GB2622594A - Verifying decontamination procedures - Google Patents
Verifying decontamination procedures Download PDFInfo
- Publication number
- GB2622594A GB2622594A GB2213756.6A GB202213756A GB2622594A GB 2622594 A GB2622594 A GB 2622594A GB 202213756 A GB202213756 A GB 202213756A GB 2622594 A GB2622594 A GB 2622594A
- Authority
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- United Kingdom
- Prior art keywords
- composition
- verification
- wax
- composition according
- dyestuff
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- 238000000034 method Methods 0.000 title claims abstract description 39
- 238000005202 decontamination Methods 0.000 title claims abstract description 21
- 230000003588 decontaminative effect Effects 0.000 title claims abstract description 19
- 239000000203 mixture Substances 0.000 claims abstract description 172
- 238000012795 verification Methods 0.000 claims abstract description 102
- 239000001993 wax Substances 0.000 claims abstract description 46
- 239000000975 dye Substances 0.000 claims abstract description 33
- OSVXSBDYLRYLIG-UHFFFAOYSA-N dioxidochlorine(.) Chemical compound O=Cl=O OSVXSBDYLRYLIG-UHFFFAOYSA-N 0.000 claims abstract description 28
- 239000003995 emulsifying agent Substances 0.000 claims abstract description 18
- 239000003921 oil Substances 0.000 claims abstract description 17
- 239000004155 Chlorine dioxide Substances 0.000 claims abstract description 14
- 235000019398 chlorine dioxide Nutrition 0.000 claims abstract description 14
- 239000002904 solvent Substances 0.000 claims abstract description 14
- 244000068988 Glycine max Species 0.000 claims abstract description 11
- 235000010469 Glycine max Nutrition 0.000 claims abstract description 11
- 230000008859 change Effects 0.000 claims abstract description 11
- 239000012166 beeswax Substances 0.000 claims abstract description 10
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 9
- 235000013871 bee wax Nutrition 0.000 claims abstract description 9
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 9
- BANXPJUEBPWEOT-UHFFFAOYSA-N 2-methyl-Pentadecane Chemical compound CCCCCCCCCCCCCC(C)C BANXPJUEBPWEOT-UHFFFAOYSA-N 0.000 claims abstract description 8
- 235000010208 anthocyanin Nutrition 0.000 claims abstract description 8
- 239000004410 anthocyanin Substances 0.000 claims abstract description 8
- 229930002877 anthocyanin Natural products 0.000 claims abstract description 8
- 150000004636 anthocyanins Chemical class 0.000 claims abstract description 8
- 229940008396 carrot extract Drugs 0.000 claims abstract description 8
- 235000012677 beetroot red Nutrition 0.000 claims abstract description 7
- 239000001654 beetroot red Substances 0.000 claims abstract description 7
- 239000007787 solid Substances 0.000 claims abstract description 7
- DHHFDKNIEVKVKS-FMOSSLLZSA-N Betanin Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC(C(=C1)O)=CC(C[C@H]2C([O-])=O)=C1[N+]2=C\C=C\1C=C(C(O)=O)N[C@H](C(O)=O)C/1 DHHFDKNIEVKVKS-FMOSSLLZSA-N 0.000 claims abstract description 6
- DHHFDKNIEVKVKS-MVUYWVKGSA-N Betanin Natural products O=C(O)[C@@H]1NC(C(=O)O)=C/C(=C\C=[N+]/2\[C@@H](C(=O)[O-])Cc3c\2cc(O)c(O[C@H]2[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O2)c3)/C1 DHHFDKNIEVKVKS-MVUYWVKGSA-N 0.000 claims abstract description 6
- 235000002185 betanin Nutrition 0.000 claims abstract description 6
- 239000004203 carnauba wax Substances 0.000 claims abstract description 6
- GTJOHISYCKPIMT-UHFFFAOYSA-N 2-methylundecane Chemical compound CCCCCCCCCC(C)C GTJOHISYCKPIMT-UHFFFAOYSA-N 0.000 claims abstract description 5
- 244000020551 Helianthus annuus Species 0.000 claims abstract description 5
- 235000003222 Helianthus annuus Nutrition 0.000 claims abstract description 5
- SGVYKUFIHHTIFL-UHFFFAOYSA-N Isobutylhexyl Natural products CCCCCCCC(C)C SGVYKUFIHHTIFL-UHFFFAOYSA-N 0.000 claims abstract description 5
- 229930014669 anthocyanidin Natural products 0.000 claims abstract description 5
- 150000001453 anthocyanidins Chemical class 0.000 claims abstract description 5
- 235000008758 anthocyanidins Nutrition 0.000 claims abstract description 5
- VKPSKYDESGTTFR-UHFFFAOYSA-N isododecane Natural products CC(C)(C)CC(C)CC(C)(C)C VKPSKYDESGTTFR-UHFFFAOYSA-N 0.000 claims abstract description 5
- 229940043268 2,2,4,4,6,8,8-heptamethylnonane Drugs 0.000 claims abstract description 4
- RFVNOJDQRGSOEL-UHFFFAOYSA-N 2-hydroxyethyl octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCCO RFVNOJDQRGSOEL-UHFFFAOYSA-N 0.000 claims abstract description 4
