Kit for mounting impellers on process vessels

Abstract

The kit for a bioreactor includes a bioreactor bag, a connector, an impeller assembly, and a clamp. The connector defines an opening. The connector also includes a welding surface extending between a first end and a second end, the second end including an outwardly extending flange. The welding surface can be heat-sealable to the bioreactor bag. The impeller assembly includes a shaft and blades configured to pass through the opening. The impeller assembly includes an impeller flange configured to contact the flange of the connector when the impeller shaft is received in the opening. The impeller assembly also includes a bearing supporting the impeller shaft. The clamp is configured to secure the connector flange to the impeller assembly. Preparing the bioreactor includes welding the connector to the neck of the bioreactor bag and then inserting the shaft and blades into the bioreactor bag through the opening.

Description

[Technical field]

[0001] The present disclosure relates to a kit for providing a process vessel with a disposable impeller assembly, particularly using a connector that is welded to the bag and clamped to the impeller assembly. [Background technology]

[0002] Process vessels such as bioreactors can use disposable bags to hold reagents during processing. These bags can be welded directly to the disposable impeller device to seal the process vessel to the impeller so that the impeller can agitate the reagents. During the welding process, the impeller is already inside the bag. Summary of the Invention

[0003] The present disclosure relates to a kit for providing a process vessel with a disposable impeller assembly, particularly using a connector that is welded to the bag and clamped to the impeller assembly.

[0004] Impeller assemblies for bioreactors can be large, requiring large tools to weld them to the process vessel. Furthermore, there may be spatial limitations that make such welding difficult or less secure. In contrast, the connector can be welded to the process vessel much easier than the entire impeller assembly using a smaller welding tool. The connector can provide an opening that allows for the insertion of the impeller shaft into the process vessel. The impeller assembly can be secured to the connector by a clip, making it easier and simpler to connect the process vessel to the impeller compared to direct welding. Welding the connector to the bag instead of the impeller also eliminates the complexity of finishing a three-dimensional bag with the impeller located inside. Welding the connector to the bag instead of the impeller further eliminates the risk of the impeller blades cutting or puncturing the bag during welding.

[0005] In one embodiment, a kit for a bioreactor includes a bioreactor bag including a neck and a connector defining an opening and including a weld surface extending between a first end and a second end. The second end includes an outwardly extending flange. The weld surface is configured to be heat sealed to the neck of the bioreactor bag. The kit further includes an impeller assembly. The impeller assembly includes an impeller shaft and impeller blades configured to pass through the opening of the connector and an impeller flange configured to contact the outwardly extending flange of the connector when the impeller shaft is received in the opening. The impeller assembly also includes a bearing that supports the impeller shaft. The kit further includes a clamp configured to secure the connector flange to the impeller assembly.

[0006] In one embodiment, the kit further includes a gasket configured to be disposed between the outwardly extending flange of the connector and the impeller flange. In one embodiment, the outwardly extending flange of the connector includes a channel configured to receive at least a portion of the gasket. In one embodiment, the impeller flange includes a channel configured to receive at least a portion of the gasket.

[0007] In one embodiment, at least one of the outwardly extending flange of the connector and the impeller flange includes a sealing mechanism.

[0008] In one embodiment, the bioreactor bag and the connector each comprise polyethylene. In one embodiment, the bioreactor bag and the connector each comprise a fluoropolymer.

[0009] In one embodiment, the connector is generally cylindrical.

[0010] In one embodiment, the welding surface is defined on an inner surface of the connector.In one embodiment, the welding surface is defined on an outer surface of the connector.

[0011] In one embodiment, the neck of the bioreactor bag is joined to the welding surface of the connector by welding.

[0012] In one embodiment, the bioreactor bag is a three-dimensional bag with gussets.

[0013] In one embodiment, a method of assembling a bioreactor includes joining a neck of a bioreactor bag to a weld surface of a connector. The connector defines an opening and includes a connector flange. The connector flange is disposed on an exterior side of the bioreactor bag. The method further includes inserting blades and a shaft of an impeller assembly into the bioreactor bag through the opening of the connector. The impeller assembly further includes an impeller flange configured to contact the connector flange when the blades and shaft are inserted into the bioreactor. The method also includes clamping the connector flange to the impeller flange to secure the connector flange and the impeller flange to one another.

[0014] In one embodiment, the method further includes disposing a gasket between the impeller flange and the connector flange. In one embodiment, the gasket is disposed in at least one channel formed in one or more of the impeller flange and the connector flange.

[0015] In one embodiment, the bonding comprises heat welding, hi one embodiment, the heat welding is performed using a sealer.

[0016] In one embodiment, the method includes assembling a bioreactor according to the method described above, adding a bioreactor fluid to the bioreactor bag, and rotating the impeller blades within the bioreactor fluid.

[0017] In one embodiment, the bioreactor bag is a three-dimensional bag with gussets.

[0018] In one embodiment, a bioreactor kit includes a bioreactor bag including a neck, a connector, and an impeller assembly. The connector defines an opening and includes a welding surface surrounding the opening. The welding surface is configured to be heat sealed to the neck of the bioreactor bag. The impeller assembly includes an impeller shaft and impeller blades configured to pass through the opening of the connector. The impeller assembly and the connector are configured to be mechanically coupled to one another.

[0019] In one embodiment, the kit further includes a clamp, the connector includes an outwardly extending flange, and the impeller assembly includes an impeller flange configured to contact the outwardly extending flange of the connector, the impeller assembly and the connector are configured to be mechanically coupled to one another using the clamp to secure the outwardly extending flange of the connector and the impeller flange to one another.

[0020] In one embodiment, the impeller assembly and connector are configured to be mechanically coupled to one another by a press fit between the impeller assembly and a cup formed on an end of the connector.

[0021] In one embodiment, the impeller assembly and the connector are configured to be mechanically coupled to one another by an engagement feature included on at least one of the impeller assembly or the connector.

[0022] In one embodiment, the impeller assembly and connector are configured to be mechanically coupled to one another by engagement of a captive nut disposed on one of the connector or the impeller assembly with threads on the other of the connector or the impeller assembly.

[0023] In one embodiment, the impeller assembly and connector are configured to be mechanically coupled to one another by a number of rotating bolts and lock nuts included on one of the impeller assembly or connector and a number of recesses formed in the other of the impeller assembly or connector and configured to receive the rotating bolts.

[0024] In one embodiment, a seal is formed between the impeller assembly and the connector when the impeller assembly and the connector are mechanically joined to one another.

[0025] In one embodiment, the bioreactor bag and the connector each comprise polyethylene. In one embodiment, the bioreactor bag and the connector each comprise a fluoropolymer.

[0026] In one embodiment, the welding surface is defined on an inner surface of the connector.In one embodiment, the welding surface is defined on an outer surface of the connector.

[0027] In one embodiment, the bioreactor bag is a three-dimensional bag with gussets.

[0028] In one embodiment, a method of assembling a bioreactor includes joining a neck of a bioreactor bag to a weld surface of a connector, the connector defining an opening, the method includes inserting blades and a shaft of an impeller assembly into the bioreactor bag through the opening of the connector, the method further includes mechanically securing the impeller assembly to the connector.

[0029] In one embodiment, mechanically securing the impeller assembly to the connector includes clamping an impeller flange included in the impeller assembly to a connector flange included in the connector.

