Flexible baffle for use in bioreactor or mixer and method of mounting baffle

Abstract

A flexible baffle (200) and a method of installing the same into a bioreactor or mixer vessel are provided. The flexible baffle (200) includes a plurality of segments (210) connected to each other via hinges (220). Each segment includes at least one alignment element (230) that assists in aligning the segments when the baffle is placed within the bioreactor or mixer vessel such that the baffle can change from a non-linear shape (e.g., bending) during installation to a linear shape when installation into the bioreactor or mixer vessel is completed.

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 Art

[0002] In the biopharmaceutical industry, the use of single-use or disposable containers is increasing. Such containers can be flexible or collapsible plastic vessels or bags, which are supported by external rigid structures such as stainless steel shells or housings. Use sterile disposable bags to eliminate time-consuming housing cleaning steps and reduce the chance of contamination. The bag can be positioned in a rigid housing and filled with the desired fluid for mixing. The agitator assembly arranged in the bag is used for mixing fluids. Existing agitators are top-driven (with a shaft extending downwardly into the bag, on which one or more impellers are mounted), or bottom-driven (with an impeller arranged in the bottom of the bag, which is driven by a magnetic drive system or a motor positioned outside the bag and / or the vessel).

[0003] Baffles are typically placed within an external rigid structure. When a container is placed into the rigid structure, such baffles act as protrusions that press against the container, thereby creating indentations within the container. When the agitator mixes the fluid, these indentations help create turbulence of the fluid within the container, which improves mixing. The indentations also help prevent eddies of the fluid when stirring, which can be harmful to the contents of the container (e.g., cells or cell products). Although some bioreactors have baffles integrated into the rigid structure, there are many situations in which baffles are manually added to the bioreactor depending on the user's wishes. In larger scale applications (e.g., 500 L and above), the external rigid structure (also referred to as a vessel) is large, and similarly, the baffles are tall, heavy, and cumbersome to install.

[0004] Reference Figure 1 , showing a prior art bioreactor or mixer system 10. The bioreactor or mixer system 10 includes a substantially rigid bioreactor or mixer vessel 12 mounted on top of a base 14 having a plurality of legs 16. The bioreactor or mixer vessel 12 may be formed of, for example, stainless steel, polymers, composite materials, glass or other metals, and may be cylindrical in shape, but other shapes may also be utilized without departing from the broader aspects of the present invention. A single-use flexible vessel or bag 15 is disposed within the bioreactor or mixer vessel 12. The bioreactor or mixer vessel 12 may be of any shape or size as long as it is capable of supporting a single-use flexible bioreactor bag 15. For example, according to one embodiment of the present invention, the bioreactor or mixer vessel 2 is capable of receiving and supporting a 10-2000L flexible or collapsible bioprocessing bag 15.

[0005] Referring to FIG. 1 which shows a top view of a bioreactor or mixer vessel 12 Figure 2 , a plurality of baffles 14 are located within the bioreactor or mixer vessel 12 around the inner periphery of the bioreactor or mixer vessel 12. However, such baffles 14 known in the prior art are either integrated into the bioreactor or mixer vessel 12 or added manually. However, when manual addition is to be performed, height and size restrictions generally prevent such installations.

[0006] For example, Figure 3A As shown by An XDR2000 bioreactor (e.g., a 2000L bioreactor) is provided having a height (H1) of approximately 2600 mm (8.5 ft). The length of a standard baffle 14 required for use in a bioreactor of this size is approximately 1500 mm (4.9 ft). Inserting such a long baffle 14 into such a vessel (e.g., an XDR2000) is cumbersome or impossible due to the height of the vessel itself and the height H2 of the top plate 13. For example, the standard top plate 13 height (H2) in the industry is approximately 10 ft to 12 ft, and therefore a standard baffle 14 cannot be inserted (e.g., because the distance H2-H1 is too small compared to the length of the baffle 14). Therefore, there is a need for an improved baffle that can be used with bioreactors and mixers where height constraints prevent the use of standard baffles. Summary of the invention

[0007] Embodiments of the present invention provide a baffle (100, 200) for use with a bioreactor or mixer (10), comprising: a plurality of segments (110, 210), wherein each segment is attached to at least one other segment (110, 210) of the plurality of segments by a hinge (120, 220), and wherein each segment comprises at least one alignment element (130, 230), the at least one alignment element (130, 230) being 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 fixing element (113, 213) configured to be attached to a bioreactor or mixer (10). The baffle also includes a bottom segment having a taper (115, 215).

