WO2021048802A1 - Composition and method for sterilising and reconditioning substrates - Google Patents
Composition and method for sterilising and reconditioning substrates Download PDFInfo
- Publication number
- WO2021048802A1 WO2021048802A1 PCT/IB2020/058452 IB2020058452W WO2021048802A1 WO 2021048802 A1 WO2021048802 A1 WO 2021048802A1 IB 2020058452 W IB2020058452 W IB 2020058452W WO 2021048802 A1 WO2021048802 A1 WO 2021048802A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- composition
- weight
- substrate
- solution
- carbonate
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
- A01N25/34—Shaped forms, e.g. sheets, not provided for in any other sub-group of this main group
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
Landscapes
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Zoology (AREA)
- Pest Control & Pesticides (AREA)
- Plant Pathology (AREA)
- Agronomy & Crop Science (AREA)
- Environmental Sciences (AREA)
- Dentistry (AREA)
- Wood Science & Technology (AREA)
- Toxicology (AREA)
- Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention relates to a composition comprising at least one peroxy acid and/or at least one salt of a peroxy acid, at least one halide of an alkali or alkaline earth metal, lithium carbonate (U2CO3) and optionally at least a further carbonate other than the latter. The composition according to the invention preferably comprises the lithium carbonate in an amount comprised between 1 and 25% by weight and said optional at least a further carbonate in an amount comprised between 2 and 50% by weight relative to the total weight of the composition. The composition of the invention can be formulated in the form of a powder or tablet soluble in an aqueous solvent. The subject matter of the invention further relates to an aqueous solution comprising 0.1 - 0.5% w/w of the composition of the invention and an aqueous solvent. The invention also relates to the use of said composition or of the solution comprising said composition and a method for the decontamination, disinfection, cleaning, reconditioning and/or sterilisation of a substrate or a part thereof.
Description
Translation (PCT Rule 12.3) 09 October 2020 WO 2021/048802 PCT/IB2020/058452
1
“COMPOSITION AND METHOD FOR STERILISING AND RECONDITIONING
SUBSTRATES”
DESCRIPTION
Technical field
The present invention belongs to the field of decontamination, disinfection, cleaning, reconditioning and/or sterilisation of substrates, in particular of instruments used in a health and/or hospital setting and relates to a composition comprising at least one peroxy acid and/or at least one salt of a peroxy acid, lithium carbonate (Li2C0.3) and at least one halide of an alkali or alkaline earth metal.
Prior art
In recent years the risk deriving from exposure to biological agents has constituted a phenomenon of growing interest, above all because of the appearance of new modes of infection and the “re-emergence” of infectious pathologies that were considered sufficiently controlled with the available therapeutic and prevention measures. In particular, in health facilities there is a concentration of infected individuals and contaminated materials that give rise to a high frequency of exposure to biological agents and pathogenic microorganisms, to which both care and service personnel and patients are subject. Within the set of prevention recommendations pertaining to biological risk, cleaning measures and disinfection and sterilisation activities are of particular importance. The latter, in particular, represent a fundamental moment of prevention and are irreplaceable in controlling infections that may manifest themselves in a health and/or hospital setting.
The disinfection and, to an even larger extent, the sterilisation of reusable instruments and/or medical devices, such as, for example, parts of endoscopes, prostheses, implants etc., thus represent one of the principal and most critical activities in the process of prevention and control of infections.
As regards sterilisation, a technique commonly used up to now is based on the heat treatment of the contaminated substrate carried out by means of an autoclave at an operating temperature of around 130-140 °C. However, this type of treatment entails the risk of compromising the structural integrity of more delicate and sensitive substrates,
which are very common among medical instruments and devices, such as, for example, endoscopes, for which a less aggressive sterilisation process is thus necessary, for example a cold process, that is, a process at room temperature.
The most traditional cold sterilisation technique consists in immersing the substrate to be treated in solutions maintained at room temperature and comprising chemical agents with a high biocidal activity.
The active ingredients most widely used for cold sterilisation are presently aqueous solutions of glutaraldehyde or peracetic acid.
Glutaraldehyde, though it has the advantage of not being corrosive, has, however, a very slow action and requires many hours in order to effectively perform its sterilising action. Furthermore, its use poses several disadvantages from the operator’s point of view due to the toxic nature of its vapours and its extremely sensitizing action whenever it comes into contact with skin. Another disadvantage connected to the use of glutaraldehyde is tied to its capacity to form intercellular protein bridges leading to the formation of organic agglomerates on the surface of the treated substrate, which hinder the biocidal activity.
As regards peracetic acid, though it enables a decidedly more rapid sterilisation process (about 30 minutes versus the 12 hours necessary for treatment with glutaraldehyde), it poses numerous disadvantages, tied mainly to its instability, which allows only a few sterilisation cycles and requires continual measurement of its residual activity, its characteristic pungent odour, which spreads throughout the environment and its corrosiveness, which can compromise the integrity of particular substrates.
Furthermore, both glutaraldehyde and peracetic acid, commonly used in the sector for many decades by now, can be considered obsolete due to the potential resistance of several biological agents to such compounds.
