EP1519758A1 - Procede et dispositif de decontamination d'une salle blanche - Google Patents

Procede et dispositif de decontamination d'une salle blanche

Info

Publication number
EP1519758A1
EP1519758A1 EP03729776A EP03729776A EP1519758A1 EP 1519758 A1 EP1519758 A1 EP 1519758A1 EP 03729776 A EP03729776 A EP 03729776A EP 03729776 A EP03729776 A EP 03729776A EP 1519758 A1 EP1519758 A1 EP 1519758A1
Authority
EP
European Patent Office
Prior art keywords
clean room
gaseous agent
clean
room
ammonia
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Withdrawn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
EP03729776A
Other languages
German (de)
English (en)
Inventor
Claude Moirandat
Volker Sigwarth
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.)
SKAN AG
Original Assignee
SKAN 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 SKAN AG filed Critical SKAN AG
Publication of EP1519758A1 publication Critical patent/EP1519758A1/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Withdrawn legal-status Critical Current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
    • 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
    • A61L2/24—Apparatus using programmed or automatic operation
    • 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
    • A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
    • 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
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • the present invention relates to a process for the decontamination of a clean room in which the clean room is supplied with gaseous H 2 0 2, as well as to an arrangement for decontamination of a clean room having a H 2 0 2 - urging means for urging the clean room with H 2 0 2 includes.
  • decontamination is also understood to mean sterilization and disinfection.
  • Clean room stands for all tightly lockable rooms such as Isolators, locks, microbiological safety cabinets, sterilizers and transfer containers for the pharmaceutical industry, cosmetics, chemistry, food technology, electronics, nuclear industry, laboratory animals, medicine, etc.
  • H 2 0 2 hydrogen peroxide in liquid form has been used as a decontamination agent for many years. Since it can have a corrosive effect on various materials in high concentrations (> 3%), it was initially not used in clean room technology.
  • H 2 0 2 has therefore been used for the quick and safe decontamination of cleanrooms in recent years.
  • An arrangement for the decontamination of a clean room having a H 2 0 2 comprises -Beetzschlagungs adopted for pressurizing the clean room with H 2 0 is, for example disclosed in CH-A-689 178th
  • this arrangement has an evaporator unit, an H 2 0 2 storage container and a conveying device for conveying liquid H 2 0 2 from the H 2 0 2 storage container to the evaporator unit.
  • the H 2 0 2 storage container is arranged outside the clean room and connected via a hose to the evaporator unit arranged inside the clean room.
  • liquid H 2 0 2 is conveyed from the H 2 0 2 storage tank to the evaporator unit and evaporated there, after which it is distributed in the clean room. This continues until the decontamination concentration is reached. At H 2 0 2, this is approximately 100-5000 ppm and is normally maintained for approximately 10 to 120 minutes.
  • an exhaust air flap is opened and the exhaust air containing H 2 0 2 is flushed out of the clean room and discharged via an exhaust air duct, a catalyst which can decompose the H 2 0 2 , for example in H 2 , being present in the exhaust air duct to reduce emissions 0 and 0 2 .
  • a recirculation of the H 2 0 -energized air via a catalyst is also known.
  • a disadvantage of this decontamination process is that the excess H 2 0 2 - if at all - is broken down with a catalyst. In order to achieve sufficiently rapid breakdown times, relatively large amounts of catalyst are required, which is very expensive. Another disadvantage is that the catalysts used have to be regenerated. In addition, any H 2 0 2 degradation takes place outside the clean room, ie the H 2 0 2 must first be flushed out of the clean room. Completely flushing H 2 0 2 out of the clean room is relatively difficult since it partially condenses in the clean room and adheres to surfaces. liable. In order to achieve a desired residual concentration of normally 5 to 0.05 ppm, a rinsing time of at least one hour is generally necessary, even if the clean room is heated to evaporate the condensed H 2 O 2 .
