Flexible baffle for use in a bioreactor or mixer

Abstract

A flexible baffle and method for installing the same in a bioreactor or mixer vessel are provided. The flexible baffle includes multiple segments connected to one another via hinges. Each segment includes at least one alignment element that assists in aligning the segments when the baffle is placed in the bioreactor or mixer vessel, allowing the baffle to change from a non-linear shape (e.g., curved) during installation to a linear shape upon completion of installation in the bioreactor or mixer vessel.

Description

[Technical Field]

[0001] One or more embodiments of the subject matter described herein generally relate to flexible baffles and their use in bioreactors and mixers. [Background technology]

[0002] Single-use or disposable containers are increasingly being utilized in the biopharmaceutical industry. Such containers can be flexible or collapsible plastic vessels or bags supported by an outer rigid structure, such as a stainless steel shell or housing. Utilizing sterile, disposable bags eliminates the need for time-consuming housing cleaning steps and reduces the chance of contamination. The bag can be placed within the rigid housing and filled with the desired fluids for mixing. An agitator assembly located within the bag is utilized to mix the fluids. Existing agitators are either top-driven (having a shaft extending downward into the bag, on which one or more impellers are mounted) or bottom-driven (having an impeller located at the bottom of the bag driven by a magnetic drive system or motor located outside the bag and / or vessel).

[0003] Baffles are often located within the outer rigid structure. These baffles act as protrusions that push against the container when it is placed within the rigid structure, creating depressions within the container. These depressions help create turbulence in the fluid within the container as the agitator mixes the fluid, thereby improving mixing. The depressions also help prevent swirling of the fluid as agitation occurs, which can adversely affect the contents of the container (e.g., cells or cell products). While some bioreactors have baffles built into and directed into the rigid structure, there are also many instances in which baffles are manually added to the bioreactor according to user requirements. In larger-scale applications (e.g., greater than 500 L), the outer rigid structure (also referred to herein as the vessel) is large, and the baffles are similarly tall, heavy, and cumbersome to install.

[0004] Referring to FIG. 1, a prior art bioreactor or mixer system 10 is shown. The bioreactor or mixer system 10 includes a generally rigid bioreactor or mixer vessel 12 mounted on a base 14 having a plurality of legs 16. The bioreactor or mixer vessel 12 may be formed, for example, from stainless steel, a polymer, a composite, glass, or other metal and may be cylindrical in shape, although other shapes may be utilized without departing from the broader aspects of the present invention. Disposed within the bioreactor or mixer vessel 12 is a single-use, flexible container or bag 15. The bioreactor or mixer vessel 12 may be of any shape or size, so long as it is capable of supporting the single-use, flexible bioreactor bag 15. For example, according to one embodiment of the present invention, the bioreactor or mixer vessel 12 is capable of receiving and supporting a 10-2000 L flexible or collapsible bioprocess bag 15.

[0005] 2, which is a top-down view of a bioreactor or mixer vessel 12 having a plurality of baffles 14 disposed about its inner periphery. However, as is known in the prior art, such baffles 14 are either integrated into the bioreactor or mixer vessel 12 or manually added. However, when manual addition is performed, height and size constraints often prohibit such installation.

[0006] For example, as shown in FIG. 3A , the XDR2000 bioreactor (e.g., a 2000 L bioreactor) offered by Cytiva® has a height (H1) of approximately 2600 mm (8.5 feet). The length of a standard baffle 14 required for use with a bioreactor of this size is approximately 1500 mm (4.9 feet). Inserting such a long baffle 14 into such a vessel (e.g., the XDR2000) is cumbersome or impossible due to the combination of the height of the vessel itself and the height H2 of the ceiling 13. For example, the industry standard ceiling 13 height (H2) is approximately 10 to 12 feet, which makes it impossible to insert a standard baffle 14 (e.g., because the distance H2-H1 is too small compared to the length of the baffle 14). Thus, there is a need for a modified baffle that can be used with bioreactors and mixers where height limitations prevent the use of standard baffles. Summary of the Invention [Means for solving the problem]

