EP1945274A1 - Composition and method - Google Patents

Composition and method

Info

Publication number
EP1945274A1
EP1945274A1 EP06744206A EP06744206A EP1945274A1 EP 1945274 A1 EP1945274 A1 EP 1945274A1 EP 06744206 A EP06744206 A EP 06744206A EP 06744206 A EP06744206 A EP 06744206A EP 1945274 A1 EP1945274 A1 EP 1945274A1
Authority
EP
European Patent Office
Prior art keywords
sterilising
composition
composition according
peracetic acid
solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP06744206A
Other languages
German (de)
French (fr)
Inventor
Keith Martin Macgregor
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ebiox Ltd
Original Assignee
Ebiox Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ebiox Ltd filed Critical Ebiox Ltd
Publication of EP1945274A1 publication Critical patent/EP1945274A1/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18Liquid substances or solutions comprising solids or dissolved gases
    • A61L2/186Peroxide solutions
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION 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
    • A01N37/00Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
    • A01N37/16Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing the group; Thio analogues thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • the present invention relates to a composition and method for use in sterilising applications, particularly in the field of sterilising medical equipment.
  • An alternative sterilising method is immersion of equipment in a sterilising composition.
  • Such compositions are well known. However, they are often time-consuming to prepare, require long immersion periods, are unstable, or are of inadequate efficacy.
  • a sterilising composition comprising a source of peracetic acid, at least one anionic surfactant and at least one amphoteric surfactant .
  • the sterilising solution is provided in concentrated form which may be diluted with water to form a sterilising solution.
  • the source of peracetic acid may comprise any suitable source.
  • it comprises a peracetic acid precursor, and an activator.
  • the peracetic acid precursor comprises an organic compound having at least one acetyl residue, preferably more than one acetyl residue.
  • the peracetic acid precursor compound preferably comprises an amine or alcohol having an acetyl group appended thereto i.e., preferably the peracetic acid precursor compound comprises an organic compound in which an acetyl group is bonded to a nitrogen or oxygen atom.
  • the peracetic acid precursor compound comprises an amine, preferably an amine having an acetyl residue bonded thereto.
  • the peracetic acid precursor compound may comprise more than one amine group. At least one of said amine groups has an acetyl group appended thereto. Preferably there are at least two amine groups, each of which has an acetyl group appended thereto.
  • the peracetic acid precursor compound comprises an organic compound having an amine group, said amine group having at least two acetyl groups bonded to a single nitrogen atom.
  • the organic compound comprises a diamine.
  • each nitrogen atom of said diamine has two acetyl groups appended thereto.
  • the peracetic acid precursor compound comprises tetraacetylethylene diamine.
  • the peracetic acid precursor compound may be selected from the list comprising acetylsalicyclic acid, acetic acid, tetraacetyl glycouracil, pentaacetylglucose, N,N-diacetylaniline, N, N- diacetyl-p-toluidine; 1, 3-diacylated hydantoins, N- acylated cyclic hydrazides, and acylated triazones or urazoles .
  • Suitable activators for use in the present invention include any means which may bring about the conversion of the peracetic acid precursor to peracetic acid.
  • the activator comprises an oxidising agent.
  • Said oxidising agent is able to oxidise the acetyl groups on the peracetic acid precursor compound to form peracetic acid.
  • Suitable oxidising agents for use in the invention include alkali metal peroxides; hydrogen peroxide; organic peroxides, for example, urea peroxide, perbenzoic acid and peroxycarboxylic acids such as mono or diperoxyphthalic acid, diperoxy-azelaic acid, 2-octyldiperoxysuccinic acid, diperoxydodecanedicarboxylic acid, imidoperoxycarboxylic acid, the salts thereof, phlalimidoperhexanoic acid (PAP) ; and inorganic persalts, such as the alkali metal perborates, percarbonates , perphosphates , persilicates and persulfates .
  • PAP phlalimidoperhexanoic acid
  • the activator comprises a perborate compound.
  • the activator comprises sodium perborate, especially as a mo ⁇ ohydrate .
  • a preferred source of peracetic acid is tetraacetylethyl diamine as a peracetic acid precursor and sodium perborate monohydrate as an activator.
  • any following definition which refers to the amount of a component present in a composition of the present invention more than one of any such components may be present and the reference is made to the total amounts of all such components present in the composition.
  • composition preferably comprises at least 20 wt% of the source of peracetic acid, more preferably at least
  • the composition preferably comprises up to 90 wt% of the source of peracetic acid, more preferably up to 80 wt%, more preferably up to 75 wt%, most preferably up to 70 wt%.
  • the above percentages refer to the total amount of the source of peracetic acid, including the peracetic acid precursor and the activator.
  • the composition comprises at least 5 wt% peracetic acid precursor, more preferably at least 10 wt%, most preferably at least 12 wt%.