For these reasons, increasing efforts have been made in recent years in order to find innovative technologies that can overcome the drawbacks illustrated.
Document US 5,945,032 describes, for example, a system based on a polymer suitable for complex formation with hydrogen peroxide, in combination with at least one metal colloid and/or metal salt. Also known in the field of medical and/or surgical instrument disinfection are solutions containing EDTA, in combination with hydrogen peroxide and iron salts.
Notwithstanding the effectiveness of such additional solutions, in the sector there remains a need to find a composition which has a high reconditioning, disinfectant, cleaning and/or sterilising capacity (i.e. bactericidal, fungicidal, sporicidal and/or virucidal), is capable of performing that action in a short time, is effective also at room temperature and at the same time does not compromise the structural and chemical- physical integrity of the treated substrates. The Applicant has discovered that it is possible to resolve such problems by means of a composition comprising at least one peroxy acid and/or at least one salt of a peroxy acid, lithium carbonate (U2CO3) and at least one halide of an alkali or alkaline earth metal and that this combination enables an effective reconditioning, disinfection, cleaning and/or sterilisation to be obtained also at room temperature, in a short time; it is also compatible with any type of substrate, thus making it possible to overcome the disadvantages of the oxidative mechanism of action of the sterilising agents presently available on the market, which, as already noted, may inevitably compromise the integrity of the structure of the treated substrate.
Summary of the invention
The present invention relates to a composition comprising at least one peroxy acid and/or at least one salt of a peroxy acid, lithium carbonate (U2GO3) and at least one halide of an alkali or alkaline earth metal.
Said composition can optionally comprise at least a further carbonate other than lithium carbonate and selected from a carbonate of an alkali or alkaline earth metal. The composition according to the present invention can preferably comprise the lithium carbonate in an amount comprised between 1 and 25% by weight, relative to the total weight of the composition, and said optional at least a further carbonate in an amount comprised between 2 and the 50% by weight relative to the total weight of the composition. The composition of the invention can also further comprise at least one buffering agent having a buffer capacity at pH values comprised between 2 and 10 and, preferably, it can be formulated in the form of a powder or tablet soluble in an aqueous solvent.
The subject matter of the present invention thus further relates to an aqueous solution comprising the composition of the invention and an aqueous solvent, preferably comprising from 0.1 to 0.5% w/w of the composition of the invention and an aqueous solvent.
The present invention also relates to the use of the composition or of the solution comprising the composition according to the present invention for the decontamination, disinfection, cleaning, reconditioning and/or sterilisation, preferably cold, of a substrate or a part thereof.
Finally, the present invention also relates to a method for the decontamination, disinfection, cleaning, reconditioning and/or sterilisation, preferably cold, of a substrate or a part thereof, the method comprising the immersion, for a preestablished period of time, of the substrate to be treated, or a part thereof, in a solution comprising the composition of the invention.
Detailed description of preferred embodiments of the invention
For the purposes of the present invention, the measures of concentration indicated by “w/w” or “weight/weight” are expressed as grams of solute per grams of solvent.
The term “decontamination” means, for the purposes of the present invention, the removal of any organic material that might be present on a substrate or a part thereof. The term “cleaning” means, for the purposes of the present invention, decontamination from any “visible dirt” (i.e. dust, grease, liquids, organic material) that might be present on a substrate or a part thereof.
The term “disinfection” means, for the purposes of the present invention, the destruction of pathogenic microorganisms present on a substrate or a part thereof.
The term “sterilisation” means, for the purposes of the present invention, the elimination and/or inactivation of all living forms, including spores, present on a substrate or a part thereof.
The term “reconditioning” means, for the purposes of the present invention, the decontamination (or cleaning) and simultaneous sterilisation of a substrate or a part thereof.
The term “biological agent” or “pathogenic agent” means, for the purposes of the present invention, any microorganism, also if genetically modified, cell culture, fungus, spore and human endoparasite that could potentially cause infections, allergies or intoxications.
The term “pathogenic microorganism” is used to indicate biological agents responsible for the onset of a disease condition in the host organism and comprises viruses,
prokaryotic organisms, such as for example bacteria, and eukaryotic organisms, such as for example fungi and protozoa.
“Cold” or “room temperature”, for the purposes of the present invention, means a range of temperature comprised between 15 and 30 °C, preferably between 15 and 25 °C. “Aqueous solvent” means, for the purposes of the present invention, a solvent selected from water, organic solvents completely miscible with water and mixtures thereof.
“Total weight of the composition” means, for the purposes of the present invention, the overall weight of the components comprised in the composition, excluding the buffering agent.
For the purposes of the present invention, solubility and miscibility are to be understood as referring to room temperature and pressure.
The present invention relates to a composition comprising at least one peroxy acid and/or at least one salt of a peroxy acid, lithium carbonate (U2CO3) and at least one halide of an alkali or alkaline earth metal.
