[go: up one dir, main page]

WO2010064272A1 - Stérilisation de dispositifs médicaux à l'aide d'acides organiques expansés - Google Patents

Stérilisation de dispositifs médicaux à l'aide d'acides organiques expansés Download PDF

Info

Publication number
WO2010064272A1
WO2010064272A1 PCT/IT2009/000545 IT2009000545W WO2010064272A1 WO 2010064272 A1 WO2010064272 A1 WO 2010064272A1 IT 2009000545 W IT2009000545 W IT 2009000545W WO 2010064272 A1 WO2010064272 A1 WO 2010064272A1
Authority
WO
WIPO (PCT)
Prior art keywords
expanded
process according
organic acids
liquid
autoclave
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/IT2009/000545
Other languages
English (en)
Other versions
WO2010064272A8 (fr
Inventor
Ernesto Reverchon
Giovanna Della Porta
Renata Adami.
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.)
Universita degli Studi di Salerno
Original Assignee
Universita degli Studi di Salerno
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 Universita degli Studi di Salerno filed Critical Universita degli Studi di Salerno
Publication of WO2010064272A1 publication Critical patent/WO2010064272A1/fr
Publication of WO2010064272A8 publication Critical patent/WO2010064272A8/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
    • A01N37/16—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing the group; Thio analogues thereof
    • 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
    • A61L2/22—Phase substances, e.g. smokes, aerosols or sprayed or atomised substances