  • the composition comprises up to 40 wt% peracetic acid precursor, more preferably up to 30 wt%, most preferably up to 20 wt%.
  • the composition comprises at least 10 wt% activator, more preferably at least 20 wt%, more preferably at least 30 wt%, and most preferably at least
  • the composition comprises up to 70 wt% activator, more preferably up to 60 wt%, more preferably up to 55 wt%, and most preferably up to 50 wt%.
  • the composition comprises at least 0.1 wt% anionic surfactant, more preferably at least 0.5 wt%, more preferably at least 1 wt%, most preferably at least 1.5 wt%.
  • the composition comprises up to 10 wt% anionic surfactant, more preferably up to 8 wt%, most preferably up to 5 wt% anionic surfactant .
  • Suitable anionic surfactants include sodium and potassium salts of fatty carboxylic acids, sulfonates, alkyl sulfates, alkylether carboxylic acids and their salts, sulfosuccinates, alkoxylated alkyl sulfates, torides, alkylphosphates and sarcosocides .
  • alkyl sulfates and alkyl polyalkoxylated sulfates may be produced by the sulfonation of higher C 8 - C 20 fatty alcohols .
  • alkyl sulfate surfactants are those of formula:
  • R is a C 8 -C 20 hydrocarbon group and M is a water- solubilising cation.
  • R is Ci 0 -C 16 alkyl, for example Ci 2 -C 14
  • M is an alkali metal such as lithium, sodium or potassium.
  • alkoxylated alkyl sulfates are ethoxylated alkyl sulfates of the formula: RO(C 2 H 4 O) n SO 3 -M +
  • R is a C 8 -C 20 alkyl group, preferably C 10 -Ci 8 such as a Ci 2 -Ci 6
  • n is at least 1, for example from 1 to 20, preferably 1 to 15, especially 1 to 6
  • M is a salt- forming cation such as lithium, sodium, potassium, ammonium, alkylammonium or alkanolammonium.
  • alkyl sulfates and alkyl ether sulfates may be used in the form of mixtures comprising varying alkyl chain lengths and, if present, varying degrees of alkoxylation.
  • anionic surfactants which may be employed are salts of C 8 -Ci 8 fatty acids, especially the sodium or potassium salts, and alkyl, for example C 8 -Ci 8 , benzene sulfonates .
  • the anionic surfactant comprises a sulfonate, more preferably an alkylbenzene sulfonate, most preferably a linear alkylbenzene sulfonate.
  • said linear alkylbenzene sulfonate has between 8 and 18 carbon atoms.
  • a suitable linear alkylbenzene sulfonate is commercially available under the trade mark Nansa HS80/S.
  • a composition of the present invention comprises at least 0.1 wt% amphoteric surfactant, more preferably at least 0.5 wt%, more preferably at least 1 wt%, most preferably at least 1.5 wt%.
  • the composition comprises up to 10 wt% amphoteric surfactant, more preferably up to 8 wt%, most preferably up to 5 wt% amphoteric surfactant.
  • amphoteric surfactants include amphoteric betaine surfactant compounds having the following general formula:
  • R is a hydrophobic group which is an alkyl group containing from 8 to 20 carbon atoms ; each R ⁇ is an alkyl group independently containing from 1 to 3 carbon atoms; and R2 is an alkylene group containing from 1 to 6 carbon atoms .
  • exemplary useful amphoteric surfactants include those selected from alkylampho (mono) - and (di) - acetates, alkylampho (mono) - and (di) -propionates, and aminopropionates .
  • alkylampho (mono) acetates include those according to the general structure:
  • R represents a R represents a C8 to C24 alkyl moiety.
  • R represents a C8 to C24 alkyl moiety.
  • Suitable alkylampho (mono) propionates include those according to the according to the general structure :
  • R represents a R represents a C8 to C24 alkyl moiety.
  • Suitable alkylampho (di) propionates include those according to either of the general structures :
  • R represents a R represents a C8 to C24 alkyl moiety.
  • Suitable aminopropionates include those according to the following general structure : CH 2 CH 2 COO 0 RNH 9 CH 2 CH 2 COOH
  • R represents a R represents a C8 to C24 moiety.
  • R represents a C8- C24 alkyl group and desirably is a C10-C16 alkyl group, especially derived from soy or coconut the latter of which typically provides a mixture of C8-10, C12, C14 and C16 alkyl groups .
  • amphoteric surfactant comprises beta- alanine,N- (carboxyethyl) -N-dodecyl monosodium salt.
  • the mass ratio of anionic surfactant to amphoteric surfactant is preferably in the range of from 1:3 to 3:1.
  • the anionic surfactant is present in a mass excess compared with the amphoteric surfactant.
  • the ratio of anionic surfactant to amphoteric surfactant is between 1:1 and 2:1, most preferably it is about 1.5:1.
  • composition of the present invention further comprises a weak acid, preferably an organic acid.
