EP0693942A1 - Procede de sterilisation a l'aide d'une substance de sterilisation sous forme de gaz ou de vapeur - Google Patents

Procede de sterilisation a l'aide d'une substance de sterilisation sous forme de gaz ou de vapeur

Info

Publication number
EP0693942A1
EP0693942A1 EP94913055A EP94913055A EP0693942A1 EP 0693942 A1 EP0693942 A1 EP 0693942A1 EP 94913055 A EP94913055 A EP 94913055A EP 94913055 A EP94913055 A EP 94913055A EP 0693942 A1 EP0693942 A1 EP 0693942A1
Authority
EP
European Patent Office
Prior art keywords
carrier gas
sterilization
conditioned
active ingredient
sterilization method
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.)
Withdrawn
Application number
EP94913055A
Other languages
German (de)
English (en)
Inventor
Dieter Achterberg
Jörg SEELMÄCKER
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.)
Mmm Muenchener Medizin Mechanik GmbH
Original Assignee
Mmm Muenchener Medizin Mechanik 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 Mmm Muenchener Medizin Mechanik GmbH filed Critical Mmm Muenchener Medizin Mechanik GmbH
Publication of EP0693942A1 publication Critical patent/EP0693942A1/fr
Withdrawn legal-status Critical Current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
    • 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
    • A61L2/204—Formaldehyde