Definitions

  • the present invention concerns procedures for the sterilization of medical devices using organic acids expanded by compressed gases to form an "expanded liquid".
  • expanded liquid means, in the technical literature, an organic compound that is liquid at room temperature and pressure, modified by dissolution therein of a compressed gas to modify the diffusivity and the surface tension of the liquid compound, while maintaining part of its original liquid characteristics.
  • Sterilization is conventionally performed by different well known meth- ods, such as by means of pressurized steam, ethylene oxide, oxidizing agents (e.g. peroxides or peracids), gamma irradiation or ultrafiltration.
  • oxidizing agents e.g. peroxides or peracids
  • gamma irradiation e.g. peroxides or peracids
  • ultrafiltration e.g. peroxides or peracids
  • the endoscopes and similar devices come into contact with mucous membranes and other tissues of the patient under examination or treatment; therefore, they may be contaminated with several patho- genie microorganisms including HBV, HCV/HIV, spirochetes, tubercle bacilli, Pseudomonas aeruginosa, Helicobacter pylori and many others.
  • patho- genie microorganisms including HBV, HCV/HIV, spirochetes, tubercle bacilli, Pseudomonas aeruginosa, Helicobacter pylori and many others.
  • These microorganisms can have high levels of pathogenicity, infectivity and resistance to disinfectants. Therefore, a high level sterilization is required, due to the risk of cross-infections with known and unknown bacteria and viruses.
  • endoscopes are the most difficult devices to be sterilized due to their particular contamination conditions and complex micro- structure.
  • repeated thermal stresses due to the sterilization procedures can produce distortions of their delicate internal structures as, for example, their telescopic lenses; whereas, gamma radiation showed to compromise the mechanical properties of some of the polymers involved in the fabrication of these medical devices.
  • Ethylene oxide on the other hand, is toxic, mutagenic and carcinogenic and it can also react with some polymers.
  • Liquid organic acids may not reach some internal parts of the concerned medical devices, and are frequently too reactive with some parts of these delicate devices.
  • the adoption of improved sterilization technologies is particularly required for such kind of medical devices, in order to improve their useful life and assure their safe operation.
  • SC-CO 2 supercritical carbon dioxide
  • the present invention proposes an innovative sterilization proc- ess that uses "expanded” acetic acid or expanded mixtures of acetic acid and peracetic acid obtained by adding "dense gases” (where a “dense gas” is defined as a fluid used in the proximity of its critical point).
  • the "expanded acids” are for the first time used as sterilizing agents with the advantage of achieving "gas-like" transport properties and large tunability of their oxidizing action.
  • the invention is related to a sterilization process performed using "expanded' organic acids (peracetic acid or acetic acid or their mixtures in all proportions) adding a compressed gas to produce a solution (expanded liquid) that will have a reduced surface tension and, large diffusivi- ties that therefore, have improved mass transfer properties with respect to the disinfection of internal surfaces of medical devices, that can be very difficult to be reached.
  • the expanded solutions formed by an organic acid and a compressed gas for example, carbon dioxide at operating conditions in the range between 50-150 bar and 35-80°C
  • expanded acids formed by an organic acid and carbon dioxide in percentages from 99 to 20% by weight, preferably from 90 to 50% by weight.
  • Carbon dioxide is the preferred compressed gas for this application because it can further improve the sterilization process due to its non-oxidative bacteria killing properties; and because its strong action in modulating the oxidizing activity of the acid solutions is related to its operation near the critical conditions where small variations of the process parameters (mainly pressure and temperature) can induce large variations of its properties.
  • other gases can also be used to generate the sterilizing "expanded liquid'.
  • a non exhaustive list comprises, ethylene peroxide, nitrogen protoxide, trifluoromethane and propane.
  • the disclosed process consists of the following steps: a) formation of an expanded liquid solution from one or more organic acids which are in the liquid state at room temperature and pressure and an expanding compound which is gaseous at room conditions, the lat- ter compound being included in the mixture in an amount of from 99% to 20% by weight, in a high pressure mixer; b) delivery of the expanded liquid solution in a pressurized autoclave, previously filled with the medical devices to be sterilized; c) sterilizing the devices at a fixed pressure and temperature, and for a fixed processing time; d) eliminating the organic acid residues in the autoclave by washing it with the same compressed gas; e) depressurizing the solution at the exit of the autoclave to recover the organic acids in one or more separators located downstream the auto- clave.
  • the proposed process also includes a further operation f) of precipitation of the extracted residues and , optionally, a further operation g) of depressurisation of the expanded solution to recover the organic acids.
  • the compounds selected as the expanding component are gaseous at room conditions and can be chosen from the following: carbon dioxide, nitrogen protoxide, trifluoromethane, propane; but many other compounds can also be used. Carbon dioxide is the preferred expanding compound.
  • the organic acids used in the proposed process are preferably chosen in the group consisting of: acetic acid, peracetic acid and their mixtures in all proportions.
  • the formed expanded solution contains from 99 to 20% by weight of the organic acids, preferably from 90 to 50% by weight, more preferably from 90 to 70%.
  • the operating conditions in the mixer and in the autoclave (operations a) and b)) are performed in a pressure range between 80 and 200 bar (preferably between 80-100 bar) and at a temperature range between 25 and 80 0 C (preferably between 30 and 60 0 C).
  • the residence time in the autoclave can vary between 5 and 190 minutes, and is preferably between 10 and 60 minutes.
  • the solution is obtained in a mixer and then, delivered to the sterilizing autoclave previously charged with the contaminated medical device.
  • the microorganisms, bacteria and/or spores, present on the device surface are contacted with the expanded liquid of acetic acid or mixtures of acetic acids and peracetic acid with dense gases (for example CO 2 ) for a fixed period and at a given flow rate of time.
  • the mixture at the exit of the sterilizing autoclave (organic solvent+CO 2 ) is, then, delivered to the separator, where, changing the operating pressure and temperature, the de-mixing of the organic solvent from CO 2 is obtained. Both CO 2 and the organic solvents can be recycled.
  • the degree of deactivation can be calculated from the measure of the number of microorganisms on an untreated device and the number of micro- organism on a treated device with the following equation (UNI EN 556-1):
  • Pieces of small medical devices namely tweezers and scalpets, were placed with a sample of B.
  • the autoclave was loaded with the contaminated devices on which the spores were previously spread.
  • the solution was used in a pressure range of 80-100 bar (preferably at 90 bar) and in a temperature range of 30-50 0 C (preferably at 35°C) to produce the expanded liquid.
  • the solution was delivered to the sterilizing autoclave with a flow rate ranging between 0.8 and 5 kg/h (preferably 1 kg/h).
  • the expanded solution because of its characteristics of surface tension, density and viscosity, covered all the surfaces reaching all the inner parts of the devices, also the most difficult to be reached.
  • the process was performed for a period time ranging between 10 and 90 minutes (usually 30 minutes). Downstream the autoclave, the solution was sent to the separator operating at pressures between 30 and 10 bar (preferably 20 bar) and at temperatures between 0 and 25°C (preferably 10 0 C). In the separator, PA and AA were precipitated and recovered by decompression, whereas, CO 2 is separated as gas. The number of CFUs on each Petri dish was counted after 24 and 48 hours incubation at 30-35 0 C.
  • acetic acid (AA) and CO 2 were mixed at weight ratios between 90 and 20% (preferably 50% of PA solution by weight) in a static mixer.
  • the solution was used in a pressure range of 80-1 10 bar (preferably at 90 bar) and in a temperature range of 30-50 0 C (preferably at 35°C) to obtain the formation of the expanded liquid.
  • the solution was, then, delivered to the sterilizing auto- clave with a flow rate ranging between 0.8 and 5 kg/h (preferably 0.9 kg/h).
  • the high diffusivity and the near zero surface tension of the expanded solution allowed to reach all the inner parts of the endoscope.
  • the process was performed for a period time ranging between 10 and 90 minutes (usually 25 minutes). Downstream the autoclave, the solution was sent to the separator operating at pressures between 30 and 10 bar (preferably 20 bar) and at temperatures between 0 and 25 0 C (preferably 20 0 C). In the separator, PA and AA are precipitated and recovered by decompression, whereas, CO 2 is separated as gas. The number of CFUs was calculated as in the Example 1. Log reductions of 6.3 and 6.1 were measured with B. atropheus and B. anthracis spores, respectively.
  • Example 1 was repeated, except that a sample of B. subtilis spores/vegetative preparations (1 mL) was used to contaminate the medical device, that was a piece of 80 mm length of intubation fiberscope.
  • the autoclave was loaded with the contaminated devices on which the spores were previously spread.
  • a solution of peracetic acid (PA) 25% in acetic acid (AA) was mixed with CO 2 at weight ratios between 90 and 20% of solution with CO 2 .
  • the experiment was performed at a pressure of 60-100 bar and in a temperature range of 30-50°C, to obtain the formation of the expanded liquid.
  • the solution was delivered to the sterilizing autoclave with a flow rate ranging between 0.8 and 5 kg/h (preferably 1 kg/h).
  • the process was performed for period of time of 30-40 minutes. Downstream the autoclave, the solution was sent to the separator operating at pressures between 30 and 10 bar (preferably 15 bar) and at temperatures between 0 and 25°C (preferably 18°C). In the separator, PA and AA are pre- cipitated and recovered by decompression, whereas, CO 2 is separated as gas.
  • the number of CFUs was calculated as in the Example 1. Log reduc- tion in CFUs of 6.3-6.5 were observed for multiple experimental evaluations.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Environmental Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Dentistry (AREA)
  • Plant Pathology (AREA)
  • Pest Control & Pesticides (AREA)
  • Agronomy & Crop Science (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • External Artificial Organs (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

