WO2002078753A1 - Procede de sterilisation d'objets - Google Patents

Procede de sterilisation d'objets Download PDF

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Publication number
WO2002078753A1
WO2002078753A1 PCT/EP2002/002266 EP0202266W WO02078753A1 WO 2002078753 A1 WO2002078753 A1 WO 2002078753A1 EP 0202266 W EP0202266 W EP 0202266W WO 02078753 A1 WO02078753 A1 WO 02078753A1
Authority
WO
WIPO (PCT)
Prior art keywords
sterilization chamber
process gas
sterilization
steam mixture
condensate
Prior art date
Application number
PCT/EP2002/002266
Other languages
German (de)
English (en)
Inventor
Robert Frost
Peter Awakowicz
Werner Stahlecker
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
Publication of WO2002078753A1 publication Critical patent/WO2002078753A1/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
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • A61L2/186—Peroxide solutions
    • 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
    • A61L2/04—Heat
    • A61L2/06—Hot gas
    • A61L2/07—Steam
    • 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
    • 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
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail

Definitions

  • the invention relates to a method for sterilizing objects in a sterilization chamber, in which a steam mixture containing water vapor and hydrogen peroxide vapor is introduced into the previously evacuated sterilization chamber and the surfaces to be sterilized are wetted by condensation, after which the condensate is removed from the sterilized surfaces by drying and a sterile process gas is introduced into the sterilization chamber.
  • a method of this kind is known from JP (B2) 61-4543.
  • a vapor mixture consisting of water vapor and hydrogen peroxide vapor reaches an evacuated sterilization chamber with the aid of a carrier air stream.
  • Condensate formation takes place there with the aim of achieving a sterilizing effect both through the aqueous solution and through the gaseous state.
  • the steam mixture reaches all surfaces even with complicated shapes of the objects.
  • the condensate formed is removed by means of a process gas, in the present case with filtered air, which is heated and thereby also removes the condensate from the sterilization chamber. In the known method, this process can additionally be facilitated by heating the objects.
  • Process gases after sterilization are not only used to remove the condensate or to flood the sterilization chamber after removing the condensate, but also when, for example, after sterilizing washed objects, a so-called depyrogenization takes place, through which bacterial endotoxins, which result are always inactive on the surfaces of the objects during a washing process.
  • the process gas is a gas with which a plasma can be ignited in a suitable manner. In this case too, the gas used to generate the plasma must be passed through a sterile filter, which in turn must first be sterilized after a break in operation.
  • the invention is therefore based on the object of designing the method of the type mentioned at the outset such that in any case the required process gas, of whatever type, also enters the sterilization chamber in an actually sterile state.
  • the object is achieved in that, after each pause in operation when the sterilization chamber is started up, the devices associated with the process gas, including a sterile filter for sterilization, are also evacuated and the steam mixture is subjected to the formation of condensate, after which the condensate is pumped out.
  • “Moment” is to be understood as the period of time that is required for the condensation from the gas phase. Depending on the technical configuration, this can be a few tenths of a second, in particular in the case of sudden adiabatic expansion, or else a few seconds in another configuration of one required for this evaporator.
  • the enthalpy of vaporization released during the condensation provides the energy required to be able to dissociate a hydrogen peroxide molecule in such a way that an oxygen atom is released chemically highly reactive atomic oxygen is responsible for the germicidal effect It is sufficient if the surfaces to be sterilized are wetted with a microscopically thin homogeneous liquid film which is almost invisible to the naked eye in order to achieve a sterilizing effect in a matter of seconds.
  • JP (B2) 61-4543 which also works with condensing hydrogen peroxide vapor, the actually advantageous sterilization effect was neither recognized nor exploited.
  • the known publication assumes that objects can be sterilized either by immersing them in a concentrated water solution of hydrogen peroxide or by means of steam containing hydrogen peroxide. That in the The known method using the condensation of the steam mixture is based on the intention to achieve the disinfectant effect both through the solution and through the gaseous state, without recognizing that when using a very thin condensation film, not through the liquid and gaseous phase, but by condensing the germicidal effect.
  • the devices assigned to the process gas are very branched lines or large volumes, then it is Expedient if the devices concerned are subjected to the steam mixture several times in succession. In order to avoid so-called condensation nests, which could form in angled lines at critical points, it can alternatively be advantageous if the devices assigned to the process gas are continuously supplied with a vapor mixture over a certain period of time. With such continuous supersaturation, the steam mixture flows from the evaporator into the sterilization chamber, the process of exposure to the steam mixture extending over a longer period of time, so that the steam mixture can always be homogeneously distributed and condensate formation therefore takes place everywhere.
  • Aqueous solution is continuously evaporated over a certain period of time, as a result of which an overpressure is maintained in the evaporator and a steam mixture can therefore be continuously introduced into the sterilization chamber and into the devices assigned to the process gas.
  • the steam mixture expands in the sterilization chamber, which in turn leads to cooling.
  • the pressure in the sterilization chamber is increased by the continuously flowing steam mixture. Both cooling and pressure increase lead to an over-saturation of the steam mixture accumulating in the sterilization chamber and in the devices assigned to the process gas, since both processes push the state of the steam mixture below the dew point. As long as the steam mixture is supplied, condensate is formed on all accessible surfaces.
  • a sterilization chamber 1 and the devices assigned to it are drawn schematically, with the aid of which the surfaces 2 of objects, for example containers 3, are to be sterilized.
