EP4313578A1 - Matériau multicouche et son procédé de fabrication et d'utilisation - Google Patents

Matériau multicouche et son procédé de fabrication et d'utilisation

Info

Publication number
EP4313578A1
EP4313578A1 EP22776821.5A EP22776821A EP4313578A1 EP 4313578 A1 EP4313578 A1 EP 4313578A1 EP 22776821 A EP22776821 A EP 22776821A EP 4313578 A1 EP4313578 A1 EP 4313578A1
Authority
EP
European Patent Office
Prior art keywords
layer
composition
packaging
vhp
layered material
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.)
Pending
Application number
EP22776821.5A
Other languages
German (de)
English (en)
Inventor
Jianfeng Zhang
Rachel Z. PYTEL
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.)
Saint Gobain Performance Plastics Corp
Original Assignee
Saint Gobain Performance Plastics 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 Saint Gobain Performance Plastics Corp filed Critical Saint Gobain Performance Plastics Corp
Publication of EP4313578A1 publication Critical patent/EP4313578A1/fr
Pending legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B1/00—Layered products having a general shape other than plane
    • B32B1/08—Tubular products
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/12—Layered products comprising a layer of synthetic resin next to a fibrous or filamentary layer
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/28—Layered products comprising a layer of synthetic resin comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42
    • B32B27/281—Layered products comprising a layer of synthetic resin comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42 comprising polyimides
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/28—Layered products comprising a layer of synthetic resin comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42
    • B32B27/283—Layered products comprising a layer of synthetic resin comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42 comprising polysiloxanes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/306—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl acetate or vinyl alcohol (co)polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B32B27/322—Layered products comprising a layer of synthetic resin comprising polyolefins comprising halogenated polyolefins, e.g. PTFE
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/34—Layered products comprising a layer of synthetic resin comprising polyamides
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/40—Layered products comprising a layer of synthetic resin comprising polyurethanes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B38/00—Ancillary operations in connection with laminating processes
    • B32B38/0008—Electrical discharge treatment, e.g. corona, plasma treatment; wave energy or particle radiation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/02—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by structural features of a fibrous or filamentary layer
    • B32B5/022—Non-woven fabric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/02—Physical, chemical or physicochemical properties
    • B32B7/022—Mechanical properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/24—All layers being polymeric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/724—Permeability to gases, adsorption
    • B32B2307/7242—Non-permeable
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/02—Open containers
    • B32B2439/06—Bags, sacks, sachets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2553/00—Packaging equipment or accessories not otherwise provided for

Definitions

  • the present disclosure relates to a multi-layer material, and more particularly to, a multi-layer material with a second layer and a first layer.
  • Packagings are used for housing many products shipped and sold. In some cases, packagings may be used to ship sensitive products that are used in clean room or sterilized conditions, such as medical, biological, or pharmaceutical products. In other cases, packagings may be used to house sensitive products or materials, such as medical tubing. In some cases, these packagings must be sterilized or otherwise treated themselves to avoid contamination of the packaging surroundings when and where the product is needed. In certain cases, noxious gases, such as vaporized hydrogen peroxide (VHP), require sterilization or treatment of the packagings to protect these sensitive products. These sterilizations may be burdensome. Therefore, improvements in packagings are needed, particularly in enabling packagings to achieve optimal noxious gas resistance while allowing improved ease of use.
  • VHP vaporized hydrogen peroxide
  • FIG. 1 illustrates a side view of the multi-layer material according to a number of embodiments of the present disclosure.
  • FIG. 2 illustrates a side view of the multi-layer material according to a number of embodiments of the present disclosure.
  • FIG. 3A illustrates a perspective view of a packaging according to a number of embodiments of the present disclosure.
  • FIG. 3B illustrates a cross-section view of the packaging of FIG. 3A through section line 3, in a first configuration according to a number of embodiments of the present disclosure.
  • FIG. 3C illustrates a cross-section view of the packaging of FIG. 3A through section line 3, in a second configuration according to a number of embodiments of the present disclosure.
  • Skilled artisans appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the invention.
  • FIG. 1 illustrates a side view of a multi-layered material according to a number of embodiments of the present disclosure.