- 241000196324 Embryophyta Species 0.000 claims abstract description 4
- 235000021355 Stearic acid Nutrition 0.000 claims abstract description 4
- 235000013869 carnauba wax Nutrition 0.000 claims abstract description 4
- 235000014113 dietary fatty acids Nutrition 0.000 claims abstract description 4
- 239000000194 fatty acid Substances 0.000 claims abstract description 4
- 229930195729 fatty acid Natural products 0.000 claims abstract description 4
- 150000004665 fatty acids Chemical class 0.000 claims abstract description 4
- 229940100242 glycol stearate Drugs 0.000 claims abstract description 4
- KUVMKLCGXIYSNH-UHFFFAOYSA-N isopentadecane Natural products CCCCCCCCCCCCC(C)C KUVMKLCGXIYSNH-UHFFFAOYSA-N 0.000 claims abstract description 4
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract description 4
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims abstract description 4
- 239000003208 petroleum Substances 0.000 claims abstract description 4
- 229920000059 polyethylene glycol stearate Polymers 0.000 claims abstract description 4
- 239000008117 stearic acid Substances 0.000 claims abstract description 4
- 235000011925 Passiflora alata Nutrition 0.000 claims abstract description 3
- 235000000370 Passiflora edulis Nutrition 0.000 claims abstract description 3
- 235000011922 Passiflora incarnata Nutrition 0.000 claims abstract description 3
- 240000002690 Passiflora mixta Species 0.000 claims abstract description 3
- 235000013750 Passiflora mixta Nutrition 0.000 claims abstract description 3
- 235000013731 Passiflora van volxemii Nutrition 0.000 claims abstract description 3
- 240000003935 Sclerocarya birrea Species 0.000 claims abstract description 3
- 235000001836 Sclerocarya caffra Nutrition 0.000 claims abstract description 3
- 235000019198 oils Nutrition 0.000 claims description 14
- 239000003755 preservative agent Substances 0.000 claims description 9
- 230000002335 preservative effect Effects 0.000 claims description 9
- 239000004359 castor oil Substances 0.000 claims description 4
- 235000019438 castor oil Nutrition 0.000 claims description 4
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 4
- 239000004204 candelilla wax Substances 0.000 claims description 3
- 235000013868 candelilla wax Nutrition 0.000 claims description 3
- 229940073532 candelilla wax Drugs 0.000 claims description 3
- IUJAMGNYPWYUPM-UHFFFAOYSA-N hentriacontane Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCC IUJAMGNYPWYUPM-UHFFFAOYSA-N 0.000 claims description 3
- 235000019484 Rapeseed oil Nutrition 0.000 claims description 2
- 239000003240 coconut oil Substances 0.000 claims description 2
- 235000019864 coconut oil Nutrition 0.000 claims description 2
- 239000004006 olive oil Substances 0.000 claims description 2
- 235000008390 olive oil Nutrition 0.000 claims description 2
- 229940100460 peg-100 stearate Drugs 0.000 claims description 2
- 239000002600 sunflower oil Substances 0.000 claims description 2
- 235000019486 Sunflower oil Nutrition 0.000 claims 1
- 241001133760 Acoelorraphe Species 0.000 abstract 1
- 240000002791 Brassica napus Species 0.000 abstract 1
- 235000004977 Brassica sinapistrum Nutrition 0.000 abstract 1
- 244000060011 Cocos nucifera Species 0.000 abstract 1
- 235000013162 Cocos nucifera Nutrition 0.000 abstract 1
- 241001553290 Euphorbia antisyphilitica Species 0.000 abstract 1
- 240000007817 Olea europaea Species 0.000 abstract 1
- 235000004443 Ricinus communis Nutrition 0.000 abstract 1
- 230000000249 desinfective effect Effects 0.000 description 11
- 239000003153 chemical reaction reagent Substances 0.000 description 9
- 239000000645 desinfectant Substances 0.000 description 8
- 230000008569 process Effects 0.000 description 8
- 238000004659 sterilization and disinfection Methods 0.000 description 8
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- 239000000126 substance Substances 0.000 description 5
- 238000012549 training Methods 0.000 description 5
- XTEGARKTQYYJKE-UHFFFAOYSA-M Chlorate Chemical compound [O-]Cl(=O)=O XTEGARKTQYYJKE-UHFFFAOYSA-M 0.000 description 4
- 238000004140 cleaning Methods 0.000 description 4
- 150000001335 aliphatic alkanes Chemical class 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 238000012958 reprocessing Methods 0.000 description 3
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 2
- CFKMVGJGLGKFKI-UHFFFAOYSA-N 4-chloro-m-cresol Chemical group CC1=CC(O)=CC=C1Cl CFKMVGJGLGKFKI-UHFFFAOYSA-N 0.000 description 2
- 235000021537 Beetroot Nutrition 0.000 description 2
- 240000005605 Clitoria ternatea Species 0.000 description 2
