WO1986005100A1 - Procede et installation pour la sterilisation d'appareils ou de materiels - Google Patents

Procede et installation pour la sterilisation d'appareils ou de materiels Download PDF

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Publication number
WO1986005100A1
WO1986005100A1 PCT/DE1986/000074 DE8600074W WO8605100A1 WO 1986005100 A1 WO1986005100 A1 WO 1986005100A1 DE 8600074 W DE8600074 W DE 8600074W WO 8605100 A1 WO8605100 A1 WO 8605100A1
Authority
WO
WIPO (PCT)
Prior art keywords
ozone
chamber
indicates
sterilized
items
Prior art date
Application number
PCT/DE1986/000074
Other languages
German (de)
English (en)
Inventor
Bernd Jochen Schniewind
Gerhard Neuhaus
Volker Roggenbuck
Original Assignee
Weiss Umwelttechnik Gmbh
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 Weiss Umwelttechnik Gmbh filed Critical Weiss Umwelttechnik Gmbh
Publication of WO1986005100A1 publication Critical patent/WO1986005100A1/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
    • A61L2/202—Ozone
    • 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
    • A61L2/24—Apparatus using programmed or automatic operation

Definitions

  • the invention relates to a method for the sterilization of medical devices or materials in particular (items to be sterilized) which are introduced into a chamber and are exposed to the action of a germicidal gas, and a device for carrying out the method.
  • ethylene oxide or formaldehyde is disadvantageous because of the carcinogenic effect of the gases used.
  • ethylene oxide in particular diffuses into the surface of the items to be sterilized to such an extent that the desorption may take several days after the sterilization has been completed.
  • ethylene oxide released after sterilization represents an environmental pollution.
  • the object of the invention is to create a reproducible and economically usable method for the sterilization of, in particular, medical devices and materials, and a device suitable for carrying out the method.
  • the invention provides for a method in which devices or materials are sterilized and placed in a chamber and exposed to the action of a germicidal gas
  • the ozone has the highest germicidal activity, so that all pathogenic particles and viruses are killed in the sterilization according to the invention.
  • ozone is only stable for a relatively short time and passes into the harmless oxygen, no sterilized goods can have any carcinogenic or environmental effects after sterilization.
  • ozone in a concentration of about 100 ppm to about 20,000 ppm, based on the volume, with particularly short sterilization times in the range from about 3,000 ppm to about 12,000 ppm.
  • the temperature at which the ozone is applied to the items to be sterilized can be between approximately -20 degrees Celsius and approximately +60 degrees Celsius.
  • the germicidal effect of the ozone is enhanced in a continuation of the method according to the invention by exposing the material to be sterilized to an appropriately saturated atmosphere which is enriched with water vapor before or during the action of the ozone.
  • the ozone is generated from pure oxygen and the oxygen / ozone mixture is introduced into the chamber, the formation of aggressive substances which are harmful to the items to be sterilized and the chamber is excluded production of ozone from air in the form of nitrogen oxides can occur.
  • the chamber is expediently evacuated before the introduction of the ozone, for example to a pressure of 20 Torr.
  • the chamber is first evacuated to about 20 torr after the items to be sterilized have been introduced, the atmosphere in the chamber is saturated with water vapor at about +50 degrees Celsius and then the items to be sterilized are filled with oxygen / ozone Mixture with an ozone fraction of about 3,000 ppm, based on the volume, is fumigated for a period of, for example, 3 hours.
  • a sterilization device with a chamber that can be closed by an access door is suitable for carrying out the method according to the invention, in which an ozone generator is provided according to the invention, the ozone outlet line of which is connected to the interior of the chamber via a shut-off device.
