Flexible biological treatment containers and rigid support structures

Abstract

An apparatus 100 for supporting a flexible bioprocessing container includes a rigid body 102 having a hexagonal interior 104 including a bottom surface and six sides surrounding the bottom surface, the hexagonal interior having a substantially open top. The apparatus further includes a selectively openable door 112 allowing access to the hexagonal interior; and a support portion attached to the rigid body allowing access to the lower side of the rigid body. The hexagonal interior is configured to receive a hexagonal flexible bioprocessing container having a liquid level height-to-width ratio of ≤1.

Description

[0001] Cross-references to related applications This patent application relates to U.S. Patent Application No. _______, which was filed concurrently, is co-examined and co-assigned, entitled “Apparatus, System and Method for Transporting and Installing Flexible Bioprocessing Containers” (Attorney’s File No.: P2023-3885-US01), the disclosure of which is incorporated herein by reference. Technical Field

[0002] Embodiments of the present invention generally relate to biological treatment, and more specifically to flexible biological treatment containers and rigid support structures for flexible biological treatment containers. Background Technology

[0003] Mixers and bioreactors are commonly used to perform biochemical and biological processes, and / or manipulate liquids and other products of such processes. These devices typically utilize single-use containers, such as flexible or collapsible bags supported by an external rigid structure, such as a stainless steel shell / tank. As will be appreciated, the use of sterile single-use bags eliminates the time-consuming step of cleaning the tank after each use and reduces the chance of contamination.

[0004] In use, a disposable / single-use bag is positioned within a rigid container and filled with the desired fluid for processing. An impeller assembly, including a rotating impeller with one or more blades, is disposed within the bag and is used to mix the fluid. Existing impeller systems are either top-driven, with a shaft extending downward into the bag and one or more impellers mounted on the shaft; or bottom-driven, with an impeller disposed at the bottom of the bag, for example, the impeller is driven by a magnetic drive system positioned outside the bag.

[0005] The supporting structure / tank can be relatively large, with a capacity of 2000L to 3000L or greater. As will be appreciated, such tanks are typically installed in existing cleanroom spaces. Therefore, the tank should be compatible with the existing cleanroom architecture, meaning the installation should not require costly and time-consuming internal modifications. For example, a 3000L tank should be able to pass through a double door with a height of 213.4cm (7 feet) and a width of 182.9cm (6 feet). However, many cylindrical and cuboid / cubic tanks with capacities greater than 2000L have heights that make such passage impossible.

[0006] Furthermore, the height of the tank is largely determined by the size of the flexible, single-use bag supported within it. Known 2000L and 3000L bags have an undesirable height-to-width ratio greater than 1, meaning their height is greater than their width. For example, a 2000L cubic mixer bag has a height-to-width ratio of 1.6. A known 3000L cubic mixer bag has a height-to-width ratio of 2.4. Due to the limited width of available flexible membranes, it is not easy to easily increase the width of such bags to reduce their height.

[0007] These flexible, single-use bags must also be shipped and installed in tanks. The 2000L and 3000L flexible bags are relatively large, and installation can be challenging given their size and flexibility. Known tanks do not include features to facilitate alignment of the flexible containers for easy installation.

[0008] Mixing efficiency is important in container and tank design. Overall mixing efficiency depends on the mixing power and the ability to disperse that power across the volume of fluid within the container. For example, mixers with a height relatively greater than their width (with impellers mounted at the bottom or top) are typically very limited in their ability to disperse the mixed powder in the top or bottom sections of the container, respectively. Furthermore, cuboid / cubic containers typically do not induce eddies but instead generate high levels of turbulence. In contrast, cylindrical containers generate eddies, but with low levels of turbulence. As a result, cuboid and cubic containers are generally suitable for use with floating powders (culture media), while cylindrical containers are suitable for use with settling powders (buffer solutions). Consequently, these containers lack ideal mixing versatility.

[0009] In light of the above, there is a need for a flexible bioprocessing container and a rigid support structure that allow for installation in existing cleanrooms without requiring internal modifications. There is also a need for a flexible bioprocessing container and a rigid support structure that allows for versatile and efficient integration across a variety of applications and provides ease of installation of the container within the rigid support structure. Summary of the Invention

[0010] The following outlines some embodiments commensurate with the scope of the originally claimed subject matter. These embodiments are not intended to limit the scope of the claimed subject matter, but are intended to provide only a brief overview of possible embodiments. In fact, this disclosure may cover a variety of forms that may be similar to or different from the embodiments listed below.