[0030] In one embodiment, mechanically securing the impeller assembly to the connector includes pressing the connector and the impeller assembly together to form a press fit.

[0031] In one embodiment, mechanically securing the impeller assembly to the connector includes contacting an engagement feature included on one of the impeller assembly or the connector with the other of the impeller assembly or the connector.

[0032] In one embodiment, mechanically securing the impeller assembly to the connector includes engaging a captive nut located on one of the impeller assembly or the connector with threads on the other of the impeller assembly or the connector.

[0033] In one embodiment, the bonding comprises heat welding, hi one embodiment, the heat welding is performed using a sealer.

[0034] In one embodiment, the method includes assembling a bioreactor, adding a bioreactor fluid to a bioreactor bag, and rotating impeller blades within the bioreactor fluid.

[0035] In one embodiment, a kit for a process vessel includes a bag including a neck, the kit further includes a connector defining an opening and including a welding surface surrounding the opening, the welding surface configured to be heat sealed to the neck of the bioreactor bag, the kit further includes an impeller assembly including an impeller shaft and impeller blades configured to pass through the opening of the connector, the impeller assembly and the connector configured to be mechanically coupled to one another.

[0036] In one embodiment, the kit further includes a clamp, the connector includes an outwardly extending flange, the impeller assembly includes an impeller flange configured to contact the outwardly extending flange of the connector, and the impeller assembly and the connector are configured to be mechanically coupled to one another using the clamp to secure the outwardly extending flange of the connector and the impeller flange to one another.

[0037] In one embodiment, the impeller assembly and connector are configured to be mechanically coupled to one another by a press fit between the impeller assembly and a cup formed on an end of the connector.

[0038] In one embodiment, the impeller assembly and the connector are configured to be mechanically coupled to one another by an engagement feature included on at least one of the impeller assembly or the connector.

[0039] In one embodiment, the impeller assembly and connector are configured to be mechanically coupled to one another by engagement of a captive nut disposed on one of the connector or the impeller assembly with threads on the other of the connector or the impeller assembly.

[0040] In one embodiment, the impeller assembly and connector are configured to be mechanically joined together by a number of rotating bolts and locking nuts included on one of the impeller assembly or connector and a number of recesses formed in the other of the impeller assembly or connector and configured to receive the rotating bolts.

[0041] In one embodiment, a seal is formed between the impeller assembly and the connector when the impeller assembly and the connector are mechanically coupled to one another.

[0042] In one embodiment, the bag and the connector each comprise a polyolefin.

[0043] In one embodiment, the bag and the connector each comprise a fluoropolymer.

[0044] In one embodiment, the welding surface is defined on an inner surface of the connector.

[0045] In one embodiment, the welding surface is defined on an outer surface of the connector.

[0046] In one embodiment, the bag is a gusseted three-dimensional bag.

[0047] In one embodiment, the process vessel is a bioreactor and the bag is a bioreactor bag.

[0048] In one embodiment, a method of assembling a process vessel includes joining a neck of a bag to a welding surface of a connector, the connector defining an opening, inserting blades and a shaft of an impeller assembly into the bag through the opening of the connector, and mechanically securing the impeller assembly to the connector.

[0049] In one embodiment, mechanically securing the impeller assembly to the connector includes clamping an impeller flange included in the impeller assembly to a connector flange included in the connector.

[0050] In one embodiment, mechanically securing the impeller assembly to the connector includes pressing the connector and the impeller assembly together to form a press fit.

[0051] In one embodiment, mechanically securing the impeller assembly to the connector includes contacting an engagement feature included on one of the impeller assembly or the connector with the other of the impeller assembly or the connector.

[0052] In one embodiment, mechanically securing the impeller assembly to the connector includes engaging a captive nut located on one of the impeller assembly or the connector with threads on the other of the impeller assembly or the connector.

[0053] In one embodiment, the bonding comprises a heat weld.

[0054] In one embodiment, the process vessel is a bioreactor and the bag is a bioreactor bag. [Brief description of the drawings]

[0055] [Figure 1] FIG. 1 is an exploded view of components of a bioreactor kit according to one embodiment. [Diagram 2] FIG. 1 shows a connector of a bioreactor kit according to one embodiment. [Diagram 3] FIG. 1 shows a clamp for a bioreactor kit according to one embodiment. [Figure 4] 1 is a cross-sectional view of a connector and a portion of an impeller assembly according to one embodiment. [Diagram 5] FIG. 1 shows a flow chart of a method for assembling a bioreactor. [Figure 6] 1 illustrates a connector and impeller assembly according to one embodiment. [Figure 7A] FIG. 2 illustrates a connector and impeller assembly according to one embodiment, including a cross-sectional view of a captive nut. [Figure 7B] FIG. 2 illustrates a connector and impeller assembly according to one embodiment, including a cross-sectional view of a captive nut. [Figure 8] 1 illustrates a connector and impeller assembly according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0056] The present disclosure relates to a kit for providing a bioreactor bag with a disposable impeller assembly, particularly using a connector that is welded to the bag and secured to the impeller assembly.

[0057] 1 is an exploded view of components of a bioreactor kit according to one embodiment. The bioreactor kit 100 includes a bag 102, a connector 104, an impeller assembly 106, and a clamp 108.

[0058] The bag 102 is a bioreactor bag configured to hold one or more reagents. The bag 102 can be any suitable material that does not adversely affect the reaction performed therein. The bag 102 can be a disposable bag for storing process solutions, such as chemical and / or biological reaction mixtures, reaction products, etc. The bag 102 can be a bioprocess bag, for example, for storing biological process solutions. The bag 102 can be part of a mixing system, for example. In one embodiment, the bag 102 can be a container used in or for a process, such as, for example, a biological and / or chemical process. The bag 102 can be a flexible bag, for example, by incorporating one or more flexible materials into the bag. The bag 102 can have an operating temperature range suitable for the process performed, which can include a cryogenic processing or storage step. The material of the bag 102 can be selected to reduce particulate generation, reduce absorption of the contents of the bag 102, and / or for other properties that improve the purity of the bag 102 and its compatibility with the process solutions stored therein. The bag 102 can be configured to be sterilizable, for example, by gamma irradiation. The bag 102 can include one or more polymeric materials, for example, fluoropolymers and / or polyolefins, such as, for example, polyethylene as a non-limiting example. The bag 102 can have any suitable shape for storing reagents. The bag 102 can be, for example, a two-dimensional or three-dimensional bag. The bag 102 can be, for example, a three-dimensional bag with gussets. The bag 102 can be sized and / or shaped to fit within another container. The bag 102 can be any suitable size for a particular use, such as storage, mixing, use as a reactor, or other suitable role in chemical or biological processing. In one embodiment, the bag 102 can contain between 50 liters and 3000 liters.

[0059] The bag 102 includes a neck 110. The neck 110 is a portion of the bag 102 that extends from the bag 102. The neck 110 is shaped and sized to be sealed to the connector 104. The neck 110 is continuous with the interior space of the bag 102. In one embodiment, the bag 102 can include multiple necks 110. In this embodiment, the kit can include additional connectors 104, impeller assemblies 106, and clamps, for example, one for each neck 110 of the bag. In one embodiment, the kit 100 excludes the bag and includes only the connector 104 and impeller assembly 106, and can optionally further include a clamp 108.