[0007] An embodiment of the present invention provides a baffle (100, 200) for use with a bioreactor or mixer (10) that includes a plurality of segments (110, 210), each connected to at least one other segment (110, 210) of the plurality of segments by a hinge (120, 220), and each segment including at least one alignment element (130, 230) configured to align each segment (110, 210) with an adjacent segment (110, 210) such that the baffle (100, 200) is configured to move between a non-linear shape and a linear shape.

[0008] The baffle includes a top segment (112, 212) having a fastening element (113, 213) configured to be attached to a bioreactor or mixer (10). The baffle also includes a bottom segment with a tapered portion (115, 215).

[0009] The at least one alignment element includes at least one magnet (132, 232), the magnets (132, 232) in adjacent segments (110, 210) having opposite polarities such that they attract each other to align each segment (110, 210) with the adjacent segment (110, 210).

[0010] Alternatively and / or additionally, at least one alignment element (130, 230) comprises a mechanical element, the mechanical element being selected from the group consisting of an alignment rod, a recess, a snap fit element, a tongue, and a groove.

[0011] Each hinge (120, 220) of the baffle is attached to two adjacent segments (110, 210) and allows the adjacent segments (110, 210) to move relative to one another.

[0012] The baffles (100, 200) and each of the plurality of segments (110, 210) may have a triangular cross-sectional shape.

[0013] When the baffles (100, 200) are in a straight configuration, the outer surfaces (140, 240) of the baffles (100, 200) are free of sharp edges.

[0014] Each of the plurality of segments (110, 210) includes a top surface (116, 216) and a bottom surface (118, 218), and the top surface (116, 216) and / or the bottom surface (118, 218) of adjacent segments (110, 210) each includes an alignment element (130, 230).

[0015] An embodiment of the present invention further provides a method of installing a baffle (100, 200) in a bioreactor or mixer (10), comprising the steps of providing a baffle (100, 200) of claim 1; bending the baffle (100, 200) to assume a non-linear shape; inserting a bottom segment (114, 214) of the baffle (100, 200) into a top opening in the bioreactor or mixer (10) and lowering the baffle (100, 200) into the bioreactor or mixer; aligning adjacent segments (110, 210) via respective alignment elements (130, 230) on each of the segments (110, 210); and attaching top segments (112, 212) of the plurality of segments (110, 210) to the bioreactor or mixer (10).

[0016] The step of aligning adjacent segments (110, 210) includes magnetically coupling the adjacent segments (110, 210), and magnetically coupling the adjacent segments (110, 210) includes positioning magnets (132, 232) of opposite polarity in the adjacent segments (110, 210) in close proximity to each other.

[0017] Alternatively and / or additionally, the step of aligning adjacent segments (110, 210) includes mechanically coupling the adjacent segments, and mechanically coupling the adjacent segments (110, 210) includes placing an alignment rod in a recess, snap-fitting elements together, or placing a tongue in a groove.

[0018] The method further includes circulating a heat transfer fluid through the baffles (100, 200).

[0019] The method further includes passing at least one tubing or cable through the baffle (100, 200).

[0020] The method further includes attaching at least one bioprocessing component to the baffle (100, 200).