[0011] According to one aspect of the invention, an apparatus for supporting a flexible bioprocessing container includes a rigid body having a hexagonal interior including a bottom surface and six sides surrounding the bottom surface, the hexagonal interior having a substantially open top. The apparatus further includes a selectively openable door allowing access to the hexagonal interior; and a support portion attached to the rigid body allowing access to the lower side of the rigid body. The hexagonal interior is configured to receive a hexagonal flexible bioprocessing container having a liquid level height-to-width ratio of ≤1.

[0012] In one embodiment, the hexagonal interior is configured to receive a 2000L hexagonal flexible biological treatment container, and the device has an overall width of approximately 170cm and an overall height of approximately 202cm.

[0013] In another embodiment, the hexagonal interior is configured to receive a 3000L hexagonal flexible bioprocessing container, and the device has an overall width of approximately 195cm and an overall height of approximately 210cm.

[0014] In another embodiment, the bottom surface has at least one alignment aperture configured to engage at least one positioning tab on the base portion of the hexagonal flexible bioprocessing container to align the hexagonal flexible bioprocessing container within the hexagon.

[0015] In another embodiment, the rigid body has a hexagonal exterior formed by six rigid panels, the six rigid panels further defining six sides inside the hexagon.

[0016] In another embodiment, one of the six rigid panels faces the front of the device and includes a selectively openable door.

[0017] In another embodiment, the device includes an opening in a rigid body located beneath a selectively openable door, which facilitates the connection of one or more fluid lines and / or probes to a hexagonal flexible bioprocessing container.

[0018] In another embodiment, the rigid body may include a sill located between a selectively openable door and a bottom surface inside the hexagon, the sill having a notch configured to receive a hexagonal flexible bioprocessing container in a folded or collapsed state to facilitate mounting the hexagonal flexible bioprocessing container onto the bottom surface inside the hexagon.

[0019] In another embodiment, the bottom surface includes at least one opening configured to allow tubing from the hexagonal flexible bioprocessing container to exit the interior of the hexagon.

[0020] According to one aspect of the invention, a hexagonal flexible bioprocessing container includes six flexible panels forming sides of the hexagonal flexible bioprocessing container, and a top panel adjacent to the six flexible panels, the top panel forming the top of the hexagonal flexible bioprocessing container. The container further includes a bottom panel adjacent to the six flexible panels, located at one end of the hexagonal flexible bioprocessing container opposite the top surface, and forming the bottom of the hexagonal flexible bioprocessing container. The six flexible panels, the top surface, and the bottom panel define an inner cavity configured for processing fluid, and at least one fluid inlet and at least one fluid outlet for adding fluid to and removing fluid from the inner cavity of the hexagonal flexible bioprocessing container, respectively. The hexagonal flexible bioprocessing container has a liquid level height to width ratio of ≤1.

[0021] In one embodiment, the hexagonal flexible bioprocessing container has a capacity of 2000L and a liquid level height to width ratio of approximately 0.91.

[0022] In another embodiment, the hexagonal flexible bioprocessing container has a width of about 150 cm, an overall height of about 151 cm, and a liquid level height of about 137 cm.

[0023] In one embodiment, the hexagonal flexible bioprocessing container has a capacity of 3000L and a liquid level height to width ratio of approximately 0.86.

[0024] In one embodiment, the hexagonal flexible bioprocessing container has a width of approximately 175 cm, an overall height of approximately 159 cm, and a liquid level height of approximately 151 cm.

[0025] In an embodiment, the bottom panel and / or the top panel may be separate panels.

[0026] In one embodiment, each of the six flexible panels is thermally welded to an adjacent panel.

[0027] In one embodiment, the inner cavity includes an impeller, and the top panel includes a selectively removable impeller cover to protect the impeller during transport of the hexagonal flexible bioprocessing container.

[0028] In one embodiment, the hexagonal flexible bioprocessing container can be folded for storage and / or transport, and unfolded for mounting on the bottom surface of a rigid support structure. Attached Figure Description

[0029] The invention will be better understood by referring to the following description of non-limiting embodiments, in which: Figure 1 This is a perspective view of a rigid support structure according to an embodiment of the present invention; Figure 2 yesFigure 1 The top view of the rigid support structure depicts the interior of a hexagon with a bottom surface having alignment orifices for aligning a flexible container placed inside the hexagon. Figure 3 yes Figure 1 Front view of the rigid support structure; Figure 4 yes Figure 1 Side view of the rigid support structure; Figure 5 There is no door that can be selectively removed. Figure 1 Front view of the rigid support structure; Figure 6 This is an exploded perspective view of a flexible biological treatment container according to an embodiment of the present invention, showing individual panels for assembly; Figure 7 This is a perspective view of an assembled flexible biological treatment container according to an embodiment of the present invention; Figure 8 This is another perspective view of a flexible biological treatment container according to an embodiment of the present invention, depicting the container being fixed to a device for transporting and installing the container in a rigid support structure; Figure 9 It is used in Figure 8 A perspective view of the equipment for transporting and installing containers in a rigid support structure; Figure 10 This is an illustration of a user transporting and installing a flexible biological treatment container into a rigid support structure according to an embodiment of the present invention. Figure 11 This is another illustration of a flexible bioprocessing container being mounted into a rigid support structure according to an embodiment of the present invention, depicting tabs engaging alignment orifices in the rigid support structure to facilitate container alignment. Figure 12 This is yet another illustration of a flexible biological treatment container being mounted into a rigid support structure according to an embodiment of the present invention.

