US20150247281A1 - Reduced medical wet packs, post steam sterilization - Google Patents

Reduced medical wet packs, post steam sterilization Download PDF

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Publication number
US20150247281A1
US20150247281A1 US14/193,374 US201414193374A US2015247281A1 US 20150247281 A1 US20150247281 A1 US 20150247281A1 US 201414193374 A US201414193374 A US 201414193374A US 2015247281 A1 US2015247281 A1 US 2015247281A1
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United States
Prior art keywords
surfactant
nonwoven fabric
treatment
sterilization
wrap
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Abandoned
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US14/193,374
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English (en)
Inventor
Catherine J. Turnbow
Roger B. Quincy, III
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Avent Inc
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Avent Inc
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Priority to US14/193,374 priority Critical patent/US20150247281A1/en
Assigned to KIMBERLY-CLARK WORLDWIDE, INC. reassignment KIMBERLY-CLARK WORLDWIDE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: TURNBOW, CATHERINE J., QUINCY, ROGER B., III.
Assigned to AVENT, INC. reassignment AVENT, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KIMBERLY-CLARK WORLDWIDE, INC.
Priority to MX2016009618A priority patent/MX2016009618A/es
Priority to PCT/US2015/018028 priority patent/WO2015131054A1/en
Priority to AU2015222839A priority patent/AU2015222839B2/en
Priority to CN201580008977.0A priority patent/CN106029109B/zh
Priority to CA2940963A priority patent/CA2940963C/en
Priority to BR112016019979A priority patent/BR112016019979A2/pt
Priority to KR1020167022983A priority patent/KR102337658B1/ko
Priority to JP2016554204A priority patent/JP6586100B2/ja
Priority to RU2016135790A priority patent/RU2703727C2/ru
Priority to US15/127,065 priority patent/US10575916B2/en
Priority to EP15709066.3A priority patent/EP3132087B1/en
Assigned to MORGAN STANLEY SENIOR FUNDING, INC. reassignment MORGAN STANLEY SENIOR FUNDING, INC. SECURITY INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: AVENT, INC.
Publication of US20150247281A1 publication Critical patent/US20150247281A1/en
Assigned to CITIBANK, N.A. reassignment CITIBANK, N.A. INTELLECTUAL PROPERTY SECURITY INTEREST ASSIGNMENT AGREEMENT Assignors: MORGAN STANLEY SENIOR FUNDING, INC.
Assigned to AVENT, INC., AVANOS MEDICAL SALES, LLC reassignment AVENT, INC. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: CITIBANK, N.A.
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/33Trays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2/06Hot gas
    • A61L2/07Steam
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M13/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment
    • D06M13/10Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment with compounds containing oxygen
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M13/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment
    • D06M13/10Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment with compounds containing oxygen
    • D06M13/165Ethers
    • D06M13/17Polyoxyalkyleneglycol ethers
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M13/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment
    • D06M13/244Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment with compounds containing sulfur or phosphorus
    • D06M13/248Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment with compounds containing sulfur or phosphorus with compounds containing sulfur
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M13/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment
    • D06M13/244Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment with compounds containing sulfur or phosphorus
    • D06M13/248Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment with compounds containing sulfur or phosphorus with compounds containing sulfur
    • D06M13/256Sulfonated compounds esters thereof, e.g. sultones
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M13/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment
    • D06M13/244Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment with compounds containing sulfur or phosphorus
    • D06M13/282Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment with compounds containing sulfur or phosphorus with compounds containing phosphorus
    • D06M13/292Mono-, di- or triesters of phosphoric or phosphorous acids; Salts thereof
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M13/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment
    • D06M13/50Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment with organometallic compounds; with organic compounds containing boron, silicon, selenium or tellurium atoms
    • D06M13/51Compounds with at least one carbon-metal or carbon-boron, carbon-silicon, carbon-selenium, or carbon-tellurium bond
    • D06M13/513Compounds with at least one carbon-metal or carbon-boron, carbon-silicon, carbon-selenium, or carbon-tellurium bond with at least one carbon-silicon bond
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M13/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment
    • D06M13/52Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with non-macromolecular organic compounds; Such treatment combined with mechanical treatment combined with mechanical treatment
    • D06M13/53Cooling; Steaming or heating, e.g. in fluidised beds; with molten metals
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M15/00Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment
    • D06M15/19Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment with synthetic macromolecular compounds
    • D06M15/37Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • D06M15/53Polyethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00Surgical drapes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M2101/00Chemical constitution of the fibres, threads, yarns, fabrics or fibrous goods made from such materials, to be treated
    • D06M2101/16Synthetic fibres, other than mineral fibres
    • D06M2101/18Synthetic fibres consisting of macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M2101/00Chemical constitution of the fibres, threads, yarns, fabrics or fibrous goods made from such materials, to be treated
    • D06M2101/16Synthetic fibres, other than mineral fibres
    • D06M2101/18Synthetic fibres consisting of macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • D06M2101/20Polyalkenes, polymers or copolymers of compounds with alkenyl groups bonded to aromatic groups
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M2200/00Functionality of the treatment composition and/or properties imparted to the textile material
    • D06M2200/10Repellency against liquids
    • D06M2200/12Hydrophobic properties
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/20Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer

Definitions

  • This disclosure relates to reducing the incidence of water remaining on steam sterilized packages in a medical setting.
