric acid monohydrate pH modifier 3.5 g Silicone emulsion (Dowsil Antifoam DB-110a, Anti-foam

[0118] 0.03 g Dow Corning) agent

[0119] Benzophenone-3 UV filter 1.5 g Propane-1, 3-diol (Zemea Propanediol) Organic

[0120] 12.5 g solvent

[0121] Citrus fragrance (Medichem Products) Fragrance 4.0 g

[0122] The resulting solution was mixed for 30 minutes, before the addition of the dyestuff as follows:

[0123] P6112PC00 Table 4

[0124] Red Radish Extract Dyestuff

[0125] 14.0 g (Natpure Xfine Radish RR319)

[0126] The result was an aqueous solution with the following composition:

[0127] Table 5

[0128] Water 87.9 wt%

[0129] Propane-1 ,3-diol (Zemea Propanediol) 2.5 wt%

[0130] Xanthan gum 0.3 wt%

[0131] Sodium chloride 2.0 wt%

[0132] Glutamic acid, N,N-diacetic acid, tetrasodium

[0133] 0.3 wt%

[0134] salt (Dissolvine GL38)

[0135] Decyl glucoside (non-water component of

[0136] 1.7 wt%

[0137] Suga Det D)

[0138] Alcohol ethoxylate / propoxylate

[0139] 2.03 wt%

[0140] (non-water component of Berol 185, Nouryon)

[0141] Citrus fragrance 0.4 wt% phenoxyethanol, butylbenzisothiazolone and

[0142] bis(3-aminopropyl)dodecylamine 1.0 wt%

[0143] (parmetol BPX, Vink Chemicals)

[0144] Citric acid monohydrate 0.35 wt%

[0145] Silicone emulsion (Dowsil Antifoam DB-110a) 0.003 wt% Benzophenone-3 0.15 wt%

[0146] Red radish extract 1.4 wt%

[0147] The pH of the composition was between pH 3 and pH 4.

[0148] P6112PC00 Example 2 - use of the cleaning and marking composition of Example 1

[0149] The cleaning and marking composition of Example 1 was applied by wipe to a transvaginal ultrasound probe to which ultrasound gel had been previously applied. Upon initial inspection, the cleaning and marking composition exhibited a colour change from red to pink in regions where ultrasound gel was present. The cleaning and marking composition was agitated on the surface using the wipe, and it was noted that the viscosity of the ultrasound gel appeared to decrease as agitation continued. The probe was inspected again and the coverage of the cleaning and marking composition was assessed. It was observed that, after wiping, a red colour was visible on the probe over all wiped areas of the probe, with good uniformity.

[0150] After application of the cleaning and marking composition, the probe was subjected to a disinfection procedure using a two-part disinfectant system producing chlorine dioxide as the active disinfectant (Tristel Duo (RTM)). The two parts of the Tristel Duo product were dispensed as foams onto a wipe and then applied to the probe in accordance with the product instructions. Upon application of the disinfectantcarrying wipe to the probe, the areas of the probe that were contacted by the disinfectant rapidly changed colour from red to colourless. Inspection of the probe after disinfection revealed no trace of ultrasound gel.

[0151] Example 3 - cleaning and marking composition

[0152] Another cleaning and marking composition was prepared in an analogous manner to Example 1, with the following composition:

[0153] P6112PC00 Table 6

[0154] Water 88.5 wt%

[0155] Propane-1 ,3-diol (Zemea Propanediol) 2.5 wt%

[0156] Xanthan gum 0.25 wt%

[0157] Sodium chloride 2.0 wt%

[0158] Glutamic acid, N,N-diacetic acid, tetrasodium

[0159] 0.25 wt%

[0160] salt (Dissolvine GL38)

[0161] Decyl glucoside (non-water component of

[0162] 1.7 wt%

[0163] Suga Det D)

[0164] Alcohol ethoxylate / propoxylate

[0165] 1.58 wt%

[0166] (non-water component of Berol 185, Nouryon)

[0167] Citrus fragrance 0.25 wt% phenoxyethanol, butylbenzisothiazolone and

[0168] bis(3-aminopropyl)dodecylamine 1.0 wt%

[0169] (parmetol BPX, Vink Chemicals)

[0170] Citric acid monohydrate 0.35 wt% Benzophenone-3 0.075 wt%

[0171] Red radish extract 1.6 wt%

[0172] The result was an aqueous solution with a pH between 3 and 4.

[0173] Comparative Examples

[0174] For comparison purposes, compositions without sodium chloride were prepared, with the following compositions.