  • the multi-layered material 100, or any layers thereof may be a laminated film.
  • the multi-layered material 100, or any layers thereof may be a fluid gel.
  • the multi-layered material 100, or any layers thereof may be made of solid film or nonwoven material.
  • the multi-layered material 100 may include a second layer 110 and a first layer 120 provided on one interior surface side of the second layer 110.
  • the first layer 120 may include a first composition including a polyolefin, fluoropolymer, or copolymer thereof.
  • the first layer 120 may include a second composition including polyethylene (high or low density) or polypropylene (high or low density).
  • the second layer 110 may include a second composition including polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof.
  • the second layer 110 may include a second composition including nylon.
  • the first layer 120 may be bonded to the second layer 110.
  • the bonding may be done by lamination, adhesion force, a co-extrusion process, a surface activation process (corona treatment, flame treatment, chemical etch, photo activation etc.), an adhesive layer, a primer, a combined process thereof, or through another method.
  • the multi-layered material 100 may have a thickness T MLM ⁇
  • the thickness T MLM of the multi-layered material 100 may be at least about .001 mm, such as, at least about .005, at least about 0.01 mm, at least about .05 mm, at least about 0.1 mm, or at least about 0.2 mm or at least about 0.3 mm or at least about 0.4 mm or even at least about 0.5 mm.
  • the thickness T MLM of the multi-layered material 100 may be not greater than about 30 mm, such as, not greater than about 10 mm, not greater than about 5 mm or even not greater than about 2.5 mm.
  • the thickness T MLM of the multi-layered material 100 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness T MLM of the multi-layered material 100 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness TMLM of the multi-layered material 100 may be at least 0.1 mm mil and no greater than 30 mm.
  • the second layer 110 of the multi-layered material 100 may have a thickness T OL ⁇
  • the thickness TOL of the second layer 110 may be at least about .001 mm, such as, at least about .005 mm, or at least about 0.1 mm or at least about 0.2 mm or at least about 0.3 mm or at least about 0.4 mm or even at least about 0.5 mm.
  • the thickness T OL of the second layer 110 may be not greater than about 1 mm, such as, not greater than about 0.5 mm or even not greater than about 0.25 mm.
  • the thickness TOL of the second layer 110 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness T OL of the second layer 110 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness TOL of the second layer 110 may be between 1 pm and 1000 pm, such as between 5 pm and 500 pm, or such as between 20 pm and 350 pm.
  • the first layer 120 of the multi-layered material 100 may have a thickness T IL .
  • the thickness T IL of the first layer 120 may be at least about .001 mm, such as, at least about .005 mm, at least about 0.01 mm, at least about .05 mm, at least about 0.1 mm, or at least about 0.2 mm or at least about 0.3 mm or at least about 0.4 mm or even at least about 0.5 mm.
  • the thickness T IL of the first layer 120 may be not greater than about 1 mm, such as, not greater than about 0.5 mm or even not greater than about 0.25 mm.
  • the thickness T IL of the first layer 120 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness T IL of the first layer 120 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness T IL of the first layer 120 may be between 1 pm and 1000 pm, such as between 5 pm and 500 pm, or such as between 20 pm and 350 pm.
  • FIG. 2 illustrates a side view of a multi-layered material according to a number of embodiments of the present disclosure.
  • the multi-layered material 200 may be a laminated multi-layer film.
  • the multi-layered material 200, or any layers thereof may be a fluid gel.
  • the multi-layered material 200 includes a second layer 210 and a first layer 220 provided on one interior surface side of the second layer 210 as shown in FIG. 1.
  • the multi layered material 200 may include a third layer 230 provided between the first layer 220 and the second layer 210.
  • the third layer 230 may include a third composition including ethylene vinyl alcohol.
  • the third layer 230 of the multi-layered material 200 may have a thickness T TL .
  • the thickness T TL of the third layer 230 may be at least about .001 mm, such as, at least about .005 mm, at least about 0.01 mm, at least about .05 mm, at least about 0.1 mm, or at least about 0.2 mm or at least about 0.3 mm or at least about 0.4 mm or even at least about 0.5 mm.
