WO2002022447A1 - Procede pour realiser la sterilisation et la depyrogenation de contenants laves - Google Patents

Procede pour realiser la sterilisation et la depyrogenation de contenants laves Download PDF

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Publication number
WO2002022447A1
WO2002022447A1 PCT/EP2001/009191 EP0109191W WO0222447A1 WO 2002022447 A1 WO2002022447 A1 WO 2002022447A1 EP 0109191 W EP0109191 W EP 0109191W WO 0222447 A1 WO0222447 A1 WO 0222447A1
Authority
WO
WIPO (PCT)
Prior art keywords
sterilization
treatment chamber
containers
carried out
plasma
Prior art date
Application number
PCT/EP2001/009191
Other languages
German (de)
English (en)
Inventor
Robert Frost
Peter Awakowicz
Original Assignee
Rüdiger Haaga 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 Rüdiger Haaga GmbH filed Critical Rüdiger Haaga GmbH
Priority to AU2001277562A priority Critical patent/AU2001277562A1/en
Publication of WO2002022447A1 publication Critical patent/WO2002022447A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18Liquid substances or solutions comprising solids or dissolved gases
    • A61L2/186Peroxide solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2/06Hot gas
    • A61L2/07Steam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/14Plasma, i.e. ionised gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/208Hydrogen peroxide
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • B65B55/04Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/23Containers, e.g. vials, bottles, syringes, mail

