Six-panel bag

Abstract

A polymeric biocontainer having a polymeric front panel, a polymeric back panel, a polymeric top panel, a polymeric bottom panel, and two polymeric side panels, wherein the front panel, the back panel, the top panel, the bottom panel, and the two side panels have the same length and height dimensions and are bonded together, wherein the front panel, the back panel, the top panel, the bottom panel, and the two side panels are joined to form eight comer joints to create an internal volume.. Methods for forming the polymeric biocontainer are also disclosed.

Description

Attorney Docket No.: P24-031-WO-PCT SIX-PANEL BAG Cross-Reference to Related Applications

[0001] The present application claims the benefit of priority of U.S. Provisional Application. No.63 / 559,982, filed March 1, 2024, the entire content of which is incorporated herein by reference. BACKGROUND Field of the Technology

[0002] Embodiments of the technologies disclosed herein relate to containers. More specifically, the embodiments described herein are six-panel, three-dimensional polymeric bags for the storage, mixing, and / or processing of biological fluids. Description of Related Art

[0003] The use of single use bioreactors, mixing bags, and other biocontainers is growing in the bioprocessing industry. These bioreactors, mixing bags, and biocontainers have replaced stainless tanks in that biological fluids need not contact the steel, which is difficult and expensive to clean and sterilize. These bioreactors, mixing bags, and biocontainers comprise films that contact biological fluids. Therefore, all parts of these single use devices must be harmless to the cells grown or stored therein. Totes and bins for the storage and transportation of liquids and solids such as raw materials, intermediates, and finished goods, are also expensive. The bags are used for processes such as cell culturing and other bioprocessing for the production of desired products, e.g., processing during the inactivation of viruses in plant and animal-based cells.

[0004] Typically, bags and bioreactors comprise expensive custom multi-layer laminates and / or co-extruded polymeric film constructions and are generally bulky. For example, some films used in the production of bags are 0.03cm to 0.06cm in thickness. Some films are between 0.017cm to 0.044cm in thickness. Typically, laminates include four or more film regions (generally between 4 and 10 sheets or film layers). The laminates comprise, at least, an inner sheet having a surface that is in contact with the liquid or solid within the bag and an outer sheet or film. The inner sheet comprises multiple films and comprises a generally inert material having low extractables, such as polyethylene, which is specified for chemical resistance and strength. An outer sheet provides support and some measure of protection to the remaining layers of theAttorney Docket No.: P24-031-WO-PCT biocontainer, which is generally formed of one or more plastic films, such as polyethylene, polypropylene, polyethylene-vinyl acetate (EVA), polyethylene terephthalate (PET), polyamide (nylon), and the like and make further comprise a substrate within or between one or more layers. A barrier sheet is typically disposed between the inner sheet and the outer sheet, which often has one or more gas impermeable films, such as polyethylene vinyl acetate, polyethylene vinyl alcohol (EVOH), and the like. The barrier sheet may be laminated with the first inner sheet or the outer sheet. The gas impermeable film(s) are formed of plastic materials which tend to be crystalline and are, accordingly, brittle and / or susceptible to cracking and crazing. Thicker films have therefore become an industry standard, and, with the foregoing in view, films used to make bags are expensive.

[0005] Past and current bags are formed from diecut panels, comprising the films above, which are welded and / or adhesively joined together to form the bag. Also, bags have different designs and may be formed of different polymeric materials and / or have different or variable thicknesses. For example, cylindrical bags having circular top and bottom panels and a rectangular panel rolled into a cylinder therebetween. Other bags may be rectangular in shape and further comprises panels of film differing sizes and shapes, i.e., some panels are square, some rectangular, some triangular, and some rhombohedral in a single bag. These bags are manufactured using semi-automated processes at best. Another bag may require the joining of a triangular panel with two other panels, i.e., three panels joined at one point. These configurations present manufacturing problems. One such problem is that three or four separate films, each film having multi-layers, are joined at corners and other junctions of the bags. The joined films are from 0.02cm to 0.22cm in thickness across bonded areas. Because the films are so thick, the joints are adhesively joined to form strong bonds, which is contra- indicated for bags that will contain biological products, i.e., the adhesives harm living biological cells. Alternatively, the joints may be heated and pressed together to form a bond. However, three or four bulky films pressed and heated together is difficult to manufacture consistently. Specifically, the three or four films must be through-heated at least through both of the outer layers to produce an adequate bond. Because the films comprise polyethylene on the exterior surfaces, which has a low melting temperature relative to other materials in typical film structures that have higher melting or softening temperatures in inner layer(s), the processing window, i.e., suitable temperature ranges and pressures that can accommodate all materials, is narrow. If too low a temperatureAttorney Docket No.: P24-031-WO-PCT is used, the films will not soften and melt adequately to become bonded or remain bonded, i.e., delamination may result during use in a product. And, if too high a temperature is used to improve the strength of the joint, the polyethylene can degrade or thin out in some areas, also resulting in a poor joint, i.e., bag with leaks and / or cracks. Too little pressure can lead to a weak bond while too high pressures can degrade the polymeric structure of the films. Accordingly, a joint having three film layers, as is required in past prior art bags, suffers from quality problems. Such joints are flat, two- dimensional bonds that are under constant stress. Moreover, three- and four-layer bonds, i.e., where three or four films meet at a joint (whether a corner joint or at another junction), necessarily have a higher joint mass, leading to bonding problems as described above. In addition to quality problems, higher joint mass bonds require higher manufacturing cycle times.