  • the thickness T TL of the third layer 230 may be not greater than about 1 mm, such as, not greater than about 0.5 mm or even not greater than about 0.25 mm.
  • the thickness T TL of the third layer 230 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness T TL of the third layer 230 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness T TL of the third layer 230 may be between 1 pm and 1000 pm, such as between 5 pm and 500 pm, or such as between 20 pm and 350 pm. Further intervening layers may be included between any of the layers listed and is still contemplated within the scope of the invention.
  • FIG. 3A illustrates a perspective view of a packaging according to a number of embodiments of the present disclosure.
  • FIG. 3B illustrates a cross- section view of the packaging of FIG. 3 A through section line 3, in a first configuration according to a number of embodiments of the present disclosure.
  • FIG. 3C illustrates a cross- section view of the packaging of FIG. 3 A through section line 3, in a second configuration according to a number of embodiments of the present disclosure.
  • the packaging 300 may be mad of the multi-layer material described herein. As best illustrated in FIG. 3A, the packaging 300 may include a top edge 302, a left edge 304, a right edge 306, and a base edge 308.
  • the packaging 300 may include a first face (or front side) 310 and a second face (or back side) 312 opposite the first face 310.
  • the first face 310 or second face 312 of the packaging 300 may be generally polygonal cross-section (e.g., rectangular).
  • the first face 310 or second face 312 of the packaging 300 may have a polygonal, oval, circular, semi-circular, or substantially circular cross-section.
  • the first face 310 or second face 312 of the packaging 300 may be generally flat.
  • the packaging 300 may have a first wall 311 (opposite the first face), a second wall 313 (opposite the first face), an open end 317, a closed end 318, and closed lateral sides 305, 307 such that an internal cavity 315 is created.
  • the packaging 300 may be a bag or container opened at a proximal 317 and/or a distal end 318.
  • the packaging 300 may be opened along a portion of one of the first wall 311 or second wall 313.
  • the packaging 300 may be configured as a tube including at least one open end.
  • the packaging 300 may have a width Wp B -
  • the width W PB of the packaging 300 is the distance from the left edge 304 to the right edge 306.
  • the width W PB of the packaging 300 may be at least about 100 mm, such as, at least about 150 mm or at least about 200 mm or at least about 250 mm or at least about 300 mm or even at least about 500 mm.
  • the width W PB of the packaging 300 may be not greater than about 1500 mm, such as, not greater than about 1200 mm or even not greater than about 1000 mm. It will be appreciated that the width W PB of the packaging 300 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the width W PB of the packaging 300 may be any value between any of the minimum and maximum values noted above.
  • the packaging 300 can have a length L PB .
  • the length L PB of the packaging 300 is the distance from the top edge 302 to the base edge 308.
  • the length L PB of the packaging 300 may be at least about 100 mm, such as, at least about 150 mm or at least about 200 mm or at least about 250 mm or at least about 300 mm, or even at least about 500 mm.
  • the length L PB of the packaging 300 may be not greater than about 1500 mm, such as, not greater than about 1200 mm or even not greater than about 1000 mm. It will be appreciated that the length L PB of the packaging 300 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the length L PB of the packaging 300 may be any value between any of the minimum and maximum values noted above.
  • the packaging system 300 is configured to contain a product 330.
  • the product may be medical, biological, or pharmaceutical device, such as a vascular catheter.
  • the packaging system may contain a product type for biopharma/life sciences that are designed for a single use.
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition can be formed of a material including a polymer.
  • at least one of the packaging, the first composition, or the second composition may include a blend of polymers or polymeric polymers including a thermoplastic elastomeric hydrocarbon block copolymer, a polyether- ester block co-polymer, a thermoplastic polyamide elastomer, a thermoplastic polyurethane elastomer, a thermoplastic polyolefin elastomer, a thermoplastic vulcanizate, an olefin-based co-polymer, an olefin-based ter-polymer, a polyolefin plastomer, or combinations thereof.
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may include a styrene based block copolymer such as styrene-butadiene, styrene-isoprene, blends or mixtures thereof, mixtures thereof, and the like.
