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WO2024252035A1 - Composition désinfectante et sporicide qui contient une faible concentration de glutaraldhéhyde pour le nettoyage et la désinfection de matériel d'usage médical, vétérinaire ou industriel - Google Patents

Composition désinfectante et sporicide qui contient une faible concentration de glutaraldhéhyde pour le nettoyage et la désinfection de matériel d'usage médical, vétérinaire ou industriel Download PDF

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Publication number
WO2024252035A1
WO2024252035A1 PCT/ES2023/070377 ES2023070377W WO2024252035A1 WO 2024252035 A1 WO2024252035 A1 WO 2024252035A1 ES 2023070377 W ES2023070377 W ES 2023070377W WO 2024252035 A1 WO2024252035 A1 WO 2024252035A1
Authority
WO
WIPO (PCT)
Prior art keywords
concentration
disinfectant
glutaraldehyde
sporicidal
composition according
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.)
Pending
Application number
PCT/ES2023/070377
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English (en)
Spanish (es)
Inventor
Rafael Herruzo Cabrera
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.)
Medivican SL
Original Assignee
Medivican SL
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 Medivican SL filed Critical Medivican SL
Priority to PCT/ES2023/070377 priority Critical patent/WO2024252035A1/fr
Priority to PCT/EP2024/065658 priority patent/WO2024251907A1/fr
Publication of WO2024252035A1 publication Critical patent/WO2024252035A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N31/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic oxygen or sulfur compounds
    • A01N31/02—Acyclic compounds
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
    • A01N25/02—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests containing liquids as carriers, diluents or solvents
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N35/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having two bonds to hetero atoms with at the most one bond to halogen, e.g. aldehyde radical
    • A01N35/02—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having two bonds to hetero atoms with at the most one bond to halogen, e.g. aldehyde radical containing aliphatically bound aldehyde or keto groups, or thio analogues thereof; Derivatives thereof, e.g. acetals
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01P—BIOCIDAL, PEST REPELLANT, PEST ATTRACTANT OR PLANT GROWTH REGULATORY ACTIVITY OF CHEMICAL COMPOUNDS OR PREPARATIONS
    • A01P1/00—Disinfectants; Antimicrobial compounds or mixtures thereof