Said at least one peroxy acid is preferably peroxymonosulphuric acid (H2SO5) and/or said at least one salt of a peroxy acid is an alkaline peroxymonosulphate, more preferably it is selected from potassium peroxymonosulphate (or potassium hydrogenated persulphate KHSOs), sodium peroxymonosulphate (NaHSOs) and combinations thereof. Even more preferably, said at least one salt of a peroxy acid is potassium hydrogenated persulphate (KHSOs).
In one embodiment, the composition according to the present invention comprises 30- 80% by weight, preferably 30-70% by weight, more preferably 30-60% by weight, even more preferably 40-50% by weight of at least one peroxy acid and/or at least one salt of a peroxy acid, relative to the total weight of the composition.
The at least one halide is preferably selected in the group consisting of: chloride, iodide and bromide of an alkali metal and combinations thereof.
Even more preferably, said at least one halide of an alkali metal is selected in the group consisting of: sodium bromide (NaBr), potassium bromide (KBr) and combinations thereof.
In one embodiment, the composition according to the invention comprises 10-40% by weight, preferably 20-35% by weight, of said at least one halide, relative to the total weight of the composition.
In one embodiment, the composition according to the present invention comprises at least a further carbonate other than lithium carbonate. Said at least a further carbonate is preferably selected from carbonates of an alkali or alkaline earth metal.
Said at least a further carbonate is preferably a carbonate of an alkali metal and is selected in the group consisting of potassium carbonate (K2CO3), sodium carbonate (Na2CC>3) and combinations thereof. Even more preferably, said at least a further carbonate of an alkali metal is sodium carbonate (Na2CC>3).
In one embodiment, the composition according to the present invention comprises said at least a further carbonate, other than lithium carbonate, in an amount comprised between 2 and 50% by weight, preferably between 5 and 30% by weight, relative to the total weight of the composition.
In one embodiment, the composition according to the present invention, comprises lithium carbonate in an amount comprised between 1 and 25% by weight, preferably between 2 and 20% by weight, relative to the total weight of the composition.
In one embodiment, the composition according to the present invention further comprises at least one buffering agent having a buffer capacity at pH values comprised between 2 and 10.0, preferably between 7.0 and 10.0. Said buffering agent is preferably selected in the group consisting of: potassium tetraborate (K2B4O7), alkaline phosphates and combinations thereof.
In a preferred embodiment, the optional use of at least one buffering agent makes it possible to obtain a composition which, once in the form of an aqueous solution, has a basic pH value, preferably comprised between 7.0 and 10.0, even more preferably comprised between 8.0 and 9.5.
In one embodiment, the composition comprises or consists of:
- potassium hydrogenated persulphate (KHSOs) 30-80% by weight
- lithium carbonate (U2CO3) 1 -25% by weight
- sodium carbonate (Na2CC>3) 2-50% by weight
- sodium bromide (NaBr) 10-40% by weight, wherein the sum of the amounts of the above components is equal to 100% by weight, and
- buffering agent q.s. to pH 7-10.
In one embodiment, the composition comprises or consists of:
- potassium hydrogenated persulphate (KHSOs) 30-70% by weight
- lithium carbonate (U2CO3) 1-25% by weight
- sodium carbonate (Na2CC>3) 2-50% by weight
- sodium bromide (NaBr) 10-40% by weight, wherein the sum of the amounts of the above components is equal to 100% by weight, and
- buffering agent q.s. to pH 7-10.
In one embodiment, the composition comprises or consists of:
- potassium hydrogenated persulphate (KHSOs) 30-60% by weight
- lithium carbonate (U2CO3) 1 -25% by weight
- sodium carbonate (Na2CC>3) 2-50% by weight
- sodium bromide (NaBr) 10-40% by weight, wherein the sum of the amounts of the above components is equal to 100% by weight, and
- buffering agent q.s. to pH 7-10.
In a preferred embodiment, the composition comprises or consists of:
- potassium hydrogenated persulphate (KHSOs) 44% by weight
- lithium carbonate (U2CO3) 5% by weight
- sodium carbonate (Na2C03) 23% by weight
- sodium bromide (NaBr) 28% by weight and
- potassium tetraborate buffer (K2B4O7) q.s. to pH 7-10.
In a further preferred embodiment, the composition comprises or consists of:
- potassium hydrogenated persulphate (KHSOs) 43% by weight
- lithium carbonate (U2CO3) 4% by weight
- sodium carbonate (Na2C03) 26% by weight
- sodium bromide (NaBr) 27% by weight and
- potassium tetraborate buffer (K2B4O7) q.s. to pH 7-10.
In a further preferred embodiment, the composition comprises or consists of:
- potassium hydrogenated persulphate (KHSOs) 69% by weight
- lithium carbonate (U2CO3) 1% by weight
- sodium carbonate (Na2CC>3) 15% by weight
- sodium bromide (NaBr) 15% by weight and
- potassium tetraborate buffer (K2B4O7) q.s. to pH 7-10.
In a further preferred embodiment, the composition comprises or consists of:
- potassium hydrogenated persulphate (KHSOs) 48% by weight
- lithium carbonate (U2CO3) 16% by weight
- sodium carbonate (Na2CC>3) 6% by weight
- sodium bromide (NaBr) 30% by weight and
- potassium tetraborate buffer (K2B4O7) q.s. to pH 7-10.
