FR2855973A1 - Liquid detergent concentrate for pre-disinfection treatment, e.g. of medical instruments, comprises a quaternary ammonium salt, a surfactant and a chelating or sequestering agent - Google Patents

Abstract

Dilutable liquid detergent concentrate for pre-disinfection treatment comprises a quaternary ammonium salt, a detergency-enhancing or biocidal surfactant and a chelating or sequestering agent.

Description

The present invention relates to a liquid composition

  detergent / pre-disinfectant, concentrated and dilutable, against bacterial biofilms.

  It relates to the industrial and commercial field of the manufacture and distribution of products intended for the treatment of objects intended to be disinfected after their cleaning, in particular of circuits, surfaces, instruments, equipment, washing machines, and more particularly to the treatment. medical, surgical or endoscopic instruments.

  As such, it will find its applications, for example, in the field of the food industry, the hospital sector, medical or paramedical, cosmetic, pharmaceutical or veterinary, facilities 15 for communities or the general public.

  Traditionally, for cleaning or disinfecting by detergency, various quaternary ammonium compositions are used which offer a relatively broad spectrum of activity for satisfactory disinfecting power.

  However, these components do not have a detergent and solubilizing power powerful enough to attack mixtures of greases deposited on surfaces and more particularly, bacterial biofilms adhered to the surface of the medical-surgical equipment, at least at the concentrations on the surface. more often recommended in ready-to-use products.

  In addition, these molecules most often comprising a halide (chloride or bromide) are frequently corrosive at high concentration and at high temperature.

  The purpose of cleaning the surface of a medical device with a detergent product is to eliminate, as much as possible, soils of particular organic origin, such as blood, proteins or others, as well as microbial contaminations that may proliferate and form a biofilm. The level of contamination after cleaning should be as low as possible to ensure optimum efficiency of subsequent sterilization or disinfection.

  However, a bacterial biofilm may form in a few hours on the surface of medical-surgical equipment left wet or contaminated in aqueous media. The survival of microorganisms is mainly due to their ability to adhere to surfaces, to establish communications between cells to organize themselves into a pluricellular structure, a true organized biological system called biofilm. This biofilm consists of a matrix of lipopolysaccharides (the glycocalyx) secreted by the microorganisms, which will protect them from external aggressions (detergents, antibiotics, etc.). Within this protective gangue, microorganisms remain viable and may release endotoxins responsible for septic shock, such as detach and recontaminate the medium.

  This biofilm, very difficult to detach once established, therefore allows the bacteria to resist sterilization and disinfection treatments, resulting in a significant risk of recontamination of the medical device treated.

  Indeed, the resistance of microorganisms to antimicrobial agents when they are included in a biofilm is much greater than that of suspended cells (in the so-called planktonic form). The cleaning phase must therefore cause the disorganization of this structure to allow the action of the biocidal molecules.

  The physicochemical action of the detergent formulation, in combination with the mechanical action of water spraying and a thermal action in washing phase, determines the effectiveness of cleaning. This physico-chemical action is not only the accumulation of the effectiveness of each of the components of the formula, it results from a synergy between their physicochemical properties.

  Detergents, or detergents / decontaminants, or detergents / disinfectants, usually used for cleaning or decontaminating medical and surgical equipment generally consist of surfactants which increase the wettability, loosen and emulsify the soils in the wash solution; sequestering agents that trap calcium and magnesium ions in the water; emulsifying agents to prevent re-deposition; corrosion inhibitors; enzymes (proteases, lipases, amylases, etc.); and other additives of various properties (defoamers, dyes, pH correctants, etc.).

  Water-dilutable detergent compositions are known using the combination of active agents such as pyrrolidones and a glycol ether emulsifier.

  For example, patent WO 91 00 893 (STEVENS SCIENCES) mentions a composition formed of a mixture of biodegradable components intended to eliminate paint on rigid or flexible surfaces and in particular containing terpene or methyl pyrrolidone. and glycol ethers.

