CN117120253A - Multilayer material and methods of making and using the same - Google Patents

Multilayer material and methods of making and using the same Download PDF

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Publication number
CN117120253A
CN117120253A CN202280024883.2A CN202280024883A CN117120253A CN 117120253 A CN117120253 A CN 117120253A CN 202280024883 A CN202280024883 A CN 202280024883A CN 117120253 A CN117120253 A CN 117120253A
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CN
China
Prior art keywords
layer
composition
vhp
permeability
package
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
CN202280024883.2A
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Chinese (zh)
Inventor
张剑锋
R·Z·皮特尔
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Saint Gobain Performance Plastics Corp
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Saint Gobain Performance Plastics Corp
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Filing date
Publication date
Application filed by Saint Gobain Performance Plastics Corp filed Critical Saint Gobain Performance Plastics Corp
Publication of CN117120253A publication Critical patent/CN117120253A/en
Pending legal-status Critical Current

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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 non-planar shape
    • 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

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Textile Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Thermal Sciences (AREA)
  • Wrappers (AREA)
  • Laminated Bodies (AREA)

Abstract

The present application relates to a multilayer material comprising: a first layer having a first composition comprising a polyolefin, a fluoropolymer, or a copolymer thereof, wherein the first layer has a first VHP permeability; and a second layer having a second composition comprising a polyamide, polyimide, polyurethane, polyester, siloxane, or a copolymer thereof, wherein the second layer has a second VHP permeability, wherein the multilayer material comprises a third VHP permeability that is less than 10% of the first VHP permeability or the second VHP permeability.

Description

Multilayer material and methods of making and using the same
Technical Field
The present disclosure relates to multilayer materials, and more particularly to multilayer materials having a second layer and a first layer.
Background
Packages are used to hold many products for shipping and sale. In some cases, the package may be used to transport sensitive products, such as medical products, biological products, or pharmaceutical products, for use in a clean room or under sterile conditions. In other cases, the package may be used to contain sensitive products or materials, such as medical catheters. In some cases, these packages themselves must be sterilized or otherwise handled to avoid contaminating the packaging environment at the time and place where the product is needed. In some cases, toxic gases such as Vaporized Hydrogen Peroxide (VHP) require sterilization or treatment of the package to protect these sensitive products. These sterilization can be burdensome. Thus, there is a need for improved packages, in particular to enable optimal resistance to toxic gases, while allowing improved ease of use.
Drawings
Embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings.
Fig. 1 illustrates a side view of a multi-layer material according to various embodiments of the present disclosure.
Fig. 2 illustrates a side view of a multi-layer material according to various embodiments of the present disclosure.
Fig. 3A illustrates a perspective view of a package according to various embodiments of the present disclosure.
Fig. 3B illustrates a cross-sectional view of the package of fig. 3A in a first configuration through section line 3 according to various embodiments of the present disclosure.
Fig. 3C illustrates a cross-sectional view of the package of fig. 3A in a second configuration through section line 3, according to various embodiments of the present disclosure.
Skilled artisans will 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 improve the understanding of the embodiments of the present application.
Detailed Description
The following description in conjunction with the accompanying drawings is provided to aid in the understanding of the teachings disclosed herein. The following discussion will focus on specific embodiments and implementations of the teachings. This focus is provided to aid in describing the teachings and should not be construed as limiting the scope or applicability of the teachings. However, other embodiments may be used based on the teachings as disclosed in the present disclosure.
The terms "comprising," "including," "having," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a method, article, or apparatus that comprises a list of features is not necessarily limited to only those features, but may include other features not expressly listed or inherent to such method, article, or apparatus. Furthermore, unless expressly stated to the contrary, "or" means an inclusive or, rather than an exclusive or. For example, the condition a or B is satisfied by any one of: a is true (or present) and B is false (or absent), a is false (or absent) and B is true (or present), and both a and B are true (or present).
In addition, the use of "a" or "an" is used to describe the elements and components described herein. This is done merely for convenience and to give a general sense of the scope of the invention. The description should be read to include one, at least one, or the singular, as well as the plural, or vice versa, unless it is clear that it is meant otherwise. For example, when a single embodiment is described herein, more than one embodiment may be used in place of a single embodiment. Similarly, where more than one embodiment is described herein, a single embodiment may be substituted for the more than one embodiment.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The materials, methods, and examples are illustrative only and not intended to be limiting. To the extent not described herein, many details regarding specific materials and processing acts are conventional and can be found in textbooks and other sources within the packaging arts.
The following disclosure describes multi-layer materials and packages that are adapted to achieve improved performance on toxic gases in a surprising and unexpected manner. These concepts will be better understood in view of the embodiments described below, which illustrate but do not limit the scope of the invention.
For purposes of illustration, fig. 1 shows a side view of a multi-layer material according to various embodiments of the present disclosure. In various embodiments, the multilayer material 100 or any layer thereof may be a laminate film. In various embodiments, the multilayer material 100 or any layer thereof may be a fluid gel. In various embodiments, the multilayer material 100, or any layer thereof, may be made of a solid film or a nonwoven material. In one or more embodiments, the multi-layer material 100 can include a second layer 110 and a first layer 120 disposed on one interior surface side of the second layer 110. In various embodiments, the first layer 120 may comprise a first composition comprising a polyolefin, a fluoropolymer, or a copolymer thereof. In various embodiments, the first layer 120 may comprise a second composition comprising polyethylene (high density or low density) or polypropylene (high density or low density). In various embodiments, the second layer 110 may comprise a second composition comprising a polyamide, polyimide, polyurethane, polyester, silicone, or copolymers thereof. In various embodiments, the second layer 110 may comprise a second composition comprising nylon. In various embodiments, the first layer 120 can be bonded to the second layer 110. Bonding may be accomplished by lamination, adhesion, coextrusion, surface activation (corona treatment, flame treatment, chemical etching, photoactivation, etc.), adhesive layers, primers, combinations thereof, or by other methods.