  • the composition of the present invention comprises a carboxylic acid having from 1 to 5 carbon atoms, and between 1 and 4 carboxylic acid residues.
  • the composition of the present invention comprises citric acid.
  • the composition comprises said weak acid in an amount of at least 5 wt%, more preferably at least 10 wt%, most preferably at least 15 wt%.
  • the composition comprises up to 50 wt% weak acid, more preferably up to 40 wt%, most preferably up to 30 wt%.
  • composition of the present invention further comprises one or more solubilising agents.
  • Suitable solubilising agents include common salts of group 1 and group 2 metals .
  • solubilising agents are selected from the group consisting of sulfates, nitrates, carbonates and bicarbonates .
  • the composition of the present invention comprises sodium bicarbonate and sodium sulphate as solubilising agents .
  • composition of the present invention further comprises a sequestrant.
  • sequestrants include citrate, succinate, malonate, carboxymethyl succinate, carboxylate, polycarboxylate and polyacetyl carboxylate, as the salts of group 1 or group 2 metals, or as free acids .
  • Examples include the sodium, potassium and lithium salts of oxydisuccinic acid, mellitic acid, benzene polycarboxylie acids, Ci O -C 2 2 fatty acids and citric acid.
  • Preferred sequestering agents are organic phosphonate type sequestering agents such as those sold by Monsanto under the trade mark Dequest, and alkylhydroxy phosphonates .
  • a preferred sequestrant is phosphonic acid Deguest.
  • the sequestering agent is preferably present in an amount of less than 1 wt%.
  • composition of the present invention further comprises an indicator, most preferably a visual indicator.
  • said indicator changes colour in the pH range of between 3 and 10, preferably of between 6 and 8.
  • Suitable indicators include phenol red, brilliant yellow, cresol red, neutral red, paranitrophenol, and bromothymol blue.
  • a preferred indicator is Phenol Red.
  • the indicator is preferably such that a colour change occurs when the useful life of a solution prepared from the composition of the present invention has expired.
  • composition of the present invention is preferably provided as a powder.
  • the above weight percentages of components present in the composition refer to this dry powder .
  • composition is diluted to form a solution prior to use .
  • the composition of the present invention has a solubility at 40 0 C in water of at least 5g per litre, more preferably at least 1Og per litre, most preferably at least 15g per litre. Said solubilities are measured by stirring the composition in water at 40° C for a period of 5 minutes .
  • the composition of the present invention forms an aqueous solution having pH of between 4 and 12, more preferably of between 2 and 11, more preferably between 5 and 11, preferably between 6 and 10, and most preferably between 7 and 9.
  • the composition of the present invention forms a solution having an alkaline pH, preferably least 7.5.
  • the composition of the present invention provides a solution having an initial pH of about 8. The pH of the solution may vary over time, preferably the pH does not fall below 6 during the first 24 hours .
  • the composition of the present invention forms a solution having a peracetic acid content of at least 900 ppm, after 5 minutes. More preferably at least 1,000, preferably at least 1,200 ppm, most preferably at least 1,400 ppm, after 5 minutes.
  • composition of the present invention provides a solution which after 4 hours has a peracetic acid concentration of at least 700 ppm, more preferably at least 800 ppm, most preferably at least 1,000 ppm.
  • the composition of the present invention forms a solution which maintains a peracetic acid concentration of at least 700 ppm, more preferably at least 800 ppm, preferably at least 900 ppm, most preferably at least 1,000 ppm for at least 4 hours, more preferably at least 6 hours, more preferably at least 8 hours, and most preferably at least 10 hours.
  • the present invention provides a composition which dissolves to form a solution having a peracetic acid concentration of at least 1,400 ppm within 5 minutes, and which also maintains a peracetic acid concentration of at least 1,000 ppm over a period of 10 hours.
  • a concentrate composition comprising:
  • amphoteric surfactant - 1 to 3.5 wt% amphoteric surfactant .
  • a method of preparing a sterilising solution comprising dissolving a composition of the first or second aspect in water at 40 0 C.
  • the method comprises dissolving between 10 and 3Og, most preferably between 18 and 22g, of the composition of the first or second aspect in 1 litre of water at 40 °C.
  • the method further comprises allowing the temperature of the solution to fall to room temperature once dissolution is complete.
  • dissolution is complete after 10 minutes, more preferably after 5 minutes .
  • an aqueous sterilising solution comprising:
  • amphoteric surfactant - 0.04 to 0.05 wt% amphoteric surfactant.
  • a method of sterilising medical equipment comprising the steps of :
  • the appropriate period is the time necessary to inhibit or kill a significant portion of the microbes present on the medical equipment .
  • the appropriate period is at least 1 minute, more preferably at least 2 minutes, more preferably at least 3 minutes, most preferably at least 5 minutes.
  • the appropriate period is less than 4 hours, more preferably less than 3, more preferably less than 2 hours, most preferably less than 1 hour.