  • the invention is based on the following object.
  • a method and an arrangement for decontamination of a clean room are to be created which enable decontamination with H 2 0 2 in the most cost-effective manner possible and then the desired residual concentration for H 2 0 2 to be reached as quickly as possible.
  • Claim 15 relates to an H 2 0 2 dismantling device according to the invention for such an arrangement. Preferred design variants result from the dependent patent claims.
  • the essence of the invention is that in a method for decontamination of a clean room, the clean room is charged with gaseous H 2 0 2 and, at a later point in time, H 2 0 2 still present in the clean room without catalyst by adding at least one gaseous agent which with which H 2 0 2 reacts, is broken down chemically.
  • H 2 0 2 residues in a product located in the clean room are advantageously subsequently broken down in a targeted manner on the product. This is important, for example, if a lower H 2 0 2 concentration is desired for the product than is present in the clean room after the H 2 0 2 breakdown, and can be done using the same means.
  • the at least one gaseous agent is preferably metered in such a way that after the chemical degradation of the H 2 0 2 in the clean room, at most 1 ppm of H 2 0 2 remain. Such a residual concentration is not a problem.
  • the at least one gaseous agent preferably comprises ammonia (NH 3 ). This reacts with the H 2 0 2 as follows:
  • the ammonia reduces the H 2 0 2 , whereby only N 2 and water, which is primarily gaseous, is formed, harmful, environmentally friendly reaction products. Since there is no precipitation, these degradation products can be easily flushed out of the clean room into the exhaust air duct, which does not have to meet any special requirements with regard to chemical resistance. In addition, the exhaust air, which can also contain ammonia residues, can be released outdoors without further treatment, since in addition to the degradation products, the ammonia itself is environmentally friendly.
  • ammonia is a gas, it is easy to dose and is freely available on the market.
  • the usual quality > 99.7%
  • only small amounts of ammonia are required, namely about 0.5 1 NH 3 gas per g of pure H 2 0 2 .
  • the amount of H 2 0 2 and ammonia used naturally depends on the volume of the clean room and can therefore be very different.
  • the space and power requirements for storing and introducing the ammonia into the clean room are low. Overall, the use of ammonia is therefore significantly cheaper than the use of catalysts, particularly in terms of purchase, but also in terms of consumption.
  • ammonia has the advantage that, like H 2 0 2, it has a great affinity for water and is very easy to borrow. Condensed H 2 0 2 absorbs NH 3 gas very well and is rapidly broken down.
  • ammonia Another advantage of ammonia is that it can also be used very well in large clean rooms.
  • ammonia is environmentally friendly and the MAK value (maximum workplace concentration) is 50 ppm, which is significantly higher than H 2 0 2 . Ammonia residues are therefore less problematic than H 2 0 2 residues. In addition, the smell of ammonia is characteristic and warns. Ammonia gas is therefore also used, for example, to test the tightness of the isolator containing the clean room and any gloves that may be present. With the method according to the invention, these tests can be carried out at the end of the cycle directly before flushing the clean room.
  • the regulation of the introduction of ammonia is simple. It can be based on the detection of an excess of ammonia or H 2 0 2 in the clean room with chemical indicators or with sensors.
  • An excess of ammonia is preferably introduced into the clean room so that the degradation reaction takes place quickly and as completely as possible.
  • ammonia is flammable.
  • concentration required in the process according to the invention is low and the ammonia is largely immediately degraded by the H 2 O. Just an all due ammonia excess is critical. This is therefore advantageously kept so low that the ignition limit of 15% is not reached.
  • the dosage is such that the excess of ammonia is at most 500 ppm.
  • hydrazine N 2 H 4
  • H 2 0 2 H 2 0 2
  • the at least one gaseous agent can also comprise ozone (0 3 ). This reacts with the H 2 0 2 as follows:
  • ozone is not used to accelerate the sterilization, but to break down the H 2 O 2 .