- 235000008358 Clitoria ternatea Nutrition 0.000 description 2
- 241000243142 Porifera Species 0.000 description 2
- 239000002535 acidifier Substances 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 239000000356 contaminant Substances 0.000 description 2
- 230000007613 environmental effect Effects 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- UKLNMMHNWFDKNT-UHFFFAOYSA-M sodium chlorite Chemical compound [Na+].[O-]Cl=O UKLNMMHNWFDKNT-UHFFFAOYSA-M 0.000 description 2
- 229960002218 sodium chlorite Drugs 0.000 description 2
- 230000007480 spreading Effects 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 description 1
- GCZLBHOAHLBGEA-UHFFFAOYSA-N 3-butyl-1,2-benzothiazole 1-oxide Chemical compound C1=CC=C2C(CCCC)=NS(=O)C2=C1 GCZLBHOAHLBGEA-UHFFFAOYSA-N 0.000 description 1
- 240000001890 Ribes hudsonianum Species 0.000 description 1
- 235000016954 Ribes hudsonianum Nutrition 0.000 description 1
- 235000001466 Ribes nigrum Nutrition 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 235000021028 berry Nutrition 0.000 description 1
- 235000019209 bilberry extract Nutrition 0.000 description 1
- 229940102480 bilberry extract Drugs 0.000 description 1
- 230000003749 cleanliness Effects 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 238000012790 confirmation Methods 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000009408 flooring Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 235000013373 food additive Nutrition 0.000 description 1
- 239000002778 food additive Substances 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 235000021579 juice concentrates Nutrition 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
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- 238000012986 modification Methods 0.000 description 1
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- 239000002245 particle Substances 0.000 description 1
- 239000012169 petroleum derived wax Substances 0.000 description 1
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- 239000000843 powder Substances 0.000 description 1
- 150000003138 primary alcohols Chemical class 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
- C09B—ORGANIC DYES OR CLOSELY-RELATED COMPOUNDS FOR PRODUCING DYES, e.g. PIGMENTS; MORDANTS; LAKES
- C09B67/00—Influencing the physical, e.g. the dyeing or printing properties of dyestuffs without chemical reactions, e.g. by treating with solvents grinding or grinding assistants, coating of pigments or dyes; Process features in the making of dyestuff preparations; Dyestuff preparations of a special physical nature, e.g. tablets, films
- C09B67/0071—Process features in the making of dyestuff preparations; Dehydrating agents; Dispersing agents; Dustfree compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- C—CHEMISTRY; METALLURGY
- C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
- C09B—ORGANIC DYES OR CLOSELY-RELATED COMPOUNDS FOR PRODUCING DYES, e.g. PIGMENTS; MORDANTS; LAKES
- C09B61/00—Dyes of natural origin prepared from natural sources, e.g. vegetable sources
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
- G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Detergent Compositions (AREA)
- Paints Or Removers (AREA)
Abstract
A verification composition for application to a surface to be decontaminated, the composition being a manually-spreadable solid at room temperature, and comprising up to 50 wt% of one or more waxes, up to 25 wt% of one or more oils, up to 30 wt% of a solvent, up to 15 wt% of one or more emulsifiers, and up to 10 wt% of a dyestuff. The dyestuff (e.g., anthocyanin, anthocyanidin, betanin, black carrot extract) may undergo a colour change in the presence of chlorine dioxide. The wax(es) may be non-petroleum based wax or plant-derived (e.g., soya, palm, candelilla, carnauba wax; stearic acid; sunflower wax; beeswax). The oil may be castor, olive, rapeseed, passionflower, sunflower, coconut, and/or marula oil. The solvent may comprise isododecane or isohexadecane. The emulsifier may comprise polyethylene glycol, glycol stearate, or a fatty acid. Also claimed is use of verification composition for verifying complete removal of the composition from a decontaminated surface. Also claimed is a verification composition and container comprising tube housing and a block of the verification composition extendable from the housing. Also claimed is a method of verifying a decontamination procedure comprising applying the decontaminating composition to a surface using an applicator.
