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WO2002074351A1 - Procede de sterilisation de contenants - Google Patents

Procede de sterilisation de contenants Download PDF

Info

Publication number
WO2002074351A1
WO2002074351A1 PCT/EP2002/002268 EP0202268W WO02074351A1 WO 2002074351 A1 WO2002074351 A1 WO 2002074351A1 EP 0202268 W EP0202268 W EP 0202268W WO 02074351 A1 WO02074351 A1 WO 02074351A1
Authority
WO
WIPO (PCT)
Prior art keywords
sterilization chamber
pressure
containers
sterilization
group
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2002/002268
Other languages
German (de)
English (en)
Inventor
Robert Frost
Peter Awakowicz
Werner Stahlecker
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Haaga Ruediger GmbH
Original Assignee
Haaga Ruediger 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 Haaga Ruediger GmbH filed Critical Haaga Ruediger GmbH
Priority to JP2002573058A priority Critical patent/JP4162208B2/ja
Publication of WO2002074351A1 publication Critical patent/WO2002074351A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61L2/208—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
    • 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
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • A61L2103/23—
    • 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

Definitions

  • the invention relates to a method for sterilizing a group of containers located in an evacuable sterilization chamber.
  • a method of this type, but with method steps which differ as a result, is prior art, for example, from DE 44 08 301 A1.
  • the known method is carried out in a sterilization chamber, which is part of a so-called linear filler, in which the containers to be filled run straight through the machine system.
  • a sterilization chamber which is part of a so-called linear filler, in which the containers to be filled run straight through the machine system.
  • a group of, for example, six containers is simultaneously in a sterilization chamber. All containers in the group are therefore at the same position in the relevant process cycle at all times.
  • the machine system works discontinuously.
  • the sterilization itself is carried out by means of a low-temperature plasma generated in the sterilization chamber.
  • the invention is based on the object, in a basic method of the type mentioned, but without the low-temperature plasma used for sterilization, to show a method with which such cyclically operating linear fillers work with much better efficiency during sterilization.
  • the object is achieved in that the following procedural steps are carried out in succession:
  • activating When sterilizing using hydrogen peroxide, which is always present in aqueous solution, the actual germ killing takes place purely chemically, through the action of “activated” hydrogen peroxide.
  • activating used here is undefined per se, but it has been found that by suitable heat supply A chemical and / or physical change takes place on the hydrogen peroxide, which ultimately causes the germs to be killed.
  • the “activation” of the hydrogen peroxide takes place precisely when it is needed for sterilization, so with the condensation.
  • the subsequent removal of the hydrogen peroxide residues is carried out by merely evacuating to a pressure at which the components of the condensate evaporate, which is possible in a matter of seconds and safely removes all hydrogen peroxide residues.
  • the steam mixture of water vapor and hydrogen peroxide vapor required for sterilization is generated in an evaporator, the design of which is arbitrary per se for the present invention, provided that it is capable of producing a sufficiently large amount of steam with a sufficiently high concentration of hydrogen peroxide vapor in the steam mixture in a sufficiently short time to create.
  • the actual "activation" of the hydrogen peroxide contained in the steam mixture then takes place during condensation on the surfaces to be sterilized. This causes the steam mixture to wet the surfaces with the thinnest possible homogeneous liquid film. Due to the small layer thickness, it does not occur during the subsequent drying by evacuation to any signs of icing.
  • 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 responsible for the germicidal effect.
  • the temperature of the steam mixture, the pressure of the steam mixture before it flows into the sterilization chamber and the pressure in the sterilization chamber at which the condensation takes place are available to influence the sterilization effect.
  • the condensation pressure should definitely be below 500 mb, preferably wise in a range of 250 to 150 mb.
  • the pressure required to remove the condensate should be below 4 mb.
  • a pumping station consisting of a rotary vane pump and a subsequent Roots pump can be used for both process steps for evacuating the sterilization chamber, although the Roots pump during the pre-evacuation is appropriately avoided by a bypass. This prevents the Roots pump from being exposed to an excessively high pressure difference.
  • the sterilization chamber exceeds a certain volume, it is provided in a further embodiment of the invention that the steam mixture to be fed into the sterilization chamber and / or the sterile gas required for flooding the sterilization chamber are in each case kept in a store upstream of the sterilization chamber and the relevant store during the Process steps in which the memory is not required are replenished.
  • the required throughput of the evaporator or sterile filter is lower, since a relatively long time is available to fill the storage.
  • FIG. 1 shows a plan view of a sterilization chamber and the way in which a group of containers is fed and removed
  • FIG. 2 shows a diagram for explaining the individual method steps
  • Figure 3 is a diagram for explaining the functional elements required for the inventive method.
  • FIG. 1 shows a section of a machine system in the area of a sterilization chamber 1.
  • the machine system is a clocked, linear machine network that integrates the sterilization chamber 1 and a filling and closing device in a single frame and for small and medium-sized ones Outputs of around 12,000 containers per hour, for example.
  • a conveyor belt 2 brings a group of containers 3 laterally next to the sterilization chamber 1 in the feed direction A.
  • the group contains a total of ten containers 3.
  • the containers next to the sterilization chamber 1 are placed on the conveyor belt 2 waiting