  • At least 4.5 loglO of microbes present on the medical equipment prior to sterilisation are inhibited or destroyed, more preferably at least 5 loglO, more preferably at least 5.5 loglO, more preferably at least 6 loglO, most preferably at least 7 loglO.
  • composition of the present invention is active after the appropriate period, for example 5 minutes, against one or more of, and preferably all of, the following spores: Bacillus subtilis var niger and the following bacteria: Escheria coli, Mycobacterium tuberculosis, Staphylococcus aureus, Salmonella typhimurium, Pseudomonas aeruginosa, Campylobacter jejuni, Klebsiella aerogenes, Enterococcus faecium, Bacillus stearothermopohilus, Bacillus coagulans .
  • Bacillus subtilis var niger and the following bacteria: Escheria coli, Mycobacterium tuberculosis, Staphylococcus aureus, Salmonella typhimurium, Pseudomonas aeruginosa, Campylobacter jejuni, Klebsiella aerogenes, Enterococcus faecium, Bac
  • the composition of the present invention is active after the appropriate period, for example 5 minutes, against one or more of, and preferably all of, the following viruses: HIV, Adenovirus, Hepatitis B, Hepatitis C, Poliovirus, Cocksackievirus, Echovirus, Herpes simplex, Rotavirus.
  • viruses HIV, Adenovirus, Hepatitis B, Hepatitis C, Poliovirus, Cocksackievirus, Echovirus, Herpes simplex, Rotavirus.
  • the composition of the present invention is active after the appropriate period, for example 5 minutes, against one or more of, and preferably both of, the following Fungi: Candida albicans, Aspergillus niger (spores) .
  • the sterilising method of the fifth aspect of the present invention may be carried out at room temperature .
  • the sterilising solution is prepared from the composition of the first or second aspect immediately prior to use.
  • the composition may continue to be suitable for use for a period of at least 4 hours, more preferably at least 6 hours, more preferably at least 8 hours, most preferably at least 10 hours.
  • the composition will no longer be sufficiently active against microbes, there is a colour change of the sterilising solution.
  • a composition was prepared having the following components :
  • Nansa HS80/S linear alkylbenzene sulphonate
  • Beta-alanine,N- (carboxyethyl) -N-dodecyl monosodium salt (AMA 100)
  • Figure 1 shows a graph of the average peracetic acid release over the first 24 hours.
  • HIRL Hospital Infection Research Laboratory
  • University of Birmingham, UK found a reduction in colony forming units of > 6.5 loglO for Bacillus subtilis var niger spores in less than 2 minutes under clean and dirty conditions and a reduction of >5 loglO (5-8 loglO) c.f.u. for Mycobacterium tuberculosis in a clean and dirty carrier test with a contact time of 5 minutes .

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Abstract

A sterilising composition comprising a source of peracetic acid, at least one anionic surfactant and at least one amphoteric surfactant. A method of using the composition to sterilise medical equipment is also described.

Description

COMPOSITION AND METHOD
The present invention relates to a composition and method for use in sterilising applications, particularly in the field of sterilising medical equipment.
It is essential that medical equipment is effectively sterilised between uses to prevent the spread of infection.
Many sterilising techniques rely on the use of high temperatures. However, some equipment may be heat- sensitive and become damaged if exposed to such harsh conditions .
An alternative sterilising method is immersion of equipment in a sterilising composition. Such compositions are well known.. However, they are often time-consuming to prepare, require long immersion periods, are unstable, or are of inadequate efficacy.
According to a first aspect of the present invention, there is provided a sterilising composition comprising a source of peracetic acid, at least one anionic surfactant and at least one amphoteric surfactant .
Preferably the sterilising solution is provided in concentrated form which may be diluted with water to form a sterilising solution.
The source of peracetic acid may comprise any suitable source. Preferably it comprises a peracetic acid precursor, and an activator. Preferably the peracetic acid precursor comprises an organic compound having at least one acetyl residue, preferably more than one acetyl residue.
The peracetic acid precursor compound preferably comprises an amine or alcohol having an acetyl group appended thereto i.e., preferably the peracetic acid precursor compound comprises an organic compound in which an acetyl group is bonded to a nitrogen or oxygen atom.
Preferably the peracetic acid precursor compound comprises an amine, preferably an amine having an acetyl residue bonded thereto. The peracetic acid precursor compound may comprise more than one amine group. At least one of said amine groups has an acetyl group appended thereto. Preferably there are at least two amine groups, each of which has an acetyl group appended thereto. In preferred embodiments the peracetic acid precursor compound comprises an organic compound having an amine group, said amine group having at least two acetyl groups bonded to a single nitrogen atom.