The composition can be formulated in the form of a powder or tablet, said powder or tablet being soluble in an aqueous solvent.
The composition is preferably formulated in the form of a powder soluble in an aqueous solvent. Preferably, said powder has a fine or ultrafine particle size so that it can be advantageously solubilised in an aqueous solvent without agglomeration and/or precipitation phenomena and in a short time, less than 30 seconds, preferably comprised between 2 and 10 seconds, more preferably in a time comprised between 2 and 5 seconds.
In the embodiment wherein the composition is in the form of a tablet, said time is less than 20 minutes, preferably comprised between 10 and 15 minutes.
The present invention also relates to an aqueous solution comprising the composition of the invention as previously described and an aqueous solvent.
According to one embodiment, said aqueous solution comprises from 0.1 to 0.5% w/w, preferably from 0.2 to 0.4% w/w, even more preferably from 0.25 to 0.35% w/w of the composition of the invention as previously described and an aqueous solvent.
According to one embodiment, said aqueous solution is obtained by dissolving the composition of the invention in the form of powder or tablet as previously described, in an aqueous solvent.
Said aqueous solvent is preferably water, said water being preferably selected in the group consisting of distilled water, mains water, deionised water, purified water and water filtered by reverse osmosis.
According to the embodiment wherein the composition according to the present invention further comprises at least one buffering agent as previously described, the various components of the composition can preferably all be dissolved in said aqueous solvent (to form said aqueous solution) simultaneously in a single step, or, alternatively, they can be dissolved in two steps: in a first step the components are dissolved in said aqueous solvent with the exception of the at least one buffering agent, and in a second step said at least one buffering agent is dissolved in the aqueous solution obtained previously from the dissolution of the other components. Without wishing to be bound to a specific theory, it is nonetheless possible to argue that, according to this embodiment, said at least one buffering agent performs an activator function.
In one embodiment of the invention, the composition and the aqueous solution comprising the composition do not comprise catalysts, detergents and/or enzymatic complexes.
The Applicant has found that the specific combination of at least one peroxy acid and/or at least one salt of a peroxy acid, preferably potassium hydrogenated persulphate (KHSO5), at least one halide of an alkali or alkaline earth metal, and lithium carbonate (U2CO3), makes it possible, thanks to the oxidation-reduction equilibrium of these compounds, to assure a high disinfectant, decontaminating, cleaning, reconditioning and/or sterilising capacity leading to the elimination and/or inactivation of biological agents, in particular pathogenic microorganisms and spores, rapidly and effectively also at room temperature.
Furthermore, advantageously, the preferably basic pH values of the solution of the invention, together with the reducing nature thereof, make it scarcely aggressive or innocuous for metals or plastic, materials that the instruments and/or the devices used in the medical field are commonly made of.
Another advantage of the solution of the present invention is that not only does it not emit vapours or odours into the work environment, but it also possesses low toxicity, mainly because of the relatively low concentration of said composition in said solution (i.e. preferably comprised between 0.1 and 0.5% w/w, preferably between 0.2 and 0.4% w/w, even more preferably between 0.25 and 0.35% w/w).
The subject matter of the present invention further relates to the use of the composition or of the aqueous solution comprising said composition as previously described for the
decontamination, disinfection, cleaning, reconditioning and/or sterilisation of a substrate or a part thereof.
The decontamination, disinfection, cleaning, reconditioning and/or sterilisation are carried out in a cold process, i.e. at room temperature.
The possibility of using the composition or the aqueous solution of the present invention effectively in a cold process is therefore particularly advantageous, since it enables the treatment of substrates or parts thereof which are particularly sensitive to heat (thermosensitive), such as parts of or entire instruments and/or medical devices, for example selected in the group consisting of: endoscopes, surgical instruments, medical devices of everyday use, as well as small surfaces.
The present invention also relates to a method for the decontamination, disinfection, cleaning, reconditioning and/or sterilisation of a substrate or a part thereof, the method comprising the steps of:
(a) placing the aqueous solution described above in detail in contact with the substrate to be treated, or a part thereof, the solution preferably being at room temperature,
(b) maintaining the solution and the substrate, or a part thereof, in contact for a time comprised between 2 seconds and 15 minutes.
In one embodiment, step (a) of placing a substrate or a part thereof in contact with the aqueous solution of the invention is preferably carried out by immersion of said substrate, or a part thereof, in said aqueous solution.
In one embodiment, step (a) of placing a substrate or a part thereof in contact with the aqueous solution of the invention is carried out by spraying the aqueous solution on the substrate or a part thereof. The aqueous solution can be sprayed with manual applicators or with the use of automatic systems.
Step (b) of the present invention can have a different duration depending on the degree of contamination of the substrate and depending on the type of treatment it is intended to carry out, i.e. decontamination, disinfection, cleaning, reconditioning and/or sterilisation of the substrate or a part thereof.
For example, in order to sterilise a clean substrate or a part thereof, that is, a substrate that is not contaminated by residual organic material (for example, a surgical instrument that has already been cleaned and/or decontaminated), the solution and the substrate
or a part thereof are maintained in contact for a time comprised between 2 and 60 seconds.