In various embodiments, the multilayer material 100 may have a thickness T MLM . For the purposes of the embodiments described herein and shown in fig. 1, the thickness T of the multilayer material 100 MLM May be at least about 0.001mm, such as at least about 0.005mm, at least about 0.01mm, at least about 0.05mm, at least about 0.1mm, or at least about 0.2mm, or at least about 0.3mm, or at least about 0.4mm,or even at least about 0.5mm. According to other embodiments, thickness T of multilayer material 100 MLM May be no greater than about 30mm, such as no greater than about 10mm, no greater than about 5mm, or even no greater than about 2.5mm. It should be appreciated that the thickness T of the multi-layer material 100 MLM May be in a range between any of the minimum values and any of the maximum values described above. It should also be appreciated that the thickness T of the multi-layer material 100 MLM Any value between any minimum value and any maximum value described above. In various embodiments, thickness T of multilayer material 100 MLM May be at least 0.1mm mil and not greater than 30mm.
In various embodiments, the second layer 110 of the multilayer material 100 may have a thickness T OL . For the purposes of the embodiments described herein and shown in fig. 1, the thickness T of the second layer 110 OL May be at least about 0.001mm, such as at least about 0.005mm, or at least about 0.1mm, or at least about 0.2mm, or at least about 0.3mm, or at least about 0.4mm, or even at least about 0.5mm. According to other embodiments, thickness T of second layer 110 OL May be no greater than about 1mm, such as no greater than about 0.5mm, or even no greater than about 0.25mm. It should be appreciated that the thickness T of the second layer 110 OL May be in a range between any of the minimum values and any of the maximum values described above. It should also be appreciated that the thickness T of the second layer 110 OL Any value between any minimum value and any maximum value described above. In various embodiments, the thickness T of the second layer 110 OL May be between 1 μm and 1000 μm, such as between 5 μm and 500 μm, or such as between 20 μm and 350 μm.
In various embodiments, the first layer 120 of the multilayer material 100 may have a thickness T IL . For the purposes of the embodiments described herein and shown in fig. 1, the thickness T of the first layer 120 IL May be at least about 0.001mm, such as at least about 0.005mm, at least about 0.01mm, at least about 0.05mm, at least about 0.1mm, or at least about 0.2mm, or at least about 0.3mm, or at least about 0.4mm, or even at least about 0.5mm. According to other embodiments, the thickness T of the first layer 120 IL May be no greater than about 1mm, such as no greater than about 0.5mm, or even no greater than about 0.25mm. It should be understood thatThickness T of first layer 120 IL May be in a range between any of the minimum values and any of the maximum values described above. It should also be appreciated that the thickness T of the first layer 120 IL Any value between any minimum value and any maximum value described above. In various embodiments, the thickness T of the first layer 120 IL May be between 1 μm and 1000 μm, such as between 5 μm and 500 μm, or such as between 20 μm and 350 μm.
For purposes of illustration, fig. 2 shows a side view of a multi-layer material according to various embodiments of the present disclosure. In various embodiments, the multilayer material 200 or any layer thereof may be a laminated multilayer film. In various embodiments, the multilayer material 200 or any layer thereof may be a fluid gel. In one or more embodiments, the multi-layer material 200 includes a second layer 210 and a first layer 220 disposed on one inner surface side of the second layer 210, as shown in fig. 1. In one or more embodiments, the multi-layer material 200 can include a third layer 230 disposed between the first layer 220 and the second layer 210. The third layer 230 may comprise a third composition comprising ethylene vinyl alcohol.
In various embodiments, the third layer 230 of the multilayer material 200 can have a thickness T TL . For the purposes of the embodiment described herein and shown in fig. 1, the thickness T of the third layer 230 TL May be at least about 0.001mm, such as at least about 0.005mm, at least about 0.01mm, at least about 0.05mm, at least about 0.1mm, or at least about 0.2mm, or at least about 0.3mm, or at least about 0.4mm, or even at least about 0.5mm. According to other embodiments, thickness T of third layer 230 TL May be no greater than about 1mm, such as no greater than about 0.5mm, or even no greater than about 0.25mm. It should be appreciated that the thickness T of the third layer 230 TL May be in a range between any of the minimum values and any of the maximum values described above. It should also be appreciated that the thickness T of the third layer 230 TL Any value between any minimum value and any maximum value described above. In various embodiments, thickness T of third layer 230 TL May be between 1 μm and 1000 μm, such as between 5 μm and 500 μm, or such as between 20 μm and 350 μm. May include between any of the listed layersAdditional intervening layers are also contemplated as being within the scope of the present invention.