[0030] Figure 13 This is an illustration of a flexible biological treatment container being installed into a rigid support structure according to an embodiment of the present invention, depicting the foot portion engaging a groove in the rigid support structure to facilitate container alignment. Figure 14 It is based on Figure 13 Another illustration of an embodiment of mounting a flexible bioprocessing container into a rigid support structure; Figure 15 It is based on Figure 13 Another illustration of an embodiment of the flexible biological treatment container being mounted into a rigid support structure. Detailed Implementation

[0031] The following detailed reference will be made to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar portions.

[0032] As used in this article, the terms "flexible" or "collapseable" refer to a structure or material that is flexible or capable of bending without breaking, and may also refer to materials that are compressible or expandable. An example of a flexible structure is a bag formed from a polyethylene film.

[0033] As used herein, the term "container" refers to a flexible bag, flexible container, semi-rigid container, or rigid container, as appropriate. As used herein, the term "container" is intended to encompass containers with flexible walls or portions thereof (e.g., bioprocessing containers), single-use flexible bags, and other containers or conduits commonly used in biological or biochemical processes, including, for example, cell culture / purification systems, fermentation systems, mixing systems, culture medium / buffer preparation systems, and filtration / purification systems.

[0034] As used in this article, the term "bag" refers to a flexible or semi-rigid container, for example, used as a mixer or bioreactor for its internal contents.

[0035] The embodiments can be used in conjunction with a wide range of biological and chemical processes (collectively referred to herein as "bioprocessing"). This term encompasses, but is not limited to, various processes occurring in bioreactors, mixers, fermenters, etc. A "bioprocessing vessel" is a container suitable for use with or in connection with a bioreactor, mixer, fermenter, or other biological or chemical processing apparatus. Some embodiments may be suitable for use in other industries where size, ease of installation, and / or efficient and versatile fluid mixing are desirable.

[0036] Now for reference Figure 1 This paper depicts an apparatus 100 for supporting a flexible bioprocessing container according to an embodiment of the invention. The apparatus 100 includes a rigid body 102 having a hexagonal interior 104, the hexagonal interior 104 including a bottom surface 106 and six rigid panels 108 forming sides around the bottom surface 106. The hexagonal interior 104 has a substantially open top 110 and a selectively openable door 112 including a polycarbonate viewing window 119. Of course, in embodiments, the viewing window 119 may have different sizes, shapes, and materials without departing from the invention. As will be appreciated, the selectively openable door 112 allows access to the hexagonal interior 104, which is configured to receive a hexagonal flexible bioprocessing container 300. Figure 7 ).

[0037] In the depicted embodiment, the rigid body 102 has a hexagonal exterior formed by six rigid panels 108, which also define six sides of the hexagonal interior 104. However, as will be appreciated, in other embodiments, the exterior of the rigid body 102 may have a shape, structure, or configuration that deviates from the hexagonal interior 104. For example, in embodiments, the exterior may have a different structure from the hexagonal interior; for instance, the rigid body may have an exterior of a square, cuboid, cylindrical, or other shape while maintaining its hexagonal interior 104. In an embodiment, a selectively openable door 112 is located on one of the six rigid panels facing the front of the device.

[0038] Refer again Figure 1 The device 100 also includes a space or opening 160 in a rigid body 102 located below a selectively openable door 112, the opening 160 facilitating the connection of tubing (e.g., one or more fluid lines and / or probes) to the hexagonal flexible bioprocessing container. That is, it allows the tubing to exit the hexagonal interior. In a particular embodiment, the opening 160 allows access to the sample line port 309, sensor port 313, and discharge port 306. Figure 7 ).

[0039] The rigid body 102 further includes a support portion 115 attached to the rigid body 102, which allows access to the space beneath the rigid body. In the depicted embodiment, the support portion 115 includes a plurality of legs. However, the number of legs may vary, and some embodiments may utilize structures other than the legs to elevate the rigid body 102 or otherwise allow access to the lower side of the rigid body. In some embodiments, the leg height is adjustable and may include load cells. As will be appreciated, access to the space beneath the rigid body 102 is important because the hybrid motor, seat locking mechanism, and forklift aisle (and other features) are located beneath the rigid body 102.