Description
VERIFYING DECONTAMINATION PROCEDURES
FIELD
This disclosure relates to a verification composition for application to a surface to be decontaminated, in particular, but not exclusively, for verifying that a substance has been applied to, or removed from, the whole of a desired area of a surface.
BACKGROUND
Within the healthcare market, decontamination procedures are widely used for disinfection and cleaning. Areas of particular importance include the reprocessing of non-lumened medical devices and environmental surface disinfection. 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. Accordingly, it is desirable to provide methods for verifying that a decontamination procedure has been performed correctly and effectively.
Unlike many other oxidising disinfectants, chlorine dioxide is typically generated at point of use by combining sodium chlorite or chlorate with an acidifier. This allows a long product shelf life without the hazards associated with shipping high strength oxidising solutions. Reprocessing of non-lumened medical devices using chlorine dioxide disinfectants may be conducted manually by the user via the application of disinfectant to the surface using a spreading medium (including but not limited to wipes, sponges, gloves). This manual approach has multiple advantages compared to automated processes, such as: * lower capital investment; * reduced space requirements; * flexibility of location of use; * elimination of service and maintenance provision.
Automated processes are also not practical for the disinfection of other surfaces, such as floors, walls, work surfaces and so on. -2 -
A drawback of manual decontamination processes is that effective disinfection relies exclusively on the user adhering to not only the user instructions but also ensuring that all parts of the surface to be treated are adequately covered in disinfectant with enough to ensure that the drying time is longer than the contact time.
Against that background, it would be desirable to provide means for verifying that the application of a substance to a surface in a decontamination procedure has been performed correctly.
SUMMARY OF THE INVENTION
Aspects of the invention are specified in the independent claims. Preferred features are specified in the dependent claims.
Disclosed herein is a verification composition for application to a surface to be decontaminated. The composition is a manually-spreadable solid at room temperature, and comprises: - up to 50 wt% of one or more waxes; - up to 25 wt% of one or more oils; -up to 30 wt% of a solvent; - up to 15 wt% of one or more emulsifiers; and - up to 10 wt% of a dyestuff.
The verification composition, by virtue of its constituents, is a waxy, mouldable, solid material at room temperature (i.e. 25°C) that exhibits shear-thinning behaviour. In this way, the verification composition can be applied to and spread over a surface, such as a medical device, using a gloved finger or an applicator device to achieve a uniform, even coating of the verification composition on the surface. Once applied, the verification composition remains adhered to the surface and does not run or drip.
The verification composition preferably remains in a mouldable solid form in a temperature range of between 10°C and 40°C, and more preferably in a temperature -3 -range of between 15°C and 35°C.
The verification composition, when applied to the surface, allows a user to visually identify the presence of the verification composition. After application, the verification composition can be removed from a surface using an applicator or procedure required in a decontamination process, and any remaining verification composition will show regions of the surface from which the verification composition has not been successfully removed. The verification composition can therefore act as a training aid and/or a compliance aid.
The dyestuff allows the verification composition to be readily seen after application to the surface. The dyestuff may undergo a colour change upon exposure to a decontaminating composition, such as a disinfectant. Preferably, the dyestuff undergoes a colour change in the presence of chlorine dioxide. In this case, when used with a chlorine dioxide disinfectant composition, the verification composition can additionally provide verification that chlorine dioxide is present. The dyestuff may for example comprise an anthocyanin, an anthocyanidin or a betanin dyestuff. In one embodiment, the dyestuff comprises black carrot extract. The composition may comprise up to 10% of the dyestuff.
The or each wax is preferably a non-petroleum based wax. The or each wax may have a dropping point of at approximately 50 to 60°C. The wax or at least one of the waxes may comprise a plant-derived wax. In an example, the wax or at least one of the waxes is selected from the group consisting of soya wax, palm wax, candelilla wax, carnauba wax, stearic acid and sunflower wax, and beeswax. In a preferred embodiment, the verification composition comprises a blend of beeswax and soya wax. The verification composition may comprise up to 40 wt% of the one or more waxes. The total wax content of the verification composition may be between 25% and 35% by weight.
The oil enhances spreadability of the verification composition, and may be selected from the group consisting of castor oil, olive oil, rapeseed oil, passionflower oil, -4 -sunflower oil, coconut oil and marula oil.
The composition may include up to 25 wt%, preferably up to 20 wt%, of the solvent. The solvent may comprise isododecane or isohexadecane.
The emulsifier or one of the emulsifiers may comprise a polyethylene glycol (PEG) or a fatty acid. For example, the composition may comprise PEG 100 and/or glycol stearate as an emulsifier.
The verification composition may comprise a preservative. For example, the verification composition may comprise up to 2% of the preservative.