[0021] A further embodiment provides a baffle (300) for use with a bioreactor or mixer (10) that includes a unitary structure made from a flexible material such that the baffle (300) is configured to bend between a non-linear shape and a linear shape, the flexible material being rubber. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 shows a bioreactor according to the prior art. [Figure 2] FIG. 2 is a top-down view of the bioreactor of FIG. 1. [Figure 3A] FIG. 1 illustrates the difficulties associated with conventional baffle installation in the prior art. [Figure 3B] 10A-10C illustrate the advantages of installing flexible baffles, according to an embodiment of the present invention. [Figure 4A] FIG. 1 is a front view of a flexible baffle according to an embodiment of the present invention. [Figure 4B] FIG. 2 is a side view of a flexible baffle according to an embodiment of the present invention. [Figure 5A] FIG. 2 is a cross-sectional view of a flexible baffle according to an embodiment of the present invention. [Figure 5B] FIG. 10 is a rear view of a flexible baffle according to an embodiment of the present invention. [Figure 5C] FIG. 2 is an enlarged view of area A of a flexible baffle in accordance with an embodiment of the present invention. [Figure 6A] FIG. 5D is a side view of the flexible baffle of FIGS. 4A-5C in a curved state. [Figure 6B] FIG. 5D is a perspective view of the flexible baffle of FIGS. 4A-5C in a curved state. [Figure 6C] FIG. 5D is an enlarged view of region B of the flexible baffle of FIGS. 4A-5C in a curved state. [Figure 7A]FIG. 10 is a front view of a flexible baffle according to a further embodiment of the present invention. [Figure 7B] FIG. 10 is a side view of a flexible baffle according to a further embodiment of the present invention. [Figure 8A] FIG. 7C is a cross-sectional view of the baffle of FIGS. 7A-7B. [Figure 8B] FIG. 7C is an enlarged view of region C of the baffle of FIGS. 7A-7B. [Figure 9A] FIG. 8C is a perspective view of the flexible baffle of FIGS. 7A-8B. [Figure 9B] FIG. 8C is an enlarged view of region D of the flexible baffle of FIGS. 7A-8B. [Figure 10] FIG. 8C is a perspective view of the flexible baffle of FIGS. 7A-8B in a non-linear configuration. [Figure 11A] FIG. 10 is a perspective view of a flexible baffle according to a further embodiment of the present invention. [Figure 11B] FIG. 10 is a side view of a flexible baffle according to a further embodiment of the present invention. [Figure 11C] FIG. 10 is a front view of a flexible baffle according to a further embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0023] As used herein, elements or steps defined in the singular and preceded by the word "a" or "an" should be understood not to exclude a plurality of such elements or steps, unless such exclusion is expressly stated. Furthermore, references to "one embodiment" are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the specified features. Also, unless expressly stated to the contrary, embodiments that "comprise" or "have" an element or elements having a particular characteristic can include additional such elements that do not have that characteristic.

[0024] It should be noted that the particular configuration (e.g., number, type, arrangement, etc.) of the components of the illustrated embodiment may be modified in various alternative embodiments. For example, different numbers of baffles, as well as the number of segments comprising each baffle, may be modified in various embodiments and remain within the scope of the present invention.

[0025] As used herein, a structure, limitation, or element that is "configured" to perform a task or operation can be specifically structurally formed, constructed, or adapted in a manner corresponding to that task or operation. For clarity and avoidance of doubt, an object that is merely capable of being modified to perform a task or operation is not "configured" to perform a task or operation as used herein. Instead, the use of "configured" as used herein indicates a structural fit or characteristic, and indicates a structural requirement of any structure, limitation, or element that is described as being "configured" to perform a task or operation.

[0026] 3B, as described in more detail below, flexible baffles 100, 200 according to embodiments of the present invention are provided, thereby enabling manual addition of baffles to any size bioreactor or mixer. By providing multiple hinged segments 110, 120 on the flexible baffles 100, 200, the baffles 100, 200 can assume non-linear (e.g., curved) shapes during installation, eliminating height limitations. When the baffles 100, 200 are installed in the bioreactor or mixer vessel 12 (or once fully positioned), the multiple hinged segments 110, 120 align and / or connect to one another via alignment elements 130, 230, allowing the baffles 100, 200 to assume a linear shape and act to crush the fluid in the bag 15 as the fluid in the bag is agitated.