  The patent N FR 2 788 703 (ARCANES INDUSTRIES) describes a concentrated and dilutable washing and stripping product consisting of one or two glycol ethers associated with an N-alkyl pyrrolidone or a hydrophobic active agent with a cleavage index. KB greater than or equal to 30.

  However, these solvent detergents do not have sufficient efficacy in the case of bacterial biofilms.

  The object of the present invention is to create a synergy between the detergent and disinfectant effects of one or more quaternary ammoniums, alone or in combination with other detergent and sequestering molecules, carried in an aqueous phase, by the formation a homogeneous emulsion between this aqueous phase, and an organic phase based on one or more solvents such as glycol ethers of different polarity.

  The presence of these organic solvents in fact facilitates the solubilization of fats and in particular bacterial biofilm, which then allows the action of hydrophilic detergent or disinfectant molecules at the level of the bacterial cell.

  The invention thus has the advantage of being effective on bacterial biofilm, by allowing the disorganization of the biofilm structure and the solubilization of its protective matrix.

  The composition according to the invention has been specifically developed, formulated and tested for its effectiveness on bacterial biofilms throughout its development; it uses in a stable, clear, concentrated and dilutable microemulsion, both the degreasing and solubilizing properties of organic solvents such as glycol ethers, and the solubilizing and germicidal properties of hydrophilic molecules such as quaternary ammoniums. The synergy created between the two phases, hydrophobic and hydrophilic, allows the use of these quaternary ammoniums at concentrations much lower than the concentrations usually used, thereby controlling the corrosion phenomena encountered with the usual compositions, even in acidic medium.

  Its physico-chemical action also combined with the specifically biocidal properties of certain detergent / disinfectant molecules makes it possible both to solubilize the hydrophobic protective gangue that constitutes the biofilm, and simultaneously to achieve the viability of the bacterial cells, thus preventing their revivification after the cleaning cycle / disinfection and recontamination of the medical device.

  A first object of the invention is therefore to provide an effective cleaning / pre-disinfecting composition on bacterial biofilms, for the treatment of objects, such as, for example, medical, surgical or endoscopic instruments, or instruments or installations in agricultural industries. food, pharmaceuticals, veterinary, cosmetics, or in establishments or 20 public or other public The invention thus relates in a first aspect to a concentrated composition, which can be used at high dilution for the treatment of objects as mentioned above, intended to be disinfected or sterilized later.

  A second object of the invention relates to its use in concentrated form for the cleaning / pre-disinfection of hot water networks, or cooling circuits of heating or air conditioning systems (cooling towers, condensate trays, humidifiers), in public or collective institutions, in which it is now well known that the proliferation of Legionella pneumophila bacteria is responsible for severe prognosis of lung diseases. Like other pathogenic bacteria, L. pneumophila is likely to adhere to the internal surfaces of pipes, all the more easily if they are scaled, and to establish a highly resistant biofilm which will be a source of re-contamination of water hot circulating.

  Indeed, one of the additional interests of the composition according to the invention when it is used concentrated, is its anti-limescale properties, thus fighting against scale deposits in the pipes, and thus making it more difficult to establish the bacterial biofilm.

  The invention presents, among other things, the advantage of being physically and chemically stable in the concentrated state, in the form of an "oil-in-water" emulsion during the lifetime necessary for its marketing, but also of being usable at low concentration in water, particularly for its biomedical applications.

  The composition according to the present patent application consists of a dilutable, stable and clear concentrated liquid intended in particular for the disinfection of objects such as medical-surgical instruments, this liquid comprising one or more glycol ethers. and at least one organic quaternary ammonium salt, at least one chelating or sequestering agent and at least one surfactant capable of reinforcing the detergent action or itself possessing an intrinsic biocidal efficacy.

  Other objects and advantages of the present invention will become apparent from the following description which develops some embodiments for guidance and which is not intended to limit it.

  The invention utilizes the degreasing properties of a stable, clear, concentrated and dilutable organic emulsion phase in an aqueous phase containing biocidal detergents and other agents capable of enhancing the detergent or disinfectant activity.