Also disclosed is the use of a verification composition as described above for verifying the complete removal of the composition from a surface during decontamination.
Also disclosed is a method of verifying a decontamination procedure in which the decontamination procedure comprises applying a decontaminating composition to a surface using an applicator, the method comprising, before applying the decontaminating composition, applying to a whole area of the surface a verification composition as described above, applying the decontaminating composition to the surface using the applicator, such that application of the applicator to the surface removes the verification composition, and inspecting the surface to verify that all of the verification composition has been removed. When the decontaminating composition comprises chlorine dioxide and the dyestuff of the verification composition undergoes a colour change in the presence of chlorine dioxide, the method may further comprise, after applying the decontaminating composition to the surface, inspecting the applicator to verify that the colour change has occurred.
The verification composition can also be used as a visual indicator to identify that a surface is in a dirty or unknown state to avoid potential contamination events. -5 -
The verification composition is preferably in the form of a waxy, spreadable solid, and may be applied to a surface by any suitable means, including spreading using a gloved hand, or by a suitable applicator device.
The verification composition and associated methods are particularly suitable for use in healthcare settings where cleaning and/or disinfection is required. Areas of use may include medical surfaces (such as in a patient bed space area), invasive and non-invasive medical devices (including ultrasound probes, endoscopes, nasendoscopes and so on), flooring and walls, janitorial applications, and training and compliance aids.
Throughout this specification, the amount of a component in a composition, expressed as a percentage, is a reference to the percentage by weight (i.e. weight/weight, wt% or wt/wt).
BRIEF DESCRIPTION OF THE DRAWINGS
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: Figure 1 is a flowchart showing steps in a prior art process for decontaminating a surface, for example of a medical device; Figure 2 is a flowchart showing a method of verifying that a substance has been 25 removed correctly from a surface; and Figure 3 is a schematic illustration of the method of Figure 2 being performed.
DETAILED DESCRIPTION
Figure 1 describes a prior art decontamination procedure using a system of a type -6 -known for example from WO 2005/107823 Al. Such a system comprises a plurality of pre-clean wipes contained within individual sachets, a two-part disinfecting wipes system, and a plurality of rinse wipes, again contained within individual sachets. The disinfecting wipes system comprises a dispenser containing a first reagent and a plurality of disinfecting wipes impregnated with a second reagent and contained within individual sachets, whereby a disinfecting composition can be prepared by dispensing the first reagent onto the disinfecting wipe to mix with the second reagent. The first and second reagents react to form a disinfecting composition. For example, chlorine dioxide can be generated using a first reagent comprising sodium chlorite or chlorate and a second reagent comprising an acidifier.
In a first step 101, the pre-cleaning composition is prepared by removing a pre-clean wipe from its sachet. In a second step 102, the pre-cleaning composition is applied to the surface to be cleaned by wiping the surface with the pre-clean wipe. In this way, the pre-clean wipe can be used to remove major contaminants, such as fluids or particles, from the surface.
In a third step 103, the decontaminating composition is prepared, by first removing a disinfecting wipe from its sachet, and then dispensing a quantity of the second reagent onto the wipe from the dispenser (for example as a foam). The wipe is then folded and scrunched to mix the reagents and generate the liquid disinfecting composition in-situ in the wipe.
In a fourth step 104, the decontaminating composition is applied to the surface by wiping the surface with the activated disinfecting wipe, to coat the surface with the liquid decontaminating composition. Then, in a fifth step 105, the user waits for a prescribed contact time, to allow the decontamination composition to dwell on the surface for long enough to be effective in chemically disinfecting the surface.
In a sixth step 106, a rinsing composition is prepared by removing a rinse wipe from its sachet. In a seventh step 107, the rinsing composition is applied to the surface by wiping the surface with the rinse wipe. The rinse wipe is used to remove any -7 -residual decontaminating composition from the surface to prepare the surface for its next clinical use.
In the decontamination procedure of Figure 1, effective disinfection or decontamination with the decontaminating composition, and effective use of the pre-clean and rinse wipes, rely upon several steps being correctly performed. For example, in the fourth step 104, it is important that the decontaminating composition is applied to the whole surface to be decontaminated, without leaving areas not wetted by the decontamination composition. One object of the present invention is to provide a verification method, and associated verification composition, for validating whether this requirement has been met by a user performing at least step 104 of the procedure of Figure 1.
In one aspect, the present invention provides a composition, referred to as a verification composition, which when applied to a surface provides a visual indication of the extent to which the verification composition has covered the surface. The visual indication is provided by the presence of a dyestuff that renders the verification composition visible to the user.