For illustration purposes, fig. 3A shows a perspective view of a package according to various embodiments of the present disclosure. Fig. 3B illustrates a cross-sectional view of the package of fig. 3A in a first configuration through section line 3 according to various embodiments of the present disclosure. Fig. 3C illustrates a cross-sectional view of the package of fig. 3A in a second configuration through section line 3, according to various embodiments of the present disclosure. Package 300 may be made from the multi-layer materials described herein. As best shown in fig. 3A, package 300 may include a top edge 302, a left edge 304, a right edge 306, and a bottom edge 308. The package 300 may include a first side (or front side) 310 and a second side (or back side) 312 opposite the first side 310. In various embodiments, the first side 320 or the second side 312 of the package 300 may be generally polygonal in cross-section (e.g., rectangular). In many variations, the first face 320 or the second face 312 of the package 300 may have a polygonal, oval, circular, semi-circular, or substantially circular cross-section. In various embodiments, the first side 320 or the second side 312 of the package 300 may be substantially planar. The package 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, thereby forming a cavity 315. In other embodiments, the package 300 may be a pouch or container that opens at the proximal end 317 and/or the distal end 318. In other embodiments, the package 300 may be opened along a portion of one of the first wall 311 or the second wall 313. In other embodiments, package 300 may be configured as a tube including at least one open end.
In various embodiments, package 300 may have a width W PB . For the purposes of the embodiment described herein and shown in fig. 3A, the width W of the package 300 PB Is the distance from the left edge 304 to the right edge 306. According to a certain embodiment, width W of package 300 PB May be at least about 100mm, such as at least about 150mm, or at least about 200mm, or at least about 250mm, or at least about 300mm, or even at least about 500mm. According to other embodiments, width W of package 300 PB May be no greater than about 1500mm, such asNo greater than about 1200mm, or even no greater than about 1000mm. It should be appreciated that the width W of the package 300 PB May be in a range between any of the minimum values and any of the maximum values described above. It should also be appreciated that the width W of the package 300 PB Any value between any minimum value and any maximum value described above.
In various embodiments, package 300 may have a length L PB . For the purposes of the embodiments described herein and as shown in fig. 3A, the length L of the package 300 PB Is the distance from top edge 302 to bottom edge 308. According to a certain embodiment, length L of package 300 PB May be at least about 100mm, such as at least about 150mm, or at least about 200mm, or at least about 250mm, or at least about 300mm, or even at least about 500mm. According to other embodiments, length L of package 300 PB May be no greater than about 1500mm, such as no greater than about 1200mm, or even no greater than about 1000mm. It should be appreciated that length L of package 300 PB May be in a range between any of the minimum values and any of the maximum values described above. It should also be appreciated that the length L of the package 300 PB Any value between any minimum value and any maximum value described above.
In some embodiments, packaging system 300 is configured to contain product 330. The product may be a medical device, a biological device or a pharmaceutical device, such as a vascular catheter. In particular embodiments, the packaging system may comprise a product type designed for single use biopharmaceutical/life sciences.
In particular embodiments, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may be formed from a material comprising a polymer. In embodiments, at least one of the package, the first composition, or the second composition may comprise a polymer or a blend of polymeric polymers, including thermoplastic elastomeric hydrocarbon block copolymers, polyether-ester block copolymers, thermoplastic polyamide elastomers, thermoplastic polyurethane elastomers, thermoplastic polyolefin elastomers, thermoplastic vulcanizates, olefin-based copolymers, olefin-based terpolymers, polyolefin plastomers, or combinations thereof. In one place In an embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may comprise a styrene-based block copolymer, such as styrene-butadiene, styrene-isoprene, blends or mixtures thereof, and the like. Exemplary styrenic thermoplastic elastomers include triblock Styrenic Block Copolymers (SBCs) such as styrene-butadiene-styrene (SBS), styrene-isoprene-styrene (SIS), styrene-ethylene butylene-styrene (SEBS), styrene-ethylene propylene-styrene (SEPS), styrene-ethylene-butadiene-styrene (SEEBS), styrene-ethylene-propylene-styrene (SEEPS), styrene-isoprene-butadiene-styrene (SIBS), or combinations thereof. Commercial examples include some grades of Kraton TM And hybrid TM And (3) resin.
In one embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may comprise a polyolefin polymer. Typical polyolefins may include homopolymers, copolymers, terpolymers, alloys, or any combination thereof formed from monomers such as ethylene, propylene, butene, pentene, methylpentene, hexene, octene, or any combination thereof. In one embodiment, the polyolefin polymer may be a copolymer of ethylene and propylene or an alpha-olefin or a copolymer of polypropylene and ethylene or an alpha-olefin prepared by a metallocene or non-metallocene polymerization process. Examples of commercial polyolefins include Affinity produced by Dow, exxonMobil, londel-Basell and Mitsui TM 、Engage TM 、Flexomer TM 、Versify TM 、Infuse TM 、Exact TM 、Vistamaxx TM 、Softel TM And Tafmer TM 、Notio TM . In one embodiment, 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). Exemplary suppliers of these ethylene copolymer resins include DuPont, dow Chemical, mitsui, arkema, and the like. In another embodiment, the polyalkeneThe hydrocarbon polymer may be a terpolymer of ethylene, maleic anhydride and an acrylate ester, such as Lotader manufactured by Arkema TM Evalloy produced by DuPont TM . In yet another embodiment, the polyolefin polymer may be an ionomer of ethylene and acrylic acid or methacrylic acid, such as Surlyn manufactured by DuPont TM . In embodiments, the polyolefin is a reactor grade thermoplastic polyolefin polymer, such as P6E2A-005B available from Flint Hills Resources. In one embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may include, but is not limited to, thermoplastic materials, thermoset materials, fluoropolymers, and combinations thereof. A specific example of a suitable polymeric material may be polyvinylidene fluoride (PVDF). In one embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may be formed from a thermoplastic elastomer, a silicone, or a combination thereof. For example, a particular type of thermoplastic elastomer may be those described in U.S. patent application publication 2011/024372, the entire contents of which are incorporated herein by reference for all useful purposes.