[0027] 4A and 4B, front and side views of a flexible baffle 100 are shown in accordance with an embodiment of the present invention. The flexible baffle 100 includes a plurality of segments 110. Each segment 110 is attached to at least one other segment 110 of the plurality of segments by a hinge 120. As shown, a top segment 112 is attached at its bottom end to an adjacent segment 110 by a hinge 120, allowing the two segments 110 to move relative to one another. A plurality of middle segments 110 are connected to adjacent segments by hinges 120 located at their top and bottom ends. Similarly, a bottom segment 114 is attached at its top end to an adjacent segment 110 by a hinge 120. As shown in FIGS. 6A and 6B, by constructing the baffle 100 from a plurality of segments 110 connected by hinges, the baffle 100 can assume a curved or linear shape (see, for example, FIGS. 4A-5C). The curved shape allows the baffle 100 to be inserted into the bioreactor or mixer vessel 12 with much less clearance (e.g., a distance of H2-H1 or less). The baffle 100 can then be made from the curved shape to a straight shape by aligning the segments 110 as further described below.

[0028] 4A and 4B , the top segment 112 includes a fastening element 113 for attaching the top of the baffle 100 to the bioreactor or mixer vessel 12. The fastening element 113 can be, for example, a flange, a t-bar, or any other mechanical element that can hook onto the top of the wall of the bioreactor or mixer vessel 12. The bottom segment 114 includes a tapered surface 115. The tapered surface 115 is implemented to help ensure that the baffle 100 does not come into contact with an agitator (e.g., an impeller) disposed within the single-use, flexible container or bag 15. Each segment 110 can optionally include multiple holes or voids 117 to reduce the amount of material required to construct the baffle 100.

[0029] 5A, which is a cross-sectional view of the baffle 100, each segment 110 can include at least one alignment element 130. Each alignment element 130 is configured to interact with or engage with an alignment element 130 in an adjacent segment 110. Each alignment element 130 is disposed on the bottom surface 118 or the top surface 116 of each segment 110 such that the abutting top and bottom surfaces 116, 118, respectively, have an alignment element 130. The alignment elements 130 are configured to connect abutting / adjacent segments 110 to one another so that when (or after) the baffle 100 is installed in the bioreactor or mixer vessel 12, adjacent segments automatically align with one another, thereby assisting in changing the shape of the baffle 100 from a non-linear to a linear shape.

[0030] In embodiments, each alignment element 130 can be a magnet, alignment rod, recess, snap-fit element, tongue, or groove. By way of example, the alignment element 130 located on the bottom surface 118 of one segment 110 can be a magnet 132 having a first polarity, while the alignment element 130 located on the top surface 116 of the adjacent, lower segment 110 can be a magnet 132 having a polarity opposite to the first polarity. Thus, when the top and bottom surfaces 116, 118 of adjacent segments 110 are brought into close proximity with each other, the magnets 132 attract each other, thereby linearly aligning the segments 110 with each other. In other examples, adjacent segments 110 can have corresponding mating mechanical elements, such as alignment rods and grooves, snap-fit elements, tongues and grooves, etc. In this manner, the top and bottom surfaces 116, 118 of adjacent segments 110 can reversibly connect to one another when they contact one another, helping to ensure that the baffle 100 maintains a straight shape when installed in the bioreactor or mixer vessel 12.

[0031] 5B and 5C, which show a rear view and a close-up view of baffle 100, hinges 120 can be connected to the rear and / or underside of each segment 110. Additionally, gaps 121 can exist between adjacent segments on the rear side of baffle 100, but not on the front side, to accommodate all or part of hinges 120 (see, e.g., FIGS. 4A and 4B).