In a verification process, the verification composition is used as an aid to check that a decontaminating composition (for example a pre-clean composition, disinfecting composition or rinse composition) that must be applied to the surface using an applicator (such as a wipe, mop sponge, gloved hand etc.) as part of a verification procedure has been applied to the whole area of a surface to be decontaminated.
In the verification process, shown in Figures 2 and 3, the verification composition 16 is first applied to all areas of the surface 10 to be decontaminated using a suitable applicator or by hand (step 301 in Figure 2). Figure 3(a) shows an example in which the verification composition 16 is provided in a lipstick-style tube container 17.
As is known in the art, in such a container 17, a movable carriage (not shown) holds a block or stick of the substance (in this case the verification composition 16) and is -8 -arranged to telescope with respect to a body 18 of the container 17. In this example, a ring 19 can be rotated with respect to the body 18 to drive the carriage linearly with respect to the body 18 (via a screw mechanism, not shown) to extend or retract the verification composition 16 out of or in to the body 18, although in other cases the carriage may be directly movable by the user (e.g. in a push-up type container).
In the illustrated example, the verification composition 16 is extended from the container 17 and applied to the surface 10 by rubbing the verification composition 16 against the surface (Figure 3(b)). In other examples, the verification composition 16 could be spread on the surface 10 by a gloved finger after transfer from the container 17, or the verification composition 16 could be transferred from the container 17 to a gloved finger and applied to the surface 10 by the finger. In the latter case, the verification composition 16 could be provided in a different type of container, such as a tube, tub, can, bag, pouch and so on.
After application of the verification composition 16, the surface 10 is inspected to ensure that all of the desired areas are covered by the verification composition 16 (see Figure 3(c)). Then, the applicator 22 (e.g. a wipe) used to apply the decontaminating composition 24 to the surface 10 (step 302 in Figure 2) in the manner prescribed in the decontaminating procedure, optionally with the decontaminating composition 24 pre-applied to the applicator 22 as shown in Figures 3(c) and 3(d). The applicator 22 removes the verification composition 16 from the surface 10, as shown in Figure 3(e), and the verification composition 16 is transferred to the applicator 22. After use of the applicator 22, the surface 10 can be inspected (step 303 in Figure 2) to reveal any areas in which the verification composition 16 has not been removed, indicating that the applicator 22 did not sufficiently cover those areas. If no such missed areas are identified, the suitability of the prescribed applicator 22 and application method has been verified. If missed areas are identified, appropriate corrective action can be taken.
The dyestuff used in the verification composition may exhibit a colour change upon exposure to an active component in a decontaminating composition. For example, -9 -the dyestuff may be oxidised in the presence of a disinfectant, so that the dyestuff loses its colour. In such cases, when the verification composition is removed from a surface using a wipe that carries the decontaminating composition, as shown in Figure 3, the wipe 22 can be inspected subsequently (step 304 in Figure 2) to check that the verification composition that has been transferred to the wipe 22 has undergone the colour change (Figure 3(f)), verifying the presence of the decontaminating composition on the wipe.
When used in the way described in Figures 2 and 3, the verification composition 16 can act as a compliance aid. The surface 10 is first fully covered with the verification composition 16 and then removed with the wipe 22 carrying the decontaminating composition 24. Compliance is achieved when all of the verification composition 16 has been removed, indicating that the wipe 22 has contacted all of the areas of the surface.
It will be appreciated that using the process described in Figures 2 and 3, the verification composition can be used as a training aid during training of users, to ensure that the technique employed by a user in covering a surface when using an applicator is sufficiently thorough to adequately contact all of the necessary areas of the surface.
A further use of the verification composition is as a visual indicator of non-clean status. The verification composition can be applied partly or wholly to a surface, such as a medical device, to provide a clear visual indicator that the device or other surface requires decontamination and/or other reprocessing before it can be used again. Used in this way, the verification composition can be helpful in reducing the risk of a device being left in an unverified state with regards to cleanliness and suitability of use, for example in a busy clinical setting with multiple users.
The verification composition may be provided in a single-use package, such as a pouch or sachet, in which a suitable quantity of the verification composition is contained to cover the surface to which the application relates, such as the surface -10 -of a medical device. In this way, the user is assisted in applying an appropriate quantity of the verification composition to the surface.
In its broadest form, the verification composition used in the above processes contains a combination of one or more waxes, one or more oils, and one or more dyestuffs. Preferably, the composition also includes one or more solvents and one or more emulsifiers. The verification composition also preferably includes a preservative.
The wax component may include one or more waxes and preferably comprises up to 50% of the composition by weight. The or each wax is a mouldable solid at room temperature. The wax component provides the bulk texture and structure of the composition and provides the composition with the shear-thinning, malleable characteristics associated with the spreadability of the composition. A blend of waxes may be used to provide optimum spreadability and structure. Preferably, the or each wax is a non-petroleum derived wax. For example, plant-derived waxes such as soya wax, candelilla wax, carnauba wax, stearic acid or sunflower wax may be used. Beeswax is also suitable. The waxes are preferably cosmetic grade, and may have a dropping point of around 60°C to 60°C (measured in accordance with ASTM D3954).
