WO1995024933A1 - Systemes d'emballage pour processus de sterilisation au peracide - Google Patents

Systemes d'emballage pour processus de sterilisation au peracide Download PDF

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Publication number
WO1995024933A1
WO1995024933A1 PCT/US1995/003241 US9503241W WO9524933A1 WO 1995024933 A1 WO1995024933 A1 WO 1995024933A1 US 9503241 W US9503241 W US 9503241W WO 9524933 A1 WO9524933 A1 WO 9524933A1
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WO
WIPO (PCT)
Prior art keywords
package
indicator
color
exposure
vapor
Prior art date
Application number
PCT/US1995/003241
Other languages
English (en)
Inventor
Afaf Wensky
Phillip A. Martens
Ross A. Caputo
Original Assignee
Abtox, Inc.
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 Abtox, Inc. filed Critical Abtox, Inc.
Priority to AU19994/95A priority Critical patent/AU1999495A/en
Publication of WO1995024933A1 publication Critical patent/WO1995024933A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
    • G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
    • G01N31/226—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators for investigating the degree of sterilisation
    • 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
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/22—Testing for sterility conditions

Definitions

  • the present invention generally relates to sterilization process packaging with components such as chemical indicators, which are useful in indicating that medical devices or apparatus have been exposed to one or more sterilization process conditions, and more particu ⁇ larly relates to devices useful to indicate sterilization cycle exposure when the sterilization cycle includes use of an acidic gas or vapor such as peracetic acid.
  • Chemical indicators are generally used to monitor whether or not an article, such as medical apparatus, has been exposed to sterilizing conditions.
  • the type of chemical indicator discussed here is commonly known as a "throughput indicator.” This type of indicator responds to one or more physical or chemical components in the sterilization environment, but it does not necessarily have to respond to all the components necessary for sterilization. Since the indicator response may occur in the absence of one or more essential sterilization components, the indicator response is not necessarily an indication of sterility.
  • the chemical indicator only indicates that it and the accompanying articles have been processed in a sterilizer.
  • the indicator takes the form of a reactive chemical which reacts with a chemical in the sterilizing environment to form a new chemical with different properties, frequently a different color.
  • Other indicators react to physical conditions encountered during sterilization; for instance, wax indicators melt when exposed to the high temperatures encountered during autoclaving. Descriptions of various chemical indicators may be found in the monograph "Biological and Chemical Indicators," Report 78-4.4 of the Health Industry Manufacturer's Association (HIMA) .
  • readability refers to the indicator characteristics which allow users to differentiate between unexposed indicators and those which have been exposed to sterilization conditions.
  • Good readability means that virtually all healthcare workers, including those with common vision problems such as color blindness, can distinguish exposed indicators from unexposed indicators. For example, readability may be difficult when a user attempts to determine the shade of a color such as light brown turning to medium brown as the color change. Further, indicators should change in contrast as well as color. An indicator which changed, for example, from red to green, could pose problems for users with color vision defects unless there was an accompanying (sufficient) contrast change.
  • Stability is also an important characteristic.
  • the indicating means of both unexposed and exposed indicators must not change under the normal storage conditions the article encounters.
  • One type of commercially available chemical indicator, for example, must be stored in a refrigerator to prevent incorrect color changes over normal storage, which is inconvenient and disadvantageous.
  • a device useful to monitor whether or not an article, such as medical apparatus, has been exposed to sterilizing conditions comprises a package and an indicator associated with the package.
  • the package has at least a portion that is sufficiently permeable to admit a sterilizing amount of gas or vapor into the package when it is sealed (such as sealed to enclose the article being sterilized) .
  • the package is substantially bacterial impermeable when sealed.
  • the indicator associated with the package changes color from a first color to a second color in response to acidic gas or vapor exposure. Both the first and second colors of this indicator are substantially stable. Preferred embodiments of the invention include indicators that substantially maintain their colors under ambient conditions for at least about one year.
  • Figure 1 illustrates a schematic cross-section of a sterilizing apparatus with a plane view of an inventive embodiment within the schematically represented sterilizing apparatus before use of the apparatus to sterilize;