[0032] 6A-6C are side views, perspective views, and an enlarged view of region B of the flexible baffle 100. As shown in FIGS. 6A and 6B, the baffle 100 can assume a non-linear (e.g., curved) shape as well as a linear shape (see, e.g., FIGS. 4A-5B). By assuming such a non-linear shape, a method for installing the baffle 100 into the bioreactor or mixer vessel 12 can include bending the baffle 100 to assume the non-linear shape, inserting bottom segments (114, 214) of the baffle (100, 200) into a top opening in the bioreactor or mixer vessel 12 and lowering the baffle 100 into the bioreactor or mixer vessel 12, aligning adjacent segments 110 via respective alignment elements on each of the segments, and attaching top segments 112 of the plurality of segments 110 to the bioreactor or mixer vessel 12.

[0033] As best shown in FIG. 6C , the bottom and top surfaces 118, 116 of adjacent segments 110 include alignment elements 130 configured to connect or otherwise interlock with one another to ensure that the baffle 100 maintains a linear shape when installed in the bioreactor or mixer vessel 12. This figure also illustrates how the bottom and top surfaces 118, 116 of adjacent segments 110 are not planar. Rather, the front portions of each surface are configured to contact one another, while the rear portions of each surface are separated (e.g., by gaps 121, shown in FIG. 5C ), which accommodate the hinges 120. Additionally, the hinges 120 can be attached to the rear side of the segments 110 (e.g., as shown in FIGS. 5A-5C ) or can connect to the respective top and bottom surfaces 116, 118 of adjacent segments 110 (e.g., as shown in FIG. 6C ). The gaps 121 accommodate all or part of the hinges 120, as discussed above.

[0034] 7A-9B, another embodiment of a flexible baffle 200 is shown. Similar to the previous embodiment, the flexible baffle 200 includes multiple segments 210, with adjacent segments attached to one another via hinges 220. Each segment 210 includes a top surface 216 and a bottom surface 218. The baffle 200 includes a top segment 212 with a securing element 213 attached thereto and a bottom segment 214 with a tapered front surface 215. Alignment elements 230 are disposed on the top surface 216 and bottom surface 218 of each of adjacent segments 210 to align the segments 210 when the baffle 200 is inserted into the bioreactor or mixer vessel 12. Unlike the segments 110, the baffle 200 includes segments 210 that do not include holes. Rather, the segments 210 may be constructed from sheets of material having a completely hollow interior.

[0035] As best shown in FIGS. 8B, 9A, and 9B, each alignment element 230 can be disposed within a housing 231 attached to the inner surface of each segment 210 (see, for example, FIG. 9A). Alternatively, the housing 231 can be omitted, and each alignment element can be directly attached to (or integral with) its respective segment 210. As in the previous embodiment, each alignment element 230 can be a magnet 232, an alignment rod, a recess, a snap-fit element, a tongue, or a groove. By way of example, the alignment element 230 disposed on the bottom surface 218 of one segment 210 can be a magnet 232 having a first polarity, while the alignment element 230 disposed on the top surface 216 of the adjacent, lower segment 210 can be a magnet 232 having a polarity opposite to the first polarity. In this manner, when the top and bottom surfaces 216, 218 of adjacent segments 210 are brought into close proximity with each other, the magnets 232 attract each other, thereby linearly aligning the segments 210 with respect to each other. In other examples, adjacent segments 210 can have corresponding mating mechanical elements, such as alignment rods and grooves, snap-fit elements, tongues and grooves, etc. In this manner, the top and bottom surfaces 216 and 218 of adjacent segments 210 can reversibly connect to one another when they contact one another, helping to ensure that the baffle 100 maintains a straight shape when installed in the bioreactor or mixer vessel 12.

[0036] 9A and 9B, the top and bottom surfaces 216, 218 of adjacent segments 210 may be planar. Unlike the previous embodiment, in this embodiment, the hinge 220 may be accommodated in the open space on the base side of the segments 210.

