WO2002072159A1 - Melange gazeux sterilisateur destine a des applications de sterilisation - Google Patents

Melange gazeux sterilisateur destine a des applications de sterilisation Download PDF

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Publication number
WO2002072159A1
WO2002072159A1 PCT/US2001/007671 US0107671W WO02072159A1 WO 2002072159 A1 WO2002072159 A1 WO 2002072159A1 US 0107671 W US0107671 W US 0107671W WO 02072159 A1 WO02072159 A1 WO 02072159A1
Authority
WO
WIPO (PCT)
Prior art keywords
ethylene oxide
sterilization
weight percent
hexafluoropropene
weight
Prior art date
Application number
PCT/US2001/007671
Other languages
English (en)
Inventor
Donald E. Turner
Mark E. Avant
Original Assignee
Turner Donald E
Avant Mark E
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 Turner Donald E, Avant Mark E filed Critical Turner Donald E
Priority to PCT/US2001/007671 priority Critical patent/WO2002072159A1/fr
Publication of WO2002072159A1 publication Critical patent/WO2002072159A1/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
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/206—Ethylene oxide

Definitions

  • the invention is a new compositional formulation of ethylene oxide and hexafluoropropene that may be used as a replacement for the commercial sterilization product generically known as 12/88 (12 percent ethylene oxide and 88 percent dichlorodifluoromethane) which has been used in the medical field for the sterilization of medical instruments and other sterilization applications.
  • 12/88 (12 percent ethylene oxide and 88 percent dichlorodifluoromethane) which has been used in the medical field for the sterilization of medical instruments and other sterilization applications.
  • the 12/88 blend, with dichlorodifluoromethane, or CFC-12, as the primary component is no longer commercially available because of CFC-12's potential depletion of stratospheric ozone. This perceived harmful characteristic has led to the prohibition of CFC- 12 manufacture as agreed to by most nations of the developed world by means of the Montreal Protocol.
  • the present invention is a sterilant blend to replace the 12/88 blend for sterilization equipment which traditionally used this now banned material and to also provide a more effective sterilant than the alternative sterilants subsequently developed for use in sterilization equipment.
  • the present invention exhibits minimal, if any, ozone depleting potential but exhibits an unexpectedly effective sterilization capability when used in medical instrument and other sterilization equipment.
  • Medical instrument sterilization is a critical activity in hospitals, doctor's offices and other diagnostic centers.
  • Various types of medical instruments are used in examination of patients for determining proper medical intervention diagnosis and in intervention treatments. Many of these instruments, such as endoscopes, involve insertion into body cavities or surgical apertures by physicians, to remotely view, photograph or otherwise document internal physical conditions of the patient.
  • the new methods and equipment include: 100% ethylene oxide, ion plasma, vaporized hydrogen peroxide and peracetic acid plasma. Studies have concluded that these alternative agents and equipment often provide between one-third and two-thirds of the sterilization efficacy of the conventional 12/88 sterilant.
  • the combination of efficacy decrease, an increase in the number and severity of infectious diseases and the inclusion of normal operator error and shortened time-cycle sterilizations (due to increased patient loads), has created a dramatically dangerous situation for doctors, hospitals and their patients as well as other sterilization applications.
  • This invention provides safety and efficacy available before the removal of 12/88, and in certain formulations offers more effective agents in both sterilizing capacity as well as a more effective vehicle to carry the ethylene oxide into the instruments.
  • the present invention provides an effective sterilization gas having properties at least equal to ethylene oxide/dichlorodifluoromethane sterilant which is ozone friendly.
  • the present invention provides a nonflammable mixture of ethylene oxide in a range of about 6% by weight to about 22% by weight and hexafluoropropene in a range of about 94% by weight to about 78% by weight, and with some formulations including an inert propellant in a small percentage by weight.
  • Ethylene oxide is an effective and known sterilization agent and is utilized as the sterilization agent for the sterilization gas blend in the present invention.
  • Ethylene oxide has traditionally been used in this role and is recognized as effective when medical instruments are sterilized with gas blends including ethylene oxide.
  • One primary limitation in the use of ethylene oxide is found in its flammability which amount of the ethylene oxide, by weight, that may be safely used in this type of application.
  • the prior effective sterilant known as 12/88 consisted of 12% maximum ethylene oxide with the remainder of the composition being CFC-12 primarily because of the flammability wherein the CFC-12 suppressed the flammability of the ethylene oxide.
  • hexafluoropropene also known as hexafluoropropylene or FC- 1216
  • FC- 1216 hexafluoropropylene
  • Hexafluoropropene also provides a flame suppression contribution to the blend, allowing an effective amount of ethylene oxide sterilant to be utilized in the blend without increasing flammability risk beyond acceptable limits.
  • the discovered miscibility of the ethylene oxide in the hexafluoropropene enables the utilization of lower amounts of ethylene oxide in the mixture with hexafluoropropene in providing a sterilization agent which exhibits an efficacy at least equal to the available replacement blends or methods. Accordingly, since the presence of ethylene oxide in the atmosphere surrounding its use must be limited and monitored, the lesser amounts necessarily used with the present invention make this inventive agent more friendly to the user environment.
  • the increased efficiency of the ethylene oxide in hexafluoropropene provides an additional benefit in the sterilization process of specialized medical instruments with the increased amount of ethylene oxide that we have found that may be mixed with the hexafluoropropene and still retain the nonflammability of the sterilization gas.
  • This feature enables the formulation of an agent which is more effective than 100% ethylene oxide and as or more effective than 12/88, which may be used in a nonflammable mixture providing increased efficacy in sterilizing against more resistant microbes, or, in the alternative, sterilizing instruments which present a greater challenge to get the sterilizing agent into all of the cracks and crevices to ensure a complete exposure of the article or instrument to the sterilizing agent.
  • a novel sterilizing agent blend at least as effective to the currently available replacements or methods for 12/88 may include about 6% by weight percent of ethylene oxide and about 94 percent by weight of hexafluoropropene.
  • By increasing the weight percentage of the ethylene oxide up to about 12 percent by weight of ethylene oxide and reducing the weight percentage of the hexafluoropropene to about 88 percent by weight provides a nonflammable sterilant gas with remarkably increased sterilizing effectiveness, of more than 100% ethylene oxide.
  • the ethylene oxide may be increased up to about 22 % by weight with the remainder being hexafluoropropene alone, or with an included inert propellant.
  • Preferred compositions of the sterilization blend of the present invention are from about 10 to about 16 percent by weight ethylene oxide and from about 90 to about 84 percent by weight of hexafluoropropene.
  • Certain inert propellants may be included in the sterilant blend of the present invention as a secondary carrier gas and/or vapor pressure modifier for the blend.
  • Inert propellants may be used to provide specialty blends for medical equipment or new sterilizing apparatus which may require an adjusted or specific vapor pressure and temperature relationship for efficient operation.
  • the novel combination of the ethylene oxide and hexafluoropropene with inert propellants provides an added advantage and flexibility to the inventive sterilant blend not provided by other sterilants presently known.
  • Suitable propellants include chlorodifluoromethane, trifluoromethane, carbon dioxide, nitrogen and argon.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un gaz de stérilisation destiné à stériliser du matériel tel que des instruments médicaux, qui peut remplacer les agents stérilisants de type oxyde d'éthylène y compris le dichlorodifluorométhane et qui comprend environ 6 à environ 22 % en poids d'oxyde d'éthylène, environ 94 à environ 74 % en poids d'hexafluoropropène et 0 à environ 16 % en poids de chlorodifluorométhane.
PCT/US2001/007671 2001-03-10 2001-03-10 Melange gazeux sterilisateur destine a des applications de sterilisation WO2002072159A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2001/007671 WO2002072159A1 (fr) 2001-03-10 2001-03-10 Melange gazeux sterilisateur destine a des applications de sterilisation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2001/007671 WO2002072159A1 (fr) 2001-03-10 2001-03-10 Melange gazeux sterilisateur destine a des applications de sterilisation

