FR2855759A1 - AQUEOUS STABILIZED COMPOSITION, DISINFECTANT BASED ON A PERACETIC ACID COMPLEX OF STABILIZED HUDROGEN PEROXIDE AND STABILIZED ACID, AND A PROCESS FOR MANUFACTURING THE SAME - Google Patents

Abstract

This aqueous disinfectant composition based on a complex of peracetic acid, hydrogen peroxide and acetic acid also comprises a stabilizing agent based on 8-hydroxyquinoline.

Description

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 The present invention relates to a stabilized aqueous disinfectant composition which is based on peracetic acid, hydrogen peroxide and acetic acid, and a process for its manufacture.

 Peracetic acid or peroxyacetic acid has the general formula: CH3-CO3H. He is known to be explosive and have an unpleasant odor. Disinfectant compositions based on peracetic acid, such as those described for example in documents EP-797, are already known. 387-A, FR-2. 823.978-A and FR-2.829.394A. These compositions of the prior art comprise peracetic acid, hydrogen peroxide or hydrogen peroxide and acetic acid. Thus according to FR-2.823.978-A, it is known a composition of the above kind to which benzotriazole is added; this composition is used to disinfect ophthalmology equipment intended for non-invasive acts: this product is therefore not in contact with the eye.

 FR-2. 829.394-A relates to a process for preparing an aqueous disinfecting composition comprising mixing an aqueous solution of the above kind with an aqueous solution containing at least two corrosion inhibitors of which at least one is a phosphate compound to give a composition which is then diluted in water. The final composition is used to disinfect medical devices.

 In document EP-797.387-A, reference is made to prior documents relating to compositions of hydrogen peroxide, acetic acid and peracetic acid, in particular for disinfecting hemodialysis equipment: it is mentioned that such a composition is capable of being diluted in water.

 More generally, the known compositions based on peracetic acid, hydrogen peroxide and acetic acid

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 are in fact of two types: compositions prepared during their use and compositions ready for use.

 The former are themselves divided into two groups.

The first group comprises compositions comprising two compounds: the first based on peracetic acid and the second consisting of an activator, the mixture of the two leading to a disinfectant composition for immediate use. The second group comprises compositions based on peracetic acid in the form of powder: the addition of water gives the disinfectant composition to be used immediately.

 The seconds comprise ready-to-use peracetic acid-based compositions whose open cork storage time is at least 8 days.

 According to other documents, it can be used to stabilize the whole peracetic acid - hydrogen peroxide, heavy metals such as silver salts.

 It has also been tried to stabilize this set using aldehydes, formaldehyde or glutaraldehyde these materials being volatile, there is a risk of the formation of vapors dangerous for personnel and the environment.

 It will be remembered that formulas based on peracetic acid are not only unstable over time (more than hydrogen peroxide) but in addition they emit a very strong smell of vinegar that can inconvenience users. Compared with those of hydrogen peroxide, peracetic acid vapors are highly volatile and have a flash point of 56 C. They can be corrosive and toxic.

 It is therefore an object of the present invention to provide an aqueous disinfecting composition based on a complex of peracetic acid, hydrogen peroxide and acetic acid which obviates the drawbacks mentioned above.

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 Another object of the invention is to provide such a composition which is stable over time.

 These and other objects which will become apparent are attained by an aqueous disinfectant composition based on a complex of peracetic acid, hydrogen peroxide and acetic acid, which composition is characterized, according to the the present invention in that it also comprises a stabilizing agent based on 8-hydroxyquinoline.

 Advantageously, this composition comprises less than 1% by volume of peracetic acid.

 Preferably, this composition comprises from 2 to 6% by volume of hydrogen peroxide.

 Advantageously, this composition comprises from 0.1 to 1% by volume of essential oil.

 Preferably, this composition comprises at most 2% by volume of the stabilizing agent.

 Advantageously, the stabilizing agent is a mixture of 8 hydroxyquinoline, phosphoric acid, tartaric acid, citric acid, tridocylamyne, copper and iron.

 Preferably, this aqueous composition comprises ultrapure water less than 2 Ms and resistivity higher than 108 # / m.

 According to the present invention, an aqueous disinfecting composition based on a complex of peracetic acid, acetic acid and hydrogen peroxide is stabilized as will be described hereinafter.

 Hydrogen peroxide or hydrogen peroxide of general formula H 2 O 2 is of two types: γ-hydrogen peroxide whose characteristics are summarized in Table I below and γ-hydrogen peroxide whose characteristics are summarized in the table. He below.