[0040] As mentioned, device 100 is configured to receive a hexagonal flexible bioprocessing container. Specifically, the hexagonal flexible bioprocessing container has a total bag height of ≤1 and a height-to-width ratio of liquid level (e.g., maximum liquid level). In one embodiment, the hexagonal interior 104 is configured to receive a 2000L hexagonal flexible bioprocessing container, and the device has an overall width of approximately 172cm, a depth of approximately 165cm (including probe supports), and an overall height of approximately 203cm. In another embodiment, the hexagonal interior 104 is configured to receive a 3000L hexagonal flexible bioprocessing container, and the device has an overall width of approximately 195cm, a depth of approximately 186cm (including probe supports), and an overall height of approximately 210cm.

[0041] As mentioned, the height of known cuboid and cylindrical support structures for 2000L to 3000L containers does not allow for installation in existing cleanrooms without internal modifications. Furthermore, challenges, such as membrane width limitations, in manufacturing large cuboid flexible containers for use within wider support structures limit the height of 2000L / 3000L cubic / cuboid (e.g., square) tanks, which would otherwise allow for greater width. However, the use of hexagonal flexible bioreactor container configurations, combined with a greater number of relatively small / narrow panels, allows for the creation of 2000L to 3000L flexible bioreactor containers with a height-to-width ratio of less than or equal to approximately 1. This, in turn, facilitates the use of rigid support structures with a height (and width) lower than existing standard cleanroom doors, such as double doors with a height of 213.4 cm (7 ft) and a width of 182.9 cm (6 ft).

[0042] While embodiments of the rigid body and flexible hexagonal bioprocessing container are not limited to a specific height or width, it is envisioned that the rigid body and flexible hexagonal bioprocessing container will have a capacity of 2000L or greater while maintaining a height that allows passage through existing cleanroom doors as described above.

[0043] Now for reference Figure 2 The embodiment of device 100 facilitates alignment of the flexible bioprocessing container during installation. Specifically, the bottom surface 106 of the rigid body 102 includes at least one alignment aperture 114, and in the depicted embodiment, two alignment apertures. Each alignment aperture 114 is shaped and configured to receive a tab 520 operably attached to the bottom of the flexible container 400. Figure 8 and Figure 9 The alignment orifices 114 need not be of any particular shape or size, as long as they functionally engage features on the container to prompt the user for proper alignment. The alignment orifices are generally equidistant from the drive motor head / impeller engagement mechanism 118. As will be appreciated, in this embodiment, the alignment orifices 114 align the container's impeller substantially with the motor that engages the impeller to provide rotation (e.g., mixing).

[0044] The bottom surface 106 further includes an opening 116 that allows an exhaust line from the flexible biotreatment container to pass through the bottom surface 106 for connection to an external receiving portion (not shown). In this respect, the rigid body 102 also includes a bracket 161 for holding or supporting the exhaust line. Figure 1 These features can take various shapes and sizes, as long as the discharge line can be effectively connected and supported for use.

[0045] The bottom surface 106 further includes a groove 117 (or multiple grooves), which, in embodiments, leads to or is part of an opening 116. The groove 117 is located... Figure 5 and Figure 10 The rear of the sill 120 is shown. The size or shape of the slot 117 is not limited, as long as they allow sufficient positioning / alignment functionality. As described in more detail below, the alignment aperture 114 and slot 117 are used for aligning and mounting the container within the hexagonal interior 104.

[0046] In an embodiment, the rigid body 102 may be equipped with heating and cooling, which may be in the form of a jacket (not shown). For this purpose, the rigid body includes a heating inlet 130 and a heating outlet 131. The rigid body 102 further includes one or more mounting brackets 132 for securing a controller and / or a cabinet containing a pump, load cell connections, etc., to the body (not shown).

[0047] In one embodiment, the rigid body 102 is made of stainless steel. However, the invention is not limited to this, and other suitable rigid and durable materials may be used. In some embodiments, the rigid body 102 may be made of a polymer material. The rigid body 102 includes panels welded together or connected by mechanical and / or chemical fastening mechanisms. In some embodiments, the rigid body 102 may be cast or molded, and therefore may be integral.

[0048] Although the six rigid panels 108 are depicted as being of equal size, in some embodiments the panels may have different widths. That is, for example, it is possible that two opposing panels have a first width, and the remaining panels have a second width that is greater than or less than the first width. Similarly, the six rigid panels 108 need not each be monolithic, and each panel may be composed of two or more connected / welded sub-panels. The rigid panels are also not limited to a specific thickness and may be multilayer composite materials or single-layer rigid materials. In embodiments, the rigid panels may also include insulating material.