In one embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may comprise a fluorinated polymer. In embodiments, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may comprise a polymer comprising at least one of: ethylene-tetrafluoroethylene (ETFE), tetrafluoroethylene-perfluoro (methyl vinyl ether) (MFA), polyvinylidene fluoride (PVDF), ethylene-chlorotrifluoroethylene (ECTFE), polyimide (PI), polyamideimide (PAI), polyphenylene sulfide (PPS), polyethersulfone (PES), polyphenylsulfone (PPSO) 2 ) Liquid Crystal Polymer (LCP), polyetherketone (PEK), polyetheretherketone (PEEK), aromatic polyester (Ekonol), polyetheretherketone (PEEK), polyetherketone (PEK), liquid Crystal Polymer (LCP), polyamide (PA), polyethylene (PE), UHMPE, polypropylene (PP), polystyrene, styrene butadiene copolymer, polyester, polycarbonate, polyacrylonitrile, polyamideStyrene block copolymers, ethylene vinyl alcohol copolymers, ethylene vinyl acetate copolymers, polyesters grafted with maleic anhydride, polyvinylidene chloride, aliphatic polyketones, liquid crystal polymers, ethylene methyl acrylate copolymers, ethylene norbornene copolymers, polymethylpentene and ethylene acrylic acid copolymers, mixtures, copolymers and any combination thereof.
Further, in one embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may comprise one or more additives. For example, the one or more additives may 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. In particular embodiments, the plasticizer may comprise mineral oil.
In one embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may be formed as a single piece or may be formed as multiple pieces. In one embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may be a molded part. In one embodiment, at least one of the multilayer material, package, first composition, second composition, or third composition may be formed by overmolding or other methods known in the art. In one embodiment, the polymer or polymer blend included in at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may be processed by any known method to form a polymer mixture. The polymer or polymer blend may be melt processed by dry blending or compounding. The dry blend may be in the form of a powder, granules or pellets. The blend may be prepared by a continuous twin screw compounding process or a batch related Banbury process. Pellets of these mixtures can then be fed into a single screw extruder to make articles such as flexible tubing products. The mixture may also be mixed in a single screw extruder equipped with a mixing element and then extruded directly into articles such as pipe products. In particular embodiments, the mixture may be melt processed by any contemplated method known in the art, such as lamination, casting, molding, extrusion, and the like. In embodiments, the mixture may be injection molded.
In various embodiments, at least one of the first, second, or third compositions can be bonded with another of the first, second, or third compositions to form a multilayer material and/or package. In various embodiments, for example, the polyethylene of the first composition may be bonded to the nylon of the second composition. In various embodiments, this may bond the first layer to the second layer to form the package. In various embodiments, the package may be peelable or tearable, thereby opening the package. In various embodiments, any of the layers on the multilayer material as described above may each be placed in and peeled from a roll, joined together by an adhesive or by any combination thereof under pressure and at elevated temperature (hot or cold or roll). As mentioned above, any of the layers of the multi-layer material may be laminated together such that they at least partially overlap one another. As noted above, any of the layers on the multi-layer material may be applied together using a coating technique (such as, for example, physical or vapor deposition, spraying, electroplating, powder coating) or by other chemical or electrochemical techniques. In a particular embodiment, any layer of the multilayer material may be applied by a roll-to-roll coating process (including, for example, extrusion coating). Any layer of the multi-layer material may be heated to a molten or semi-molten state and extruded through a slot die onto the inner or outer surfaces of other layers of the multi-layer material to form the package.
In one embodiment, the polymer or polymer blend of at least one of the package, the first composition, or the second composition may be formed as a single layer article, a multi-layer article, or may be laminated, coated, or formed on a substrate to form at least one of the package, the first composition, or the second composition. The multi-layer article may include layers such as reinforcing layers, adhesive layers, barrier layers, chemical resistant layers, metal layers, any combination thereof, and the like. The polymer or polymer blend may be formed into any useful shape, such as films, sheets, packages, sleeves, tubing, etc., to form at least one of a multi-layer material, package, first composition, or second composition. Useful shapes are closed, sealed, resealed, or otherwise combined around the product according to any known method in the packaging arts.
In one embodiment, the polymer or polymer blend of at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may be formed as a single layer article, a multilayer article, or may be laminated, coated, or formed on a substrate to form at least one of the package, the first composition, or the second composition. The multi-layer article may include layers such as reinforcing layers, adhesive layers, barrier layers, chemical resistant layers, metal layers, any combination thereof, and the like. The polymer or polymer blend may be formed into any useful shape, such as a film, sheet, tube, etc., to form at least one of a multi-layer material, package, first composition, second composition, or third composition.
In one embodiment, the polymer or polymer blend of at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may advantageously withstand a treatment or sterilization process. In embodiments, the polymer or polymer blend may be sterilized by any conceivable method. For example, the polymer or polymer blend is sterilized after at least one of the multilayer material, the package, the first composition, the second composition, or the third composition is formed. Exemplary sterilization methods include radiation sterilization, autoclaving, X-ray radiation, electron beam techniques, combinations thereof, and the like. In specific embodiments, the polymer or polymer blend is sterilized by vaporized hydrogen peroxide sterilization (VHP). In particular embodiments, the polymer or polymer blend is sterilized by gamma irradiation. For example, the polymer or polymer blend of at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may be gamma sterilized between about 25kGy and about 50 kGy.
