Packaging bag and method of making and using the same

Abstract

The present application is directed to a packaging bag including: a first bag element including a first multilayer composition defining a first void; and a second bag element including a second multilayer composition defining a second void, where a first layer of the first multilayer composition is bonded to a first layer of the second multilayer composition, where the second void is located entirely within the first void.

Description

PACKAGING BAG AND METHOD OF MAKING AND USING THE SAMEFIELD OF THE DISCLOSURE

[0001] The present disclosure relates to a packaging bag, and more particularly to, a packaging bag for use in a sterilized environment.RELATED ART

[0002] Packaging bags are used for packaging many products shipped and sold. In some cases, packaging bags may be used to house products (e.g. biological agents) in clean room or sterilized conditions, such as medical, biological, or pharmaceutical laboratories (e.g. isolators). In some cases, these packaging bags must be sterilized themselves to avoid contamination of the packaging bag surroundings as well as the contents (e.g. products) of the packaging bag itself. In certain cases, vaporized hydrogen peroxide (VHP) sterilization is required such that VHP resistant packaging is needed to protect these sensitive products. However, these VHP packaging bags may be difficult to sterilize and handle in laboratory settings. Conventionally, packaging bags must be kept out during the isolator sterilization process as the materials of the packaging bags allowed VHP contamination of the products within. Therefore, improvements in packaging bags are needed, particularly in enabling packaging bags to achieve optimal VHP resistance while allowing improved ease of use for the products the packaging bags contain in isolator environments.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] Embodiments are illustrated by way of example and are not limited in the accompanying figures.

[0004] FIG. 1A illustrates a front perspective view of a packaging bag according to a number of embodiments of the present disclosure.

[0005] FIG. IB illustrates a front perspective of a packaging bag according to a number of embodiments of the present disclosure.

[0006] FIG. 1C illustrates a front view of a packaging bag according to a number of embodiments of the present disclosure.

[0007] FIG. ID illustrates a front view of a packaging bag according to a number of embodiments of the present disclosure.

[0008] FIG. IE illustrates a front view of a packaging bag according to a number of embodiments of the present disclosure.

[0009] FIG. 2A illustrates a side view of the first multilayer composition of the first bag element of the packaging bag according to a number of embodiments of the present disclosure.

[0010] FIG. 2B illustrates a side view of the first multilayer composition of the first bag element of the packaging bag according to a number of embodiments of the present disclosure.

[0011] FIG. 3 A illustrates a side view of the second multilayer composition of the second bag element of the packaging bag according to a number of embodiments of the present disclosure.

[0012] FIG. 3B illustrates a side view of the second multilayer composition of the second bag element of the packaging bag according to a number of embodiments of the present disclosure.

[0013] 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

[0014] 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.

[0015] 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).

[0016] 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 theinvention. 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.

[0017] 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 bag arts.

[0018] The following disclosure describes packaging bags adapted to achieve substantial seal engagement to the container to ensure an adequate seal in assembling a packaging bag and container. The concepts are better understood in view of the embodiments described below that illustrate and do not limit the scope of the present invention.

[0019] For purposes of illustration, FIG. 1 A illustrates a front perspective view of a packaging bag according to a number of embodiments of the present disclosure. For purposes of illustration, FIG. IB illustrates a front perspective view of a packaging bag according to a number of embodiments of the present disclosure. For purposes of illustration, FIG. 1C illustrates a front view of a packaging bag according to a number of embodiments of the present disclosure. For purposes of illustration, FIG. ID illustrates a front view of a packaging bag according to a number of embodiments of the present disclosure. For purposes of illustration, FIG. IE illustrates a front view of a packaging bag according to a number of embodiments of the present disclosure. As best illustrated in FIGs. 1A-1E, the packaging bag 100 may include a first axial end 102, a first side end 104, a second side end 106, and a second axial end 108. The packaging bag 100 may include a first face (or front face) 111 and a second face (orback face) 113 opposite the first face 100. As shown in FIGs. 1A-1E, the packaging bag 100 may include a first bag element 120 having a first multilayer composition defining a first void 127 or internal cavity. The packaging bag 100 may further include a second bag element 160 having a second multilayer composition defining a second void 167 or internal cavity. In a number of embodiments, as described in further detail below, a first layer of the first multilayer compositionmay be bonded to a first layer of the second multilayer composition, where the second void 167 may be located entirely within the first void 127. In an embodiment, the first bag element 120 may include the first axial end 102, the first side end 104, the second side end 106, the second axial end 108, the first face (or front face) 110 and the second face (or back face) 113 of the packaging bag 100.

[0020] In a number of embodiments, the first face 111 of the packaging bag 100 (or first bag element 120) may be generally flat. In a number of embodiments, the first face 111 of the packaging bag 100 (or first bag element 120) may be generally polygonal cross-section (e.g. rectangular). In a number of variations, the first face 111 of the packaging bag 100 (or first bag element 120) may have a polygonal, oval, circular, semi-circular, or substantially circular crosssection. In a number of embodiments, the second face 113 of the packaging bag 100 (or first bag element 120) may be generally flat. In a number of embodiments, the second face 113 of the packaging bag 100 (or first bag element 120) may be generally polygonal cross-section (e.g. rectangular). In a number of variations, the second face 113 of the packaging bag 100 (or first bag element 120) may have a polygonal, oval, circular, semi-circular, or substantially circular cross-section.

[0021] In a number of embodiments, the packaging bag 100 (or first bag element 120) may have a width WPB. For purposes of embodiments described herein and as shown best in FIG. IB, the width WPB of the packaging bag 100 is the distance from the first side end 104 to the second side end 106. According to certain embodiment, the width WPB of the packaging bag 100 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 WPB of the packaging bag 100 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 WPB of the packaging bag 100 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the width WPB of the packaging bag 100 may be any value between any of the minimum and maximum values noted above.

