The present invention relates to a disinfectant system, notably to a system for preparing chlorine dioxide using a two-part chemistry. The invention is particularly for use in disinfecting medical devices and surfaces, notably surfaces in clinical environments, but it is not limited to these uses.
Two-part disinfectant systems which produce chlorine dioxide when mixed are known. Such systems typically include a chlorite and an acid, or a chlorate, a reducing agent and an acid.
WO 2005/011756 discloses a two-part disinfecting system (shown in
WO 2005/107823 describes a system (shown in
WO 2006/079822 A1 describes another disinfecting system. In this case the first and second reagents are each carried in aqueous media to which foam promoters are added, so that both the first and second parts of the system are dispensed as first and second foams respectively. The first and second foams are mixed to generate the disinfecting composition, which may then be applied to an item or surface to be disinfected directly or with a wipe.
To ensure full effectiveness of a disinfectant wipe or other chlorine dioxide disinfecting system, it is desirable to ensure that chlorine dioxide has been generated and that the action of generating chlorine dioxide can be verified by the end user.
It has been proposed to include in one of the components a pH-sensitive indicator which changes colour or becomes coloured when adequate mixing has occurred. A problem with this approach is that pH may not change much, or a change in pH may not reliably correlate with generation of sufficient chlorine dioxide.
As the medical industry develops there are pressures to move towards automated disinfection systems that are perceived to provide additional assurances that the disinfection process has been successfully completed. The primary arguments in favour of these systems are that they eliminate or reduce the probability of user error and can provide a digital ticket at the end of a machine cycle.
Currently available technologies include test strips, odour detection, titrations and spectrophotometry. Although all able to determine chlorine dioxide concentration they are limited by accuracy of measurement (with some methods semiquantitative), the requirement for a laboratory facility and the impingement on the natural process flow of device reprocessing.
Aspects of the invention are specified in the independent claims. Preferred features are specified in the dependent claims.
By incorporating a suitable dyestuff in one of the parts of the system, it is possible to verify, either by eye or by opto-electronic means, that chlorine dioxide has been produced at an efficacious level in the combined parts prior to use for sterilisation or disinfection. It is also possible to verify that chlorine dioxide has been produced in the whole of the medium comprising the combined parts, by checking whether the colour change has occurred spatially uniformly throughout the medium.
Suitable dyestuffs are those that oxidise in the presence of chlorine dioxide to produce a visible colour change upon mixing of the first reagent with the second reagent, but that do not exhibit the same colour change upon exposure to a disinfecting composition comprising hydrogen peroxide and/or peracetic acid. Preferably, the dyestuff also does not exhibit the same colour change upon exposure to disinfecting compositions including quaternary ammonium compounds and/or triamines.
The dyestuffs used in embodiments of the invention are therefore selective for chlorine dioxide, meaning that the colour change does not occur in the presence of other commonly-used high-level disinfectants or sterilants. In this way, the present invention provides a safeguard against incorrect use of the disinfectant system, for example in scenarios where one part of the system could be mistakenly substituted with one or more other disinfectant products.
Anthocyanin dyestuffs and anthocyanidin dyestuffs have been found to be suitable for use in the present invention. Betanin dyestuffs have also been found to be suitable.
Suitable anthocyanin dyestuffs may be referred to as E163 food additives. The dyestuff may for example be an anthocyanin dyestuff selected from the group consisting of: black carrot extract, purple carrot extract, haskapa berry extract, and blackcurrant extract. In a particularly preferred embodiment, the dyestuff comprises Black Carrot Extract (an anthocyanin dyestuff, also referred to as Antho Black Carrot Extract or AnthoCarrot). Examples of anthocyanidin dyestuffs that may be suitable for use include bilberry extract and blue pea extract (clitoria ternatea). Suitable betanin dyestuffs may be referred to as E162 food additives. Examples of betanin dyestuffs that may be suitable for use include red beetroot powder and beetroot juice concentrate.