[0060] The connector 104 includes a connector body 112 that defines an opening 114. The connector body 112 includes a weld surface 116 formed on an inner surface facing the opening or on an outer surface opposite the inner surface. A connector flange 118 is formed at one end of the connector body 112 and extends outwardly from the opening 114.

[0061] The opening 114 is an opening through the connector 104 that is sized to allow a portion of the impeller assembly 106 to pass therethrough. In particular, the opening 114 is sized to allow the impeller shaft 122 to be inserted therethrough. In one embodiment, the impeller blades 120 may also be configured to pass through the opening 114, for example, by folding the blades 120 into a state that allows them to pass through the opening 114.

[0062] The connector body 112 has a surface with a weld surface 116. The weld surface 116 is a portion of the connector body 112 that can be welded to the bag 102. The weld surface can include at least one material that is compatible with the material of the bag 102 so that the connector 104 and the bag 102 can be joined by welding. The welding can be, for example, ultrasonic welding, heat welding, or any other suitable welding technique. In one embodiment, the bag 102 is joined to the connector body 112 at the weld surface 116 by heat welding. In one embodiment, the welding can be provided by a sealing machine. In one embodiment, the weld surface 116 can instead be used to attach the bag 102 to the connector body 112 by any other suitable method of joining the bag 102 to the connector body 112, such as through the use of an adhesive. For example, if the bag 102 is polyethylene, at least the weld surface 116 of the connector 104 can also be polyethylene. The neck 110 of the bag 102 can be sized so that it can be sealed to the welding surface 116 by welding the two together. When the bag 102 is welded to the welding surface 116, the neck 110 of the bag 102 is held open around the opening 114 and the impeller shaft 122 and the blades 120 pass through the opening 114 and enter the interior space of the bag 102.

[0063] The impeller assembly 106 is an assembly that includes impeller blades 120 located at the end of an impeller shaft 122. When the bioreactor is assembled from the kit 100, the impeller shaft 122 can be rotated to rotate the blades 120, for example, to agitate reagents within the bag 102. The impeller assembly further includes a housing 124 that can contain bearings (not shown) that allow the shaft 122 to rotate. The housing 124 includes an impeller flange 124.

[0064] The impeller blades 120 are blades configured to perturb a fluid when the impeller blades 120 rotate. The impeller blades 120 can have any suitable geometry for agitating a reagent in a process vessel, such as the bag 102. The impeller blades 120 can be configured to be able to pass through the opening 114. In one embodiment, the impeller blades 120 can be foldable into a state in which they can pass through the opening 114 and have a deployed state in which they cannot pass through the opening 114. In one embodiment, the impeller blades 120 are sized to be able to pass through the opening 114.

[0065] The impeller shaft 122 is a shaft that supports the impeller blades 120. The impeller shaft 122 is sized so that it can pass through the opening 114, for example, by having a diameter smaller than the diameter of the opening 114. In one embodiment, the impeller shaft 122 includes a motor contact surface (not shown) on an end opposite the impeller blades 120. The motor contact surface can be, for example, a gear or a mechanical engagement mechanism that allows the impeller shaft 122 to be driven to rotate.

[0066] The housing 124 includes at least a portion sized to fit within the opening 114. The housing 124 supports the impeller shaft 122 by one or more bearings (not shown) contained therein. An impeller flange 126 extends outwardly from the housing 124. The impeller flange 126 extends outwardly from the housing 124 such that it cannot pass through the opening 114. The impeller flange 126 can be sized to match the dimensions of the connector flange 118, e.g., to have the same shape and size when viewed in cross section. In one embodiment, the flange can include a channel (not shown) configured to accommodate a seal, such as, for example, a gasket (not shown). In one embodiment, the channel can be configured to accommodate a sealing feature protruding from an opposing face of the connector flange 118.

[0067] The clamp 108 is a clamp that secures the connector flange 118 to the impeller flange 126. The clamp 108 can be any suitable clamp capable of securing the connector flange 118 to the impeller flange 126. In one embodiment, the clamp 108 includes a first segment 128 and a second segment 130 joined by a hinge 132. Ends of the first segment 128 and the second segment 130 distal from the hinge 132 can be joined by a fastener 134. The first segment and the second segment can each include a channel configured to accommodate the connector flange 118 and the impeller flange 126 when pressed together, the channel surrounding at least a portion of the connector flange 118 and the impeller flange 126. The fastener 134 can be, for example, a screw fastener, a snap, or any other suitable mechanical connection for joining the respective ends of the first segment 128 and the second segment 130. When the first segment 128 and the second segment 130 are joined by the fasteners 134, the clamp 108 can surround the connector flange 118 and the impeller flange 126 to hold them together.

[0068] In the kit 100, the bag 102, connector 104, impeller assembly 106, and clamp 108 can be provided as a set of their individual components separate from one another. The elements of the kit 100 can then be combined together to provide a bioreactor, for example, by placing the bag 102 in a containment vessel, filling it with reagents, then welding the connector 104 to the bag 102, then inserting the impeller assembly 106 through the opening 114 in the connector 104, and finally clamping the connector flange 118 and the impeller flange 126 together using the clamp 108. In one embodiment, two or more of these individual components can be pre-connected to one another, for example, the connector 104 can be welded to the bag 102 in the kit 100 prior to assembly into the bioreactor.

[0069] 2 illustrates a connector of a bioreactor kit according to one embodiment. The connector 200 includes a connector body 202 that defines an opening 204. The connector body 202 includes an inner surface 206 and an outer surface 208. A connector flange 212 extends outwardly from an end 214 of the connector body 202. The connector flange 212 includes a sealing mechanism 216.

[0070] Connector 200 is a connector configured to be connected to a process vessel, such as bag 102 described above and shown in Figure 1, to facilitate insertion of an impeller assembly, such as impeller assembly 106, into the bag and to secure the impeller assembly and bag together. Connector 200 can be more easily assembled and welded with a process vessel, such as a bioreactor bag, as compared to an entire impeller assembly.

[0071] The connector body 202 forms the connector 200. The connector body 202 can have any suitable shape for coupling to a bag and providing an opening through which the shaft passes. In one embodiment, the connector body 202 has a generally cylindrical shape. The connector body 202 can have a rounded cross-sectional shape, such as a circular or oval cross-sectional shape. In one embodiment, the connector body 202 has a cross-sectional shape selected for welding to a neck portion of a bag, such as the bag 102. The connector body 202 can be any suitable material for contacting a bag, such as the bag 102, or any reagents that may be stored therein. The connector body 202 can include a polymeric material, such as, for example, polyethylene or a fluoropolymer. In one embodiment, the connector body 202 is made entirely of polyethylene or a fluoropolymer.

[0072] Opening 204 is an opening defined by connector body 202. Opening 204 is sized to allow the impeller shaft and blades to pass through the opening from one side of connector body 202 to the opposite side of connector body 202.

[0073] The inner surface 206 is the surface of the connector body 202 that faces inwardly towards the opening 204. The outer surface 208 is the surface of the connector body 202 opposite the inner surface 206 and faces outwardly from the opening 204. The welding surface 210 may be provided on either the inner surface 206 or the outer surface 208. The welding surface 210 is a surface that can be welded to a bag, for example a surface that can be heat welded to a bag.