[0022] In a number of embodiments, the packaging bag 100 (or first bag element 120) can have a length LPB. For purposes of embodiments described herein and as shown in FIG. IB, the length LPB of the packaging bag 100 (or first bag element 120) is the distance from the first axialend 102 to the second axial end 108. According to certain embodiment, the length LPB of the packaging bag 100 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 PB of the packaging bag 100 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 LPB of the packaging bag 100 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the length LPB of the packaging bag 100 may be any value between any of the minimum and maximum values noted above.

[0023] In a number of embodiments, the packaging bag 100 (or first bag element 120) can have a void 127 creating an internal volume (or first volume), VF. For purposes of embodiments described herein and as shown best in FIG. IB, the first volume, VF, of the packaging bag 100 (or first bag element 120) may be at least about 0.1 L, such as, at least about 0.5 L or at least about 1 L or at least about 2 L or at least about 5 L, or even at least about 10 L. According to still other embodiments, the first volume, VF, of the packaging bag 100 (or first bag element 120) may be not greater than about 150 L, such as, not greater than about 100 L, not greater than about 50 L or even not greater than about 25 L. It will be appreciated that the first volume, VF, of the packaging bag 100 (or first bag element 120) may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the first volume, VF, of the packaging bag 100 (or first bag element 120) may be any value between any of the minimum and maximum values noted above.

[0024] In an embodiment, as shown best in FIG. ID, the second bag element 160 may include a first axial end 162, a first side end 164, a second side end 166, a second axial end 168, a first face (or front face) 161 and a second face (or back face) 163. In a number of embodiments, the first face 161 of the second bag element 160 may be generally flat. In a number of embodiments, the first face 161 of the second bag element 160 may be generally polygonal cross-section (e.g. rectangular). In a number of variations, the first face 161 of the second bag element 160 may have a polygonal, oval, circular, semi-circular, or substantially circular cross-section. In a number of embodiments, the second face 163 of the second bag element 160 may be generally flat. In a number of embodiments, the second face 163 of the second bag element 160 may be generally polygonal cross-section (e.g. rectangular). In a number of variations, the second facesubstantially circular cross-section.

[0025] Alternatively, in an embodiment, as shown best in FIGs. 1 A-1B, the second bag element160 may include a first axial end 162, a first side end 164, a second side end 166, a second axial end 168, a first face (or front face) 161, a second face (or back face) 163, a first side face 165, a second side face 168, and a bottom face 169. In a number of embodiments, the first face 161 of the second bag element 160 may be generally flat. In a number of embodiments, the first face161 of the second bag element 160 may be generally polygonal cross-section (e.g. rectangular). In a number of variations, the first face 161 of the second bag element 160 may have a polygonal, oval, circular, semi-circular, or substantially circular cross-section. In a number of embodiments, the second face 163 of the second bag element 160 may be generally flat. In a number of embodiments, the second face 163 of the second bag element 160 may be generally polygonal cross-section (e.g. rectangular). In a number of variations, the second face 163 of the second bag element 160 may have a polygonal, oval, circular, semi-circular, or substantially circular cross-section. In a number of embodiments, the first side face 165 of the second bag element 160 may be generally flat. In a number of embodiments, the first side face 165 of the second bag element 160 may be generally polygonal cross-section (e.g. rectangular). In a number of variations, the first side face 165 of the second bag element 160 may have a polygonal, oval, circular, semi-circular, or substantially circular cross-section. In a number of embodiments, the second side face 168 of the second bag element 160 may be generally flat. In a number of embodiments, the second side face 168 of the second bag element 160 may be generally polygonal cross-section (e.g. rectangular). In a number of variations, the second side face 168 of the second bag element 160 may have a polygonal, oval, circular, semi-circular, or substantially circular cross-section. In a number of embodiments, the bottom face 165 of the second bag element 160 may be generally flat. In a number of embodiments, the bottom face 165 of the second bag element 160 may be generally polygonal cross-section (e.g. rectangular). In a number of variations, the bottom face 165 of the second bag element 160 may have a polygonal, oval, circular, semi-circular, or substantially circular cross-section.

[0026] In a number of embodiments, the second bag element 160 may have a width WSB. For purposes of embodiments described herein and as shown best in FIG. IB, the width WSB of the second bag element 160 is the distance from the first side end 164 to the second side end 166.According to certain embodiment, the width WSB of the second bag element 160 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 WSB of the second bag element 160 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 WSB of the second bag element 160 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the width WSB of the second bag element 160 may be any value between any of the minimum and maximum values noted above.

[0027] In a number of embodiments, the second bag element 160 can have a length LSB. For purposes of embodiments described herein and as shown best in FIG. IB, the length LSB of the second bag element 160 is the distance from the first axial end 162 to the second axial end 168. According to certain embodiment, the length LSB of the second bag element 160 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 LSB of the second bag element 160 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 LSB of the second bag element 160 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the length LSB of the second bag element 160 may be any value between any of the minimum and maximum values noted above.

[0028] In a number of embodiments, the second bag element 160 can have a void 167 creating an internal volume (or second volume), Vs. For purposes of embodiments described herein and as shown best in FIG. IB, the second volume, Vs, of the second bag element 160 may be at least about 0.1 L, such as, at least about 0.5 L or at least about 1 L or at least about 2 L or at least about 5 L, or even at least about 10 L. According to still other embodiments, the second volume, Vs, of the second bag element 160 may be not greater than about 100 L, such as, not greater than about 50 L or even not greater than about 25 L. It will be appreciated that the second volume, Vs, of the second bag element 160 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the second volume, Vs, of thesecond bag element 160 may be any value between any of the minimum and maximum values noted above.