[0009] At least one alignment element includes at least one magnet (132, 232), wherein the magnets (132, 323) in adjacent segments (110, 210) have opposite polarities such that they attract each other to align each segment (110, 210) with an adjacent segment (110, 210).

[0010] Alternatively and / or additionally, at least one alignment element (130, 230) comprises a mechanical element selected from the group consisting of an alignment bar, 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) so that the adjacent segments (110, 210) are movable relative to each other.

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

[0013] When the baffle (100, 200) is configured in a linear shape, the outer surface (140, 240) of the baffle (100, 200) does not have sharp edges.

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

[0015] An embodiment of the present invention also provides a method for installing a baffle (100, 200) into a bioreactor or mixer (10), comprising: providing a baffle (100, 200) according to claim 1; flexing the baffle (100, 200) so that it presents a nonlinear 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 bioreactor or mixer; aligning adjacent segments (110, 210) via corresponding alignment elements (130, 230) in each of the segments (110, 210), and attaching a top segment (112, 212) of the plurality of segments (110, 210) to the bioreactor or mixer (10).

[0016] Aligning the adjacent segments (110, 210) includes magnetically coupling the adjacent segments (110, 110), wherein magnetically coupling the adjacent segments (110, 210) includes placing magnets (132, 232) of opposite polarity in the adjacent segments (110, 210) proximate to each other.

[0017] Alternatively and / or additionally, aligning adjacent segments (110, 210) includes mechanically coupling adjacent segments, wherein mechanically coupling adjacent segments (110, 210) includes placing alignment rods within recesses, snapping elements together, or placing tongues within grooves.

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

[0019] The method also includes routing at least one pipe or cable through the baffle (100, 200).

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

[0021] A further embodiment provides a baffle (300) for use with a bioreactor or mixer (10), comprising: an integral structure made of a flexible material such that the baffle (300) is configured to flex between a non-linear shape and a linear shape, wherein the flexible material is rubber. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A bioreactor according to the prior art is shown.

[0023] Figure 2 Show Figure 1 Top view of the bioreactor.

[0024] Figure 3A The difficulties associated with the installation of conventional baffles in the prior art are illustrated.

[0025] Figure 3B The benefits of installation of a flexible baffle according to an embodiment of the present invention are shown.

[0026] Figure 4A-4B A front view and a side view of a flexible baffle according to an embodiment of the present invention are respectively shown.

[0027] Figure 5A -C shows a cross-sectional view, a rear view and an enlarged view of area A of a flexible barrier according to an embodiment of the present invention.

[0028] Figures 6A-6C Shown separately Figures 4A-5C A side view, a perspective view and an enlarged view of area B of the flexible baffle in a bent state.

[0029] Figure 7A-7B A front view and a side view are respectively shown of a flexible baffle according to a further embodiment of the present invention.

[0030] Figures 8A-8B Show Figure 7A-7B Cross-sectional view of the baffle and enlarged view of area C.

[0031] Fig. 9A -B shows Figures 7A-8B Perspective view of the flexible baffle and enlarged view of area C.

[0032] Fig.10 Showing a nonlinear shape Figures 7A-8B Perspective view of the flexible baffle.

[0033] Fig.11A -C shows a perspective view, a side view and a front view of a flexible baffle according to a further embodiment of the present invention. DETAILED DESCRIPTION

[0034] As used herein, an element or step recited in the singular and preceded by the word "a" or "an" should be understood as not excluding a plurality of said elements or steps, unless such exclusion is expressly indicated. Furthermore, reference to "one embodiment" is not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the features recited. Furthermore, unless expressly indicated to the contrary, embodiments that "comprise" or "have" an element or elements with a particular property may include additional such elements that do not have that property.

[0035] It should be noted that the particular arrangement (e.g., number, type, placement, etc.) of the components of the illustrated embodiments may be modified in various alternative embodiments. For example, in various embodiments, different numbers of baffles and the number of segments that make up each baffle may be modified and within the scope of the present invention.

[0036] As used herein, a structure, restriction, or element that is "configured to" perform a task or operation may be specifically formed, constructed, or altered structurally in a manner corresponding to the task or operation. For clarity and avoidance of doubt, an object that can only be modified to perform a task or operation is not "configured to" perform a task or operation as used herein. Rather, the use of "configured to" as used herein indicates a structural change or feature, and indicates a structural requirement for any structure, restriction, or element described as "configured to" perform a task or operation.