[0074] The connector flange 212 extends outwardly from the connector body 202 at an end 214 thereof, away from the opening 204. The connector flange 212 may be a continuous perimeter opening 204. The connector flange 212 may generally maintain the cross-sectional shape of the connector body 202, for example remaining circular if the connector body 202 is circular in cross-section, or elliptical or oval if the connector body 202 is elliptical in cross-section. In one embodiment, the shape and dimensions of the connector flange 212 are selected to correspond to the shape and dimensions of a flange provided on an impeller assembly used with the connector 200.

[0075] The sealing feature 216 may be provided on a flange face 218 of the connector flange 212. The sealing feature 216 may surround the opening 204. In one embodiment, the sealing feature 216 is a protrusion or ridge that surrounds the opening 204. In one embodiment, the sealing feature 216 is a gasket disposed within a channel formed in the flange face 218. In one embodiment, the gasket is a resilient material and is sized to be compressed when the connector flange 212 is secured to a flange of the impeller assembly, e.g., when the flanges are clamped together. The gasket may be, for example, a polymeric material. In one embodiment, the gasket is silicone.

[0076] 3 shows a clamp of a bioreactor kit according to one embodiment. The clamp 300 includes a first segment 302 connected to a second segment 304 by a hinge 306, with a fastener 308 disposed opposite the hinge 306 when the clamp 300 is closed. The clamp 300 has a channel 310 formed in the inwardly facing surfaces of the first segment 302 and the second segment 304.

[0077] The clamp 300 can be used to clamp together a flange on the impeller assembly and a corresponding flange on a connector. The connector can be welded to a bag to which the impeller assembly is coupled, such as a bioreactor. In one embodiment, the clamp 300 is a tri-clamp. In one embodiment, the clamp 300 has a ridged thread closure.

[0078] The first segment 302 and the second segment 304 are separate segments that, when joined together by the hinge 306 and the fastener 308, form a continuous shape configured to surround the flange of the impeller assembly and the flange of the connector. The continuous shape can correspond to the cross-sectional shape of the flange of the impeller assembly and the flange of the connector. In one embodiment, the first segment 302 and the second segment 304 define a shape having a circular cross-sectional shape. In one embodiment, each of the first segment and the second segment are approximately the same length and each defines approximately one-half of the clamp 300.

[0079] A hinge 306 connects the first segment 302 and the second segment 304. The hinge 306 may be any suitable hinge that allows the first segment 302 and the second segment 304 to move relative to one another by rotation about the hinge 306. In one embodiment, the hinge 306 is formed by a pin that passes through a hole in each of the first segment 302 and the second segment 304. In one embodiment, the hinge 306 is formed by a mechanical fit of portions of the first segment 302 and the second segment 304 with detents or other mechanisms that allow the hinge 306 to rotate.

[0080] The fastener 308 couples the ends of the first segment 302 and the second segment 304 distal to the hinge 306 together. The fastener 308 can use any suitable mechanical means for coupling the first segment 302 to the second segment 304. In one embodiment, the fastener 308 includes engagement features on the first segment 302 and the second segment 304 that interface to form a snap fit. In one embodiment, one of the first segment 302 and the second segment 304 includes a swingable screw 312 and the other of the first segment 302 and the second segment 304 includes an engagement feature 316 configured to receive the swingable screw. A bolt 314 can be provided on the swingable screw 312 such that the swingable screw 312 can rotate into a position that presses against the engagement feature 316 to secure the first segment to the second segment, particularly when the clamp 300 encircles a flange of the impeller assembly and a flange of the connector.

[0081] Channel 310 is a channel on the inwardly facing surfaces of first segment 302 and second segment 304. Channel 310 is sized to accommodate outer edges of flanges on each of the connector and impeller assembly. Channel 310 is configured to secure a flange on the connector to a flange on the impeller assembly such that opposing surfaces are pressed together. In one embodiment, the pressing of the opposing surfaces of the flanges can compress a gasket to form a seal around an opening formed in the connector.

[0082] 4 is a cross-sectional view of a portion of a connector and impeller assembly according to one embodiment. The connector 400 includes a connector body 402 with a connector flange 404 extending outwardly therefrom. The connector 400 defines an opening 406. The flange 404 has a channel 408 in a surface thereof. The channel 408 receives a gasket 410. The impeller assembly 412 includes a housing 414 that includes an outwardly extending housing flange 416. The housing 414 includes an extension 418 that extends through the opening 406.

[0083] The connector 400 is configured to be welded to a bag using a weld, such as, for example, a heat weld. The connector 400 is configured to allow the shaft and blades of the impeller assembly 412 to pass through the interior of the bag to which the connector 400 is welded. The connector 400 can be provided along with the impeller assembly 412, a clamp, and optionally a bag, such as a bioreactor bag, to provide a kit for assembling a process vessel.

[0084] The connector body 402 includes a welding surface and a connector flange 404. The connector flange 404 is a flange that extends outwardly from an end of the connector body. The connector flange 404 may be sized and shaped to correspond to the housing flange 416 such that the flanges can be clamped together. The connector body 402 is further shaped to define an opening 406.

[0085] The opening 406 is an opening through the connector 400 defined by the connector body 402. The opening 406 is sized to allow the shaft and blades of the impeller assembly 412 to pass through the connector body 402. When the connector 400 is welded to the bag, the opening 406 allows the impeller to pass from the exterior of the bag to the interior space of the bag. The opening 406 can also accommodate an extension 418 of the housing 414 of the impeller assembly. The opening 406 is sized such that the housing flange 416 cannot pass through the opening 406.

[0086] The seal channel 408 is a channel formed in a surface of the connector flange 404 that surrounds the opening 406. The seal channel 408 may be shaped and sized to accommodate a portion of the seal 410 such that the seal 410 can provide a seal between the connector flange 404 that surrounds the opening 406 and a housing flange 416.

[0087] The seal 410 may be a gasket, an O-ring, or any other suitable sealing member. The seal 410 in the embodiment shown in FIG. 4 is a gasket. The seal 410 may extend from the seal channel 408 onto a surface of the connector flange 404. The seal 410 may include a resilient material. The seal 410 may be compressed between the connector flange 404 and the housing flange 416. The seal 410 may be at least partially disposed within the seal channel 408. In one embodiment, another portion of the seal 410 may be received in a channel formed in a surface of the housing flange 416. The seal 410 may be a polymeric material. In one embodiment, the seal 410 is made of silicone.

[0088] 4, the connector 400 includes a weld face flange 420. The weld face flange extends outwardly from an end of the connector 400 opposite the connector flange 404. The weld face flange 420 may include a weld surface configured to be welded to a bag. The bag and the weld face flange 420 may be sized relative to one another such that the bag may be placed in contact with the weld surface provided on the weld face flange 420.

[0089] The impeller assembly 412 includes a housing 414. The impeller assembly 412 may further include a shaft (not shown) that passes through the housing 414 and is supported by bearings (not shown). Blades (not shown) may be located at the end of the shaft. The housing 414 is part of the impeller assembly 412 that is configured to be secured to the connector 400, for example, by clamping, while allowing the shaft to rotate freely, for example, by supporting the shaft by bearings.

