SAME

TECHNICAL FIELD

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.

BACKGROUND ART

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.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments are illustrated by way of example and are not limited in the accompanying figures.

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.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

The following description in combination with the figures is provided to assist in understanding the teachings disclosed herein. The following discussion will focus on specific implementations and embodiments of the teachings. This focus is provided to assist in describing the teachings and should not be interpreted as a limitation on the scope or applicability of the teachings. However, other embodiments can be used based on the teachings as disclosed in this application.

The terms “comprises,” “comprising,” “includes,” “including,” “has,” “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 only to those features but may include other features not expressly listed or inherent to such method, article, or apparatus. Further, unless expressly stated to the contrary, “or” refers to an inclusive-or and not to an exclusive-or. For example, a condition A or B is satisfied by any one of the following: A is true (or present), and B is false (or not present), A is false (or not present), and B is true (or present), and both A and B are true (or present).

Also, the use of “a” or “an” is employed to describe elements and components described herein. This is done merely for convenience and to give a general sense of the scope of the invention. This description should be read to include one, at least one, or the singular as also including 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 that more than one embodiment.

Unless otherwise defined, 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 may be found in textbooks and other sources within the packaging arts. The following disclosure describes multi-layered materials and packagings adapted to achieve improved performance against noxious gases in surprising and unexpected ways.

The concepts are better understood in view of the embodiments described below that illustrate and do not limit the scope of the present invention.

For purposes of illustration, FIG. 1 illustrates a side view of a multi-layered material according to a number of embodiments of the present disclosure. In a number of embodiments, the multi-layered material 100, or any layers thereof, may be a laminated film. In a number of embodiments, the multi-layered material 100, or any layers thereof, may be a fluid gel. In a number of embodiments, the multi-layered material 100, or any layers thereof, may be made of solid film or nonwoven material. In one or a plurality of embodiments, 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. In a number of embodiments, the first layer 120 may include a first composition including a polyolefin, fluoropolymer, or copolymer thereof. In a number of embodiments, the first layer 120 may include a second composition including polyethylene (high or low density) or polypropylene (high or low density). In a number of embodiments, the second layer 110 may include a second composition including polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof. In a number of embodiments, the second layer 110 may include a second composition including nylon. In a number of embodiments, 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.

In a number of embodiments, the multi-layered material 100 may have a thickness T _MLM · For purposes of embodiments described herein and as shown in FIG. 1, 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. According to still other embodiments, 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. It will be appreciated that 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.

In a number of embodiments, the second layer 110 of the multi-layered material 100 may have a thickness T _OL · For purposes of embodiments described herein and as shown in FIG. 1, 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. According to still other embodiments, 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. It will be appreciated that 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.

In a number of embodiments, the first layer 120 of the multi-layered material 100 may have a thickness T _IL . For purposes of embodiments described herein and as shown in FIG. 1, 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. According to still other embodiments, 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. It will be appreciated that 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.

For purposes of illustration, FIG. 2 illustrates a side view of a multi-layered material according to a number of embodiments of the present disclosure. In a number of embodiments, the multi-layered material 200, or any layers thereof, may be a laminated multi-layer film. In a number of embodiments, the multi-layered material 200, or any layers thereof, may be a fluid gel. In one or a plurality of embodiments, 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. In one or a plurality of embodiments, 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.

In a number of embodiments, the third layer 230 of the multi-layered material 200 may have a thickness T _TL . For purposes of embodiments described herein and as shown in FIG. 1, 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. According to still other embodiments, 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. It will be appreciated that 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.

For purposes of illustration, 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. In a number of embodiments, the first face 310 or second face 312 of the packaging 300 may be generally polygonal cross-section (e.g., rectangular). In a number of variations, 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. In a number of embodiments, 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. In other embodiments, the packaging 300 may be a bag or container opened at a proximal 317 and/or a distal end 318. In still other embodiments, the packaging 300 may be opened along a portion of one of the first wall 311 or second wall 313. In other embodiments, the packaging 300 may be configured as a tube including at least one open end.