[0037] Reference Figure 3B, and as will be described in more detail below, by providing a flexible baffle 100, 200 according to an embodiment of the present invention, manual addition of the baffle to a bioreactor or mixer of any size is enabled. By providing a flexible baffle 100, 200 having a plurality of articulated segments 110, 120, the baffle 100, 200 can assume a non-linear shape (e.g., bend) during installation, thereby eliminating height constraints at the installation site. When the baffle 100, 200 is installed (or once fully placed) in the bioreactor or mixer vessel 12, the plurality of articulated segments 110, 120 are aligned and / or connected to each other via alignment elements 130, 230, so that the baffle 100, 200 assumes a liner shape and can act to block the fluid in the bag 15 when the fluid in the bag is stirred.

[0038] Reference Figure 4A and 4B , showing a front view and a side view of a flexible baffle 100 according to 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, the top segment 112 is attached to the adjacent segment 110 by a hinge 120 at its lower end so that the two segments 110 can move relative to each other. The plurality of intermediate segments 110 are connected to adjacent segments via hinges 120 located at the top end and the bottom end. Similarly, the bottom segment 114 is attached to the adjacent segment 110 by a hinge 120 at its top end. As shown by Fig. 6A and 6B As shown, by forming the baffle 100 with a plurality of segments 110 connected by hinges, the baffle 100 can take on a curved or linear shape (see, for example, Figures 4A-5C ). The curved shape allows the baffle 100 to be inserted into the bioreactor or mixer vessel 12 with a much smaller gap (e.g., a distance equal to or less than H2-H1). The baffle 100 can then be moved from the curved shape to a linear shape by aligning the segments 110, as further described below.

[0039] As further shown in Figures 4 and 4B, the top segment 112 includes a fixing element 113 for attaching the top of the baffle 110 to the bioreactor or mixer vessel 12. The fixing element 113 can be, for example, a flange, a t-bar, or any other mechanical element that can be hooked 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 contact the agitator (e.g., impeller) located within the single-use flexible vessel or bag 15. Each segment 110 can optionally include a plurality of holes or voids 117 to reduce the amount of material required to construct the baffle 100.

[0040] Referring to the cross-sectional view of the baffle 100 Figure 5A , each segment 110 may include at least one alignment element 130. Each alignment element 130 is configured to interact or engage with an alignment element 130 in an adjacent segment 110. Each alignment element 130 is located at the bottom surface 118 or the top surface 116 of each segment 110, such that the adjacent top surfaces 116 and bottom surfaces 118 each have an alignment element 130. The alignment elements 130 are configured to connect adjacent / adjacent segments 110 to each other, such that when (or after) the baffle 100 is installed in the bioreactor or mixer vessel 12, the adjacent segments automatically align with each other, thereby facilitating the change of the shape of the baffle 100 from non-linear to linear.

[0041] In embodiments, each alignment element 130 may be a magnet, an alignment rod, a recess, a snap-fit ​​element, a tongue, or a groove. For example, the alignment element 130 located at the bottom surface 118 of one segment 110 may be a magnet 132 having a first polarity, while the alignment element 130 located at the top surface 116 of the adjacent lower segment 110 may be a magnet 132 having a polarity opposite to the first polarity. In this manner, when the top and bottom surfaces 116, 118 of the adjacent segments 110 are brought close to each other, the magnets 132 attract, thereby linearly aligning the segments 110 with each other. In other examples, the adjacent segments 110 may have mechanical elements that engage correspondingly, such as an alignment rod and groove, a snap-fit ​​element, a tongue and groove, etc. In this manner, when the top and bottom surfaces 116 , 118 of adjacent segments 110 are in contact with one another, they may be reversibly connected to one another, thereby helping to ensure that the baffle 100 maintains a linear shape when installed in a bioreactor or mixer vessel 12 .

[0042] Referring to the rear view and the enlarged A view showing the baffle 100 Figure 5B and 5C , the hinge 120 may be connected to the rear and / or underside of each segment 110. In addition, the gap 121 may exist between adjacent segments at the rear side of the baffle 100, rather than the front side (see, for example Figure 4A and 4B ) to accommodate all or part of the hinge 130.