[0090] The housing flange 416 is an outward protrusion from the housing 414. The housing flange 416 can have a size and shape that at least generally corresponds to the size and shape of the connector flange 404 such that the housing flange 416 and the connector flange 404 can be clamped together. In one embodiment, a seal channel similar to the seal channel 408 can be provided in a surface of the housing flange 416 that faces the connector flange 404.

[0091] The extension 418 is a portion of the housing 414 that is sized to fit within the opening 406. The extension 418 can provide separation between a shaft of an impeller assembly (not shown) and the connector body 402. The extension 418 can extend at least a portion of the length of the opening 406 through the connector body 402. In one embodiment, the extension 418 extends through the opening 406 beyond an end of the connector body 402.

[0092] Figure 4 shows the connector 400 and impeller assembly 412 connected together to illustrate the relative sizes and shapes of the connector and impeller assembly. A kit according to an embodiment may include the connector 400 and the impeller assembly 412 as separate components configured to be later assembled together to provide the combination connector 400 and impeller assembly 412 shown in Figure 4. An embodiment may also include a method for combining the connector 400 and impeller assembly 412 to provide the arrangement shown in Figure 4.

[0093] 5 shows a flow chart of a method for assembling a bioreactor. In method 500, optionally, a bag is filled with reagents at 502. A connector is mated to the neck of the bag at 504. One or more blades and shaft of an impeller assembly are inserted into the bag through an opening in the connector at 506. Optionally, a seal can be placed between the impeller assembly and the connector at 508. The impeller assembly is clamped to the connector at 510. Optionally, a reaction can be performed using the bag at 512, which can optionally include rotating the shaft and blades of the impeller assembly at 514.

[0094] Optionally, at 502, the bag is filled with a reagent. The bag may be, for example, bag 102 shown in FIG. 1 and described above. Filling at 502 may be accomplished either through a neck formed in the bag or a separate fill port in the bag. The reagent may be any reagent used in the process for which the bag provides a process vessel. The bag may be filled at 502 before a connector is joined to the bag at 504. In one embodiment, the bag may be filled at 502 after a connector is joined to the bag at 504. In one embodiment, the bag may be filled at 502 after an impeller assembly is clamped to the connector at 510. In this embodiment, the bag is filled at 502 using a fill port separate from the neck of the bag.

[0095] At 504, a connector is coupled to the neck of the bag. The connector can be, for example, connector 104 or connector 200, described above and shown in Figures 1 and 2, respectively. The bag can be, for example, bag 102 having neck 110, described above and shown in Figure 1. The neck of the bag can be placed adjacent to or in contact with a welding surface on the connector, and then the neck and welding surface are joined. The joining can be done by heat welding to join the neck and welding surface. The joining can be done, for example, using a sealing machine. The joining of the welding surface of the connector to the neck of the bag at 504 can be done before or after filling the bag at 502. In one embodiment, the connector can be joined to the neck at 504 before the bag is attached to the containment vessel.

[0096] At 506, one or more blades and shaft of the impeller assembly are inserted into the bag through the opening in the connector. In one embodiment, the blades of the impeller assembly can be placed in a folded state so that they can pass through the opening in the connector. Insertion of the blades and shaft into the bag at 506 can occur after coupling of the connector to the bag at 504. The impeller assembly can be moved into the opening in the connector until a flange of the impeller assembly, which is too large to pass through the opening, contacts a flange of the connector.

[0097] Optionally, at 508, a seal may be placed between the impeller assembly and the connector. The seal surrounds an opening in the connector. The seal may be placed between the impeller assembly and the connector at 508 any time prior to clamping the impeller assembly to the connector at 510. In one embodiment, the seal may include one or more features, such as a ridge, a channel, an overmolded portion, on one or both of the connector flange or the impeller assembly flange. In one embodiment, the seal may be a gasket, an O-ring, or other sealing member separate from the connector and the impeller assembly. The gasket, O-ring, or other sealing member may be received in one or more channels on one or both of the connector flange and the impeller assembly flange. In one embodiment, the gasket, O-ring, or other sealing member may be placed between the connector flange and the impeller assembly flange and compressed when the flanges are clamped together at 510. The seal may include, for example, a polymeric material. The seal may include, for example, a silicone.

[0098] At 510, the impeller assembly is clamped to the connector. The clamping may use a clamp such as clamp 108 or clamp 300 described above and shown in FIGS. 1 and 3, respectively, to clamp the impeller assembly flange to the connector flange. The clamping may include placing one or more clamps on the impeller assembly flange and the connector flange when they are in close proximity or contact with one another. The clamping may include rotating a segment of the clamp about a hinge to enclose the impeller assembly flange and the connector flange. The clamping may include securing the clamp closure using a fastener such as a snap, a screw, or any other suitable mechanical closure of the clamp. The clamping of the impeller assembly to the connector at 510 may apply a force that presses the impeller assembly flange and the connector flange, respectively, toward one another. The force may contribute to sealing the joint between the impeller assembly and the flange around the opening, for example, by pressing a sealing mechanism together or by compressing a gasket, O-ring, or other sealing member.

[0099] Optionally, a reaction can then be carried out using the bag at 512, which can optionally include rotating the shaft and blades of the impeller assembly at 514. The reaction can be any suitable reaction of reagents stored in the bag. The reaction at 512 can be driven by agitation, for example by rotation of the shaft and blades of the impeller assembly at 514. The shaft and blades of the impeller assembly can be driven to rotate at 514 by mechanical contact with a motor, such as a geared contact, using a socket on the end of the shaft opposite the blades, or any other suitable mechanical linkage for driving the rotation of the shaft. The shaft can be held while allowing it to rotate by one or more bearings included in the housing of the impeller assembly, the housing being the portion that includes the flange that is clamped to the connector at 510.

[0100] 6 illustrates a connector and impeller assembly according to one embodiment. The connector 600 and impeller assembly 610 are configured to be coupled to one another to form a sealed connection between the impeller assembly 610 and the interior of a reactor bag (not shown) coupled to the connector 600.

[0101] The connector 600 has a connector body 602 and an opening 604 through the connector body 602. A cup 606 configured to receive a connector contact surface portion 618 of the impeller assembly 610 can be disposed at one end of the connector body 602, with one end of the opening 604 positioned within the cup 606. The cup 606 can optionally include one or more connector engagement features 608. The connector engagement features 608 can be any suitable feature for interfacing with the connector contact surface portion 618 or the impeller assembly engagement features 620 to retain the connector contact surface portion 618 within the cup 606. Non-limiting examples of the connector engagement features 608 include tabs configured to snap-fit ​​with the connector contact surface portion 618, protrusions from a surface of the connector contact surface portion 618, detents, protrusions, or recesses, slots, or channels configured to receive any other suitable feature for securing the connector contact surface portion 618 within the cup 606.

[0102] The impeller assembly 610 includes a shaft 612, blades 614, and a motor housing 616. The motor housing 616 includes a connector interface portion 618 configured to be received within a cup 606 of the connector 600 when the shaft 612 extends through the opening 604 of the connector 600. The connector interface portion 618 can be configured to be retained within the cup 606 when the shaft 612 extends through the opening 604. As a non-limiting example, the connector interface portion 618 can be sized and / or shaped to form a press fit with the cup 606. The motor housing 616 can include one or more impeller assembly engagement features 620 to facilitate retention of the connector interface portion 618 within the cup 606. The impeller assembly engagement features 620 can be provided on the connector interface portion 618 of the motor housing 616, for example. The impeller assembly engagement features 620 may be, by way of non-limiting example, tabs or protrusions configured to engage with the connector engagement features 608 to provide a snap fit, protrusions configured to be received in channels or slots when they are provided as the connector engagement features 608, or any other suitable feature for forming a connection between the motor housing 616 and the cup 606 that can retain the connector contact surface portion 618 within the cup 606 when the shaft 612 extends through the opening 604.