[0006] Also, another problem is that the bulky bags, especially bags having many pieces leads to many joints having three to four layers at corners and therefore cannot be repeatably folded or compacted, resulting in unpredictable creasing, i.e., leading to quality problems. The folding, handling and manipulation of the bag or biocontainer, during testing, folding, packing, unpacking, and / or use in bioprocessing stresses the films and leads to the formation of defects, e.g., stress concentrations and cracks. These cracks tend to propagate and spread through as intra-layer cracks and inter-layer cracks, eventually compromising and, in turn, damaging the biocontainer, wherein leaks and a loss of sterility within an inner volume of the bag or biocontainer are created, resulting in losses in expensive biological products.

[0007] Another drawback of prior art bags, given their geometry, i.e., irregularly- shaped panels, is that they cannot be tessellated, and therefore it presents another mode for these same manufacturing and quality problems to emerge. Tessellation allows bags to be expanded and folded along predictable planes.

[0008] Current 3D single use bags of triangular or round shapes typically are made of a three or four panel construction. This in return requires a manufacturing process where the film cutting, and bonding produce several inefficiencies, such as excessive film consumption and poor thermal transfer effects. These three-dimensional bags are formed from many non-uniformly shaped panels cut from stock rolls of film, leading to film losses and inefficient waste prior to a bag being manufactured. These oddly shaped panels also comprise tabs and holes for handling. And, because so many features are cut into the panels, more fines or shreds of the films result, which is lessAttorney Docket No.: P24-031-WO-PCT than optimal in a cleanroom environment where bags are assembled. Specifically, as much as 30% of expensive films is discarded, as opposed to nearly 0% if a single sized and shaped panel is used, representing a significant difference in raw materials use, costs, disposal of wastes in an environmentally conscious world. Furthermore, manufacturing of these bags cannot be automated. Further still, because of the shapes of the panels used, scaling a design to a larger size presents additional manufacturing problems. Also, the panels of these bags are joined by adhesives or custom heat-staking machines owing to their geometry. Moreover, it is sometimes desirable to facilitate the emptying of biological products by pressurizing the bag nearing the end of a production run. Because of the way in which these bags are constructed, the joints are weak and, therefore, the bag cannot be pressurized. With the foregoing in view, biocontainer and mixing bag products have become prohibitively expensive.

[0009] Embodiments of the disclosure solve the drawbacks described above. What the art does not currently have is a mixing bag or bioreactor that has regularly-shaped panels that can be handled and joined easily and repeatably, especially via automated methods, wherein the films are heated from both sides to create a bond. A bag constructed of films having the same geometry for all panels would also represent an advance in the art. Furthermore, a bag having corner joints, i.e., three-dimensional joints, wherein no more than two film layers overlap, resulting in a much stronger joint, also represents an advance in the art. A three-dimensional bag having all the benefits of current three-dimensional bags and none of the drawbacks described above represents a significant advance in the art.

[0010] A rectangular biocontainer, bag, liner, mixing bag, and / or bioreactor that is resistant to stress concentrations and cracks, while remaining thin and flexible, comprising fewer panels, and which comprises effective, easy, and practical bonding methods for inexpensive manufacturability would represent an advance in the art. SUMMARY

[0011] Some embodiments of a bag, container, or bioreactor, comprising six rectangular and / or square panels and methods of forming the bag, substantially as shown in and / or described in connection with at least one of the figures, as set forth more completely in the claims, are disclosed. The 3D bag assembly may be constructed of six individual cut panels and bonded together to create a 3D square or rectangular bag. In some embodiments, all six panels are similar in dimensions in a 3DAttorney Docket No.: P24-031-WO-PCT bag. In some embodiments, the panels of a 3D bag comprises and / or consists of square and rectangular panels. The design of the bag provides at least two distinct features, including manufacturing advantages in bonding and cutting of the film. The bag assembly is designed with a six-panel construction, simplifying film panel shapes and resulting in novel cutting and bonding processes. The edges are tab-less and allow for film reclaiming, reducing film consumption per bag assembly of 30% or more. The six films can be bonded using two-layer bonds, allowing improvement of thermal transfer and pressure management across seams due to lower mass of film material. Improved film cutting processing, improved bonding efficiencies (fewer bonding cycles needed by up to 50%), and improved product flexibilities are also possible due to the designs disclosed herein. Automation of the bag manufacturing is also significantly improved.

[0012] The bag assembly is capable of being used in the single use bioprocessing industry, where a robust disposable carrier liner is needed that produces no leaks and is of low cost. The bag, which may be a mixer bag, a storage container, or a bioreactor, may be placed in a customer carrier and filled with several differing biological, liquid materials.

[0013] These and other provisions will become clear from the description, claims, and figures below. Various benefits, aspects, novel and inventive features of the present disclosure, as well as details of exemplary embodiments thereof, will be more fully understood from the following description and drawings. So the manner in which the features disclosed herein can be understood in detail, more particular descriptions of the embodiments of the disclosure, briefly summarized above, may be had by reference to the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this disclosure and are therefore not to be considered limiting of its scope, for the described embodiments may admit to other equally effective bags, biocontainers, films and / or materials. It is also to be understood that elements and features of one embodiment may be found in other embodiments without further recitation and that, where possible, identical reference numerals have been used to indicate comparable elements that are common to the figures. BRIEF DESCRIPTION OF THE FIGURES

[0014] FIG.1 depicts a front perspective view of a bag or container, according to some embodiments of the disclosure;

[0015] FIG.2 depicts close up views of a corner joint of the bag or container of FIG.1, according to some embodiments of the disclosure;Attorney Docket No.: P24-031-WO-PCT

[0016] FIG. 3 depicts a rectangular bag or container, further comprising tessellated panels, according to some embodiments of the disclosure;

[0017] FIG.4 depicts bond-making apparatus, according to some embodiments of the disclosure;

[0018] FIG. 5 depicts a first process for forming a bag or container, according to embodiments of the disclosure; and

[0019] FIG. 6 depicts a second process for forming a bag or container, according to embodiments of the disclosure. DETAILED DESCRIPTION OF SOME EMBODIMENTS

[0020] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which these embodiments pertain. Also, the following terms used herein are subject to the following definitions, unless the context indicates otherwise.