In various embodiments, the multi-layer material, package, first composition, second composition, or third composition may be Vapor Hydrogen Peroxide (VHP) resistant. In various embodiments, the first layer 120 may have a first VHP permeability. In various embodiments, the second layer 110 may have a second VHP permeability. In various embodiments, the multilayer material 100 may have a third VHP permeability. In various embodiments, the third VHP permeability of multilayer material 100 may be less than 10% of the first VHP permeability of first layer 120 or the second VHP permeability of second layer 110. VHP permeability may be defined as the VHP content (ppm) in the environment outside of multilayered material 100 exceeding the VHP content (ppm) in the environment inside of multilayered material 100. The VHP content may be measured by sensors, titration (gas column titration), analytical test equipment, or any other method known in the art.
The material will be tested to obtain the optimal permeability for other toxic gases (such as oxygen, carbon dioxide or other gases) between the layers of material, the package, the first composition, the second composition or the third composition. The materials of the first, second and third layers will vary among these experiments. Positive manifestations regarding the optimal permeability of other toxic gases may be based on the change in the materials of the first and second layers, some of which potentially indicate criticality. The optimal permeability, or overall permeability or VHP content, for other toxic gases (e.g., hydrogen peroxide) between the first and second layers can be measured by two methods. Hydrogen peroxide can slowly permeate into the package during the decontamination process. To collect hydrogen peroxide, two analytical methods were developed. The first method is to completely fill the package with water to form a "water vapor sphere". Once the hydrogen peroxide diffuses into the bag, it will be absorbed and dissolved in the water. Thus, the accumulated hydrogen peroxide may be indicated by its concentration in water and tested via a hydrogen peroxide test kit comprising a test strip. Test strips are provided having detection ranges of 0ppm, 0.05ppm, 0.3ppm, 0.5ppm, 1ppm, 2ppm, 3ppm, 4ppm, 10ppm, 30ppm, 50 ppm. Some examples of test strips for hydrogen peroxide test kits are low range hydrogen peroxide test strips, waterWorks TM Low range peroxide detection orVisualization kit.
The test method of the water balloon is as follows:
1) The film was cut to a 6 x 6 inch film size and three sides of the film were sealed into bags having an ID of 4 x 5 inches (seal width of about 0.0825 inches).
2) The "water balloon" was prepared by first filling about 30 grams of distilled water into the bag and then removing as much air as possible from the bag. The bag was sealed and checked for leakage by visual inspection.
3) The bag is suspended within the isolator, and the bag is spaced apart to ensure complete immersion in the VHP.
4) Start the decontamination process
5) After decontamination, the bag is removed from the isolator via the RTP port during the aeration step (after VHP <25ppm or safety level for operation)
6) Measurement of hydrogen peroxide concentration of water in "water balloon" using test paper/kit
Due to the different test ranges and accuracies, the tests were performed as needed in the following order:
a. high range hydrogen peroxide test-test strip (0 ppm-50ppm, laMotte)
i. About 5ml of the sample from the bag was placed in a container/beaker for measurement;
testing (dipping and reading, but care should be taken in packaging) according to the description at the packaging;
compare to the reference value and record the value, if the reading >30ppm, skip the following two tests.
If the reading is <30ppm, the following two tests are performed:
a. low Range Hydrogen peroxide test-test strips (0 ppm-4ppm, waterworks) TM )
i. About 5ml of the sample from the bag was placed in a container/beaker for measurement;
testing (dipping and reading, but care should be taken in packaging) according to the description at the packaging;
comparing with a reference value, recording the value, and then performing the next test;
b. using a hydrogen peroxide for low range testingDouble confirmation of the kit
(0ppm-0.8ppm，1ppm-10ppm)
i. Taking about 25ml of the sample from the bag and placing it into a beaker for measurement;
testing according to the instructions at the packaging (breaking the tip of the ampoule in the beaker and placing the ampoule in the beaker until the reaction is complete);
compare with the reference value and record the value
The beaker was rinsed with distilled water at least 3 times for the next measurement.
The second method is to use a glass detection tube. By being fitted with an air pump, the air in the bag is forced to circulate through a glass tube, which is essentially a column (2H) containing chemicals that absorb and react with hydrogen peroxide 2 O 2 +2KI→I 2 +2H 2 O+O 2 ). The reaction with hydrogen peroxide causes these chemicals to change color, so the amount of hydrogen peroxide can be read from the glass tube. Glass tubes used include, but are not limited to, drager glass detection tubes, detection range/level: 0.1ppm to 3.0ppm, or a gartec glass detection tube, detection range/level: 0.5ppm to 10.0ppm. In contrast to the first method, the method allows for real-time monitoring of hydrogen peroxide.
The test method of the water balloon is as follows:
1) Cutting the film to the appropriate size of the adaptable assembly;
2) Breaking two tips of the VHP test tube, and then connecting the test tube and the air pump with a flexible tube;
3) The bag was inflated and then sealed, and checked for leaks by visual inspection;
4) Starting the pump before closing the isolator; the bag is suspended adjacent the cover glazing for easy reading during decontamination.
5) Readings are recorded during and after the decontamination process.
From these processes, it can be determined whether the VHP permeability has increased, decreased, or remained constant. As described above, the multi-layer material determined as described above and tested according to embodiments herein may include: a first layer having a first composition comprising a polyolefin, a fluoropolymer, or a copolymer thereof, wherein the first layer has a first VHP permeability; and a second layer having a second composition comprising a polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, wherein the second layer has a second VHP permeability, wherein the multilayer material has a third VHP permeability from the second layer to the first layer that is 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.