In one embodiment, the composition comprises approximately 13 wt% soya wax and 14 wt% beeswax, by weight. Soya wax is non-petroleum derived, renewable and biodegradable. Beeswax is harder than soya wax and also acts as an emulsifier, helping to produce a composition with a suitable hardness and homogeneity. An approximately equal amount of beeswax and soya wax has been found to provide a suitable consistency and spreadability.
The oil component enhances the spreadability of the composition. It has been 30 determined that the composition may include up to 25 wt% of the oil component without adversely affecting the drying behaviour and greasiness of the composition. Preferably, the oil is a vegetable or other naturally-derived oil. One particularly suitable oil is castor oil, which has a suitable consistency, is readily accessible and biodegradable.
The solvent component enhances drying of the verification composition on the surface after application. The solvent is preferably one or a combination of primary alcohols, secondary alcohols, straight chain alkanes and branched chain alkanes. Preferably, the solvent comprises straight chain and/or branched chain alkanes. More preferably, the solvent is isododecane or isohexadecane. The composition preferably comprises up to 30 wt%, more preferably up to 25 wt%, and most preferably up to 20 wt% of the solvent.
The emulsifier component acts as a thickener and emulsifier, and helps the composition to adopt the colouring from the dyestuff homogeneously. Suitable emulsifiers include polyethylene glycol (PEG) chains and fatty acids. A combination of glycerol stearate and PEG 100 has been found to be particularly suitable. Up to wt% of the composition may be the emulsifier component. The emulsifier component is typically water-soluble, and a suitable quantity of water (e.g. up to 15 wt%) may be included in the composition to dissolve the emulsifier component.
The dyestuff component provides a visual indicator that allows confirmation that the surface has been covered. Preferably, the dyestuff undergoes a colour change in the presence of the decontaminating composition concerned. For example, the dyestuff may be oxidised in the presence of an oxidising disinfectant. In one example, which is particularly useful when the decontaminating composition is a two-part system in which first and second parts react together to form a chlorine dioxide decontaminating composition, the dyestuff is an anthocyanin, anthocyanidin or betanin dyestuff, which undergo a colour change from a distinctive purple or red colour to colourless in the presence of chlorine dioxide.
Suitable dyestuffs are described in the present applicant's International Patent Application No. WO 2022/013543 Al, the contents of which are incorporated herein by reference. The dyestuff may for example be an anthocyanin dyestuff selected -12 -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 composition preferably comprises up to 10% of the dyestuff.
The verification composition may include a preservative to inhibit the growth of mould and other contaminants. Any suitable preservative could be used. One suitable example is Parmetol BPX (a registered trade mark of Vink Chemicals GmbH & Co. KG, Kakenstorf, Germany), which is a blend of phenoxyethanol, butylbenzisothiazolone, and bis(3-aminopropyl)dodeclamine. The composition may for example comprise up to 2% of the preservative by weight, and more preferably comprises up to 1% of the preservative by weight.
An example verification composition has the formulation: %w/w soya wax 13 beeswax 14 castor oil 22 glycol stearate & PEG 100 11 Anthocyanin dye 9 water 11 isododecane 19 parmetol bpx 1 The above formulation has been found to provide a verification composition that is -13 -solid and stable at room temperature, and that can be easily spread by hand or by a lipstick-style applicator or a similar device onto a surface to leave an even, uniform coating of the verification composition. The anthocyanin dye in this instance is black carrot extract, which gives the verification composition a distinctive purple/red colour that changes to colourless after contact with chlorine dioxide. The spreadability of the verification composition can be temporarily increased by warming the composition by hand before application.
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.
Claims (20)
- -14 -CLAIMS1. A verification composition for application to a surface to be decontaminated, the composition is a manually-spreadable solid at room temperature, and comprises: - up to 50 wt% of one or more waxes; - up to 25 wt% of one or more oils; - up to 30 wt% of a solvent; - up to 15 wt% of one or more emulsifiers; and -up to 10 wt% of a dyestuff A verification composition according to Claim 1, wherein the dyestuff undergoes a colour change in the presence of chlorine dioxide.
- A verification composition according to Claim 1 or Claim 2, wherein the dyestuff comprises an anthocyanin, an anthocyanidin or a betanin dyestuff.
- A verification composition according to Claim 3, wherein the dyestuff comprises black carrot extract.
- A verification composition according to any preceding claim, wherein the or each wax is a non-petroleum based wax.