La présente invention concerne un procédé de stérilisation de dispositifs biomédicaux à l'aide d'acides organiques expansés par des gaz comprimés pour former un « liquide expansé », terme qui désigne un solvant organique liquide à température et pression ambiantes modifié en y dissolvant un gaz comprimé pour changer la diffusivité et la tension de surface du composé liquide, tout en conservant une partie de ses caractéristiques initiales comme le pouvoir dissolvant et la capacité d'oxydation. L’invention concerne également l’utilisation d'acides organiques expansés comme agents de stérilisation pour des dispositifs biomédicaux complexes, dont l’efficacité particulière résulte de leurs propriétés de transfert favorables (similaires aux propriétés d’un gaz) et de leurs propriétés d'oxydation, qui peuvent varier en fonction de la composition du mélange gaz-liquide.
PCT/IT2009/000545 2008-12-03 2009-12-03 Stérilisation de dispositifs médicaux à l'aide d'acides organiques expansés Ceased WO2010064272A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000036A ITSA20080036A1 (it) 2008-12-03 2008-12-03 Sterilizzazione di strumenti bio-medicali mediante acidi organici espansi
ITSA2008A000036 2008-12-03

Publications (2)

Publication Number Publication Date
WO2010064272A1 true WO2010064272A1 (fr) 2010-06-10
WO2010064272A8 WO2010064272A8 (fr) 2010-09-30

Family

ID=40666743

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IT2009/000545 Ceased WO2010064272A1 (fr) 2008-12-03 2009-12-03 Stérilisation de dispositifs médicaux à l'aide d'acides organiques expansés

Country Status (2)

Country Link
IT (1) ITSA20080036A1 (fr)
WO (1) WO2010064272A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999066960A2 (fr) 1998-06-25 1999-12-29 Massachusetts Institute Of Technology Procede de sterilisation par fluide supercritique
WO2004012510A1 (fr) * 2002-08-06 2004-02-12 Ecolab Inc. Compositions antimicrobiennes contenant un fluide critique et utilisation et production de celles-ci
DE10236791A1 (de) * 2002-08-10 2004-02-19 Deutsches Textilforschungszentrum Nord-West E.V. Konservierungs-, Desinfektions- und Sterilisationsverfahren mit flüssigem und überkritischem Kohlendioxid und Ozon
US20040120852A1 (en) 1999-12-27 2004-06-24 Kabushiki Kaisha Sr Kaihatsu Method of sterilizing medical instruments
US20070003432A1 (en) * 2004-06-17 2007-01-04 Christensen Timothy W Sterilization methods and apparatus which employ additive-containing supercritical carbon dioxide sterilant
WO2007008618A2 (fr) 2005-07-13 2007-01-18 University Of South Carolina Sterilisation au dioxyde de carbone a haute pression
US20070073081A1 (en) 2005-09-26 2007-03-29 Fisher Steven A Peracetic acid in an anhydrous sterilant delivery system