In order to recondition, i.e. decontaminate/clean and simultaneously sterilise, a substrate or a part thereof still contaminated by organic material, step (b) envisages maintaining the solution and the substrate, or a part thereof, in contact for a time comprised between 1 and 15 minutes.
In one embodiment, the method can comprise at least a preliminary step, carried out before step (a), of dissolving the composition in the form of a powder or tablet as previously described in a suitable amount of aqueous solvent so as to obtain an aqueous solution preferably comprising from 0.1 to 0.5% w/w, preferably from 0.2 to 0.4% w/w, even more preferably from 0.25 to 0.35% w/w of the composition of the invention. The solubilisation of the composition of the invention in an aqueous solvent takes place in a relatively short time. In particular, if the composition is in the form of a powder, said time is less than 20 seconds, preferably comprised between 2 and 10 seconds, more preferably between 2 and 5 seconds.
If the composition is in the form of a tablet, said temp is less than 20 minutes, preferably comprised between 10 and 15 minutes, more preferably between 5 and 10 minutes.
In one embodiment said aqueous solvent is water, said water being preferably selected in the group consisting of distilled water, deionised water, mains water, purified water and water filtered by inverse osmosis.
In a preferred embodiment, the method according to the present invention is carried out cold, i.e. without applying external sources of heat and carrying out steps (a) and (b) and, optionally, the preliminary dissolving step, at room temperature.
Advantageously, the method according to the present invention enables a substrate or a part thereof contaminated by biological agents to be decontaminated, disinfected, cleaned, reconditioned and/or sterilised in a single treatment, preferably at room temperature. In particular, the method according to the present invention makes it possible to avoid the use of multiple repeated steps, as it enables an effective decontamination, disinfection, cleaning, reconditioning and/or sterilisation by simple contact, preferably by immersion in an aqueous solution comprising the composition of the invention as previously described or, alternatively, by spraying said aqueous solution.
Advantageously, the method according to the invention enables the complete decontamination, disinfection, cleaning, sterilisation and/or the reconditioning of a substrate or a part thereof in a single treatment of extremely brief duration.
The method according to the present invention enables a substrate or a part thereof to be decontaminated, disinfected, cleaned, reconditioned and/or sterilised by simple contact, preferably by immersion of the substrate or a part thereof in the solution of the invention or by spraying the solution on the substrate or a part thereof, without the need to apply any mechanical action, such as, for example, that provided by flows of water in an autoclave, or high temperatures, since pathogenic agents are eliminated and/or inactivated upon simple contact of the substrate or a part thereof with the solution comprising the composition of the invention, which, with the same mechanism of action responsible for the disinfectant/sterilising activity, dissolves and removes the residual organic material.
Furthermore, preferably, the method according to the present invention enables a given contaminated substrate or a part thereof to be decontaminated, disinfected, cleaned, reconditioned and/or sterilised without the use of detergents or enzymatic complexes as mentioned above.
Advantageously, the method according to the present invention enables the effective decontamination, disinfection, reconditioning and/or sterilisation of contaminated instruments and/or medical devices (or parts thereof), while respecting the structural and chemical-physical integrity thereof. In particular, the present method proves effective and applicable also in the case of delicate substrates (or parts thereof), for example, thermosensitive substrates (or parts thereof).
Furthermore, the rapidity and ease of use, connected with the decontaminating, disinfectant, reconditioning and/or sterilising efficiency, enable, even with a single treatment, an effective and complete disinfection, reconditioning and/or sterilisation of the substrates (or parts thereof), while respecting the structural and chemical-physical integrity thereof and, furthermore, preventing possible toxic contaminations of the outside environment or of the operator.
When the composition according to the invention is dissolved in an aqueous solvent, preferably water, or comes into contact therewith, thanks to the oxidation-reduction equilibria that are established between the species in the solution, free radicals with an
oxidising action are made available, preferably free radicals *OH_, which, on being converted into reducing electrons (preferably in the absence of catalysts), are capable of reconditioning, i.e. decontaminating/cleaning and simultaneously sterilising, a substrate, also at room temperature and in a short time.
According to one embodiment, therefore, the aqueous solution according to the present invention comprises free radicals with an oxidising action, preferably free radicals *OH_, produced by the oxidation-reduction equilibria that are established in the solution between the compounds comprised in said solution, which are then converted into reducing electrons (preferably in the absence of catalysts). Preferably, said aqueous solution is as previously described and preferably comprises from 0.1 to 0.5% w/w, preferably from 0.2 to 0.4% w/w, more preferably from 0.25 to 0.35% w/w, of the composition as previously described, and an aqueous solvent.
Said aqueous solution is preferably obtained by dissolving the composition in the form of a powder or tablet as previously described in a suitable amount of aqueous solvent so as to obtain an aqueous solution preferably comprising from 0.1 to 0.5% w/w, preferably from 0.2 to 0.4% w/w, even more preferably from 0.25 to 0.35% w/w of the composition of the invention.
