WO2007137556A1 - Procédé de stérilisation - Google Patents

Procédé de stérilisation Download PDF

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Publication number
WO2007137556A1
WO2007137556A1 PCT/DE2007/000931 DE2007000931W WO2007137556A1 WO 2007137556 A1 WO2007137556 A1 WO 2007137556A1 DE 2007000931 W DE2007000931 W DE 2007000931W WO 2007137556 A1 WO2007137556 A1 WO 2007137556A1
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WO
WIPO (PCT)
Prior art keywords
plasma
mhz
sterilization
frequency
gas
Prior art date
Application number
PCT/DE2007/000931
Other languages
German (de)
English (en)
Inventor
Peter Awakowicz
Original Assignee
Koldsteril Ag
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 Koldsteril Ag filed Critical Koldsteril Ag
Publication of WO2007137556A1 publication Critical patent/WO2007137556A1/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
    • A61L2/02—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

Definitions

  • the invention relates to a sterilization method according to the features in the preamble of patent claim 1.
  • Sterilization refers to the deactivation of viable organisms and pathogens by more than six decades. Deactivation means that the germs are no longer capable of replication. Furthermore, biomolecules that cause the immune system to inflammatory immune reactions must be destroyed. These include, for example, pyrogens, that is to say particles or molecules which consist of dead cells or cell fragments of bacteria and are feverish when they enter the bloodstream. These must also be deactivated or depyrogenated in this case, ie their fever-producing effect must be prevented by targeted destruction of the molecule by more than three decades.
  • the depyrogenation is in practice usually carried out by treatment with dry heat at about 300 0 C. Since this temperature and the residence time are also suitable for sterilization, the sterilization and depyrogenation is often carried out in a single operation.
  • Conventional sterilization methods include autoclaving, ie the application of moist heat, gamma irradiation and irradiation with other ionizing radiation. Furthermore, the gas sterilization with Ethylene oxide (ETO) and hydrogen peroxide sterilization. Processes that are carried out under elevated temperatures are not suitable for thermo-labile materials. Even ceramics and metals can be severely affected by autoclaving. The application of a moist heat is not suitable for depyrogenation anyway.
  • ETO Ethylene oxide
  • Ethylene oxide is a highly toxic gas that can be used for the sterilization of thermolabile materials, but the great disadvantage is based on the relatively long Ausgasungs founded the objects to be sterilized, the Ausgasungs committee can be many times higher than the actual treatment time. Due to the toxicity the handling of ETO is critical. Depyrogenation can not be achieved with ETO.
  • Hydrogen peroxide sterilization also has many disadvantages, most notably in that hydrogen peroxide is a liquid at room temperature.
  • the known methods are based on evaporation of the hydrogen peroxide, although condensation in the region of the objects to be sterilized must be avoided in order to completely remove the vapor phase.
  • the removal of hydrogen peroxide succeeds only poorly when larger amounts of liquid have accumulated.
  • the evaporation is uneven in this case and takes a long time. Also hydrogen peroxide taken alone is not suitable for depyrogenation.
  • ionizing radiation requires a great apparatus and safety effort.
  • ionizing radiation can possibly damage the material of the sterilizing objects. Even by means of ionizing radiation, no depyrogenation can be carried out per se.
  • the known plasma sterilization methods do not have these disadvantages or only to a small extent.
  • the sterilizing effect of a plasma is based inter alia on a destruction of the germs and biomolecules by UV and VUV light destroying the DNA.
  • VUV is meant so-called vacuum UV radiation whose wavelengths are below 200 nm.
  • radicals are generated in the plasma, which chemically attack the germs or biomolecules.
  • the germs or biomolecules undergo ion bombardment, which likewise has a destructive effect.
  • the gas temperature of the plasma can be reduced so that heat-sensitive objects can be treated, such as plastic-containing medical implants.
  • DE 102 11 976 A1 discloses in this context a method and a device at least for the sterilization of containers and / or their closure elements.
  • the output signal of an electromagnetic oscillator is modulated to produce a plasma in a conventional manner in the sign and in amplitude, wherein the modulation frequency in the range of a few hertz to several hundred megahertz and in the case of the microwave to typically 2.45 GHz range, but preferably between 50 kHz and 27 MHz is.
  • vibrations in the radio frequency range of 13.56 MHz and 27.12 MHz are suitable because they are internationally approved frequencies.