[0021] Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the embodiments selected for illustration in the drawings. In the drawings and the following description below, it is to be understood that like numeric designations refer to components of like structure and / or function.

[0022] As used in the specification, various devices and parts may be described as "comprising" other components. The terms “comprise(s),” “include(s),” “having,” “is,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that do not preclude the possibility of additional components.

[0023] As used herein, approximating language may be applied to modify any quantitative representation that may vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about,” “approximately,” and “substantially,” may not be limited to the precise value specified, in some cases. The modifier “about” should also be considered as disclosing the range defined by the absolute values of the two endpoints. For example, the expression “from about 2 to about 4” also discloses the range “from 2 to 4.”Attorney Docket No.: P24-031-WO-PCT

[0024] The term “sterile” is defined as a condition of being free, or substantially free, from contaminants and, particularly within the bioprocessing industry, free from bacteria, germs, and other microorganisms.

[0025] It should be noted that some terms used herein are relative terms. For example, the terms “upper” and “lower” are relative to each other in location, i.e., an upper component is located at a higher elevation than a lower component and is not to be construed as requiring a particular orientation or location of the structure. As a further example, the terms “interior,” “exterior,” “inward,” and “outward” are relative to a center and should not be construed as requiring a particular orientation or location of the structure.

[0026] The terms “top” and “bottom” are relative to an absolute reference, i.e., the surface of the earth. Put another way, a top location is always located at a higher elevation than a bottom location, relative to the surface of the earth.

[0027] So the manner in which the features disclosed herein can be understood in detail, a more particular description of the embodiments of the disclosure, briefly summarized above, may be had by reference to the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this disclosure and are therefore not to be considered limiting of its scope, for the embodiments described and shown may admit to other equally effective embodiments. It is also to be understood that elements and features of one embodiment may be found in other embodiments without further recitation and that identical reference numerals are sometimes used to indicate comparable elements that are common to the figures.

[0028] The terms “bioreactor,” “bag,” “mixing bag,” “biocontainer,” and “container” are generally used interchangeably within this disclosure except where context dictates otherwise. A flexible bioreactor, bag, or container connotes a flexible vessel that can be folded, collapsed, and expanded and / or the like, capable of containing, for example, a biological fluid. A single use bioreactor, bag, or container, typically also flexible, is a vessel that is used once and discarded.

[0029] A biocontainer, bioreactor, or bag having an inner volume defined by its sealed sides, top and bottom may be formed from any of the films described herein. The inner volume of the biocontainer, bag, or mixing bag can range from 10 liters to 3500 liters or greater. A variety of sizes, such as 10, 20, 50, 100, 200, 500, 1000 and 2000 liters are typical, although larger than 2000L, may be constructed as desired or asAttorney Docket No.: P24-031-WO-PCT appropriate for any particular bioprocessing operation. The biocontainer or bag can used to store or process fluids, (gases, liquids or combinations of both) and / or solids and may be formed into a biocontainer or mixer or storage bag. For example, the biocontainer may be a mixer and may be used to mix various liquids together or a liquid or liquids with one or more solids such as buffer media, cell culture media and the like. The biocontainer or bioreactor may be used for the storage or transport of liquids such as intermediate or finished pharmaceutical products. Various additions such as impellers, sensors, gas and liquid tube sets and the like, as are known to those in the art, may also be added as desired.

[0030] FIG.1 depicts a front perspective view of a bag 100, according to some embodiments of the disclosure. The bag 100 is constructed of six panels in some embodiments. Shown are a front panel 102, a left panel 110, a right panel 108, a back panel 104, a top panel 110, and a bottom panel 112. As depicted, all six panels are substantially similar. Specifically, all panels are squares, i.e., equivalent in size and dimension. As discussed above, in some embodiments according to the disclosure, some bags may be a combination of square and rectangular panels. The bag 100 comprises panels that are joined together. In some embodiments, the panels are bonded using adhesives. In preferred embodiments, the panels are bonded by heating, which partially melts the panels and solidifies as bonds, wherein at a corner joint comprising three films, only two films overlap, creating a strong, repeatable bond. The heating, which creates seals between panels, may be by any suitable heating method, e.g., ultrasonic heating, induction heating, electromagnetic heating, and / or contact heating. Optionally, one or more of the panels 102, 104, 106, 108, 110, and 112, when bonded (or welded) to an adjacent panel, may comprise an overhang, i.e., unbonded edges of film. For example, a non-exhaustive description depicts a right-side 105 of the top panel 106 meeting and joined at the top edge 109 of the right panel 108 to form a joint. Similarly, the front edge 107 of the top panel 106 meets and is joined with the top edge 103 of the front panel 102 to form a joint, and the right edge 113 of the right panel 108 meets and is joined with the left edge 111 of the front panel 102 to form a joint. It is to be understood that all panels are joined on all four sides of its perimeter with the other adjacent panels. It is to be further understood that the corner joints are formed initially and the more middle surfaces between corners are formed subsequently. One aspect of a six-panel bag is that it can be easily scaled to smaller and larger designs because of the regular-shaped panels. A square bag would have all six panels equal in size. AAttorney Docket No.: P24-031-WO-PCT rectangular bag comprises a bag having four rectangular panels of the same size and two square panels, which would be opposite each other in the rectangular bag. Also, embodiments of the bags described herein, owing to the stronger joints and bonds, have a greater ability to withstand pressure. It is sometimes advantageous to introduce pressure into the bag, particularly from a top-side port, following use, to bias expensive biological fluids out of the bag. The bags described herein can withstand greater pressures and, because the top is flat, i.e., parallel with a surface of the Earth, ports for such evacuation can be placed there. In fact, a port of any kind can be placed on any of the surfaces of the bag. Whether the panels are all square or two or more are rectangular, the features allow for automation in the bag manufacturing process.

