IT202000027849A1 - COMPOSITION FOR THE DISINFECTION OF SURFACES - Google Patents

Description

Title: ?COMPOSITION FOR DISINFECTION OF SURFACES?

DESCRIPTION

The present invention relates to a composition for broad-spectrum disinfection of surfaces, in particular a composition that can be delivered by nebulization.

Infection control ? a major concern for healthcare professionals. Viruses, bacteria and spores spread easily between people, on surfaces and between people and surfaces. Of course, the risk of infections ? present not only in healthcare facilities, but also in public places such as gyms, restaurants, schools, hotels, offices, etc.

Is there a trend in hospital structures, in the food and hospitality sector, towards higher levels? high levels of infection control. Furthermore, there is a growing awareness of infectious diseases that can be transferred through the respiratory system, but also through the contact of the subject with contaminated surfaces and therefore with the mouth, nose or eyes (for example Sars-Cov-2). Among other viral infections pi? dangerous, we remember the Ebola virus, the yellow fever virus, the HIV virus and the hepatitis virus HAV-HBV-HCV.

Even among the bacteria there are many dangerous if not lethal infections for humans (Acinetobacter baumanni, Pseudomonas aeruginosa, Staphylococcus aureus etc.), while among the spores they are to be remembered for their dangerousness Clostridium difficile and Bacillus anthracis.

Although in most of the infections described above, and in particular for the Sars-Cov-2 virus, the main transmission route is airborne, the contagion following contact with an infected surface? even more insidious. In fact, if sufficient personal hygiene is not ensured, ? It's easy to get infected by putting your hands to your mouth, nose or eyes.

AND? also note that not all surfaces with which you can? come into contact can be easily sanitized by rubbing with a cloth soaked in disinfectant or by direct pouring of the disinfectant on the surface. Think for example of clothes, sheets, blankets or towels. Various cases of transmission in the home are in fact attributable to contacts with these surfaces.

Furthermore, in case of emergency situations such as epidemics or pandemics, ? also felt the need to be able to sanitize the surfaces of public environments or for mixed use in a relatively short time.

In fact, for the eradication of spores for example, two treatments are used with formaldehyde and/or glutaraldehyde, classified as harmful substances, and for long treatment times (at least 2 hours for each treatment).

There is therefore the need to make available a composition for the disinfection of surfaces that has a broad spectrum of action, acting on viruses, bacteria and fungal or yeast spores, relatively quickly and quickly. of action, a low toxicity? for humans and which preferably can also be delivered by means of a nebulizer.

The aforementioned technical problem ? substantially achieved by a composition for the disinfection of surfaces which includes the technical characteristics set out in one or more? of the annexed claims, the definitions of which form an integral part of the present description for the purposes of the sufficiency of the description.

Object of the present invention ? therefore an aqueous composition for broad-spectrum disinfection of surfaces, comprising:

- hydrogen peroxide between 0.5% and 10% by weight;

- mixture of ethanol and isopropanol between 5% and 30% by weight;

- lactic acid between 2% and 6% by weight;

- water.

A further object of the invention ? the use of said composition for the disinfection of surfaces by nebulization and a surface disinfection method comprising the steps of:

- make available a composition as described above;

- nebulizing, for example by means of an aerosol, nebulizer, atomizer or system for generating wet or dry fog, said composition in an environment comprising surfaces to be treated or at a distance from said surfaces to be treated for a time preferably less than 30 minutes.

Further characteristics and advantages of the present invention will appear more clearly from the indicative and therefore non-limiting description of preferred but not exclusive embodiments of the invention.

The present invention relates to an aqueous composition for the broad spectrum disinfection of surfaces, comprising:

- hydrogen peroxide between 0.5% and 10% by weight;

- mixture of ethanol and isopropanol between 5% and 30% by weight;

- lactic acid between 2% and 6% by weight;

- water.

Preferably, the mixture of ethanol and isopropanol is a 1:1 mixture by weight.

Preferably, the quantity? of hydrogen peroxide? between 4% and 9%, or between 5% and 8%, or between 5.5% and 7%, pi? preferably ? about 6% by weight.

Preferably, the quantity? of mixture of ethanol and isopropanol ? between 7% and 25%, or between 8% and 20%, or between 9% and 15%, pi? preferably ? about 10% by weight.

Preferably the quantity? of lactic acid? between 2.5% and 5%, or between 2.7% and 4.5%, pi? preferably ? about 3% by weight.