[0049] In some embodiments, the panels are removably connected together, such that the rigid body can be detached after use for storage and / or shipped as a flat package for on-site assembly.

[0050] Now for reference Figure 3 and Figure 4 The rigid body 102 further includes a seat locking handle / mechanism 140 for clamping an impeller seat on a container (not shown) to the rigid body 102. The door 112 further includes a latching mechanism and a handle 113, which in an embodiment may include a locking device or sensor to provide an alarm if opened during use. The device 100 is also depicted having a hybrid motor 150 operatively connected to the rigid body 102.

[0051] Now go to Figure 5 The invention depicts a rigid body 102 with a selectively openable door removed. Embodiments of the invention include a sill 120 as previously mentioned. The sill 120 is located between the selectively openable door 112 and the hexagonal interior 104. The sill 120 has a rectangular recess or notch 122 configured to receive a folded hexagonal flexible bioprocessing container for mounting on the bottom surface 106 of the hexagonal interior 104. Thus, the notch 122 provides an initial alignment feature to guide the container into the hexagonal interior 104. In an embodiment, the notch 122 is sized to correspond with the base portion 502 of a support device for transporting and mounting the container. Figure 8 and Figure 9 The width of the notch is approximately equal to that of the base portion 502, which has a width of 34 cm. In one embodiment, the notch 122 has a width sized to accommodate the passage of the base portion 502.

[0052] The sill 120 is not limited to a specific thickness, shape, or size. However, the notch 122 in the sill 120 should be configured to allow the folded container to pass through while generally guiding it toward alignment features such as alignment apertures 114 on the bottom surface 106 of the hexagonal interior 104.

[0053] Embodiments of the present invention also pertain to hexagonal biological treatment containers. For example... Figure 6 As shown, in one embodiment, the hexagonal flexible bioprocessing container 200 includes six flexible panels 202, which are fixed to a top panel 204 (in an embodiment, the top panel 204 may be a double-panel design). Figure 8 )) and bottom panel 206, which define an inner cavity 214 configured for handling fluid.

[0054] The inner cavity 214 includes an impeller 210 (the impeller seat here is welded to the container and is shown without blades), and the top panel 204 includes a protective cover 207 attached to the container via a flange 209. The protective cover 207 covers and protects the impeller 210 during the shipment / transportation of the container.

[0055] As will be appreciated, the embodiments are not limited to any particular impeller design or construction. For example, various impellers can be used to assume that desired mixing power and minimum mixing / stirring volume are achieved. Examples of impeller designs suitable for use with embodiments of the invention are described in U.S. Patent No. 11,065,589, which is incorporated herein by reference in its entirety, unless any of the incorporated material is inconsistent with the explicit disclosure herein.

[0056] In one embodiment, the six flexible panels, the top panel, and the bottom panel are each thermally welded to adjacent panels. As will be appreciated, various manufacturing techniques and processes can be employed to assemble, weld, or otherwise construct the flexible bioprocessing container of the present invention, and the embodiments are not limited thereto. Although depicted as consisting of nine separate panels, including a separate bottom panel and a top panel, the bottom and / or top may be integrally integrated into the six flexible panels 302 forming the sides of the container.

[0057] Now for reference Figure 7 The image depicts an assembled hexagonal flexible bioprocessing container 300 configured for use with embodiments of the present invention. The container 300 includes the six flexible panels 302 described above, forming the sides of the hexagonal flexible bioprocessing container. The flexible bioprocessing container 300 includes a single top panel 304 adjacent to the six flexible panels 302 and forming the top of the hexagonal flexible bioprocessing container 300, and a bottom panel 308 located at the end of the hexagonal flexible bioprocessing container 300 opposite to the top panel 304, the bottom panel 308 adjacent to the six flexible panels 302 and forming the bottom of the hexagonal flexible bioprocessing container 300. The six flexible panels 302, the top panel 304, and the bottom panel 308 define an inner cavity for receiving fluids for mixing / processing.

[0058] The hexagonal flexible bioprocessing container 300 further includes at least one fluid inlet 310 and at least one fluid outlet (e.g., an exhaust port 306) for adding fluid to and removing fluid from the container's interior cavity, respectively. In embodiments, the container 300 further includes a sample line port 309, a powder port 311, and one or more sensor ports 313, which can be mounted on a plate welded to the container. In some embodiments, the container 300 includes an inflation port 315 for inflating the bag during installation, and one or more metering ports 317. The container also includes an impeller (not shown) (e.g., see...). Figure 8 ).

