WO1989006121A1 - Procede de depyrogenation de vapeur de peroxyde d'hydrogene - Google Patents

Procede de depyrogenation de vapeur de peroxyde d'hydrogene Download PDF

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Publication number
WO1989006121A1
WO1989006121A1 PCT/US1988/004506 US8804506W WO8906121A1 WO 1989006121 A1 WO1989006121 A1 WO 1989006121A1 US 8804506 W US8804506 W US 8804506W WO 8906121 A1 WO8906121 A1 WO 8906121A1
Authority
WO
WIPO (PCT)
Prior art keywords
hydrogen peroxide
concentration
depyrogenating
peroxide vapor
period
Prior art date
Application number
PCT/US1988/004506
Other languages
English (en)
Inventor
James R. Rickloff
Original Assignee
American Sterilizer Company
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 American Sterilizer Company filed Critical American Sterilizer Company
Publication of WO1989006121A1 publication Critical patent/WO1989006121A1/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

Definitions

  • the present invention relates to depyrogenation methods, and more particularly to a depyrogenation method using hydrogen peroxide vapor.
  • Endotoxins are high molecular weight complexes associated with gram negative bacteria. When the bacteria undergoes lysis, all endotoxin is released. Sterilization methods which kill bacteria are not always effective for removing or inactivating endotoxins. Whether by removal or inactivation, the effects of fever producing endotoxins, or pyrogens, must be eliminated from parenteral solutions or water used for injection in patients. In addition, the effects of pyrogens must be substantially eliminated from the surfaces of articles, such as medical instruments, solution bottles and tubing which come into contact with patients. There are few methods which simultaneously sterilize and depyrogenate. Dry heat has been shown to be effective for sterilizing and depyrogenating, but requires temperatures of about 250°C which is unacceptable for heat labile articles.
  • Additional methods of depyrogenating, without sterilizing include heat treatment, hydrolysis with mild acetic acid or mild alkali, treatment with oxidizing agents, acetylation, hydroxylaminolysis and reductive cleavage by lithium aluminum hydride. Some of these methods are satisfactory only for simple solutions. Articles and solid surfaces, unlike solutions, cannot always be sterilized or depyrogentated by the combination of liquid hydrogen peroxide and heat. Methods using hydrogen peroxide vapor at temperatures below 80°C have been shown to be effective for sterilizing the surfaces of articles. See Moore et al. U.S. Patent No. 4,169,123 and Forstrom et al. U.S. Patent No. 4,169,124. Neither patent addresses the question of depyrogenation.
  • An object of the present invention is to provide a method of depyrogenating surfaces which does not depend on the application of the elevated temperatures heretofore required by the dry heat and the boiling hydrogen peroxide methods of depyrogenation. It is a further object of the present invention to provide a method for simultaneously sterilizing and depyrogenating surfaces at temperatures relatively lower than the temperatures required by the prior art methods.
  • the present invention provides a method for depyrogenating surfaces by exposing such surfaces to hydrogen peroxide vapor at a temperature less than about 100°C at a concentration and for a period of time sufficient for depyrogenating such surfaces.
  • the period of time is preferably sufficient for simultaneously sterilizing and deprogenating the surfaces.
  • the method may also include the step of aerating the surfaces to remove any absorbed hydrogen peroxide following depyrogenation.
  • the period of time may be less than or equal to about twenty-four hours and the concentration may be up to about 2 mg/1. Alternatively, the period of time may be less than about thirty minutes and the concentration may be up to about 10 mg/1.
  • the method of the present invention employs hydrogen peroxide vapor at temperatures less than about 100°C, and preferably about 50-70°C, to simultaneously sterilize and depyrogenate surfaces.
  • the method involves exposing the surfaces of articles to hydrogen peroxide vapor at a temperature below 100°C for a period of time sufficient for depyrogenating the surfaces.
  • the concentration of the hydrogen peroxide vapor is preferably less than or equal to about 10 mg/1.
  • the hydrogen peroxide vapor concentration varies with the temperature employed. The greater the temperature, the higher the concentration of hydrogen peroxide vapor that can exist in the relevant air space. For example, at room temperature, about 20°C, the concentration may be 2 mg/1. At 55°C, the concentration may be 10 mg/1. Higher concentrations of hydrogen peroxide vapor lead to faster depyrogenation and therefore, lower exposure times. As the two examples set forth below illustrate, low concentrations may require a longer exposure time.
  • Example 1 Samples of 1 square centimeter 316 stainless steel coupons having a dose of 2200 endotoxin units dried onto the surfaces were suspended approximately two inches over a 30% hydrogen peroxide solution at 55°C for twenty-four hours. The vapor concentration contacting the samples was determined to reach 1.9 mg/1. A limulus amebocyte lysate (LAL) assay revealed that, even under less than ideal conditions, 99.97% of the endotoxin was inactivated. The conditions of Example 1 were much more crude than would be expected in most practical applications of the invention. The exposure time was therefore longer than it might ordinarily be under more sophisticated conditions.
  • LAL limulus amebocyte lysate
  • Example 2 Samples of 316 stainless steel coupons having varying does of endotoxin dried onto the surfaces were exposed to a vapor phase hydrogen peroxide sterilization cycle at 55°C for twenty-five minutes.
  • the hyrogen peroxide vapor concentration in the sterilizer reached a maximum of 10 mg/1.
  • the sterilization cycle did not employ means necessary to maintain the concentration of sterilant in the chamber.
  • LAL analysis revealed that the endotoxin activity in a sample initially having a dose of 6500 endotoxin units was reduced by 90.8% while another sample having an initial dose of 90,000 endotoxin units was reduced by 87.2%.
  • a higher percentage of endotoxin destruction should be achievable either by increasing the exposure time or by increasing the concentration of hydrogen peroxide or both.
  • the temperature of the depyrogenation process must be maintained within a range that will not harm the articles that are being depyrogenated. The preferred range is between about 50-80°C. Temperatures above 80°C but less than about 100°C and temperatures less than 50°C may also be effective.
  • the method of the present invention may also include the step of aerating the surfaces of the articles to remove any hydrogen peroxide which may have been absorbed by such surfaces.
  • Vapor phase hydrogen peroxide is particularly advantageous for depyrogenation because it can be used at relatively low temperatures and low concentrations. In addition, it simultaneously sterilizes the surfaces being treated. The natural tendency for hydrogen peroxide vapor to degrade into water and oxygen over time virtually eliminates concerns for contaminating the articles with potentially harmful substances that might be employed to chemically remove the depyrogenating agent which is required in the case of hydrogen peroxide liquid depyrogenation practices.
  • the articles may be packaged in any of a number of commercially available hydrogen peroxide vapor permeable packages to prevent recontamination after exposure to the process.