  • Figure 2 is a cut-away of the inventive embodiment as in Fig. 1, but following use of the sterilizing apparatus to expose the inventive embodiment to sterilizing conditions;
  • Figure 3 is a cross-sectional view taken along lines 3-3 of Fig. 2;
  • Figure 4 is similar to Fig. 3, but of another embodiment of the invention.
  • Devices in accordance with this invention are useful to indicate sterilization cycle exposure of an article (such as medical apparatus) when the sterilization cycle includes an acidic fluid, typically a gas or vapor.
  • inventive device embodiments of this invention are those comprising a package and one or more indicators associated with the package.
  • One indicator component of the inventive packaging system is of the chemical indicator type.
  • a sterilizing apparatus 10 with which the invention is useful may comprise, for example, a plasma chamber 12, a sterilization chamber 22, and access into chamber 22, such as door 26.
  • Means for generating the plasma may include waveguide assembly 16, microwave 18, and magnetron 20 which generate plasma upstream of sterilization chamber 22 from a suitable gas mixture introduced at inlet 14.
  • gas is energized by microwave radiation and forms a plasma having an initial high concentration of ions and ultraviolet emissions.
  • the plasma's active downstream product consists essentially of highly reactive uncharged atoms and free radicals and uncharged electronically excited molecules.
  • another inlet 24 may deliver an additional sterilizing species during a separate cycle, such as an antimicrobial fluid.
  • An inventive embodiment 40 of the invention comprises a package, or pouch, 42 sealed along one edge 48 with a medical device for sterilization (here, illustrated as forceps 46) within pouch 42.
  • An indicator 44 is associated with the pouch and adapted to be visually observed.
  • the indicator has first color (illustrated as 44a, lined to indicate a blue color).
  • first color illustrated as 44a, lined to indicate a blue color.
  • Fig. 2 one sees the indicator (here illustrated after exposure to a sterilization cycle and thus designed 44b), with a changed color lined to indicate a yellow color. That is, the chemical indicator 44 associated with the package 42 visually indicates whether exposure to an acidic fluid of a sterilization cycle has occurred by changing color from a first color (44a of Fig. 1) to a second color (44b of Fig. 2) in response to acidic gas or vapor exposure.
  • acidic is meant “capable of causing an indicator in the basic form to turn to the acidic form.”
  • use of the term “acidic” is not limited to a pH less than 7, since an indicator with a pK a of 11 would turn from its basic form to its acidic form if exposed to a pH of lower than about 10.5.
  • the manner of association of the indicator with the package can take various forms, which will be described hereinafter.
  • Packages of the invention have at least a portion that is gas or vapor permeable, but bacteria impermeable.
  • the gas or vapor permeable portion is con- figured so as to define at least one path for providing entry of sterilizing gas into contact with the article to be sterilized.
  • sterilizing gas we mean an acidic fluid, preferably in gaseous or vapor form.
  • gas and vapor are used throughout as being substantially synonymous, but embodiments of the invention are particularly useful to indicate exposure to an antimicrobial fluid (e.g. peracid vapor), such as peracetic acid that vaporizes from solution due to reduced sterilizing chamber pressure and/or heating.
  • the permeable package portion may constitute the entire package, but frequently the package will be constructed of the permeable portion and one or more other materials.
  • the other material(s), when present, are usually gas and bacteria impermeable.
  • the portion that is permeable to gas or vapor, but impermeable to bacteria, will typically be microporous with the volume average diameter of pores being in the range of from about 0.02 to about 0.5 ⁇ m.
  • Suitable microporous materials include spunbonded polyethylene, spunbonded polypropylene, microporous polyethylene, and microporous polypropylene, usually in the form of film or sheet. Paper can also be used as the permeable portion for inventive embodiments.
  • the thickness of the permeable material can vary, but usually will be in the range of from about 0.23 to about 0.65 mm.
  • impermeable materials suitable in forming part of the inventive packages include polyester, polyethylene, polypropylene, poly(vinyl chloride), and poly(ethylene terephthalate) , usually in the form of film, sheet, or tube.
  • the impermeable materials will also be sufficiently transparent or translucent as to permit visual observation into the package from a position exterior to the package when the package is sealed. This visual observation into the package is important for one embodiment of the invention wherein an indicator, or dye composition, is adapted to be sealed within the package and to be visually observed therein.
  • Packages of the invention can be formed with seams, joints, and seals made by conventional techniques, such as, for example, heat sealing and adhesive bonding.
  • heat sealing include sealing through use of heated rollers, sealing through use of heated bars, radio frequency sealing, and ultrasonic sealing. Peelable seals based on pressure sensitive adhesives may also be used.
