CA2357838A1 - A method of sterilizing an article and certifying the article as sterile - Google Patents

A method of sterilizing an article and certifying the article as sterile Download PDF

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Publication number
CA2357838A1
CA2357838A1 CA002357838A CA2357838A CA2357838A1 CA 2357838 A1 CA2357838 A1 CA 2357838A1 CA 002357838 A CA002357838 A CA 002357838A CA 2357838 A CA2357838 A CA 2357838A CA 2357838 A1 CA2357838 A1 CA 2357838A1
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CA
Canada
Prior art keywords
hydrogen peroxide
water
sterilizer
ratio
vapor
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.)
Granted
Application number
CA002357838A
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French (fr)
Other versions
CA2357838C (en
Inventor
Paul Jacobs
Szu-Min Lin
Jenn-Hann Wang
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Ethicon Inc
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Individual
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Application filed by Individual filed Critical Individual
Publication of CA2357838A1 publication Critical patent/CA2357838A1/en
Application granted granted Critical
Publication of CA2357838C publication Critical patent/CA2357838C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61L2/208—Hydrogen peroxide
    • 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
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/14—Plasma, i.e. ionised gases
    • 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
    • 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
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/122—Chambers for sterilisation
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

The present invention relates to a process for sterilization of medical instruments by concentrating a sterilant such as hydrogen peroxide inside of a sterilizer and sterilizing articles therewith. This concentrating process is monitored by determining the concentrations of water and peroxide in the chamber.

Claims (20)

1. A method of sterilizing, and certifying as sterile, an article by furnishing concentrated hydrogen peroxide vapor to said article, the method comprising the steps of:
a) placing the article into a sterilizer;
b) introducing hydrogen peroxide and water into the sterilizer c) vaporizing said hydrogen peroxide and water to form a vapor comprising hydrogen peroxide and water;
d) determining the concentration of hydrogen peroxide in the vapor;
e) determining the concentration of water in the vapor;
f) selectively drawing water vapor from the sterilizer to increase the ratio of hydrogen peroxide to water in the sterilizer;
g) repeating steps c) - f) until the ratio of hydrogen peroxide to water is at a desired level; and h) furnishing the vaporized hydrogen peroxide to the article for a sufficient time to effect sterilization thereof and then certifying the sterility of said article based upon achieving said desired level.
2. A method according to claim 1 wherein the desired level is chosen from the group consisting of:
i) attaining a ratio of hydrogen peroxide to water of at least 0.1 to 1 by weight, ii) attaining a ratio of hydrogen peroxide to water in the vapor which is at least two times higher than the ratio of hydrogen peroxide to water which is introduced into the sterilizer in step b), iii) attaining a concentration of hydrogen peroxide and water of at least 60%
by weight of hydrogen peroxide, and iv) attaining a hydrogen peroxide concentration of at least 0.45 mg/L.
3. A method according to claim 1 wherein said sterilizer is a diffusion-restricted area.
4. A method according to claim 1 wherein said sterilizer comprises a chamber and an enclosure, said enclosure is in fluid communication with the chamber and wherein the step of introducing hydrogen peroxide and water into the sterilizer comprises introducing the hydrogen peroxide and water into the enclosure.
5. A method according to claim 4 wherein said enclosure is a diffusion-restricted area.
6. A method according to claim 1 wherein the ratio of hydrogen peroxide to water introduced into the sterilizer is less than 0.1 to 1 by weight.
7. A method according to claim 1 and further comprising the step of evacuating the sterilizer to a pressure below the atmospheric pressure.
8. A method according to claim 7 wherein the sterilizer is evacuated to a pressure below the vapor pressure of the hydrogen peroxide and water in solution.
9. A method according to claim 1 wherein after the ratio of hydrogen peroxide to water is at said desired level a portion of the hydrogen peroxide is in liquid form and further comprising the step vaporizing said hydrogen peroxide which is in liquid form.
10. A method according to claim 1 and further comprising the step of generating a plasma in the sterilizer.
11. A method according to claim 1 and further comprising the step of monitoring the temperature of unvaporized hydrogen peroxide and water in the sterilizer.
12. A method according to claim 1 wherein the desired level comprises attaining a ratio of hydrogen peroxide to water of at least 0.1 to 1 by weight.
13. A method according to claim 1 wherein the desired level comprises attaining a ratio of hydrogen peroxide to water in the vapor which is at least two times higher than the ratio of hydrogen peroxide to water which is introduced into the sterilizer in step b).
14. A method according to claim 1 wherein the desired level comprises attaining a concentration of hydrogen peroxide and water of at least 60% by weight of hydrogen peroxide.
15. A method according to claim 1 wherein the desired level comprises attaining a hydrogen peroxide concentration of at least 0.45 mg/L.
16 A method according to claim 1 wherein the ratio hydrogen peroxide to water introduced into the sterilizer comprises 12% or less hydrogen peroxide by weight.
17. A method according to claim 1 wherein the load contains a maximum challenge equivalent to sterilizing the center of a lumen 1 mm in diameter and mm long.
18. A method according to claim 1 wherein the load contains a maximum challenge equivalent to sterilizing the center of a lumen 1 mm in diameter and mm long.
19. A method according to claim 1 wherein the hydrogen peroxide vapor is furnished to the article for a period of at least 15 minutes.
20. A method according to claim 1 wherein the hydrogen peroxide vapor is furnished to the article for a period of at least 30 minutes.
CA2357838A 1998-12-30 1999-12-29 A method of sterilizing an article and certifying the article as sterile Expired - Lifetime CA2357838C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/223,479 1998-12-30
US09/223,479 US6325972B1 (en) 1998-12-30 1998-12-30 Apparatus and process for concentrating a liquid sterilant and sterilizing articles therewith
PCT/US1999/031100 WO2000038745A1 (en) 1998-12-30 1999-12-29 A method of sterilizing an article and certifying the article as sterile