  • the container 3 is simultaneously pushed into holders, not shown, of a lowered loading floor or the like, also not shown, which can then be moved upwards into the sterilization chamber 1.
  • the loading floor is lowered again.
  • the now sterilized containers 4 are pulled out of the sterilization chamber 1 as a group and transferred to a conveyor belt 5.
  • the present invention relates exclusively to the process steps that take place in the area of the sterilization chamber 1.
  • the chronological sequence of the sterilization process in the sterilization chamber 1 is shown as a diagram in FIG. 2, the abscissa indicating the time t in seconds [s] and the ordinate indicating the respective pressure P in millibars [mb] prevailing in the sterilization chamber 1.
  • Curve 6 of the diagram shown in FIG. 2 thus shows the pressure curve over time.
  • a first method step (a) the containers 3 provided in a group are introduced into the sterilization chamber 1, which takes place at atmospheric pressure (1000 mb).
  • the sterilization chamber 1 is then hermetically sealed. The closing time takes about 0.7 seconds.
  • the sterilization chamber 1 is evacuated to a pressure of less than 400 mb, preferably to about 150 mb, that is to say a pressure which allows a subsequently flowing steam mixture of water vapor and hydrogen peroxide vapor to reach the Surfaces of the container 3 can condense. Pre-evacuation takes about 0.8 seconds.
  • process step (f) the condensate must now be removed from the sterilized containers 4, which is done by evacuating the sterilization chamber 1 to a pressure below the current boiling points of water and hydrogen peroxide. It has been shown that the final pressure of process step (f) should be slightly below 4 mb. This is the most time-consuming phase of the sterilization process, which takes about 3.4 seconds.
  • the sterilization chamber 1 is suddenly flooded with a sterile gas, for example sterile air or sterile nitrogen, within 0.5 seconds. This takes place during process step (g), after which a pressure is reached which is approximately 0.3 mb above the atmospheric pressure prevailing on the outside of the machine system.
  • a sterile gas for example sterile air or sterile nitrogen
  • the total effort of the sterilization process, including loading and unloading the sterilization chamber 1, is approximately 10.8 seconds.
  • FIG. 3 schematically shows the interaction of the functional elements assigned to the sterilization chamber 1, with the aid of which the containers 3 are to be sterilized.
  • process steps (c) and (f) take place at different times, and therefore a common pumping station 7 can be used for both process steps.
  • the pumping station 7 consists of a rotary vane pump 8 and a Roots pump 9.
  • the gas stream of process step (c) can be bypassed the Roots pump 9 via a controllable valve 10 by means of a bypass 11 and this Roots pump 9 can be short-circuited in terms of pressure, so to speak.
  • the pre-evacuation phase (c) is handled by the rotary vane pump 8 alone.
  • a gas buffer 12 which can be opened via a controllable valve 13, this can be flooded at the beginning of phase (c), as a result of which a large amount of the gas flows suddenly from the sterilization chamber 1 into this pre-evacuated volume and not from that Rotary vane pump 8 needs to be promoted.
  • the rotary vane pump 8 could then be made smaller.
  • the filled gas buffer 12 could then during process steps (a), (b), (g), (h) and (i) are evacuated again, i.e. in the phases during which no pump power is otherwise requested.
  • the steam mixture which is required during process step (d) and consists of water vapor and hydrogen peroxide vapor is generated by an evaporator 14 during the remaining phases and is kept available in a store 15 heated to at least 100 °.
  • the steam mixture flows into the sterilization chamber 1 by briefly opening several likewise heated valves 16.
  • the number of valves 16 is intended to ensure that the steam mixture flows uniformly into the sterilization chamber 1.
  • Nozzles 17 are provided on the sterilization chamber 1, through which the steam mixture flows into the sterilization chamber 1 and which ensure a suitable spatial distribution of the inflow and a suitable inflow speed.
  • the aqueous hydrogen peroxide solution is fed to the evaporator 14 in the direction of arrow C via a valve 18.
  • a valve 19 enables the evaporator 14 to be shut off from the store 15 if necessary.
  • Another valve 20 enables the storage 15 to be evacuated via a line 21. At the start of operation, air can thus be removed from the storage 15.
  • a cyclical pressure reduction in the memory 15 can also be carried out, if necessary. This could be necessary if, after the steam mixture flows into the sterilization chamber 1, an excessively high residual pressure remains in the accumulator 15.
  • the memory 15 has a temperature sensor 25 and a pressure sensor 26 for controlling the process and for monitoring the proper functioning.
  • the residue-free removal of the condensate during process step (f) is monitored by means of a pressure sensor 22. If the pressure falls below a limit of around 3.8 mb, pump valves are activated
  • a quantity of gas of about 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.
  • a further store 27 is provided, which during the remaining process phases is continuously pre-filled with pressurized air or pressurized nitrogen via a sterile filter 28 and a shut-off valve 29 with sterile gas fed.
  • the pressure generated in the sterilization chamber 1 can practically not be regulated. With known volume ratios, as is the case here, however, the pressure that arises in the sterilization chamber 1 can be precisely determined by building up a very specific pressure in the accumulator 27 before flooding. After the pressure equalization, this pressure determines the final pressure to be expected in the accumulator 27. For this purpose, a very precisely working pressure sensor 30 is provided. Before opening the sterilization chamber 1, the pressure in the sterilization chamber 1 must correspond very precisely 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.
  • the volume of the storage 27 for the sterile gas should be as small as possible so that space is saved.
  • the pressure required should only be so high that the accuracy of the flooding to the level of the external pressure is not impaired.
  • a good compromise is between 1.5 and 2.5 bar. This results in a storage volume that corresponds to approximately 1.5 to 2 times the volume of the sterilization chamber 1.