Definitions

  • Disinfectant and sporicidal composition containing a low concentration of glutaraldehyde for cleaning and disinfecting material for medical, veterinary or industrial use.
  • the present invention relates to a disinfectant and sporicidal composition containing a low concentration of glutaraldehyde, which is useful for cleaning and disinfecting materials used in medical, veterinary or industrial environments, including the food industry.
  • the composition of the present invention is highly effective in eliminating a wide range of bacteria, viruses, fungi and spores.
  • HLD high-level disinfectant
  • this composition due to its high concentration of glutaraldehyde, was toxic or a respiratory irritant, since at 2% it produces vapours that require forced ventilation to prevent their accumulation, which is not always the case in rooms where instrument disinfection is carried out.
  • this composition is not aggressive on hospital material, but if it contained traces of organic matter, it fixed it to the substrate and, on the one hand, altered the instrument and, on the other, caused a reduction in the diameter of narrow lumens, to the point of requiring repair of the fomite.
  • US3968250 describes aqueous sporicidal and disinfectant compositions comprising glutaraldehyde in a concentration of from 0.02% to 5%, an alcohol, a sodium bicarbonate buffer and a nonionic or anionic surfactant which is an ethoxylate of linear isomeric alcohols in a concentration between 0.01% and 1%.
  • These compositions are used in conjunction with ultrasonic irradiation over a wide range of frequencies (10 to 850 kHz). The latter greatly complicates and reduces its use in various settings, whether hospital or not, and does not eliminate the toxicity of glutaraldehyde, since in the examples it is preferably used at concentrations greater than 1%, typically 2%.
  • Document CN111955488A describes aqueous disinfectant compositions comprising 0.1 to 1.5% glutaraldehyde, isopropanol, a salt such as sodium nitrite, isopropyl alcohol and the surfactants dodecyl-dimethyl-benzyl-ammonium chloride and didecyl-dimethyl-ammonium chloride (chlorinated quaternary ammonium compounds).
  • This document discloses that this composition is of low toxicity both for humans and for the environment and that it does not corrode materials such as aluminum, stainless steel and carbon steel.
  • the inventor of the present invention has found that, with the compositions of the invention, it is possible to achieve a sporicidal DAN in very short times, of the order of 10-15 minutes at a concentration of glutaraldehyde of only 0.25%.
  • activators that have demonstrated a synergistic effect with glutaraldehyde are used in combination with glutaraldehyde at a very low concentration.
  • the effectiveness of the compositions of the invention against mycobacteria and other more sensitive (hospital) bacteria, which are found on germ carriers with a rough surface (endodontic files), has been proven. It is completely effective in 10 minutes and is not aggressive on metal or after 7 days of immersion.
  • the disinfectant and sporicidal composition of the present invention comprises glutaraldehyde, water, a low concentration alcohol and at least one surfactant.
  • Glutaraldehyde is present in a concentration range of 0.1% to 1% w/v, more preferably 0.1% to 0.5% w/v, and even more preferably about 0.25% w/v.
  • the surfactant is a non-chlorinated cationic quaternary ammonium surfactant, and is present in a concentration range, in use, of 0.1% to 5%, more preferably 1 to 3%.
  • Water is used as a diluent, and is present in sufficient quantity to reach 100% vol.
  • the invention is directed to a disinfectant and sporicidal composition comprising:
  • non-chlorinated cationic quaternary ammonium surfactant selected from didecyl methyl polyoxyethyl ammonium propionate in a concentration, in use, of 0.1-5% v/v, or tetradecyl trimethyl ammonium bromide in a concentration, in use, of 0.1-5% w/v.
  • the invention is directed to a method for cleaning and disinfecting materials for medical or veterinary use using the above composition, comprising diluting the composition with water to the desired concentration, applying the diluted composition to the surface and/or passages of the material to be disinfected, leaving the composition on the surface for a predetermined time, rinsing the material with water, and drying the material.
  • the invention is directed to the use of the above-mentioned composition in the high-level disinfection of medical or veterinary instruments or in the medium/low-level disinfection of surfaces or medical or veterinary instruments or even in the food industry.
  • the invention is directed to a kit for the in situ reconstitution of the disinfectant and/or sporicidal composition, indicated above, in which the glutaraldehyde is in a first container, the alcohol and the surfactant in a second container, and the (at least one) salt, in a third container.
  • a is n-propanol, 6 ml per 100 ml (%v/v),
  • T8 is tetranil T80 (coco-alkyl-dimethyl-benzyl-ammonium chloride), 1% v/v,
  • B is Bardap 26 (didecyl-methyl-polyoxy-ethyl-ammonium propionate), 1% v/v,
  • T is Tetradecyl-trimethyl ammonium bromide, 0.125% w/v,
  • Q is alkylpropylenediamine-guanidinoacetate, 1% v/v,
  • E is Emal 40 (triethanolamine lauryl sulfate), 2% v/v,
  • D is dodecyl sulfate, 0.1% w/v
  • the function of the "s" component is to make glutaraldehyde alkaline in a stable manner.