[0037] As shown in FIGS. 11A-11C , according to further embodiments, the flexible baffle 300 can omit the segments and hinges and instead be made of a unitary, flexible material. According to embodiments, the flexible material is a flexible polymeric material. According to preferred embodiments, the polymeric material is rubber (e.g., ethylene propylene diene monomer rubber, nitrile butadiene rubber, silicone rubber, etc.). The flexibility of the material allows the baffle 300 to bend into a non-linear shape during installation, such that the baffle 300 assumes a curved or semi-curved shape when inserted into the bioreactor or mixer vessel 12. Once the baffle 300 is loaded into the bioreactor or mixer vessel 12, the baffle 300 will return to its original linear shape. Similar to the previously described flexible baffles 100 and 200, the baffle 300 can further include a fastening element 313 for attaching the top of the baffle 300 to the bioreactor or mixer vessel 12. Additionally, a hole or through-hole can be located through the center of baffle 300 along its longitudinal axis to allow for the passage of tubing, wiring, or temperature-regulating fluid. Compared to the previous embodiment, baffle 300 is inexpensive to manufacture due to the lack of metal parts, hinges, etc. Additionally, the baffle can be made from a flexible polymer material (e.g., rubber) so that there are no sharp edges or surfaces that could puncture bag 15. Furthermore, the flexible polymer material (e.g., rubber) can be selected to be a thermally conductive material so that the fluid within bag 15 can be heated / cooled more efficiently.

[0038] Baffles 100, 200, 300 according to embodiments of the present invention can have a generally triangular shape when viewed in cross section in a transverse plane (i.e., a top-down view). While a preferred embodiment encompasses a triangular shape, other shapes are within the scope of the present invention (e.g., semicircular, rectangular, square, etc.). However, to ensure that the bag 15 is not punctured during installation or use, the baffles 100, 200, 300 may not include sharp edges facing the interior of the bioreactor or mixer vessel 12. For example, as shown in the drawings, the leading and side edges of the baffles 100, 200, 300 may be curved with chamfers or fillets to prevent the creation of hard / sharp edges that could puncture the bag 15.

[0039] The baffles 100, 200, 300 may also be utilized for purposes other than bridging fluid. For example, the baffles 100, 200 may be utilized as heat transfer surfaces for tubing and / or cabling and / or as mounting surfaces for additional components. To act as heat transfer elements, the baffles 100, 200, 300 may have a heat transfer fluid (e.g., gas or liquid) routed therethrough. For example, because the baffles 100, 200, 300 need not be solid, the heat transfer fluid may be circulated through the baffles 100, 200, 300 or through tubing located within or behind the baffles 100, 200, 300. The temperature of the fluid may be adjusted to the desired temperature of the fluid within the bag 15. Because the baffles 100, 200, 300 are in direct contact with the bag 15, they may efficiently transfer thermal energy into or out of the bag 15 as needed. Additionally, because the baffles 100, 200, 300 are not solid, and there is space either within or behind the segments 110, 210, tubing or cables necessary for bioprocessing operations can be routed through the baffles. Additionally, because the baffles 100, 200, 300 become fixed structures once installed in the bioreactor or mixer vessel 12, they can act as mounting surfaces for additional components such as filters, cameras, etc.

[0040] Embodiments of the present invention further include a method of installing the aforementioned flexible baffles 100, 200 into a bioreactor or mixer vessel 12. The method includes (i) bending the baffles 100, 200 to assume a non-linear shape, for example, as shown in FIGS. 6A-6C and 10 . Once in the non-linear shape, the method can further include (ii) inserting bottom segments 114, 214 of the baffles 100, 200 into a top opening in the bioreactor or mixer vessel 12 and lowering the baffle 100 into the bioreactor or mixer vessel 12. As the baffles 100, 200 are lowered, the segments 110, 210 begin to enter the bioreactor or mixer vessel 12. Once the segments have entered, a further step of the method can include (iii) aligning adjacent segments 110, 210 via respective alignment elements 130, 230 on each of the segments. According to embodiments, this step can be accomplished by bringing the magnets 132 of adjacent segments 110, 210 close to each other so that opposite polarities attract each other. Due to the location of the magnets, the adjacent segments align with each other, creating a linear shape. In other embodiments, mechanical elements (e.g., alignment rods, recesses, snap-fit elements, tongues, and grooves) fit together when the adjacent segments 110, 210 are within the bioreactor or mixer vessel 12. For example, (i) an alignment rod of one segment 110, 210 can be inserted into a recess or hole of the adjacent segment 110, 210, (ii) complementary snap-fit elements of the adjacent segments 110, 210 can fit together, or (iii) a tongue of a first segment 110, 210 can fit into a groove of the adjacent segment 110, 210. As a final step, the method may include (iv) attaching the top segment 112 of the plurality of segments 110, 210 to the bioreactor or mixer vessel 12.