Landscapes

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

Abstract

L'invention concerne un procédé pour stériliser un groupe de contenants. Ce procédé consiste à introduire ce groupe de contenants dans une chambre de stérilisation ouverte, à fermer cette chambre de façon hermétique puis à la pré-évacuer, à injecter un mélange de vapeur d'eau et de vapeur de peroxyde d'hydrogène dans ladite chambre de stérilisation, à permettre la condensation du mélange de vapeur sur les surfaces des contenants, à éliminer le condensat formé en évacuant la chambre de stérilisation, à remplir cette dernière d'un gaz stérile, à ouvrir la chambre de stérilisation pour en retirer le groupe de contenants.
PCT/EP2002/002268 2001-03-20 2002-03-02 Procede de sterilisation de contenants Ceased WO2002074351A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2002573058A JP4162208B2 (ja) 2001-03-20 2002-03-02 容器を滅菌する方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10114758A DE10114758B4 (de) 2001-03-20 2001-03-20 Verfahren zum Sterilisieren von Behältern
DE10114758.9 2001-03-20

Publications (1)

Publication Number Publication Date
WO2002074351A1 true WO2002074351A1 (fr) 2002-09-26

Family

ID=7679052

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2002/002268 Ceased WO2002074351A1 (fr) 2001-03-20 2002-03-02 Procede de sterilisation de contenants

Country Status (4)

Country Link
JP (2) JP4162208B2 (fr)
CN (1) CN100408105C (fr)
DE (1) DE10114758B4 (fr)
WO (1) WO2002074351A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009118096A1 (fr) * 2008-03-25 2009-10-01 Khs Ag Machine de traitement de récipients
US8092757B2 (en) 2005-06-24 2012-01-10 Sidel Participations Method for sterilizing preforms and installation for producing sterile bodies from these preforms

Families Citing this family (12)