[0031] FIG.2 depicts close up views of a corner joint of the bag or container of FIG. 1, according to some embodiments of the disclosure. FIG. 2A is a first close-up view 120 of a corner 140 of the bag 120 of FIG.1, according to some embodiments of the disclosure. The corner 140 comprises parts of the top panel 106, the right panel 108, and the front panel 102. A seal or bonded region 122 is disposed between an edge 105 and an edge 109, between an edge 107 and edge 103, and between an edge 113 and an edge 111. As can be seen, there is an overhang on the seal 122a, 122b, and 122c. For example, the seal 122a is comprised of the panel 106 and the panel 108. And, as shown, the seal 122a is bonded not at the most distal area or perimeter of the panels 106 and 108 but rather a distance away from the edges 105, 109. In other words, an overhang 126 is created on the right panel 108 and an overhang 124 is created on the top panel 106. Similar bonds, such as seals 122b and 122c are also created and shown in close up view 120. The bonds between other panels at other corners within the bag 100 are substantially similar to corner 140, e.g., overhangs 128 and 130; overhangs 132 and 134. In total, the bag 100 comprises seven other corners substantially similar to corner 140. The bag 100 my comprise sixteen overhangs and eight corners, which contribute to the bag 100 being relatively stiff and self-supporting. It is to be understood that all corners, e.g., corner joints, comprise two films only. In other words, there is no joint in the bag 100 wherein three or more films form a bonded overlap.

[0032] FIG. 2B is an alternative close-up view 120 of a corner 140 of the bag 120 of FIG.1, according to some embodiments of the disclosure.

[0033] Some embodiments of the disclosure include bags manufactured using tessellated panels, i.e., panels that have features that bias a fold in a certain manner. Bags manufactured using tessellated panels can be folded for storage more easily thanAttorney Docket No.: P24-031-WO-PCT a bag that does not comprise tessellated panels. This allows the manufacturing of bags having fewer quality problems, e.g., cracks and leaks due to bonding issues and / or automation problems, and / or scrapping of films.

[0034] In some embodiments, a biocontainer made from the panels discussed above comprise a front panel, a back panel, a top panel, a bottom panel, and two side panels, wherein the front panel, the back panel, the top panel, the bottom panel, and the two side panels have the same length and height dimensions. In some of the embodiments, the six panels are rectangular. In some embodiments, two panels are square and four panels are rectangular. In some embodiments, one or more of the panels are tessellated. In some embodiments, all of the panels are tessellated.

[0035] Methods for manufacturing the bags are described herein. Six panels are cut and, in some cases, from a roll of film. In some embodiments, these panels may be rectangular or square and are heat-bonded. Also, optionally, the panels may be tessellated or non-tessellated. Tessellated panels are described in US Publ. No. 2022 / 0323300, assigned to EMD Millipore Corporation, Burlington, MA, USA, and particularly at FIGS.10A-10C and 19A-19C in that publication, which are incorporated by reference in entirety.

[0036] FIG.3 depicts a tessellated square biocontainer 200, according to some embodiments of the disclosure. The biocontainer 200 comprises tessellations front panel 202, left panel 108, and top panel 206. The biocontainer 1900 is, in some embodiments, rectangular and, in some embodiments, square. The biocontainer 200, as shown, depicts a four-plane tessellated biocontainer. The tessellated lines are shown as 202a, 202b, and 202c in the front panel 200. The left panel 208 has tessellations 208a, 208b, and 208c. In addition, the left panel 208 further comprises tessellations 208cx and 208cy, which form approximately 45° angles with tessellation 208c. Similarly, the left panel 208 comprises tessellation 208b, which is above tessellation 208c. The left panel 208 further comprises tessellations 208bx and 208by, which form approximately 45° angles with tessellation 208b. Also, in addition, the tessellations 208cx and 208cy are at right angles with tessellations 208bx and 208by respectively. The left panel 208 comprises tessellation 208a, which is above tessellation 208b. The left panel 208 further comprises tessellations 208a2x and 208a2y, which form approximately 45° angles with tessellation 208a. Also, in addition, the tessellations 208a2x and 208a2y are at right angles with tessellations 208bx and 208by respectively. The left panel 208 further comprises tessellationsAttorney Docket No.: P24-031-WO-PCT 208a1x and 208a1y, which form approximately 45° angles with tessellation 208a. In addition, the tessellations 208a2x and 208a2y are at right angles with tessellations 208a1x and 208a1y respectively. In this context, tessellations are modified areas (thinned, thickened, or bent areas) formed within a flexible film, which biased folds in the film in a predictable and repeatable pattern. It is to be understood that the joints and corner joints of a bag having tessellations are formed the same as panels and films having no tessellations.