Preferably, said aqueous solvent is water, said water being preferably selected in the group consisting of distilled water, mains water, deionised water, purified water and water filtered by reverse osmosis.
Preferably, said free radicals with an oxidising action are made available when the composition as previously described is dissolved in or comes into contact with said aqueous solvent.
In a further aspect thereof, the present invention relates to the use of a solution comprising free radicals with an oxidising activity, preferably *OH_, to recondition, i.e. to decontaminate/clean and simultaneously sterilise, a substrate, preferably a metal or plastic substrate, preferably at room temperature, and in a time comprised between 1 and 15 minutes.
According to one embodiment, said solution is an aqueous solution as previously described.
The is illustrated below with some non-limiting examples.
MATERIALS AND METHODS
Preparation of spores of Bacillus Subtilis
Spores of B. Subtilis ATCC 19695 or ATCC 6633 were prepared following the directions provided by the manufacturer. The laboratory test was performed by following standard UNI EN 13704. The inoculum used in the experiments was prepared so as to obtain a suspension with a turbidity of 0.8 McFarland (about 108 colony-forming units/ml)
Method for the detection of microbial growth - manual method
After each contact time tested, an aliquot of 100 mI_ of the tested suspensions was seeded in plates with sheep blood agar incubated at 37 °C for 24 hours. At the end of incubation, the microbial growth was evaluated. A second aliquot of 100 mI_ was transferred into test tubes containing nutrient broth; after an incubation of 24 hours at 37 °C, 100 mI_ were seeded in plates with sheep blood agar. Following incubation, the microbial growth was evaluated. In all of the experiments performed, a negative control was included to identify any contaminations of the solutions under examination, along with a positive control for microbial growth.
Method for the detection of microbial growth - automated method: Alifax Alfred 60
Alifax Alfred 60 is a totally automated system which, thanks to technology based on light scattering, is capable of determining the presence of microorganisms and enabling detection of their replication activity by displaying real time growth curves and providing quantitative results expressed as the count of colony-forming units/ml (CFU/ml).
After every contact time tested, an aliquot of 100 mI_ was transferred into the dedicated reading vials containing a eugonic broth, which in the system is constantly stirred and temperature controlled (37 °C). In order to evaluate the effectiveness of the tested solutions of the present invention, a 24-hour period of incubation was set. In all of the experiments performed, a negative control was included to identify any contaminations of the solutions under examination, along with a positive control for microbial growth. Example 1
2.5 g of the composition of the invention (described in Table 1) in powder form were dissolved in 1 L of mains water, mixing for a few seconds until obtaining a homogeneous solution. The solution obtained is an aqueous solution containing 0.25% w/w of said composition.
Table 1 - Composition 1
The solution obtained takes on a pale yellow colour which confirms the development of radicals.
Example 2 - tests on sporicidal activity The solution obtained as per example 1 was tested to evaluate their sterilising activity.
A surgical instrument endowed with a smooth surface was immersed in a solution consisting of generic organic dirt and spores of Bacillus Subtilis ATCC 6633 at an initial concentration of 8.00 log-ioCFU/ml obtained as described in the spore preparation method. The solution was maintained at an incubation temperature of 37 °C for 3 days in order to obtain a “polluted” surgical instrument.
The spore value measured on the polluted surgical instrument before treatment with the solution of the present invention was equal to 5.43logioCFU/ml.
Table 2 shows the results obtained after three tests conducted at room temperature by immersing the polluted surgical instrument in the solution obtained as per example 1 , 15 minutes after the preparation of the solution itself. Table 2
The tests were conducted by maintaining the solution in contact with the contaminated surgical instrument for 5 and 10 minutes; they were performed on a single surgical instrument taken as a sample after having immersed, in the same solution, already submitted to a test at T, another 1 1 surgical instruments polluted like the previous one and left immersed in the solution for a time of 5’ and 10’.
The technique used to detect the amount of spores killed is provided by European reference standard UNI EN 13704.
The results obtained demonstrate that the aqueous solution comprising the composition of the present invention has both an effective decontamination and sterilisation capacity at room temperature, i.e. it proves capable of sterilising and simultaneously decontaminating the contaminated instrument (i.e. reconditioning action) without any need for pre-treatments with disinfectants, enzyme-based detergents or other methods employed in the prior art. The results further demonstrate that the solution has sterilising activity also in the presence of organic material.
Example 3
5 g of the composition according to the invention prepared in example 1 in the form of powder were dissolved in 2L of mains water, mixing for a few seconds until obtaining a homogeneous solution. The solution obtained is an aqueous solution containing 0.25% w/w of said composition.
The solution obtained takes on a pale yellow colour which confirms the development of radicals.
Example 4 - tests on sporicidal activity The solution obtained as per example 3 was tested to evaluate its reconditioning and sterilising activity.
The solution obtained as per example 3 was tested 15 minutes after its preparation and assayed for the contact time with a solution of Bacillus Subtilis ATCC 6633 spores at an initial concentration of 8.68 log-ioCFU/ml, obtained by incubation at 37 °C as described in the spore preparation method. Table 3 shows the results obtained after a test conducted at room temperature by adding 100 mI_ of spore solution to 10 ml of solution obtained as per example 3,.