  • a styrene based block copolymer such as styrene-butadiene, styrene-isoprene, blends or mixtures thereof, mixtures thereof, and the like.
  • Exemplary styrenic thermoplastic elastomers include triblock styrenic block copolymers (SBC) such as styrene -butadiene-styrene (SBS), styrene-isoprene-styrene (SIS), styrene-ethylene butylene- styrene (SEBS), styrene-ethylene propylene- styrene (SEPS), styrene-ethylene-ethylene-butadiene-styrene (SEEBS), styrene-ethylene-ethylene -propylene- styrene (SEEPS), styrene-isoprene-butadiene-styrene (SIBS), or combinations thereof.
  • SBC triblock styrenic block copolymers
  • SBS styrene -butadiene-styrene
  • SEBS styren
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may include a polyolefin polymer.
  • a typical polyolefin may include a homopolymer, a copolymer, a terpolymer, an alloy, or any combination thereof formed from a monomer, such as ethylene, propylene, butene, pentene, methyl pentene, hexene, octene, or any combination thereof.
  • the polyolefin polymer may be copolymers of ethylene with propylene or alpha- olefins or copolymers of polypropylene with ethylene or alpha-olefins made by metallocene or non-metallocene polymerization processes.
  • Commercial polyolefin examples include AffinityTM, EngageTM, FlexomerTM, VersifyTM, InfuseTM, ExactTM, VistamaxxTM, SoftelTM and TafmerTM, NotioTM produced by Dow, ExxonMobil, Londel-Basell and Mitsui.
  • the polyolefin polymer may include copolymers of ethylene with polar vinyl monomers such as acetate (EVA), acrylic acid (EAA), methyl acrylate (EMA), methyl methacrylate (EMMA), ethyl acrylate (EEA) and butyl acrylate (EBA).
  • EVA acetate
  • EMA acrylic acid
  • EMMA methyl methacrylate
  • EBA ethyl acrylate
  • EBA butyl acrylate
  • Exemplary suppliers of these ethylene copolymer resins include DuPont, Dow Chemical, Mitsui and Arkema etc.
  • the polyolefin polymer can be a terpolymer of ethylene, maleic anhydride and acrylates such as LotaderTM made by Arkema and EvalloyTM produced by DuPont.
  • the polyolefin polymer can be an ionomer of ethylene and acrylic acid or methacrylic acid such as SurlynTM made by DuPont.
  • the polyolefin is a reactor grade thermoplastic polyolefin polymer, such as P6E2A-005B available from Flint Hills Resources.
  • at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may include, but are not limited to, thermoplastic, thermosets, fluoropolymers, and combinations thereof.
  • suitable polymer material can be polyvinylidene fluoride (PVDF).
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition can be formed of a thermoplastic elastomer, silicone, or combinations thereof.
  • a thermoplastic elastomer for example, specific types can be those described in U.S. Patent Application Publication No. 2011/0241262, which is incorporated herein by reference, in its entirety, for all useful purposes.
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may include a fluorinated polymer.
  • at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may include a polymer including at least one of ethylene-tetrafluoroethylene (ETFE), tetrafluoro-ethylene-perfluoro (methyl vinyl ether) (MFA), polyvinylidene fluoride (PVDF), ethylene - chlorotrifluoroethylene (ECTFE), polyimide (PI), polyamide-imide (PAI), polyphenylene sulfide (PPS), polyethersulfone (PES), polyphenylene sulfone (PPSO2), liquid crystal polymers (LCP), polyetherketone (PEK), polyether-ether-ketone (PEEK), aromatic polyesters (Ekonol) of polyether-ether-ketone (PEEK), polyetherketone (PEK),
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition can include one or more additives.
  • the one or more additives can include a plasticizer, a catalyst, a silicone modifier, a silicon component, a stabilizer, a curing agent, a lubricant, a colorant, a filler, a blowing agent, another polymer as a minor component, or a combination thereof.
  • the plasticizer can include mineral oil.