The composition of the invention can further contain:

- citric acid between 0.020% and 0.030%, preferably about 0.025% by weight;

- phosphoric acid between 0.3% and 0.7%, preferably about 0.5% by weight;

- excipients and/or natural fragrances (for example, vanilla, cinnamon or lavender).

The composition of the invention can be used as it is.

In the event that the composition of the invention is used in an environment in the presence of other people, it will be? preferable to use a composition comprising:

- hydrogen peroxide between 0.5% and 4% by weight;

- mixture of ethanol and isopropanol between 5% and 10% by weight;

- lactic acid between 2% and 2.5% by weight.

The composition of the invention ? effective on viruses, bacteria (both Gram+ and Gram-), mycobacteria, yeasts, fungi and spores. The composition also has anti-mite action.

Does hydrogen peroxide have excellent properties? oxidants and degraders on most organic compounds, including microorganisms.

The alcoholic mix? known for its germicidal efficacy and assists hydrogen peroxide for rapid disinfection, it also improves the drying of the disinfectant solution on surfaces, allowing application without rinsing (manual use) and dry nebulization (use with mesh nebulizer).

The lactic acid? a known natural system of control of bacterial colonization, ? of vegetable origin, completely biodegradable and gives greater capacity? formulated disinfectant. Furthermore, lactic acid has a chelating power and is used in place of?EDTA that ? classified as a toxic compound. Lactic acid belongs to the alpha-hydroxy acid family and is widely exploited in the pharmaceutical and cosmetic industry for its actions: pH buffer, antifungal, antibacterial. Lactic acid also performs an important preservative action.

Last but not least, lactic acid ? an odor regulator (for the action it has on pH). This allows you to eliminate the acrid smell typical of peroxides.

The composition of the invention can be prepared by mixing the various components and adding water up to the desired volume.

The composition of the invention can be distributed on a surface either manually (e.g. by means of a sprayer for cleaning/disinfectant solutions) or by means of a nebuliser, aerosol dispenser, atomizer or wet or dry mist dispenser, operated manually or automatically (without the presence of personnel in the environment to be treated). For the sanitization of large environments (for example, industrial warehouses) you can use a booster misting system, forced misting or misting using compressors.

The disinfection treatment with the composition of the invention can be led by one or more times a day to one or more? times a month, or whenever necessary.

The composition of the invention can be used in the home, in the community? or in an industrial environment, for the treatment of any surface, including furnishings, furnishings, mattresses, blankets, sheets, towels, clothing and so on. Street. AND? suitable for healthcare facilities and hospitals, analysis laboratories, activities? high-traffic shops, schools, gyms, shopping centres, trains, buses, means of transport in general, etc.

The composition of the invention can be used both as a surface disinfectant and for the elimination of bad odours.

EXPERIMENTAL PART

To document and confirm the biocidal efficacy of the product, the following tests were carried out in accordance with the to the EN ISO 17272:2020 standard.

- BACTERICIDAL ACTIVITY

- FUNGICIDAL ACTIVITY? YEAHICIDE

- MYCOBACTERICIDAL ACTIVITY

- SPORICIDAL ACTIVITY

- VIRUCIDAL ACTIVITY.

Were the following activities tested:

Activities bactericidal: Capacity? of the product to give rise to a reduction of at least 10<5 >(log5) in the number of viable bacterial cells belonging to the reference strains of Escherichia Coli K12 (NCTC 10538) and Staphylococcus Aureus in standard experimental conditions;

Activities fungicide: Capacity? of the product to give rise to a reduction of at least 10<4 >(log4) in the number of viable cells of molds belonging to the reference species of Aspergillus Niger under standard experimental conditions;

Activities yeasticide: Capacity? of the product to result in a reduction of at least 10<4 >(log4) in the number of viable yeast cells belonging to the reference species of Candida Albicans and in standard experimental conditions;

Activities virucidal: Capacity? of the product to give rise to a reduction of at least 10<4 >(log4) of the viral titer of a SARS-CoV-2 strain under standard experimental conditions and in the presence of interfering substances.

Surfaces were tested both in clean conditions (on which there are minimal quantities of organic and/or inorganic substances) and in dirty conditions (on which there are minimal quantities of organic and/or inorganic substances).

The interfering substances used are protein solutions and erythrocytes.

Dimensions and characteristics of the container and test start conditions:

Container dimensions 0.25 m<3 >(0.60 L x 0.70 W x 0.60 H)

T?C test start 20 ?C ? 2?C

Humidity? relative trial start 50%

Holder position and number of samples:

Type of placement Vertical

Height 50% of the container height

Distance from dispenser ? at 40% of the diagonal of the container

Number of samples from 1 to 3.