  • Bacterial filtration efficiency is a measure of how easily bacteria can pass through the sheet material used to wrap the medical items. A higher BFE indicates that the wrapped, sterilized items should remain bacteria free for a longer period of time than similar sterilized items wrapped with a lower BFE wrap material.
  • Appropriate protective sheet material includes those as shown, for example, in U.S. Pat. No. 5,635,134 to Bourne, et al. which discloses a multi-ply sterilization wrap which is formed by joining one or more sheets of sterilization wrap (e.g., two separate sheets or one sheet folded over) together to form two similarly sized, superposed panels that allow convenient dual wrapping of an article.
  • US patent publication 20010036519 by Robert T. Bayer discloses a two ply sterilization wrap that is formed of a single sheet of sterilization wrap material which is folded to form two similarly sized, superposed panels that are bonded to each other.
  • a sterilization wrap material that has a first main panel and a second panel that is smaller than the main panel.
  • the second panel is superposed and bonded to the central portion of the main panel such that it is contained entirely within the main panel to reinforce the main panel and/or provide additional absorbency.
  • U.S. Pat. No. 8,261,963 to Gaynor et al. discloses a multi-panel sterilization assembly that includes a barrier panel composed of a permeable sheet material having barrier properties, panel attachment means for securing the barrier panel into a package; and a fold protection panel.
  • the barrier panel includes: a first surface and a second opposing surface; a first end generally defining a pre-determined fold line; a second end opposite the first end; a first edge that is generally perpendicular to the pre-determined fold line; a second edge that is generally opposite the pre-determined fold line; and a third edge that is generally perpendicular to the pre-determined fold line.
  • Sterilization wraps may also have a single ply only and these are suitable for use with this disclosure.
  • Sterilization wraps are commonly made from non-woven materials made by the spunbonding and meltblowing processes and are often electret treated to increase the bacterial filtration efficiency. Electret treatment is described, for example, in U.S. Pat. No. 5,592,357.
  • wet packs Items subjected to steam sterilization can sometimes emerge from the sterilization process still containing visible water. These water-containing steam sterilized packages are referred to as “wet packs” and require re-sterilization, costing the medical facility time and money. Reduction in wet packs while maintaining an acceptable BFE level is highly desirable.
  • the present disclosure describes a surfactant treatment for a polyolefinic nonwoven fabric used to wrap items to be sterilized.
  • the surfactant treatment consists essentially of carbon, hydrogen and oxygen atoms.
  • the surfactant treated sterile wrap has a BFE after electret treatment and after sterilization of at least 97 percent. This treatment should produce fewer wet packs than the same fabric after electret treatment and after sterilization but without such surfactant treatment.
  • This disclosure also describes a sterilization wrap that has the dried residue of an aqueously applied surfactant treatment.
  • the surfactant treatment is essentially free of silicon, potassium, phosphorus and sulfur, and the sterilization wrap has a BFE after electret treatment and after sterilization of at least 97 percent.
  • This method has the steps of providing a nonwoven fabric, applying a surfactant treatment consisting essentially of carbon, hydrogen and oxygen atoms to the nonwoven fabric, drying the fabric, electret treating the fabric, wrapping items to be sterilized in the fabric and sterilizing the wrapped items.
  • a surfactant treatment consisting essentially of carbon, hydrogen and oxygen atoms
  • Sterilized trays should be wrapped in materials having high bacterial filtration efficiency (BFE) so that they remain bacteria free until they are opened for use.