Definitions

  • the invention relates to a sterilization process using a gaseous or vaporous sterilizing medium.
  • Sterilization processes of this type are known in sterilization technology, in which sterilization media are used in different active substance concentrations and compositions.
  • the sterilizing medium is e.g. in the interior of a sterilization chamber, or as known from the patent specification DD 134 839, by passing atmospheric air through a formaldehyde-water solution.
  • the composition of the sterilizing medium used is subject to fluctuations and is dependent in particular on the quantity of items to be sterilized in the sterilizer or the temperature of the items to be sterilized or also on weather conditions. With regard to sufficient sterilization safety, it is necessary to operate these processes with sterilization media of sufficiently high active substance concentrations.
  • a high concentration of active substance however, not only affects the operational safety and the economic viability of the system, but also its environmental compatibility. Even with increased active substance concentrations, the sterilization results are also different with regard to active substance residues adhering to the items to be sterilized and cannot be reproduced with certainty.
  • the invention has for its object to provide a safe and reliable sterilization process with which consistent and reproducible sterilization results are achieved, in particular independent of climatic changes.
  • this object is achieved by conditioning the carrier gas with respect to temperature and / or humidity in the course of a preceding step and by conditioning the carrier gas with an active ingredient for loading with it to form the sterilizing medium in the course of a subsequent sterilizing step is brought into contact and that the sterilization dium is then introduced into a sterilization room 1.
  • preconditioning which takes place separately from the active ingredient loading, it is also possible in a particularly advantageous manner to determine the conditioning parameters largely independently of the thermal stability of the active ingredient.
  • the method according to the invention makes the composition of the sterilizing medium reproducible easily and reliably, regardless of the installation site or the climatic conditions.
  • air is used as the carrier gas.
  • the method is particularly cost-effective and simple to carry out.
  • the construction of a plant operating according to the method according to the invention is also simplified in this way, since in particular no additional measures for gas storage and gas metering have to be taken. There are also extensive test results and empirical values available for the sterilizing effect of air-containing sterilizing media.
  • the carrier gas consists by weight of a mixture of nitrogen and carbon dioxide. This enables the use of non-oxygen-resistant active substances or the sterilization and treatment of non-oxygen-resistant materials and items to be sterilized in a particularly advantageous manner.
  • a particularly favorable measure for conditioning the carrier gas is given by conditioning the carrier gas by moistening it with water moisture. This makes it possible in a particularly simple manner to obtain a carrier gas with a certain water moisture. Especially when it comes to With a saturated carrier gas, the absolute moisture content can be regulated particularly easily via the temperature of the carrier gas.
  • a further measure, which is particularly favorable for the conditioning of the carrier gas, is given in that the conditioning of the carrier gas is carried out by drying.
  • a particular state of the carrier gas can be set in a particularly simple and reliable manner. Drying can be carried out using measures known from air conditioning technology, but in particular with the aid of water-absorbing substances, e.g. Salts, granules and acids take place.
  • a measure which is also particularly advantageous for conditioning the carrier gas is given in that the carrier gas is conditioned by heating. This measure can advantageously also take place in combination with the measures mentioned above.
  • a measure which is also particularly favorable for conditioning the carrier gas is given in that the carrier gas is conditioned by cooling. This makes it possible, particularly in the case of air with a high air humidity in the initial state, to separate water by falling below the dew point, so that a licensed, saturated air is obtained, the humidity of which can be adjusted via the cooling temperature. This measure can also be advantageously combined with further conditioning measures.
  • a particularly favorable embodiment of the sterilization process is provided by moistening the carrier gas by creating a large contact area between water and carrier gas.
  • the creation of a large contact area or an intimate contact of water and carrier gas can also be advantageously achieved by combining several measures.
  • a particularly inexpensive method for conditioning the carrier gas This is due to the fact that the carrier gas is moistened by bubbling through it with water. This method is particularly effective and requires little equipment. It is particularly advantageous if the carrier gas is moistened by the carrier gas exiting from a gas inlet device which is sunk in a water bath.
  • the carrier gas in a particularly advantageous manner, it is also possible for the carrier gas to be moistened by bringing the carrier gas into contact with atomized water.
  • the atomization of the water can e.g. by means of fine nozzles or by spraying the water onto obstacles. It is also possible to control the nozzles so that e.g. the spray duration or the flow rate can be adjusted to the required moisture content or air volume flow. It is also possible to carry out this moistening method in combination with further conditioning measures.
  • the carrier gas For the conditioning of the carrier gas, it is likewise possible in a particularly favorable manner for the carrier gas to be moistened by supplying water vapor.
  • This water vapor can take place in a separate, preferably electrically operated and controlled steam generator, but also in a combustion, e.g. a gas flame, originate.
  • a combustion exhaust gas By using a combustion exhaust gas, it is possible to obtain a germ-free carrier gas in a particularly favorable manner.
  • a particularly advantageous measure for conditioning the carrier gas is given by the relative humidity of the conditioned carrier gas being 100%. This makes it possible in a particularly simple manner to control the absolute moisture content of the conditioned carrier gas via the carrier gas temperature.
  • the conditioning of the carrier gas can advantageously be achieved in that the carrier gas with water-absorbing brought into contact with the fabrics and thereby dried. It is possible to use regenerable substances, for example fillings with capillary bodies or salts, from which the stored or optionally chemically bound water can be removed again by supplying heat.
  • the conditioning of the carrier gas can be carried out in a particularly favorable manner by heating the carrier gas by means of a heater. This can consist in a particularly advantageous manner in a heated pipeline.
  • a particularly advantageous measure for conditioning the carrier gas is given in that the carrier gas is heated by the dampening water. This measure can be carried out with little expenditure on equipment.
  • a particularly advantageous measure for conditioning the carrier gas is given in that the carrier gas is cooled by cooling a pipeline.
  • This pipeline can preferably be sunk in a water bath and be provided with a number of turns to extend the cooling section.
  • a measure which is particularly advantageous for the production of the sterilization medium is given in that the active substance loading is carried out by bringing the conditioned carrier gas into contact with the active substance. This advantageously makes it possible to obtain a composition of the sterilizing medium that is independent of the initial state of the carrier gas, which is unconditioned with regard to temperature and moisture.
  • a particularly favorable measure for producing the sterilizing medium is given in that the conditioned carrier gas is loaded with the active substance by creating a large contact area between the active substance and the conditioned carrier gas. As a result, an effective continuous transfer of active ingredient is achieved in a particularly favorable manner.
  • a be- A particularly favorable measure is given in that the conditioning of the conditioned carrier gas takes place by finely bubbling discharge from a gas introduction device immersed in a liquid active substance or an active substance solution for introducing gases into liquids in finely divided form.
  • This gas introduction device can be designed, for example, as a pipeline provided with bores into which the conditioned carrier gas is introduced, or can consist of a gas-permeable body which advantageously rests with its underside on a cavity into which the conditioned carrier gas flows.
  • a large contact area between the active ingredient and the conditioned carrier gas can likewise be achieved in a particularly advantageous manner by bringing the conditioned carrier gas into contact with an atomized active ingredient or an atomized active ingredient solution. It is also possible in a particularly advantageous manner to combine the active ingredient loading process. For example, a conveyor device sucks up a liquid active substance or an active substance solution from a bath bubbled with the conditioned carrier gas and spray it at a distance above the bath by means of atomizing nozzles, so that the undissolved active substance or its solvent falls back into the bath.
  • the concentration of the active substance solution brought into contact with the conditioned carrier gas can advantageously be kept constant by constant supply of active substance or by continuous exchange of the active substance solution or by providing a supersaturated active substance solution.
  • Another particularly advantageous embodiment of the charging of the conditioned carrier gas is given by the fact that the conditioning of the conditioned carrier gas with the active substance takes place in a mixing chamber. This advantageously makes it possible to carry out additional measures which support or initiate the loading of active substance.
  • Another particularly advantageous measure for generating the Sterilization medium is provided in that the conditioning of the conditioned carrier gas with the active substance is carried out by passing the conditioned carrier gas through a layer of active substance.