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition can be formed as a single piece or may be formed as multiple pieces. In an embodiment, at least one of the multi layered material, packaging, the first composition, the second composition, or the third composition can be a molded component. In an embodiment, at least one of the multi layered material, packaging, the first composition, the second composition, or the third composition can be formed through over-molding or other methods known in the art. In an embodiment, the polymer or polymeric blend included in at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may be processed by any known method to form the polymeric mixture.
  • the polymer or polymeric blend may be melt processed by dry blending or compounding.
  • the dry blend may be in powder, granular, or pellet form.
  • the blend can be made by a continuous twin- screw compounding process or batch related Banbury process. Pellets of these mixtures may then be fed into a single screw extruder to make articles such as flexible tubing products. Mixtures can also be mixed in a single- screw extruder equipped with mixing elements and then extruded directly into articles such as tubing products.
  • the mixture can be melt processed by any method envisioned known in the art such as laminating, casting, molding, extruding, and the like.
  • the mixture can be injection molded.
  • At least one the first composition, the second composition, or the third composition may be bonded to another off the first composition, the second composition, or the third composition to form the multi-layer material and/or packaging.
  • the polyethylene of the first composition may be bonded to the nylon of the second composition. In a number of embodiments, this may bond the first layer to the second layer to form the packaging.
  • the packaging may be peelable or tearable to open the packaging.
  • any of the layers on the multi-layered material as described above can each be disposed in a roll and peeled therefrom to join together under pressure, at elevated temperatures (hot or cold pressed or rolled), by an adhesive, or by any combination thereof.
  • Any of the layers of the multi-layered material, as described above may be laminated together such that they at least partially overlap one another.
  • Any of the layers on the multi-layered material as described above may be applied together using coating technique, such as, for example, physical or vapor deposition, spraying, plating, powder coating, or through other chemical or electrochemical techniques.
  • any of the layers of the multi-layered material may be applied by a roll-to-roll coating process, including for example, extrusion coating.
  • Any of the layers of the multi layered material may be heated to a molten or semi-molten state and extruded through a slot die onto an interior or exterior surface of the other layers of the multi-layered material to form the packaging.
  • the polymer or polymeric blend of at least one of the packaging, the first composition, or the second composition may be formed into a single layer article, a multi-layer article, or can be laminated, coated, or formed on a substrate to form at least one of the packaging, the first composition, or the second composition.
  • Multi-layer articles may include layers such as reinforcing layers, adhesive layers, barrier layers, chemically resistant layers, metal layers, any combination thereof, and the like.
  • the polymer or polymeric blend can be formed into any useful shape such as film, sheet, packaging bag, sleeve, tubing, and the like to form at least one of the multi-layered material, packaging, the first composition, or the second composition.
  • the useful shape may be closed, sealed, re-sealed, or otherwise combined around a product according to any known methods in the packaging arts.
  • the polymer or polymeric blend of at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may be formed into a single layer article, a multi-layer article, or can be laminated, coated, or formed on a substrate to form at least one of the packaging, the first composition, or the second composition.
  • Multi-layer articles may include layers such as reinforcing layers, adhesive layers, barrier layers, chemically resistant layers, metal layers, any combination thereof, and the like.
  • the polymer or polymeric blend can be formed into any useful shape such as film, sheet, tubing, and the like to form at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition.
  • the polymer or polymeric blend of at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition can advantageously withstand a treatment or sterilization processes.
  • the polymer or polymeric blend may be sterilized by any method envisioned.
  • the polymer or polymeric blend is sterilized after at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition is formed.
  • Exemplary sterilization methods include radiation sterilization, autoclave sterilization, X-ray radiation, electron ray, E-beam techniques, combinations thereof, and the like.
  • the polymer or polymeric blend is sterilized by vaporized hydrogen peroxide sterilization (VHP).
  • the polymer or polymeric blend is sterilized by gamma irradiation.
  • the polymer or polymeric blend of at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may be gamma sterilized at between about 25 kGy to about 50 kGy.
  • the multi-layered material, packaging, the first composition, the second composition, or the third composition may be vaporized hydrogen peroxide (VHP) resistant.
  • the first layer 120 may have a first VHP permeability.
  • the second layer 110 may have a second VHP permeability.
  • the multi-layered material 100 may have a third VHP permeability.