In one embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may have further desirable physical and mechanical properties. For example, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may exhibit transparency or at least translucency. For example, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may have a light transmittance of greater than about 2% or greater than about 5% in the visible wavelength range. In particular, the resulting article has a desired transparency or translucency. In addition, at least one of the multilayer material, package, first composition, second composition, or third composition also has advantageous physical properties such as any one or more of hardness, flexibility, surface lubricity, tensile strength, elongation, shore a hardness, gamma resistance, weld strength, and seal integrity balanced to an optimal level.
In one embodiment, at least one of the multilayer material, the package, the first composition, the second composition, or the third composition may have a desired thermal stability. The use of polymers or polymer blends is numerous. In particular, the polymer or polymer blend is non-toxic, such that the material may be used in any application where toxicity is not desired. For example, the polymer or polymer blend may be substantially free of plasticizers or other low molecular weight extenders, which may be leached into the fluid it transfers. As used herein, "substantially free" refers to a polymer mixture having a Total Organic Content (TOC) (measured according to ISO 15705 and EPA 410.4) of less than about 100 ppm. In addition, the polymer or polymer blend is biocompatible and free of animal derived components of the formulation ingredients. For example, polymer mixtures have the potential for FDA, USP, EP, ISO and other regulatory approval. In exemplary embodiments, the polymer or polymer blend may be used in applications such as industrial, medical, health, biomedical, pharmaceutical, potable water, food and beverage, laboratory, dairy, and the like. In one embodiment, the polymer mixture may be used in applications where low temperature resistance is desired. In embodiments, the polymer or polymer blend may also be safely disposed of because it generates substantially no toxic gases when incinerated and, if landfilled, does not leach the plasticizer into the environment.
In particular embodiments, the package may be torn or peeled away to form an "open position" from a "closed position". In particular embodiments, the package 200 may be tearable or peelable to form an open position when a force is applied, the force applied being no greater than about 10lbf, no greater than about 5lbf, no greater than about 2.5lbf, no greater than about 2lbf, or no greater than about 1lbf. In some embodiments, the package may be resealable to form a "closed position" from an "open position".
According to various embodiments, a method may be used to form a package. The method may include a first step comprising providing a first layer comprising a first composition comprising a polyolefin, a fluoropolymer, or a 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 a 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-layer material in a packaged form. The method may include a fourth step of processing the package such that the package has a third VHP permeability that is less than 10% of the first VHP permeability or the second VHP permeability. Optionally, the method may include the step of placing the product within the package prior to bonding the second composition to the first composition. In various embodiments, this treatment step may be accomplished via radiation sterilization or autoclaving.
The use of multi-layer materials or packages may provide increased benefits in several applications or other types of applications in fields such as, but not limited to, industrial, medical, healthcare, biomedical, pharmaceutical, potable water, food and beverage, laboratory, dairy, and the like. Notably, the use of a multi-layer material or package can provide a sealing mechanism for containing a product intended for treatment or sterilization, such as a medical device, pharmaceutical or biological product used in surgery. Furthermore, the use of multiple layers of materials or packages may provide VHP resistant materials with minimal layers, thereby reducing cost, material use, and manufacturing complexity. This may provide optimal VHP and other toxic gas tolerance while improving ease of use in difficult environments such as operating rooms, hospitals or pharmacies.
Many different aspects and embodiments are possible. Some of those aspects and embodiments are described below. Those skilled in the art will appreciate after reading this specification that those aspects and embodiments are merely exemplary and do not limit the scope of the present invention.
Embodiment 1: a multilayer material, the multilayer material comprising: a first layer having a first composition comprising a polyolefin, a fluoropolymer, or a copolymer thereof, wherein the first layer has a first VHP permeability; and a second layer comprising a second composition comprising a polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, wherein the second layer has a second VHP permeability, wherein the multilayer material has a third VHP permeability from the second layer to the first layer that is 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, the packaging assembly comprising: a product; and a package enclosing the product to provide a sterilizable package assembly, wherein the package comprises a multi-layer material comprising: a first layer having a first composition comprising a polyolefin, a fluoropolymer, or a copolymer thereof, wherein the first layer has a first VHP permeability; and a second layer comprising a second composition comprising a polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, wherein the second layer has a second VHP permeability, wherein the multilayer material has a third VHP permeability from the second layer to the first layer that is 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 package, the method comprising: providing a first layer comprising a first composition comprising a polyolefin, a fluoropolymer, or a copolymer thereof, wherein the first layer has a first VHP permeability; providing a second layer comprising a second composition comprising a 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-layer material in the form of a package; and processing the package such that the multilayer material has a third VHP permeability from the second layer to the first layer that is 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 multilayer material, packaging component, or method according to any one of the preceding embodiments, wherein the second layer comprises a fluid gel.
Embodiment 5: the multilayer material, packaging component or method according to any one of the preceding embodiments, wherein the second layer is bonded to the first layer.
Embodiment 6: the multilayer material, packaging component, or method of any one of the preceding embodiments, wherein the second layer comprises a laminate film.
Embodiment 7: the multilayer material, packaging component, or method of any one of the preceding embodiments, wherein the first layer comprises a laminate film.
Embodiment 8: the multilayer material, packaging component, or method of any one of the preceding embodiments, further comprising a third layer comprising ethylene vinyl alcohol between the second layer and the first layer.
Embodiment 9: the multilayer material, packaging component or method according to any one of the preceding embodiments, wherein the multilayer material has a thickness of between 10 μιη and 30 mm.
Embodiment 10: the multilayer material, packaging component or method according to any one of the preceding embodiments, wherein the thickness of the second layer is between 1 μm and 1000 μm, such as between 5 μm and 500 μm, or such as between 20 μm and 350 μm.