Most preferably the organic compound comprises a diamine. Preferably each nitrogen atom of said diamine has two acetyl groups appended thereto. Most preferably the peracetic acid precursor compound comprises tetraacetylethylene diamine. Alternatively, the peracetic acid precursor compound may be selected from the list comprising acetylsalicyclic acid, acetic acid, tetraacetyl glycouracil, pentaacetylglucose, N,N-diacetylaniline, N, N- diacetyl-p-toluidine; 1, 3-diacylated hydantoins, N- acylated cyclic hydrazides, and acylated triazones or urazoles . Suitable activators for use in the present invention include any means which may bring about the conversion of the peracetic acid precursor to peracetic acid.
Preferably the activator comprises an oxidising agent. Said oxidising agent is able to oxidise the acetyl groups on the peracetic acid precursor compound to form peracetic acid.
Suitable oxidising agents for use in the invention include alkali metal peroxides; hydrogen peroxide; organic peroxides, for example, urea peroxide, perbenzoic acid and peroxycarboxylic acids such as mono or diperoxyphthalic acid, diperoxy-azelaic acid, 2-octyldiperoxysuccinic acid, diperoxydodecanedicarboxylic acid, imidoperoxycarboxylic acid, the salts thereof, phlalimidoperhexanoic acid (PAP) ; and inorganic persalts, such as the alkali metal perborates, percarbonates , perphosphates , persilicates and persulfates .
Most preferably the activator comprises a perborate compound. In especially preferred embodiments the activator comprises sodium perborate, especially as a moήohydrate .
A preferred source of peracetic acid is tetraacetylethyl diamine as a peracetic acid precursor and sodium perborate monohydrate as an activator.
In any following definition which refers to the amount of a component present in a composition of the present invention, more than one of any such components may be present and the reference is made to the total amounts of all such components present in the composition.
The composition preferably comprises at least 20 wt% of the source of peracetic acid, more preferably at least
30 wt%, more preferably at least 40 wt%, most preferably at least 50 wt%.
The composition preferably comprises up to 90 wt% of the source of peracetic acid, more preferably up to 80 wt%, more preferably up to 75 wt%, most preferably up to 70 wt%.
The above percentages refer to the total amount of the source of peracetic acid, including the peracetic acid precursor and the activator.
Preferably the composition comprises at least 5 wt% peracetic acid precursor, more preferably at least 10 wt%, most preferably at least 12 wt%.
Preferably the composition comprises up to 40 wt% peracetic acid precursor, more preferably up to 30 wt%, most preferably up to 20 wt%.
Preferably the composition comprises at least 10 wt% activator, more preferably at least 20 wt%, more preferably at least 30 wt%, and most preferably at least
40 wt%.
Preferably the composition comprises up to 70 wt% activator, more preferably up to 60 wt%, more preferably up to 55 wt%, and most preferably up to 50 wt%. Preferably the composition comprises at least 0.1 wt% anionic surfactant, more preferably at least 0.5 wt%, more preferably at least 1 wt%, most preferably at least 1.5 wt%.
Preferably the composition comprises up to 10 wt% anionic surfactant, more preferably up to 8 wt%, most preferably up to 5 wt% anionic surfactant .
Suitable anionic surfactants include sodium and potassium salts of fatty carboxylic acids, sulfonates, alkyl sulfates, alkylether carboxylic acids and their salts, sulfosuccinates, alkoxylated alkyl sulfates, torides, alkylphosphates and sarcosocides .
Straight-chained or branched alkyl sulfates and alkyl polyalkoxylated sulfates, also known as alkyl ether sulfates may be produced by the sulfonation of higher C8- C20 fatty alcohols .
Examples of alkyl sulfate surfactants are those of formula:
ROSO3 "M+
wherein R is a C8-C20 hydrocarbon group and M is a water- solubilising cation. Preferably R is Ci0-C16 alkyl, for example Ci2-C14, and M is an alkali metal such as lithium, sodium or potassium.
Examples of alkoxylated alkyl sulfates are ethoxylated alkyl sulfates of the formula: RO(C2H4O)nSO3-M+
wherein R is a C8-C20 alkyl group, preferably C10-Ci8 such as a Ci2-Ci6, n is at least 1, for example from 1 to 20, preferably 1 to 15, especially 1 to 6, and M is a salt- forming cation such as lithium, sodium, potassium, ammonium, alkylammonium or alkanolammonium.
The alkyl sulfates and alkyl ether sulfates may be used in the form of mixtures comprising varying alkyl chain lengths and, if present, varying degrees of alkoxylation.
Examples of other anionic surfactants which may be employed are salts of C8-Ci8 fatty acids, especially the sodium or potassium salts, and alkyl, for example C8-Ci8, benzene sulfonates .
Preferably the anionic surfactant comprises a sulfonate, more preferably an alkylbenzene sulfonate, most preferably a linear alkylbenzene sulfonate. In especially preferred embodiments said linear alkylbenzene sulfonate has between 8 and 18 carbon atoms. A suitable linear alkylbenzene sulfonate is commercially available under the trade mark Nansa HS80/S.