[0029] In some embodiments, as shown best in FIG. IB, the packaging system 100 may be configured to contain a product 130 and form a packaging assembly. The product may be medical, biological, or pharmaceutical device. In specific embodiments, the packaging system may contain a product type for biopharma / life sciences that are designed for a single use. In a number of embodiments, as shown best in FIG. 1A, the product 130 may be commensurate with the second bag element 160. In a number of embodiments, as shown best in FIG. IB, the product 130 may be disposed within the second bag element 160. In a number of embodiments, the product 130 may include a biomedia fluid for use in medical, biological, or pharmaceutical applications. In a number of embodiments, the product 130 may include a biological agent. In a number of embodiments, the product 130 may include a fluid. In a number of embodiments, the product 130 may include a fluid for use in medical, biological, or pharmaceutical applications. In a number of embodiments, the product 130 may include a biomedia fluid for use in medical, biological, or pharmaceutical applications.

[0030] In a number of embodiments, as shown in FIGs. 1A-1E, the second bag element 160 may include at least one port 180. In a number of embodiments, the at least one port 180 may include a plurality of ports 180, 180’. In a number of embodiments the at least one port 180 may allow the product 130 to be moved within the second bag element 160. In a number of embodiments the at least one port 180 may be adapted for dispensing the product 130. In a number of embodiments, as shown best in FIGs. 1A-1B, the at least one port 180 may include tubing 182. In a number of embodiments, as shown best in FIGs. 1A-1D, the at least one port 180 may include at least one nozzle or needle 184 for dispensing the product 130 outside of the second bag element 160. In a number of embodiments, as shown best in FIGs. 1A-1C, the at least one port 180 may include a plurality of nozzles or needles 184, 184’ for dispensing the product 130 outside of the second bag element 160. In a number of embodiments, as shown best in FIGs. 1A-1B, the at least one port 180 may include a filter 186 for filtering the product 130. In a number of embodiments, as shown best in FIGs. 1D-1E, the at least one of the second bag element 160 or at least one port 180 may include a vent 188 to vent to an environment outside of the second bag element 160. In a number of embodiments, as shown best in FIGs. 1C-1E, the at least one of the second bag element 160 or at least one port 180 may include a sensor 189 todetect changes of the product 130 within the second bag element 160. It is contemplated herein that sensor 189 can measure luminescence, fluorescence, incandescence, a change in temperature, a change in pressure, a change in viscosity, a change in flowrate, or any other suitable changing characteristic in the product 130.

[0031] In a number of embodiments, as shown in FIGs. 1 A-1E, the second bag element 160 may include an inlet 175 for depositing the product 130 within the second bag element 160. In a number of embodiments, as shown in FIG. 1 A, the second bag element 160 may include an inlet 175 on the first face 161 of the second bag element 160. In a number of embodiments, as shown in FIG. IB, the second bag element 160 may include an inlet 175 on the first side end 164 of the second bag element 160. In a number of embodiments, as shown in FIG. 1C, the second bag element 160 may include an inlet 175 on the port 180 of the second bag element 160. In a number of embodiments, the inlet 175 may include a bore, spigot, nozzle, or any known variation for feeding product 130 into a bag as known conventionally in the art.

[0032] In a number of embodiments, as shown in FIGs. 1 A-1E, the packaging bag 100 may include a handle portion 140. In a number of embodiments, the handle portion 140 may be adapted to be held for handling and / or positioning the packaging bag by a user. In a number of embodiments, the handle portion 140 may include at least one void 142 adapted to allow for grasping the packaging bag 100 by a user. In a number of embodiments, as shown best in FIG. ID, the handle portion 140 may include a plurality of voids 142, 142’ adapted to allow for grasping the packaging bag 100 by a user. In a number of embodiments, the handle portion 140 may include the first multilayer composition of the first bag element 120. In a number of embodiments, the handle portion 140 may consist entirely of the first multilayer composition of the first bag element 120.

[0033] In a number of embodiments, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) can be formed of a material including a polymer. In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) 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 thermoplasticvulcanizate, an olefin-based co-polymer, an olefin-based ter-polymer, a polyolefin plastomer, or combinations thereof. In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may include a styrene based block copolymer such as styrenebutadiene, 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.

[0034] In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) 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 Tafimer™, 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, Mitusi 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 packaging bag 100, the first multilayercomposition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may include, but are not limited to, thermoplastic, thermosets, fluropolymers, and combinations thereof. Specific examples of suitable polymer material can be polyvinyldiene fluoride (PVDF). In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) can be formed of a thermoplastic elastomer, silicone, or combinations thereof.

[0035] In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may include a fluorinated polymer. In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may include a polymer including at least one of ethylene-tetrafluoroethylene, tetrafluoro-ethylene-perfluoro (methyl vinyl ether), polyvinylidene fluoride, ethylene-chlorotrifluoroethylene, polyimide, polyamidimide, polyphenylene sulfide, polyethersulfone, polyphenylene sulfone, liquid crystal polymers, polyetherketone, polyether ether ketones, aromatic polyesters (Ekonol), of polyether-ether-ketone, polyetherketone, liquid crystal polymer, polyamide, polyethylene / UHMPE, polypropylene, 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-norbomene copolymers, polymethylpentene and ethylene acyrilic acid copoloymer, mixtures, copolymers and any combination thereof.

[0036] Further, in an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) can include one or more additives. For example, the one or more additives can include a plasticizer, an adhesive, 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.