The dyestuff preferably changes from coloured to colourless in the presence of chlorine dioxide. In such cases, the part of the system containing the dyestuff preferably exhibits a distinctive pre-exposure colour of the dyestuff, which is observed to disappear after efficacious mixing of the two parts.
The first reagent may comprise a metal chlorite and the second reagent may comprise an acid. The dyestuff may be provided in either the first part, or the second part, or even in both parts.
The first part and the second part of the disinfectant system can each be of any form, subject to compatibility with one another. In general, the first part could for example be any one of a liquid, a foam or a powder or may be impregnated into or otherwise carried on a wipe. The second part could also for example be any one of a liquid, a foam or a powder or may be absorbed or impregnated into or otherwise carried on a wipe. The disinfecting composition may be ready to use, with no dilution required after mixing of the two parts, or may be concentrated for subsequent dilution after mixing to provide a suitable concentration for use.
In one embodiment, the first part is contained in a dispenser whereby it may be dispensed as a fluid, in particular as a liquid or a foam, and the second part is absorbed or impregnated in at least one fabric wipe. In such cases, the second part may comprise the dyestuff, so that the colour change can be most readily observed when the first part is applied to the wipe.
It has been found that, in applications in which the part containing the dyestuff is carried by a wipe, the colour change that occurs upon exposure to chlorine dioxide may be less discernible compared to applications in which the part containing the dyestuff is provided in other forms, such as a liquid. Accordingly, for applications including wipes, it may be preferable that the dyestuff has a strong, distinctive colour that contrasts with the base colour of the wipe (usually white) and/or the yellowish colour of chlorine dioxide. Anthocyanin, anthocyanidin and betanin dyes typically have characteristic deep colours in the red/purple/blue region of the spectrum and therefore provide a clearly distinguishable colour change particularly in applications in which the part containing the dyestuff is carried by a wipe. Black carrot extract, for example, has been found to be particularly effective in providing a distinctive pre-reaction colour when applied to a wipe.
In another example, the first part and/or the second part comprise foams. Again, in this case, it may be preferable that the dyestuff has a strong, distinctive colour that is readily visible in the foam, which usually has a white appearance in the absence of a dyestuff due to light scattering effects. In this connection, the characteristic deep colours associated with anthocyanin, anthocyanidin and betanin dyes may be of particular benefit.
The first part or the second part respectively may comprise between about 0.01% and about 2% dyestuff. Preferably, after mixing of the first reagent with the second reagent, substantially all of the dyestuff is oxidised by the resulting chlorine dioxide.
The present invention extends to a method of verifying the production of a chlorine dioxide disinfecting composition using a disinfectant system as described above. The method comprises mixing the first part and the second part then, during mixing of the first part and the second part, observing said colour change, and determining that the chlorine dioxide disinfecting composition has been produced when said colour change is complete and spatially uniform. The colour change may be observed by eye, or by a suitable opto-electrical system. A suitable machine vision system may be used to perform the observing and determining steps.
For disinfectant systems including a wipe, a method of determining whether the wipe contains chlorine dioxide comprises illuminating at least one surface region of the fabric wipe with at least one wavelength of light, determining an intensity value by measuring the intensity of the at least one wavelength of light reflected from at least one surface region of the fabric wipe, said wavelength corresponding to a wavelength absorbed by the dyestuff, comparing the intensity value with a preset threshold value, and signalling that the wipe contains sufficient chlorine dioxide if the intensity value is at or above the threshold value, or signalling that the wipe contains insufficient chlorine dioxide if the intensity value is below the threshold value. A corresponding apparatus comprises a device for measuring, from at least one surface region of a wipe, an intensity value of at least one wavelength of light corresponding to a wavelength absorbed by the dyestuff, a comparator device for comparing the intensity value with a preset threshold value, and a signalling device for signalling that a wipe contains sufficient chlorine dioxide if the intensity value is at or above the threshold value, or signalling that the wipe contains insufficient chlorine dioxide if the intensity value is below the threshold value.