Preferably a composition of the present invention comprises at least 0.1 wt% amphoteric surfactant, more preferably at least 0.5 wt%, more preferably at least 1 wt%, most preferably at least 1.5 wt%. Preferably the composition comprises up to 10 wt% amphoteric surfactant, more preferably up to 8 wt%, most preferably up to 5 wt% amphoteric surfactant.
Suitable amphoteric surfactants include amphoteric betaine surfactant compounds having the following general formula:
R-N+(Ri)2— R2COO"
wherein R is a hydrophobic group which is an alkyl group containing from 8 to 20 carbon atoms ; each R^ is an alkyl group independently containing from 1 to 3 carbon atoms; and R2 is an alkylene group containing from 1 to 6 carbon atoms .
Further exemplary useful amphoteric surfactants include those selected from alkylampho (mono) - and (di) - acetates, alkylampho (mono) - and (di) -propionates, and aminopropionates .
Exemplary alkylampho (mono) acetates include those according to the general structure:
wherein R represents a R represents a C8 to C24 alkyl moiety.
Alkylampho (di) acetates according to either of the general structures shown may be used:
wherein R represents a C8 to C24 alkyl moiety.
Suitable alkylampho (mono) propionates include those according to the according to the general structure :
wherein R represents a R represents a C8 to C24 alkyl moiety.
Suitable alkylampho (di) propionates include those according to either of the general structures :
wherein R represents a R represents a C8 to C24 alkyl moiety.
Suitable aminopropionates include those according to the following general structure : CH2CH2COO0 RNH9 CH2CH2COOH
wherein R represents a R represents a C8 to C24 moiety. In each of the above indicated structures, R represents a C8- C24 alkyl group and desirably is a C10-C16 alkyl group, especially derived from soy or coconut the latter of which typically provides a mixture of C8-10, C12, C14 and C16 alkyl groups .
Preferably the amphoteric surfactant comprises beta- alanine,N- (carboxyethyl) -N-dodecyl monosodium salt.
The mass ratio of anionic surfactant to amphoteric surfactant is preferably in the range of from 1:3 to 3:1. Preferably the anionic surfactant is present in a mass excess compared with the amphoteric surfactant. Most preferably the ratio of anionic surfactant to amphoteric surfactant is between 1:1 and 2:1, most preferably it is about 1.5:1.
Preferably the composition of the present invention further comprises a weak acid, preferably an organic acid.
Preferably, the composition of the present invention comprises a carboxylic acid having from 1 to 5 carbon atoms, and between 1 and 4 carboxylic acid residues. Most preferably the composition of the present invention comprises citric acid. Preferably the composition comprises said weak acid in an amount of at least 5 wt%, more preferably at least 10 wt%, most preferably at least 15 wt%.
Preferably the composition comprises up to 50 wt% weak acid, more preferably up to 40 wt%, most preferably up to 30 wt%.
Preferably the composition of the present invention further comprises one or more solubilising agents. Suitable solubilising agents include common salts of group 1 and group 2 metals .
Most preferably the solubilising agents are selected from the group consisting of sulfates, nitrates, carbonates and bicarbonates . Most preferably the composition of the present invention comprises sodium bicarbonate and sodium sulphate as solubilising agents .
Preferably the composition of the present invention further comprises a sequestrant. Suitable sequestrants include citrate, succinate, malonate, carboxymethyl succinate, carboxylate, polycarboxylate and polyacetyl carboxylate, as the salts of group 1 or group 2 metals, or as free acids .
Examples include the sodium, potassium and lithium salts of oxydisuccinic acid, mellitic acid, benzene polycarboxylie acids, CiO-C22 fatty acids and citric acid. Preferred sequestering agents are organic phosphonate type sequestering agents such as those sold by Monsanto under the trade mark Dequest, and alkylhydroxy phosphonates . A preferred sequestrant is phosphonic acid Deguest. The sequestering agent is preferably present in an amount of less than 1 wt%.
Preferably the composition of the present invention further comprises an indicator, most preferably a visual indicator. Preferably said indicator changes colour in the pH range of between 3 and 10, preferably of between 6 and 8. Suitable indicators include phenol red, brilliant yellow, cresol red, neutral red, paranitrophenol, and bromothymol blue. A preferred indicator is Phenol Red.
The indicator is preferably such that a colour change occurs when the useful life of a solution prepared from the composition of the present invention has expired.
The composition of the present invention is preferably provided as a powder. The above weight percentages of components present in the composition refer to this dry powder .
Suitably the composition is diluted to form a solution prior to use .
Preferably the composition of the present invention has a solubility at 400C in water of at least 5g per litre, more preferably at least 1Og per litre, most preferably at least 15g per litre. Said solubilities are measured by stirring the composition in water at 40° C for a period of 5 minutes .