[0037] FIG. 4 depicts a top view of a bond-making apparatus 400 for films, according to some embodiments of the disclosure. A first heating element 402 is disposed at right angles to a second heating element 404. The first heating element 402 has a heating surface 406 that is attached and opposite a mounting side 410. The second heating element 404 has a second heating surface 408 that is attached and opposite a mounting side 412. The first heating element 402 and second heating element are L- shaped. In other words, each has a heating surface at right angles so that one aspect of each has a vertical element and a horizontal element. The first heating element 402 and second heating element 404 are manipulable, i.e., can be moved to closer to and further from a stationary heating element 430. The stationary heating element 430 comprises heating areas 420a and 420b, which are at right angles to one another and meet at a corner 426. The stationary heating element 430 optionally comprises a base 422, a top surface 424, and a beveled edge 420 disposed therebetween. As shown, the beveled edge 420 forms approximately a 45° angle with the top surface 424. The beveled edge 420 can mate with a beveled edge of another heating element, such as the first heating element 402 and the second heating element 404, wherein a plastic film(s) disposed therebetween is heated and pressed together, forming a bond between the films. As shown, there are two beveled edges 420a and 420b which are meant to correlate with the first heating element 402 and the second heating element 404. In other words, when in a film heating / bonding operation, a substantially consistent gap is created between heating surfaces 406 and 408 and edges 420a and 420b. As shown, the first heating element 402 comprises a base area 412 of a height that more or less matches that of a base height 422 of the second heating element 430. The first and second heating elements 402, 404 are disposed on a frame (not shown) which further comprises pinch rollers (not shown) for edge handling of the films during bonding. The edge handling of the films and the fact that the films are of the same dimensions, allows for an automated bag-manufacturing process. For example, three panels of film may be diecutAttorney Docket No.: P24-031-WO-PCT as the film is unrolled from a large roll of film. The panels can then be delivered to the pinch rollers for automatic placement within the heating system, e.g., the first and second heating elements 402, 404 and the stationary heating element 430.

[0038] The heating areas 404, 406, and 420 are coordinated to pinch and heat three films to form a 90° bond. The heating areas 404, 406, and 420 coordinate to pinch and heat the three films to form three bonds at right angles at the same time, forming a Y-shaped corner joint as described more fully below. The Y-shaped corner joint comprises three 2-layer bonds. In other words, the three films of the Y-shaped corner joint form three bonds but nowhere do all three films overlap in a bond. The heating area may be achieved by a contact heater or a non-contact heater. In some embodiments, there is a duration of non-contact heating followed by a duration of contact heating, followed by the application of pressure between the first heating element 402 and the second heating element 430. It is to be understood that the first and second heating elements 402, 404 are on one side, e.g., an external side of a film panel that will become part of a bag and the stationary heating element 430 on the opposite of the films, e.g., to form a bond on what will become an interior part of the bag.

[0039] Also depicted in FIG. 4 are three films 440, 442, and 444, which are at right angles to one another. For example, films 440 and 442 are thin films that are disposed vertically, while the film 444 is horizontal, i.e., parallel to the top surface 424 of the stationary heating element 430. The films 440, 442, and 444 are shown in partial view for the sake of simplicity. It is to be further understood that the corner bonds between three films are approximately one inch to six inches in length, although smaller and larger bonds of which a corner joint is comprised may be smaller or larger, depending on the overall size of the bag. Smaller bags, e.g., 1L-10L may have shorter bonds while larger bag, e.g., 500L, 100L, 3000L, etc., may have longer bonds. It is to be noted that the three films 440, 442, 444, at a corner joint, are bonded to each other in a Y-shaped bonded area, wherein the three films 440, 442, 444 are at right angles. The Y-shaped corner joint comprises three bonds, a first bond between the film 440 and the film 442, a second bond between the film 442 and the film 444 and a third bond between the film 440 and the film 444. The first, second, and third bonds need not be on the edges of those films, i.e., the outside edges of the perimeter of the films may be un-bonded. Irrespective of whether the first, second, and third bonds of all the corner joints, eight in all, are bonded out to the very edges of the films or not, all eight corner joints can be formed, as subsequent panels of films are added, of which there are six inAttorney Docket No.: P24-031-WO-PCT all in creating a 3D bag. Because only the corners of what will become the bag are bonded, the first and second heating elements 402, 404 and the stationary heating element 430 can form all corners and can retreat from the interior of the bag through an unbonded area between corners of the films. The areas between the corner joints are bonded subsequently in another bonding operation.

[0040] The first and second heating elements 402, 404 and the stationary heating element 430 are made of a metal or a ceramic. In some embodiments, the metal is a steel, stainless-steel, or any suitable metal capable of transmitting heat well. In some embodiments, the first heating element 402 and the second heating element 430 comprise a metal substrate having an electrical insulation material deposed via metal deposition or coated. Some electrical insulation coatings comprise a ceramic, such as various types of glass, to passivate the metal substrate. A protective enamel is also optionally coated thereon to protect the electrical insulation coating.

[0041] Tables and, in some embodiments, vacuum tables, hold the panels by drawing a vacuum. Grips are used to place three panels at right angles to one another. Heating elements, which are at right angles to one another, then close around the films, pinching the films. The heating elements may contact the films, e.g., conductive heaters, on each side of the films or on just one side of the films. And, in some cases, the films may be pre-heated to assist in bonding, for example, by using a heated table from which the panels are supplied, induction heaters, and / or laser heating. A separate method for pre-heating the films is to allow a short residence time in which the films are close to, but not contacting, the heating elements. It is contemplated herein that linear bonds, i.e., body joints, between corner joints can first be formed, i.e., before the corner joints. An alternative method produces a corner joint between the three panels and form the linear bonds between two adjacent corners thereafter.

[0042] After a corner joint(s) is made, or after two or all eight corner joints in a bag are made, roller-heaters are used to heat the films between corner joints to form a linear bond therebetween, forming a body joint. Of course, for a square or rectangular bag, there are twelve body joints along its perimeter. In some embodiments, an upper roller-heater heats an upper film and a lower roller-heater heats a lower film. The roller- heaters provide approximately 175 kilopascals (kPa) (25 PSI) to 250 kilopascals (35 PSI) and pinch the films together, depending on the films to be joined. The roller- heaters are heated to approximately 125-300°C, depending on the films to be joined. In some embodiments, the roller-heaters provide from 200-240 kPa of pressureAttorney Docket No.: P24-031-WO-PCT therebetween. In some embodiments, the roller-heaters provide from 210-230 kPa. In some embodiments, the roller-heaters are heated to 125-250°C. In some embodiments, the roller-heaters are heated to 140-220°C. In some embodiments, the roller-heaters are heated to 150-200°C.

