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WO1999056892A1 - Nettoyage d'un fluide dans l'intervalle sous-critique et systeme et procede de decontamination antimicrobienne - Google Patents

Nettoyage d'un fluide dans l'intervalle sous-critique et systeme et procede de decontamination antimicrobienne Download PDF

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Publication number
WO1999056892A1
WO1999056892A1 PCT/US1999/009770 US9909770W WO9956892A1 WO 1999056892 A1 WO1999056892 A1 WO 1999056892A1 US 9909770 W US9909770 W US 9909770W WO 9956892 A1 WO9956892 A1 WO 9956892A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
cleaning fluid
further characterized
antimicrobial
chamber
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/US1999/009770
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English (en)
Inventor
Paul S. Malchesky
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.)
Steris Corp
Original Assignee
Steris Corp
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 Steris Corp filed Critical Steris Corp
Priority to US09/674,787 priority Critical patent/US6558622B1/en
Publication of WO1999056892A1 publication Critical patent/WO1999056892A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • 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
    • A61L2/183—Ozone dissolved in a liquid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B08—CLEANING
    • B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B7/00—Cleaning by methods not provided for in a single other subclass or a single group in this subclass
    • B08B7/0021—Cleaning by methods not provided for in a single other subclass or a single group in this subclass by liquid gases or supercritical fluids
    • D—TEXTILES; PAPER
    • D06—TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06F—LAUNDERING, DRYING, IRONING, PRESSING OR FOLDING TEXTILE ARTICLES
    • D06F43/00—Dry-cleaning apparatus or methods using volatile solvents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • A61B2090/701—Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes
    • 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
    • A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • 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
    • A61L2202/17—Combination with washing or cleaning means
    • 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 the sterilization and disinfection arts. It finds particular application in conjunction with sub-critical fluids associated with antimicrobial agents, such as sterilants or disinfectants, for combined cleaning and sterilization or disinfection of medical instruments, equipment, and supplies, and will be described with particular reference thereto. It should be appreciated, however, that the invention is also applicable to the sterilization or disinfection of other items, including food processing equipment and packaging and hospital supplies, such as bed linen and protective clothing, and the like.
  • Cleaning systems traditionally use solvents which sometimes leave harmful residues on the instruments or which pose environmental hazards.
  • Water-based cleaning compositions while tending to be less hazardous, often lead to corrosion of metal parts of the instruments with repeated cleaning. Poor water quality sometimes results in deposits on the instruments or to microbiological contamination. Processing time is often lengthy due to the need for drying the instruments between the cleaning and sterilization or disinfection phases.
  • a supercritical fluid is a pure compound or mixture which is at a temperature and pressure at or above the critical temperature and pressure of the compound.
  • Carbon dioxide is a particularly advantageous fluid because it is a non- polar solvent. This allows cosolvents to be added having a high degree of selectivity. Cleaning is effectuated more rapidly than for many conventional systems, in part because the fluid rapidly evaporates from the cleaned surfaces when the pressure is reduced.
  • Supercritical fluid cleaning systems do not necessarily sterilize or disinfect the instruments. To date, such systems have not been used for cleaning medical instruments, and the like. Where sterilization or disinfection, as well as cleaning, is required, a separate sterilization or disinfection process conventionally increases the processing time and poses hazards to workers handling the unsterilized instruments.
  • Jackson, et al. U.S. Patent No. 5,213,619 discloses a supercritical cleaning process in which chemical oxidizing agents, such as hydrogen peroxide, are transported into a cleaning chamber together with a supercritical fluid. The oxidizing agent is exposed to -3 - high energy acoustic radiation to create oxidizing radicals within the supercritical fluid. Other additives, such as surfactants, biocides, and the like, may also be included.
  • the high pressures employed in supercritical cleaning call for specialized equipment capable of withstanding the high pressures.
  • the present invention provides a new and improved combined cleaning and sterilization or disinfection system and process at sub-critical pressures which overcomes the above referenced problems and others.
  • a method for cleaning contaminants from articles and microbially decontaminating the articles is provided.
  • the method is characterized by the steps of: a) contacting the articles with a dense cleaning fluid at a sub-critical pressure, and b) contacting the articles with an antimicrobial fluid.
  • a sub-critical fluid cleaning and microbial decontamination system for combined cleaning of contaminants from medical instruments, and killing microbes on the medical instruments.