  • the package prevents contamination after sterilization for an enclosed article (such as medical apparatus) and any additionally enclosed, optional components during shelf life until use. Microorganisms external to the package are prevented entry by the packaging barrier.
  • inventive embodiments were developed for preferred use with a particular gas sterilization process. However, some embodiments of the invention are broadly useful with other acidic sterilants and other acidic sterilizing processes.
  • a gas typically a peracid, such as peracetic acid vapor
  • a peracid such as peracetic acid vapor
  • U.S. Patents 5,084,239 and 5,244,629 describe this sterilizing process, in which one step, or sterilizing cycle, can utilize peracid vapor, such as peracetic acid, as sterilant.
  • peracid as used herein, is defined to include well known peracid antimicrobial agents, such as saturated and unsaturated peralkanoic acids including peraralkanoic acids having from one to eight carbon atoms and halogenated derivatives thereof.
  • the halogenated peracids contain one or more chloro, bromo, iodo, or fluoro groups.
  • suitable peracids include peracetic acid, halogenated peracetic acids, performic acid, perpropionic acid, halogenated perpropionic acids, perbutanoic acid and its halogen derivatives, percapronic acid and its halogen derivatives, percrotonic acid, monopersuccinic acid, monoperglutaric acid, and perbenzoic acid, for example.
  • the preferred peracids are sufficiently volatile to form an effective sporicidal vapor concentration at temperatures of less than 80°C.
  • Peracid sterilization is effected by contact of the article with antimicrobial concentrations of the peracid vapor.
  • a pulsed peracid treatment may be carried out by exposing the article to be sterilized to peracid vapor having a concentration of from 1 to 35% (w/w) peracid, and more preferably from 5 to 12% (w/w) peracid, for a time sufficient to permit contact of the vapor with all surfaces of the article being sterilized. More than one such exposure, or pulsed period, may be used.
  • the pulsed contact exposure time is preferably from about 10 to about 20 minutes per pulsed period with packaged articles. Six such periods, for a total exposure of about two hours, are particularly preferred.
  • the peracid exposure can be carried out at a temperature of from 20° to 80°C, and preferably from 40° to 60°C.
  • peracetic acid in certain concentrations are explosive at elevated temperatures. For this reason, peracetic acid is usually transported and stored in aqueous solutions having less than 35 wt.% peracetic acid.
  • the peracetic acid solution is easily vaporized, and effective treatment of articles, according to this invention, can be achieved by exposing the articles to peracetic acid vapors at reduced chamber pressures, such as in the range of from about 1 to about 30 torr.
  • the lower pressure limit is the lower range limit of the effective concentration of the peracetic acid necessary for reasonably short processing times.
  • the article being sterilized is preferably exposed to gaseous antimicrobial agent at partial pressures of from about 4 to 50 torr and a treatment time of at least about 5 minutes, preferably about 10 to 15 minutes.
  • the gas mixture with antimicrobial agent is removed by evacuating the sterilizing chamber to less than about 4 torr.
  • Embodiments of the invention include chemical indicators that change color from a first color to a second color in response to the just described acidic gas or vapor exposure.
  • the first color is that which is observable when the indicator has not been exposed to acidic gas or vapor, but rather is the color at normal, ambient conditions (that is, the first color is the basic form of the pH sensitive dye). It is believed that particularly preferred indicators of this invention, as below further described and exemplified, actually respond to acetic acid vapor, which is a component of vaporized peracetic acid solution, and can also be formed by the breakdown of peracetic acid.
  • Preferred embodiments of the invention are sufficiently selective, or sensitive, so as to change from the first color to the second color when exposed to sufficient concentration of the acid gas or vapor within a practical time or exposure.
  • a solution of 10% peracetic acid and 11% acetic acid can provide a concentration of about 2.2 mg/1 acetic acid vapor, which causes chemical indicator embodiments prepared as hereinafter described by Example 1 to change color after about a 15 minute exposure while another formulation (5% peracetic acid and 11% acetic acid) can provide a concentration of about 1.75 mg/1 of acetic acid vapor to cause the indicator to change color within about 20 minutes.
  • the indicator maintains the second color and is substantially stable under normal storage conditions (typically ambient conditions). Both unexposed and exposed indicator colors should be stable. Preferred embodiments of the present invention include indicators that substantially and stably maintain their colors under ambient conditions for at least about one year. If an unexposed indicator were to change color to that of an exposed indicator as the result of storage, an unsterilized device might be used on a patient. This could be disastrous.