  • the ozone generator is expediently arranged outside the chamber and is connected on the input side with particular advantage to an oxygen pressure source.
  • a filter for separating the ozone can be provided in this.
  • shut-off line which is connected to a water line via a further, shut-off line and can be equipped with a heater for heating the water.
  • the chamber of the sterilization device is expediently surrounded by an outer container at a distance, one in the space between the chamber and the outer container Air circulation device and an air temperature control device can be provided. Furthermore, it proves to be expedient if the chamber is connected to the suction side of a vacuum pump. Furthermore, an ozone measuring device can be provided in the interior of the chamber which detects the ozone concentration in the chamber and controls the ozone generation rate in the ozone generator.
  • the sterilization device has a chamber 1, which is a cylindrical pressure vessel with a removable front cover 2.
  • the chamber is designed so that it can be evacuated to at least 20 torr when the lid 2 is closed.
  • the chamber 1 is surrounded by an outer container 3, the inner walls of which keep a distance suitable for an air flow from the outer walls of the chamber.
  • the storage of the chamber 1 in the interior of the outer container 3 is not shown separately.
  • the end plate 4 of the outer container, which lies opposite the cover 2 can be removed, so that devices or materials to be sterilized, such as medical devices in the form of catheters or the like, are introduced into the interior of the chamber 1 with the end plate 4 and cover 2 removed and can be stored there on racks or the like.
  • a blower 6 with a drive motor 12 and air temperature control devices in the form of heat exchangers 14, 15 are accommodated in the intermediate space 13 enlarged by a bulging of the rear wall 5 of the outer container 3.
  • Switching on the drive motor 12 causes around the jacket of the chamber 1 through the heat exchangers 14, 15th conditioned air is guided in the direction of arrows 16, 17 and the chamber is heated to the desired temperature.
  • the interior of the chamber is connected to a suction line 20 having a shut-off valve 21, which leads to a filter 22.
  • the filter 22 cleans the gas emerging from the chamber 1 from entrained ozone.
  • the downstream side of the filter 22 is connected via a line 24 to the suction end of a vacuum pump 26, from which a vent line 28 leads to the outside.
  • the sensor 31 of a pressure measuring device (pressostat) 30 projects into the interior of the chamber 1 and supplies control signals corresponding to the pressure prevailing in the chamber 1 to an operating control system, schematically designated by 50, via control signal line 32.
  • An ozone supply line 40 with a shut-off valve 41 opens into the chamber 1, so that when the shut-off valve 41 is open, an oxygen / ozone mixture of a certain composition can be fed into the interior of the chamber 1 from a switched-on ozone generator 42.
  • a feed line 43 to the ozone generator 42 is connected to an oxygen pressure source 44, for example in the form of an oxygen bottle.
  • the ozone generator contains, for example, a tube through which oxygen passes from the source 44 and flows through an electric field there, which, depending on the strength set, generates ozone in a corresponding concentration from part of the oxygen.
  • the sensor 45 of an ozone sensor 46 projects into the interior of the chamber 1, which detects the ozone concentration prevailing in the chamber, for example by monitoring the spectral absorption of the gas mixture removed from the chamber 1 via the sensor 45, and supplies an output signal representative of the determined ozone concentration via a control line 47 to the operating control 50.
  • a humidifier 62 equipped with a heater 63 is connected to the interior of the chamber 1 via a feed line 60 with a shut-off valve 61.
  • the temperature of the water stored in the humidifier is measured by a temperature sensor 64 which is connected to the operating control 50 via a control signal line 65.
  • the humidifier 62 is connected to a water pressure source via a water supply line 66 and an outlet valve 67.