  • the system includes a chamber, which receives the instruments, and a source of a dense cleaning fluid, fluidly connected with the chamber.
  • the dense cleaning fluid is one which is gaseous under ambient conditions.
  • a source of an antimicrobial fluid is fluidly connected with the chamber.
  • An injection system is connected with the source of cleaning fluid and with the chamber.
  • the system is characterized by the injection system supplying pressurized dense cleaning fluid to the chamber at a pressure sufficient for bringing the dense cleaning fluid within the chamber to a sub- critical pressure.
  • a composition for cleaning and microbial decontamination of articles is provided.
  • the composition is characterized by a dense cleaning fluid at a sub-critical pressure and at a temperature below the critical temperature and an antimicrobial fluid.
  • One advantage of the present invention is that it provides a unitary sterilization or disinfection and cleaning process which reduces processing time. Another advantage of the present invention is that hazards which would otherwise be posed by microbially contaminated instruments during transfer of the instruments between the cleaning and the decontamination systems are eliminated. Yet another advantage of the present invention is that it employs cleaning fluids which are amenable to non-hazardous disposal after use, without posing significant environmental hazards.
  • a further advantage of the present invention is that it enables cleaning fluids and antimicrobial agents to be separately recycled.
  • a yet further advantage of the present invention is that the processing equipment need not withstand supercritical pressures.
  • a yet still further advantage of the present invention is that it enables heat sensitive instruments to be cleaned without risk of heat damage.
  • Still further advantages reside in the ability to clean and microbially decontaminate instruments directly after patient use, without prior drying of the instruments.
  • the invention may take form in various components and arrangements of components, and in various steps and arrangements of steps.
  • the drawings are only for purposes of illustrating a preferred embodiment and are not to be construed as limiting the invention.
  • FIGURE 1 is a schematic view of a sub-critical cleaning and decontamination system in accordance with the present invention
  • FIGURE 2 is a front elevational view of the chamber of FIGURE 1;
  • FIGURE 3 is a schematic view of an alternative embodiment of a sub-critical cleaning and decontamination system in accordance with the present invention.
  • FIGURE 4 is a side elevational view of a processing tray in accordance with the present invention.
  • a system for sub-critical cleaning and microbial decontamination of articles includes a combined cleaning and microbial decontamination chamber, such as processing chamber 10, and a source of a dense cleaning fluid, such as a storage vessel 12.
  • the storage vessel maintains the dense cleaning fluid, which is gaseous under ambient conditions, under pressure, preferably in the liquid state.
  • the system also includes a source of antimicrobial agents, preferably an antimicrobial fluid container 16.
  • a single storage vessel 12 contains both the dense cleaning fluid and the antimicrobial fluid.
  • the system is effective for removing biological wastes, such as blood, urine, and tissue fluids and particles, from medical instruments, surgical devices, and the like. It is particularly suited to cleaning of instruments with complex shapes, such as endoscopes and other instruments with internal passageways.
  • an antimicrobial fluid to the dense fluid renders the cleaned equipment in a sterilized or disinfected condition and thus the instruments are ready for reuse, without further antimicrobial decontamination.
  • gases most suitable as dense cleaning fluids include inorganics, such as carbon dioxide, argon, krypton, xenon, nitrous oxide, oxygen, helium, and mixtures of these.
  • Supercritical cleaning employs temperatures at or above the critical temperature and pressures at or above the critical pressure.
  • the critical temperature and pressure vary with the gas selected.
  • the critical temperature of a gas is the temperature above which the gas can no longer be liquefied, irrespective of the pressure applied.
  • the critical pressure is the pressure at which a substance may exist as a gas in equilibrium with a liquid at the critical temperature. Thus, the properties of a dense fluid change appreciably at or above the critical pressure.
  • the present invention employs a sub-critical dense cleaning fluid which is in the liquid state. That is, a dense cleaning fluid at a sub-critical pressure and preferably also at a sub-critical temperature, to effect cleaning.
  • sub-critical pressure it is meant that the pressure is below the critical pressure for the cleaning fluid.
  • the properties of the dense cleaning fluid are distinctly different below the critical pressure.
  • the preferred sub-critical pressures are those which are up to 95% of the critical -7- pressure, although the pressure can be significantly lower and still achieve dense fluid cleaning.
  • preferred sub critical pressures are those which are below about 70 kilograms per square centimeter.
  • the minimum pressure for cleaning is dependent on the temperature used, since this affects the minimum pressure at which the dense fluid is in the liquid state.