[0175] P6112PC00 Comparative Example 1:

[0176] Table 7

[0177] Water 91.8 wt%

[0178] Xanthan gum 0.2 wt%

[0179] Glycerine 1.5 wt%

[0180] Glutamic acid, N,N-diacetic acid, tetrasodium

[0181] 0.25 wt%

[0182] salt (Dissolvine GL38)

[0183] Dipropylene glycol n-propyl ether

[0184] 1.5 wt%

[0185] (Dowanol DPnP, Dow Chemicals)

[0186] Cocamidopropyl betaine (CAPB)

[0187] (non-water component of 30% CAPB, Surfac B4, 0.8 wt% Surfachem Group Ltd)

[0188] Alcohol ethoxylate / propoxylate

[0189] 1.58 wt%

[0190] (non-water component of Berol 185, Nouryon)

[0191] phenoxyethanol, butylbenzisothiazolone and

[0192] bis(3-aminopropyl)dodecylamine 1.0 wt%

[0193] (parmetol BPX, Vink Chemicals)

[0194] Citric acid monohydrate 0.35 wt%

[0195] Red Radish Extract

[0196] 1.0 wt%

[0197] (Natpure Xfine Radish RR319)

[0198] The pH of this composition was adjusted with citric acid to between pH 3 and pH 4.

[0199] P6112PC00 Comparative Example 2:

[0200] Table 8

[0201] Water 82.1 wt% Xanthan gum 0.2 wt% Glycerine 1.5 wt%

[0202] Citric acid monohydrate 0.1 wt% Glutamic acid, N,N-diacetic acid, tetrasodium

[0203] 0.25 wt%

[0204] salt (Dissolvine GL38)

[0205] 3-methoxy-3-methyl-1 -butanol 3.0 wt%

[0206] Decyl glucoside (non-water component of

[0207] 1.7 wt%

[0208] Suga Det D)

[0209] Alcohol ethoxylate / propoxylate

[0210] 1.58 wt%

[0211] (non-water component of Berol 185, Nouryon)

[0212] phenoxyethanol, butylbenzisothiazolone and

[0213] bis(3-aminopropyl)dodecylamine 1.0 wt% (parmetol BPX, Vink Chemicals)

[0214] Citric acid monohydrate 0.1 wt% Spirulina extract

[0215] 8.5 wt% (Natpure Xfine Spirulina SL615)

[0216] The pH of this composition was between pH 5 and pH 6. In this composition, some of the spirulina extract remained suspended in the solid phase after preparation.

[0217] Example 4 - cleaning efficacy tests

[0218] The cleaning and marking compositions of Examples 1 and 3 and the compositions of Comparative Examples 1 and 2 were subjected to identical cleaning efficacy tests as follows.

[0219] P6112PC00 1) Test soil was prepared based on Edinburgh test soil (in accordance with EN ISO 15883-5), with ultrapure water used in place of sheep blood.

[0220] 2) 3 g of the test soil prepared in step 1 was applied to the inside of a protective sheath, which was then placed over a transvaginal ultrasound probe (GEHC IC5-9D) and manipulated to apply the test soil to all surfaces of the probe within the sheath, including any crevices, indentations, recesses and so on.

[0221] 3) The probe was left for 10 minutes for the soil to settle, then the sheath was remove and the probe allowed to dry for 30 minutes.

[0222] 4) The test composition was applied to the probe using a polypropylene wipe, and all surfaces of the probe were wiped until visual assessment indicated that all traces of test soil had been removed and only the test composition remained.

[0223] 5) The probe was then into a bag and 10 mL of 0.1 % Tween-20 PBS diluent was added. The probe was rinsed by shaking and then the sealed bag was placed into an ultrasonic bath for 10 minutes. The rising was repeated for a total of three times.

[0224] 6) The bag was opened and the rinse extract poured into a glass vial.

[0225] 7) A 2 mL sample of the rinse extract was centrifuged at 12,000 rpm for 5 minutes.

[0226] 8) 1 mL of Pierce 660nm Protein Assay Solution (Thermo Scientific) was mixed with 1 mL of the rinse extract, and allowed to stand for 10 minutes at room temperature.

[0227] 9) The mixture was then analysed in a spectrophotometer to obtain an absorbance reading at 660 nm.

[0228] 10) Spectrophotometry was repeated with a control sample (obtained using the same procedure as above, but with no soiling and no cleaning step); and with a calibration sample (200 mg / mL bovine serum albumin, Sigma Aldrich) to convert the spectrophotometry results to a protein content, and then to a protein concentration per unit area of probe surface.