Contamination and drying of control media

Contaminate the supports placed in sterile Petri dishes by depositing 0.05 ml = 50 ?l of initial suspension of microorganisms with the formation of a single drop in the center of the support. Then distribute the inoculum evenly on the holder, covering an area of 3.0?0.5 cm<2>.

To do this, use a sterile inoculating loop and, working from the center, spread the inoculum in several circular motions to cover a constant circular area approximately 2.0 to 0.2 cm in diameter.

For each organism tested, contaminate two identical survival check media. The supports must be dried, they are placed in a Petri dish, with the lid open, and then dried for no more than 10 minutes. of 120 minutes at a temperature not exceeding 37°C (samples which have not dried at the end of this period cannot be used for tests). Regularly monitor (approximately every 10 minutes) the status of deposits. Once visibly dry, the supports are removed and the Petri dish is resealed.

Before drying the supports, ? important to take into account the following points: the sensitivity? to the drying of the different test organisms pu? vary significantly.

Furthermore, the adjustment of the suspension strength must take into account the potential loss during the drying phase.

After drying, the automated airborne disinfection process begins. Control media should not be exposed to the product.

At the end of the treatment time, transfer the two media into two screw cap tubes containing 100 mL of sterile recovery fluid. Shake by hand for a few seconds. To remove test organisms from the surface, use a glass stirrer, pipette tip or glass beads (5mm diameter) or other equivalent apparatus. Apply a mechanical action on the substrate surfaces for at least 1 min. Dilute 1 ml of recovery liquid in 9 ml of diluent and continue to carry out serial dilutions until reaching the 10<-3 > dilution (dilution to be adapted according to the titres of the prepared suspensions). Transfer two sets of 1 mL of the 10<-2 >and 10<-3 >concentration recovery liquid dilutions so? obtained in Petri dishes to perform plate counts for bacteria.

For each microorganism tested, count the numbers of colonies in the agar medium, determine the averages for each of the dilutions listed above and express the result in proportional terms as the number of bacteria, bacterial spores, yeast or fungal spores recovered on the vector control. The loss of vitality? (after drying and end of treatment time and aeration time, if applied) shall be calculated and recorded in the test report.

In tests in the presence of an interfering substance, the supports are pretreated as follows.

Using a calibrated precision pipette, place 0.05 mL = 50 ?L of only 10 % (V/V) prepared interferent into the diluent. For sensitive test organisms, deposit 50 ?L of reconstituted milk diluted 1:5 for tests selecting this option. Allow media to air dry.

ACTIVITY TEST VIRUCIDAL

Before running the test, stabilize all reagents - except the viral suspension - ie. the interfering substance, water, cell culture medium, diluent and product test solution, at 20?2?C using a controlled water bath.

The test tubes are filled with refrigerated medium (EMEM 2% FCS) for the various titres to be conducted after the various exposure times and placed in a melted ice bath. Microwell plates are labeled for identification.

a) Preparation of the media: Using a precision pipette, deposit 50 ?L of diluent containing the reconstituted interfering substance at the appropriate final concentration on the media, then distribute and dry;

b) Exposure of the media to treatment: Expose the media to the automated airborne disinfection process in the case during the test phase;

c) Recovery of supports and neutralization of the activity? of the applied product: After the treatment time and the subsequent aeration time, if applicable, recover the supports and transfer them to 20 ml of recovery liquid to neutralize the action of the product.

Susceptibility? of cells to viruses

The reduction of susceptibility? of cells to viruses is evaluated by comparative virus titers on cells treated and untreated with the product.

Treatment:

a) monolayer cells: 0.1 ml of product solution (invention composition) or PBS are dispensed into each well of the 96-well microplate. After 1 hour at 37?1?C, the supernatant was removed;

b) Suspended cells: 0.1 mL of product solution or PBS is added to a double strength volume of cell suspension. After 1 hour at 37?1?C, the cells are centrifuged and resuspended in the culture medium.

Comparative virus titer:

The virus is diluted from 10<-2 > to 10<-10 > and titrated on treated and untreated cells in parallel. Not C'? loss of sensitivity? when the product solution:

c) indicates a low mortality rate? of cells (25% of monolayer cells);

d) induces a reduction of the virus titer <1 log.

EXECUTION OF VIRUCIDAL EFFECTIVENESS TEST

Media Contamination: Prepare three media per test organism. Nine volumes of viral suspension are mixed with 1 volume of interfering substance. For each test, prepare three test media and three control media by depositing 50 µL of the suspension described above. Then spread and dry the substrates as defined above. Use dried media within one hour to avoid virus inactivation over time. Expose media to the automated airborne disinfection process in the test environment during the test phase.