In a number of embodiments, the packaging 300 may have a width Wp _B - For purposes of embodiments described herein and as shown in FIG. 3A, the width W _PB of the packaging 300 is the distance from the left edge 304 to the right edge 306. According to certain embodiment, 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. According to still other embodiments, 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.

In a number of embodiments, the packaging 300 can have a length L _PB . For purposes of embodiments described herein and as shown in FIG. 3A, the length L _PB of the packaging 300 is the distance from the top edge 302 to the base edge 308. According to certain embodiment, 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. According to still other embodiments, 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.

In some embodiments, 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. In specific embodiments, the packaging system may contain a product type for biopharma/life sciences that are designed for a single use.

In particular embodiments, 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. In an embodiment, 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. In an embodiment, 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. 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. Commercial examples include some grades of Kraton™ and Hybrar™ resins.

In an embodiment, 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. In an embodiment, 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 Affinity™, Engage™, Flexomer™, Versify™, Infuse™, Exact™, Vistamaxx™, Softel™ and Tafmer™, Notio™ produced by Dow, ExxonMobil, Londel-Basell and Mitsui. In an 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 and Arkema etc. In another embodiment, the polyolefin polymer can be a terpolymer of ethylene, maleic anhydride and acrylates such as Lotader™ made by Arkema and Evalloy™ produced by DuPont. In yet another embodiment, the polyolefin polymer can be an ionomer of ethylene and acrylic acid or methacrylic acid such as Surlyn™ made by DuPont. In an embodiment, the polyolefin is a reactor grade thermoplastic polyolefin polymer, such as P6E2A-005B available from Flint Hills Resources. In an embodiment, 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. Specific examples of suitable polymer material can be polyvinylidene fluoride (PVDF). 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 of a thermoplastic elastomer, silicone, or combinations thereof. For example, specific types of thermoplastic elastomers 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.

In an embodiment, at least one of the multi-layered material, packaging, the first composition, the second composition, or the third composition may include a fluorinated polymer. In an embodiment, 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), liquid crystal polymer (LCP), polyamide (PA), polyethylene (PE), UHMPE, polypropylene (PP), polystyrene, styrene butadiene copolymers, polyesters, polycarbonate, polyacrylonitriles, polyamides, styrenic block copolymers, ethylene vinyl alcohol copolymers, ethylene vinyl acetate copolymers, polyesters grafted with maleic anhydride, poly-vinylidene chloride, aliphatic polyketone, liquid crystalline polymers, ethylene methyl acrylate copolymer, ethylene - norbornene copolymers, polymethylpentene and ethylene acrylic acid copolymer, mixtures, copolymers and any combination thereof. Further, in an embodiment, 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. For example, 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. In a particular embodiment, the plasticizer can include mineral oil.

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 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. In a particular embodiment, the mixture can be melt processed by any method envisioned known in the art such as laminating, casting, molding, extruding, and the like. In an embodiment, the mixture can be injection molded.

In a number of embodiments, 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. In a number of embodiments, for example, 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. In a number of embodiments, the packaging may be peelable or tearable to open the packaging.

In a number of embodiments, 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. In a particular embodiment, 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.

In an embodiment, 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.

In an embodiment, 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.

In an embodiment 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. In an embodiment, the polymer or polymeric blend may be sterilized by any method envisioned. For instance, 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. In a particular embodiment, the polymer or polymeric blend is sterilized by vaporized hydrogen peroxide sterilization (VHP). In a particular embodiment, the polymer or polymeric blend is sterilized by gamma irradiation. For instance, 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.

In a number of embodiments, the multi-layered material, packaging, the first composition, the second composition, or the third composition may be vaporized hydrogen peroxide (VHP) resistant. In a number of embodiments, the first layer 120 may have a first VHP permeability. In a number of embodiments, the second layer 110 may have a second VHP permeability. In a number of embodiments, the multi-layered material 100 may have a third VHP permeability. In a number of embodiments, 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.