  • This bed of active substance is advantageously applied to a sieve or a porous element.
  • a particularly advantageous embodiment of the method is also given in that formaldehyde is used as the active ingredient.
  • a particularly advantageous form of application of formaldehyde is given by the fact that the formaldehyde is dissolved in water.
  • a particularly preferred form of use of the formaldehyde solution is given by the fact that the proportion by weight of formaldehyde in the solution corresponds to the formaldehyde concentration of 37%.
  • a particularly favorable embodiment of the process using formaldehyde is provided by charging the conditioned carrier gas with formaldehyde which is formed from paraformaldehyde.
  • This paraformaldehyde is in the solid form, preferably in the form of a fine-grained bed, and is brought into contact with the conditioned carrier gas in such a way that formaldehyde is formed and the conditioned carrier gas is loaded with it.
  • active ingredient loading processes e.g. to go through several times or to combine drug loading processes.
  • An advantageous embodiment of the method is also provided in that a preparation is introduced into the space filled with items to be sterilized as part of a preparation step.
  • a preparation is introduced into the space filled with items to be sterilized as part of a preparation step.
  • This advantageously makes it possible, for example, to moisten and heat the items to be sterilized and to create suitable conditions for a sterilization step.
  • a particularly advantageous measure when carrying out a preparation step is given by the fact that the preparation means contains the conditioned carrier gas. This will also make it possible to increase the sterilization reliability of the method in an advantageous manner, since the effect of the preparation agent is also independent of the ambient condition of the air, especially when using conditioned air to form the preparation agent.
  • a rinsing agent is introduced into the space filled with items to be sterilized in the course of a rinsing step.
  • the formaldehyde contained in the space filled with the items to be sterilized is advantageously removed and a risk to persons is avoided.
  • This rinsing step advantageously contains several rinsing processes which can also be carried out with different compositions of the rinsing medium.
  • a particularly advantageous embodiment of the purging step is given in that the purging agent contains the conditioned carrier gas, since this ensures a purging effect that is independent of the initial state of the carrier gas.
  • the purging agent containing the conditioned carrier gas can be provided with little outlay on equipment.
  • the conditioned carrier gas can be fed directly either to the sterilization room or to the active substance loading device.
  • a particularly favorable embodiment of a device for carrying out the method according to the invention is provided in that a container is provided which is at least partially filled with active substance or an active substance solution, in which for Formation of the sterilization medium, the conditioned carrier gas comes into contact with the active ingredient and which container is connected to the sterilization chamber.
  • a container is provided which is at least partially filled with active substance or an active substance solution, in which for Formation of the sterilization medium, the conditioned carrier gas comes into contact with the active ingredient and which container is connected to the sterilization chamber.
  • a particularly advantageous development of the device is given by the fact that a heating device is provided which heats the active substance or the active substance solution. As a result, the loading of the conditioned carrier gas with the active ingredient can be controlled in a simple manner.
  • a mixing device is provided in the interior of the container to create a large-area contact between the active substance and the conditioned carrier gas. This makes it possible to load the conditioned carrier gas with the active ingredient in a particularly simple manner.
  • the mixing device consists of a gas introduction device arranged in the active ingredient or in the active ingredient solution for introducing gases into liquids in finely divided form. This makes it particularly easy to generate a large contact area between the conditioned carrier gas and the active substance or the active substance solution.
  • a sterilization chamber 1 loaded with items to be sterilized is connected via a pipeline and a vacuum pump shut-off valve 11 to a vacuum pump 6 for lowering the pressure in the interior of the sterilization chamber 1.
  • untreated gas in particular ambient air, can flow into the sterilization chamber 1 via a gas shut-off valve 9.
  • Carrier gas is fed to a carrier gas conditioning device 2 through a carrier gas line 17.
  • the carrier gas is conditioned by heating and moistening.
  • the carrier gas flows through a gas introduction device 21 and bubbles in fine carrier gas bubbles through humidification water 4 heated by means of a heater 14.
  • the carrier gas heats up and absorbs water moisture.
  • the humidified carrier gas is fed to an active substance loading device 3. It is advantageously possible to provide a flow divider branch 10 in a connecting line between the carrier gas conditioning device 2 and the agent loading device 3, so that a portion of the conditioned carrier gas of the agent loading device 3 and the remaining portion via one Pipeline and optionally a dampening gas shut-off valve 8 is supplied to the sterilization room 1.
  • the conditioned carrier gas fed from the carrier gas conditioning device 2 to the agent loading device 3 flows through a gas introduction device 19 and bubbles through the agent 5 in fine bubbles.
  • the conditioned carrier gas is loaded with the agent 5 and a sterilizing medium is formed.
  • the active substance can be heated to a predetermined temperature by an active substance heating device 20.
  • the sterilizing medium is fed through a pipe and a given if present, the sterilizing medium shut-off valve 7 is directed into the sterilizing room 1. By opening the vacuum pump shut-off valve 11 and starting up the vacuum pump 6, the sterilizing medium can be conveyed out of the sterilizing room 1.
  • conditioned carrier gas can be fed to the sterilization chamber as part of a preparation step and / or a rinsing step via the damp gas shut-off valve 8.
  • the arrangement described above can be used, for example, in the following manner.
  • glass ampoules coming from a vaccine filling system and filled with vaccine and sealed by melting are inserted into a carrying device.
  • the carrying device equipped with the ampoules is introduced into a sterilization room of a sterilization device.
  • the sterilization chamber is filled by successively introducing carrying devices equipped with glass ampoules.
  • the sterilization room is closed.
  • a vacuum pump shut-off valve By opening a vacuum pump shut-off valve and starting up a vacuum pump, the pressure inside the sterilization room is reduced.
  • the air which is conveyed out of the sterilization space and is possibly contaminated with germs is passed through a germicidal agent and sterilized.
  • the vacuum pump shut-off valve is closed and the vacuum pump is switched off.
  • a dampening gas shut-off valve is opened to carry out a preparation step.
  • a conditioned carrier gas in this case a heated and humidified carrier gas, is sucked in via a pipeline from a carrier gas conditioning device.
  • the dampening gas shut-off valve is closed after pressure equalization occurs.
  • the vacuum pump valve is opened, the vacuum pump is started up and the gas mixture located in the sterilization room is sucked off. The pump is switched off and the vacuum pump shut-off valve is closed. This procedure can be carried out several times.
  • a sterilization medium shut-off valve is opened. Conditioning agent loaded with active ingredient is removed from an active ingredient loading facility. extracted carrier gas.
  • This sterilization medium flows into the sterilization room and remains in the sterilization room for an exposure period. Germs which come into contact with the sterilizing medium are killed during this exposure time.
  • the sterilizing medium shut-off valve is closed.
  • the vacuum pump shut-off valve is opened, the vacuum pump is started and the sterilizing medium is at least partially aspirated.
  • the sterilization medium sucked off is treated chemically, for example, so that the active substance is rendered harmless.
  • the active ingredient can be rendered harmless, in particular, by a subsequent combustion.
  • Such 'sterilizing step can also several times with different parameters, in particular concerning Einwir ⁇ effect and duration, are carried out drug concentration.
  • a rinsing step is carried out.
  • the conditioned carrier gas can also be used for this purpose, which is drawn into the sterilization chamber after the pressure has been reduced in the interior of the sterilization chamber and the damp gas shut-off valve has subsequently been opened from the carrier gas conditioning device.
  • the dampening gas shut-off valve is closed.
  • the gas in the sterilization room is suctioned off and, if necessary, treated.
  • Such a rinsing step can also be carried out several times.
  • the sterilization room is opened by opening a second door.
  • the externally sterilized glass ampoules inserted into the sterilized carrying devices are removed from the sterilization room and can be fed to a packaging device.
  • the conditioning of the carrier gas in the carrier gas conditioning device takes place in this embodiment, as already mentioned, by moistening and heating.
  • the carrier gas flows through a gas inlet device and bubbles in fine bubbles through a water bath heated to a predetermined temperature.
  • the bubbled distance in the water bath, the water temperature and the temperature of the humidified carrier gas can be adjusted so that the carrier gas tioning device with a relative humidity of 100%.
  • the conditioning of the conditioned carrier gas with active substance takes place by the carrier gas escaping from a gas introduction device arranged sunk in an active substance solution and subsequently bubbling the conditioned carrier gas through the active substance.
  • the conditioning of the conditioned carrier gas with the active ingredient can also take place in a mixing chamber by spraying on atomized active ingredient.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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