Publications (1)

Publication Number Publication Date
WO2002072159A1 true WO2002072159A1 (fr) 2002-09-19

Family

ID=21742387

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/007671 WO2002072159A1 (fr) 2001-03-10 2001-03-10 Melange gazeux sterilisateur destine a des applications de sterilisation

Country Status (1)

Country Link
WO (1) WO2002072159A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2258404A3 (fr) * 2002-10-25 2014-08-20 Honeywell International Inc. Compositions contenant des oléfines substituées par du fluor
EP2335740A3 (fr) * 2005-06-24 2014-09-24 Honeywell International Inc. Compositions contenant des oléfines substituées de fluorine

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5254309A (en) * 1992-07-21 1993-10-19 E. I. Du Pont De Nemours And Company Sterilant mixture and sterilization method
US5314682A (en) * 1992-09-21 1994-05-24 Great Lakes Chemical Corp. Ozone friendly sterilant mixture
US5342579A (en) * 1990-09-26 1994-08-30 Alliedsignal Inc. Sterilant mixture
US5376333A (en) * 1989-07-28 1994-12-27 Alliedsignal, Inc. Ethylene oxide-carrier gas compositions having improved flammability suppressant characteristics
US5510377A (en) * 1992-04-21 1996-04-23 Hoechst Ag Sterilant gas mixture comprising alkylene oxide and 1,1,1,2,3,3,3-heptafluoropropane
US5976554A (en) * 1992-05-08 1999-11-02 Alliedsignal Inc. Sterilizing gas compositions of ethylene oxide and heptafluoropropane

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5376333A (en) * 1989-07-28 1994-12-27 Alliedsignal, Inc. Ethylene oxide-carrier gas compositions having improved flammability suppressant characteristics
US5342579A (en) * 1990-09-26 1994-08-30 Alliedsignal Inc. Sterilant mixture
US5510377A (en) * 1992-04-21 1996-04-23 Hoechst Ag Sterilant gas mixture comprising alkylene oxide and 1,1,1,2,3,3,3-heptafluoropropane
US5976554A (en) * 1992-05-08 1999-11-02 Alliedsignal Inc. Sterilizing gas compositions of ethylene oxide and heptafluoropropane
US5254309A (en) * 1992-07-21 1993-10-19 E. I. Du Pont De Nemours And Company Sterilant mixture and sterilization method
US5314682A (en) * 1992-09-21 1994-05-24 Great Lakes Chemical Corp. Ozone friendly sterilant mixture

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2258404A3 (fr) * 2002-10-25 2014-08-20 Honeywell International Inc. Compositions contenant des oléfines substituées par du fluor
EP2335740A3 (fr) * 2005-06-24 2014-09-24 Honeywell International Inc. Compositions contenant des oléfines substituées de fluorine

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