  The organic phase contains a glycol ether, especially dipropylene glycol methyl ether, or preferably a mixture of several different HLB glycol ethers. There may be mentioned, for example, dipropylene glycol methyl ether (HLB = 8.2); propylene glycol n-propyl ether (HLB = 7.3); The n-propyl ether of dipropylene glycol (HLB = 7.2), the n-butyl ether of propylene glycol (HLB = 6.9).

  This organic phase will represent from 10 to 30% by weight of the concentrated composition. In the case of the use of 2 ethers of glycols, the ratio between the 2 ethers of glycols may range from 1:20 to 1:10 by weight.

  According to the invention, the aqueous phase contains a quaternary ammonium salt whose biocidal properties are known, and more precisely one or more quaternary ammonium halides, at a level of 5 to 10% by weight.

  Indeed, the synergy provided by the organic phase in the composition makes it possible to reduce the effective biocidal concentration of quaternary ammonium halides and thus to limit its corrosive power on metals.

  The composition according to the invention may optionally contain other agents intended to enhance the detergent and biocidal activity (for example biguanides, piperazines, N-acetyl-cysteine, amphoteric, alcohols, in an aqueous or hydro-organic medium, or other). It will contain, for example, a biocidal amphoteric agent such as that marketed by Rhodia under the trade name Amphionic SFB (alkyl amino carboxylate) at a level of 10 to 40% by weight.

  The composition in accordance with the invention may also comprise chelating or sequestering agents, pH-regulating agents (alkalizing or acidifying agents) or surfactants such as ethoxylated fatty alcohols, ethoxylated alkylphenols and ethylene oxide copolymers. or propylene, alkylaminocarboxylates or alkylpolyglycosides.

  The composition may be declined according to the needs of its intended application in a concentrated acid formulation, with a pH of less than 6; in a neutral concentrated formulation of about pH 7; or in an alkaline concentrated formulation of pH greater than 8.

  For this purpose, the sequestering agents will be chosen according to the pH intended for the composition and therefore according to its final application, for example: in the case of an alkaline composition, ethylene diamine tetraacetic acid or its tetrasodium salt or preferably the disodium salt ethylene diamine disuccinate, for its better toxicological acceptability, or a phosphonate; in the case of a neutral composition, the disodium salt of iminodisuccinic acid, for its stability in a pH range of 4 to 13.5, as well as its cleaning and chelating power, and its toxicological and ecotoxicological safety; in the case of an acidic composition, an organic acid such as a carboxylic acid or, preferably, an alpha-hydroxy carboxylic acid. In this case, glycolic acid is chosen in particular at a level of from 2 to 10% by weight for its rapidity of chelation, its biocidal character, its excellent solubility in water, its descaling and anti-scaling power, its low corrosive power and also its toxicological safety as ecotoxicological. Its chelating power can also be enhanced by the presence in the composition of another organic acid such as citric acid or succinic acid. The buffering power of the composition may also benefit from the addition of one of these organic acids.

  The aqueous phase will represent 70 to 90% by weight of the concentrated composition. Said composition is miscible in all proportions in water. The dosage varies, in particular, by weight, from 0.1% to 2% by volume of water, according to the cleaning procedure, manual and / or automated, used.

  The said composition may be used in the form of a bath in which the objects to be disinfected or sterilized are immersed for manual or machine treatment. It may still be a spray or other.

  Examples of Possible Formulations of the Invention Various formulations constructed around this composition were tested on bacterial biofilms according to the methodology developed and published by the BIOTECH-GERMANDE laboratory (Pineau L, Roques C, Luc J, Michel G. Automatic washer-disinfector for flexible endoscope - a new valuation process.

  Endoscopy 1997, 29: 372-377). This methodology uses a Pseudomonas aeruginosa biofilm established on an inert support. These formulations have demonstrated their detergent and biocidal efficacy in less than 3 minutes of contact time between 20 and 40 C.

  Two nonlimiting examples of acid or alkaline formulation of detergent / disinfectant compositions in accordance with the invention are given below (the proportions are given in weight / weight), and the effectiveness of which has been demonstrated on bacterial biofilms. These examples illustrate the present application.