Embodiment 11: the multilayer material, packaging component or method according to any one of the preceding embodiments, wherein the thickness of the first layer is between 1 μιη and 1000 μιη, such as between 5 μιη and 500 μιη, or such as between 20 μιη and 350 μιη.
Embodiment 12: the multilayer material, packaging component or method according to any one of embodiments 9 to 11, wherein the thickness of the third layer is between 1 μιη and 1000 μιη, such as between 5 μιη and 500 μιη, or such as between 20 μιη and 350 μιη.
Embodiment 13: the multilayer material, packaging assembly or method according to any one of the preceding embodiments, wherein the multilayer material comprises tubing.
Embodiment 14: the multilayer material, packaging assembly, or method according to any one of the preceding embodiments, wherein the packaging assembly comprises a package or sleeve.
Embodiment 15: the method of embodiment 3, further comprising placing a product within the package prior to bonding the second composition to the first composition.
Embodiment 16: the packaging assembly or method according to any one of embodiments 2 and 15, wherein the product is a medical device or a biomedical device.
Embodiment 17: the method of embodiment 3, wherein the treating step is accomplished via radiation sterilization or autoclaving.
Embodiment 18: the method of embodiment 17, wherein the radiation sterilization is accomplished by electron beam sterilization, gamma sterilization, or X-ray sterilization.
Embodiment 19: the multilayer material, packaging component, or method according to any one of the preceding embodiments, wherein the second layer is a solid film or a nonwoven material.
Embodiment 20: the multilayer material, packaging component or method according to any one of the preceding embodiments, wherein the second composition of the second layer comprises nylon.
Embodiment 21: the multilayer material, packaging component or method according to any one of the preceding embodiments, wherein the first composition of the first layer comprises polyethylene or polypropylene.
Examples
Preliminary tests were performed on the multilayer materials according to embodiments disclosed herein. Vaporized Hydrogen Peroxide (VHP) was tested against several materials used in the multi-layer materials, packages, first compositions (first layer) and second compositions (second layer). The test is performed by chemical indicators, biological/enzymatic indicators or sensors (e.g., using a picaro PI2114 hydrogen peroxide gas concentration analyzer). Three tests were performed among the tests performed 1) low range hydrogen peroxide test strip, detection range/level: 0ppm, 1ppm, 3ppm, 10ppm, 30ppm, 50ppm; 2) WaterWorks TM Low range peroxide detection, detection range/level: 0.05ppm, 0.3ppm, 0.5ppm, 1.0ppm, 2.0ppm, 4.0ppm; 3) peroxyHydrogen chemical test kitVisualization kit, detection range/level: 0.05ppm to 10ppm (0 ppm, 0.1ppm, 0.2ppm, 0.3ppm, 0.4ppm, 0.5ppm, 0.8ppm and 1ppm, 2ppm, 3ppm, 4ppm, 5ppm, 6ppm, 7ppm, 8 ppm). Hydrogen Peroxide (VHP) permeability was tested using the "water balloon" method.
The water balloon method is as follows: 1) Cutting the film to a 6 x 6 inch film size and sealing three sides of the film into bags having an ID of 4 x 5 inches (seal width of about 0.0825 inches); 2) The "water balloon" was prepared by first filling about 30 grams of distilled water into the bag and then removing as much air as possible from the bag. Sealing the bag and checking for leaks by visual inspection; 3) Suspending the bag in a closed container containing an air pump to continually evaporate the VHP by bubbling in 35% hydrogen peroxide solution, the bag being spaced to ensure complete immersion in VHP; 4) Starting the test at room temperature for a certain time (2 to 12 hours); 5) The hydrogen peroxide concentration of the water within the "water balloon" was then measured using a test paper/kit. Due to the different test ranges and accuracies, the tests were performed as needed in the following order:
High range hydrogen peroxide test-test strip (0 ppm-50ppm, laMotte)
About 5ml of the sample from the bag was placed in a container/beaker for measurement;
tests were performed according to the description at the packaging (dipping and reading, but care should be taken in packaging);
compare to the reference value and record the value, if the reading >30ppm, skip the following two tests.
If the reading is <30ppm, the following two tests are performed:
low Range Hydrogen peroxide test-test strips (0 ppm-4ppm, waterworks) TM )
About 5ml of the sample from the bag was placed in a container/beaker for measurement;
tests were performed according to the description at the packaging (dipping and reading, but care should be taken in packaging);
comparing with a reference value, recording the value, and then carrying out the next test;
using a hydrogen peroxide for low range testingThe kit was double-confirmed- (0 ppm-0.8ppm,1ppm-10 ppm)
Taking about 25ml of the sample from the bag and placing it into a beaker for measurement;
testing was performed according to the instructions at the package (breaking the tip of the ampoule in the beaker and placing the ampoule in the beaker until the reaction was completed);
compare with the reference value and record the value
The beaker was rinsed with distilled water at least 3 times for the next measurement.
The results are shown in Table 1 below
Material and structure Nylon LDPE Nylon/LDPE 1
Penetrating VHP (ppm) >100 4 to 5 0.1 to 0.2
TABLE 1
As shown in table 1, nylon (e.g., second layer) and LDPE (e.g., first layer) exhibited very high VHP permeabilities when tested alone. However, when combined together in a multi-layer material according to embodiments shown herein, the combined material shows surprisingly and unexpectedly very low VHP permeation results. Furthermore, the correct orientation of the multilayer material is also extremely important, as if the nylon (e.g., second layer) is directly facing the VHP rich environment, the permeability is much lower than the opposite orientation of the LDPE (e.g., first layer) that is directly facing the VHP rich environment. The results of this effect are shown in table 2 below.