  • BFE bacterial filtration efficiency
  • SMS spunbond/meltblown/spunbond
  • the basis weight of such SMS material(s) may be from 1 ounce per square yard or “osy” (which is approximately 33 grams per square meter or “gsm”) to about 3 osy (100 gsm).
  • the basis weight of the SMS material(s) may be from 1.2 osy (40 gsm) to about 2 osy (67 gsm).
  • the basis weight of the SMS material(s) may be from 1.4 osy (47 gsm) to about 1.8 osy (60 gsm).
  • the basis weight may be determined in accordance with ASTM D3776-07. Multiple plies or layers of SMS material may be used to provide basis weights ranging from about 2 osy (67 gsm) to about 5 osy (167 gsm).
  • nonwoven fabric or web means a web having a structure of individual fibers or threads which are interlaid, but not in an identifiable manner as in a knitted fabric.
  • Nonwoven fabrics or webs have been formed from many processes such as for example, meltblowing processes, spunbonding processes, and bonded carded web processes.
  • the basis weight of nonwoven fabrics is usually expressed in ounces of material per square yard (osy) or grams per square meter (gsm) and the fiber diameters useful are usually expressed in microns. (Note that to convert from osy to gsm, multiply osy by 33.91).
  • spunbonded fibers refers to small diameter fibers which are formed by extruding molten thermoplastic material as filaments from a plurality of fine, usually circular capillaries of a spinneret with the diameter of the extruded filaments then being rapidly reduced as by, for example, in U.S. Pat. No. 4,340,563 to Appel et al., and U.S. Pat. No. 3,692,618 to Dorschner et al., U.S. Pat. No. 3,802,817 to Matsuki et al., U.S. Pat. Nos. 3,338,992 and 3,341,394 to Kinney, U.S. Pat.
  • Spunbond fibers are generally not tacky when they are deposited onto a collecting sheet.
  • Spunbond fibers are generally continuous and have average diameters (from a sample of at least 10) larger than 7 microns, more particularly, between about 10 and 20 microns.
  • the fibers may also have shapes such as those described in U.S. Pat. No. 5,277,976 to Hogle et al., U.S. Pat. No. 5,466,410 to Hills and U.S. Pat. Nos. 5,069,970 and 5,057,368 to Largman et al., which describe fibers with unconventional shapes.
  • meltblown fibers means fibers formed by extruding a molten thermoplastic material through a plurality of fine, usually circular, die capillaries as molten threads or filaments into converging high velocity, usually hot, gas (e.g. air) streams which attenuate the filaments of molten thermoplastic material to reduce their diameter, which may be to microfiber diameter. Thereafter, the meltblown fibers are carried by the high velocity gas stream and are deposited on a collecting sheet to form a web of randomly dispersed meltblown fibers.
  • gas e.g. air
  • the permeability of the wrap material may range from 25 to about 500 cubic feet per minute (CFM) as characterized in terms of Frazier permeability.
  • CFRM cubic feet per minute
  • the permeability of the wrap material may range from 50 to about 400 cubic feet per lo minute.
  • the permeability of the wrap material may range from 100 to about 300 cubic feet per minute.
  • the Frazier permeability which expresses the permeability of a material in terms of cubic feet per minute of air through a square foot of area of a surface of the material at a pressure drop of 0.5 inch of water (or 125 Pa), was determined utilizing a Frazier Air Permeability Tester available from the Frazier Precision Instrument Company and measured in accordance with Federal Test Method 5450, Standard No. 191A.
  • the permeability of the wrap material may range from about 20 cubic feet per minute to about 75 cubic feet per minute when determined generally in accordance with ISO 9237:1995 (measured with an automated air permeability machine using a 38 cm 2 head at a test pressure of 125 Pa,—exemplary air permeability machine is TEXTEST FX 3300 available from TEXTEST AG, Switzerland).
  • the permeability of the wrap material may range from about 10 cubic feet per minute to about 30 cubic feet per minute when determined generally in accordance with ISO 9237:1995.
  • AFT Automated Filter Tester
  • the AFT test was performed on a sample area of 140 square cm.
  • the performance or efficiency of a filter medium is expressed as the percentage of sodium chloride particles which penetrate the filter. Penetration is defined as transmission of a particle through the filter medium.
  • the transmitted particles were detected downstream from the filter.
  • the percent penetration (% P) reflects the ratio of the downstream particle count to the upstream particle count. Light scattering was used for the detection and counting of the sodium chloride particles.