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BOARD
HYDROGEN PEROXIDE TYPE A RESIDUE MANDATORY FILTRATION AT 0.2 p

<Tb>
<tb> Chlorides <SEP><<SEP> 0.001%
<tb> Nitrites <SEP><<SEP> 0.00001 <SEP>% <SEP>
<tb> Sulfates <SEP> 20 <SEP> PPM <SEP>
<tb> Gold <SEP> 0.2 <SEP> PPM
<tb> Ions <SEP> S04 <SEP> No <SEP> detectable
<tb> Calcium <SEP> 200 <SEP> PPM
<tb> Sulphated <SEP> Ash <0.05 <SEP>% <SEP>
<tb> Ash <SEP> - <SEP><<SEP> 0.01 <SEP>% <SEP>
<tb> Carbon <SEP> -55mg / l
<Tb>

TABLEAUII
HYDROGEN PEROXIDE TYPE B Ultra-pure type and NO 0.2 FILTRATION

<Tb>
<tb> Mass <SEP> volume <SEP> to <SEP> 25 C <SEP> in <SEP> g. <SEP> cm-3 <SEP> 1,2
<tb> Taking <SEP> of <SEP> ions <SEP> ag <SEP> 2500mg <SEP> - <SEP> 3600mg / L
<tb> TRIDODECYLAMINE <SEP> 0.1 <SEP> PPM <SEP>
<Tb>

A mixture of these two types of hydrogen peroxide is used in an A / B ratio of at least 3/2 by volume
Acetic acid is a more than 90% pure acid, as is peracetic acid.

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 The essential oil present in the final composition has the function of masking the pungent odor generated by the presence of acetic and peracetic acids: obviously, such an essential oil must not oxidize with the hydrogen peroxide-acid mixture acetic. As essential oil, citronella, those derived from rose, mint or thyme, for example, and mixtures thereof.

 The water used is ultra-pure water less than 2 Ms and having a resistivity higher than 108 # / m.

 The stabilizing agent is itself a mixture comprising, in particular, 8-hydroxyquinoline and phosphoric, tartaric, citric, tridodecylamyne, copper and iron acids.

 This stabilizing agent is also a regulator of the pH of the composition: it thus makes it possible to avoid a chain reaction between the hydogen peroxide and the acetic and peracetic acids. The stability thus obtained ensures that the essential oil remains present in the composition without oxidation.

 One of the functions of 8-hydroxyquinoline is to sequester the heavy metals responsible for accelerating the decomposition of peroxides.

 The pH of the composition according to the present invention remains between 4 and 6: the best stability is obtained at a pH as close to 5 as possible.

 The compositions according to the present invention therefore have for general formulation: Hydrogen peroxide A 3% - 5% Hydrogen peroxide B 0.005% - 0.001% Acetic acid <1.5% Peracetic acid <1% Essential oil 0.1% - 1%

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Stabilizing agent:
8-hydroxyquinoline 0.01% - 0.05%
Phosphoric acid 0.001% - 0.01%
Citric acid 0.001% - 0.01%
Tridodecylamyne 0.000001% - 0.00001%
Tartaric acid 0.0001% - 0.0008%
Copper 0.0001% - 0.001%
Iron 0.0003% - 0.003%
Water qs 100%
This composition has been subjected to various tests, the results of which are summarized in Tables III to VIII below: TABLE III
EUROPEAN STANDARD 1040 in 5 minutes NF EN 1040 MINIMUM DISCOUNT 5 Log

<Tb>
<tb> STEPS <SEP> CONCENTRATION
<tb> PSEUDOMONAS <SEP> AERUGINOSA <SEP> 5 <SEP>% <SEP>
<tb> STAPHYLOCOCCUS <SEP> AUREUS <SEP> ATCC <SEP> 6538 <SEP> 10 <SEP>% <SEP>
<Tb>

TABLE IV STANDARD AFNOR NF T 72171 SPECTRUM 4 IN THE PRESENCE OF INTERFERING SUBSTANCES MINIMUM REDUCTION 5 Log

<Tb>
<tb> STEPS <SEP> CONCENTRATION
<tb> PSEUDOMONAS <SEP> AERUGINOSA <SEP> CIP <SEP> A22 <SEP> 25 <SEP>% <SEP>
<tb> STAPHYLOCOCCUS <SEP> AUREUS <SEP> CIP <SEP> 53154 <SEP> 5 <SEP>% <SEP>
<Tb>

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TABLE V EUROPEAN STANDARD NF EN 1275 MINIMUM REDUCTION 4 Log

<Tb>
<tb> STEPS <SEP> CONCENTRATION
<tb> CANDIDA <SEP> ALBICAN <SEP> ATCC <SEP> 10231 <SEP> 2 <SEP>% <SEP>
<tb> ASPERGILLUS <SEP> NIGER <SEP> ATCC <SEP> 16404 <SEP> 80 <SEP>% <SEP>
<Tb>