  • the plasmas used hitherto are only conditionally suitable for the treatment or sterilization of complex structures, since the penetration of the plasmas into narrow gaps and lumens is not very good. Furthermore, it can be seen that in the case of the so-called capacitively coupled plasmas, the coling mobility is high, but the intensity of the action mechanisms is poor, since their plasma density is low. In the case of inductively coupled plasmas as well as microwave plasmas, on the other hand, the plasma density is high, but the colloidal mobility is low. The same applies to the DC plasmas.
  • the present invention seeks to provide a method for plasma sterilization, with which the sterilization efficiency, especially in complex structures, is significantly increased and with which the Spaltjankeit is improved
  • the plasma can ignite from the outside into lumens, which are formed of dielectric materials. This therefore applies to all plastic materials or ceramic materials that can be penetrated by an electromagnetic wave and within which therefore can ignite the plasma in enclosed lumen. Especially with thin long plastic tubing, this property is of great importance because the plasma can not penetrate into the tubing from the open ends due to the length of the tubing.
  • the core of the invention can be seen in the capacitive coupling of an electric field in combination with a specific high-frequency range, called VHF range.
  • VHF range a specific high-frequency range
  • a collision of fast electrons ie those with high kinetic energy absorbed from the electric field, takes place with an atom or molecule.
  • This electron impact ionization can be generated by a sufficiently strong alternating electromagnetic field, which is applied in the case of capacitive coupling between two electrodes or capacitor plates. Due to the said ionization processes, a plasma is formed between the electrodes in which all charged particles oscillate with the frequency of the alternating field, unless the oscillation frequency is too high.
  • the electrodes are within a vacuum chamber connected to a high frequency electromagnetic radiation generator.
  • the chamber is typically in a vacuum range from a few pascals to a few hundred pascals. In order to maintain this low pressure at constant gas flow, is at the Pumped chamber while the fresh gas required in the process admitted.
  • An alternating current flows through the electrodes since the electrodes are in direct contact with the electrically conductive plasma.
  • the current within a plasma is mainly carried by the faster, that is, more mobile electrons.
  • a so-called boundary layer builds up in each plasma, which encloses the electrons as far as possible and forms a potential well.
  • the ions are thereby transported outwards, so that from their point of view forms a potential mountain.
  • the surface layer is dependent on the plasma parameters and very small compared to the dimensions of the plasma. In the case of a capacitively coupled alternating electric field, this potential well is particularly large in comparison with the smaller electrode driven with high frequency. Thus, the potential drop in the so-called boundary layer is very high and is for example many hundreds of volts. In most other plasmas, the potential drop in the surface layer is seldom more than twenty volts. This property of the surface layer leads to a strong alternating electric field in these plasmas with capacitive electromagnetic excitation of the plasmas. In capacitive electromagnetic excitation therefore relatively high electric field strengths are generated within the plasma, which are useful, for example, to ignite a plasma within a plastic tube to be sterilized, since the electrical Field penetrates dielectric materials almost unhindered. This makes it clear that capacitively excited high-frequency plasmas are better suited, due to the pronounced dipole character of the boundary layer, to ignite a plasma in closed lumens or narrow gaps than is possible with other types of excitation.
  • the frequency was kept constant at 13.56 MHz or, in some cases, at double, that is at 27.12 MHz.
  • the desired during sterilization Spaltjankeit can not be achieved at very low and very high frequencies, but optimally in a frequency range of 40 MHz to 150 MHz, in particular in a range of 60 MHz to 120 MHz.
  • the plasma is heated more effectively, that is, the electron density is greater than in classical plasmas excited at 13.56 MHz and 27.12 MHz, respectively.
  • the modulation of the field strength is significantly higher than in the case of inductive electromagnetic excitation or the microwave excitation.
  • the increase in frequency continuously leads to an improvement in the colortability and the plasma density. From 40 MHz, this effect is sufficiently pronounced for the plasma sterilization, with a particularly favorable frequency range between 60 MHz and 100 MHz.
  • the upper limit of the frequency range is limited, since standing at high frequencies, especially in larger machines standing waves, which may result in uneven treatment of the objects to be sterilized.