[0103] In one embodiment, a seal 622 can be included. In one embodiment, the seal 622 can surround the opening 604. In an embodiment such as shown in FIG. 6, the seal 622 can surround where the shaft 612 extends from the connector interface portion 618. In one embodiment, the seal 622 can surround a surface of the connector interface portion 618 that contacts the cup 606. In one embodiment, the seal 622 can be disposed on an inner surface of the cup 606 configured to contact the connector interface portion 618. In one embodiment, the seal 622. In an embodiment, multiple seals 622 can be included, where the seals are, for example, concentric O-rings or gaskets. In an embodiment having multiple seals 622, each different seal 622 can be located in a different location suitable for the seal 622, for example, one located on the inner surface of the cup 606 and another located on the connector interface portion 618. The seal 622 can be located in a channel 624 that can be formed in the cup 606 or the connector interface portion 618 depending on which portion the seal 622 is located in. In the embodiment shown in FIG. 6, the channel 624 is formed in the connector contact surface portion 618 .

[0104] 7A illustrates a connector and impeller assembly according to one embodiment, including a cross-sectional view of a captive nut. The connector 700 and impeller assembly 720 are configured to be coupled to one another to form a sealed connection between the impeller assembly and the interior of a reactor bag (not shown) coupled to the connector 700.

[0105] Connector 700 has a connector body 702 and an opening 704 through connector body 702. Connector body 702 includes a threaded extension 706 at one end. Threaded extension 706 is sized to engage threads 736 of captive nut 732 such that the captive nut can be used to secure impeller assembly 720 to connector 700.

[0106] The impeller assembly 720 includes a shaft 722, blades 724, and a motor housing 726. The motor housing 726 includes a neck 728 and an extension 730. A captive nut 732 surrounds the neck 728 and the extension 730. The captive nut 732 includes an opening 734 at one end that is sized such that the captive nut 732 can move along the neck 728 of the motor housing 726 but cannot pass through the extension 730. The captive nut 732 includes an interior space configured to surround and extend beyond the extension 730 when the captive nut 732 is at the point where the neck 728 meets the extension 730. An interior surface of the captive nut 732 that defines this interior space includes threads 736. The threads 736 are configured to engage the threaded extension 706 of the connector 700. When the captive nut 732 is tightened onto the threaded extension 706 , contact between the captive nut 732 and the impeller assembly 720 may retain the impeller assembly 720 in the connector 700 .

[0107] In one embodiment, a seal 738 can be provided to seal the connection between the impeller assembly 720 and the connector 700. By way of non-limiting example, the seal 738 can be provided in the threaded extension 706, in the captive nut 732, in the peripheral opening 704, in the extension 730, such as where the impeller assembly 720 contacts the connector 700 when held in the connector 700, or any other such suitable location for providing a seal.

[0108] FIG. 7B illustrates a connector and impeller assembly according to one embodiment, including a cross-sectional view of a captive nut. In the embodiment illustrated in FIG. 7B, the connector body 702 includes a neck 708 and a flange 710. The captive nut 732 is configured to surround the neck 708, and the opening 734 is sized such that the captive nut 732 can move along the neck 708, but cannot pass through the flange 710. In one embodiment, a seal 738 is disposed on the flange 710. In one embodiment, a channel 712 is formed on the flange 710 and configured to accommodate the seal 738. The seal 738 is sized and positioned such that when the impeller assembly 720 is secured to the connector 700 using the captive nut 732, it can form a seal surrounding the opening 704.

[0109] In the embodiment shown in Figure 7B, the motor housing 726 includes threads 740 configured to engage with the threads 736 of the captive nut 732. In the embodiment shown in Figure 7B, when the captive nut 732 is tightened onto the motor housing 726 by engagement of the respective threads 736, 740, contact between the captive nut 732 and the flange 710 holds the connector 700 and the impeller assembly 720 together. In one embodiment, a seal 738 contacts the motor housing 726 and forms a seal surrounding the opening 704 of the connector 700.

[0110] 8 illustrates a connector and impeller assembly according to one embodiment. The connector 800 and impeller assembly 820 are configured to be coupled to one another to form a sealed connection between the impeller assembly 820 and the interior of a reactor bag (not shown) coupled to the connector 800.

[0111] The connector 800 includes a connector body 802, an opening 804 through the connector body 802, a flange 806 surrounding the opening, and a seal 808 disposed within the flange 806. The connector body 802 defines a connector. The opening 804 is an opening sized to allow a shaft 824 of an impeller assembly 820 to pass through such that the shaft 824 can enter a reactor bag joined to the connector 800. The flange 806 can include a number of recesses 810 each configured to receive a moveable bolt 830, with the portion of the flange 806 surrounding the recesses 810 configured to contact the lock nut 832 when the lock nut 832 is tightened. In the embodiment shown in FIG. 8, a seal 808 is provided on the flange 806. The seal 808 is configured to contact a housing flange 828 of the impeller assembly 820 when the impeller assembly 820 is coupled to the connector 800. In one embodiment, seal 808 is disposed in a channel 812 formed in flange 806. In an embodiment, seal 808 may alternatively or additionally be disposed on a housing flange 828 of impeller assembly 820 and configured to contact flange 806 when impeller assembly 820 is coupled to connector 800. Seal 808 may be any suitable seal capable of forming a seal around opening 804 when impeller assembly 820 is coupled to connector 800. As one non-limiting example, seal 808 is a flat gasket.

[0112] The impeller assembly 820 includes a motor housing 822, a shaft 824, and one or more impeller blades 826. The motor housing 822 can include a housing flange 828. The housing flange 828 is sized so that it cannot pass through the opening 804 of the connector 800. The housing flange 828 can include a plurality of moveable bolts 830. The moveable bolts 830 can be pivotally connected to the housing flange 828. The moveable bolts 830 can be distributed about the housing flange 828 to correspond to the recesses 814 of the connector 800 when the impeller assembly 820 is coupled to the connector 800. The moveable bolts 830 can be threaded with a locking nut 832 engaged with the threads of the moveable bolt 830. The locking nut 832 can be configured to move the moveable bolt 830 up and down with rotation of the locking nut 832. The lock nut 832 and moveable bolt 830 can be configured such that as the moveable bolt 830 rotates into the recess 814 in the flange 806, the lock nut 832 rotates into contact with the flange 806 to apply pressure to hold the flange 806 and the housing flange 828 together and couple the connector 800 to the impeller assembly 820. The pressure provided by the contact between the lock nut 832 and the flange 806 can compress the seal 816.

[0113] In one embodiment, the moveable bolt 830 can be rotatably mounted to the flange 806 of the connector 800, and instead the recess 814 can be provided in the housing flange 828. In this embodiment, the portion of the housing flange 828 surrounding the recess 814 can be configured to be contacted by a lock nut 832 while pressure is applied to the housing flange 828 by the lock nut 832 which holds the housing flange 828 to the flange 806.