  • Bacterial filtration efficiency employs a test where samples are challenged with a biological aerosol of Staphylococcus aureus and the results employ a ratio of the bacterial challenge counts to sample effluent counts, to determine percent bacterial filtration efficiency (% BFE).
  • % BFE percent bacterial filtration efficiency
  • a suspension of S. aureus was aerosolized using a nebulizer and delivered to the test article at a constant flow rate.
  • the aerosol droplets were drawn through a six-stage, viable particle Andersen sampler for collection. This test procedure allows a reproducible bacterial challenge to be delivered to the sterilization wrap and complies with ATSM F2101 (Nelson Lab #373162).
  • the testing herein was performed by Nelson Laboratories, Inc., Salt Lake City, Utah, according to “Bacterial Filtration Efficiency,” Procedure No. SOPARO007L.1.
  • the acceptable BFE for a sterilization wrap is desirably at least 97 percent, more desirably 98 percent and still more desirably 99 percent or greater.
  • the Andersen sampler is known in the art and is used to collect viable samples of airborne bacteria and fungal spores.
  • the samples can act as a measure of the number of bacteria or fungal spores in the air at a specific location and time.
  • the sampler works through impaction in which air is drawn through a sampling head with 400 small holes at constant rate (in this case 28.3 L/min or 1 cubic foot per minute) for a known period of time. Before sampling a media plate is placed inside the sampling head and as air is pulled through the holes heavier particles such as bacteria and fungal spore's impact on the agar surface and stick there. The air continues through the sampler and into the pump. After sampling the plate can be removed for culturing.
  • Electret treatment increases the BFE of a fabric.
  • Electret treatment is described, for example, in U.S. Pat. No. 5,592,357.
  • Electret treatment is used to produce an intense corona current at reduced voltages to help reduce the potential for arcing and provide a more efficient, stable discharge at atmospheric pressure, for electrostatically charging an advancing web or film. Once ionization occurs, excess charged particles cannot be lost until they collide with a solid body, preferably the remaining electrode, achieving the desired result. It has been found that this applies to both AC and DC voltages.
  • the charging bar can be replaced with a longitudinally extending tube having spaced apertures for delivering a gas to the discharge-forming elements of the electrode.
  • These discharge-forming elements can include either a series of pins which extend through the spaced apertures of the tube, or a series of nozzles which project from the surface of the tube. In either case, this places the gas in the vicinity of the pins, or the nozzles, which in turn receive appropriate biasing voltages for developing the electric field which is to produce the improved discharge.
  • the charging shell can be replaced with a hollow body which similarly incorporates a series of apertures, and a cooperating series of pins or nozzles, to achieve a similar result.
  • the two common steam-sterilizing temperatures are 121° C. (250° F.) and 132° C. (270° F.). These temperatures (and other high temperatures) must be maintained for a minimal time to kill microorganisms. Recognized minimum exposure periods for sterilization of wrapped healthcare supplies are 30 minutes at 121° C. (250° F.) in a gravity displacement sterilizer or 4 minutes at 132° C. (270° F.) in a pre-vacuum sterilizer. Sterilization for the BFE tests herein took place at 134° C. (273° F.).
  • the criteria for deciding that a wet pack exists after sterilization is two-fold; firstly, is the tray's weight after (i.e. post) sterilization higher than the pre-sterilization weight by 3 percent or more? Secondly, is there any sign of moisture visible on the top of the tray or inside of the tray after sterilization? If the answer to either or both of these questions is “yes” then the tray is a wet pack.
  • the wrap used in the testing was a 2.57 osy (87 gsm) SMS except for Sample 1 which was a 1.85 osy (62.7 gsm) SMS.
  • the surfactant treatment was applied to the wrap by a dip and squeeze (saturation) process, using an aqueous formulation containing the surfactant. The amount of surfactant treatment in weight percent is indicated in the Sample descriptions below for the treated and dried wrap.
  • the wrap having the dried surfactant treatment residue was subjected to electret treatment as indicated in the Table.
  • trays were wrapped using the double layer wrap and according to the method of U.S. Pat. No. 5,635,134, sterilized at 134° C. (273° F.) and tested for wet packs. TSI and BFE were tested according to the procedures above.
  • Electret treatment is used, as discussed above, to increase the BFE of a fabric. This treatment also increases the TSI. It is not believed that differing electret treatment conditions had a great effect on these result and is reported merely for thoroughness.