[0043] Figures 6A-6C A side view, a perspective view, and an enlarged view of area B of the flexible baffle 100 are provided. Fig. 6A and 6B As shown, the baffle 100 can take on non-linear (eg, curved) shapes as well as linear shapes (see, for example, Figures 4A-5B). By presenting such a nonlinear shape, a method of installing the baffle 100 into a bioreactor or mixer vessel 12 may include flexing the baffle 100 so that it presents a nonlinear shape; inserting a bottom segment (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 corresponding alignment elements in each of the segments; and attaching a top segment 112 of the plurality of segments 110 to the bioreactor or mixer vessel 12.

[0044] like Figure 6C , the bottom surfaces 118 and top surfaces 116 of adjacent segments 110 include alignment elements 130 that are configured to connect or otherwise mate with each other to ensure that the baffle 100 maintains a linear shape when installed in a bioreactor or mixer vessel 12. The figure also shows how the bottom surfaces 118 and top surfaces 116 of adjacent segments 110 are not flat. Instead, the front portions of the respective surfaces are configured to contact each other, while the rear portions of the respective surfaces are separated (e.g., by Figure 5C 121), which accommodates the hinge 120. In addition, the hinge 120 can be attached to the back side of the segment 110 (e.g., as shown in FIG. Figures 5A-5C ), or connected to the corresponding top surface 116 and bottom surface 118 of the adjacent segment 110 (e.g., as shown in Figure 6C As mentioned above, gap 121 accommodates all or part of hinge 130.

[0045] Reference Figures 7A-9B , another embodiment of a flexible baffle 200 is shown. Similar to the previous embodiment, the flexible baffle 200 includes a plurality of segments 210, wherein adjacent segments are attached to each other via hinges 220. Each segment 210 includes a top surface 216 and a bottom surface 218. The baffle 200 includes a top segment 212 and a bottom segment 214, the top segment 212 having a fixing element 213 attached thereto, and the bottom segment 214 having a tapered front surface 215. Alignment elements 230 are located in the respective top surfaces 216 and bottom surfaces 218 of adjacent segments 210 to align the segments 210 when the baffle 200 is inserted into a bioreactor or mixer vessel 12. Unlike the segments 110, the baffle 200 includes segments 210 that do not include any holes. Instead, the segments 210 can be constructed of a sheet having a completely hollow interior.

[0046] like Figure 8B , 9A 9B, each alignment element 230 may be located within a housing 231 that is attached to the inner surface of each segment 210 (see, e.g., Fig. 9A ). Alternatively, the housing 231 may be omitted and each alignment element may be directly attached to (or integrated with) the corresponding segment 210. Like the previous embodiments, each alignment element 230 may be a magnet 232, an alignment rod, a recess, a snap-fit ​​element, a tongue, or a groove. For example, the alignment element 230 located at the bottom surface 218 of one segment 210 may be a magnet 232 having a first polarity, while the alignment element 230 located at the top surface 216 of the adjacent lower segment 210 may be a magnet 232 having a polarity opposite to the first polarity. In this way, when the top and bottom surfaces 216, 218 of adjacent segments 110 are brought into proximity with each other, the magnets 232 attract, thereby linearly aligning the segments 210 with each other. In other examples, adjacent segments 210 may have mechanical elements that engage correspondingly, such as alignment rods and grooves, snap-fit ​​elements, tongues and grooves, etc. In this manner, when the top and bottom surfaces 216 , 218 of adjacent segments 210 are in contact with one another, they may be reversibly connected to one another, thereby helping to ensure that the baffle 100 maintains a linear shape when installed in a bioreactor or mixer vessel 12 .

[0047] In addition, if Fig. 9A and 9B As best shown in FIG. 2 , the top and bottom surfaces 216 , 218 of adjacent segments 210 may be flat. Unlike the previous embodiments, in this embodiment, the hinge 220 may be accommodated in an empty space on the base side of the segment 210 .