Table 3
The technique used to detect the amount of spores killed is the standard filter membrane method, carried out at room temperature.
The results obtained demonstrate that the aqueous solution comprising the composition of the present invention has both an effective decontamination and sterilisation capacity at room temperature, i.e. it proves capable of sterilising and simultaneously cleansing the contaminated instrument (i.e. reconditioning action) without any need for pre- treatments with disinfectants, enzyme-based detergents or other methods employed in the prior art.
The results further demonstrate that the solution has a sterilising activity also in the presence of organic material and is effective also with a contact time of less than one minute (15 seconds).
Claims
1. A composition comprising the following compounds: at least one peroxy acid and/or at least one salt of a peroxy acid, lithium carbonate (U2CO3) and at least one halide of an alkali or alkaline earth metal, said at least one halide being preferably selected in the group consisting of: chloride, iodide and bromide of an alkali metal and combinations thereof; more preferably it is selected in the group consisting of: sodium bromide (NaBr), potassium bromide (KBr) and combinations thereof.
2. The composition according to claim 1 , wherein said at least one peroxy acid is peroxymonosulphuric acid (H2SO5), and/or said at least one salt of a peroxy acid is an alkaline peroxymonosulphate, preferably selected from potassium peroxymonosulphate (potassium hydrogenated persulphate KHSOs), sodium peroxymonosulphate (NaHSOs) and combinations thereof, more preferably it is potassium hydrogenated persulphate.
3. The composition according to claim 1 or 2, comprising a further carbonate other than lithium carbonate and preferably selected from carbonates of an alkali or alkaline earth metal, more preferably said further carbonate being selected in the group consisting of potassium carbonate (K2CO3), sodium carbonate (Na2CC>3) and combinations thereof, more preferably said further carbonate being sodium carbonate.
4. The composition according to any one of the preceding claims, comprising said lithium carbonate in an amount comprised between 1 and 25% by weight, preferably between 2 and 20% by weight relative to the total weight of the composition.
5. The composition according to any one of the preceding claims, wherein said further carbonate other than lithium carbonate is present in an amount comprised between 2 and 50% by weight, preferably between 5 and 30% by weight, relative to the total weight of the composition.
6. The composition according to any one of the preceding claims, further comprising at least one buffering agent having a buffer capacity at pH values comprised between 2.0 and 10.0, said buffering agent preferably being potassium tetraborate (K2B4O7).
7. The composition according to any one of the preceding claims comprising:
- potassium hydrogenated persulphate (K2S2O8) 30-80% by weight
- lithium carbonate (U2CO3) 1-25% by weight
- sodium carbonate (Na2CC>3) 2-50% by weight
- sodium bromide (NaBr) 10-40% by weight
- buffering agent q.s. to pH 7-10
8. The composition according to any one of the preceding claims in the form of a powder or tablet, said powder or tablet being soluble in an aqueous solvent.
9. An aqueous solution comprising the composition according to any one of the previous claims and an aqueous solvent, said composition being preferably present in an amount between 0.1 and 0.5% w/w, preferably between 0.2 and 0.4% w/w, more preferably between 0.25 and 0.35% w/w, said aqueous solvent preferably being water, even more preferably said water being selected in the group consisting of distilled water, mains water, deionized water, purified water, water filtered by reverse osmosis; said solution comprising free radicals with an oxidising action, preferably free radicals *OH_, produced by the oxidation-reduction equilibria that are established, in the solution, between the compounds comprised in said composition.
10. A use of the composition according to any one of claims 1 to 8 or of the solution according to claim 9 for the decontamination, disinfection, cleaning, reconditioning and/or sterilisation, preferably cold, of a substrate or a part thereof.
11. A method for the decontamination, disinfection, reconditioning and/or sterilisation, preferably cold, of a substrate or a part thereof, the method comprising the steps of:
(a) placing the aqueous solution according to claim 9 in contact with the substrate to be treated, or a part thereof, said solution preferably being at room temperature;
(b) maintaining the solution and the substrate, or a part thereof, in contact for a time comprised between 2 seconds and 15 minutes.
12. The method according to claim 11, wherein step (a) of placing the substrate or a part thereof in contact with the aqueous solution according to claim 9 is carried out by immersion of said substrate or a part thereof in said solution or by spraying said solution on said substrate or a part thereof.