In an embodiment, the invention provides a disinfectant system comprising a first part comprising a first reagent in a carrier medium; and a second part which is miscible with the first part and which comprises a second reagent in a carrier medium, wherein the first reagent and the second reagent will react when the first and second parts are mixed to provide a chlorine dioxide disinfecting composition. The first part or the second part further comprises an anthocyanin dyestuff, an anthocyanidin dyestuff, or a betanin dyestuff.
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.
The invention will now be further described, by way of example only, with reference to the following drawings, in which:
The prior art systems illustrated in
In the present example, the first part comprises less than 1% sodium chlorite, and less than 2.5% amphoteric surfactant. The remainder is deionised water. In this specification, all parts are by weight unless otherwise indicated. Operation of the pump trigger dispenses the first part as a foam.
The wipes 16 are impregnated with an aqueous acid solution (second part). In this example, the acid solution comprises 1-5% citric acid and 1% Antho Black Carrot Extract as the anthocyanin dyestuff. The remainder is deionised water.
The anthocyanin dyestuff provides the fabric wipe 16 (
Use of a stable, selective dyestuff allows for the verification of not only the presence of chlorine dioxide but additionally the correct level of chlorine dioxide to ensure efficacy. The dyestuff also provides an environmental risk mitigator in the event of using the product outside of its recommended use temperature. The rationale is that the rate of chlorine dioxide generation is slower at colder temperatures and faster at higher temperatures. The rate of dye oxidation will be proportional to the level of chlorine dioxide generated.
Various dyestuffs were investigated for the ability to provide selectivity towards chlorine dioxide. In addition, the safety profile of each dye required assessment to ensure that during the oxidation process no harmful byproducts were formed which would have the potential to be detrimental to patient safety.
Potassium iodide, for example, exhibits a detectable colour change upon oxidation in the presence of chlorine dioxide, but also exhibits the same behaviour with other common oxidising disinfectants, such as hydrogen peroxide. Potassium iodide is therefore non-selective for chlorine dioxide and is not suitable for use in the present invention. Metal-based pigments are generally not suitable, as they are not readily oxidised by chlorine dioxide.
Research led to the finding that anthocyanin-based dyes, anthocyanidin-based dyes and betanin-based dyes are suitable for use in chlorine dioxide disinfectant systems because of ease of oxidation, selectivity and safety.
Anthocyanins, such as Antho Black Carrot Extract (AnthoCarrot), are a family of naturally derived pigments which are often responsible for the red-blue colours observed in fruits and vegetables. These compounds are readily found in food, being present in much of our produce as well as being used as natural dyes and food additives. Anthocyanins for food use are referred to by the E-number E163 and include E163(ii) Grape skin extract (Enociania, Eno), E163(iii) Blackcurrant extract, E163(iv) Purple corn colour, E163(v) Red cabbage colour, E163 (vi) Black carrot extract, E163 (vii) Purple sweet potato colour, E163 (viii) Red radish colour, E163(ix) Elderberry colour and E163(x) Hibiscus colour.
Anthocyanins have no reported toxicological information or warnings and are generally considered safe for use.
Anthocyanin (AnthoCarrot) is red when incorporated into a phase two liquid solution (i.e. the aqueous acid second part of the disinfectant system) and is oxidised to colourless when activated with a phase one foam (i.e. a foam containing the sodium chlorite-containing first part). In order to assess the degree of oxidation of anthocyanin, post activation, spectrophotometric analysis of activated (mixed) and non-activated (before mixing) phase two liquid solution with 0.5% anthocyanin (AnthoCarrot) was conducted.
Samples were activated with a 1:3 addition of phase one foam solution to phase two liquid solution and allowed to reach peak chlorine dioxide generation before testing (2 minutes).
Several chlorine dioxide generation tests were conducted to ensure that, although oxidation of the dyestuff consumes some chlorine dioxide, overall chlorine dioxide generation is still reaching expected levels.