  • the frequencies become very high (eg in the case of the microwave: 2.45 GHz)
  • even the fast electrons can not follow and the dipole character of the capacitive heating is lost.
  • the very high frequencies therefore do not lead to the desired plasma properties.
  • a frequency of about 70 MHz can now be built up as a cantilever with simple transistor circuits, ie not with tubes and in particular without a Matching network (Matchbox), which makes a commercial construction smaller and much cheaper.
  • a measure of ignitability of plasmas in narrow lumens is the electric field strength. This is much greater in the case of capacitive coupling of the electromagnetic field than in the case of inductive coupling.
  • the thickness of the surface layer decreases very much when the plasmas are operated in the said frequency range, resulting in improved penetration into externally accessible narrow gaps and lumens.
  • the frequency range from 40 MHz to 150 MHz for sterilization has not been further investigated, since the frequency range is outside the permitted frequencies.
  • the properties of these relatively new plasmas are little known.
  • their unwanted Spaltjankeit falls on what devices with close-meshed, especially in the field of viewing windows made necessary to avoid direct contact with the plasma.
  • the ability to penetrate capacitively excited plasma at a frequency of 40 MHz to 150 MHz into narrow lumens, long thin tubes, and covered areas, and to be able to ignite plasma in externally sealed lumens is of paramount importance in sterilization.
  • the inventive method is characterized in that the dipole character of the capacitive coupling leads to a high electric field strength within the plasma and the high frequencies lead to a high plasma density with high efficiency.
  • the high frequency of the capacitively excited plasma produces high plasma densities, which in turn result in high light intensity, a high radical flux density and a high ion flux density.
  • the method according to the invention is particularly advantageous for medical and pharmaceutical purposes, such as sterilizing and depyrogenating implants and bone substitutes, medical devices such as cutlery, endoscopes, catheters, but also pharmaceutical containers such as vials, syringes or bottles.
  • the claimed plasma sterilization process has additional positive accompanying effects.
  • UHMWPE ultra-high molecular weight polyethylene
  • a targeted surface modification of the material can be achieved, whereby the abrasion behavior of the surface can be purposefully reduced.
  • the thickness of the modified layer is controlled by the contact time and the entire operating state of the plasma. It is also advantageous that the elasticity of the internal material is not influenced by the surface modification.
  • the growth behavior of medical implants that are used in the human body significantly improved because the surface can be adjusted or modified so that the human cells grow on this preferred.
  • the objects to be sterilized are accommodated in an evacuable sterilization chamber, which can be connected to a supply line for gas to be ionized.
  • a generator or a transmitting device is provided for coupling a high-frequency alternating electromagnetic field in a range from 40 MHz to 150 MHz.
  • the electromagnetic alternating field is capacitively coupled into the plasma in the sterilization chamber via two electrodes or antennas.
  • the generator can be designed as a cantilever to save the matching network (matchbox) of a typical high-frequency supply.
  • the figure shows a simplified representation of a device for carrying out the claimed sterilization process.
  • the device 1 comprises a sterilization chamber 2 into which a reaction gas is introduced via a gas inlet 3. At the same gas is pumped through a gas outlet 4 via a pump, not shown, so that a total negative pressure in the sterilization chamber 2 prevails.
  • a gas inlet 3 At the same gas is pumped through a gas outlet 4 via a pump, not shown, so that a total negative pressure in the sterilization chamber 2 prevails.
  • two electrodes 5, 6, which are connected to a generator 7 for high-frequency electromagnetic radiation, so that between the electrodes 5, 6 an alternating electromagnetic field 8 is formed, which is symbolized by the marked field lines.
  • the alternating electric field oscillates at a frequency in a range of 40 MHz to 150 MHz and leads to electron impact ionization of the gas in the sterilization chamber 2, so that a plasma 9 is formed between the electrodes 5, 6.
  • the article 10 is, for example, an elongate, slender body with a lumen, which article is to be sterilized not only externally but also internally.
  • a high electric field strength in the capacitively coupled electromagnetic field leads to a high ignitability of the plasma, so that the plasma state also exists within the object 10.
  • the high plasma density resulting from the frequency of 40 MHz to 150 MHz sets in addition to a high light intensity mechanisms that lead to an accelerated and thorough sterilization of the object.