[0041] According to a further embodiment, a method of installing a flexible baffle 300 into a bioreactor or mixer vessel 12 is provided. The method can include the steps of (i) bending the baffle 300 to assume a non-linear shape. Once in the non-linear shape, the method can further include (ii) inserting the baffle 300 into a top opening in the bioreactor or mixer vessel 12 and lowering the baffle 300 into the bioreactor or mixer vessel 12. Once the baffle 300 is lowered, it returns to its original linear shape in the bioreactor or mixer vessel 12 because the baffle is made from a flexible polymeric material.

[0042] While the above description and embodiments depict flexible baffles having a particular number of segments (i.e., six or seven), flexible baffles 100, 200, 300 according to the present invention are not so limited. Baffles 100, 200, 300 can include any number of segments and be any length (i.e., sized for use with different bioreactors of different heights). Also, while the figures show separate hinges 120, 220 connecting adjacent segments 110, 210, it is contemplated that the hinges can be an integral part of the segments themselves (i.e., each segment can have a mechanical element that engages with a complementary mechanical element on an adjacent segment). Additionally, any mechanical element that can physically connect adjacent segments while also allowing them to move relative to one another is within the scope of the present invention.

[0043] It should be understood that the above description is intended to be illustrative, and not limiting. For example, the above-described embodiments (and / or aspects thereof) can be utilized in combination with each other. In addition, many modifications can be made to adapt a particular situation or material to the teachings of the present invention without departing from its scope. The dimensions, types of materials, orientations of various components, and the numbers and locations of various components set forth herein are intended to define the parameters of some embodiments and are in no way limiting; they are merely exemplary embodiments. Many other embodiments and modifications within the spirit and scope of the claims will be apparent to those skilled in the art upon reviewing the above description. The scope of the present invention should, therefore, be determined with reference to the appended claims, along with the full range of equivalents to which such claims are entitled. In the appended claims, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "first," "second," and "third," etc., are used merely as labels and are not intended to impose numerical requirements on their objects. Moreover, the following claim limitations are not written in means-plus-function form, and are not intended to be construed under 35 U.S.C. §112(f) unless and until such claim limitations expressly utilize the phrase "means for" followed by a description of function without further structure.

[0044] This written description uses examples to disclose various embodiments and to enable one of ordinary skill in the art to practice the various embodiments, including making and using any device or system and performing any incorporated methods. The patentable scope of the various embodiments is defined by the claims, and may include other examples that 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 do not differ from the literal language of the claims, or if they include equivalent structural elements that do not differ substantially from the literal language of the claims. [Explanation of symbols]

[0045] 12 Bioreactor or mixer vessel 100 Baffles 110 segments 112 apical segment 113 Fixed Elements 114 bottom segment 115 Tapered surface 116 Top surface 117 void 118 bottom 120 Hinge 121 Gap 130 Alignment Elements 200 Baffle 210 segments 212 apical segment 213 Fixed Elements 215 Tapered section front 216 Top surface 218 bottom 220 Hinge 230 Alignment Elements 231 Housing 300 Baffle 313 Fixed Elements

Claims

1. A baffle (100, 200) for use with a bioreactor or mixer (10), comprising: The baffle (100, 200) includes a plurality of segments (110, 210), each of the segments being connected to at least one other segment (110, 210) of the plurality of segments by a hinge (120, 220), Each of the segments includes at least one alignment element configured to align each of the segments with an adjacent segment such that the baffle is configured to move between a non-linear shape and a linear shape.