Definitions

  • the invention relates to a method for sterilizing and depyrogenizing washed containers.
  • Sterilizing is the release of an object from reproductive organisms. This requirement is met by killing all microorganisms. This includes not only the vegetative cells, but also the permanent forms and in particular the particularly resistant bacterial endospores.
  • Containers to be sterilized which are used, for example, in the pharmaceutical industry or for filling beverages and which usually consist of glass or plastic, must be cleaned by a wash cycle before sterilization. These containers pass through a washing machine before they reach the sterilization system, with small amounts of residual water.
  • lipopolysaccharides Bacterial endotoxins, so-called lipopolysaccharides, are always present in the water that is applied to the surfaces of the containers during washing. These are cell membrane components of so-called gram-negative bacteria and are released when they die and break down into their cell components. If the lipopolysaccharides enter the bloodstream, they produce a fever. The lipopolysaccharides must therefore be inactivated, a process commonly referred to as depyrogenization.
  • depyrogenation usually takes place by treatment in dry heat at about 300 ° C. Since this temperature and the residence time are also suitable for sterilization, sterilization and depyrogenization are usually combined in one carried out joint operation.
  • this rational method has the disadvantage that the optimal methods are not necessarily used for the two process steps. This is particularly true when it would be desirable per se to sterilize containers made of plastic, for example, at lower temperatures.
  • the invention is based on the object of making the sterilization and depyrogenization of washed containers more variable.
  • the object is achieved in that depyrogenization is carried out in a separate operation after sterilization.
  • the depyrogenation is carried out by the action of plasma, because suitable plasma gases are able to inactivate the lipopolysaccharides by electron and ion bombardment and by chemical reaction.
  • a high-frequency generator is switched on, the high-frequency power of which can be coupled inductively or capacitively and which works, for example, with an approved frequency of 13.56 MHz.
  • a low-pressure plasma is advantageously used for the depyrogenation. This has the advantage that a “cold” plasma can be generated, as a result of which the containers to be depyrogenized are not or only slightly thermally stressed.
  • a gas which is suitable for depyrogenization in the plasma phase is to be used as the plasma gas. This is the case, for example, with oxygen, which is enriched with ozone in the maximum possible concentration.
  • the gas mixture must be passed through a sterile filter before depyrogenation, since it is not a sterile gas and the containers to be depyrogenized have already been sterilized by the previous sterilization process and, of course, must not be recontaminated.
  • a gas mixture can be used which enhances the effect of the ozone-oxygen plasma with another component.
  • provision can advantageously be made for the sterilization and depyrogenization to be carried out at intervals in a common treatment chamber. However, this is not a mandatory requirement.
  • the sterilization can, depending on the application, be carried out optimally, for example by condensing a steam mixture containing water vapor and hydrogen peroxide vapor onto the surfaces of the containers.
  • hydrogen peroxide which is always present in aqueous solution
  • the actual germ killing takes place purely chemically, through the action of "activated” hydrogen peroxide.
  • activate used here is undefined, but chemical and / or physical change that ultimately kills germs. Such "activation" of the hydrogen peroxide takes place during condensation, that is to say precisely when it is actually needed for sterilization.
  • the steam mixture is generated in an evaporator and then passed into a treatment chamber, the chamber pressure of which is significantly below the steam pressure of the steam mixture. Due to the negative pressure in the treatment chamber, the steam mixture to be condensed reaches all surfaces to be sterilized without any carrier gas medium and wets them with a thin, homogeneous liquid film. A microscopic condensate layer that is almost invisible to the naked eye is sufficient for this.
  • the vapor mixture condensed onto the surfaces of the containers to be sterilized can be easily removed from the treatment chamber by evacuating to a pressure below the boiling points of water and hydrogen peroxide. Neither subsequent cleaning nor subsequent heating is necessary to evaporate the condensate.
  • Residual amounts of water which, as mentioned at the beginning, can adhere to the containers due to the washing process, may hinder effective sterilization because the condensate does not reach the surfaces to be sterilized or the germs contained in the liquid quickly or under certain circumstances can. It is therefore provided in a further embodiment of the invention that the washed containers are freed of any residual moisture before sterilization. As a result, the surfaces to be sterilized the container is placed in a state which enables effective sterilization by condensing the steam mixture consisting of water and hydrogen peroxide.
  • the residual moisture is removed by drying by means of microwave radiation.
  • the chamber in which the microwave radiation occurs is evacuated.
  • the water to be evaporated can already reach its boiling point at a temperature of 60 ° C, for example. It is possible to remove the residual moisture in the same treatment chamber in which the sterilization takes place. This makes the apparatus simpler, for example in that one and the same vacuum pump can be used for the different process steps.
  • the process steps which are considered the most advantageous by the applicant in combination are freeing the containers of residual moisture by microwave radiation, sterilizing by condensing a steam mixture containing water vapor and hydrogen peroxide vapor onto the surfaces of the containers and depyrogenizing using a low pressure plasma.
  • FIG. 1 shows a block diagram for explaining the method steps according to the invention
  • Figure 2 is a schematic representation of a preferred embodiment of the invention.
  • the containers 1 pass through a washing machine 2, a drying chamber 3, a sterilization chamber 4, a depyrogenization chamber 5 and subsequently a filling station 6 and a sealing station 7.
  • the sterilization takes place in the sterilization chamber 4 and the depyrogenization in the depyrogenization chamber 5
  • drying is supported by microwave radiation 8, sterilization by reaction gas supply 9 and depyrogenation by plasma gas supply 10.
  • a steam mixture of water vapor and hydrogen peroxide vapor can be used as the reaction gas for the sterilization.
  • the drying chamber 3, the sterilization chamber 4 and the depyrogenization chamber 5 are connected to a vacuum pump (not shown) via a common vacuum connection 11.
  • the drying chamber 3, the sterilization chamber 4 and the depyrogenization chamber 5 can alternatively be combined to form a common treatment chamber 12, but the process steps of drying, sterilizing and depyrogenizing are carried out at intervals in time.
  • Such a common treatment chamber 12 which is grounded, is shown schematically in FIG.
  • the direction of transport through the treatment chamber 12 runs from the viewer to the plane of the drawing, the treatment chamber 12 being provided with inlet and outlet openings (not shown) and corresponding locks.
  • the individual containers 1 are placed in the treatment chamber 12 on a grating 13.
  • the treatment chamber 12 is connected to a vacuum pump 15 via a vacuum line 14 and a valve 16. This can be designed for a vacuum below a Pa.
  • the containers 1 are freed of any residual moisture by a drying process.
  • the power of the microwave is radiated in the present case, as an example, via a waveguide 18.
  • the waveguide 18, which is rectangular in cross section, is widened to form an antenna 19 which is closed off from the treatment chamber 12 by a microwave-transparent window 20 made of quartz glass, for example.
  • the window 20 must be mechanically very stable, since there is negative pressure in the treatment chamber 12, but there is atmospheric pressure in the antenna 19 and the waveguide 18.
  • an impedance converter 21 is provided, for example a three-screw transformer.
  • a so-called isolator 22 is attached between the impedance converter 21 and the microwave generator 17 and branches off the reflected wave, for example, into a water load, ie into a water-cooled resistor that has the same wave resistance as the waveguide 18.
  • the next process step takes place with the subsequent sterilization of the containers 1.
  • a steam mixture of water vapor and hydrogen peroxide vapor is first generated, it being basically irrelevant whether the steam in question is wet steam or superheated steam.
  • the evaporator or carburetor the design of which is basically arbitrary, is provided with the reference number 26.
  • An aqueous solution of hydrogen peroxide with the desired concentration is fed to the evaporator 26 via a feed line 27 and a valve 28 in the direction of the arrow.
  • the evaporator 26 is arranged upstream of the treatment chamber 12, in which the containers 1 to be sterilized and which have meanwhile dried are located.
  • the treatment chamber 12 is also evacuated in the desired manner for sterilization.
  • the treatment chamber 12 is then isolated from the vacuum pump 15 by closing a valve 16, so that suction is no longer carried out.
  • Depyrogenization then takes place in a further step. This is done with the aid of a low-pressure plasma with the treatment chamber 12 likewise being evacuated.
  • a feed line 33 plasma gas to be ionized can be introduced into the evacuated treatment chamber 12, preferably oxygen enriched with ozone.
  • a throttle valve 34 regulates the inflow of the plasma gas.
  • a gas container 35 is provided for the plasma gas itself. So that the already sterilized containers 1 are not recontaminated, the feed line 33 is connected to the treatment chamber 12 via a sterile filter 36.
  • a high-frequency generator 37 of, for example, 13.56 MHz or another approved frequency is used to ignite the low-pressure plasma required for the depyrogenation.
  • the high-frequency generator 37 generates an alternating voltage, which is transmitted to the plasma to be formed by an adaptation network 38, a so-called matchbox.
  • the matching network 38 serves the purpose of matching the impedance of the load to the characteristic impedance of the high-frequency generator 37.
  • Two identical electrodes 39 and 40 are located within the treatment chamber 12.
  • Electrodes 39 and 40 in the form of plates are electrically insulated from the plasma, which can be done, for example, by means of a coating that withstands the action of the plasma. This insulation ensures that the average over time Electrodes 39 and 40 cannot flow a direct current that would result in an ohmic loss in the electrode edge layer.
  • neither of the two electrodes 39 and 40 should be at the same electrical potential as the metallic treatment chamber 12. Rather, a symmetrical structure should be chosen in which the two electrodes 39 and 40 are electrically isolated from the ground potential via a transformer contained in the matching network 38. Both electrodes 39 and 40 are then equal to the potential of the metallic wall of the treatment chamber 12, which is expressed in a largely symmetrical plasma geometry.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Mechanical Engineering (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un procédé pour réaliser la stérilisation et la dépyrogénation de contenants lavés. Selon l'invention, on procède à la dépyrogénation après la stérilisation, au cours d'une étape séparée. De préférence, la stérilisation est effectuée par condensation d'un mélange constitué de vapeur d'eau et de vapeur de peroxyde d'hydrogène. On utilise de préférence un plasma basse pression pour effectuer la dépyrogénation. Avant la stérilisation, on élimine l'humidité résiduelle, éventuellement présente dans les contenants, en exposant ces derniers par exemple à un rayonnement micro-ondes.
PCT/EP2001/009191 2000-09-15 2001-08-09 Procede pour realiser la sterilisation et la depyrogenation de contenants laves WO2002022447A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001277562A AU2001277562A1 (en) 2000-09-15 2001-08-09 Method for sterilising and depyrogenating washed containers