Dans les procédés de stérilisation classiques qui font appel à des substances de stérilisation sous forme de gaz ou de vapeur, on utilise des substances de stérilisation dont la composition est sujette à des fluctuations dues au degré de remplissage d'un stérilisateur et/ou à des influences atmosphériques. Dans le procédé défini selon l'invention, la composition de la substance de stérilisation ne dépend pas de ce type d'influences du fait que dans une étape préliminaire, un gaz porteur requis pour former la substance de stérilisation est conditionné en fonction de la température et/ou de l'humidité et que dans l'étape suivante il est mis en contact avec un principe actif afin d'être chargé dudit principe actif, et qu'ensuite il est acheminé jusque dans une chambre de stérilisation. Ce procédé de stérilisation permet tout particulièrement d'obtenir des résultats constants et reproductibles en matière de stérilisation, notamment indépendamment des variations climatiques.
EP94913055A 1993-04-13 1994-03-25 Procede de sterilisation a l'aide d'une substance de sterilisation sous forme de gaz ou de vapeur Withdrawn EP0693942A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE4312004 1993-04-13
DE19934312004 DE4312004A1 (de) 1993-04-13 1993-04-13 Sterilisierverfahren unter Einsatz eines gas- oder dampfförmigen Sterilisiermediums
PCT/EP1994/000956 WO1994023762A1 (fr) 1993-04-13 1994-03-25 Procede de sterilisation a l'aide d'une substance de sterilisation sous forme de gaz ou de vapeur