  • the third VHP permeability of the multi-layered material 100 may be less than 10% of the first VHP permeability of the first layer 120 or the second VHP permeability of the second layer 110.
  • the VHP permeability may be defined as the VHP content (ppm) in an environment on an exterior side of the multi layered material 100 over the VHP content (ppm) in an environment on an interior side of the multi-layered material 100.
  • the VHP content may be measured by sensor, titration (gas- column titration), analytical testing equipment, or any other method known in the art.
  • the first method is to fill the package fully with water for a “water balloon”. Once the hydrogen peroxide diffuses into the bag, it will be absorbed and dissolved in water. Therefore, the accumulative hydrogen peroxide could be indicated by its concentration in the water and tested via Hydrogen Peroxide Test Kits including test strips. Test strips with detection ranges of 0, .05, 0.3, 0.5, 1, 2, 3, 4, 10, 30, 50 ppm are provided. Some examples of the test strips for the Hydrogen Peroxide Test Kit are Low Range Hydrogen Peroxide Test Strips, WaterworksTM Low Range Peroxide Check, or CHEMets® Visual Kit.
  • the “water balloon” testing method is as follows:
  • the tests are performed by following sequence base on necessary: a. High range hydrogen peroxide test - test trip (0-50 ppm, LaMotte) i. Measure ⁇ 5 ml sample from bag into a container/beaker; ii. Perform the test according to the introduction at package (dip and reading, but notice the trick in the package); iii. Compared with reference, and record the value, skip the following two tests if the reading is > 30 ppm.
  • the second method is use a glass detect tube.
  • the air inside the bag is forced to circulated through the glass tube, which is essentially a column contains chemicals that can absorb and react with hydrogen peroxide (23 ⁇ 4q 2 + 2KI + 23 ⁇ 40 + O2).
  • the reaction with hydrogen peroxide causes these chemicals to change color so the amount of hydrogen peroxide could be read from the glass tube.
  • the glass tubes used included, but not limited to, Draeger Glass Detector Tube, detection range/level: 0.1 to 3.0 ppm, or Gastec Glass Detector Tube, detection range/level: 0.5 to 10.0 ppm.
  • the hydrogen peroxide can be monitored in real-time.
  • the “water balloon” testing method is as follows:
  • the multi-layered material tested as recited above and according to embodiments herein may include: a first layer having a first composition including a polyolefin, fluoropolymer, or copolymer thereof, where the first layer has a first VHP permeability; and a second layer including a second composition including polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, where the second layer has a second VHP permeability, where the multi-layered material has a third VHP permeability from the second layer to the first layer of less than 30%, such as less than 20%, such as less than 15%, or such as less than 10% of the first VHP permeability or the second VHP permeability.
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may have further desirable physical and mechanical properties.
  • at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may appear transparent or at least translucent.
  • at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may have a light transmission greater than about 2%, or greater than about 5% in the visible light wavelength range.
  • the resulting articles have desirable clarity or translucency.
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition have advantageous physical properties, such as a balance of any one or more of the properties of hardness, flexibility, surface lubricity, tensile strength, elongation, Shore A hardness, gamma resistance, weld strength, and seal integrity to an optimum level.
  • At least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may have desirable heat stability properties.
  • Applications for the polymer or polymeric blend are numerous.
  • the polymer or polymeric blend is non-toxic, making the material useful for any application where no toxicity is desired.
  • the polymer or polymeric blend may be substantially free of plasticizers or other low-molecular weight extenders that can be leached into the fluids it transfers. “Substantially free” as used herein refers to a polymeric mixture having a total organic content (TOC) (measured in accordance to ISO 15705 and EPA 410.4) of less than about 100 ppm.
  • TOC total organic content
  • the polymer or polymeric blend has biocompatibility and animal derived component-free formulation ingredients.
  • the polymeric mixture has potential for FDA, USP, EP, ISO, and other regulatory approvals.
  • the polymer or polymeric blend may be used in applications such as industrial, medical, health care, biopharmaceutical, pharmaceutical, drinking water, food & beverage, laboratory, dairy, and the like.
  • the polymeric mixture may be used in applications where low temperature resistance is desired.