Preferably once dissolved the composition of the present invention forms an aqueous solution having pH of between 4 and 12, more preferably of between 2 and 11, more preferably between 5 and 11, preferably between 6 and 10, and most preferably between 7 and 9. In especially preferred embodiments the composition of the present invention forms a solution having an alkaline pH, preferably least 7.5. Most preferably the composition of the present invention provides a solution having an initial pH of about 8. The pH of the solution may vary over time, preferably the pH does not fall below 6 during the first 24 hours .
Preferably once dissolved the composition of the present invention forms a solution having a peracetic acid content of at least 900 ppm, after 5 minutes. More preferably at least 1,000, preferably at least 1,200 ppm, most preferably at least 1,400 ppm, after 5 minutes.
Preferably the composition of the present invention provides a solution which after 4 hours has a peracetic acid concentration of at least 700 ppm, more preferably at least 800 ppm, most preferably at least 1,000 ppm.
Preferably the composition of the present invention forms a solution which maintains a peracetic acid concentration of at least 700 ppm, more preferably at least 800 ppm, preferably at least 900 ppm, most preferably at least 1,000 ppm for at least 4 hours, more preferably at least 6 hours, more preferably at least 8 hours, and most preferably at least 10 hours.
In especially preferred embodiments the present invention provides a composition which dissolves to form a solution having a peracetic acid concentration of at least 1,400 ppm within 5 minutes, and which also maintains a peracetic acid concentration of at least 1,000 ppm over a period of 10 hours.
According to a second aspect of the present invention there is provided a concentrate composition comprising:
- 35 to 55 wt% sodium perborate monohydrate;
- 10 to 25 wt% tetraacetylethylene diamine;
- 2 to 5 wt% anionic surfactant;
- 1 to 3.5 wt% amphoteric surfactant .
According to a third aspect of the present invention there is provided a method of preparing a sterilising solution, comprising dissolving a composition of the first or second aspect in water at 400C.
Preferably the method comprises dissolving between 10 and 3Og, most preferably between 18 and 22g, of the composition of the first or second aspect in 1 litre of water at 40 °C. Preferably the method further comprises allowing the temperature of the solution to fall to room temperature once dissolution is complete.
Preferably dissolution is complete after 10 minutes, more preferably after 5 minutes .
According to a fourth aspect of the present invention there is provided an aqueous sterilising solution comprising:
- 0.8 to 0.9 wt% sodium perborate monohydrate;
- 0.3 to 0.4 wt% tetraacetylethylene diamine; - 0.05 to 0.07 wt% anionic surfactant; and
- 0.04 to 0.05 wt% amphoteric surfactant.
According to a fifth aspect of the present invention there is provided a method of sterilising medical equipment, the method comprising the steps of :
(a) preparing a sterilising solution by dissolving a composition of the first or second aspect in water; and
(b) immersing the medical equipment in the sterilising solution for an appropriate period.
The appropriate period is the time necessary to inhibit or kill a significant portion of the microbes present on the medical equipment .
Preferably the appropriate period is at least 1 minute, more preferably at least 2 minutes, more preferably at least 3 minutes, most preferably at least 5 minutes.
Preferably the appropriate period is less than 4 hours, more preferably less than 3, more preferably less than 2 hours, most preferably less than 1 hour.
Preferably after the appropriate period, for example 5 minutes, at least 4.5 loglO of microbes present on the medical equipment prior to sterilisation are inhibited or destroyed, more preferably at least 5 loglO, more preferably at least 5.5 loglO, more preferably at least 6 loglO, most preferably at least 7 loglO. Preferably the composition of the present invention is active after the appropriate period, for example 5 minutes, against one or more of, and preferably all of, the following spores: Bacillus subtilis var niger and the following bacteria: Escheria coli, Mycobacterium tuberculosis, Staphylococcus aureus, Salmonella typhimurium, Pseudomonas aeruginosa, Campylobacter jejuni, Klebsiella aerogenes, Enterococcus faecium, Bacillus stearothermopohilus, Bacillus coagulans .
Preferably the composition of the present invention is active after the appropriate period, for example 5 minutes, against one or more of, and preferably all of, the following viruses: HIV, Adenovirus, Hepatitis B, Hepatitis C, Poliovirus, Cocksackievirus, Echovirus, Herpes simplex, Rotavirus. Preferably the composition of the present invention is active after the appropriate period, for example 5 minutes, against one or more of, and preferably both of, the following Fungi: Candida albicans, Aspergillus niger (spores) .
Preferably the sterilising method of the fifth aspect of the present invention may be carried out at room temperature .
Preferably the sterilising solution is prepared from the composition of the first or second aspect immediately prior to use. Suitably the composition may continue to be suitable for use for a period of at least 4 hours, more preferably at least 6 hours, more preferably at least 8 hours, most preferably at least 10 hours. Suitably when the composition will no longer be sufficiently active against microbes, there is a colour change of the sterilising solution.
The invention will now be further described by way of the way of the following non-limiting example.