Landscapes

  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (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

Procédé de stérilisation selon lequel des objets à stériliser (10) sont disposés dans une chambre de stérilisation (2) et soumis à un plasma à basse pression (9) pendant une durée suffisante pour la stérilisation. Un champ alternatif électrique à haute fréquence est généré au moyen d'un générateur (7) à une fréquence comprise dans une plage allant de 40 MHz à 150 MHz entre deux électrodes (5, 6), pour faire passer un gaz se trouvant dans la chambre de stérilisation à l'état de plasma, par le couplage capacitif d'un champ électrique.
PCT/DE2007/000931 2006-05-31 2007-05-23 Procédé de stérilisation WO2007137556A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006025736.7 2006-05-31
DE102006025736A DE102006025736A1 (de) 2006-05-31 2006-05-31 Sterilisationsverfahren

Publications (1)

Publication Number Publication Date
WO2007137556A1 true WO2007137556A1 (fr) 2007-12-06

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PCT/DE2007/000931 WO2007137556A1 (fr) 2006-05-31 2007-05-23 Procédé de stérilisation

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DE (1) DE102006025736A1 (fr)
WO (1) WO2007137556A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8821788B2 (en) 2008-08-30 2014-09-02 Krones Ag Electron beam sterilisation for containers

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011076404B4 (de) 2011-05-24 2014-06-26 TRUMPF Hüttinger GmbH + Co. KG Verfahren zur Impedanzanpassung der Ausgangsimpedanz einer Hochfrequenzleistungsversorgungsanordnung an die Impedanz einer Plasmalast und Hochfrequenzleistungsversorgungsanordnung

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4042325A (en) * 1976-06-21 1977-08-16 Eli Lilly And Company Method of killing microorganisms in the inside of a container utilizing a plasma initiated by a focused laser beam and sustained by an electromagnetic field
WO2002022447A1 (fr) * 2000-09-15 2002-03-21 Rüdiger Haaga GmbH Procede pour realiser la sterilisation et la depyrogenation de contenants laves
WO2003075965A1 (fr) * 2002-03-08 2003-09-18 Rüdiger Haaga GmbH Dispositif de sterilisation d'objets
WO2003077959A1 (fr) * 2002-03-19 2003-09-25 Robert Bosch Gmbh Procede et dispositif permettant au moins la sterilisation de recipients et/ou de leurs elements de fermeture

Family Cites Families (10)

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Publication number Priority date Publication date Assignee Title
US4207286A (en) * 1978-03-16 1980-06-10 Biophysics Research & Consulting Corporation Seeded gas plasma sterilization method
US5200146A (en) * 1991-02-26 1993-04-06 Air Techniques, Inc. Apparatus for effecting plasma sterilization
US5262125A (en) * 1991-02-26 1993-11-16 Air Techniques, Inc. Process and apparatus for effecting plasma sterilization
US5633424A (en) * 1994-12-29 1997-05-27 Graves; Clinton G. Device and methods for plasma sterilization
DE19640528A1 (de) * 1996-10-01 1998-04-02 Roland Dr Gesche Verfahren, Vorrichtung und Behälter für die Behandlung von Teilen mit vakuumtechnischen Prozessen
DE19806516A1 (de) * 1998-02-17 1999-08-19 Ruediger Haaga Gmbh Verfahren zum Sterilisieren von Behältern
DE19944631A1 (de) * 1999-09-17 2001-03-22 Aurion Anlagentechnik Gmbh Entkeimung und Beschichtung von Hohlkörpern durch Mikrowellenplasma
KR100411930B1 (en) * 2002-06-17 2003-12-18 Human Meditek Co Ltd Plasma sterilizing apparatus with dehumidifier
DE102004049783B4 (de) * 2004-10-12 2009-03-19 Je Plasmaconsult Gmbh Vorrichtung zur Bearbeitung von Gütern unter Zuhilfenahme einer elektrischen Entladung
DE102004054662B4 (de) * 2004-11-12 2009-05-07 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Verfahren und Vorrichtung zur Innenbehandlung von Hohlprofilen

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4042325A (en) * 1976-06-21 1977-08-16 Eli Lilly And Company Method of killing microorganisms in the inside of a container utilizing a plasma initiated by a focused laser beam and sustained by an electromagnetic field
WO2002022447A1 (fr) * 2000-09-15 2002-03-21 Rüdiger Haaga GmbH Procede pour realiser la sterilisation et la depyrogenation de contenants laves
WO2003075965A1 (fr) * 2002-03-08 2003-09-18 Rüdiger Haaga GmbH Dispositif de sterilisation d'objets
WO2003077959A1 (fr) * 2002-03-19 2003-09-25 Robert Bosch Gmbh Procede et dispositif permettant au moins la sterilisation de recipients et/ou de leurs elements de fermeture

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8821788B2 (en) 2008-08-30 2014-09-02 Krones Ag Electron beam sterilisation for containers

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Publication number Publication date
DE102006025736A1 (de) 2007-12-06

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