Confirmatory microbiological testing was also conducted which shows efficacy is maintained on inclusion of the selective dyestuff.
Dye selectivity testing was conducted to test whether the anthocyanin dye would react or degrade in the presence of other common use high level disinfectants and oxidisers, including hydrogen peroxide, peracetic acid, and chlorine. Tests were conducted on wipes impregnated with 9 ml of 1% AnthoCarrot base, with 3 ml of each product (equivalent to a single dose of the first part from the pump 2). The wipes were then scrunched by hand for 15 s with pictures taken at time points 0, 30 and 60 s. The wipes are shown in
As can be seen, only chlorine (1000 ppm) influenced the dye. No other high level disinfectant or strong oxidiser fully degraded the colour in the wipes. Chlorine successfully removed much of the dye colouration, however it was not able to fully degrade it, with some spotting remaining even at 60 s. Furthermore, the wipe itself was affected by chlorine, with it turning to an off-white colour rather than its original colour, as the wipes do when exposed to chlorine dioxide. Based on this it can be safely said that the anthocyanin dye has a high specific selectivity for chlorine dioxide and can be used as a measure of wipe activation.
In a further selectivity test, 0.5% anthocyanin (AnthoCarrot) was added to common oxidisers in liquid form and the resulting mixture spectroscopically analysed. The results are shown in
Various other dyes have been tested to assess suitability for use in the present invention. The primary requirements for a suitable dyestuff are that it is stable in at least one of the two parts of the disinfectant system, was readily oxidised in the presence of chlorine dioxide and was unstable or not oxidised in other leading oxidising compounds.
Samples of dyes where tested on liquid and wipe variants of the second part of the system for stability and chlorine dioxide generated from the combination of the second part with samples of liquid and foam versions of the first part, and in addition tested against the below oxidisers/disinfectants which are commonly used:
The following types of dyestuffs were tested and identified as suitable for selective oxidation by chlorine dioxide and stability prior to use. None of the dyes produced an identical outcome result when used with the above disinfectants:
Several other dyestuffs were found to be less suitable for use, compared to anthocyanin, anthocyanidin and betanin dyestuffs. For example:
A further benefit of the disinfectant system of the present invention is that the use of a chlorine dioxide-selective dyestuff allows for confirmation not just that chlorine dioxide has been produced, but that the correct level of chlorine dioxide has been generated. The rate at which the chosen dyestuff is oxidised is directly proportional to the rate of inclusion. It is therefore possible to tailor the inclusion rate (i.e. the amount of dyestuff added) to ensure that total removal of colour occurs once a certain chlorine dioxide level has been reached.
It is known that chlorine dioxide rate of generation is directly proportional to temperature (see, for example, Mo et at., “Kinetics of the Preparation of Chlorine dioxide by Sodium Chlorite and Hydrochloric Acid at Low Concentration”, Chemical Engineering Transactions (46) 49-54 2015). Higher temperatures result in faster rates of generation. As the rate of dye oxidation is directly proportional to the rate of generation, the inclusion of a selective chlorine dioxide dye indicator allows for the mitigation of temperature on the rate of generation in use. Accordingly, regardless of the temperature at which the system is being used, it can be relied upon that until all dye colour has visibly disappeared the desired chlorine dioxide level has not been reached.
Testing was conducted to show that the inclusion of an anthocyanin dyestuff provided positive confirmation of the correct level of chlorine dioxide. Testing was conducted using the AnthoCarrot dye and two other comparative examples with solutions reacted at various temperatures, as set out in Table 2. When all dyestuff was oxidised, spectrophotometry analysis confirmed that intended levels of chlorine dioxide had been generated. Analysing chlorine dioxide levels before all dye had oxidised showed sub optimal levels of chlorine dioxide. Each dye tested was used in a different chlorine dioxide formulation with a different intended final concentration to show that the verification effect was observed across multiple dye stuffs and products.