  A) Example of an alkaline pH composition according to the invention - Dipropylene glycol methyl ether: 15 to 20% - Propylene glycol n-butyl ether: 0 to 5% - Alkyl amino carboxylate: 10 to 30% 15 - Chloride Didecyl dimethylammonium: 0 to 10% - Tetrasodium salt of ethylene diamine tetraacetic acid: 2 to 10% - Ethylene diamine tetraacetic acid: 1 to 2% - Oleo-cetyl poly (ethyleneoxy) ethanol: 0 to 5% Excipients and water demineralized: Qsp 100% B) Example of composition of acidic pH according to the invention - Dipropylene glycol methyl ether: 15 to 20% - n-butyl ether of propylene glycol: 0 to 5% 25 - Alkyl amino carboxylate: 10 to 30% - Didecyldimethylammonium chloride: 0 to 10% Oleo-cetyl poly (ethyleneoxy) ethanol: 0 to 5% - Glycolic acid: 0 to 10% Excipients and demineralized water: Qsp 100% These excipients consist, for example, of antifoam, alcohol, anti-corrosion agents, alkalizing agents or acidic colors, perfume, or others.

  Of course, other embodiments within the reach of those skilled in the art could have been envisaged without departing from the scope of the present invention.

  The detergent properties demonstrated on biofilms of Pseudomonas aeruginosa according to the aforementioned methodology of these two examples of compositions according to the invention justify their use for the cleaning of medical devices such as flexible endoscopes before disinfection, both in manual procedure than in automated procedure.

  The positioning of the various constituent elements gives the object of the invention a maximum of useful effects that had not been obtained so far by similar products.

Claims (12)

  1. A liquid detergent / pre-disinfectant composition, concentrated and dilutable, against bacterial biofilms, intended for treatment before disinfection, in particular of circuits, surfaces, instruments, equipment, washing machines, and more particularly of medical, surgical or endoscopic instruments, characterized in that it comprises: at least one quaternary ammonium organic salt, at least one surfactant capable of reinforcing the detergent action or having an intrinsic biocidal efficacy, at least one chelating or sequestering agent.   2. Composition according to Claim 1, characterized in that it comprises 5 to 10% by weight of one or more quaternary ammonium halides.   3. Composition according to any one of the preceding claims, characterized in that it comprises one or more surfactant (s) chosen from the following: ethoxylated fatty alcohols, ethoxylated alkylphenols, copolymers ethylene oxide or propylene oxide, alkylaminocarboxylates, alkylpolyglycosides.   4. Composition according to any one of the preceding claims, characterized in that it further comprises, in combination with the surfactant (s), antimicrobial agents consisting of biguanides.   5. Composition according to any one of the preceding claims, characterized in that it also comprises, in combination with the surfactant (s), antimicrobial agents consisting of piperazines.   6. Composition according to any one of the preceding claims, characterized in that it additionally comprises, in combination with the surfactant (s), antimicrobial agents consisting of N-acetyl-cysteine. .   7. Composition according to any one of the preceding claims, characterized in that the chelating or sequestering agents consist of sodium ethylene diamine tetraacetate.   8. Composition according to any one of Claims 1 to 6, characterized in that the chelating or sequestering agents consist of sodium ethylene diamine disuccinate.   9. Composition according to any one of Claims 1 to 6, characterized in that the chelating or sequestering agents consist of sisodium salt disodium salt of iminodisuccinic acid.   10. Composition according to any one of Claims 1 to 6, characterized in that the chelating or sequestering agents consist of glycolic acid or citric acid.   O11. Composition according to any one of the preceding claims, characterized in that it comprises a glycol ether or a mixture of several different glycol ethers of HLB representing 10 to 30% by weight.   12. A composition according to claim 11, characterized in that at least one of said glycol ethers is dipropylene glycol methyl ether.   13. Composition according to any one of Claims 11 and 12, characterized in that it comprises propylene glycol n-propyl ether or dipropylene glycol n-propyl ether or n-propyl ether. butyl propylene glycol.