[0037] The adhesive may include any known adhesive material common to the fastener arts including, but not limited to, fluoropolymers, epoxy resins, polyimide resins, polyether / polyamide copolymers, ethylene vinyl acetates, ethylene tetrafluoroethylene (ETFE), ETFE copolymer, perfluoroalkoxy (PF A), or any combination thereof. Additionally, the adhesive can include at least one functional group selected from -C=O, -C-O-R, -COH, -COOH, -COOR, -CF2=CF-OR, or any combination thereof, where R is a cyclic or linear organic group containing between 1 and 20 carbon atoms. Additionally, the adhesive can include a copolymer. In an embodiment, the hot melt adhesive can have a melting temperature of not greater than 250°C, such as not greater than 220°C. In another embodiment, the adhesive may break down above 200°C, such as above 220°C. In further embodiments, the melting temperature of the hot melt adhesive can be higher than 250°C or even higher than 300°C.

[0038] In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) can be formed as a single piece or may be formed as multiple pieces. In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) can be a molded component. In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) 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 packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) 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.

[0039] For purposes of illustration, FIG. 2A illustrates a side view of a multi-layered material of the first multilayer composition according to a number of embodiments of the present disclosure. In a number of embodiments, the first multilayer composition 200, or any layers thereof, may be a laminated film. In a number of embodiments, the first multilayer composition 200, or any layers thereof, may be a fluid gel. In a number of embodiments, the first multilayer composition 200, or any layers thereof, may be made of solid film or nonwoven material. In one or a plurality of embodiments, the first multilayer composition 200 may include a first layer 210 and a second layer 220. In a number of embodiments, the first layer 210 may be provided on the interior surface of the first multilayer composition 200 and be the interior layer. In a number of embodiments, the second layer 220 may be provided on the interior surface of the first multilayer composition 200 such that the first layer 210 is the exterior layer. In a number of embodiments, the first layer 210 may include a first composition including a bondable polymer, such as a polyolefin, fluoropolymer, or copolymer thereof. In a number of embodiments, the first layer 210 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 220 may include a second composition including polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof. In a number of embodiments, the second layer 220 may include a second composition including at least one of nylon or ethylene vinyl alcohol. In a number of embodiments, the first layer 210 may be bonded to the second layer 220. 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.), welding, laser sealing, heat sealing, an adhesive layer, a primer, a combined process thereof, or through another method.

[0040] In a number of embodiments, the first multilayer composition 200 may have a thickness TFMC. For purposes of embodiments described herein and as shown in FIG. 2A, the thickness TFMC of the first multilayer composition 200 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 TFMC of the first multilayer composition 200 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 TFMC of the first multilayer composition 200 may be within a range between any of the minimum andmaximum values noted above. It will be further appreciated that the thickness TFMC of the first multilayer composition 200 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness TFMC of the first multilayer composition 200 may be at least 0.1 mm and no greater than 15 mm.

[0041] In a number of embodiments, the first layer 210 of the first multilayer composition 200 may have a thickness TFLI. For purposes of embodiments described herein and as shown in FIG. 2A, the thickness TFLI of the first layer 210 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 TFLI of the first layer 210 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 TFLI of the first layer 210 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness TFLI of the first layer 210 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness TFLI of the first layer 210 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.

[0042] In a number of embodiments, the second layer 220 of the first multilayer composition 200 may have a thickness TSLL For purposes of embodiments described herein and as shown in FIG. 2A, the thickness TSLI of the second layer 220 may be at least about .001 mm, such as, at least about .005, 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 TSLI of the second layer 220 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 TSLI of the second layer 220 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness TSLI of the second layer 220 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness TSLI of the second layer 220 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.

[0043] For purposes of illustration, FIG. 2B 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 first multilayer composition 200, or any layers thereof, may be a laminated multi-layer film. In a number of embodiments, the first multilayer composition 200, or any layers thereof, may be a fluid gel. In a number of embodiments, the first multilayer composition 200, or any layers thereof, may be made of solid film or nonwoven material. In one or a plurality of embodiments, the first multilayer composition 200 includes a first layer 210, a second layer 220, and a third layer 230 as shown in FIG. 2B. In one or a plurality of embodiments, the first multilayer composition 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 at least one of nylon or ethylene vinyl alcohol. In a number of embodiments, the third layer 230 may be bonded to at least one of the first layer 210 or the second layer 220. 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.), welding, laser sealing, heat sealing, an adhesive layer, a primer, a combined process thereof, or through another method.

[0044] In a number of embodiments, the third layer 230 of the first multilayer composition 200 may have a thickness TTLI. For purposes of embodiments described herein and as shown in FIG. 2B, the thickness TTLI of the third layer 230 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 TTLI 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 TTLI 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 TTLI 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 TTLI 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 are still contemplated within the scope of the invention. The intervening layers can include any of the materials listed herein. In certain embodiments, intervening layers may bond or glue any of the layers together using adhesives conventionally known in the art. Further, it is contemplated herein that the order of the layering between the first layer 210, thesecond layer 220, and the optional third layer 230 may be rearranged in any pattern and still be within the scope of the invention.

[0045] For purposes of illustration, FIG. 3A illustrates a side view of a multi-layered material of the second multilayer composition according to a number of embodiments of the present disclosure. In a number of embodiments, the second multilayer composition 300, or any layers thereof, may be a laminated film. In a number of embodiments, the second multilayer composition 300, or any layers thereof, may be a fluid gel. In a number of embodiments, the second multilayer composition 300, or any layers thereof, may be made of solid film or nonwoven material. In one or a plurality of embodiments, the second multilayer composition 300 may include a first layer 310 and a second layer 320. In a number of embodiments, the first layer 310 may be provided on the interior surface of the second multilayer composition 300 and be the interior layer. In a number of embodiments, the second layer 320 may be provided on the interior surface of the second multilayer composition 300 such that the first layer 310 is the exterior layer. In a number of embodiments, the first layer 310 may include a first composition including a bondable polymer, such as a polyolefin, fluoropolymer, or copolymer thereof. In a number of embodiments, the first layer 310 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 320 may include a second composition including polyamide, polyimide, polyurethane, polyester, siloxane, or copolymer thereof. In a number of embodiments, the second layer 320 may include a second composition including at least one of nylon or ethylene vinyl alcohol. In a number of embodiments, the first layer 310 may be bonded to the second layer 320. 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.), welding, laser sealing, heat sealing, an adhesive layer, a primer, a combined process thereof, or through another method.