[0059] Importantly, and as previously mentioned, the hexagonal geometry of the flexible container allows for the creation of flexible bioprocessing containers ranging from 2000L to 3000L, with a height-to-width ratio of liquid level (e.g., maximum liquid level) of less than or equal to 1. This, in turn, allows for the construction and use of lower and wider rigid support structures / tanks.

[0060] In one embodiment, the hexagonal flexible bioreactor has a capacity of 2000L and a liquid level height-to-width ratio of approximately 0.91. The 2000L container has a width of approximately 150cm, a height of approximately 151cm, and a liquid level (e.g., maximum liquid level) height of approximately 137cm. A 3000L hexagonal flexible bioreactor according to another embodiment has a liquid level height-to-width ratio of approximately 0.86, a width of approximately 175cm, an overall height of approximately 159cm, and a liquid level height of approximately 151cm.

[0061] In addition to facilitating the installation of rigid support structures in existing cleanroom / laboratory spaces, the hexagonal flexible container geometry has also been shown to facilitate efficient mixing of both floating and settling powders, providing a level of versatility not found in known cubic or cylindrical containers and tanks.

[0062] Furthermore, the hexagonal flexible bioprocessing container also has a large volume range. In a particular embodiment, the 2000L hexagonal container has a nominal maximum volume of approximately 2000L, a minimum stirring volume of approximately 24L, a minimum sensing volume of approximately 51L, and a minimum mixing volume of approximately 172L. In another embodiment, the 3000L hexagonal container has a nominal maximum volume of approximately 3000L, a minimum stirring volume of approximately 36L, a minimum sensing volume of approximately 62L, and a minimum mixing volume of approximately 236L.

[0063] As will be appreciated, embodiments of the container can be made of a variety of flexible materials, including various polymeric materials. The invention is not limited to any particular membrane material, thickness, etc. The membrane can be a multilayer composite or a single-layer material, and can be opaque or transparent.

[0064] Although the six flexible panels 202 are depicted as having the same dimensions, in some embodiments the panels may have different dimensions (e.g., widths). That is, for example, two opposing panels may have a first width, and the remaining panels may have a second width greater than or less than the first width. Similarly, the six flexible panels 202 need not be monolithic, and each panel may be composed of two or more connected / welded sub-panels, similar to... Figure 6 The top panel 204 shown.

[0065] Now for reference Figure 8An embodiment of a 3000L hexagonal flexible bioprocessing container 400 is depicted. As shown, the container is connected to a device 500 for transporting and installing the container. The device 500 is secured to the container via a bottom-facing portion of the exterior of an impeller 510. The device 500 includes a base portion 502, which includes a first wing portion 504 and a second wing portion 506, each hingedly attached to the base portion 502. In use, the first wing portion 504 and the second wing portion 506 are configurable relative to the base portion 502 in a first position (where the device is folded to form a storage cavity 572 for the container). Figure 9 The device can be selectively moved between a first position and a second position (where the device is deployed and is substantially planar / flat within the support structure, allowing the container to be used).

[0066] exist Figure 9 In the first position depicted, the first wing portion 504 and the second wing portion 506 are angled relative to the base portion 502, for example, at an angle of approximately 90 degrees, to form a storage cavity 572. The device 500 further has a handle 524, which facilitates the transport and installation of the device 500. In this position, the container is folded and located within the device 500, and can be further packaged and shipped.

[0067] In an embodiment, at least one of the first wing portion 504 and the second wing portion 506 includes a side flap 522 extending in a first position between the first wing portion 504 and the second wing portion 506 to define the upper surface of a storage cavity 572. Each side flap 522 may include a connecting tab 550 that can be fitted through a slot 552 in an opposing wing portion. The tab 550 may include a hole configured to receive a cable tie or similar connector to secure the wing portion and the side flap 522 into place to form the storage cavity 572. In an embodiment, each side flap 522 may include one or more integrally engaged handles 524 that unfold when the device 500 is in the first position. In any case, in an embodiment, at least one of the first wing portion 504 and the second wing portion 506 includes a handle 524.

[0068] Furthermore, one of the base portion 502, the first wing portion 504, and / or the second wing portion 506 includes a front wing 530 and / or a rear wing 532, which respectively define the front surface and / or rear surface of the storage cavity in the first position. In the depicted embodiment, each of the first wing portion and the second wing portion includes a front wing 530. When the device 500 is in the first position, the front wings can be connected together via a slot 531.

[0069] As shown in the figure, in this embodiment, each of the front flaps 530 includes a tab or foot portion 521 that performs a positioning / alignment function by falling into a groove 117 behind the sill 120 of the rigid hexagonal support structure to facilitate proper alignment of the container. The front flap also includes an opening or cutout portion 526 that facilitates the connection of one or more fluid lines and / or probes to the flexible bioprocessing container 400.