Example
A composition was prepared having the following components :
3g sodium bicarbonate
44g sodium perborate monohydrate
17.5g tetraacetylethylene diamine
24g citric acid
3.5g Nansa HS80/S (linear alkylbenzene sulphonate)
2.4g Beta-alanine,N- (carboxyethyl) -N-dodecyl monosodium salt (AMA 100)
6.9g sodium sulphate
0.3g phosphonic acid Dequest 4266D
0.015g Phenol red
2Og of the above composition was dissolved in 1 litre of stirred water at 400C. The concentration of peracetic acid present in the solution was measured at intervals of between 5 minutes and 24 hours. This was done by iodometric titration. The pH of the solution was also measured over these periods .
The solution was observed to gradually change colour from red to orange to yellow. In order to show that the solution could be prepared with reliable reproducibility, preparation as described above and the measurements taken were repeated 10 times. The results are shown in Tables 1 and 2 below.
Table 1
Table 2
Figure 1 shows a graph of the average peracetic acid release over the first 24 hours. These results clearly demonstrate that the present invention provides a reliable method of producing a composition having and a biocidally- effective concentration of peracetic acid for a prolonged period.
The composition has been independently evaluated by the Hospital Infection Research Laboratory (HIRL) , University of Birmingham, UK. HIRL found a reduction in colony forming units of > 6.5 loglO for Bacillus subtilis var niger spores in less than 2 minutes under clean and dirty conditions and a reduction of >5 loglO (5-8 loglO) c.f.u. for Mycobacterium tuberculosis in a clean and dirty carrier test with a contact time of 5 minutes .

Claims

Claims
1. A sterilising composition comprising a source of peracetic acid, at least one anionic surfactant and at least one amphoteric surfactant .
2. A sterilising composition according to claim 1 wherein the source of peracetic acid comprises a peracetic acid precursor and an activator.
3. A sterilising composition according to claim 2 wherein the peracetic acid precursor comprises tetraacetylethylene diamine .
4. A sterilising composition according to claims 2 or 3 wherein the activator comprises sodium tetraborate.
5. A sterilising composition according to any preceding claim wherein the anionic surfactant comprises a linear alkylbenzene sulfonate.
6. A sterilising composition according to any preceding claim wherein the amphoteric surfactant comprises beta- alanine,N- (carboxyethyl) -N-dodecyl monosodium salt.
7. A concentrate sterilising composition comprising:
- 35 to 55 wt% sodium perborate monohydrate ;
- 10 to 25 wt% tetraacetylethylene diamine;
- 2 to 5 wt% anionic surfactant;
- 1 to 3.5 wt% amphoteric surfactant .
8. A sterilising composition according to any preceding claim which further comprises citric acid.
9. A sterilising composition according to any preceding claim which further comprises a sequestering agent.
10. A sterilising composition according to any preceding claim which further comprises an indicator.
11. A sterilising composition according to claim 10 wherein the indicator is phenyl red.
12. A method of preparing a sterilising solution comprising dissolving a composition as claimed in any preceding claim in water at 40°C.
13. An aqueous sterilising solution comprising:
- 0.8 to 0.9 wt% sodium perborate monohydrate ;
- 0.3 to 0.4 wt% tetraacetylethylene diamine;
- 0.05 to 0.07 wt% anionic surfactant; and
- 0.04 to 0.06 wt% amphoteric surfactant.
14. A method of sterilising medical equipment, the method comprising the steps of :
(a) preparing a sterilising solution by dissolving a composition of the first or second aspect in water; and
(b) immersing the medical equipment in the sterilising solution for an appropriate period.
15. A method as claimed in claim 14 wherein the appropriate period is between 5 minutes and 1 hour.
16. A method as claimed in claim 14 or claim 15 in which the method is carried out at room temperature.
17. A composition or method as hereinbefore described with reference to the examples .
EP06744206A 2005-11-07 2006-06-14 Composition and method Withdrawn EP1945274A1 (en)

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EP2224802A2 (en) * 2007-12-21 2010-09-08 Cognis IP Management GmbH Adjuvants for agrochemical applications
GB201010374D0 (en) 2010-06-21 2010-08-04 Mtp Innovations Ltd Disinfectant composition
JP6239643B2 (en) * 2012-12-14 2017-11-29 サバン ベンチャーズ ピーティーワイ リミテッド Synergistic disinfection enhancement
CN104981158B (en) 2012-12-14 2017-12-22 萨班企业私人有限公司 Disinfectant
WO2019034747A1 (en) * 2017-08-16 2019-02-21 Ceva Sante Animale New disinfectant for hatcheries

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US6436445B1 (en) * 1999-03-26 2002-08-20 Ecolab Inc. Antimicrobial and antiviral compositions containing an oxidizing species
ES2203377T3 (en) * 1999-06-30 2004-04-16 Kao Corporation VIRUCIDE AND SPORTS COMPOUND.
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