2. 2. The baffle of claim 1, wherein a top segment (112, 212) of the plurality of segments (110, 210) includes a fixing element (113, 213), the fixing element (113, 213) being configured to be attached to the bioreactor or the mixer (10).

3. The baffle of claim 1, wherein a bottom segment (114, 214) of the plurality of segments (110, 210) has a tapered portion (115, 215).

4. The baffle of claim 1 , wherein the at least one alignment element comprises at least one magnet (132, 232).

5. 5. The baffle of claim 4, wherein the magnets (132, 232) of adjacent segments (110, 210) have opposite polarities such that they attract each other to align each segment (110, 210) with the adjacent segment (110, 210).

6. 2. The baffle of claim 1, wherein at least one of the alignment elements (130, 230) comprises a mechanical element, the mechanical element being an alignment rod, a recess, a snap-fit element, a tongue, or a groove.

7. 2. The baffle of claim 1, wherein each of the hinges (120, 220) is attached to two of the adjacent segments (110, 210), allowing the adjacent segments (110, 210) to move relative to one another.

8. The baffle of claim 1, wherein the baffle (100, 200) and each of the plurality of segments (110, 210) have a triangular cross-sectional shape.

9. 2. The baffle of claim 1, wherein an outer surface (140, 240) of the baffle (100, 200) does not have sharp edges when the baffle (100, 200) is configured in a straight shape.

10. Each of the plurality of segments (110, 210) includes a top surface (116, 216) and a bottom surface (118, 218); The baffle of claim 1, wherein the top surface (116, 216) and / or the bottom surface (118, 218) of each of the adjacent segments (110, 210) includes the alignment element (130, 230).

11. A method for installing a baffle (100, 200) inside a bioreactor or mixer (10), comprising: Providing a baffle (100, 200) according to claim 1; curving the baffle (100, 200) to a non-linear shape; inserting a bottom segment (114, 214) of the baffle (100, 200) into a top opening of the bioreactor or mixer (10) and lowering the baffle (100, 200) into the interior of the bioreactor or mixer; aligning adjacent segments (110, 210) via alignment elements (130, 230) of each of said segments (110, 210); attaching a top segment (112, 212) of the plurality of segments (110, 210) to the bioreactor or mixer (10); A method of providing

12. The method of claim 11, wherein aligning the adjacent segments (110, 210) comprises magnetically coupling the adjacent segments (110, 210).

13. 13. The method of claim 12, wherein magnetically coupling the adjacent segments comprises placing magnets of opposite polarity of the adjacent segments in close proximity to each other.

14. The method of claim 11 , wherein the step of aligning the adjacent segments (110, 210) comprises mechanically coupling the adjacent segments.

15. 15. The method of claim 14, wherein mechanically coupling the adjacent segments (110, 210) is by placing an alignment rod in a recess, snap-fitting elements together, or placing a tongue in a groove.

16. The method of claim 11, comprising circulating a heat transfer fluid through the baffles (100, 200).

17. The method of claim 11, further comprising passing at least one tubing or cable through the baffle (100, 200).

18. The method of claim 11, further comprising attaching at least one bioprocessing component to the baffle (100, 200).

19. A baffle (300) for use with a bioreactor or mixer (10), comprising:

1. A baffle (300) comprising a unitary structure made of a flexible material such that the baffle (300) is configured to bend between a non-linear shape and a linear shape, the unitary structure being configured to bend between a non-linear shape and a linear shape.

20. 20. The baffle (300) of claim 19, wherein the flexible material is rubber.

Images