  • the sub-critical pressure can be as low as about 10% of the critical pressure.
  • the critical pressure For carbon dioxide, this is equivalent to a pressure of about 7-8 kilograms per square centimeter. More preferably, the sub-critical pressure is between about 20 and 90% of the critical pressure, or about 15-65 kilograms per square centimeter for carbon dioxide.
  • a particularly preferred sub-critical pressure for carbon dioxide is between 35 and 60 kilograms per square centimeter (about 50-80% of the critical pressure) .
  • the temperature of the dense cleaning fluid in the chamber is preferably sub-critical, by which it is meant that the temperature is below the critical temperature, such that the dense fluid is a liquid.
  • the temperature of the dense cleaning fluid in the chamber is preferably sub-critical, by which it is meant that the temperature is below the critical temperature, such that the dense fluid is a liquid.
  • preferred temperatures are above the freezing point of water, i.e. 0°C, to avoid freeze cracking of instruments, and up to 30°C.
  • a particularly preferred sub-critical temperature is in the room temperature range to just below the critical temperature, i.e. about 18 - 30°C for carbon dioxide. The possibility of damage to heat sensitive medical instruments is minimized in this range.
  • the temperature of the dense -8- cleaning fluid is at around room temperature.
  • the temperature for sub critical cleaning is more preferably between about 18°C and 25°C. At such temperatures, heating of the vessel is not necessary.
  • the temperature is cycled, for example, by raising the temperature to around the critical temperature and then dropping the temperature.
  • a fluid injection system 18 such as a pump, or other delivery system, transfers cleaning fluid from the storage vessel 12 through a fluid flow line 20 to the chamber 10.
  • the injection system preferably also delivers antimicrobial fluid to the chamber from the antimicrobial fluid container 16.
  • the dense cleaning fluid is provided at high pressure, eliminating the need for a pump.
  • the antimicrobial fluid and the cleaning fluid are delivered to the chamber by separate injection systems 18 and 22.
  • a separate antimicrobial fluid flow line 24 conveys the antimicrobial fluid into the processing chamber 10.
  • the separate sources of antimicrobial fluid and cleaning fluid allow for a two-stage cleaning and decontamination process, in which the bulk of the soil present on surfaces of the items is first removed with the sub-critical fluid alone and then the items are decontaminated and further cleaned by the antimicrobial -9 - fluid and sub-critical fluid together.
  • the dense cleaning fluid and antimicrobial fluid are introduced contemporaneously, or the antimicrobial fluid is introduced first.
  • appropriate valves such as a supply valve 26, control the rate and the timing of the addition of cleaning fluid and antimicrobial fluid to the chamber.
  • Cleaning fluid and antimicrobial fluid are removed from the chamber through a fluid outlet 32.
  • An outlet valve 34 controls the rate and timing of fluid removal.
  • Monitors 36 detect conditions within the chamber, such as pressure, temperature, and antimicrobial fluid concentration.
  • a control circuit 38 receives signals from the monitors, addresses a look-up table 40, and determines the variation in the detected conditions from preselected chamber conditions.
  • the control circuit signals the pump, preheater, valves 26 and 34, and other appropriate components of the system, to regulate the chamber conditions in accordance with the preselected conditions.
  • control circuit 38 generates a print-out of the process conditions, such as temperature and pressure, which were monitored throughout the cleaning and decontamination process, or otherwise provides an indication that the process has been appropriately conducted, or not, as the case may be. -10-
  • Spent cleaning fluid and antimicrobial fluid passes from the outlet valve 34 to a separator 36.
  • the separator filters contaminants, such as organic matter and other dirt, from the cleaning fluid and antimicrobial fluid by evaporation of the antimicrobial fluid and the cleaning fluid. Where the antimicrobial fluid and cleaning fluid have different vapor pressures, the separator optionally fractionates the antimicrobial fluid from the cleaning fluid, allowing the two components to be recovered separately.
  • the antimicrobial fluid is withdrawn through a separator outlet 42. Alternatively, the cleaning fluid and antimicrobial fluid are evaporated together and exit the separator in the gaseous state.
  • a separator valve 44 controls the rate of flow through the separator 36. Filtered organic matter and dirt are periodically removed from the separator through a waste outlet 46.
  • the cleaning fluid is preferably recirculated through the chamber 10 for further cleaning of the instruments.
