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WO1998032334A1 - Decontamination a l'aide de thiocyanate de guanidine - Google Patents

Decontamination a l'aide de thiocyanate de guanidine Download PDF

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Publication number
WO1998032334A1
WO1998032334A1 PCT/US1998/001324 US9801324W WO9832334A1 WO 1998032334 A1 WO1998032334 A1 WO 1998032334A1 US 9801324 W US9801324 W US 9801324W WO 9832334 A1 WO9832334 A1 WO 9832334A1
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WO
WIPO (PCT)
Prior art keywords
die
composition
guanidine
equipment
tiiiocyanate
Prior art date
Application number
PCT/US1998/001324
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English (en)
Inventor
Laura Manuelidis
Original Assignee
Yale University
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 Yale University filed Critical Yale University
Priority to AU59635/98A priority Critical patent/AU5963598A/en
Publication of WO1998032334A1 publication Critical patent/WO1998032334A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • 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
    • A01N47/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid
    • A01N47/40—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides
    • A01N47/48—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides containing —S—C≡N groups

Definitions

  • This invention relates to the decontamination of infectious agents causing Creutzfeidt-Jakob Disease, other transmissible encephalopathies, and die like, using guanidium compounds such as guanidine thiocyanate.
  • Creutzfeldt-Jakob Disease is a rare but devastating nerurode- generative disease. Although caused by a transmissible agent, clinical symptoms may not become apparent for as long as 30 years after infection. Because white blood cells carry die infectious agent, the possibility ⁇ iat this disease could be transmitted through routine medical and surgical procedures was considered (1). Over the past 10 years England has witnessed an explosive epidemic infection of cows with a similar agent that induces bovine spongiform encephalopathy (BSE). The BSE agent probably originated in processed feed contaminated with the sheep scrapie agent (2) but it is biologically distinct from common scrapie agent strains in sheep (3).
  • tiiree memods have been used to reduce instru- ment contamination and mese generally reduce titer by > 3 logs. They are i) exposure to household bleach (a procedure diat can corrode many fine instruments, mechanical parts and stainless steel); ⁇ ) prolonged autoclaving (a method not feasible for many large instruments or surfaces); and iii) immersion in concentrated alkaline solutions, i.e., 0.1-1M NaOH. The latter solutions are corrosive not only to instruments and surfaces, but also cause severe skin burns.
  • me present invention provides a metiiod for decontaminating a substrate such as medical or veterinary equipment, tissue, or tissue products to remove infectious agents by contacting the substrate witii an effective amount of a guanidium compound such as guanidine thiocyanate.
  • medical or veterinary equipment such as surgical or dental instruments are decontaminated by immersing or wetting the equipment in a composition containing a guanidium compound, or by wiping d e surfaces of the equipment wim a material embedded or coated with a guanidium compound composition.
  • a composition containing a guanidium compound or by wiping d e surfaces of the equipment wim a material embedded or coated with a guanidium compound composition.
  • One embodiment employs solutions containing at least about 3 M guanidine thiocyanate.
  • potentially infective tissue or tissue products are decontaminated by contacting diem with a composition containing from about 0.5 to about 3.5 M guanidium compound.
  • Methods of die invention may include other steps such as sonication and/or heating (including autoclaving) and/or soaking articles in die presence of a guanidium compound, as well as otiier steps incorporating otiier mediods of disinfection and cleaning such as treatment wim chlorine dioxide and otiier germ- killing compositions.
  • Guanidine tiiiocyanate, guanidine hydrochloride, and the like guanidium compound compositions used in die practice of die invention may contain other ingredients such as detergents, wetting agents, stabilizers and die like in the formulations.
  • this invention provides a method for decontaminating a substrate to remove infectious agents by contacting d e substrate with an effec- tive amount of a guanidium compound.
  • Substrates include any type of surface or carrier which could provide a locus for me accumulation of viruses, bacteria, fungi, spores and the like disease-causing microorganisms and pathogens.
  • Typical substrates include, but are not limited to, medical and veterinary equipment, especially hardware such as surgical and dental instruments, as well as potentially infective tissue and tissue products.
  • a substrate to be decontaminated is contacted with an effective amount of a guanidium compound (herein occasionally referred to as Gdn).
  • Guanidium compounds include guanidine hydrochloride, guanidine thiocyanate, related compounds, including guanidium-containing compounds and derivatives, and mixmres thereof.
  • guanidine tiiiocyanate is meant guanidine tiiiocyanate (GdnSCN), active derivatives of guanidine tiiiocyanate, guanidine isothiocyanate, active derivatives of guanidine isothiocyanate, and mixtures thereof.
  • guanidine hydrochloride is meant guanidine hydrochloride (GdnHCl), active derivatives of guanidine hydrochloride, and mixtures thereof.
  • d e substrate is contacted with a composition containing GdnSCN; liquid compositions are particularly preferred.
  • Liquid compositions of the invention include any type diat will dissolve, suspend, or otherwise disperse die active ingredient such as solutions, suspensions, gels, and die like.
  • Aqueous GdnSCN, GdnHCl, or GdnSCN/GdnHCl solutions are employed in many embodiments. Though lower concentrations may be employed where substrates are soaked in guanidium compositions for extended periods, typical concentrations range between about 2.5 and 6 M.
  • compositions containing at least about 2.5 M, preferably greater tiian 3.8 M, GdnSCN are useful for certain applications.
  • tissue or tissue products including blood, blood products (including serum proteins), and organs involved in transplants
  • lower concentrations i.e., from about 0.5 M to about 3 M
  • potentially transmissible agents are removed prior to extraction of medically active compounds by contact with guanidium solutions. The decontamination solution is then removed from die tissue.