These results show that various dyestuffs, including anthocyanin dyestuffs suitable for use in the present invention, can effectively confirm the presence of a desired level of chlorine dioxide by exhibiting total oxidation, regardless of temperature. By increasing or decreasing the dye inclusion rate, the concentration of chlorine dioxide at which the dye is fully oxidised can be suitably selected.
Using a camera and appropriate software, or other suitable apparatus, it is possible to accurately determine the presence or absence of the dye pigment. This allows robust verification that active chlorine dioxide has been generated.
Referring now to
The step of determining the intensity value may comprise measuring the intensity of at least one wavelength of light reflected from a plurality of surface regions of the fabric wipe and calculating the intensity value as the mean average of each measurement. To facilitate this, the apparatus 18 may further comprise a component for calculating the intensity value as the mean average of a plurality of intensity measurements.
The apparatus may be arranged to measure the intensity of multiple wavelengths of light and/or a range of wavelengths of light. The wavelength or wavelengths selected should preferably correspond to a wavelength that is strongly absorbed by the dye before activation and that is not absorbed after activation, and preferably should avoid any interference from chlorine dioxide, which exhibits absorption at around 360 nm and around 445 nm. For Antho Black Carrot Extract, the selected wavelength may be in the range of between around 500 nm and around 560 nm, and is preferably around 530 nm.
As an alternative to spectroscopic analysis, it is also possible to use a machine vision system in which image analysis techniques are used to discern the pre- and post-reaction colours to determine when sufficient chlorine dioxide has been produced.
The term “fluid” is used herein to include liquids, foams, sprays, pastes, aerosols, powders, sols and gels. It is particularly preferred that the first part is dispensed as a foam or a spray to facilitate its coverage of a desired area of the wipe. The term “chlorine dioxide disinfecting composition” is used to refer to disinfecting compositions in which the active agent is chlorine dioxide.
While the above-described examples relate to a disinfectant system comprising a foam activator (providing the first part) and a fabric wipe (providing the second part), with the dyestuff included in the second part, this is merely one example. Table 3 describes examples of possible delivery forms for the first part, including sodium chlorite, and Table 4 describes examples of possible delivery forms for the second part, including an acid.
In either or both parts, additional components may be added to enhance performance or provide desired effects or behaviour. These include, for example, powdered/liquid surfactants (preferably non-ionic, but may include cationic, amphoteric and/or anionic); chelating agents with high affinity for sodium sequestration (to increase rate of sodium chlorite decomposition) and foam building; dyes; fragrances; fragrance suppressants (such as zeolites); secondary oxidisers such as sodium percarbonate; absorbent materials (including superabsorbent polymers, naturally derived clays and pumice blends etc.); and thickening agents.
Table 5 presents some possible combinations of these delivery forms. In some cases, mixing of the parts results in a concentrated disinfecting composition, which may be diluted before use. In other cases, mixing of the parts creates a ready-to-use disinfecting product. The ratio of the parts for mixing can be selected according to the composition and application, and may be between 1:3 and 3:1 or greater. In some examples, the ratio is 1:1.
A delivery combination in which both the first and second parts are delivered as foams is described in WO 2006/079822 A1. In such a system, the foams can be mixed together after delivery from a dispenser, or may be mixed within the dispenser immediately before delivery. In the context of the present invention, the selective dyestuff is added to either or both of the first and second parts, so that the mixture of foams first exhibits the pre-change colour of the dyestuff, and then the colour changes to the post-oxidation colour once sufficient chlorine dioxide has been generated in the mixture. The mixed foams can be applied directly to a surface or item, to a wipe for subsequent application to the surface, or in any other suitable way.
Further modifications and variations not explicitly described above may also be contemplated without departing from the scope of the invention as defined in the appended claims.
Number | Date | Country | Kind |
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2010736.3 | Jul 2020 | GB | national |
Filing Document | Filing Date | Country | Kind |
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PCT/GB2021/051793 | 7/13/2021 | WO |