  • cleaning fluid and antimicrobial fluid which are free from contaminants, are passed from the separator 36 to a condenser 50 where the fluids are condensed.
  • the antimicrobial fluid is a liquid under ambient conditions, it tends to condense before the cleaning fluid, allowing it to be recovered separately, if desired, through an antimicrobial fluid outlet line 54.
  • the spent antimicrobial fluid is collected in an antimicrobial fluid containment vessel 56 and returned to the container 16, or passed directly to a vent 58, where it is optionally destroyed, i.e. converted to non-hazardous components.
  • the condenser includes first and second condenser compartments, or sections 50a and 50b, respectively.
  • the least volatile component typically the antimicrobial fluid
  • the remaining, more volatile component is separately condensed at higher pressure in the second condenser compartment 50b.
  • a recirculation pump 60 returns the condensed cleaning fluid to the chamber 10 through a return line 62.
  • a combined antimicrobial fluid and cleaning fluid condensate is returned to the chamber through the return line 62.
  • the return line feeds the decontaminated fluid into the fluid flow line 20 at a point before the preheater 28.
  • the fluid is returned directly to the chamber 10.
  • the cleaning fluid is circulated through the chamber prior to introduction of antimicrobial fluid.
  • Organic matter deposited on the instruments is removed from the instruments by the cleaning fluid and then leaves the chamber through the outlet 32. This reduces the amount of organic material in the chamber which otherwise could lead to a partial inactivation of the antimicrobial fluid.
  • the preferred timing of addition of the antimicrobial fluid is also dependent on other factors, such as the natural state of the antimicrobial fluid, either solid, liquid, or gaseous, the ease of introducing the antimicrobial fluid into the chamber, and the degree of miscibility of the antimicrobial fluid in the cleaning fluid. Therefore, the antimicrobial fluid is optionally introduced at the same time, or prior to, addition of the cleaning fluid.
  • an impeller 70 within the chamber 10, circulates the cleaning fluid and antimicrobial fluid throughout the chamber and over the instruments to be cleaned and decontaminated.
  • a filter 72 filters cleaning -12 - fluid and antimicrobial fluid entering the chamber.
  • a heater 74 heats the chamber to maintain the cleaning fluid in the cleaning fluid within the critical or sub critical range.
  • a support system 80 supports instruments to be cleaned and sterilized or disinfected within the chamber 10. The support system is constructed so as to provide ready access to the surfaces of the instruments for the cleaning fluid and the antimicrobial fluid. Depending on the nature of the instruments to be decontaminated, racks, shelves or mesh baskets provide suitable support systems.
  • a rigid, open-celled porous media such as POREX brand expanded polymer material, is optionally used for holding the instruments securely, while at the same time permitting the antimicrobial fluid and the cleaning fluid to penetrate to the surfaces of the instruments.
  • a preferred support system for maintaining sterility of decontaminated items includes an enclosed tray 82. Instruments to be cleaned and sterilized or disinfected are inserted into a bottom portion of the tray. A cover portion covers the bottom portion.
  • the cleaning fluid and antimicrobial fluid enter and leave the tray through inlet and outlet openings 84a and 84b in the tray.
  • one of the openings is fluidly connected directly or via a manifold to an interior passage 86 of one or more instruments to be sterilized or disinfected.
  • Cleaning fluid and antimicrobial fluid enters the tray through inlet opening 84a and passes through the interior passage of the instrument and around exterior surfaces of the instrument before exiting the tray through outlet 84b. In this manner, the interior of the instrument is cleaned first with the freshest fluid.
  • the flow pattern is reversed.
  • Sealing members 88 selectively hermetically seal the tray openings 84a and 84b once cleaning and -13 - sterilization or disinfection are complete.
  • the members 88 include check valves, baffles, or other structures which block ambient microbes from entering the tray after it is disconnected from the decontamination system.
  • the instruments are then preferably stored in the sealed trays until needed, to avoid unnecessary handling and contamination of the sterilized or disinfected instruments.
  • the instruments, or other items to be decontaminated are introduced to the chamber through an inlet opening 90 in a side wall 92 of the chamber 10.
  • the instruments need not necessarily be dried before cleaning and decontamination since a small amount of water in the chamber does not appreciable affect the achievement of sub-critical conditions, and also may serve as a cosolvent for improving miscibility of the antimicrobial fluid, and other additives, with the cleaning fluid.
  • a door 94 seals the opening during cleaning and decontamination.