  • Experimental tests carried out by the inventor have shown that, with the double salt sodium bicarbonate + potassium carbonate, the result is better and the pH is more stable than sodium bicarbonate alone.
  • component "a” (alcohol)
  • its main function is as a diluent of the accompanying surfactant, so that it dissolves better in the water of the final composition.
  • the alcohols that give the best results are the 3-carbon alcohols, such as isopropyl and n-propyl alcohol.
  • the first step is to assess the sporicidal effect on commercial spores (3M) and then determine its bactericidal effect on material with a rough surface (endodontic files) or smooth surface (glass) to check its effectiveness on mycobacteria and other more sensitive bacteria. Its aggressiveness on the scalpel with human blood at different times is also studied. All these techniques are described in various works by doctors Herruzo, Vizca ⁇ no and cois, between 1999-2004.
  • Figures 1 and 2 show the difference in efficacy between classical glutaraldehyde (2% alkaline glutaraldehyde) and solutions with a lower concentration of aldehyde that have been activated, in this case, with the activator s+T+a, which we will call Activatorl (Actil) from now on.
  • the tests in Figure 1 show that a sporicidal action can be achieved in 5 minutes with 1% glutaraldehyde (G+1%), or in 15 minutes if only 0.25% is used (G+0.25%).
  • the sporicidal effect is expressed as a logarithmic reduction of B. atrophaeus spores in 15 minutes and the bactericidal effect (on rough germ carriers) as a logarithmic reduction of M. fortuitum in 10 minutes and of P. aeruginosa in 5 minutes.
  • Figures 3 and 4 show that activators alone (Actil or Act ⁇ 2) or glutaraldehyde without activators (Gluta 0.25%) barely produce a quantifiable microbicidal effect, while synergistic combinations (Gluta 0.25%+Actil or Gluta 0.25%+Act ⁇ 2) manage to destroy more than 5 logios (both spores, in 15 min, and mycobacteria, in 10 min). This maximum efficacy occurs even at the low concentration of glutaraldehyde, which is very useful to avoid its toxicity.
  • the first version of the activator (Gluta 0.25% + Actil) would be left with the indication of 15 min and the second (Gluta 0.25% + Act ⁇ 2) could be reduced to only 10 minutes.
  • Figure 5 summarizes the sporicidal efficacy of the various components of the liquid activator (Acti2), i.e. components "a", “B” and “s” in a manner independently each one of them together with 0.25% glutaraldehyde, (columns Gluta 0.25%+Acti-a, Gluta 0.25%+Acti-B and Gluta 0.25%+Acti-s for 0.25% glutaraldehyde together with each of the components, a, B and s respectively), or these 3 components of the Act ⁇ 2 activator together, but without glutaraldehyde (column Activ a+B+s), to compare them with the combination of glutaraldehyde and the sum of the 3 components of this Act ⁇ 2 activator (column Gluta 0.25%+Acti a+B+s), showing the synergistic effect achieved with this combination of 0.25% glutaraldehyde and the Act ⁇ 2 activator.
  • Acti2 liquid activator
  • the disinfectant and sporicidal composition of the present invention can be used for high-level cleaning and disinfection of materials used in medical or veterinary environments, including but not limited to, surgical instruments, medical devices, hospital equipment, veterinary equipment and laboratory equipment, since the composition is effective in killing a wide range of microorganisms, even those that are resistant to other disinfectants, including bacteria, viruses, fungi and spores.
  • the composition may also contain other ingredients, such as other surfactants, chelating agents and pH adjusters, to enhance its cleaning and disinfecting properties.
  • the composition may be prepared in liquid, aerosol or foam form.
  • the composition can be obtained at a higher concentration, although by diluting it with water to the desired concentration, depending on the application.
  • the diluted composition can be applied to the surface of the material as a medium-level disinfectant and left for 30 min to allow the elimination of any type of microorganisms.
  • the material can be rinsed with water and dried.
  • composition can also be used as a dipping solution (of surfaces or internal passages of instruments), where the material is soaked in the solution for a specific period of time before being removed and allowed to dry.
  • the composition of the present invention offers several advantages over existing disinfectants and sporicidal compositions.
  • the low concentration of glutaraldehyde used in the composition reduces the risk of toxicity and skin or airway irritation to personnel handling it, making it safer for use by medical and veterinary professionals. But despite that dilution, the composition is also highly effective at killing a wide range of microorganisms, including those that are resistant to other disinfectants, making it an ideal choice for use in medical, veterinary and industrial facilities.
  • the surfactant used in the composition helps to improve the wetting and penetration of the solution into the material, thus increasing its effectiveness in killing microorganisms.
  • the disinfectant and sporicidal composition of the present invention provides an effective and safe means of cleaning and disinfecting materials used in medical or veterinary environments or even in the food industry.
  • the composition can be used as a dipping solution.
  • the present invention is not limited to the specific embodiments described above, and can be modified and adapted in various ways by those skilled in the art without departing from the scope of the appended claims.