[0048] like Fig.11A-C, and according to further embodiments, the flexible baffle 300 may omit the segments and hinges, and instead have an integral structure and be made of a flexible material. According to an embodiment, the flexible material is a flexible polymer material. According to a preferred embodiment, the polymer material is a rubber (e.g., EPDM, nitrile rubber, silicone rubber, etc.). Because the material is flexible, the baffle 300 can be bent into a nonlinear shape during installation, so that the baffle 300 presents a curved or semi-curved shape when it is inserted into the bioreactor or mixer vessel 12. When the baffle 300 is loaded into the bioreactor or mixer vessel 12, the baffle 300 will bend back into its original linear shape. Similar to the previously described flexible baffles 100, 200, the baffle 300 may also include a fixing element 313 for attaching the top of the baffle 300 to the bioreactor or mixer vessel 12. In addition, an aperture or through hole may be positioned through the center of the baffle 300 along the longitudinal axis of the baffle 300 so that piping, wiring, or temperature regulating fluid may be passed through the aperture or through hole. The baffle 300 is cheaper to manufacture than previous embodiments because there are no metal parts, hinges, etc. In addition, because the baffle may be made of a flexible polymer material (e.g., rubber), there are no sharp edges or surfaces that may pierce the bag 15. Still further, the flexible polymer material (e.g., rubber) may be selected to be a thermally conductive material so that the fluid within the bag 15 may be more effectively heated / cooled.

[0049] When viewed in cross-section in a transverse plane (i.e., a top view), the baffles 100, 200, 300 according to embodiments of the present invention may have a generally triangular shape. While a triangular shape is included in a preferred embodiment, 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 figure, the front 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 can puncture the bag 15.

[0050] In addition to blocking fluids, the baffles 100, 200, 300 may also be used for additional purposes. For example, the baffles 100, 200 may be used as heat transfer surfaces, for pipe and / or cable routing, and / or as mounting surfaces for additional accessories. In order to act as heat transfer elements, the baffles 100, 200, 300 may have a heat transfer fluid (e.g., a gas or liquid) directed through them. For example, because the baffles 100, 200, 300 do not need to be solid, the heat transfer fluid may be circulated through the baffles 100, 200, 300 or through pipes located in 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, thermal energy may be effectively transferred to or from the bag 15 as desired. In addition, because the baffles 100, 200, 300 are not solid and there is space within or behind the segments 110, 210, pipes or cables required for bioprocessing operations can be routed through the baffles. Further, because the baffles 100, 200, 300 are fixed structures once installed in the bioreactor or mixer vessel 12, they can serve as mounting surfaces for additional accessories (such as filters, cameras, etc.).

[0051] Embodiments of the present invention also include methods of installing the aforementioned flexible baffles 100, 200 into a bioreactor or mixer vessel 12. The method may include (i) flexing the baffles 100, 200 so that they assume a nonlinear shape, such as Figures 6A-6Cand 10. Once the non-linear shape is present, the method may further include (ii) inserting the bottom segment 114, 214 of the baffle 100, 200 into the top opening in the bioreactor or mixer vessel 12 and lowering the baffle 100 into the bioreactor or mixer vessel 12. As the baffle 100, 200 is lowered, the segments 110, 210 begin to enter the bioreactor or mixer vessel 12. As these segments enter, another step of the method may include (iii) aligning adjacent segments 110, 210 via corresponding alignment elements 130, 230 in each of the segments. According to an embodiment, 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 position of the magnets, the adjacent segments will align with each other, thereby creating a linear shape. In other embodiments, once the adjacent segments 110, 210 are within the bioreactor or mixer vessel 12, the mechanical elements (e.g., alignment rods, recesses, snap-fit ​​elements, tongues, and grooves) fit together. For example, (i) the alignment rod of one segment 110, 210 may be inserted into a recess or hole of an adjacent segment 110, 210, (ii) complementary snap-fit ​​elements of adjacent segments 110, 210 may fit together, or (iii) the tongue of a first segment 110, 210 may fit into a groove of an 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.

[0052] According to a further embodiment, a method of installing a flexible baffle 300 into a bioreactor or mixer vessel 12 is provided. The method may include (i) flexing the baffle 300 so that it assumes a non-linear shape. Once in the non-linear shape, the method may also 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. As the baffle 300 is lowered, in the bioreactor or mixer vessel 12, the baffle returns to its original linear shape due to the fact that it is made of a flexible polymer material.

[0053] Although the above description and embodiments show flexible baffles having a particular number of segments (i.e., six or seven), the flexible baffles 100, 200, 300 according to the present invention are not so limited. The baffles 100, 200, 300 may include any number of segments and have any length (i.e., sized to be used with different bioreactors of different heights). In addition, although the figures show discrete hinges 120, 220 for connecting adjacent segments 100, 200, it is contemplated that the hinges may be integral to the segments themselves (i.e., each segment may have a mechanical element that engages with a complementary mechanical element of an adjacent segment). In addition, any mechanical element capable of physically connecting adjacent segments while also allowing them to move relative to each other is within the scope of the present invention.