  • the cleaning fluid preferably includes carbon dioxide. Carbon dioxide has a supercritical temperature of around 31°C, thereby allowing for cleaning at temperatures close to ambient.
  • additives which may include surfactants, or cosolvents, such as alcohol, acetone, or water, and detergents, are added to the cleaning fluid to enhance cleaning, increase penetration into the instruments, and improve miscibility between the cleaning fluid and the antimicrobial fluid.
  • surfactants particularly when the contaminants on the instruments include polar compounds, surfactants improve extraction of the contaminants from the instruments that are cleaned and decontaminated.
  • These additives may be recycled through the chamber, as for the anti-microbial fluid, or sent for disposal.
  • the antimicrobial fluid is one which is compatible with the cleaning fluid and which is not appreciably degraded under temperatures and pressures used -14- to provide sub-critical conditions.
  • the antimicrobial fluid preferably acts as an alkylating or oxidizing agent and kills microorganisms typically found on the instruments.
  • Ethylene oxide, propylene oxide, and hydrogen peroxide are preferred antimicrobial fluids.
  • Other antimicrobial fluids include aldehydes, such as formaldehyde or glutaraldehyde, ozone, chlorine, chlorine dioxide, hypochlorites, peracetic acid, other peroxy compounds, and the like.
  • hydrogen peroxide or peracetic acid is the antimicrobial fluid, it may be combined with water or used in a pure form.
  • combinations of antimicrobial fluids are employed.
  • preheated, pressurized carbon dioxide, or other cleaning fluid is pumped into the chamber 10 through the inlet 30 until a sufficient volume is present to maintain the desired pressure.
  • Surfactants are added together with the cleaning fluid from the source of cleaning fluid 12, or separately, from a separate source.
  • the temperature within the chamber is maintained by the heater 74.
  • the control circuit 38 controls the addition of carbon dioxide and the heater to achieve the desired sub-critical conditions.
  • the impeller 70 ensures circulation throughout the chamber.
  • the outlet valve 34 and the pump 18 are controlled to maintain the pressure in the chamber 10 during a cleaning and decontamination cycle.
  • the cleaning fluid is circulated within the chamber for a period sufficient to clean the instruments.
  • the antimicrobial fluid is then introduced to the cleaning fluid and flowed through the chamber to effect sterilization or disinfection.
  • the cleaning fluid, and optionally the antimicrobial fluid is preferably recirculated through the chamber via the separator and condenser to remove contaminants from the chamber.
  • the separator valve 42 controls the pressure within the separator so that the exiting cleaning fluid -15- and antimicrobial fluid, where present, are substantially free of contaminants.
  • the inlet 30 is closed by sealing appropriate valves, such as the valve 26.
  • the cleaning fluid and antimicrobial fluid are removed from the chamber 10 by creating a pressure differential between the separator and the chamber. As the pressure drops within the chamber, the carbon dioxide, and other cleaning and decontamination compounds which are gaseous under ambient conditions, rapidly evaporate from the decontaminated items and pass out of the chamber into the separator 36.
  • the spent antimicrobial fluid is preferably discharged through the waste line 46 or the spent antimicrobial fluid line 54 to the containment vessel 56. Optionally, the antimicrobial fluid is recovered for reuse.
  • the carbon dioxide is either vented to the atmosphere from the condenser 50 through a vent line 96 or, more preferably, returned to the cleaning fluid supply vessel through the return line 62.
  • a three way valve 98 selectively directs the cleaning fluid from the return line 48 to the fluid flow line 20 for return to the chamber 10, or to a reclaim line 100 for return to the cleaning fluid storage vessel 12.
  • the cosolvents, and other additives present may be cleaned and recycled, or discharged with the spent antimicrobial fluid.
  • additives are separated from contaminants by evaporation, vapor phase separation, filtration, or other separation method and returned to the chamber.
  • the chamber 10 is evacuated prior to addition of the cleaning fluid and antimicrobial fluid.