  • the device described above works as follows: The pressure to which the chamber 1 is to be evacuated, the temperature to which the chamber 1 is warmed up by circulating the air in the space between the outer chamber wall and the inner wall of the outer container 3 are entered into the operating control 50 or should be cooled, the time period during which the items to be sterilized are to be moistened in the chamber, the fumigation time during which the items to be sterilized in the chamber are to be exposed to the action of the oxygen / ozone mixture and the number of repetitions of the evacuation , Moistening and gassing existing sterilization cycle.
  • the operating control thereupon gives corresponding control signals to the vacuum pump 26, the drive motor 12, to a device (not shown) which heats up or cools the air around the chamber 1 by means of the heat exchangers 14, 15, to the heating device 63 of the humidifier 62 and to the ozone generator 42 and to the various shut-off valves 21, 34, 41, and 61, in order to block or open the respective lines in accordance with the sterilization program set. corresponding to that of the pressostat 30, the thermostat 36 and the ozone sensor 46 to get received control signals. After the sterilization program has ended, the chamber is flushed with fresh air by means of the open fresh air line 33 and the open suction line 20, the residual ozone being taken up by the filter 22.
  • Bioindicators according to DIN 58948, part 4 are used to test the sterilization performance of known sterilizers which work with ethylene oxide as a germicidal gas. As described in detail in this standard, the bioindicator contains the test germ Bacillus subtilis, var. Globigii, with the registration number 10073 of the National Collection of Type Culture, Colindale, London. The sterilization was carried out with this bioindicator as follows:
  • the vacuum pump 26 is switched on until the interior of the chamber is evacuated to 20 torr at room temperature.
  • the shut-off valve 21 is then closed and the drive motor 12 and the air temperature control device are switched on.
  • the air is circulated by the fan 6 around the outside of the chamber 1 and heated to +50 degrees Celsius.
  • the shut-off valve 61 is opened and the heater 63 is switched on, so that water vapor flows from the humidifier 62 into the interior of the chamber and there increases the pressure to approximately 120 torr, which is the result of the generated pressure of 20 torr plus the saturation pressure of the water vapor +50 degrees Celsius results.
  • An atmosphere saturated with water vapor forms in the interior of the chamber 1 and is maintained for a period of 90 minutes.
  • the shut-off valve 61 is then closed and the shut-off valve 41 is opened and the ozone generator 42 is switched on. Thereon- an oxygen / ozone mixture with an ozone fraction which is set to 3,000 ppm, based on the volume, flows into the interior of chamber 1 and fills the vacuum still present there.
  • the shut-off valve 21 is opened so that the chamber 1 is continuously flushed by the oxygen / ozone mixture due to the pressure prevailing in the oxygen bottle 44, which escapes to the outside via the ventilation line 28 after the ozone has been removed from the filter 22. Since the oxygen / ozone mixture initially fills the negative pressure in the chamber, ozone is reliably conducted into all folds and niches of the items to be sterilized.
  • the ozone generator 42 is switched off, the pressure source 44 is disconnected and the shut-off valve 41 is closed.
  • the shut-off valve 34 is opened and the pump 26 is switched on, so that fresh air is flushed through the chamber. If there is no more ozone in the chamber, the bioindicator is removed from chamber 1. A standard-compliant check of the indicator for existing germs shows that these were completely destroyed by the sterilization.
  • the sterilization device according to the invention can also be modified in such a way that the fan of a blower is arranged in the chamber 1, which ensures that the oxygen / ozone mixture is circulated in the chamber. As a result, the ozone consumption can be reduced, although increased demands have to be made of the corrosion resistance of the fan and the implementation of its drive shaft through a chamber wall.