  • the indicator includes a substrate and a dye composition. Referring to Fig. 3, indicator 44 is constituted by a dye composition carried on substrate 50.
  • the dye composition is preferably absorbed on substrate 50, and the substrate is of a size to be sealed within the package and visually observed from a position outside the package.
  • Suitable substrates include, for example, filter paper or acid-free blotter paper.
  • indicator 44' differs from the Fig. 3 embodiment by being carried on a wall of pouch 42' itself.
  • the chemical indicator again includes the dye composition, but this dye composition can be carried by the package itself, such as by being imprinted on an exterior (or interior, if visible), surface.
  • an elongated, flexible member, or substrate has an adhesive layer on one side and the dye composition on the other side.
  • This embodiment can then be affixed to the package either as a label and/or to hold the package or wrappings in place, and is especially useful for large loads wrapped in muslin or synthetic sheets.
  • large sterilizer loads such as trays of instruments, are packaged in sheets of muslin or sheets of porous synthetic fabrics.
  • Two or more layers of wrapping are typically used. These layers of material act as biocontamination barriers.
  • the sheets are typically held in place with tape, and the embodiment of the invention as just described is useful to hold the wrappings together as a biocontamination barrier in lieu of conventional tape.
  • Dye compositions for the inventive embodiments include a pH sensitive dye where the dye gives a color change, preferably at a pH approximately the same as or higher than the pK of the acidic fluid selected as the sterilant (or as a component in the sterilant gas or vapor) in the sterilization cycle being monitored.
  • the pK of peracetic acid is about 9
  • the pK of acetic acid is about 4.75.
  • the dyes for use with a peracetic acid exposure should change color at about 9 or at about 4.75 pH.
  • Suitable pH sensitive dyes for practicing this invention are 3 ' ,3",5 ' ,5"-tetrabromo- phenolsulfonephthalein (Bromophenol Blue) and 3',3",5',5"- tetrabromo-m-cresolsulfonephthalein (Bromocresol Green).
  • Bromophenol Blue is blue at a pH of about 4.6, and turns yellow in the pH range between about 3 to 4.6.
  • Bromocresol Green is blue at about pH 5.4, and turns yellow in the pH range between about 3.8 and 5.4. Both of these preferred dyes have been determined to be stable so as to maintain their colors (first and second colors, respectively) under ambient conditions for at least about one year.
  • Dye compositions of the invention preferably include one or more conventional pH adjusting agents, binding agents, and/or thickening agents.
  • the pH adjusting agents are useful to place the dye composition near or at the point where color change begins to occur.
  • the binding and/or thickening agents may be selected from a wide range of binding and thickening agents known to the art, and are chosen so that they do not interfere with the dye activity.
  • the binding and/or thickening agents can be used to adapt the dye composition for the selected manner by which it will be associated with packaging, substrate, or flexible member, as the case may be.
  • a substrate such as filter paper or acid-free blotter paper
  • glycerol is a useful thickening agent, as well as silica and bentonite.
  • Device embodiments of the invention comprising packaging and an associated chemical indicator may include additional components (not illustrated) .
  • Particularly preferred embodiments are packaging systems that include biological indicators as well as chemical indicators. The biological indicators are for monitoring exposure to a sterilizing process where a selected number of viable organism spores are inoculated on a carrier and included in pouch 42 or 42'.
  • Spores rather than the vegetative form of an organism in biological indicators, are used because vegetative bacteria are known to be easily killed by sterilizing processes. Spores also have superior storage characteristics as they can remain in their dormant state for years. Thus, when sterilization of a standardized spore strain occurs from a sterilization process, such can provide a high degree of confidence that sterilization of bacterial strains in the sterilizing chamber has occurred.
  • Bacillus circulans spores which can be on a carrier placed within the sealed package to maintain integrity of the spores until the biological indicator is used for its intended purpose.
  • Bacillus circulans is preferred because the organism is considered non-pathogenic, is stable enough to provide a relatively long shelf life when packaged, is easy to grow so that sterility tests can be performed using common techniques and materials, and has been found to have a high resistance and more stable resistant pattern when compared to prior art organisms such as B . subtilis and B . stearothermophilus , as exemplified by serial number 08/111,989, filed August 25, 1993.
  • Bacillus circulans cultures are available, for example, from the American Type Culture Collection, 12301 Parklawn Drive, Rockville, Maryland 20852.
  • B . circulans strains available are ATCC 61, ATCC 13403, and ATCC 21821, 21822 (subspecies n . proteophilus and n . biotinicus , respectively).