- A verification composition according to Claim 5, wherein the wax or at least one of the waxes comprises a plant-derived wax.
- A verification composition according to Claim 5 or Claim 6, wherein the wax or at least one of the waxes is selected from the group consisting of soya wax, palm wax, candelilla wax, carnauba wax, stearic acid, sunflower wax, and beeswax.
- A verification composition according to Claim 7, comprising a blend of 3. 4. 5. 6. 7. 8.
- -15 -beeswax and soya wax.
- 9. A verification composition according to any preceding claim, comprising up to 40 wt% of the one or more waxes.
- 10. A verification composition according to any preceding claim, wherein the oil is selected from the group consisting of castor oil, olive oil, rapeseed oil, passionflower oil, sunflower oil, coconut oil and marula oil.
- 11. A verification composition according to any preceding claim, comprising up to 25 wt%, preferably up to 20 wt%, of the solvent.
- 12. A verification composition according to any preceding claim, wherein the solvent comprises isododecane or isohexadecane.
- 13. A verification composition according to any preceding claim, wherein the emulsifier or one of the emulsifiers comprises a polyethylene glycol (PEG) or a fatty acid.
- 14. A verification composition according to Claim 13, comprising PEG 100 and/or glycol stearate as an emulsifier.
- 15. A verification composition according to any preceding claim, further comprising a preservative.
- 16. A verification composition according to Claim 15, comprising up to 2 wt% of the preservative.
- 17. In combination, a verification composition according to any preceding claim and a container, wherein the container comprises a tube housing and a block of the verification composition, arranged such that the block is extendable with respect to the housing.
- 18. Use of a verification composition according to any one of Claims 1 to 16 for verifying the complete removal of the composition from a surface during decontamination.
- 19. A method of verifying a decontamination procedure in which the decontamination procedure comprises applying a decontaminating composition to a surface using an applicator, the method comprising: before applying the decontaminating composition, applying to a whole area of the surface a verification composition according to any one of Claims 1 to 16; applying the decontaminating composition to the surface using the applicator, such that application of the applicator to the surface removes the verification composition; and inspecting the surface to verify that all of the verification composition has been removed.
- 20. A method according to Claim 19, wherein the decontaminating composition comprises chlorine dioxide and the verification composition is in accordance with Claim 2, the method further comprising: after applying the decontaminating composition to the surface, inspecting the applicator to verify that the colour change has occurred.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB2213756.6A GB2622594A (en) | 2022-09-20 | 2022-09-20 | Verifying decontamination procedures |
| PCT/GB2023/052436 WO2024062242A1 (en) | 2022-09-20 | 2023-09-20 | Verification composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB2213756.6A GB2622594A (en) | 2022-09-20 | 2022-09-20 | Verifying decontamination procedures |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| GB202213756D0 GB202213756D0 (en) | 2022-11-02 |
| GB2622594A true GB2622594A (en) | 2024-03-27 |
Family
ID=84817823
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| GB2213756.6A Pending GB2622594A (en) | 2022-09-20 | 2022-09-20 | Verifying decontamination procedures |
Country Status (2)
| Country | Link |
|---|---|
| GB (1) | GB2622594A (en) |
| WO (1) | WO2024062242A1 (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2597069A (en) * | 2020-07-13 | 2022-01-19 | Tristel Plc | Disinfectant system |
| WO2022120450A1 (en) * | 2020-12-07 | 2022-06-16 | União Brasileira De Educação E Assistência | Antimicrobial composition for topical and/or external use |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2386433T3 (en) * | 2002-10-09 | 2012-08-21 | The Procter & Gamble Company | Cosmetic compositions with reduced stickiness |
| GB2413765B (en) | 2004-05-07 | 2007-01-17 | Tristel Company Ltd | Decontamination system |
| DE102005037546A1 (en) * | 2005-08-09 | 2007-02-22 | Beiersdorf Ag | Cosmetic preparation with UV sunscreen filters |
| US20200129411A1 (en) * | 2018-10-29 | 2020-04-30 | Lonza Ltd. | Solid Bar Shampoo |
-
2022
- 2022-09-20 GB GB2213756.6A patent/GB2622594A/en active Pending
-
2023
- 2023-09-20 WO PCT/GB2023/052436 patent/WO2024062242A1/en unknown
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2597069A (en) * | 2020-07-13 | 2022-01-19 | Tristel Plc | Disinfectant system |
| WO2022120450A1 (en) * | 2020-12-07 | 2022-06-16 | União Brasileira De Educação E Assistência | Antimicrobial composition for topical and/or external use |
Also Published As
| Publication number | Publication date |
|---|---|
| GB202213756D0 (en) | 2022-11-02 |
| WO2024062242A1 (en) | 2024-03-28 |
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