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10045585.9 2000-09-15
DE2000145585 DE10045585A1 (de) 2000-09-15 2000-09-15 Verfahren zum Sterilisieren und Depyrogenisieren gewaschener Behälter

Publications (1)

Publication Number Publication Date
WO2002022447A1 true WO2002022447A1 (fr) 2002-03-21

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PCT/EP2001/009191 WO2002022447A1 (fr) 2000-09-15 2001-08-09 Procede pour realiser la sterilisation et la depyrogenation de contenants laves

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DE (1) DE10045585A1 (fr)
WO (1) WO2002022447A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007071486A1 (fr) * 2005-12-19 2007-06-28 Robert Bosch Gmbh Procede et systeme pour l'elimination des impuretes sur des recipients et/ou pour leur sterilisation
WO2007137556A1 (fr) * 2006-05-31 2007-12-06 Koldsteril Ag Procédé de stérilisation
CN100354010C (zh) * 2002-11-08 2007-12-12 互曼迈迪泰克公司 配备有等离子体处理模块的消毒设备和消毒方法
ITNA20090066A1 (it) * 2009-10-27 2011-04-28 Adiramef S R L Sistema per la sterilizzazione assoluta con ciclo combinato al vapor saturo ed al gas plasma di ossigeno.
EP2716305A1 (fr) * 2011-06-03 2014-04-09 Korea Basic Science Institute Appareil pour une stérilisation médicale à l'aide d'un plasma
WO2017203136A1 (fr) * 2016-05-25 2017-11-30 Sidel Participations Procede et installation de fabrication et de traitement de recipients
US10194672B2 (en) 2015-10-23 2019-02-05 NanoGuard Technologies, LLC Reactive gas, reactive gas generation system and product treatment using reactive gas
US10925144B2 (en) 2019-06-14 2021-02-16 NanoGuard Technologies, LLC Electrode assembly, dielectric barrier discharge system and use thereof
US11896731B2 (en) 2020-04-03 2024-02-13 NanoGuard Technologies, LLC Methods of disarming viruses using reactive gas

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7603829B2 (en) 2004-03-31 2009-10-20 I.M.A. Industria Macchine Automatiche Method and apparatus for sterilizing containers of plastic material and for filling them with liquid substances