[0046] In a number of embodiments, the second multilayer composition 300 may have a thickness TSMC. For purposes of embodiments described herein and as shown in FIG. 3A, the thickness TSMC of the second multilayer composition 300 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 TSMC of the second multilayercomposition 300 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 TSMC of the second multilayer composition 300 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness TSMC of the second multilayer composition 300 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness TS C of the second multilayer composition 300 may be at least 0.1 mm and no greater than 15 mm.

[0047] In a number of embodiments, the first layer 310 of the second multilayer composition 300 may have a thickness TFL2. For purposes of embodiments described herein and as shown in FIG. 3A, the thickness TFL2 of the first layer 310 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.

[0048] According to still other embodiments, the thickness TFL2 of the first layer 310 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 TFL2 of the first layer 310 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness TFL2 of the first layer 310 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness TFL2 of the first layer 310 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.

[0049] In a number of embodiments, the second layer 320 of the second multilayer composition 300 may have a thickness TSL2. For purposes of embodiments described herein and as shown in FIG. 3A, the thickness TSL2 of the second layer 320 may be at least about .001 mm, such as, at least about .005, 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 TSL2 of the second layer 320 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 TSL2 of the second layer 320 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness TSL2 of the second layer 320 may be any value between any of the minimum and maximum values noted above. In a number ofembodiments, the thickness TSL2 of the second layer 320 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.

[0050] For purposes of illustration, FIG. 3B 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 second multilayer composition 300, or any layers thereof, may be a laminated multi-layer film. In a number of embodiments, the second multilayer composition 300, or any layers thereof, may be a fluid gel. In a number of embodiments, the second multilayer composition 300, or any layers thereof, may be made of solid film or nonwoven material. In one or a plurality of embodiments, the second multilayer composition 300 includes a first layer 310, a second layer 320, and a third layer 330 as shown in FIG. 3B. In one or a plurality of embodiments, the second multilayer composition 300 may include a third layer 330 provided between the first layer 320 and the second layer 310. The third layer 330 may include a third composition including at least one of nylon or ethylene vinyl alcohol. In a number of embodiments, the third layer 330 may be bonded to at least one of the first layer 310 or the second layer 320. 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.), welding, laser sealing, heat sealing, an adhesive layer, a primer, a combined process thereof, or through another method.

[0051] In a number of embodiments, the third layer 330 of the second multilayer composition 300 may have a thickness TTL2. For purposes of embodiments described herein and as shown in FIG. 3B, the thickness TTL2 of the third layer 330 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 TTL2 of the third layer 330 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 TTL2 of the third layer 330 may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the thickness TTL2 of the third layer 330 may be any value between any of the minimum and maximum values noted above. In a number of embodiments, the thickness TTL2 of the third layer 330 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 are still contemplated within the scope of the invention. The interveninglayers can include any of the materials listed herein. In certain embodiments, intervening layers may bond or glue any of the layers together using adhesives conventionally known in the art. Further, it is contemplated herein that the order of the layering between the first layer 310, the second layer 320, and the optional third layer 330 may be rearranged in any pattern and still be within the scope of the invention.

[0052] In a number of embodiments, the first multilayer composition 200 may be bonded to the second multilayer composition 300 to form the packaging bag 100. In a number of embodiments, the first layer 210 of the first multilayer composition 200 may be bonded to the first layer 310 of the second multilayer composition 300. In a number of embodiments, the first layer 210 of the first multilayer composition 200 (where the first layer 210 an exterior layer) may be bonded to the first layer 310 of the second multilayer composition 300 (where the first layer 310 an interior layer). In a number of embodiments, the first layer 210 of the first multilayer composition 200 (where the first layer 210 an interior layer) may be bonded to the first layer 310 of the second multilayer composition 300 (where the first layer 310 an exterior layer). In a number of embodiments, the first layer 210 of the first multilayer composition 200 may be bonded to the first layer 310 of the second multilayer composition 300 by lamination, adhesion force, a co-extrusion process, a surface activation process (corona treatment, flame treatment, chemical etch, photo activation etc.), welding, laser sealing, heat sealing, an adhesive layer, a primer, a combined process thereof, or through another method.

[0053] Referring back to Figs. 1 A-1E, in a number of embodiments, the first layer of the first multilayer composition may be bonded to the first layer of the second multilayer composition at at least one bond point 190 to bond the second bag element 160 to the first bag element 120 to form the packaging bag 100. In a number of embodiments, , the first layer of the first multilayer composition may be bonded to the first layer of the second multilayer composition at a plurality of bond points 190, 190’ to bond the second bag element 160 to the first bag element 120 to form the packaging bag 100. In a number of embodiments, the bond point 190 may run at least a part of the width, WSB, or the length, LSB, of the second bag element 160. In a number of embodiments, the bond point 190 may run the entirety of the width, WSB, or the length, LSB, of the second bag element 160. In a number of embodiments, the bond point 190 may run at least a part of the width, WPB, or the length, LPB, of the first bag element 120. In a number of embodiments, the bond point 190 may run the entirety of the width, WPB, or the length, LPB, ofthe first bag element 120. In a number of embodiments, as shown in FIGs. 1A-1C, the handle portion 140 may include at least a part of the bond point 190 forming the bond between the first layer of the first multilayer composition and the first layer of the second multilayer composition. Alternatively, in a number of embodiments, the handle portion 140 may not include at least a part of the bond point 190 forming the bond between the first layer of the first multilayer composition and the first layer of the second multilayer composition.