  • compositions useful in the memods of d e invention may contain other ingredients in die formulation, preferably those diat are inert in the sense of not bringing about a significant deactivation of die active ingredient.
  • these include other disinfectants or detergents that have disinfectant properties that augment the active ingredient of the invention; stabilizers diat prolong die shelf-life of prod- ucts containing GdnHCl and/or GdnSCN; wetting agents and detergents that enhance or assist application and/or penetration, and/or hold active ingredient in contact wim die substrate; and die like.
  • a GdnSCN composition containing sarkosyl was employed.
  • the substrate is typically contacted wim GdnSCN and/or GdnHCl for such time under such conditions to effect decontamination of the surface.
  • a statistically significant decrease in viral, bacterial, and/or fungal titer, preferably by __ 3 logs, from e uwiecontaminated substrate is observed.
  • animal assays are employed to assess die extent of decontamination.
  • the substrate may be immersed in or wet with die GdnSCN or other guanidium composition, or wiped with a material embedded or coated with a GdnSCN or otiier guanidium composition.
  • Mediods of die invention employing GdnSCN and/or GdnHCl may be combined with otiier methods of sterilization, cleansing, and sanitizing.
  • some embodiments, particularly tiiose involving die disinfection and sterilization of surgical and dental instruments may involve a sonication and/or at least one heating step. Heating to at least about 55 * C, and in some cases to at least about 75'C, is preferred.
  • Instruments may be autoclaved in the presence (if in accord with E.P.A. requirements) or absence of GdnSCN and/or GdnHCl before or after contact witii it.
  • instruments immersed in a GdnSCN composition are autoclaved to achieve effective decontamination of particularly recalcitrant and/or dangerous patiiogens.
  • Medical or veterinary hardware may be sonicated before or after treatment with GdnSCN, or sonicated in its presence such as in an ultrasonic cleaning apparatus; this is particularly advantageous where tiiere is tissue adhering to the equipment or where vigorous washing is not possible. Washing and other disinfectants such as treatment with Clorox ® or chlorine dioxide, hydrogen peroxide, base, acid, and the like may be used in conjunction with GdnSCN and/or GdnHCl use.
  • tiiat GdnSCN and/or GdnHCl is/are particularly efficacious for removal of infectious agents causing Creutzfeldt-Jakob Disease and otiier transmissible encephalopathies from a substrate, as well as other resistant pathogens such as hepatitis B. They are also likely to be effective for other resistant pathogens.
  • die invention provides for extraction or separation of medically relevant biological material free of transmissible agents.
  • RNA lysis buffer #40082, Perkin Elmer RNA lysis buffer #40082, Perkin Elmer
  • This solution has a similar composition as die one we use to efficiently extract nucleic acids from more purified CJD preparations (12). It conveniently contains a detergent tiiat can aid in tissue penetration and disruption, and also has a reasonable shelf life of > 1 year. Moreover, tiiis solution can be easily modified to further enhance decontamination. Moderate heat treatment was also tested to find if agent inactivation could be augmented. The temperatures tested are easily achieved with old instrument sterilizers in dentists offices.
  • Brain tissue from a long established CJD hamster model (serial passage 31, strain SY) was chosen because it yields reproducible titers.
  • the very high lipid composition and complexity of brain can compromise inactivating procedures and therefore whole brain was chosen as a difficult inactivation target.
  • Experimental groups of six hamsters each were injected with: 1) CJD homogenates in saline without inactivation, 2) CJD saline homogenates treated at 75 'C for 25 min, 3) CJD homogenates lysed in GdnSCN and 4) CJD GdnSCN homogenates treated at 75 'C for 25 min.
  • each half of a CJD infected brain was directly homogenized in either normal saline or GdnSCN lysis buffer (10% w/v).
  • a 100- ml aliquot of each respective homogenate was heated in a 1.5 ml polypropylene tube in a PCR machine while die parallel homogenates were kept at 22 * C.
  • Each of the four homogenates were then diluted to 0.5 mg brain/ml and 50 ml was inoculated intracerbrally per hamster (11).
  • the outlined protocol is also based on the inability to find any reconsti- tution of CJD infectivity when more purified infectious preparations were treated with less concentrated and disruptive GdnHCl solutions (11). After dilution of GdnHCl, the reduction in titer remained. Thus washing trace GdnSCN should have few risks.
  • anotiier laboratory reported diat PrP rapidly refolded into an "infectious conformation" as assessed by gel assays. However, tiiere was no data showing infectious titer was restored (16).
  • Similar refolding experiments have been irreproducible, with PrP conversion ascribed to an artifact of incompletely denatured aggregates (17). Older studies have likewise shown reductions in scrapie titer widi otiier Gdn solutions, but the application of such treatments for decontaminating instruments and surfaces have not been previously considered.
  • Each of the four homogenates were then diluted to 0.5 mg brain/ml and 50 ⁇ l was inoculated intracerebrally per hamster (11).
  • the large dilution was calculated 1) to preclude any toxic effects of GdnSCN, 2) to yield incubation time titers in die linear range for saline homogenates (20) and 3) to approximate end-point LD50 dete ⁇ ninations for GdnSCN samples.
  • Titer calculations are based on die conservative estimate diat 1 infectious unit (IU) will produce clinical signs at 294 days, and tiius end-point determinations at 600 days yield a fraction of 1 IU, e. ., 1 of 5 animals with disease at 600 days is equivalent to 0.2 IU in the inoculum.
  • IU diat 1 infectious unit
  • the invention was made with partial support from Grants NS 12674 and NS34569 from die National Institote of Healdi. The government has certain rights in the invention.
  • Prusiner, SB Molecular biology of prion diseases. Science 1991; 252: 1515- 1522.
  • Dron, M and Manuelidis, L Visualization of viral candidate cDNAs in infectious brain fractions from Creutzfeldt-Jakob Disease by representational difference analysis. /. Neurovirol. 1996; 2: 240-248.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Environmental Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • Pest Control & Pesticides (AREA)
  • Agronomy & Crop Science (AREA)
  • Zoology (AREA)
  • Plant Pathology (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