  • biological indicators When biological indicators are included they can be either simply enclosed within the package or pouch 42, 42 ' or they can have their own package before they are placed within the outer package for the assemblage. It has been suggested that the type of product or carrier material inoculated can significantly affect the resistance of the biological indicator.
  • Filter paper carrier material has been shown to have excellent storage stability.
  • Preferred carriers are formed of materials such as filter paper, which can be readily macerated along with the carried spores if one wishes to perform survivor determinations.
  • the carrier such as a filter paper carrier
  • the carrier can be quite simply inoculated with spores by preparing an aqueous suspension with the desired spore concentration and pipetting aliquots onto the carrier.
  • inoculation of carrier can be performed according to the USP XXII Bacteriostasis Test Method. . Briefly, a suspension of Bacillus circulans spores in water is prepared so as to yield a desired number of spores per aliquot for inoculating a carrier such as filter paper.
  • the Bacillus circulans spores may be placed into the package as a selected number as follows. Before inoculating spores onto the carrier, a heat shock step is desirably performed. Heat shock is a sublethal thermal treatment given to spores to prepare the enzymatic reactions for germination. Thus, a preferred sequence is a heat shock step, cooling, diluting the spore suspension, and then inoculating carriers and drying. The following method can be used to prepare inoculated carriers and to perform a population count. An inoculated paper carrier is placed into a test tube containing 10 ml of water and several small glass beads. The tube is agitated vigorously until the paper is macerated by the action of the glass beads.
  • the macerated mixture is diluted using ordinary serial dilution techniques, and aliquots of the dilutions are transferred to petri plates.
  • An agar solution containing growth medium, such as Tryptic Soy Agar, is prepared, sterilized by autoclaving, and kept in liquid form by maintaining its temperature at about 60°C.
  • the agar is added to the petri plates in a quantity sufficient to fill the plates to a depth of at least 5 mm.
  • the agar is mixed with the spore aliquots by gentle agitation.
  • the mixture is allowed to stand, and the agar gels as the solution cools.
  • the plates are then inverted and incubated at 32°-37°C for 24- 48 hours. Plates with 30-300 calories are enumerated, and the average population per carrier is calculated.
  • the biological indicator itself may be separately packaged to facilitate test uses, storage, or record keeping separate from the chemical indicator or other components.
  • the just described dye composition was applied to substrate by placing a coil of Whatman 3MMCHR chromatography paper, in a beaker of the dye composition and leaving it in the beaker for a minute. The paper was then removed, drained, dried, and cut into pieces. The indicators were then individually sealed in Tyvek/Mylar pouches (commercially available as Tower Plasti-Peel pouches) and the package edges were sealed by heating.
  • Tyvek/Mylar pouches commercially available as Tower Plasti-Peel pouches
  • the peracetic acid formulation used a solution of 10% peracetic acid, 11% acetic acid, 2% H 2 0 2 , less than 1% nonvolatile substances, and the balance water.
  • the indicators were exposed to six treatments, with each treatment consisting of a 20 minute exposure to the peracetic acid vapor portion (concentration of about 2.2 mg/1 acetic acid vapor) of the process followed by a 10 minute exposure to the plasma portion of the process.
  • One Sixth Sterilization Process the indicators were exposed to one treatment consisting of 20 minute exposure to the peracetic acid followed by a 10' plasma treatment.
  • Exposure to the complete sterilization process caused the indicators to turn from dark blue to light yellow (which represents not only a color change but also a contrast change). The color of the exposed indicators shifted slightly toward green after one day. However, there was still an unmistakable color difference between exposed and unexposed indicators. Exposure to the 1/6 process caused the indicators to show a color change very similar to the full cycle immediately after exposure. This color also shifted slightly toward greenish yellow after 24 hours.
  • the indicators After 24 hours, the indicators had a blue-green color. The color change from yellow to greenish yellow upon standing was attributed to a gradual absorption of moisture which raises the pH slightly. In all cases, there was an obvious difference between the appearance of exposed and unexposed indicators at all the exposure times tested.
  • the fresh indicators that were exposed to a sterilization cycle changed color from dark blue to light yellow and remained yellow 24 hours after exposure.
  • chemical indicators of the invention are characterized by good readability, reliability, and stability, and are suitable for monitoring exposure to a sterilization process where the sterilization cycle includes an acid gas or vapor, such as peracetic acid with an acetic acid component, particularly when the cycle is conducted under reduced pressure.