[0114] In addition to connections using clamps or other mechanical connections as specifically described in detail herein and shown in the respective figures, embodiments may include any other suitable mechanical coupling between the impeller assembly and the connector that can provide a seal between the impeller assembly and the passage through the connector and into the bag.

[0115] The embodiments may further be applied to other chemical reactors in addition to bioreactors and may be used to store and agitate other reagent solutions for chemical processing, etc. In one embodiment, a kit according to an embodiment or a kit assembled according to an embodiment may contain a mixture of liquids or a mixture of liquids and powders that are reagents for a chemical reaction. The chemical reaction may be a chemical reaction carried out under agitation by an impeller assembly, e.g., gentle agitation to mix the reagents.

[0116] Aspects:

[0117] It is understood that any of the aspects 1 to 13 may be combined with any of the aspects 13 to 19, 20 to 32, 33 to 39, 40 to 52, or 53 to 59. It is understood that any of the aspects 13 to 19 may be combined with any of the aspects 20 to 32, 33 to 39, 40 to 52, or 53 to 59. It is understood that any of the aspects 20 to 32 may be combined with any of the aspects 33 to 39, 40 to 52, or 53 to 59. It is understood that any of the aspects 33 to 39 may be combined with any of the aspects 40 to 52, or 53 to 59. It is understood that any of the aspects 40 to 52 may be combined with any of the aspects 53 to 59.

[0118] Aspect 1. A kit for a bioreactor, comprising: a bioreactor bag including a neck; a connector defining an opening and including a weld surface extending between a first end and a second end, the second end including an outwardly extending flange, the weld surface configured to be heat sealed to a neck of a bioreactor bag; an impeller assembly including an impeller shaft and impeller blades configured to pass through the opening in the connector, an impeller flange configured to contact an outwardly extending flange of the connector when the impeller shaft is received in the opening, and a bearing supporting the impeller shaft; a clamp configured to secure the connector flange to the impeller assembly; A kit comprising:

[0119] Embodiment 2. The kit of embodiment 1, further comprising a gasket configured to be disposed between the outwardly extending flange of the connector and the impeller flange.

[0120] Embodiment 3. The kit of embodiment 2, wherein the outwardly extending flange of the connector includes a channel configured to accommodate at least a portion of the gasket.

[0121] Embodiment 4. The kit of any of embodiments 2 or 3, wherein the impeller flange comprises a channel configured to accommodate at least a portion of the gasket.

[0122] Aspect 5. A kit according to any one of aspects 1 to 4, wherein at least one of the outwardly extending flange of the connector and the impeller flange includes a sealing mechanism.

[0123] Aspect 6. The kit of any one of aspects 1 to 5, wherein the bioreactor bag and the connector each comprise polyethylene.

[0124] Embodiment 7. The kit of any of embodiments 1 to 6, wherein the bioreactor bag and the connector each comprise a fluoropolymer.

[0125] Embodiment 8. A kit according to any one of embodiments 1 to 7, wherein the connector is approximately cylindrical.

[0126] Embodiment 9. The kit of any of embodiments 1-8, wherein the welding surface is defined on an inner surface of the connector.

[0127] Embodiment 10. The kit of any of embodiments 1-8, wherein the welding surface is defined on an outer surface of the connector.

[0128] Embodiment 11. A kit according to any of embodiments 1 to 10, wherein the neck of the bioreactor bag is coupled to the welding surface of the connector by welding.

[0129] Embodiment 12. The kit according to any one of embodiments 1 to 11, wherein the bioreactor bag is a three-dimensional bag with gussets.

[0130] Aspect 13. Joining a neck of a bioreactor bag to a welding surface of a connector, the connector defining an opening and including a connector flange, the connector flange being disposed on an exterior side of the bioreactor bag; inserting the blades and shaft of an impeller assembly into the bioreactor bag through an opening in the connector, the impeller assembly further including an impeller flange configured to contact the connector flange when the blades and shaft are inserted into the bioreactor; clamping the connector flange to the impeller flange to secure the connector flange and the impeller flange to one another; A method for assembling a bioreactor comprising:

[0131] Example 14. The method of example 13, further comprising disposing a gasket between the impeller flange and the connector flange.

[0132] Aspect 15. The method of aspect 14, wherein the gasket is disposed in at least one channel formed in one or more of the impeller flange and the connector flange.

[0133] Example 16 The method of any one of Examples 13-15, wherein the joining comprises heat welding.

[0134] Aspect 17. The method of aspect 16, wherein the heat welding is performed using a sealing machine.

[0135] Embodiment 18. Assembling a bioreactor according to any one of the methods of embodiments 13 to 17; adding a bioreactor fluid to the bioreactor bag; Rotating impeller blades within the bioreactor fluid; A method comprising:

[0136] Embodiment 19. The method according to any one of embodiments 13 to 18, wherein the bioreactor bag is a gusseted three-dimensional bag.

[0137] 20. A kit for a bioreactor, comprising: a bioreactor bag including a neck; a connector including a welding surface defining an opening and surrounding the opening, the welding surface configured to be heat sealed to a neck of a bioreactor bag; an impeller assembly including an impeller shaft and impeller blades configured to pass through the opening of the connector; wherein the impeller assembly and the connector are configured to be mechanically joined to one another.

[0138] 21. The method further comprises: the connector includes an outwardly extending flange; an impeller assembly including an impeller flange configured to contact an outwardly extending flange of the connector; the impeller assembly and the connector are configured to be mechanically coupled to one another by using a clamp to secure an outwardly extending flange of the connector and the impeller flange to one another; 21. The kit of claim 20.

[0139] Aspect 22. A kit as described in aspect 20 or aspect 21, wherein the impeller assembly and the connector are configured to be mechanically coupled to each other by a press fit between the impeller assembly and a cup formed at an end of the connector.

[0140] Aspect 23. A kit described in any of aspects 20 to 22, wherein the impeller assembly and the connector are configured to be mechanically coupled to each other by an engagement mechanism included in at least one of the impeller assembly or the connector.

[0141] Aspect 24. A kit described in any of aspects 20 to 23, wherein the impeller assembly and connector are configured to be mechanically coupled to each other by engagement of a captive nut disposed on one of the connector or the impeller assembly with a thread provided on the other of the connector or the impeller assembly.

[0142] Aspect 25. A kit described in any of aspects 20 to 24, wherein the impeller assembly and connector are configured to be mechanically coupled to each other by a plurality of rotating bolts and locking nuts included in one of the impeller assembly or the connector and a plurality of recesses formed in the other of the impeller assembly or the connector and configured to receive the rotating bolts.

[0143] Embodiment 26. A kit described in any of embodiments 20 to 25, wherein a seal is formed between the impeller assembly and the connector when the impeller assembly and the connector are mechanically coupled to each other.

[0144] Aspect 27. A kit according to any one of aspects 20 to 26, wherein the bioreactor bag and the connector each comprise polyethylene.

[0145] Aspect 28. A kit according to any one of aspects 20 to 27, wherein the bioreactor bag and the connector each comprise a fluoropolymer.

[0146] Embodiment 29. A kit according to any of embodiments 20 to 28, wherein the welding surface is defined on an inner surface of the connector.