[0070] In the depicted embodiment, each of the first wing portion 504, the second wing portion 506, and the base portion 502 includes a rear wing flap 532. These rear wing flaps 532 may be connected together via a slot 531, wherein the rear wing flap 532 on the base portion 502 is inside the other two rear wing flaps.

[0071] As will be recognized, the first wing portion and the second wing portion, the base portion 502, and the side wing, front wing and rear wing forming all sides of the device 500, thereby surrounding the container.

[0072] Importantly, the first wing portion and / or the second wing portion includes a positioning tab 520. The positioning tab 520 is configured to engage an alignment aperture 114 of the rigid body 102 to provide a user installing the hexagonal flexible bioprocessing container with indication of proper alignment of the hexagonal flexible bioprocessing container within the hexagon of the rigid body. Although the positioning tab 520 is depicted as part of a separate mounting device 500, in some embodiments, the container itself may include a positioning tab or other feature that engages the alignment aperture of the rigid body. In fact, the device 500 may be integral with, or otherwise part of, the flexible hexagonal bioprocessing container, rather than a separate component attached to it.

[0073] Now for reference Figure 10 , Figure 11 and Figure 12 The document describes an installation method in which two users initially lift / release the device 500 (which includes a container in a storage cavity) from its outer packaging (not shown). Generally, this involves two users, one on each side of the base portion, gripping handles located on the wing portion. The device 500 is then placed within a recess 122 in a sill 120 on the leading edge of the hexagonal interior of the rigid body. The device 500 is fitted into the recess 122 and guided through the recess into the hexagonal interior. A positioning tab 520 is then received / engaged by at least one alignment aperture 114, bringing the device 500 to a substantially aligned position. Once this position is achieved, a seat locking mechanism 140 is activated, which engages an impeller seat (not shown) to lock the container in place.

[0074] Now for reference Figure 13 , Figure 14 andFigure 15 Once device 500 and container 400 are in the container, and the tabs are in the alignment orifice ( Figure 11 Once the seat lock is engaged, the user should check to ensure that each foot portion 521 of each front wing 530 is fully seated in one of the slots 117. If so, the front wing 530 and wing portions can be opened to the second position, and installation can be completed by connecting all relevant fluid lines, pumps, and sensors and inflating the container. Use can then begin.

[0075] Embodiments of the invention also envision a method for folding a hexagonal flexible bioprocessing container for storage and transport, such as within an apparatus 500 for transporting and installing the container. In a particular embodiment, the method involves placing a top panel flat on top of a bottom panel to ensure the impeller cover is positioned above the impeller to protect the container membrane. The six corners of the top panel are then pushed down onto the six corners of the bottom panel. At this stage, the six flexible panels forming the sides are substantially upright in the vertical position.

[0076] Next, the panels on each side of the weld / joint between the six flexible panels are pushed together one after another, and each weld is folded towards the operator's left side onto the top panel. This is repeated six times, so that the originally upright sides are folded onto the top panel. The resulting folded container now has a substantially hexagonal shape. At this point, the container can be folded again, with the opposing sides folded together towards the center of the container, and the fluid outlet (e.g., port) facing upwards towards the operator. The container can now be placed in an outer package for shipment / transportation.

[0077] As will be appreciated, notwithstanding the foregoing, the embodiments are not limited to specific folding or packaging processes or techniques.

[0078] As used herein, elements or steps listed in the singular and beginning with the words “an” or “a” should be understood to not exclude multiple said elements or steps unless expressly stated otherwise. Furthermore, references to “an embodiment” of the invention are not intended to exclude other embodiments that also include the said features. Additionally, unless expressly stated otherwise, embodiments that “comprise,” “include,” or “have” elements or multiple elements having a particular property may include other such elements that do not have that property.

[0079] While the dimensions and material types described herein are intended to define the parameters of the invention, they are by no means limiting and are exemplary embodiments. Many other embodiments will become apparent to those skilled in the art from the above description.

[0080] Therefore, the scope of this invention should be determined with reference to the appended claims, together with the full scope of their equivalents. In the appended claims, the terms "comprising" and "wherein" are used as common English equivalents of the corresponding terms "including" and "in which".

[0081] Furthermore, in the following claims, terms such as “first,” “second,” “upper,” “lower,” “bottom,” “top,” etc., are used merely as labels and are not intended to impose quantity or positional requirements on their objects. Moreover, the limitations of the following claims are not written in means plus function form and are not intended to be construed as such, unless and until the limitation of the claim is explicitly expressed using the phrase “means for…” followed by a statement of function without further structure.