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Abstract

Cette invention se rapporte à des dispositifs qui servent à vérifier si oui ou non un article a été exposé à des conditions de stérilisation et qui comprennent à cet effet un emballage et un indicateur associé audit emballage. Cet emballage est suffisamment perméable pour laisser entrer les gaz ou les vapeurs de stérilisation. L'indicateur associé audit emballage change de couleur en passant d'une première couleur (indiquant des conditions ambiantes) à une seconde couleur (indiquant l'exposition à des gaz ou à des vapeurs acides). Les deux couleurs de l'indicateur sont stables et ledit indicateur garde de préférence pour l'essentiel l'une et l'autre de ces couleurs dans des conditions ambiantes. Les modes de réalisation préférés sont conçus en particulier pour être utilisés avec des processus de stérilisation à l'acide peracétique.
PCT/US1995/003241 1994-03-15 1995-03-14 Systemes d'emballage pour processus de sterilisation au peracide WO1995024933A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU19994/95A AU1999495A (en) 1994-03-15 1995-03-14 Packaging systems for peracid sterilization processes

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US21311294A 1994-03-15 1994-03-15
US08/213,112 1994-03-15

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998058683A2 (fr) * 1997-06-25 1998-12-30 Minnesota Mining And Manufacturing Company Temoins de sterilisation
FR2910328A1 (fr) * 2006-12-22 2008-06-27 Satelec Soc Indicateur de sterilisation.
WO2017044806A1 (fr) 2015-09-10 2017-03-16 Ecolab Usa Inc. Produit chimique antimicrobien auto-indicateur
CN113056292A (zh) * 2018-10-31 2021-06-29 贝克顿迪金森法国公司 具有完整性丧失检测手段的多层袋