  • the polymer or polymeric blend may also be safely disposed as it generates substantially no toxic gases when incinerated and leaches no plasticizers into the environment if land filled.
  • packaging may be torn or peeled to form an “open position” from a “closed position.”
  • packaging 200 may be tearable or peelable to form an open position upon application of force of no greater than about 10 lbf, no greater than about 5 lbf, no greater than about 2.5 lbf, no greater than about 2 lbf, or no greater than about 1 lbf.
  • the packaging may be re- sealable to form a “closed position” from an “open position.”
  • a method may be used for forming a packaging according to a number of embodiments.
  • the method may include a first step including providing a first layer comprising a first composition comprising a polyolefin, fluoropolymer, or copolymer thereof, wherein the first layer has a first VHP permeability.
  • the method may include a second step of providing a second layer comprising a second composition comprising polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, wherein the second layer has a second VHP permeability.
  • the method may include a third step of bonding the first layer to the second layer to form a multi-layered material in the form of packaging.
  • the method may include a fourth step of treating the packaging such that the packaging has a third VHP permeability of less than 10% of the first VHP permeability or the second VHP permeability.
  • the method may include a step of disposing a product within the packaging before bonding the second composition to the first composition.
  • the treatment step may be done via radiation sterilization or autoclave sterilization.
  • Use of the multi-layered material or packaging may provide increased benefits in several applications in fields such as, but not limited to, industrial, medical, health care, biopharmaceutical, pharmaceutical, drinking water, food & beverage, laboratory, dairy, or other types of applications.
  • the use of the multi-layered material or packaging may provide a sealing mechanism for housing a product meant for treatment or sterilization, such as a medical device, pharmaceutical product, or biological product used in a surgical procedure.
  • the use of the multi-layered material or packaging may provide a VHP resistant material with minimal layers, reducing cost, material use, and complexity of manufacturing. This may provide optimal VHP and other noxious gas resistance while allowing improved ease of use in difficult environments, such as operating rooms, hospitals, or pharmacies.
  • Embodiment 1 A multi-layered material, comprising: a first layer having a first composition comprising a polyolefin, fluoropolymer, or copolymer thereof, wherein the first layer has a first VHP permeability; and a second layer comprising a second composition comprising polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, wherein the second layer has a second VHP permeability, wherein the multi-layered material has a third VHP permeability from the second layer to the first layer of less than 30%, such as less than 20%, such as less than 15%, or such as less than 10% of the first VHP permeability or the second VHP permeability.
  • Embodiment 2 A packaging assembly comprising: a product; and a packaging enclosing the product to provide a sterilize- able packaging assembly, wherein the packing comprises a multi-layered material comprising: a first layer having a first composition comprising a polyolefin, fluoropolymer, or copolymer thereof, wherein the first layer has a first VHP permeability; and a second layer comprising a second composition comprising polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, wherein the second layer has a second VHP permeability, wherein the multi-layered material has a third VHP permeability from the second layer to the first layer of less than 30%, such as less than 20%, such as less than 15%, or such as less than 10% of the first VHP permeability or the second VHP permeability.
  • Embodiment 3 A method for forming a packaging, comprising: providing a first layer comprising a first composition comprising a polyolefin, fluoropolymer, or copolymer thereof, wherein the first layer has a first VHP permeability; providing a second layer comprising a second composition comprising polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, wherein the second layer has a second VHP permeability; bonding the first layer to the second layer to form a multi-layered material in the form of packaging; and treating the packaging such that the has a third VHP permeability from the second layer to the first layer of less than 30%, such as less than 20%, such as less than 15%, or such as less than 10% of the first VHP permeability or the second VHP permeability.
  • Embodiment 4 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the second layer comprises a fluid gel.
  • Embodiment 5 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the second layer is bonded to the first layer.
  • Embodiment 6 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein second layer comprises a laminated film.
  • Embodiment 7 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein first layer comprises a laminated film.
  • Embodiment 8 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, further comprising a third layer comprising ethylene vinyl alcohol located between the second layer and the first layer.
  • Embodiment 9 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the multi-layered material has a thickness between 10 pm and 30 mm.