  • gaseous hydrazine or ozone to decompose the H 2 0 2 has similar advantages as the use of ammonia.
  • H 2 0 2 that is still present can be degraded photochemically by means of UV radiation. This normally happens as follows:
  • the UV light is preferably generated in the clean room by a UV lamp arranged in the clean room. It preferably has a wavelength of 254 nm.
  • the inventive arrangement for decontamination of a clean room comprising an H 2 0 2 -Beetzschlagungs adopted for pressurizing the clean room with H 2 0 2 and H 2 0 2 -Abbauein- direction for effecting a chemical degradation of H0 2 without Catalyst in the clean room, which has means for introducing at least one gaseous agent, in particular ammonia, hydrazine or ozone, into the clean room.
  • This arrangement enables the above-mentioned method according to the invention to be carried out, which is associated with the advantages described.
  • the means for introducing at least one gaseous agent comprise a storage container filled with gaseous agent, e.g. a gas bottle, or a generator for generating gaseous agent, a gas line from the storage container or generator to the clean room and a valve for regulating the amount of the gaseous agent flowing through the gas line.
  • gaseous agent e.g. a gas bottle, or a generator for generating gaseous agent
  • a gas line from the storage container or generator to the clean room
  • a valve for regulating the amount of the gaseous agent flowing through the gas line The amount of the gaseous agent introduced into the clean room can thus be regulated via the valve.
  • Gas cartridges can also be used which contain the required amount of gaseous agent. A valve and a control device can then be dispensed with.
  • the H 2 0 2 dismantling device additionally has means for generating UV light in the clean room.
  • These means include, for example, a UV lamp that generates UV light within the clean room.
  • UV lamps are part of the prior art.
  • the arrangement according to the invention advantageously has a sensor for measuring the concentration of the gaseous agent in the clean room, the measured values of which are used to regulate the H 2 0 2 degradation device. If an excess of gaseous agent is measured, which is not broken down by reaction with H 2 0 2 , the introduction of gaseous agent into the clean room is normally stopped.
  • the arrangement according to the invention has a sensor for measuring the H 2 0 2 concentration in the clean room, the measured values of which are used to regulate the H 2 0 2 degradation device. If the sensor measures an H 2 0 2 concentration in the clean room that is smaller than the desired residual concentration, for example 1 ppm, the decomposition of H 2 0 2 need not be pushed any further. This means that no additional gaseous agent has to be introduced into the clean room and no additional UV light has to be generated in the clean room.
  • H 2 0 2 application device To control or regulate the H 2 0 2 application device and the H 2 0 2 removal device, separate control and regulating devices are preferably provided, which means that the H 2 0 2 removal device is retrofitted into an existing arrangement with H 2 0 2 - Application device made possible.
  • the H 2 0 degradation device can either be designed as a separate device which introduces or generates gaseous agent into the clean room independently of the H 2 0 2 loading device, or it and the H 2 0 2 loading device can be integrated in a periphery of the clean room.
  • the integration of the H 2 0 2 dismantling device and the H 2 0 2 application device into the periphery of the clean room is generally preferable, while existing ones
  • Decontamination devices are easier to retrofit with a separate H 2 0 2 dismantling device.
  • FIG. 1 shows schematically a first exemplary embodiment of the arrangement according to the invention with a separate one
  • FIG. 2 shows schematically a second exemplary embodiment of the arrangement according to the invention with H 2 0 2 application device and H 2 0 2 removal device integrated into a periphery of the clean room.
  • first embodiment of an inventive arrangement for the decontamination of a clean room 1 is an H 2 0 2 2 -BeaufSchlagungs adopted arranged outside a periphery 3 of the clean room 1.
  • the conditions in the clean room 1 are controlled and regulated with a control and regulating device 31, in particular the pressure conditions and the air conditions.