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  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Health & Medical Sciences (AREA)
  • Environmental Sciences (AREA)
  • Plant Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Pest Control & Pesticides (AREA)
  • Agronomy & Crop Science (AREA)
  • Dentistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Toxicology (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

Composition désinfectante et sporicide qui contient une faible concentration de glutaraldéhyde pour le nettoyage et la désinfection de matériel d'usage médical, vétérinaire ou industriel en peu de temps.
PCT/ES2023/070377 2023-06-06 2023-06-06 Composition désinfectante et sporicide qui contient une faible concentration de glutaraldhéhyde pour le nettoyage et la désinfection de matériel d'usage médical, vétérinaire ou industriel Pending WO2024252035A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/ES2023/070377 WO2024252035A1 (fr) 2023-06-06 2023-06-06 Composition désinfectante et sporicide qui contient une faible concentration de glutaraldhéhyde pour le nettoyage et la désinfection de matériel d'usage médical, vétérinaire ou industriel
PCT/EP2024/065658 WO2024251907A1 (fr) 2023-06-06 2024-06-06 Composition désinfectante et sporicide contenant une faible concentration de glutaraldéhyde pour le nettoyage et la désinfection de matériel médical, vétérinaire ou industriel

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/ES2023/070377 WO2024252035A1 (fr) 2023-06-06 2023-06-06 Composition désinfectante et sporicide qui contient une faible concentration de glutaraldhéhyde pour le nettoyage et la désinfection de matériel d'usage médical, vétérinaire ou industriel

Publications (1)

Publication Number Publication Date
WO2024252035A1 true WO2024252035A1 (fr) 2024-12-12

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PCT/ES2023/070377 Pending WO2024252035A1 (fr) 2023-06-06 2023-06-06 Composition désinfectante et sporicide qui contient une faible concentration de glutaraldhéhyde pour le nettoyage et la désinfection de matériel d'usage médical, vétérinaire ou industriel
PCT/EP2024/065658 Pending WO2024251907A1 (fr) 2023-06-06 2024-06-06 Composition désinfectante et sporicide contenant une faible concentration de glutaraldéhyde pour le nettoyage et la désinfection de matériel médical, vétérinaire ou industriel

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Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3968250A (en) 1971-06-21 1976-07-06 Wave Energy Systems, Inc. Method and sporicidal compositions for synergistic disinfection or sterilization
US5863547A (en) 1997-02-25 1999-01-26 Healthpoint, Ltd. Glutaraldehyde plus alcohol product
CN101579330A (zh) 2009-06-25 2009-11-18 中国农业大学 兽用消毒剂及其制备方法
RU2395962C1 (ru) * 2009-03-18 2010-08-10 Федеральное государственное учреждение "48 Центральный научно-исследовательский институт Министерства обороны Российской Федерации" Дезинфицирующее средство
CN105394034A (zh) 2015-11-30 2016-03-16 湖北微控生物科技有限公司 内镜器械消毒液及其生产工艺
CN106804620A (zh) * 2016-11-30 2017-06-09 河池市技术开发中心 一种含季铵盐的蚕具消毒液
CN107509740A (zh) * 2017-08-16 2017-12-26 黑龙江省兽医科学研究所 一种阳离子表面活性剂复合消毒剂
CN111096322A (zh) * 2019-12-31 2020-05-05 内蒙古农业大学 一种适于低温使用的戊二醛癸甲溴铵复合消毒剂
CN111955488A (zh) 2020-07-21 2020-11-20 厦门宝沃美生物科技有限公司 一种可用于医疗机构废弃物的消毒剂及制备方法
CN115530166A (zh) * 2022-10-12 2022-12-30 湖南湘农动物药业有限公司 一种含戊二醛和癸甲溴铵的复合型兽用消毒剂及制备方法

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3968250A (en) 1971-06-21 1976-07-06 Wave Energy Systems, Inc. Method and sporicidal compositions for synergistic disinfection or sterilization
US5863547A (en) 1997-02-25 1999-01-26 Healthpoint, Ltd. Glutaraldehyde plus alcohol product
RU2395962C1 (ru) * 2009-03-18 2010-08-10 Федеральное государственное учреждение "48 Центральный научно-исследовательский институт Министерства обороны Российской Федерации" Дезинфицирующее средство
CN101579330A (zh) 2009-06-25 2009-11-18 中国农业大学 兽用消毒剂及其制备方法
CN105394034A (zh) 2015-11-30 2016-03-16 湖北微控生物科技有限公司 内镜器械消毒液及其生产工艺
CN106804620A (zh) * 2016-11-30 2017-06-09 河池市技术开发中心 一种含季铵盐的蚕具消毒液
CN107509740A (zh) * 2017-08-16 2017-12-26 黑龙江省兽医科学研究所 一种阳离子表面活性剂复合消毒剂
CN111096322A (zh) * 2019-12-31 2020-05-05 内蒙古农业大学 一种适于低温使用的戊二醛癸甲溴铵复合消毒剂
CN111955488A (zh) 2020-07-21 2020-11-20 厦门宝沃美生物科技有限公司 一种可用于医疗机构废弃物的消毒剂及制备方法
CN115530166A (zh) * 2022-10-12 2022-12-30 湖南湘农动物药业有限公司 一种含戊二醛和癸甲溴铵的复合型兽用消毒剂及制备方法

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