  • Embodiment 10 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the second layer has a thickness between 1 pm and 1000 pm, such as between 5 pm and 500 pm, or such as between 20 pm and 350 pm.
  • Embodiment 11 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the first layer has a between 1 pm and 1000 pm, such as between 5 pm and 500 pm, or such as between 20 pm and 350 pm.
  • Embodiment 12 The multi-layered material, packaging assembly, or method of any of embodiments 9-11, wherein the third layer has a thickness between 1 pm and 1000 pm, such as between 5 pm and 500 pm, or such as between 20 pm and 350 pm.
  • Embodiment 13 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the multi-layered material comprising a tubing.
  • Embodiment 14 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the packaging assembly comprising a packaging bag or sleeve.
  • Embodiment 15 The method of embodiment 3, further comprising disposing a product within the packaging before bonding the second composition to the first composition.
  • Embodiment 16 The packaging assembly or method of any of embodiments 2 and 15, wherein the product is a medical or biopharmaceutical device.
  • Embodiment 17 The method of embodiment 3, wherein the treatment step is done via radiation sterilization or autoclave sterilization.
  • Embodiment 18 The method of embodiment 17, wherein the radiation sterilization is done via electron beam sterilization, gamma sterilization, or X-ray sterilization.
  • Embodiment 19 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the second layer is a solid film or nonwoven material.
  • Embodiment 20 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the second composition of the second layer comprises nylon.
  • Embodiment 21 The multi-layered material, packaging assembly, or method of any of the preceding embodiments, wherein the first composition of the first layer comprises polyethylene or polypropylene.
  • VHP Vaporized Hydrogen Peroxide
  • the “water balloon” method is as follows: 1) Cut the film to a size of ting film 6 x 6 inch, and seal three side of the film for a bag with the ID of 4 x 5 inch (width of the seal is ⁇ 0.0825 inch); 2) Make the “water balloon” by first filling ⁇ 30 grams of distilled water into the bag, and then removing the air in the bag as much as possible.
  • Nylon e.g., second layer
  • LDPE e.g., first layer
  • Nylon e.g., second layer
  • LDPE e.g., first layer
  • the correct orientation of the multi-layer material is also extremely important for if the Nylon (e.g., second layer) directly facing the VHP rich environment, the permeation is way less than the opposite orientation the LDPE (e.g., first layer) directly facing the VHP rich environment. Results of this effect are shown below in Table 2.
  • the minimum detect level is 0.05 ppm

Abstract

La présente demande concerne un matériau multicouche, comprenant une première couche ayant une première composition comportant une polyoléfine, un fluoropolymère ou un copolymère correspondant, la première couche ayant une première perméabilité VHP ; et une seconde couche comprenant une seconde composition comprenant du polyamide, du polyimide, du polyuréthane, du polyester, du siloxane ou un copolymère correspondant, la seconde couche ayant une deuxième perméabilité VHP, le matériau multicouche comprenant une troisième perméabilité VHP inférieure à 10 % de la première perméabilité VHP ou de la deuxième perméabilité VHP.
EP22776821.5A 2021-03-26 2022-03-22 Matériau multicouche et son procédé de fabrication et d'utilisation Pending EP4313578A1 (fr)

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US202163166714P 2021-03-26 2021-03-26
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EP1138234B1 (fr) * 1999-08-25 2008-01-30 House Foods Corporation Dispositif de traitement continu
US20110127188A1 (en) * 2009-12-01 2011-06-02 Cryovac, Inc. Method of Using Coextruded Film for Sterile Barrier System to Deliver Seal and Peel Characteristics
WO2011117878A1 (fr) * 2010-03-20 2011-09-29 Pawan Trilokchand Agrawal Seringue pré-remplie en plastique
WO2013022785A2 (fr) * 2011-08-05 2013-02-14 Noxilizer, Inc. Stérilisateur en ligne
WO2018217995A1 (fr) * 2017-05-24 2018-11-29 Formycon Ag Conditionnements pharmaceutiques pré-remplis stérilisables comprenant une formulation liquide d'un antagoniste du vegf

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WO2022204675A1 (fr) 2022-09-29

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