[0147] Embodiment 30. A kit according to any of embodiments 20 to 29, wherein the welding surface is defined on an outer surface of the connector.

[0148] Embodiment 31. A kit according to any one of embodiments 20 to 30, wherein the bioreactor bag is a three-dimensional bag with gussets.

[0149] Aspect 32. Joining a neck of a bioreactor bag to a welding surface of a connector, the connector defining an opening; Inserting the blades and shaft of the impeller assembly through the opening in the connector and into the bioreactor bag; Mechanically fastening the impeller assembly to the connector; A method for assembling a bioreactor comprising:

[0150] Aspect 33. The method of aspect 32, wherein mechanically securing the impeller assembly to the connector comprises clamping an impeller flange included in the impeller assembly to a connector flange included in the connector.

[0151] Aspect 34. The method of aspect 32 or aspect 33, wherein mechanically securing the impeller assembly to the connector includes pressing the connector and the impeller assembly together to form a press fit.

[0152] Aspect 35. A method as described in any of aspects 32 to 34, wherein mechanically securing the impeller assembly to the connector includes contacting an engagement mechanism included in one of the impeller assembly or the connector with the other of the impeller assembly or the connector.

[0153] Aspect 36. A method as described in any of aspects 32 to 35, wherein mechanically securing the impeller assembly to the connector includes engaging a captive nut disposed on one of the impeller assembly or the connector with threads provided on the other of the impeller assembly or the connector.

[0154] Example 37. The method of any one of Examples 32-36, wherein the joining comprises heat welding.

[0155] Aspect 38. The method of aspect 37, wherein the heat sealing is performed using a sealing machine.

[0156] Embodiment 39. Assembling a bioreactor according to any one of the methods of embodiments 31 to 37; adding a bioreactor fluid to the bioreactor bag; Rotating impeller blades within the bioreactor fluid; A method comprising:

[0157] 40. A process vessel kit, comprising: A bag including a neck; a connector including a welding surface defining an opening and surrounding the opening, the welding surface configured to be heat sealed to a neck of a bioreactor bag; an impeller assembly including an impeller shaft and impeller blades configured to pass through the opening of the connector; wherein the impeller assembly and the connector are configured to be mechanically coupled to each other.

[0158] Embodiment 41. Further comprising a clamp, the connector includes an outwardly extending flange; an impeller assembly including an impeller flange configured to contact an outwardly extending flange of the connector; the impeller assembly and the connector are configured to be mechanically coupled to one another by using a clamp to secure an outwardly extending flange of the connector and the impeller flange to one another; 41. The kit according to embodiment 40.

[0159] Aspect 42. The kit described in Aspect 40, wherein the impeller assembly and the connector are configured to be mechanically coupled to each other by a press fit between the impeller assembly and a cup formed at an end of the connector.

[0160] Aspect 43. The kit described in Aspect 40, wherein the impeller assembly and the connector are configured to be mechanically coupled to each other by an engagement mechanism included in at least one of the impeller assembly or the connector.

[0161] Aspect 44. The kit described in Aspect 40, wherein the impeller assembly and the connector are configured to be mechanically coupled to each other by engagement of a captive nut disposed on one of the connector or the impeller assembly with a thread provided on the other of the connector or the impeller assembly.

[0162] Aspect 45. The kit described in Aspect 40, wherein the impeller assembly and connector are configured to be mechanically coupled to each other by a plurality of rotating bolts and locking nuts included in one of the impeller assembly or the connector and a plurality of recesses formed in the other of the impeller assembly or the connector and configured to receive the rotating bolts.

[0163] Embodiment 46. A kit described in any of embodiments 40 to 45, wherein a seal is formed between the impeller assembly and the connector when the impeller assembly and the connector are mechanically coupled to each other.

[0164] Aspect 47. A kit described in any one of aspects 40 to 46, wherein the bag and the connector each comprise a polyolefin.

[0165] Aspect 48. A kit described in any one of aspects 40 to 47, wherein the bag and the connector each comprise a fluoropolymer.

[0166] Embodiment 49. A kit according to any of embodiments 40 to 48, wherein the welding surface is defined on an inner surface of the connector.

[0167] Embodiment 50. A kit according to any of embodiments 40 to 49, wherein the welding surface is defined on an outer surface of the connector.

[0168] Embodiment 51. A kit described in any of embodiments 40 to 50, wherein the bag is a three-dimensional bag with a gusset.

[0169] Embodiment 52. A kit according to any one of embodiments 40 to 51, wherein the process vessel is a bioreactor and the bag is a bioreactor bag.

[0170] Aspect 53. Joining a neck of a bag to a welding surface of a connector, the connector defining an opening; Inserting the blades and shaft of the impeller assembly into the bag through the opening in the connector; Mechanically fastening the impeller assembly to the connector; A method of assembling a process vessel, comprising:

[0171] Aspect 54. The method of aspect 53, wherein mechanically securing the impeller assembly to the connector includes clamping an impeller flange included in the impeller assembly to a connector flange included in the connector.

[0172] Aspect 55. The method of aspect 53, wherein mechanically securing the impeller assembly to the connector includes pressing the connector and the impeller assembly together to form a press fit.

[0173] Aspect 56. The method of aspect 53, wherein mechanically securing the impeller assembly to the connector includes contacting an engagement mechanism included in one of the impeller assembly or the connector with the other of the impeller assembly or the connector.

[0174] Aspect 57. The method of aspect 53, wherein mechanically securing the impeller assembly to the connector includes engaging a captive nut disposed on one of the impeller assembly or the connector with threads provided on the other of the impeller assembly or the connector.

[0175] Embodiment 58. The method of any one of embodiments 53 to 57, wherein the joining comprises heat welding.

[0176] Embodiment 59. The method according to any of embodiments 53 to 58, wherein the process vessel is a bioreactor and the bag is a bioreactor bag.

[0177] The examples disclosed in this application should be considered in all respects as illustrative and not restrictive. The scope of the present invention is indicated by the appended claims, rather than the above description, and all modifications that come within the meaning and scope of the claims are intended to be embraced therein.

Claims

1. 1. A kit for a process vessel comprising: a bag including a neck; a connector including a welding surface defining an opening and surrounding the opening, the welding surface being configured to be heat sealed to the neck of the bioreactor bag; and an impeller assembly including an impeller shaft and impeller blades configured to pass through the opening of the connector, the impeller assembly and the connector being configured to be mechanically coupled to each other.

2. 10. The kit of claim 1, further comprising a clamp, the connector including an outwardly extending flange, the impeller assembly including an impeller flange configured to contact the outwardly extending flange of the connector, and the impeller assembly and the connector configured to be mechanically coupled to one another using the clamp to secure the outwardly extending flange of the connector and the impeller flange to one another.

3. 10. The kit of claim 1, wherein the impeller assembly and the connector are configured to be mechanically coupled to one another by a press fit between the impeller assembly and a cup formed on an end of the connector.

4. The kit of claim 1 , wherein the impeller assembly and the connector are configured to be mechanically coupled to one another by engagement features included on at least one of the impeller assembly or the connector.

5. A method for assembling a process vessel from a kit described in any one of claims 1 to 4, comprising joining a neck of a bag to a welded surface of a connector, inserting blades and shaft of an impeller assembly into the bag through an opening in the connector, and mechanically securing the impeller assembly to the connector.

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