[0043] FIG. 5 depicts a first process 500 for forming a bag or container, according to some embodiments of the disclosure. At least one embodiment comprises forming a bag in the form of a cube by bonding a left-side of a cube, to a back-side, to a top panel. In practice, one can start with any three adjacent panels that are at right angles to one another. Next, a right-side panel is added. A bottom panel is then added and, finally, a front panel is added. The process 500 begins and at step 502 three film panels are gripped, wherein the first film panel, the second film panel, and the third film panel are gripped or otherwise held at 90° to one another at an edge of each. Optionally, one, two, or all three of the film panels are optionally pre-heated along the perimeter edges to be bonded. For example, the panels can be heated with a contact heater, such as the heating elements described above or a non-contact heater, e.g., hot air, conductive heating, etc. At step 504, a first corner joint is formed by pinching and heating the three panels, wherein a Y-shaped corner joint is bonded using the first heating element, the second heating element, and the stationary heating element, as described above. For example, for a bag to be formed as a cube, a top panel, a left-side panel, and a back panel could be formed, with the corner joint is formed where all three panels meet, i.e., at the top-back of the cube. It is to be understood that a corner joint, formed in a single heating operation, is a three-dimensional bond, wherein the three films are at right angles to one another.

[0044] At step 506, a fourth film panel is bonded to the three bonded panels of step 504. For example, a right-side panel opposite the left-side panel, could be bonded next, wherein a corner joint is formed at the top-right side and a corner joint formed at the bottom-right side of the cube.

[0045] At step 508, a fifth panel, a bottom panel could be bonded to the sub- assembly formed in step 506. At this point, a third corner joint can be formed, i.e., formed in the lower-right position of a cube and a fourth corner joint formed in the lower-left position of a cube.

[0046] At step 510, a front panel can be bonded to the sub-assembly formed in step 508, wherein fifth and sixth corner joints are formed in a lower-front position (onAttorney Docket No.: P24-031-WO-PCT the left) and a second corner joint in the lower-front (on the right). At step 512, the process 500 for forming corner joints ends.

[0047] As above, the contact heaters are brought together and heated to a pre- set temperature(s) and pressure(s), wherein the three film panels are disposed therebetween. At the same time or a short duration of time thereafter, the first and second heating elements are brought together with the stationary heating element and held under a prescribed pressure for a prescribed duration of time. It is to be understood that the temperatures, pressures, and times depend upon the base resin(s) of the films and the thickness of those films.

[0048] FIG. 6 depicts a second process 600 for forming a bag or container, according to embodiments of the disclosure. The process 600 begins and proceeds to step 602, wherein a first film panel, a second film panel, and a third film panel are gripped or otherwise held at 90° to one another at an edge of each. At steps 604, one or both sides of the film panels are optionally pre-heated along the edges to be bonded. For example, the panels can be heated with a contact heater, such as the heating elements described above or a non-contact heater, e.g., hot air. At step 606, the contact heaters, e.g., the first heating element, the second heating element, and the stationary heating element, as described above, are heated to a pre-set temperature(s) and pressure(s), wherein the three film panels are disposed therebetween. At the same time or a short duration of time thereafter, the first, second heating elements and stationary heating elements are brought together with the stationary heating element and held under a prescribed pressure for a prescribed duration of time, forming a corner joint. It is to be understood that the temperatures, pressures, and times depend upon the base resin(s) of the films and the thickness of those films. At step 608, the first heating element and the second heating element are separated from the stationary heating element. At step 610, steps 602-608 are repeated, wherein a fourth film panel is bonded perpendicular to at least one of the first film panel, second film panel, and third panel from above, forming another corner joint. At step 612, a fifth film panel is added. At step 614, a sixth panel is added, forming a cube pre-assembly, wherein eight corner joints have been formed. At step 616, the perimeters, e.g., body joints, between the corner joints, twelve in all, are bonded to form a container having an internal volume. At step 618, the process 600 ends. It is to be understood that all six film panels are square or rectangular. The previous methods can also be used instead of or in conjunction with the process 600. It is possible to form eleven of the twelve edgesAttorney Docket No.: P24-031-WO-PCT between the corners of a cube by heating and pressing from the interior of a bag using the first heating element, second heating element, and stationary heating element, as described above. The bond joint along a twelfth edge is formed from an exterior of the bag. In some embodiments, all twelve body joints between corner joints are pinched and heated only from the outside of the bag. The body joints are also heated from both sides of the bond. The body joints formed between the corner joints may be formed using roller-heaters, as described above, to form a linear bond(s) / body joint therebetween. In some embodiments, one or more of the front panel, the back panel, the top panel, the bottom panel, and the two side panels are tessellated.

[0049] A method for producing a corner joint of three films is disclosed, comprising bringing three panels of film at right angles to each other between three heaters, wherein a first heater and a second heater are L-shaped, wherein each of the first heater and second heater has a vertical segment and a horizontal segment, wherein the vertical segment of each is parallel to one another and the horizontal segment of each are at right angles to one another, and wherein the third heater has two horizontal segments at right angles to one another; bringing the first heater, the second heater, and the third heater together, wherein the three panels of film are pinched therebetween, wherein a pre-set pressure is applied for a duration of time and the first, second, and third heaters are heated to a pre-set temperature; and separating the first heater, second heater, and third heater, wherein a corner joint is formed by overlapping only two panels of film within three bonds.