  • the H 2 0 2 loading device 2 comprises, for example, as described in CH-A-689 178, at least one H 2 0 storage container filled with liquid H 2 0 2 , at least one evaporator unit in the form of a heating plate for evaporating the H 2 0 2 and at least one H 2 0 2 line between the at least one H 2 0 2 storage container and the at least one heating plate.
  • the at least one heating plate is arranged in the clean room 1, so that the at least one of H 2 0 2 -Vorrats- container via the at least one H 2 0 2 -Leitung supplied H 2 0 2 directly in the clean room 1 on the at least one heating plate is evaporated.
  • the application of H 2 0 2 to the clean room 1 is controlled and regulated by a control and regulating device 21, which preferably comprises a programmable logic controller. So much H 2 0 2 is normally evaporated in clean room 1 that an H 2 0 2 concentration in clean room 1 concentration of approx. 100-5000 ppm for approx. 10 to 120 minutes.
  • H 2 0 2 After decontamination with H 2 0 2 still present in the clean room 1 H 2 0 2, ie, the H 2 0 2, which has not reacted • and has not been consumed, degraded with a gaseous agent, which via a gas line 13 in the clean room
  • the arrangement has a separately designed " H 2 0 2 removal device 10, which has a storage container
  • the II comprises, in which the gaseous agent is stored.
  • the supply of gaseous agent in the storage container 11 is monitored by a control unit 14.
  • the gaseous agent stored in the storage container 11 reaches the clean room 1 via the gas line 13, it being possible for one or more nozzles to be provided at the end of the gas line 13 on the clean room side, which distribute the gaseous agent in the clean room 1.
  • a valve 12 is arranged in the gas line 13, with which the amount of the gaseous agent introduced into the clean room 1 can be controlled or regulated.
  • the valve 12 is controlled by a control and regulating device 15, which has a sensor 4 for measuring the concentration of the gaseous agent and a sensor 5 for measuring the
  • H 2 0 2 concentration is related.
  • the sensors 4 and 5 are arranged in the clean room 1 and measure the concentration of the gaseous agent and the H 2 0 concentration in the clean room 1.
  • gaseous agent is supplied to clean room 1.
  • a small excess of gaseous agent is introduced into the clean room 1 so that the H 2 0 2 is broken down quickly and as completely as possible.
  • the air change is ensured again in the clean room 1, and for this purpose a supply air duct, a supply air flap, an exhaust air flap and an exhaust air duct can be provided in a known manner.
  • the arrangement can also have further elements that are known from arrangements for decontaminating a clean room of the prior art.
  • the H 2 0 2 removal device and the H 2 0 2 application device 102 are integrated into the periphery 103 of the clean room 101.
  • the H0 2 removal device comprises a gas generator 111 which generates the gaseous agent directly.
  • the gas generator 111 is controlled by a control unit 114.
  • the gaseous agent generated is supplied to the clean room 101 via a gas line 113, the amount of agent supplied being controlled or regulated by a valve 112 arranged in the gas line 113.
  • the valve 112 is controlled by a control and regulating device 115 2 0 2 concentration is connected to a sensor 104 for measuring the concentration of the gaseous agent and a sensor 105 for measuring the H in connection.
  • the sensors 104 and 105 are arranged in the clean room 101 and measure the concentration of the gaseous agent and the H 2 0 2 concentration in the clean room one hundred and first
  • the control and regulating device 115 is also connected to the control unit 114 and uses it to ensure that, according to the measured values of the sensors 104 and 105, gaseous agent is generated or not.
  • the application of the clean room 101 with H 2 0 2 is controlled and regulated by a control and regulating device 121, which preferably comprises a programmable logic controller.
  • the conditions in the clean room 101 are controlled and regulated with a control and regulating device 131, in particular those
  • the control and regulating device 121 is here connected to the control and regulating device 115 via the control and regulating device 131, so that the measured values of the sensors 104 and 105 can also be used to control the H 2 0 2 supply.