Publications (1)

Publication Number Publication Date
EP0693942A1 true EP0693942A1 (fr) 1996-01-31

Family

ID=6485349

Family Applications (1)

Application Number Title Priority Date Filing Date
EP94913055A Withdrawn EP0693942A1 (fr) 1993-04-13 1994-03-25 Procede de sterilisation a l'aide d'une substance de sterilisation sous forme de gaz ou de vapeur

Country Status (4)

Country Link
EP (1) EP0693942A1 (fr)
CZ (1) CZ282556B6 (fr)
DE (1) DE4312004A1 (fr)
WO (1) WO1994023762A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9523717D0 (en) * 1995-11-20 1996-01-24 Mdh Ltd Method and apparatus for hydrogen peroxide vapour sterilization
CZ301003B6 (cs) * 2007-10-15 2009-10-07 Block A.S. Zpusob vyvíjení sterilizacního nebo dekontaminacního média ve forme smesi par peroxidu vodíku se vzduchem a zarízení pro provedení zpusobu

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DD134839A1 (de) * 1978-03-08 1979-03-28 Horst Weiss Verfahren zur sterilisation thermolabiler gegenstaende mit formaldehyd
DE3267263D1 (en) * 1982-06-10 1985-12-12 Detec Sa Cold sterilisation method with formaldehyde
US4637916A (en) * 1983-01-28 1987-01-20 Universite Catholique De Louvain Sterilization method employing a circulating gaseous sterilant
DE3523310A1 (de) * 1985-06-29 1987-01-02 Bayer Ag Verfahren zur sterilisation von anlagen, apparaten und raeumlichkeiten mit gasfoermigen sterilisationsmitteln
GB2223678B (en) * 1988-08-25 1991-10-23 Cambridge Isolation Tech Sterilizing systems
DE3932713C2 (de) * 1989-09-29 1993-10-28 Horst Dr Weis Verfahren zur Sterilisation thermolabiler Gegenstände mit Formaldehyd
JPH04161160A (ja) * 1990-10-26 1992-06-04 Mercian Corp ホルマリン燻蒸滅菌装置
US5145642A (en) * 1991-01-31 1992-09-08 Mdt Corporation Load compensated water fill for a table top sterilizer

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9423762A1 *

Also Published As

Publication number Publication date
CZ282556B6 (cs) 1997-08-13
DE4312004A1 (de) 1995-01-05
CZ265395A3 (en) 1996-01-17
WO1994023762A1 (fr) 1994-10-27

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