Un procédé de décontamination d'un substrat tel que les équipements des tissus médicaux ou vétérinaires, afin d'éliminer les agents infectieux, consiste à mettre en contact le substrat avec une quantité efficace d'un composé de guanidium tel que le thiocyanate de guanidine. Les équipements tels que des instruments chirurgicaux ou dentaires sont décontaminés par immersion ou mouillage avec une composition à base du composé de guanidium, ou par nettoyage des surfaces avec une matière imbibée ou enrobée d'une composition à base du composé de guanidium. Des tissus et des produits à base de tissus potentiellement infectieux sont généralement décontaminés par application directe qu'une composition à base du composé de guanidium sur la matière biologique. A titre d'exemple, un mode de réalisation fait appel à des solutions contenant au moins environ 3 M de thiocyanate de guanidine. Des compositions utiles pour mettre en oeuvre l'invention peuvent contenir des ingrédients tels que des détergents ou autres agents de mouillage, stabilisateurs et autres. Dans d'autres modes de réalisation, des procédés de décontamination de l'invention comprennent d'autres étapes telles que chauffage, sonification et imbibition afin d'améliorer l'effet désinfectant.
PCT/US1998/001324 1997-01-27 1998-01-22 Decontamination a l'aide de thiocyanate de guanidine WO1998032334A1 (fr)