Landscapes

  • 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

L'invention concerne un dispositif de décontamination d'une salle blanche (1) comportant un système d'alimentation de H2O2 (2) destiné à alimenter H2O2 à la salle blanche, et un système de décomposition de H2O2 (10) destiné à provoquer une décomposition chimique de H2O2 dans la salle blanche (1) sans catalyseurs. Ledit système de décomposition de H2O2 (10) comporte un réservoir (11) contenant un agent gazeux pouvant être alimenté à la salle blanche (1) par l'intermédiaire d'une conduite de gaz (13), ledit agent gazeux réagissant avec H2O2 dans ladite salle blanche. La conduite de gaz (13) contient une soupape (12) permettant de commander ou de réguler la quantité d'agent gazeux alimentée à la salle blanche. Comme H2O2 excédentaire, c.-à-d. H2O2 n'ayant pas réagit avec d'autres substances lors de la décontamination dans la salle blanche, est décomposé de façon autonome dans la salle blanche (1), il n'est pas nécessaire d'évacuer la quantité d'H2O2 excédentaire hors de la salle blanche (1) afin d'effectuer une décomposition ultérieure.
EP03729776A 2002-07-02 2003-06-25 Procede et dispositif de decontamination d'une salle blanche Withdrawn EP1519758A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CH11562002 2002-07-02
CH01156/02A CH700121B1 (de) 2002-07-02 2002-07-02 Verfahren und Anordnung zur Dekontamination eines Reinraums.
PCT/CH2003/000418 WO2004004790A1 (fr) 2002-07-02 2003-06-25 Procede et dispositif de decontamination d'une salle blanche

Publications (1)

Publication Number Publication Date
EP1519758A1 true EP1519758A1 (fr) 2005-04-06

Family

ID=30005578

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03729776A Withdrawn EP1519758A1 (fr) 2002-07-02 2003-06-25 Procede et dispositif de decontamination d'une salle blanche

Country Status (5)

Country Link
US (1) US20050226764A1 (fr)
EP (1) EP1519758A1 (fr)
AU (1) AU2003240360A1 (fr)
CH (1) CH700121B1 (fr)
WO (1) WO2004004790A1 (fr)

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CH699032B1 (de) * 2006-05-15 2010-01-15 Skan Ag Verfahren und Anordnung zur Dekontamination eines Reinraums und von temporär darin eingebrachtem Behandlungsgut.
US9616145B2 (en) 2009-07-06 2017-04-11 Medizone International, Inc. Healthcare facility disinfecting system
IN2012DN00963A (fr) * 2009-07-06 2015-04-10 Medizone Internat Inc
AR078060A1 (es) * 2009-07-14 2011-10-12 Novartis Ag Descontaminacion de superficie de contenedores previamente llenados en empaque secundario
EP2525838B1 (fr) 2010-01-18 2016-04-27 Medizone International Inc. Neutralisation de terrorisme biologique à l'aide d'ozone et de peroxyde d'hydrogène
ES2390429B1 (es) * 2010-06-11 2013-11-08 Hispano Vema, S.L. Sistema integrado independiente de descontaminacion
US8992829B2 (en) 2010-09-08 2015-03-31 Medizone International Inc. Sports equipment and facility disinfection
CA2846259A1 (fr) 2010-09-08 2012-03-15 Medizone International Inc. Traitement de desinfection pour installations alimentaires
US20130276357A1 (en) * 2010-09-08 2013-10-24 Medizone International Inc. Combating insect infestations
DE102012111148B4 (de) 2012-11-20 2015-04-09 Metall + Plastic Gmbh Dekontaminationsanordnung sowie Verfahren zum Betreiben einer solchen
JP6761563B2 (ja) * 2015-02-20 2020-09-30 三浦工業株式会社 除染装置および除染方法
CA2983154A1 (fr) * 2015-04-20 2016-10-27 Synexis Llc Salles blanches avec peroxyde d'hydrogene gazeux dilue et leurs procedes d'utilisation
KR20190119041A (ko) * 2017-01-09 2019-10-21 사이넥시스 엘엘씨 가금류 생산 방법에 대한 건조 과산화수소(dhp) 가스의 적용
CN110833458A (zh) * 2019-09-29 2020-02-25 陆远强 医院内化学救援分通道洗消中心
DE102022100598A1 (de) 2022-01-12 2023-07-13 Syntegon Technology Gmbh Isolator

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Also Published As

Publication number Publication date
WO2004004790A1 (fr) 2004-01-15
AU2003240360A1 (en) 2004-01-23
US20050226764A1 (en) 2005-10-13
CH700121B1 (de) 2010-06-30

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