  • a common pumping station 4 is used to evacuate the sterilization chamber 1 during various process steps.
  • This consists of a rotary vane pump 5 and a Roots pump 6. Since there are very different pressure conditions during different process steps, the gas flow can be bypassed past the Roots pump 6 by means of a controllable valve 7, so that the rotary vane pump 5 is then effective on its own ,
  • a gas buffer 9 which can be opened via a controllable valve 10, this can be flooded during evacuation, as a result of which a large amount of the gas flows suddenly from the sterilization chamber 1 into this pre-evacuated volume and is not delivered by the rotary vane pump 5 needs.
  • the rotary vane pump 5 could then be made smaller.
  • the steam mixture required for sterilization consisting of water vapor and hydrogen peroxide vapor, is generated by an evaporator 11 and kept ready in a memory 12 heated to at least 100 °.
  • the steam mixture flows into the sterilization chamber 1 without an additional carrier air flow by briefly opening several likewise heated valves 13.
  • the number of valves 13 is intended to ensure a uniform flow of the steam mixture into the sterilization chamber 1.
  • Nozzles 14 are provided on the sterilization chamber 1, through which the steam mixture flows into the sterilization chamber 1 and which have a suitable spatial distribution of the Inflow and ensure a suitable inflow speed.
  • the aqueous hydrogen peroxide solution to be evaporated is fed to the evaporator 11 in the direction of arrow A via a valve 15.
  • a valve 16 enables the evaporator 11 to be shut off from the reservoir 12 if necessary.
  • Another valve 17 enables the storage 12 to be evacuated via a line 18. At the start of operation, air can thus be removed from the storage 12.
  • the memory 12 has a temperature sensor 19 and a pressure sensor 20 for controlling the process and for monitoring the proper functioning.
  • the residue-free removal of the condensate after sterilization is monitored by means of a pressure sensor 21.
  • a pressure sensor 21 When the pressure falls below a limit pressure of approximately 3.8 mb, pump valves 22 are closed, and a sterile gas is flooded into the sterilization chamber 1 via flood valves 23 until the external pressure is reached. Only then can the sterilization chamber 1 be opened to remove the containers 3.
  • a number of flood valves 23 are provided to evenly distribute this process gas in the sterilization chamber 1 and to avoid unfavorable flow conditions. For a similar reason, there are several pump valves 22.
  • a process gas quantity of, for example, 130 normal liters is required for flooding within about 0.5 seconds. This number of normal liters corresponds to the volume of the sterilization chamber 1. Such a gas stream cannot be passed through a sterile filter during flooding, since such a flow would be too large. For this reason, a further memory 24 is provided which, as long as it is not required, is continuously filled with compressed air or compressed nitrogen via a sterile filter 25 and a shut-off valve 26 with sterile gas, which is supplied in the direction of arrow B via a valve 27.
  • the pressure generated in the sterilization chamber 1 can practically not be regulated.
  • the pressure that arises in the sterilization chamber 1 can be precisely determined by building up a very specific pressure in the reservoir 24 before flooding. After pressure equalization, this pressure determines the final pressure to be expected in the accumulators 12 and 24.
  • a very precisely working pressure sensor 28 is provided.
  • the pressure in the sterilization chamber 1 Before opening the sterilization chamber 1, the pressure in the sterilization chamber 1 must correspond exactly to the outside pressure of the machine system and have a slight overpressure of approx. 0.3 mb, so that no harmful flows resulting from pressure differences enter the inside of the sterilization chamber 1. The entry of contaminated air from the machine hall into the area of the machine system must be avoided in any case.
  • depyrogenization can be carried out by the action of plasma, for which purpose a suitable process gas is fed into the sterilization chamber 1 after the condensate has been removed.
  • a suitable process gas is fed into the sterilization chamber 1 after the condensate has been removed.
  • the actual invention is explained below using the example of the sterile gas supply.
  • the invention can also be used analogously for a plasma gas.
  • the sterilization chamber 1 is evacuated, the flood valves 23 and the shut-off valve 26 are also opened during start-up, while the shut-off valve 27 is kept closed. As a result, all of the devices 29 associated with the sterile gas, including the sterile filter 25, are also evacuated. Due to the pumping speed of the rotary vane pump 5, a pressure of less than 1 mb is reached in a very short time, which is sufficient by far. Subsequent closing of the pump valves 22 seals off the entire space consisting of the sterilization chamber 1, storage 24 and sterile filter 25.
  • valves 13 By opening the valves 13, the steam mixture resulting from water vapor and hydrogen peroxide vapor can flow into the sterilization chamber 1, the steam mixture now penetrating into the reservoir 24 and the sterile filter 25. The total space formed by the currently open valves 23 and 26 is thus completely under the influence of the steam mixture. The valves 13 are then closed again, so that no further steam mixture flows in.
  • the devices 29 are continuously supplied with a vapor mixture over a certain period of time, the evaporator 11 operating with the valves 16 and 13 open. Then more and more steam mixture is slowly and steadily transported into the entire room, according to the principle of so-called continuous supersaturation.
  • the steam mixture consisting of water vapor and hydrogen peroxide vapor is not expanded suddenly from a high pressure level in order to be reflected in the next best corner. Rather, a uniform vapor pressure can build up in the entire room, which leads to steady and largely uniform condensation even on the more distant surfaces.
  • the sterilization of devices located outside the sterilization chamber need not be limited to the devices assigned to a process gas, but can also be extended to the feed devices for a filling material, which can somehow be connected to the evaporator or vacuum devices. Such a variant is particularly advantageous if, for example, a filling device filling the sterilized container with the sterilization onshunt is coupled anyway.
  • the feed devices for a filling material contain filling valves, filling material lines to the filling material buffer tank, the buffer tank itself, any further lines as well as finally a possibly integrated closing device.