Publications (2)

Publication Number Publication Date
CA2357838A1 true CA2357838A1 (en) 2000-07-06
CA2357838C CA2357838C (en) 2010-06-22

Family

ID=22836677

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002357843A Expired - Lifetime CA2357843C (en) 1998-12-30 1999-12-29 Process for concentrating a sterilant and sterilizing articles therewith
CA2357838A Expired - Lifetime CA2357838C (en) 1998-12-30 1999-12-29 A method of sterilizing an article and certifying the article as sterile

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA002357843A Expired - Lifetime CA2357843C (en) 1998-12-30 1999-12-29 Process for concentrating a sterilant and sterilizing articles therewith

Country Status (8)

Country Link
US (5) US6325972B1 (en)
EP (2) EP1146915B2 (en)
JP (2) JP2002533163A (en)
AU (2) AU755860B2 (en)
CA (2) CA2357843C (en)
DE (2) DE69931280T3 (en)
ES (2) ES2273518T3 (en)
WO (2) WO2000038745A1 (en)

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US6627150B1 (en) 2003-09-30
CA2357843A1 (en) 2000-07-06
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EP1146915B2 (en) 2009-09-02
WO2000038746A1 (en) 2000-07-06
DE69931280D1 (en) 2006-06-14
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US20020119075A1 (en) 2002-08-29
CA2357843C (en) 2007-04-03
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JP2002540815A (en) 2002-12-03
WO2000038745A1 (en) 2000-07-06
CA2357838C (en) 2010-06-22
EP1146915B1 (en) 2006-05-10
EP1146915A4 (en) 2003-07-02
AU755860B2 (en) 2003-01-02
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DE69933137D1 (en) 2006-10-19
US6325972B1 (en) 2001-12-04
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EP1146915A1 (en) 2001-10-24
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US20040170527A1 (en) 2004-09-02
JP2002533163A (en) 2002-10-08
EP1140220A1 (en) 2001-10-10
US6656426B1 (en) 2003-12-02
AU755983B2 (en) 2003-01-02
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AU755983C (en) 2004-07-08
EP1140220B1 (en) 2006-09-06

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