Determination of viral titer after exposure: Immediately after recovery, after treatment time and subsequent aeration time, if applicable, each test medium should be transferred to a flask containing 20 mL of recovery liquid. The quantity? of recovery liquid can? be reduced as long as? its neutralizing potential remains adequate.

Mix by hand for a few seconds. Using a sterile glass stirrer, scrape each side of the disc to remove any dried residue. After a final rapid swirl, dilute 1 mL of recovery solution into 9 mL and continue the serial dilutions.

Experimental conditions for all tests

? Temperature: 20?C ? 2?C

? Tested container volume : 0.25 m<3 >? Interfering substances: bovine albumin 0.3 g/l clean condition

? Interfering substances: bovine albumin 3.0 g/l dirty condition

? Aerosol dispensing time: 25 min

? Exposure time: 10 min

? quantity dispensed: 8 ml (full load).

The composition according to the invention comprised: - hydrogen peroxide 6% by weight

- 1:1 ethanol/isopropyl alcohol 10% by weight mixture

- lactic acid 3% by weight, and water to taste.

The results are reported in the tables I and II below.

Table I

Table II

How can you? it can be noted from the data reported in the aforementioned tables, the composition of the invention has demonstrated a substantial reduction in a time of less than 30 minutes of the bacterial load, of the yeast spores, of the fungal and viral load both on a clean support and on a dirty support.

A further object of the present invention ? therefore a surface disinfection method that includes the phases of:

- make available a composition as described above;

- spraying, for example by means of an aerosol, nebulizer, atomizer or system for generating wet or dry fog, said composition in an environment comprising surfaces to be treated, or at a distance from said surfaces to be treated, for a time of less than 30 minutes.

AND? It is evident that only some particular embodiments of the present invention have been described, to which the expert in the art will be capable of making all those modifications necessary for its adaptation to particular applications, without however departing from the scope of protection of the present invention.

Claims (12)

1. Aqueous composition for broad spectrum disinfection of surfaces, comprising: - hydrogen peroxide between 0.5% and 10% by weight; - mixture of ethanol and isopropanol between 5% and 30% by weight; - lactic acid between 2% and 6% by weight; - water. 2. Composition according to claim 1, wherein the mixture of ethanol and isopropanol is a 1:1 mixture by weight. 3. Composition according to claim 1 or 2, wherein the quantity? of hydrogen peroxide? between 4% and 9%, or between 5% and 8%, or between 5.5% and 7% by weight. 4. Composition according to any one of claims 1 to 3, wherein the quantity? of mixture of ethanol and isopropanol ? between 7% and 25%, or between 8% and 20%, or between 9% and 15% by weight. 5. Composition according to any one of claims 1 to 4, wherein the quantity? of lactic acid? between 2.5% and 5%, or between 2.7% and 4.5% by weight. The composition according to any one of claims 1 to 5, further comprising: - citric acid between 0.020% and 0.030%, or about 0.025% by weight; - phosphoric acid between 0.3% and 0.7%, or about 0.5% by weight; - excipients and/or natural fragrances such as essence of vanilla, cinnamon or lavender. 7. Composition according to any one of claims 1 to 6, comprising: - hydrogen peroxide between 0.5% and 4% by weight; - mixture of ethanol and isopropanol between 5% and 10% by weight; - lactic acid between 2% and 2.5% by weight; - water. 8. Composition according to any one of claims 1 to 6, comprising: - hydrogen peroxide about 6% by weight; - mixture of ethanol and isopropanol about 10% by weight; - lactic acid about 3% by weight; - water. 9. Use of the composition according to any one of claims 1 to 8 for the disinfection of surfaces from bacterial, viral, fungal and/or yeast contaminations. 10. Use according to claim 9, wherein: - bacterial contamination includes Escherichia Coli K12 and Staphylococcus Aureus; - fungal contamination includes Aspergillus Niger; - yeast contamination includes Candida Albicans; And - viral contamination includes SARS-COV-2. 11. Use according to claim 9 or 10, wherein the disinfectant composition is administered by nebulisation, aerosol, atomization, wet mist or dry mist. 12. Surface disinfection method which includes the steps of: - providing a composition according to any one of claims 1 to 8; - spraying, for example by means of an aerosol, nebulizer, atomizer or system for generating wet or dry mist, said composition in an environment comprising surfaces to be treated or at a distance from said surfaces to be treated, for a time of less than 30 minutes.