Citations (6)

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Publication number Priority date Publication date Assignee Title
EP0387022A2 (fr) * 1989-03-08 1990-09-12 Abtox, Inc. Stérilisateur à plasma gazeux et procédé
DE4408301A1 (de) * 1993-03-12 1994-09-15 Sando Iron Works Co Vorrichtung zum Sterilisieren des Inneren eines Behälters
US5645796A (en) * 1990-08-31 1997-07-08 Abtox, Inc. Process for plasma sterilizing with pulsed antimicrobial agent treatment
DE19719911A1 (de) * 1997-05-13 1998-11-19 Max Kettner Gmbh & Co Kg I K Vorrichtung zur Behandlung von Getränkebehältern
DE19806516A1 (de) * 1998-02-17 1999-08-19 Ruediger Haaga Gmbh Verfahren zum Sterilisieren von Behältern
US6037562A (en) * 1998-02-17 2000-03-14 Ruediger Haaga Gmbh Arrangement and process for sterilizing containers by means of low-pressure plasma

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0387022A2 (fr) * 1989-03-08 1990-09-12 Abtox, Inc. Stérilisateur à plasma gazeux et procédé
US5645796A (en) * 1990-08-31 1997-07-08 Abtox, Inc. Process for plasma sterilizing with pulsed antimicrobial agent treatment
DE4408301A1 (de) * 1993-03-12 1994-09-15 Sando Iron Works Co Vorrichtung zum Sterilisieren des Inneren eines Behälters
DE19719911A1 (de) * 1997-05-13 1998-11-19 Max Kettner Gmbh & Co Kg I K Vorrichtung zur Behandlung von Getränkebehältern
DE19806516A1 (de) * 1998-02-17 1999-08-19 Ruediger Haaga Gmbh Verfahren zum Sterilisieren von Behältern
US6037562A (en) * 1998-02-17 2000-03-14 Ruediger Haaga Gmbh Arrangement and process for sterilizing containers by means of low-pressure plasma

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100354010C (zh) * 2002-11-08 2007-12-12 互曼迈迪泰克公司 配备有等离子体处理模块的消毒设备和消毒方法
WO2007071486A1 (fr) * 2005-12-19 2007-06-28 Robert Bosch Gmbh Procede et systeme pour l'elimination des impuretes sur des recipients et/ou pour leur sterilisation
WO2007137556A1 (fr) * 2006-05-31 2007-12-06 Koldsteril Ag Procédé de stérilisation
ITNA20090066A1 (it) * 2009-10-27 2011-04-28 Adiramef S R L Sistema per la sterilizzazione assoluta con ciclo combinato al vapor saturo ed al gas plasma di ossigeno.
EP2716305A1 (fr) * 2011-06-03 2014-04-09 Korea Basic Science Institute Appareil pour une stérilisation médicale à l'aide d'un plasma
CN103747808A (zh) * 2011-06-03 2014-04-23 韩国基础科学支援研究院 医疗用等离子体杀菌装置
EP2716305A4 (fr) * 2011-06-03 2014-12-24 Korea Basic Science Inst Appareil pour une stérilisation médicale à l'aide d'un plasma
US9855354B2 (en) 2011-06-03 2018-01-02 Korea Basic Science Institute Apparatus for medical sterilization using plasma
US11000045B2 (en) 2015-10-23 2021-05-11 NanoGuard Technologies, LLC Reactive gas, reactive gas generation system and product treatment using reactive gas
US11882844B2 (en) 2015-10-23 2024-01-30 NanoGuard Technologies, LLC Reactive gas, reactive gas generation system and product treatment using reactive gas
US10194672B2 (en) 2015-10-23 2019-02-05 NanoGuard Technologies, LLC Reactive gas, reactive gas generation system and product treatment using reactive gas
FR3051675A1 (fr) * 2016-05-25 2017-12-01 Sidel Participations Procede de traitement de corps creux et installation de fabrication de recipients integrant un tel procede
EP3463487B1 (fr) 2016-05-25 2021-03-03 Sidel Participations Procede et installation de fabrication et de traitement de recipients
US11701443B2 (en) 2016-05-25 2023-07-18 Sidel Participations Process for treating container preforms with non-contacting plasma treatment
WO2017203136A1 (fr) * 2016-05-25 2017-11-30 Sidel Participations Procede et installation de fabrication et de traitement de recipients
US10925144B2 (en) 2019-06-14 2021-02-16 NanoGuard Technologies, LLC Electrode assembly, dielectric barrier discharge system and use thereof
US11896731B2 (en) 2020-04-03 2024-02-13 NanoGuard Technologies, LLC Methods of disarming viruses using reactive gas

Also Published As

Publication number Publication date
AU2001277562A1 (en) 2002-03-26
DE10045585A1 (de) 2002-03-28

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