[0050] A method is disclosed for producing a corner joint of three films, comprising steps for bringing three panels of film at right angles to each other between three heaters, wherein a first heater and a second heater are L-shaped, wherein each of the first heater and second heater has a vertical segment and a horizontal segment, wherein the vertical segment of each is parallel to one another and the horizontal segment of each are at right angles to one another, and wherein a stationary heater has two horizontal segments at right angles to one another; bringing the first heater, the second heater, and the stationary heaters together, wherein the three panels of film are pinched therebetween, forming a Y-shape, wherein a pressure is applied for a duration of time and the first, second, and stationary heaters are heated to a temperature; and separating the first heater and second heater from the stationary heater, wherein a corner joint is formed by overlapping only two panels of film within three bonds. A method is disclosed for producing a biocontainer corner joint of three films, comprising:Attorney Docket No.: P24-031-WO-PCT a) bringing three panels of film at right angles to each other between a first heater and a second heater, wherein the first heater and the second heater are L-shaped, wherein each of the first heater and second heater has a vertical segment and a horizontal segment, wherein the vertical segment of each is parallel to one another and the horizontal segment of each are at right angles to one another, and a stationary heater, wherein the stationary heater has two horizontal segments at right angles to one another; b) bringing the first heater, the second heater, and the stationary heater together, wherein the three panels of film are pinched therebetween forming a Y-shape, wherein a pressure is applied for a duration of time and the first, second, and stationary heaters are heated to a temperature; and c) separating the first heater, second heater, and the stationary heater, wherein a first corner joint is formed by overlapping only two panels of film within three bonds, forming a Y-shaped bond; d) repeating steps b)-c) with five additional panels, forming an additional seven corner joints; e) bonding eleven linear edges between corner joints, by bonding the linear edges from the inside and the outside of the incomplete biocontainer; and f) bonding a twelfth linear edge, forming a completed biocontainer.

[0051] Any of the films described herein may further comprise a substrate. The substrate may comprise a woven material, a nonwoven material, a spunbonded material or, a netting material, such as DELNET® film, which is an aperture or porous stretched film, marketed by Hercules, Inc., of Wilmington, DE, USA. The substrate may comprise polymer fibers or yarns, metal fibers or yarns, glass fibers or yarns or carbon fiber or yarns or combinations thereof. Polymer substrates, generally, woven, nonwoven or netted can be formed of materials such as nylons, KEVLAR® and other amides, PET, EVA, various polyethylenes and polypropylenes, and / or the like. The substrate is generally encapsulated within another layer of the films.

[0052] Polymeric woven fabrics can be formed of any of the previously mentioned polymers. Polymeric woven fabrics are commercially available either as a fabric alone or a coated fabric which has a tie layer integrated within it. Such materials are available from a variety of companies such as Eastex Products Inc. of Holbrook, MA, USA; PGI Inc. of Charlotte, NC, USA; or Freudenberg & Co. of Manchester, NH, USA. Nonwovens can be for example spunbonded or blown materials and areAttorney Docket No.: P24-031-WO-PCT commercially available for instance as TYPAR® or TYVEK® sheets from E.I. duPont De Nemours of Wilmington, DE, USA.

[0053] Any of the films described herein may comprise an inner contact zone further comprising one or more layers of material that are inert to the liquids that may be in contact with the film and / or which is / are low in extractables that might enter the liquid in contact with the inner contact zone. In some exemplary embodiments, the inner contact zone comprises, for example, a polyolefinic material, i.e., a polyethylene layer. In some embodiments, the polyethylene layer that is at least one of ultra-low- density polyethylene (ULDPE), e.g., a density of 0.857-0.908 g / cm3, a polyolefin plastomer, or a polyethylene-octene copolymer. In some embodiments, the polyethylene layer comprises ENGAGE® polyolefin elastomers, and some exemplary ethylene alpha-olefin and polyethylene-octene copolymer resins, as marketed by the Dow Corp. of Midland, MI, USA.

[0054] Any of the films described herein may comprise a gas impermeable zone formed of one or more layers of materials that are gas impermeable, such as EVA and / or EVOH, and may also comprise substrates, e.g., various metal foils such as aluminum, aluminum alloys, and / or various combinations thereof. Any of the films described herein may comprise a substrate disposed between the inner contact zone and the gas impermeable zone. The substrate may provide burst resistance as well as strength for support during articulation and / or use. In some embodiments, the tie layer is embedded into the substrate. Preferred tie layers include plastics such as poly (ethylene vinyl acetate) alone or blended with a different polymer such as polyethylene. In some embodiments, the tie layer comprises a blend of EVA and a low-density polyethylene, wherein the EVA is a high flow EVA. For example, in some embodiments, the melt flow for the tie layer may range from approximately 3-25 g / 10 min. The tie layer may also be a polyurethane material. Films of these types are disclosed in US Patent Nos. 10,272,639; 10,675,836; 11,110,684, and US Publ. No. 20210347156A1; some of which are marketed as ULTIMUS® by EMD Millipore Corporation, Burlington, MA, USA, all of which are incorporated by reference in their entireties.

[0055] All ranges for formulations recited herein include ranges therebetween and can be inclusive or exclusive of the endpoints. Optional included ranges are from integer values therebetween (or inclusive of one original endpoint), at the order of magnitude recited or the next smaller order of magnitude. For example, if the lower range value is 0.2, optional included endpoints can be 0.3, 0.4, ...1.1, 1.2, and the like,Attorney Docket No.: P24-031-WO-PCT as well as 1, 2, 3 and the like; if the higher range is 8, optional included endpoints can be 7, 6, and the like, as well as 7.9, 7.8, and the like. One-sided boundaries, such as 3 or more, similarly include consistent boundaries (or ranges) starting at integer values at the recited order of magnitude or one lower. For example, 3 or more includes 4, or 3.1 or more.