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  • 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

Le procédé décrit permet d'effectuer la dépyrogénation de surfaces. Le procédé comprend l'étape d'exposition des surfaces à une vapeur de peroxyde d'hydrogène à une température inférieure à environ 100°C et à une concentration et une période de temps suffisantes pour dépyrogéner les surfaces. Le temps d'exposition peut également être suffisant pour stériliser et dépyrogéner simultanément les surfaces.
PCT/US1988/004506 1987-12-30 1988-12-16 Procede de depyrogenation de vapeur de peroxyde d'hydrogene WO1989006121A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13999287A 1987-12-30 1987-12-30
US139,992 1987-12-30

Publications (1)

Publication Number Publication Date
WO1989006121A1 true WO1989006121A1 (fr) 1989-07-13

Family

ID=22489232

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1988/004506 WO1989006121A1 (fr) 1987-12-30 1988-12-16 Procede de depyrogenation de vapeur de peroxyde d'hydrogene

Country Status (2)

Country Link
CN (1) CN1034673A (fr)
WO (1) WO1989006121A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5652006A (en) * 1992-10-09 1997-07-29 Unilever Patent Holdings B.V. Method of heat processing foodstuff
EP1473044A2 (fr) * 1995-10-27 2004-11-03 Ethicon, Inc. Sterilisation par vapeur a l'aide de complexes de peroxyde d'hydrogene non organiques
CN111781366A (zh) * 2020-07-24 2020-10-16 褚培忠 一种检测过氧化氢溶液中内毒素的方法
CN115414531A (zh) * 2022-09-20 2022-12-02 上海亚朋生物技术有限公司 一种同种异体骨的脂肪及内毒素去除方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4169123A (en) * 1975-12-11 1979-09-25 Moore-Perk Corporation Hydrogen peroxide vapor sterilization method
DE3134050A1 (de) * 1981-08-28 1983-03-10 Dr. Franz Köhler Chemie GmbH, 6146 Alsbach Sterilisations- und entpyrogenisirungsloesung von leitungen und filtern aus edelstahl im geschlossenen system

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4169123A (en) * 1975-12-11 1979-09-25 Moore-Perk Corporation Hydrogen peroxide vapor sterilization method
DE3134050A1 (de) * 1981-08-28 1983-03-10 Dr. Franz Köhler Chemie GmbH, 6146 Alsbach Sterilisations- und entpyrogenisirungsloesung von leitungen und filtern aus edelstahl im geschlossenen system

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Immunochemistry, vol. 12, no. 6,7, July 1975 (GB) A. Cherkin: "Destruction of bacterial endotoxin pyrogenicity by hydrogen peroxide", pages 625-627 *
J. Dental Research, vol. 60, no. 5, May 1981 (US). F. DeRenzis: "Endotoxin-inactivating potency of hydrogen peroxide: effect on cell growth", pages 933-935 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5652006A (en) * 1992-10-09 1997-07-29 Unilever Patent Holdings B.V. Method of heat processing foodstuff
EP1473044A2 (fr) * 1995-10-27 2004-11-03 Ethicon, Inc. Sterilisation par vapeur a l'aide de complexes de peroxyde d'hydrogene non organiques
EP1473044A3 (fr) * 1995-10-27 2004-11-17 Ethicon, Inc. Sterilisation par vapeur a l'aide de complexes de peroxyde d'hydrogene non organiques
CN111781366A (zh) * 2020-07-24 2020-10-16 褚培忠 一种检测过氧化氢溶液中内毒素的方法
CN115414531A (zh) * 2022-09-20 2022-12-02 上海亚朋生物技术有限公司 一种同种异体骨的脂肪及内毒素去除方法
CN115414531B (zh) * 2022-09-20 2024-06-04 上海亚朋生物技术有限公司 一种同种异体骨的脂肪及内毒素去除方法

Also Published As

Publication number Publication date
CN1034673A (zh) 1989-08-16

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