TABLE VI STANDARD AFNOR NF T 72180 MINIMUM REDUCTION 4 Log IN 15 minutes

<Tb>
<tb> STEPS <SEP> CONCENTRATION
<tb> ENTEROVIRUS <SEP> POLIO <SEP> 1 <SEP> STRAIN <SEP> SABIN <SEP> 90 <SEP>% <SEP>
<tb> ADENOVIRUS <SEP> TYPE <SEP> 5 <SEP> ON <SEP> CELL <SEP> KB <SEP> 90 <SEP>% <SEP>
<tb> ORTHOPOXVIRUS <SEP> DE <SEP><SEP> VACCINE <SEP> 90 <SEP>% <SEP>
<Tb>

TABLE VII STANDARD AFNOR NF T 72180 MINIMUM REDUCTION 4 Log IN 5 minutes

<Tb>
<tb> STEPS <SEP> CONCENTRATION
<tb> ADENOVIRUS <SEP> TYPE <SEP> 5 <SEP> ON <SEP> CELL <SEP> KB <SEP> 90 <SEP>% <SEP>
<Tb>

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TABLE VIII STANDARD AFNOR NF T 72231 MINIMUM DISCOUNT 5 Log

<Tb>
<tb> STEPS <SEP> CONCENTRATION
<tb> BACILLUS <SEP> SUBTILIS <SEP> VAR <SEP> NIGER <SEP> CIP <SEP> 7718 <SEP> 75 <SEP>% <SEP>
<tb> CLOSTRIDIUM <SEP> SPOROGENES <SEP> CIP <SEP> 7939 <SEP> 25 <SEP>% <SEP>
<tb> BACILLUS <SEP> CEREUS <SEP> CIP <SEP> 7803 <SEP> 50 <SEP>% <SEP>
<Tb>

According to these tests, it appears that the composition according to the present invention has an activity on bacteria, spores, viruses, fungi and this in a very short contact time: in fact, always less than 2 minutes. Similarly, this composition is active against biofilms, films of 10 to 20 micrometers maximum thickness produced by the microorganisms themselves, and in particular by those Gram-negative.

 The composition according to the present invention is therefore an oxidizing type disinfectant, comprising no activator, aldehyde, formalin, glycol derivatives, alcohols, or triazole-type stabilizing agents. Such a composition meets the requirements of Ministerial Circular No. 138 of March 2001.

 In addition, such a composition has an open cork shelf life of greater than 2 years: in fact at least 3 years. This is a great advantage because in ophthalmology and more particularly in contactology only small amounts, generally less than 200 ml, are used each time.

 As indicated above, the present invention also relates to a method for preparing such a composition which comprises the following steps (per 1000 L of composition):

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 1) A solution of H 2 O 2 is prepared from hydrogen peroxide type A about 4% or 72 liters.

2) A solution of H2O2 is prepared from hydrogen peroxide type B about 5% or 8 liters.

3) A solution of CH3COOH is prepared from a pure acetic acid mixed with an ultrapure water of less than 2 Ms.

4) A very pure oil is added which must not be oxidized. 5) The solution of H 2 O 2 is added to the tank from the hydrogen peroxide type A copper and the iron content in the proportions of above formulation 6) The amount of 8-hydroxyquinoline is added 7) Precipitation of iron and copper is checked 8) 8 liters of hydrogen peroxide are added to the first tank B 9) The contents are checked in hydrogen peroxide between 4 and 5% with a pH ≤5 10) 10 liters of acetic acid are added between 15 and 20% Il ') The rate of peracetic acid which must be less than 0.15 is checked % preferably 0.143% 12) The vessel comprising the elements is allowed to stand for 4 to 6 hours.

13) Added essential oil to reduce odors and vapors of acetic acid and H2O2.

14) It is verified that the vapors at temperatures above 24 C are below 1 PPM.

15) Ultra-pure water as defined above is added.

16) Let stand for 6 hours at room temperature.

17) An ammonium containing without ethylene glycol is added
0.01% to 1% in order to make the solution more bactericidal and virucidal. 18) The level of peracetic acid will be checked after 48 hours.

 This process is carried out at room temperature.

Claims (7)

1 - disinfectant aqueous composition based on a complex of peracetic acid, hydrogen peroxide and acetic acid, characterized in that it also comprises a stabilizing agent based on 8-hydroxyquinoline.  2 - Composition according to claim 1, characterized in that it comprises less than 1% by volume of peracetic acid.  3 - Composition according to claim 1, characterized in that it comprises from 2 to 6% by volume of hydrogen peroxide.  4 - Composition according to claim 1, characterized in that it comprises from 0.1 to 1% by volume of essential oil.  5 - Composition according to claim 1, characterized in that it comprises at most 2% by volume of the stabilizing agent.  6 - Composition according to claim 1, characterized in that the stabilizing agent is a mixture of 8-hydroxyquinoline, phosphoric acid, tartaric acid, citric acid, tridocylamyne, copper and iron.  7 - Composition according to any one of claims 1 to 6, characterized in that it comprises ultrapure water less than 2 Ms and resistivity greater than 108 # / m.