[0056] Reference throughout this specification to “one embodiment,” “certain embodiments,” “one or more embodiments,” “some embodiments,” or “an embodiment” indicates that a feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Therefore, the appearances of the phrases such as “in one or more embodiments,” “in certain embodiments,” “in one embodiment,” “some embodiments,” or “in an embodiment” throughout this specification are not necessarily referring to the same embodiment. Nonetheless, it is to be understood that any feature described herein can be incorporated within any embodiment(s) disclosed herein.

[0057] Publications of patent applications and patents and other non-patent references, cited in this specification are herein incorporated by reference in their entirety in the entire portion cited as if each individual publication or reference were specifically and individually indicated to be incorporated by reference herein as being fully set forth. Any patent application to which this application claims priority is also incorporated by reference herein in the manner described above for publications and references.

[0058] While various aspects and embodiments have been disclosed herein, other aspects, embodiments, modifications and alterations, will be apparent to those skilled in the art upon reading and understanding the preceding detailed description. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting. It is intended that the present disclosure be construed as including all such aspects, embodiments, modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

[0059] Although some embodiments have been discussed above, other implementations and applications are also within the scope of the following claims. Although the specification describes, with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It is therefore to be further understood that numerous modifications may be made to the illustrativeAttorney Docket No.: P24-031-WO-PCT embodiments and that other arrangements and patterns may be devised without departing from the spirit and scope of the embodiments according to the disclosure. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in any one or more of the embodiments.

Claims

Attorney Docket No.: P24-031-WO-PCT CLAIMS What is Claimed is:

1. A polymeric biocontainer, comprising: a polymeric front panel, a polymeric back panel, a polymeric top panel, a polymeric bottom panel, and two polymeric side panels, wherein the front panel, the back panel, the top panel, the bottom panel, and the two side panels have the same length and height dimensions and are bonded together, wherein the front panel, the back panel, the top panel, the bottom panel, and the two side panels are joined to form eight corner joints to create an internal volume.

2. A polymeric biocontainer, comprising: a polymeric front panel, a polymeric back panel, a polymeric top panel, a polymeric bottom panel, and two polymeric side panels, wherein the front panel, the back panel, the top panel, and the bottom panel have the same dimensions, and the two side panels have the same length and height dimensions with respect to each other and are bonded with the front panel, the back panel, the top panel, and the bottom panel, forming eight corner joints to create an internal volume.

3. The biocontainer of claims 1 and 2, wherein one or more of the front panel, the back panel, the top panel, the bottom panel, and the two side panels are tessellated.

4. The biocontainer of claims 1 and 2, wherein all of the front panel, the back panel, the top panel, the bottom panel, and the two side panels are tessellated.

5. The biocontainer of claims 1 and 2, wherein at least one corner joint is formed as a Y-shaped bond.

6. The biocontainer of claims 1 and 2, wherein all eight corner joints are formed only of two films.

7. A biocontainer, consisting of: Six panels, including a front panel, a back panel, a top panel, a bottom panel, and two side panels, wherein the front panel, the back panel, the top panel, the bottom panel, and the two side panels have the same length and height dimensions; eight corner joints bonding the front panel, the back panel, the top panel, the bottom panel, and the two side panels, wherein the front panel, the back panel, the top panel, the bottom panel, and the two side panels wherein a plurality of joints comprise two film layers.Attorney Docket No.: P24-031-WO-PCT 8. A polymeric biocontainer, consisting of: a polymeric front panel, a polymeric back panel, a polymeric top panel, a polymeric bottom panel, and two polymeric side panels, wherein the front panel, the back panel, the top panel, and the bottom panel have the same dimensions, and the two side panels have the same length and height dimensions with respect to each other and are bonded with the front panel, the back panel, the top panel, and the bottom panel, forming eight corner joints to create an internal volume.

9. The biocontainer of claims 7 and 8, wherein one or more of the panels are tessellated.

10. The biocontainer of claims 7 and 8, wherein all of the panels are tessellated.

11. The biocontainer of claims 7 and 8, wherein a corner joint is formed as a Y- shaped bond.

12. The biocontainer of claims 7 and 8, wherein all corner joints are formed only of two films.

13. A method for producing a corner joint of three films, comprising: bringing three panels of film at right angles to each other between three heaters, wherein a first heater and a second heater are L-shaped, wherein each of the first heater and second heater has a vertical segment and a horizontal segment, wherein the vertical segment of each is parallel to one another and the horizontal segment of each are at right angles to one another, and wherein a stationary heater has two horizontal segments at right angles to one another; bringing the first heater, the second heater, and the stationary heaters together, wherein the three panels of film are pinched therebetween, forming a Y-shape, wherein a pressure is applied for a duration of time and the first, second, and stationary heaters are heated to a temperature; and separating the first heater and second heater from the stationary heater, wherein a corner joint is formed by overlapping only two panels of film within three bonds.

14. A method for producing a biocontainer corner joint of three films, comprising: a) bringing three panels of film at right angles to each other between a first heater and a second heater, wherein the first heater and the second heater are L-shaped, wherein each of the first heater and second heater has a vertical segment and a horizontal segment, wherein the vertical segment of each is parallel to one another and the horizontal segment of each are at rightAttorney Docket No.: P24-031-WO-PCT angles to one another, and a stationary heater, wherein the stationary heater has two horizontal segments at right angles to one another; b) bringing the first heater, the second heater, and the stationary heater together, wherein the three panels of film are pinched therebetween forming a Y-shape, wherein a pressure is applied for a duration of time and the first, second, and stationary heaters are heated to a temperature; and c) separating the first heater, second heater, and the stationary heater, wherein a first corner joint is formed by overlapping only two panels of film within three bonds, forming a Y-shaped bond; d) repeating steps b)-c) with five additional panels, forming an additional seven corner joints; e) bonding eleven linear edges between corner joints, by bonding the linear edges from the inside and the outside of the incomplete biocontainer; and f) bonding a twelfth linear edge, forming a completed biocontainer.

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