[0054] It will be understood that the above description is intended to be illustrative rather than restrictive. For example, the embodiments described above (and / or aspects thereof) may be used in combination with each other. In addition, without departing from the scope of the present invention, many modifications may be made to adapt specific situations or materials to the teachings of the present invention. The sizes of the various components described herein, the types of materials, orientations, and the number and position of the various components are intended to define the parameters of certain embodiments, and are by no means restrictive and are merely exemplary embodiments. After reviewing the above description, many other embodiments and modifications within the spirit and scope of the claims will be apparent to those skilled in the art. Therefore, the scope of the present invention should be determined with reference to the full range of equivalents enjoyed by the appended claims and such claims. In the appended claims, the terms "including" and "wherein" are used as the plain English equivalents of the corresponding terms "including" and "wherein". In addition, in the appended claims, the terms "first", "second", and "third", etc., are used only as labels, and are not intended to impose numerical requirements on their objects. Furthermore, the appended claim limitations are not drafted in means-plus-function format and are not intended to be interpreted based on 35 U.S.C. §112(f) unless and until such claim limitations expressly use the phrase "means for..." followed by a statement of function without another structure.

[0055] This written description uses examples to disclose various embodiments, and also enables those skilled in the art to practice the various embodiments (including making and using any device or system and performing any incorporated method). 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. If these other examples have structural elements that are not different from the literal language of the claims, or if these other examples include equivalent structural elements that are not significantly different from the literal language of the claims, then these other examples are intended to be within the scope of the claims.

Claims

1. A baffle (100, 200) for use with a bioreactor or mixer (10), comprising: a plurality of segments (110, 210), wherein each segment is attached to at least one other segment (110, 210) of the plurality of segments by a hinge (120, 220), and Each segment includes at least one alignment element (130, 230), and the at least one alignment element (130, 230) is configured to align each segment (110, 210) with an adjacent segment (110, 210), so that the baffle (100, 200) is configured to move between a non-linear shape and a linear shape.

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

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

4. The baffle according to claim 1, wherein: The at least one alignment element includes at least one magnet (132, 232).

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

6. The baffle according to claim 1, wherein: The at least one alignment element (130, 230) comprises a mechanical element selected from the group consisting of an alignment post, a recess, a snap-fit ​​element, a tongue, and a groove.

7. The baffle according to claim 1, wherein: Each hinge (120, 220) is attached to two adjacent segments (110, 210) such that the adjacent segments (110, 110) are movable relative to each other.

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

9. The baffle according to claim 1, wherein: When the baffle (100, 200) is in a linear shape configuration, the outer surface (140, 240) of the baffle (100, 200) has no sharp edges.

10. The baffle according to claim 1, wherein: 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 include the alignment element (130, 230).

11. A method of installing a baffle (100, 200) in a bioreactor or mixer (10), comprising: Providing a baffle (100, 200) according to claim 1; flexing the baffle (100, 200) so that it assumes a non-linear shape; Inserting the bottom section (114, 214) of the baffle (100, 200) into the top opening of 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) in each of the segments (110, 210), and A top segment (112, 212) of the plurality of segments (110, 210) is attached to the bioreactor or mixer (10).

12. The method according to claim 11, wherein: Aligning adjacent segments (110, 210) includes magnetically coupling adjacent segments (110, 210).

13. The method according to claim 12, wherein: Magnetically coupling adjacent segments (110, 210) includes placing magnets (132, 232) of opposite polarity in adjacent segments (110, 210) proximate to each other.

14. The method according to claim 11, wherein: Aligning adjacent segments (110, 210) includes mechanically coupling the adjacent segments.

15. The method according to claim 14, wherein: Mechanically coupling adjacent segments (110, 210) includes placing alignment rods within recesses, snapping elements together, or placing tongues within grooves.

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

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

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

19. A baffle (300) for use with a bioreactor or mixer (10), comprising: The integral structure is made of a flexible material so that the baffle (300) is configured to flex between a non-linear shape and a linear shape.

20. The baffle (300) according to claim 19, wherein: The flexible material is rubber.

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