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2027604A1 (de) * 1969-06-05 1971-02-11 Minnesota Mining and Manufacturing Co , Saint Paul, Minn (V St A ) Einheitliche Stenlisationsanzeige vorrichtung und Verfahren zur Anwendung der selben
US3862824A (en) * 1974-05-30 1975-01-28 Arthur William Chapman Means for indicating completion of sterilisation processes
US4091921A (en) * 1975-08-21 1978-05-30 Faser Industries Sterilizable package and method
GB1531606A (en) * 1976-08-02 1978-11-08 Propper Mfg Co Inc Sterile packs
US4188437A (en) * 1978-05-25 1980-02-12 American Can Company Thermotropic adhesive tape
EP0014447A1 (fr) * 1979-02-05 1980-08-20 Arvey Corporation Sac pour stérilisation muni d'un indicateur de stérilisation incorporable
EP0069037A1 (fr) * 1981-06-26 1983-01-05 Guy Charvin Indicateur de stérilisation
DD273776A1 (de) * 1988-07-06 1989-11-29 Erfurt Medizinische Akademie Kontrollindikator fuer die gassterilisation
WO1993024152A1 (fr) * 1992-05-28 1993-12-09 Minnesota Mining And Manufacturing Company Bandes indicatrices et leurs prodedes de fabrication
WO1995006134A1 (fr) * 1993-08-25 1995-03-02 Abtox, Inc. Indicateur biologique a bacillus circulans pour sterilisants gazeux

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2027604A1 (de) * 1969-06-05 1971-02-11 Minnesota Mining and Manufacturing Co , Saint Paul, Minn (V St A ) Einheitliche Stenlisationsanzeige vorrichtung und Verfahren zur Anwendung der selben
US3862824A (en) * 1974-05-30 1975-01-28 Arthur William Chapman Means for indicating completion of sterilisation processes
US4091921A (en) * 1975-08-21 1978-05-30 Faser Industries Sterilizable package and method
GB1531606A (en) * 1976-08-02 1978-11-08 Propper Mfg Co Inc Sterile packs
US4188437A (en) * 1978-05-25 1980-02-12 American Can Company Thermotropic adhesive tape
EP0014447A1 (fr) * 1979-02-05 1980-08-20 Arvey Corporation Sac pour stérilisation muni d'un indicateur de stérilisation incorporable
EP0069037A1 (fr) * 1981-06-26 1983-01-05 Guy Charvin Indicateur de stérilisation
DD273776A1 (de) * 1988-07-06 1989-11-29 Erfurt Medizinische Akademie Kontrollindikator fuer die gassterilisation
WO1993024152A1 (fr) * 1992-05-28 1993-12-09 Minnesota Mining And Manufacturing Company Bandes indicatrices et leurs prodedes de fabrication
WO1995006134A1 (fr) * 1993-08-25 1995-03-02 Abtox, Inc. Indicateur biologique a bacillus circulans pour sterilisants gazeux

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Section Ch Week 9019, Derwent World Patents Index; Class D22, AN 90-140189 *

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998058683A2 (fr) * 1997-06-25 1998-12-30 Minnesota Mining And Manufacturing Company Temoins de sterilisation
WO1998058683A3 (fr) * 1997-06-25 1999-03-25 Minnesota Mining & Mfg Temoins de sterilisation
AU729771B2 (en) * 1997-06-25 2001-02-08 Minnesota Mining And Manufacturing Company Sterilization monitors
FR2910328A1 (fr) * 2006-12-22 2008-06-27 Satelec Soc Indicateur de sterilisation.
WO2017044806A1 (fr) 2015-09-10 2017-03-16 Ecolab Usa Inc. Produit chimique antimicrobien auto-indicateur
EP3346836A4 (fr) * 2015-09-10 2019-03-20 Ecolab USA Inc. Produit chimique antimicrobien auto-indicateur
US10285401B2 (en) 2015-09-10 2019-05-14 Ecolab Usa Inc. Self indicating antimicrobial chemistry
US10555523B2 (en) 2015-09-10 2020-02-11 Ecolab Usa Inc. Self indicating antimicrobial chemistry
US11576378B2 (en) 2015-09-10 2023-02-14 Ecolab Usa Inc. Self indicating antimicrobial chemistry
CN113056292A (zh) * 2018-10-31 2021-06-29 贝克顿迪金森法国公司 具有完整性丧失检测手段的多层袋
CN113056292B (zh) * 2018-10-31 2023-09-01 贝克顿迪金森法国公司 具有完整性丧失检测手段的多层袋

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