TABLE 2
Note that: minimum detection level of 0.05ppm
As shown in table 2, VHP levels were significantly lower when the second layer faced the VHP-rich environment. Thus, the layer orientation of the multilayer material in the VHP-rich environment is important.
It is noted that not all of the activities described above in the general description or the examples are required, that a portion of a specific activity may not be required, and that one or more further activities may be performed in addition to those described. Still further, the order in which the activities are listed is not necessarily the order in which the activities are performed.
Benefits, other advantages, and solutions to problems have been described above with regard to specific embodiments. The benefits, advantages, solutions to problems, and any feature(s) that may cause any benefit, advantage, or solution to occur or become more pronounced, however, are not to be construed as a critical, required, or essential feature or features of any or all the claims.
The description and illustrations of the embodiments described herein are intended to provide a general understanding of the structure of the various embodiments. The description and illustrations are not intended to serve as an exhaustive and complete description of all of the elements and features of apparatus and systems that use the structures or methods described herein. Individual embodiments may also be provided in combination in a single embodiment, and conversely, various features that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any subcombination. Furthermore, references to values stated in ranges include each value within the range. Many other embodiments may be apparent to the skilled artisan only after reading this specification. Other embodiments may be utilized and derived from the disclosure, such that structural, logical, or other changes may be made without departing from the scope of the disclosure. Accordingly, the present disclosure should be considered as illustrative and not restrictive.
It is noted that not all of the activities described above in the general description or the examples are required, that a portion of a specific activity may not be required, and that one or more further activities may be performed in addition to those described. Still further, the order in which the activities are listed is not necessarily the order in which the activities are performed.
Benefits, other advantages, and solutions to problems have been described above with regard to specific embodiments. The benefits, advantages, solutions to problems, and any feature(s) that may cause any benefit, advantage, or solution to occur or become more pronounced, however, are not to be construed as a critical, required, or essential feature or features of any or all the claims.
Those skilled in the art will appreciate after reading this specification that certain features described herein in the context of separate embodiments may also be provided in combination in a single embodiment for clarity. Conversely, various features that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any subcombination. Furthermore, references to values stated in ranges include each value within the range.

Claims (15)

1. A multilayer material, the multilayer material comprising:
A first layer having a first composition comprising a polyolefin, a fluoropolymer, or a copolymer thereof, wherein the first layer has a first VHP permeability; and
a second layer comprising a second composition comprising a polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, wherein the second layer has a second VHP permeability, wherein the multilayer material has a third VHP permeability from the second layer to the first layer that is 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.
2. A packaging assembly, the packaging assembly comprising:
a product; and
a package that encapsulates the product to provide a sterilizable package assembly, wherein the package comprises a multi-layer material comprising:
a first layer having a first composition comprising a polyolefin, a fluoropolymer, or a copolymer thereof, wherein the first layer has a first VHP permeability; and
a second layer comprising a second composition comprising a polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof, wherein the second layer has a second VHP permeability, wherein the multilayer material has a third VHP permeability from the second layer to the first layer that is 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.
3. A method for forming a package, the method comprising:
providing a first layer comprising a first composition comprising a polyolefin, a fluoropolymer, or a copolymer thereof, wherein the first layer has a first VHP permeability;
providing a second layer comprising a second composition comprising a polyamide, polyimide, polyurethane, polyester, silicone, or copolymers thereof, wherein the second layer has a second VHP permeability;
bonding the first layer to the second layer to form a multi-layer material in the form of a package; and
the package is treated such that the package has a third VHP permeability from the second layer to the first layer that is 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.
4. The multilayer material, packaging assembly or method according to any one of the preceding claims, wherein the second layer is bonded to the first layer.
5. The multilayer material, packaging assembly or method according to any one of the preceding claims, wherein the second layer comprises a laminate film.
6. The multilayer material, packaging assembly or method according to any one of the preceding claims, wherein the first layer comprises a laminate film.
7. The multilayer material, packaging assembly or method according to any one of the preceding claims, further comprising a third layer comprising ethylene vinyl alcohol located between the second layer and the first layer.
8. The multilayer material, packaging assembly or method according to any one of the preceding claims, wherein the multilayer material comprises tubing.
9. The multilayer material, packaging assembly or method according to any one of the preceding claims, wherein the packaging assembly comprises a packaging bag or sleeve.
10. The method of claim 3, further comprising placing a product within the package prior to bonding the second composition to the first composition.
11. The package assembly of claim 2, wherein the product is a medical device or a biomedical device.
12. A method according to claim 3, wherein the treating step is accomplished via radiation sterilization or autoclaving.
13. The multilayer material, packaging component or method according to any one of the preceding claims, wherein the second layer is a solid film or a nonwoven material.
14. The multilayer material, packaging component or method of any one of the preceding claims, wherein the second composition of the second layer comprises nylon.
15. The multilayer material, packaging component or method according to any one of the preceding claims, wherein the first composition of the first layer comprises polyethylene or polypropylene.
CN202280024883.2A 2021-03-26 2022-03-22 Multilayer material and methods of making and using the same Pending CN117120253A (en)

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EP1138234B1 (en) * 1999-08-25 2008-01-30 House Foods Corporation Continuous processing device
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 (en) * 2010-03-20 2011-09-29 Pawan Trilokchand Agrawal Plastic pre-filled syringe
JP6043790B2 (en) * 2011-08-05 2016-12-14 ノクシライザー, インコーポレイテッドNoxilizer, Incorporated In-line sterilizer
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