[0082] This written description uses examples to disclose several embodiments of the invention, including the best mode, and also enables those skilled in the art to implement embodiments of the invention, including making and using any apparatus or system and performing any incorporated methods. The scope of the invention is defined by the claims and may include other examples that may occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that are not different from the written language of the claims, or if they include equivalent structural elements that are not substantially different from the written language of the claims.

Claims

1. An apparatus for supporting a flexible biological treatment container, comprising: A rigid body having a hexagonal interior including a bottom surface and six sides surrounding the bottom surface, the hexagonal interior having a substantially open top; A selectively openable door that allows access to the interior of the hexagon; as well as A support portion attached to the rigid body, the support portion allowing access to the underside of the rigid body; The hexagonal interior is configured to receive a flexible hexagonal biological treatment container having a liquid level height to width ratio of ≤1.

2. The device according to claim 1, wherein, The hexagonal interior is configured to receive a 2000L hexagonal flexible biological treatment container, and the device has an overall width of approximately 172cm and an overall height of approximately 203cm.

3. The device according to claim 1, wherein, The hexagonal interior is configured to receive a 3000L hexagonal flexible biological treatment container, and the device has an overall width of approximately 195cm and an overall height of approximately 210cm.

4. The device according to claim 1, wherein, The bottom surface has at least one alignment aperture configured to engage at least one positioning tab on the base portion of the hexagonal flexible bioprocessing container to align the hexagonal flexible bioprocessing container within the hexagon.

5. The device according to claim 1, wherein, The rigid body has a hexagonal exterior formed by six rigid panels, which also define six sides inside the hexagon.

6. The device according to claim 5, wherein, One of the six rigid panels faces the front of the device and includes the selectively openable door.

7. The device of claim 6, further comprising an opening in the rigid body located below the selectively openable door, the opening facilitating connection of one or more fluid lines and / or probes to the hexagonal flexible bioprocessing container.

8. The device according to claim 1, wherein, The rigid body includes a sill located between the selectively openable door and the bottom surface of the hexagonal interior, the sill having a notch configured to receive the hexagonal flexible bioprocessing container in a folded or collapsed state, so as to facilitate mounting the hexagonal flexible bioprocessing container on the bottom surface of the hexagonal interior.

9. The device according to claim 1, wherein, The bottom surface includes at least one opening configured to allow tubing from the hexagonal flexible bioprocessing container to exit the interior of the hexagon.

10. A hexagonal flexible biological treatment container, comprising: Six flexible panels form the sides of the hexagonal flexible biological treatment container; The top panel adjacent to the six flexible panels forms the top of the hexagonal flexible biological treatment container; A bottom panel adjacent to the six flexible panels, the bottom panel being located at one end of the hexagonal flexible biological treatment container opposite to the top panel and forming the bottom of the hexagonal flexible biological treatment container, the six flexible panels, the top surface and the bottom panel defining an internal cavity configured for processing fluids; as well as At least one fluid input and at least one fluid output are respectively used to add fluid to the inner cavity of the hexagonal flexible biological treatment container and to remove fluid from the inner cavity; The hexagonal flexible biological treatment container has a liquid level height to width ratio of ≤1.

11. The hexagonal flexible biological treatment container according to claim 10, wherein, The hexagonal flexible biological treatment container has a capacity of 2000L and a liquid level height to width ratio of approximately 0.

91.

12. The hexagonal flexible biological treatment container according to claim 11, wherein, The hexagonal flexible biological treatment container has a width of approximately 150 cm, an overall height of approximately 151 cm, and a liquid level height of approximately 137 cm.

13. The hexagonal flexible biological treatment container according to claim 10, wherein, The hexagonal flexible biological treatment container has a capacity of 3000L and a liquid level height to width ratio of approximately 0.

86.

14. The hexagonal flexible biological treatment container according to claim 13, wherein, The hexagonal flexible biological treatment container has a width of approximately 175 cm, an overall height of approximately 159 cm, and a liquid level height of approximately 151 cm.

15. The hexagonal flexible biological treatment container according to claim 10, wherein, The bottom panel and / or the top panel are separate panels.

16. The hexagonal flexible biological treatment container according to claim 10, wherein, Each of the six flexible panels is thermally welded to an adjacent panel.

17. The hexagonal flexible biological treatment container according to claim 10, wherein, The inner cavity includes an impeller, and the top panel includes a selectively removable impeller cover to protect the impeller during transport of the hexagonal flexible bioprocessing container.

18. The hexagonal flexible biological treatment container according to claim 10, wherein, The hexagonal flexible bioprocessing container can be folded for storage and / or transportation, and unfolded for mounting on the bottom surface of a rigid support structure.

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