13. A use of the solution according to claim 9, to recondition, i.e. decontaminate/clean and simultaneously sterilise, a substrate, preferably a metal or plastic substrate, preferably at a temperature of 15-30°C, and in a time comprised between 1 and 15 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20786045.3A EP4027788A1 (en) | 2019-09-13 | 2020-09-11 | Composition and method for sterilising and reconditioning substrates |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102019000016220 | 2019-09-13 | ||
| IT102019000016220A IT201900016220A1 (en) | 2019-09-13 | 2019-09-13 | COMPOSITION AND METHOD FOR THE STERILIZATION AND RECONDITIONING OF SUBSTRATES |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2021048802A1 true WO2021048802A1 (en) | 2021-03-18 |
Family
ID=69375717
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2020/058452 WO2021048802A1 (en) | 2019-09-13 | 2020-09-11 | Composition and method for sterilising and reconditioning substrates |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4027788A1 (en) |
| IT (1) | IT201900016220A1 (en) |
| WO (1) | WO2021048802A1 (en) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002007789A1 (en) * | 2000-07-21 | 2002-01-31 | Reginald Keith Whiteley | Medical residue treatment composition |
| EP2929781A1 (en) * | 2014-04-10 | 2015-10-14 | Omya International AG | MIC reduction with lithium ions |
| CN107279135A (en) * | 2017-05-27 | 2017-10-24 | 镇江威特药业有限责任公司 | A kind of potassium peroxymonosulfate effervescent tablet |
| CN107624785A (en) * | 2017-10-26 | 2018-01-26 | 杨强 | A kind of low-corrosiveness potassium peroxymonosulfate disinfectant |
| CN109156474A (en) * | 2018-08-06 | 2019-01-08 | 山东华实药业有限公司 | A kind of potassium hydrogen persulfate disinfection tablet |
-
2019
- 2019-09-13 IT IT102019000016220A patent/IT201900016220A1/en unknown
-
2020
- 2020-09-11 EP EP20786045.3A patent/EP4027788A1/en active Pending
- 2020-09-11 WO PCT/IB2020/058452 patent/WO2021048802A1/en unknown
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002007789A1 (en) * | 2000-07-21 | 2002-01-31 | Reginald Keith Whiteley | Medical residue treatment composition |
| EP2929781A1 (en) * | 2014-04-10 | 2015-10-14 | Omya International AG | MIC reduction with lithium ions |
| CN107279135A (en) * | 2017-05-27 | 2017-10-24 | 镇江威特药业有限责任公司 | A kind of potassium peroxymonosulfate effervescent tablet |
| CN107624785A (en) * | 2017-10-26 | 2018-01-26 | 杨强 | A kind of low-corrosiveness potassium peroxymonosulfate disinfectant |
| CN109156474A (en) * | 2018-08-06 | 2019-01-08 | 山东华实药业有限公司 | A kind of potassium hydrogen persulfate disinfection tablet |
Also Published As
| Publication number | Publication date |
|---|---|
| EP4027788A1 (en) | 2022-07-20 |
| IT201900016220A1 (en) | 2021-03-13 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Rutala et al. | Guideline for disinfection and sterilization in healthcare facilities, 2008. Update: May 2019 | |
| Rutala et al. | Disinfection, sterilization, and control of hospital waste | |
| Rutala et al. | New disinfection and sterilization methods. | |
| Rutala et al. | Uses of inorganic hypochlorite (bleach) in health-care facilities | |
| Rutala et al. | Disinfection and sterilization in health care facilities: what clinicians need to know | |
| Rutala et al. | Disinfection of endoscopes: review of new chemical sterilants used for high-level disinfection | |
| Pavarina et al. | An infection control protocol: effectiveness of immersion solutions to reduce the microbial growth on dental prostheses | |
| Rutala et al. | Draft guideline for disinfection and sterilization in healthcare facilities | |
| Mushtaq et al. | An Overview of Dental Impression Disinfection Techniques-A Literature Review. | |
| Babb et al. | Sporicidal activity of glutaraldehydes and hypochlorites and other factors influencing their selection for the treatment of medical equipment | |
| Bradley et al. | Evaluation of the Steris System 1 peracetic acid endoscope processor | |
| JPH07108056A (en) | Sterilizing method by ozone | |
| Jackson et al. | Mycobacterium gordonae in fiberoptic bronchoscopes | |
| US6331514B1 (en) | Sterilizing and disinfecting compound | |
| Hanson et al. | Enteroviruses, endoscopy and infection control: an applied study | |
| Tweij-Thu-Alfeqar Razzaq et al. | Sterilization of Surgical Tools: Removing Bacterial Endospores with a Combination of Povidone-iodine, Chlorhexidine Gluconate, Ethanol, and Methanol | |
| WO2021048802A1 (en) | Composition and method for sterilising and reconditioning substrates | |
| EP1027827A1 (en) | Disinfectant composition | |
| Widmer et al. | Antimicrobial activity of glucoprotamin: a clinical study of a new disinfectant for instruments | |
| Akamatsu et al. | Evaluation of the antimicrobial activity and materials compatibility of orthophthalaldehyde as a high-level disinfectant | |
| Sattar | Cleaning, disinfection, and sterilisation | |
| Lasemi et al. | Effects of different times of glutaraldehyde 2% on Bacillus subtilis spores (in vitro) | |
| Parija | Sterilisation and Disinfection | |
| JP2022043957A (en) | Steam cleaner exhibiting strong spore killing ability | |
| Presterl et al. | Reprocessing: cleansing, disinfection, sterilization |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 20786045 Country of ref document: EP Kind code of ref document: A1 |
|
| NENP | Non-entry into the national phase |
Ref country code: DE |
|
| ENP | Entry into the national phase |
Ref document number: 2020786045 Country of ref document: EP Effective date: 20220413 |