Experiments will be conducted regarding the materials for best permeability regarding other noxious gases (such as oxygen, carbon dioxide, or another gas) between the multi layered material, packaging, the first composition, the second composition, or the third composition. Materials of the first layer, the second layer, and the third layer will be varied through these experiments. A positive performance for the best permeability regarding other noxious gases may be based on the variations of the materials of the first layer and second layer, some potentially demonstrating criticality. The best permeability regarding other noxious gases (e.g. hydrogen peroxide) between the first layer and the second layer, or the overall permeability or VHP content, can be measured by two methods as follows. During the decontamination process, the hydrogen peroxide can slowly permeate through the packaging. In order to collect the hydrogen peroxide, two methods for the analysis were developed. 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, Waterworks™ Low Range Peroxide Check, or CHEMets® Visual Kit.

The “water balloon” testing 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. Sealing the bag, and check the leakage by vision check.

3) Hang the bags inside the isolator, space the bag to ensure fully soaking in VHP.

4) Start the decontamination process

5) After the decontamination, transfer the bags out of isolator via RTP port during the aeration step (after VHP < 25 ppm or a safe level for operation)

6) Measure the hydrogen peroxide concentration of the water in the “water balloon” using the test paper/kit

Due to the different test range and accuracy, 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.

If the reading is < 30 ppm, perform the following two tests: a. Low range hydrogen peroxide test - test trip (0-4 ppm, Waterworks™) 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, record the value, then perform next test; b. Double confirmation using the CHEMets® Kits for low range hydrogen peroxide test - (0 - 0.8 ppm, 1 - 10 ppm) i. Measure -25 ml sample from bag into the beaker; ii. Perform the test according to the introduction at package (break the tip of ampoules in the beaker, and sit the ampoules in the beaker until reaction complete); iii. Compared with reference and record the value iv. Rinse the beaker with distilled water for at least 3 times for next measurement.

The second method is use a glass detect tube. By assembling with an air pump, 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 (2¾q ₂ + 2KI + 2¾0 + 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. Compared with the first method, the hydrogen peroxide can be monitored in real-time.

The “water balloon” testing method is as follows:

1) Cut the film with the proper size that can fit the assembly;

2) Break the both tip of the VHP test tube, then connect the tube and air pump with a flexible tube;

3) Inflate and then seal the bag, check the leakage by vision check;

4) Start the pump before closing of the isolator; hang the bag close to the glass window of the hood for easy reading during the decontamination process.

5) Record the reading during and after the decontamination process.

Through these processes, we can determine if the VHP permeability has been increased, decreased, or held constant. As recited above, it has been determined that 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.

In embodiment, 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. For instance, 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. For instance, 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. In particular, the resulting articles have desirable clarity or translucency. In addition, 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.

In an embodiment, 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. In particular, the polymer or polymeric blend is non-toxic, making the material useful for any application where no toxicity is desired. For example, 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. Further, the polymer or polymeric blend has biocompatibility and animal derived component-free formulation ingredients. For instance, the polymeric mixture has potential for FDA, USP, EP, ISO, and other regulatory approvals. In an exemplary embodiment, 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. In an embodiment, the polymeric mixture may be used in applications where low temperature resistance is desired.

In an embodiment, 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.

In particular embodiments, packaging may be torn or peeled to form an “open position” from a “closed position.” In particular embodiments, 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. In some embodiments, 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. Optionally, the method may include a step of disposing a product within the packaging before bonding the second composition to the first composition. In a number of embodiments, 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. Notably, 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. Further, 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.

Many different aspects and embodiments are possible. Some of those aspects and embodiments are described below. After reading this specification, skilled artisans will appreciate that those aspects and embodiments are only illustrative and do not limit the scope of the present invention.

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.