  • the data shows that the treatments containing other than carbon, hydrogen and oxygen (C—H—O) atoms do not show an appreciable increase in TSI after electret treatment, indicating that they do not allow the fabric to hold a charge and are therefore unsuitable for electret charging.
  • Samples 1, 2 and 4 have little or no positive change in TSI after electret treatment. Note that sample three does show an average increase in TSI but the range of results is extremely wide, leading to questions about repeatability and the value of such results.
  • the successful candidates display large increases in TSI after electret treatment, showing that they allow the web to absorb the charge needed to increase the barrier to microbial infiltration.
  • Treatments limited to having only C—H—O surfactants also produce fewer wet packs when compared to the same base fabric without any treatment (i.e. Sample 10).

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  • Mechanical Engineering (AREA)
  • Chemical Or Physical Treatment Of Fibers (AREA)
  • Filtering Materials (AREA)
  • Electrostatic Separation (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Treatments For Attaching Organic Compounds To Fibrous Goods (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
US14/193,374 2014-02-28 2014-02-28 Reduced medical wet packs, post steam sterilization Abandoned US20150247281A1 (en)

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US14/193,374 US20150247281A1 (en) 2014-02-28 2014-02-28 Reduced medical wet packs, post steam sterilization
US15/127,065 US10575916B2 (en) 2014-02-28 2015-02-27 Surfactant treatment for a sterilization wrap with reduced occurrence of wet packs after steam sterilization
EP15709066.3A EP3132087B1 (en) 2014-02-28 2015-02-27 Surfactant treatment for a sterilization wrap with reduced occurrence of wet packs after steam sterilization
KR1020167022983A KR102337658B1 (ko) 2014-02-28 2015-02-27 스팀 멸균 후 습윤 팩의 발생이 감소된 멸균 랩을 위한 계면활성제 처리
JP2016554204A JP6586100B2 (ja) 2014-02-28 2015-02-27 蒸気滅菌後のウェットパックを低減させる界面活性処理剤
AU2015222839A AU2015222839B2 (en) 2014-02-28 2015-02-27 Surfactant treatment for a sterilization wrap with reduced occurrence of wet packs after steam sterilization
CN201580008977.0A CN106029109B (zh) 2014-02-28 2015-02-27 用于在蒸汽灭菌后具有减少的湿包发生的灭菌包裹物的表面活性剂处理剂
CA2940963A CA2940963C (en) 2014-02-28 2015-02-27 Surfactant treatment for a sterilization wrap with reduced occurrence of wet packs after steam sterilization
BR112016019979A BR112016019979A2 (pt) 2014-02-28 2015-02-27 Tratamento com tensoativo, invólucro de esterilização, método de redução da ocorrência de pacotes úmidos pós-esterilização
MX2016009618A MX2016009618A (es) 2014-02-28 2015-02-27 Tratamiento surfactante para una envoltura de esterilizacion con reduccion en la aparicion de paquetes humedos despues de la esterilizacion con vapor.
PCT/US2015/018028 WO2015131054A1 (en) 2014-02-28 2015-02-27 Surfactant treatment for a sterilization wrap with reduced occurrence of wet packs after steam sterilization
RU2016135790A RU2703727C2 (ru) 2014-02-28 2015-02-27 Поверхностно-активное средство для обработки стерилизационной обертки со сниженной частотой проявления влажных упаковок после паровой стерилизации

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EP (1) EP3132087B1 (ru)
JP (1) JP6586100B2 (ru)
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CN (1) CN106029109B (ru)
AU (1) AU2015222839B2 (ru)
BR (1) BR112016019979A2 (ru)
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RU2703727C2 (ru) 2019-10-22
KR102337658B1 (ko) 2021-12-13
RU2016135790A3 (ru) 2018-08-23
CA2940963A1 (en) 2015-09-03
JP2017507717A (ja) 2017-03-23
RU2016135790A (ru) 2018-03-30
WO2015131054A1 (en) 2015-09-03
BR112016019979A2 (pt) 2021-07-06
JP6586100B2 (ja) 2019-10-02
MX2016009618A (es) 2016-10-13
CN106029109A (zh) 2016-10-12
CN106029109B (zh) 2020-03-17
CA2940963C (en) 2022-10-25
US20170172682A1 (en) 2017-06-22
EP3132087B1 (en) 2018-10-03
AU2015222839A1 (en) 2016-08-04
US10575916B2 (en) 2020-03-03
EP3132087A1 (en) 2017-02-22
KR20160126997A (ko) 2016-11-02

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