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  • 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

La présente invention concerne un procédé de stérilisation d'objets (3) dans une chambre de stérilisation (1) dans laquelle est introduit un mélange de vapeur contenant de la vapeur d'eau et de la vapeur de peroxyde d'hydrogène. Ce mélange de vapeurs, à l'intérieur de la chambre de stérilisation dans laquelle le vide a été fait préalablement, humidifie ainsi les surfaces à stériliser des objets. Ensuite, le condensat est éliminé des surfaces stérilisées par séchage et un gaz de traitement stérile est introduit dans la chambre de stérilisation. Après chaque arrêt de fonctionnement, lors de la mise en service de la chambre de stérilisation, le vide est également fait dans les dispositifs (29) associés au gaz de traitement, y compris dans le filtre stérile (25), ce qui permet leur stérilisation, et ces dispositifs sont exposés au mélange de vapeurs, ce qui provoque la formation de condensat. Le condensat est alors évacué par pompage.
PCT/EP2002/002266 2001-03-29 2002-03-02 Procede de sterilisation d'objets WO2002078753A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10116395.9 2001-03-29
DE2001116395 DE10116395A1 (de) 2001-03-29 2001-03-29 Verfahren zum Sterilisieren von Gegenständen

Publications (1)

Publication Number Publication Date
WO2002078753A1 true WO2002078753A1 (fr) 2002-10-10

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Application Number Title Priority Date Filing Date
PCT/EP2002/002266 WO2002078753A1 (fr) 2001-03-29 2002-03-02 Procede de sterilisation d'objets

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DE (1) DE10116395A1 (fr)
WO (1) WO2002078753A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1454639A1 (fr) * 2003-02-27 2004-09-08 Rüdiger Haaga GmbH Procédé de stérilisation dans un système de transport et d'emballage
EP3009152A1 (fr) * 2014-10-16 2016-04-20 Gea Procomac S.p.A. Appareil de stérilisation pour la stérilisation d'un récipient et procédé de stérilisation d'un récipient

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10302344A1 (de) 2003-01-17 2004-07-29 Rüdiger Haaga GmbH Sterilisationskammer zum Sterilisieren von Gegenständen
DE10312150A1 (de) * 2003-03-17 2004-09-30 Rüdiger Haaga GmbH Verfahren zum Erzeugen und schlagartigen Zuführen eines aus Wasserdampf und Wasserstoffperoxiddampf bestehenden Dampfgemisches

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1582060A (en) * 1976-10-07 1980-12-31 Tetra Pak Int Sterilisation
DE3237082A1 (de) * 1982-09-29 1984-04-12 American Sterilizer Co., 16512 Erie, Pa. Verfahren zum sterilisieren eines gegenstandes
US4744951A (en) * 1983-11-07 1988-05-17 American Sterilizer Company Vaporization method to enhance sterilant penetration
US4851194A (en) * 1986-08-25 1989-07-25 Tetra Dev-Co Method and arrangement for the sterilization of a filter

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1582060A (en) * 1976-10-07 1980-12-31 Tetra Pak Int Sterilisation
DE3237082A1 (de) * 1982-09-29 1984-04-12 American Sterilizer Co., 16512 Erie, Pa. Verfahren zum sterilisieren eines gegenstandes
US4744951A (en) * 1983-11-07 1988-05-17 American Sterilizer Company Vaporization method to enhance sterilant penetration
US4851194A (en) * 1986-08-25 1989-07-25 Tetra Dev-Co Method and arrangement for the sterilization of a filter

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1454639A1 (fr) * 2003-02-27 2004-09-08 Rüdiger Haaga GmbH Procédé de stérilisation dans un système de transport et d'emballage
US7727464B2 (en) 2003-02-27 2010-06-01 Ptm Packaging Tools Machinery Pte. Ltd. Process for operating a packaging transport system
EP3009152A1 (fr) * 2014-10-16 2016-04-20 Gea Procomac S.p.A. Appareil de stérilisation pour la stérilisation d'un récipient et procédé de stérilisation d'un récipient

Also Published As

Publication number Publication date
DE10116395A1 (de) 2002-10-10

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