  • the pump 60 or another suitable pump, is employed for the evacuation. Additionally, evacuation of the chamber following decontamination ensures that potentially harmful antimicrobial fluids, surfactants, cleaning agents, other volatile compounds, and the like, are removed from the -16- instruments to reduce the risk of contamination of patients.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Textile Engineering (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

On décrit décrit une chambre (10) pourvue d'un agent dégraissant pressurisé de dioxyde de carbone et de cosolvants alimentés par une première source (12), et d'un fluide antimicrobien, tel qu'un oxyde d'éthylène ou un peroxyde d'hydrogène, alimentés par une deuxième source (16). Les conditions thermiques dans la chambre sont maintenues dans l'intervalle sous-critique pour le dioxyde de carbone. L'agent dégraissant et le fluide antimicrobien sont recirculés à travers un séparateur (32) et un condenseur (38) pour filtrer les contaminants et les séparer du mélange avant la réinjection du dioxyde de carbone et, éventuellement, du fluide antimicrobien et d'autres produits d'addition dans la chambre. Des instruments médicaux ou autres articles placés dans la chambre sont nettoyés par l'agent dégraissant et stérilisés par le fluide antimicrobien en un seul cycle, ce qui permet de les réutiliser dans un bref laps de temps. Ces instruments peuvent être nettoyés et entreposés dans des contenants hermétiques (82). L'agent dégraissant s'évapore rapidement des surfaces des articles à la fin du cycle lorsque la pression est réduite dans la chambre. Une pompe à vide (60) facultative peut aider à éliminer le fluide antimicrobien de la chambre.
PCT/US1999/009770 1998-05-06 1999-05-04 Nettoyage d'un fluide dans l'intervalle sous-critique et systeme et procede de decontamination antimicrobienne Ceased WO1999056892A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US09/674,787 US6558622B1 (en) 1999-05-04 1999-05-04 Sub-critical fluid cleaning and antimicrobial decontamination system and process

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US7342298A 1998-05-06 1998-05-06
US09/073,422 1998-05-06

Publications (1)

Publication Number Publication Date
WO1999056892A1 true WO1999056892A1 (fr) 1999-11-11

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Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002078752A1 (fr) * 2001-03-29 2002-10-10 Rüdiger Haaga GmbH Procede de vaporisation et d'evacuation par aspiration d'un produit de condensation issu d'une chambre de sterilisation
EP1170022A4 (fr) * 1999-12-27 2003-02-05 Sr Kaihatsu Kk Procede et appareil permettant de desinfecter/steriliser des instruments medicaux
DE10236491A1 (de) * 2002-08-09 2004-02-19 Messer Griesheim Gmbh Reinigung mittels CO2 und N2O
DE10236485A1 (de) * 2002-08-09 2004-02-19 Messer Griesheim Gmbh Reinigung von Substratoberflächen mittels CO2 und N2O
DE10236493A1 (de) * 2002-08-09 2004-02-19 Messer Griesheim Gmbh Reinigungsmittel mit CO2 und N2O
JP2008295518A (ja) * 2007-05-29 2008-12-11 Air Water Inc 滅菌方法および装置
US8017074B2 (en) 2004-01-07 2011-09-13 Noxilizer, Inc. Sterilization system and device
EP2415534A1 (fr) * 2010-08-03 2012-02-08 Linde Aktiengesellschaft Procédé de nettoyage et de désinfection d'articles
US8425837B2 (en) 2009-02-23 2013-04-23 Noxilizer, Inc. Device and method for gas sterilization
US8703066B2 (en) 2004-01-07 2014-04-22 Noxilizer, Inc. Sterilization system and method
CN107081298A (zh) * 2017-04-19 2017-08-22 重庆优玛环试医疗设备有限公司 手术器械的真空清理方法
CN108245068A (zh) * 2017-12-18 2018-07-06 许志鸿 一种能将擦手纸巾循环利用的收纳盒
CN111671957A (zh) * 2020-06-24 2020-09-18 江苏医尔健康管理有限公司 一种回路消毒系统
FR3137839A1 (fr) * 2022-07-18 2024-01-19 Biobank Procédé et installation de traitement d’un tissu d'origine humaine ou animale, utilisant une circulation dynamique de fluide supercritique additivé