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AU59635/98A AU5963598A (en) 1997-01-27 1998-01-22 Decontamination using guanidine thiocyanate

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US60/035,686 1997-01-27

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000048003A1 (fr) * 1999-02-11 2000-08-17 Id-Lelystad, Instituut Voor Dierhouderij En Diergezondheid B.V. Test du prion
US6419916B1 (en) 1999-06-01 2002-07-16 The Regents Of The University Of California Assay for compounds which affect conformationally altered proteins
WO2002069958A1 (fr) * 2001-03-01 2002-09-12 Wolfgang Weuffen Ions thiocyanate destines a la prevention et a la therapie de l'esb et de maladies similaires chez l'animal et chez l'homme
US6517855B2 (en) 1999-06-01 2003-02-11 The Regents Of The University Of California Method of sterilizing
US6720355B2 (en) 1997-02-21 2004-04-13 The Regents Of The University Of California Sodium dodecyl sulfate compositions for inactivating prions
US6719988B2 (en) 1997-02-21 2004-04-13 The Regents Of The University Of California Antiseptic compositions for inactivating prions
WO2004093552A1 (fr) 2003-04-24 2004-11-04 Banss Schlacht- und Fördertechnik GmbH Tunnel d'echaudage a condensation pour animaux de boucherie

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4537746A (en) * 1983-12-29 1985-08-27 Bausch & Lomb Incorporated Methods for disinfecting and preserving contact lenses
US5000867A (en) * 1986-10-20 1991-03-19 Lever Brothers Company Disinfectant compositions

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4537746A (en) * 1983-12-29 1985-08-27 Bausch & Lomb Incorporated Methods for disinfecting and preserving contact lenses
US5000867A (en) * 1986-10-20 1991-03-19 Lever Brothers Company Disinfectant compositions

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
MANUELIDIS L., ET AL.: "VIRAL PARTICLES ARE REQUIRED FOR INFECTION IN NEURODEGENERATIVE CREUTZFELDT-JAKOB DISEASE.", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, NATIONAL ACADEMY OF SCIENCES, US, vol. 92., 1 May 1995 (1995-05-01), US, pages 5124 - 5128., XP002912148, ISSN: 0027-8424, DOI: 10.1073/pnas.92.11.5124 *
OKEN R. J.: "LETTER TO THE EDITOR. TO THE EDITOR:.", JOURNAL OF DENTAL RESEARCH, INTERNATIONAL ASSOCIATION FOR DENTAL RESEARCH, US, vol. 74., 1 January 1995 (1995-01-01), US, pages 1836., XP002912147, ISSN: 0022-0345 *

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6720355B2 (en) 1997-02-21 2004-04-13 The Regents Of The University Of California Sodium dodecyl sulfate compositions for inactivating prions
US6719988B2 (en) 1997-02-21 2004-04-13 The Regents Of The University Of California Antiseptic compositions for inactivating prions
US7226609B2 (en) 1997-02-21 2007-06-05 The Regents Of The University Of California Sodium dodecyl sulfate compositions for inactivating prions
US7307103B2 (en) 1997-02-21 2007-12-11 The Regents Of The University Of California Sodium dodecyl sulfate compositions for inactivating prions
WO2000048003A1 (fr) * 1999-02-11 2000-08-17 Id-Lelystad, Instituut Voor Dierhouderij En Diergezondheid B.V. Test du prion
US7344842B1 (en) 1999-02-11 2008-03-18 Id-Lelystad, Instituut Voor Dierhouderij En Diergezondheid Prion test
US7566543B2 (en) 1999-02-11 2009-07-28 Id-Lelystad, Instituut Voor Dierhouderij En Diergezonheid B.V. Prion test
US6419916B1 (en) 1999-06-01 2002-07-16 The Regents Of The University Of California Assay for compounds which affect conformationally altered proteins
US6517855B2 (en) 1999-06-01 2003-02-11 The Regents Of The University Of California Method of sterilizing
WO2002069958A1 (fr) * 2001-03-01 2002-09-12 Wolfgang Weuffen Ions thiocyanate destines a la prevention et a la therapie de l'esb et de maladies similaires chez l'animal et chez l'homme
WO2004093552A1 (fr) 2003-04-24 2004-11-04 Banss Schlacht- und Fördertechnik GmbH Tunnel d'echaudage a condensation pour animaux de boucherie

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Publication number Publication date
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