[0054] In a number of embodiments, any of the layers on the first multilayer composition 200 or second multilayer composition 300 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 first multilayer composition 200 or second multilayer composition 300, as described above, may be laminated together such that they at least partially overlap one another. Any of the layers on the first multilayer composition 200 or second multilayer composition 300 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, the first multilayer composition 200 or second multilayer composition 300 may be applied by a roll-to-roll coating process, including for example, extrusion coating. The first multilayer composition 200 or second multilayer composition 300 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 of the first multilayer composition 200 or second multilayer composition 300 to form the packaging bag 100.

[0055] In an embodiment, the polymer or polymeric blend of at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may be formed into a single layer article, a multilayer article, or can be laminated, coated, or formed on a substrate to form at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160). 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 thepackaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) .

[0056] In an embodiment the polymer or polymeric blend of the packaging bag, the first multilayer composition or the second multilayer composition can advantageously withstand 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 packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) is formed. Exemplary sterilization methods include radiation (such as X-ray radiation), electron ray, E-beam or electron beam sterilization 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 packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may be gamma sterilized at between about 25 kGy to about 50 kGy.

[0057] In a number of embodiments, the packaging bag may be vaporized hydrogen peroxide (VHP) resistant. The packaging bag may be VHP resistant at a level of less than 1,000 ppm, such as less than 500 ppm, such as less than 250 ppm, such as less than 100 ppm, such as less than 50 ppm, such as less than 25 ppm, such as less than 10 ppm, such as less than 5 ppm, such as less than 2 ppm, or such as less than 1 ppm. It will be appreciated that the VHP resistance may be within a range between any of the minimum and maximum values noted above. It will be further appreciated that the VHP resistance may be any value between any of the minimum and maximum values noted above.

[0058] In embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may have further desirable physical and mechanical properties. For instance, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may appear transparent or at least translucent. For instance, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may have a light transmission greater than about 2%, or greater than about 5% in the visiblelight wavelength range. In particular, the resulting articles have desirable clarity or translucency. In addition, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) 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.

[0059] In an embodiment, at least one of the packaging bag 100, the first multilayer composition (of the first bag element 120), or the second multilayer composition (of the second bag element 160) may have desirable heat stability properties. Applications for the polymer or polymeric blend are numerous. In particular, the polymer or polymeric blend may be 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.

[0060] In particular embodiments, packaging bag may be openable, tom, or peeled to form an “open position” from a “closed position” In particular embodiments, packaging bag 100 may be tearable or peelable to form an open position upon application of force of no greater than about 10 Ibf, no greater than about 5 Ibf, no greater than about 2.5 Ibf, no greater than about 2 Ibf, or no greater than about 1 Ibf. The packaging bag 100 bag may be torn or peeled at the interface between the first bag element 120 and the second bag element 160, at a location along the first bag element 120 only, or at a location along the second bag element 160 only. In particularembodiments, the packaging bag may require a sharp to cut the first bag element 120 and the second bag element 160.

[0061] A method may be used for forming a packaging bag according to a number of embodiments. The method may include a first step including providing a first bag element including a first multilayer composition. The method may include a second step of providing a second bag element including a second multilayer composition. The method may include a third step of bonding a first layer of the first multilayer composition to a first layer of the second multilayer composition, where the second void may be located entirely within the first void to form a packaging bag. The method may include a fourth step of sterilizing the packaging bag such that the packaging bag is VHP resistant such that hydrogen peroxide concentration on an interior of the packaging bag is less than 1 ppm. Optionally, the method may include a step of disposing a product within the packaging bag (either within the first void or the second void) bonding the second multilayer composition to the first multilayer composition to form a packaging assembly.

[0062] Use of the packaging bag 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 packaging bags according to embodiments herein may provide a sealing mechanism for housing a product meant for sterilization, such as a medical device, pharmaceutical product, or biological product. Further, the use of packaging bags according to embodiments herein may provide a VHP resistant container, which can be placed in an isolator before starting VHP sterilization, allowing for improved ease of use in difficult environments, such as operating rooms, hospitals, or pharmacies. Further, after the VHP sterilization of the isolator, packaging bags according to embodiments herein may allow for easy removal of the product via opening the first packaging bag and manipulating the second packaging bag, significantly reducing required handling inside the isolator and allow for faster use of the product.

[0063] 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.

[0064] Embodiment 1 : A packaging bag, comprising: a first bag element comprising a first multilayer composition defining a first void; and a second bag element comprising a second multilayer composition defining a second void, wherein a first layer of the first multilayer composition is bonded to a first layer of the second multilayer composition, wherein the second void is located entirely within the first void.

[0065] Embodiment 2: A packaging assembly comprising: a product; and a packaging bag enclosing the product to provide a sterilize-able packaging assembly, wherein the packing bag comprises: a first bag element comprising a first multilayer composition defining a first void; and a second bag element comprising a second multilayer composition defining a second void, wherein a first layer of the first multilayer composition is bonded to a first layer of the second multilayer composition, wherein the second void is located entirely within the first void.

[0066] Embodiment 3: A method for forming a packaging bag, comprising: providing a first bag element comprising a first multilayer composition defining a first void; providing a second bag element comprising a second film multi-layer composition defining a second void; and bonding a first layer of the first multilayer composition to a first layer of the second multilayer composition, wherein the second void is located entirely within the first void to form a packaging bag.

[0067] Embodiment 4: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the packaging bag is VHP resistant such that hydrogen peroxide concentration on an interior of the packaging bag is less than 1 ppm.