Landscapes

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

Abstract

Description d'un procédé pour la stérilisation d'appareils ou de matériels en particulier médicaux, qui sont introduits dans une enceinte et exposés à l'action d'un gaz microbicide, où le gaz utilisé est l'ozone. Pour la réalisation du procédé, on utilise une installation de stérilisation, avec une enceinte pouvant être fermée par une porte d'accès, dans laquelle est prévu un producteur d'ozone, dont la tuyauterie d'évacuation de l'ozone est reliée à l'intérieur de l'enceinte en passant par un dispositif d'arrêt.
PCT/DE1986/000074 1985-02-27 1986-02-27 Procede et installation pour la sterilisation d'appareils ou de materiels WO1986005100A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DEP3506852.3 1985-02-27
DE19853506852 DE3506852A1 (de) 1985-02-27 1985-02-27 Verfahren und vorrichtung zum sterilisieren oder desinfizieren eines medizinischen geraetes

Publications (1)

Publication Number Publication Date
WO1986005100A1 true WO1986005100A1 (fr) 1986-09-12

Family

ID=6263668

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE1986/000074 WO1986005100A1 (fr) 1985-02-27 1986-02-27 Procede et installation pour la sterilisation d'appareils ou de materiels

Country Status (4)

Country Link
EP (1) EP0213161A1 (fr)
DE (1) DE3506852A1 (fr)
ES (1) ES8705235A1 (fr)
WO (1) WO1986005100A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2611343A1 (fr) * 1987-02-27 1988-09-02 Masuda Senichi Methode de sterilisation des objets a steriliser et appareil de sterilisation
EP0700319A1 (fr) * 1993-05-14 1996-03-13 Kew Import/Export Inc. Dispositif de nettoyage/sterilisation d'endoscope
EP0761237A1 (fr) 1995-09-08 1997-03-12 Carba Société Anonyme Dispositif et procédé de traitement de matériaux, notamment en vue de leur décontamination
US5882588A (en) * 1993-11-19 1999-03-16 Carbagas Process for disinfecting hot water supply systems
WO2001037887A1 (fr) * 1999-11-27 2001-05-31 Robert Mayberry Marshall Appareil et procedes de traitement de dechets

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4102055C2 (de) * 1990-01-26 1996-11-21 Olympus Optical Co Desinfektionsvorrichtung für Endoskope

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB760733A (en) * 1953-03-12 1956-11-07 Alfred Torricelli Improvements in and relating to a sterilizing process by means of an ozonized gas
FR1137268A (fr) * 1955-02-23 1957-05-27 Appareil pour aseptiser
US4239731A (en) * 1979-11-21 1980-12-16 American Sterilizer Company Apparatus for biocidal sterilization using cyclic subatmospheric pressure conditioning
US4294804A (en) * 1979-02-06 1981-10-13 American Sterilizer Company Pressure responsive conditioning control gas sterilization

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB760733A (en) * 1953-03-12 1956-11-07 Alfred Torricelli Improvements in and relating to a sterilizing process by means of an ozonized gas
FR1137268A (fr) * 1955-02-23 1957-05-27 Appareil pour aseptiser
US4294804A (en) * 1979-02-06 1981-10-13 American Sterilizer Company Pressure responsive conditioning control gas sterilization
US4239731A (en) * 1979-11-21 1980-12-16 American Sterilizer Company Apparatus for biocidal sterilization using cyclic subatmospheric pressure conditioning

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
K.H.WALLHAUSSER et al.:"Sterilisation, Desinfektion, Konservierung, Chemotherapie", 1967, G.Thieme Verlag, Stuttgart (DE) see page 100, paragraph 5.3 *

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2611343A1 (fr) * 1987-02-27 1988-09-02 Masuda Senichi Methode de sterilisation des objets a steriliser et appareil de sterilisation
EP0281870A2 (fr) * 1987-02-27 1988-09-14 Senichi Prof. Masuda Procédé pour stériliser des objets devant être stérilisés et appareil de stérilisation
EP0281870A3 (fr) * 1987-02-27 1989-05-17 Senichi Prof. Masuda Procédé pour stériliser des objets devant être stérilisés et appareil de stérilisation
EP0700319A1 (fr) * 1993-05-14 1996-03-13 Kew Import/Export Inc. Dispositif de nettoyage/sterilisation d'endoscope
EP0700319A4 (fr) * 1993-05-14 1997-12-10 Kew Import Export Inc Dispositif de nettoyage/sterilisation d'endoscope
US5882588A (en) * 1993-11-19 1999-03-16 Carbagas Process for disinfecting hot water supply systems
EP0761237A1 (fr) 1995-09-08 1997-03-12 Carba Société Anonyme Dispositif et procédé de traitement de matériaux, notamment en vue de leur décontamination
US5951948A (en) * 1995-09-08 1999-09-14 Carba Societe Anonyme Apparatus and method for the processing, particularly the decontamination, of materials
WO2001037887A1 (fr) * 1999-11-27 2001-05-31 Robert Mayberry Marshall Appareil et procedes de traitement de dechets
GB2361644A (en) * 1999-11-27 2001-10-31 Robert Mayberry Marshall Waste treatment apparatus and methods
GB2361644B (en) * 1999-11-27 2003-06-18 Robert Mayberry Marshall Waste treatment apparatus and methods

Also Published As

Publication number Publication date
DE3506852A1 (de) 1986-08-28
EP0213161A1 (fr) 1987-03-11
ES552501A0 (es) 1987-05-01
ES8705235A1 (es) 1987-05-01

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