[0229] The procedure above was repeated several times and the average results are

[0230] P6112PC00 shown in Table 2.

[0231] Table 2

[0232]

[0233] The results indicate that the compositions of Examples 1 and 3 provide significantly better cleaning performance compared with the comparative examples.

[0234] Further modifications and variations not explicitly described above can also be contemplated without departing from the scope of the invention as defined in the appended claims.

[0235] P6112PC00

Claims

CLAIMS1. A cleaning and marking composition for application to a medical device or a surface, comprising an aqueous solution including:from 1 wt% to 10 wt% nonionic surfactant selected from the group consisting of: alkyl polyglucosides, alcohol ethoxylates, alcohol ethoxylate propoxylates, and mixtures of two or more thereof;from 1 wt% to 5 wt% organic solvent selected from the group consisting of: glycol ethers, methoxymethyl butanol, propane-1, 2-diol, propane-1, 3-diol, isopropylideneglycerol, and mixtures thereof;from 0.01 wt% to 3 wt% of a neutral or anionic viscosity modifier; from 0.1 wt% to 5 wt% sodium chloride;and from 0.5 to 5 wt% of a dyestuff, the dyestuff being selected from the group comprising anthocyanin dyestuffs, anthocyanidin dyestuffs, betanin dyestuffs, phycocyanin dyestuffs, and carotene dyestuffs.

2. The cleaning and marking composition of Claim 1, wherein the dyestuff comprises red radish extract.

3. The cleaning and marking composition of Claim 1 or Claim 2, comprising from 1 wt% to 3 wt% of the dyestuff.

4. The cleaning and marking composition of any preceding claim, comprising from 1 wt% to 3 wt% sodium chloride.

5. The cleaning and marking composition of any preceding claim, wherein the nonionic surfactant is a mixture of one or more alkyl polyglucosides and one or more alcohol ethoxylate propoxylates.

6. The cleaning and marking composition of any preceding claim, comprisingP6112PC00from 1 wt% to 5 wt% of the nonionic surfactant.

7. The cleaning and marking composition of any preceding claim, wherein the organic solvent comprises propane-1 ,3-diol.

8. The cleaning and marking composition of any preceding claim, comprising from 1 wt% to 4 wt% of the organic solvent.

9. The cleaning and marking composition of any preceding claim, having a pH of between 2 and 4.

10. The cleaning and marking composition of any preceding claim, further comprising a pH modifier selected from the group consisting of: citric acid, sodium hydroxide, sodium carbonate, and mixtures thereof.

11. The cleaning and marking composition of any preceding claim, wherein the viscosity modifier is selected from the group consisting of natural polysaccharides, polysaccharide derivatives, xanthan gums, guar gums, hydroxyethyl cellulose, cellulose derivatives, polyacrylates and mixtures thereof.

12. The cleaning and marking composition of any preceding claim, wherein the viscosity of the composition is between 400 cP and 650 cP, measured using a Brookfield rotational viscometer using RV spindle 1 at 20 rpm.

13. The cleaning and marking composition of any preceding claim, further comprising a humectant selected from the group consisting of: triols, and sugar-based humectants.

14. The cleaning and marking composition of any preceding claim, further comprising a sequestering agent.P6112PC0015. The cleaning and marking composition of Claim 14, wherein the sequestering agent is selected from the group consisting of: glutamic acid, N,N-diacetic acid, tetrasodium glutamate diacetate and mixtures thereof.

16. An applicator wipe for applying a cleaning and marking composition to a medical device or a surface, wherein the applicator wipe carries a cleaning and marking composition according to any preceding claim.

17. The applicator wipe of Claim 16, wherein the wipe comprises a polypropylene substrate.

18. A method of cleaning and disinfecting a surface carrying a residual aqueous contaminant, the method comprising:applying to the surface a cleaning and marking composition according to any of Claims 1 to 15;agitating the cleaning and marking composition on the surface to mix the cleaning and marking composition with the residual aqueous contaminant, and to spread the cleaning and marking composition across a region of the surface to be disinfected, such that said region is marked with a first colour;applying a disinfection process to the surface, whereby the disinfection process causes a colour change from the first colour.

19. A method according to Claim 18, wherein the disinfection process comprises applying a chlorine dioxide disinfecting composition to the surface.

20. A method according to Claim 18 or Claim 19, comprising using a wipe to apply and / or agitate the cleaning and marking composition.

21. A method according to any of Claims 18 to 20, wherein the colour change isP6112PC00from the first colour to colourless.

22. A method according to any of Claims 18 to 21, wherein the residual aqueous contaminant is an ultrasound gel.P6112PC00

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