[0068] Embodiment 5: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the first layer of the first multilayer composition comprises a bondable polymer comprising polyethylene.

[0069] Embodiment 6: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the first layer of the second multilayer composition comprises a bondable polymer comprising polyethylene.

[0070] Embodiment 7: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein first multilayer composition further comprises a second layer comprising at least one of nylon or ethylene vinyl alcohol.

[0071] Embodiment 8: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein first multilayer composition further comprises a third layer comprising at least one of nylon or ethylene vinyl alcohol.

[0072] Embodiment 9: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the first layer is an interior layer of the first multilayer composition.

[0073] Embodiment 10: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the first layer is an exterior layer of the first multilayer composition.

[0074] Embodiment 11 : The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein second multilayer composition further comprises a second layer comprising at least one of nylon or ethylene vinyl alcohol.

[0075] Embodiment 12: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein second multilayer composition further comprises a third layer comprising at least one of nylon or ethylene vinyl alcohol.

[0076] Embodiment 13: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the first layer is an exterior layer of the second multilayer composition.

[0077] Embodiment 14: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the first layer is an interior layer of the second multilayer composition.

[0078] Embodiment 15: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein first multilayer composition is a laminated film.

[0079] Embodiment 16: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein second multilayer composition is a laminated film.

[0080] Embodiment 17: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the packaging bag further comprises a handle portion.

[0081] Embodiment 18: The packaging bag, packaging assembly, or method of embodiment 17, wherein the handle portion comprises at least a part of the bond between the first layer of the first multilayer composition and the first layer of the second multilayer composition.

[0082] Embodiment 19: The packaging bag, packaging assembly, or method of embodiment 17, wherein the handle portion does not include at least a part of the bond between the first layer of the first multilayer composition and the first layer of the second multilayer composition.

[0083] Embodiment 20: The packaging bag, packaging assembly, or method of any of embodiments 17-19, wherein the handle portion comprises a void for handling and / or positioning the packaging bag by a user.

[0084] Embodiment 21 : The packaging bag, packaging assembly, or method of any of embodiments 17-20, wherein the handle portion comprises of the first multilayer composition.

[0085] Embodiment 22: The packaging bag, packaging assembly, or method of any of embodiments 17-21, wherein the handle portion consists of the first multilayer composition.

[0086] Embodiment 23 : The packaging bag, packaging assembly, or method of any of embodiments 2-22, wherein the product is a medical or biopharmaceutical device.

[0087] Embodiment 24: The packaging bag, packaging assembly, or method of any of embodiments 2-23, wherein the product is commensurate with the second bag element.

[0088] Embodiment 25: The packaging bag, packaging assembly, or method of any of embodiments 2-24, wherein the second bag element comprises at least one port adapted for dispensing a fluid.

[0089] Embodiment 26: The packaging bag, packaging assembly, or method of embodiment 25, wherein the at least one port comprises a plurality of ports.

[0090] Embodiment 27: The packaging bag, packaging assembly, or method of any of embodiments 25-26, wherein the fluid comprises a biological agent.

[0091] Embodiment 28: The packaging assembly or method of any of embodiments 25-27, wherein the port comprises tubing.

[0092] Embodiment 29: The packaging assembly or method of any of embodiments 25-28, wherein the port comprises a nozzle or a needle.

[0093] Embodiment 30: The packaging assembly or method of any of embodiments 25-29, wherein the port comprises a sensor.

[0094] Embodiment 31 : The packaging assembly or method of any of embodiments 25-30, wherein the port comprises a filter.

[0095] Embodiment 32: The method of any of embodiments 3-31, further comprising disposing a product within the packaging bag before bonding the second multilayer composition to the first multilayer composition.

[0096] Embodiment 33: The method of any of the preceding embodiments 3-32, further comprising sterilizing the packaging bag such that the packaging bag is VHP resistant such that hydrogen peroxide concentration on an interior of the packaging bag is less than 1 ppm

[0097] Embodiment 34: The method of embodiment 33, wherein the sterilization step comprises radiation sterilization.

[0098] Embodiment 35: The method of embodiment 34, wherein the radiation sterilization comprises electron beam sterilization.

[0099] Embodiment 36: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the first bag element is openable, tearable, or peelable upon application of force of no less than 2.5 Ibf

[0100] Embodiment 37: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the first bag element comprises a first axial end, a second axial end, a first side end, and a second side end, wherein the first axial end, the second axial end, the first side end, and the second side end form a front face and a back face.

[0101] Embodiment 38: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein a thickness of the first bag element is at least 0. 1 mm and not greater than 15 mm.

[0102] Embodiment 39: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the second bag element comprises a first axial end, a second axial end, a first side end, and a second side end, wherein the first axial end, the second axial end, the first side end, and the second side end form a front face and a back face.

[0103] Embodiment 40: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the second bag element comprises a first axial end, a second axial end, a first side end, and a second side end, wherein the first axial end, the second axial end, the first side end, and the second side end together form a front face, a back face, a first side face, a second side face, and a bottom face.

[0104] Embodiment 41 : The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein a thickness of the second multilayer composition is at least 0.1 mm and not greater than 15 mm.

[0105] Embodiment 42: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the first void of the first bag element comprises a first volume of between about 0.1 L to about 50 L.

[0106] Embodiment 43 : The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the second void of the second bag element comprises a second volume of between about 0.1 L to about 50 L.

[0107] Embodiment 44: The packaging bag, packaging assembly, or method of any of the preceding embodiments, wherein the bond between the first multilayer composition and the second multilayer composition is accomplished by welding, laser sealing, or heat sealing.

[0108] 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.

[0109] 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.

[0110] 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 astructural 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.

[0111] 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.