Examples

Preliminary testing was done on a multi-layered material according to embodiments disclosed herein. Vaporized Hydrogen Peroxide (VHP) was tested against several materials used in the multi-layered material, packaging, the first composition (first layer), and the second composition (second layer). Testing was done by chemical indicator, biological/enzymatic indicator, or sensor (e.g., using Picarro PI2114 hydrogen peroxide gas concentration analyzer). In the testing done below, three tests were done: 1) Low Range Hydrogen Peroxide Test Strips, detection range/level: 0, 1, 3, 10, 30, 50 ppm; 2) Waterworks™ Low Range Peroxide Check, detection range/level: 0.05, 0.3, 0.5, 1.0, 2.0, 4.0 ppm; and 3) Hydrogen Peroxide Test Kit — CHEMets® Visual Kit, detection range/level: 0.05-10 ppm (0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.8 ppm and 1, 2, 3, 4, 5, 6, 7, 8 ppm). The hydrogen peroxide (VHP) permeation was tested using a “water balloon” method.

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. Sealing the bag and check the leakage by vision check; 3) Hang the bags inside the closed container which contain an air pump to constantly evaporating VHP by bubbling in a 35% hydrogen peroxide solution, space the bag to ensure fully soaking in VHP; 4) Start the test for certain period (vary from 2- 12 hours) under room temperature; 5) After that, the water inside the “water balloon” was measured for the hydrogen peroxide concentration using the test paper/kit. Due to the different test range and accuracy, the tests are performed by following sequence base as necessary:

High range hydrogen peroxide test - test trip (0-50 ppm, LaMotte)

Measure ~5 ml sample from bag into a container/beaker;

Perform the test according to the introduction at package (dip and reading, but notice the trick in the package);

Compared with reference, and record the value, skip the following two tests if the reading is > 30 ppm.

If the reading is < 30 ppm, perform the following two tests:

Low range hydrogen peroxide test - test trip (0-4 ppm, Waterworks™)

Measure ~5 ml sample from bag into a container/beaker;

Perform the test according to the introduction at package (dip and reading, but notice the trick in the package);

Compared with reference, record the value, then perform next test;

Double confirmation using the CHEMets® Kits for low range hydrogen peroxide test - (0 - 0.8 ppm, 1 - 10 ppm)

Measure -25 ml sample from bag into the beaker;

Perform the test according to the introduction at package (break the tip of ampoules in the beaker, and sit the ampoules in the beaker until reaction complete);

Compared with reference and record the value

Rinse the beaker with distilled water for at least 3 times for next measurement.

Results are shown below in Table 1

Table 1

As Table 1 indicates, Nylon (e.g., second layer) and LDPE (e.g., first layer), when tested individually, shown very high VHP permeation. However, when combined together in the multi-layered material according to embodiments shown herein, the combined material shown surprising and unexpected results of very low VHP permeation. Furthermore, 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.

Table 2

Note: the minimum detect level is 0.05 ppm

As shown in Table 2, when the second layer is facing the VHP rich environment, the VHP levels are significantly lower. Thus, the orientation of the layers of the multi-layer material in facing the VHP rich environment is significant.

Note 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 activities are listed is not necessarily the order in which they are performed.

Benefits, other advantages, and solutions to problems have been described above with regard to specific embodiments. However, the benefits, advantages, solutions to problems, and any feature(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature of any or all the claims.

The specification and illustrations of the embodiments described herein are intended to provide a general understanding of the structure of the various embodiments. The specification and illustrations are not intended to serve as an exhaustive and comprehensive description of all of the elements and features of apparatus and systems that use the structures or methods described herein. Separate 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. Further, reference to values stated in ranges includes each and every value within that range. Many other embodiments may be apparent to skilled artisans only after reading this specification. Other embodiments may be used and derived from the disclosure, such that a structural substitution, logical substitution, or another change may be made without departing from the scope of the disclosure. Accordingly, the disclosure is to be regarded as illustrative rather than restrictive. Note 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 activities are listed are not necessarily the order in which they are performed. Benefits, other advantages, and solutions to problems have been described above with regard to specific embodiments. However, the benefits, advantages, solutions to problems, and any feature(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature of any or all the claims. After reading the specification, skilled artisans will appreciate that certain features are, for clarity, described herein in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any subcombination. Further, references to values stated in ranges include each and every value within that range.