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999066960A2 (fr) 1998-06-25 1999-12-29 Massachusetts Institute Of Technology Procede de sterilisation par fluide supercritique
US20040120852A1 (en) 1999-12-27 2004-06-24 Kabushiki Kaisha Sr Kaihatsu Method of sterilizing medical instruments
WO2004012510A1 (fr) * 2002-08-06 2004-02-12 Ecolab Inc. Compositions antimicrobiennes contenant un fluide critique et utilisation et production de celles-ci
DE10236791A1 (de) * 2002-08-10 2004-02-19 Deutsches Textilforschungszentrum Nord-West E.V. Konservierungs-, Desinfektions- und Sterilisationsverfahren mit flüssigem und überkritischem Kohlendioxid und Ozon
US20070003432A1 (en) * 2004-06-17 2007-01-04 Christensen Timothy W Sterilization methods and apparatus which employ additive-containing supercritical carbon dioxide sterilant
WO2007008618A2 (fr) 2005-07-13 2007-01-18 University Of South Carolina Sterilisation au dioxyde de carbone a haute pression
US20070073081A1 (en) 2005-09-26 2007-03-29 Fisher Steven A Peracetic acid in an anhydrous sterilant delivery system

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
WHITE ET AL: "Effective terminal sterilization using supercritical carbon dioxide", JOURNAL OF BIOTECHNOLOGY, ELSEVIER SCIENCE PUBLISHERS, AMSTERDAM, NL, vol. 123, no. 4, 10 June 2006 (2006-06-10), pages 504 - 515, XP005433553, ISSN: 0168-1656 *

Also Published As

Publication number Publication date
ITSA20080036A1 (it) 2010-06-04
WO2010064272A8 (fr) 2010-09-30

Similar Documents

Publication Publication Date Title
US7108832B2 (en) Sterialization methods and apparatus which employ additive-containing supercritical carbon dioxide sterilant
Ayliffe Decontamination of minimally invasive surgical endoscopes and accessories.
EP1094847B1 (fr) Procede de desinfection et de sterilisation du materiel contamine par des microbes
EP1432783B1 (fr) Decontamination de surfaces contaminees par une substance infectee par des prions au moyen d'agents oxydants gazeux
TW436301B (en) Process for removing contaminants from a preselected substrate
US20050220665A1 (en) Low temperature sterilization and disinfections method and apparatus for medical apparatus and instruments
US20090110596A1 (en) Sterilization methods and apparatus which employ additive-containing supercritical carbon dioxide sterilant
WO2007103617A2 (fr) Appareil et procédé de stérilisation
WO2004020562A1 (fr) Composition destinee a desinfecter ou a laver des instruments medicaux et procede de preparation de cette composition
US6610251B1 (en) Method of sterilizing medical instruments
US20100006121A1 (en) Plasma cleaning method
Lopes et al. Evaluation of single-use reprocessed laparoscopic instrument sterilization
JP6590395B2 (ja) 気体窒素酸化物の発生法、発生装置及び回収法
Alfa Medical-device reprocessing
JPWO2009098873A1 (ja) 殺菌水及びその生成方法並びにその生成装置
WO2010064272A1 (fr) Stérilisation de dispositifs médicaux à l'aide d'acides organiques expansés
Zulli et al. SARS-CoV-2 inactivation by supercritical carbon dioxide coupled with hydrogen peroxide
CN1961964A (zh) 低温消毒灭菌方法及其装置
TWI284543B (en) Method and apparatus for low temperature sterilization and disinfections
JP2006095308A (ja) 低温消毒滅菌方法及びその装置
Desai et al. Infection control for perioperative ultrasonography and echocardiography
Bertoloni et al. Medical device disinfection by dense carbon dioxide
US20060275172A1 (en) Item reprocessing and sterile packaging apparatus
US20070154347A1 (en) Low temperature process for concurrent cleaning and sanitation of solid surfaces
TW200520799A (en) Method for cleaning and sterilizing medical devices using dense phase fluid

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 09805961

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 09805961

Country of ref document: EP

Kind code of ref document: A1