[0112] 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.

[0113] 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.

Claims

WHAT IS CLAIMED:

1. A packaging bag, comprising: a first bag element comprising a first multilayer composition defining a first void; and a second bag element comprising a second multilayer composition defining a second void, wherein a first layer of the first multilayer composition is bonded to a first layer of the second multilayer composition, wherein the second void is located entirely within the first void.

2. A packaging assembly comprising: a product; and a packaging bag enclosing the product to provide a sterilize-able packaging assembly, wherein the packing bag comprises: a first bag element comprising a first multilayer composition defining a first void; and a second bag element comprising a second multilayer composition defining a second void, wherein a first layer of the first multilayer composition is bonded to a first layer of the second multilayer composition, wherein the second void is located entirely within the first void.

3. A method for forming a packaging bag, comprising: providing a first bag element comprising a first multilayer composition defining a first void; providing a second bag element comprising a second film multi-layer composition defining a second void; and bonding a first layer of the first multilayer composition to a first layer of the second multilayer composition, wherein the second void is located entirely within the first void to form a packaging bag.

4. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the packaging bag is VHP resistant such that hydrogen peroxide concentration on an interior of the packaging bag is less than 1 ppm5. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the first layer of the first multilayer composition comprises a bondable polymer comprising polyethylene.

6. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the first layer of the second multilayer composition comprises a bondable polymer comprising polyethylene.

7. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein first multilayer composition further comprises a second layer comprising at least one of nylon or ethylene vinyl alcohol.

8. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein first multilayer composition further comprises a third layer comprising at least one of nylon or ethylene vinyl alcohol.

9. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the first layer is an interior layer of the first multilayer composition.

10. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the first layer is an exterior layer of the first multilayer composition.11 . The packaging bag, packaging assembly, or method of any of the preceding claims, wherein second multilayer composition further comprises a second layer comprising at least one of nylon or ethylene vinyl alcohol.

12. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein second multilayer composition further comprises a third layer comprising at least one of nylon or ethylene vinyl alcohol.

13. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the first layer is an exterior layer of the second multilayer composition.

14. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the first layer is an interior layer of the second multilayer composition.

15. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein first multilayer composition is a laminated film.

16. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein second multilayer composition is a laminated film.

17. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the packaging bag further comprises a handle portion.

18. The packaging bag, packaging assembly, or method of claim 17, wherein the handle portion comprises at least a part of the bond between the first layer of the first multilayer composition and the first layer of the second multilayer composition.

19. The packaging bag, packaging assembly, or method of claim 17, wherein the handle portion does not include at least a part of the bond between the first layer of the first multilayer composition and the first layer of the second multilayer composition.

20. The packaging bag, packaging assembly, or method of any of claims 17-19, wherein the handle portion comprises a void for handling and / or positioning the packaging bag by a user.

21. The packaging bag, packaging assembly, or method of any of claims 17-20, wherein the handle portion comprises of the first multilayer composition.

22. The packaging bag, packaging assembly, or method of any of claims 17-21, wherein the handle portion consists of the first multilayer composition.

23. The packaging bag, packaging assembly, or method of any of claims 2-22, wherein the product is a medical or biopharmaceutical device.

24. The packaging bag, packaging assembly, or method of any of claims 2-23, wherein the product is commensurate with the second bag element.

25. The packaging bag, packaging assembly, or method of any of claims 2-24, wherein the second bag element comprises at least one port adapted for dispensing a fluid.

26. The packaging bag, packaging assembly, or method of claim 25, wherein the at least one port comprises a plurality of ports.

27. The packaging bag, packaging assembly, or method of any of claims 25-26, wherein the fluid comprises a biological agent.

28. The packaging assembly or method of any of claims 25-27, wherein the port comprises tubing.

29. The packaging assembly or method of any of claims 25-28, wherein the port comprises a nozzle or a needle.

30. The packaging assembly or method of any of claims 25-29, wherein the port comprises a sensor.

31. The packaging assembly or method of any of claims 25-30, wherein the port comprises a filter.

32. The method of any of claims 3-31, further comprising disposing a product within the packaging bag before bonding the second multilayer composition to the first multilayer composition.

33. The method of any of the preceding claims 3-32, further comprising sterilizing the packaging bag such that the packaging bag is VHP resistant such that hydrogen peroxide concentration on an interior of the packaging bag is less than 1 ppm34. The method of claim 33, wherein the sterilization step comprises radiation sterilization.

35. The method of claim 34, wherein the radiation sterilization comprises electron beam sterilization.

36. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the first bag element is openable, tearable, or peelable upon application of force of no less than 2.5 Ibf37. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the first bag element comprises a first axial end, a second axial end, a first side end, and a second side end, wherein the first axial end, the second axial end, the first side end, and the second side end form a front face and a back face.

38. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein a thickness of the first bag element is at least 0.1 mm and not greater than 15 mm.

39. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the second bag element comprises a first axial end, a second axial end, a first side end, and a second side end, wherein the first axial end, the second axial end, the first side end, and the second side end form a front face and a back face.

40. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the second bag element comprises a first axial end, a second axial end, a first side end, and a second side end, wherein the first axial end, the second axial end, the first side end, and the second side end together form a front face, a back face, a first side face, a second side face, and a bottom face.

41. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein a thickness of the second multilayer composition is at least 0.1 mm and not greater than 15 mm.

42. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the first void of the first bag element comprises a first volume of between about 0.1 L to about 50 L.

43. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the second void of the second bag element comprises a second volume of between about 0.1 L to about 50 L.

44. The packaging bag, packaging assembly, or method of any of the preceding claims, wherein the bond between the first multilayer composition and the second multilayer composition is accomplished by welding, laser sealing, or heat sealing.

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