* 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
DE102005035528A1 (de) * 2005-07-26 2007-02-01 Heim Medizintechnik Gmbh Dampfsterilisierbare Bluttrennvorrichtung
JP5332938B2 (ja) * 2009-06-22 2013-11-06 富士電機株式会社 電子線照射型無菌真空充填方法及びその装置
DE102011054827A1 (de) * 2011-10-26 2013-05-02 Aesculap Ag Medizinischer Sterilbehälter und Verfahren zum Bestimmen des Sterilisationsstatus eines medizinischen Sterilbehälters
DE102012019937A1 (de) 2012-10-11 2014-04-17 Fresenius Medical Care Deutschland Gmbh Sterilisationsverfahren
US9302021B2 (en) * 2013-08-30 2016-04-05 American Sterilizer Company Method of performing sterilization cycle
DE102014118776A1 (de) 2014-12-16 2016-06-16 Sig Technology Ag Verfahren und Vorrichtung zum Sterilisieren von Behältern
KR101825786B1 (ko) 2015-07-21 2018-02-07 씨제이제일제당 (주) 보강리브를 포함하는 물품살균장치
DE102015121322A1 (de) 2015-12-08 2017-06-08 Aesculap Ag Medizinische Umlaufsperrvorrichtung, medizinisches Instrument und medizinischer Sterilisierbehälter
CN110960711B (zh) * 2019-12-31 2021-04-23 河南先途智能科技有限公司 等离子体消毒柜
FR3116463B1 (fr) 2020-11-26 2023-11-03 Sidel Participations Machine de formage comportant un dispositif de stérilisation d'un réseau de soufflage
WO2025089287A1 (fr) * 2023-10-23 2025-05-01 三浦工業株式会社 Procédé d'élimination de peroxyde d'hydrogène

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4512951A (en) * 1980-12-30 1985-04-23 American Sterilizer Company Hydrogen peroxide liquid film sterilization method
US4952370A (en) * 1988-05-06 1990-08-28 American Sterilizer Company Hydrogen peroxide sterilization method
US4992247A (en) * 1989-05-11 1991-02-12 Elopak Systems, A.G. Container sterilization system
WO2000038745A1 (fr) * 1998-12-30 2000-07-06 Ethicon, Inc. Methode de sterilisation d'un article garantissant l'asepsie dudit article
WO2002020066A1 (fr) * 2000-09-07 2002-03-14 Rüdiger Haaga GmbH Procede de sterilisation d'objets

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SE423313B (sv) * 1977-10-17 1982-05-03 Electrolux Ab Sett och anordning for sterilisering med formalin
SE423488C (sv) * 1977-10-17 1984-10-15 Electrolux Ab Sett och anordning for sterilisering med formalin
JPS5969077A (ja) * 1982-10-12 1984-04-19 アメリカン・ステリライザ−・コムパニ− 過酸化水素の液体膜による殺菌方法
JPH01126906A (ja) * 1987-11-11 1989-05-19 Nippon Health Supply:Kk 中敷
SE507994C2 (sv) * 1996-10-14 1998-08-10 Tetra Laval Holdings & Finance Sätt att sterilisera förpackningsmaterial
JPH10119934A (ja) * 1996-10-23 1998-05-12 Shikoku Kakoki Co Ltd 容器殺菌装置および容器包材の殺菌方法
DE19806520A1 (de) * 1998-02-17 1999-08-19 Ruediger Haaga Gmbh Verfahren zum Sterilisieren, Befüllen und Verschließen von Behältern

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4512951A (en) * 1980-12-30 1985-04-23 American Sterilizer Company Hydrogen peroxide liquid film sterilization method
US4952370A (en) * 1988-05-06 1990-08-28 American Sterilizer Company Hydrogen peroxide sterilization method
US4992247A (en) * 1989-05-11 1991-02-12 Elopak Systems, A.G. Container sterilization system
WO2000038745A1 (fr) * 1998-12-30 2000-07-06 Ethicon, Inc. Methode de sterilisation d'un article garantissant l'asepsie dudit article
WO2002020066A1 (fr) * 2000-09-07 2002-03-14 Rüdiger Haaga GmbH Procede de sterilisation d'objets

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8092757B2 (en) 2005-06-24 2012-01-10 Sidel Participations Method for sterilizing preforms and installation for producing sterile bodies from these preforms
WO2009118096A1 (fr) * 2008-03-25 2009-10-01 Khs Ag Machine de traitement de récipients
US8790576B2 (en) 2008-03-25 2014-07-29 Khs Gmbh Vessel treatment machine

Also Published As

Publication number Publication date
JP2004528886A (ja) 2004-09-24
DE10114758A1 (de) 2002-09-26
CN100408105C (zh) 2008-08-06
DE10114758B4 (de) 2013-01-31
CN1498119A (zh) 2004-05-19
JP2008133054A (ja) 2008-06-12
JP4162208B2 (ja) 2008-10-08
JP4914971B2 (ja) 2012-04-11

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