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EP0342499A2 (fr) * 1988-05-17 1989-11-23 Henkel Kommanditgesellschaft auf Aktien Procédé de nettoyage et de désinfection d'articles médicaux sensibles à la chaleur et la corrosion, en particulier d'endoscopes et produit pour mettre en oeuvre ce procédé
US5213619A (en) * 1989-11-30 1993-05-25 Jackson David P Processes for cleaning, sterilizing, and implanting materials using high energy dense fluids
US5551462A (en) * 1993-12-30 1996-09-03 Biermaier; Hans Cleaning and disinfection machine for medical devices having narrow channels, particularly endoscopes
DE29618376U1 (de) * 1996-10-28 1997-03-13 Dantschke, Ralph, Dipl.-Ing., 04445 Wachau Vorrichtung zur Reinigung, Desinfektion und Vorwärmung von medizinischen Instrumenten, insbesondere Endoskopen
EP0884115A2 (fr) * 1997-06-11 1998-12-16 Ethicon, Inc. ContrÔle d'un procédé de nettoyage

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EP0342499A2 (fr) * 1988-05-17 1989-11-23 Henkel Kommanditgesellschaft auf Aktien Procédé de nettoyage et de désinfection d'articles médicaux sensibles à la chaleur et la corrosion, en particulier d'endoscopes et produit pour mettre en oeuvre ce procédé
US5213619A (en) * 1989-11-30 1993-05-25 Jackson David P Processes for cleaning, sterilizing, and implanting materials using high energy dense fluids
US5551462A (en) * 1993-12-30 1996-09-03 Biermaier; Hans Cleaning and disinfection machine for medical devices having narrow channels, particularly endoscopes
DE29618376U1 (de) * 1996-10-28 1997-03-13 Dantschke, Ralph, Dipl.-Ing., 04445 Wachau Vorrichtung zur Reinigung, Desinfektion und Vorwärmung von medizinischen Instrumenten, insbesondere Endoskopen
EP0884115A2 (fr) * 1997-06-11 1998-12-16 Ethicon, Inc. ContrÔle d'un procédé de nettoyage

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1170022A4 (fr) * 1999-12-27 2003-02-05 Sr Kaihatsu Kk Procede et appareil permettant de desinfecter/steriliser des instruments medicaux
WO2002078752A1 (fr) * 2001-03-29 2002-10-10 Rüdiger Haaga GmbH Procede de vaporisation et d'evacuation par aspiration d'un produit de condensation issu d'une chambre de sterilisation
DE10236491A1 (de) * 2002-08-09 2004-02-19 Messer Griesheim Gmbh Reinigung mittels CO2 und N2O
DE10236485A1 (de) * 2002-08-09 2004-02-19 Messer Griesheim Gmbh Reinigung von Substratoberflächen mittels CO2 und N2O
DE10236493A1 (de) * 2002-08-09 2004-02-19 Messer Griesheim Gmbh Reinigungsmittel mit CO2 und N2O
DE10236491B4 (de) * 2002-08-09 2012-05-03 Air Liquide Deutschland Gmbh Reinigung mittels CO2 und N2O
DE10236485B4 (de) * 2002-08-09 2012-10-11 Air Liquide Deutschland Gmbh Reinigung von Substratoberflächen mittels CO2 und N2O
US8808622B2 (en) 2004-01-07 2014-08-19 Noxilizer, Inc. Sterilization system and device
US8017074B2 (en) 2004-01-07 2011-09-13 Noxilizer, Inc. Sterilization system and device
US9180217B2 (en) 2004-01-07 2015-11-10 Noxilizer, Inc. Sterilization system and device
US8703066B2 (en) 2004-01-07 2014-04-22 Noxilizer, Inc. Sterilization system and method
JP2008295518A (ja) * 2007-05-29 2008-12-11 Air Water Inc 滅菌方法および装置
US8425837B2 (en) 2009-02-23 2013-04-23 Noxilizer, Inc. Device and method for gas sterilization
US8721984B2 (en) 2009-02-23 2014-05-13 Noxilizer, Inc. Device and method for gas sterilization
EP2415534A1 (fr) * 2010-08-03 2012-02-08 Linde Aktiengesellschaft Procédé de nettoyage et de désinfection d'articles
CN107081298A (zh) * 2017-04-19 2017-08-22 重庆优玛环试医疗设备有限公司 手术器械的真空清理方法
CN108245068A (zh) * 2017-12-18 2018-07-06 许志鸿 一种能将擦手纸巾循环利用的收纳盒
CN111671957A (zh) * 2020-06-24 2020-09-18 江苏医尔健康管理有限公司 一种回路消毒系统
FR3137839A1 (fr) * 2022-07-18 2024-01-19 Biobank Procédé et installation de traitement d’un tissu d'origine humaine ou animale, utilisant une circulation dynamique de fluide supercritique additivé
WO2024018136A1 (fr) * 2022-07-18 2024-01-25 Biobank Procédé et installation de traitement d'un tissu d'origine humaine ou animale, utilisant une circulation dynamique de fluide supercritique additivé

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