EP4701774A1 - Carboy assembly and manufacturing method - Google Patents

Abstract

An assembly (100) for agitating a material including a rigid carrier manufactured byplacing polymer (330) inside a mold (340), expanding the polymer (330) against the interior of a mold (340). A tank plate (150) and an auxiliary component are placed on an interior of the mold (340), and the polymer (330) can also be expanded against portions of the tank plate (150) and the auxiliary component. An aperture may be formed within the polymer (330) such that it is aligned with the auxiliary component. Furthermore, the assembly (100) can further comprise a mixing element disposed on an interior of the rigid aligned with the tank plate (150).

Description

CARBOY ASSEMBLY AND MANUFACTURING METHOD

CROSS-REFERENCE TO RELATED APPLICATIONS

[001] This is a non-provisional of pending provisional patent application serial number 63/498,912, filed April 28, 2023, the entirety of which application is incorporated by reference herein.

TECHNICAL FIELD

[002] The present disclosure generally relates to an assembly for agitating, stirring or mixing material and, more particularly, to methods of manufacturing an assembly for agitating or mixing material. In some aspects, the present disclosure includes blow-molding and/or clamshell molding techniques for manufacturing carboys.

BACKGROUND

[003] Carboys are vessels used in various industries, including pharmaceutical manufacturing, for multiple purposes like storage, mixing, and transporting materials. Carboys include a container of rigid or semi-rigid polymer material that can hold fluid material, an internal mixer, and ports for receiving raw materials or dispensing mixed materials via one or more connectors. To assemble and join components to the carboy (e.g., internal mixer, ports), conventional carboy manufacturing includes molding a rigid container, creating openings in the wall of a carboy by, for example, mechanical milling or drilling, and joining and sealing the various components in the opening by, for example, welding or gluing. However, mechanical processing of the carboy often generates particles and introduces contaminants that may remain in the interior of the carboy or attached to the carboy body even after rigorous chemical and mechanical cleaning.

[004] Furthermore, molding, milling, welding, and other techniques of manufacturing carboys may introduce variances in shape and dimensions due to manufacturing tolerances, which may yield tolerances in the form, orientation, or location of features of the carboy. Thus, when a carboy is placed on a support rack or platform, and/or connected with a corresponding drive mechanism (as described in more detail below), the carboy and/or features thereof may be offset and/or misaligned. This may lead to mounting or attachment difficulties for fixed connections, as well as uneven or exaggerated wear for moving connections.

[005] The present disclosure is directed to overcoming one or more of the shortcomings mentioned above and/or other shortcomings in the art. For example, aspects of the present manufacturing processes may reduce or eliminate the generation of particles and contaminates to the interior of a carboy. As another example, flexible drive mounts may accommodate larger tolerances during manufacturing.

SUMMARY

[006] Embodiments of the present disclosure include an assembly for storage, mixing, and/or transporting one or more materials. The assembly includes a rigid carrier, e.g., a carboy, manufactured by expanding polymer against the interior of a mold, and may include integrating preformed components into the wall of the carrier and/or forming at least one aperture in the expanded polymer. For example, a tank plate and/or an auxiliary component, e.g., a port, can be placed on an interior wall of the mold, and the at least one aperture can be aligned with the at least one auxiliary component. The assembly can further include a mixing element disposed on an interior of the rigid carrier. In some embodiments, the mixing element is rotatably supported on the tank plate and/or positioned within the rigid carrier by the tank plate. In some embodiments, the mixing element is rotatably supported by the tank plate via one or more frictional bearing configurations, via one or fluid bearing configurations, and/or magnetically driven and/or levitated. It is contemplated that the position of the tank plate and thus the position of the mixing element may be based in whole or in part on desired mixing characteristics depending on the shape and size of the rigid carrier.

[007] Embodiments of the present disclosure include a method for manufacturing a rigid carrier. The method comprises placing a polymer inside a mold, expanding the polymer against the mold, and forming at least one polymer against the mold. A tank plate and the at least one auxiliary component are placed on an interior of the mold, and the at least one aperture is aligned with the at least one auxiliary component. It is contemplated that the rigid carrier can have any desired shape and size as configured by the shape and size of the mold and, in particular, the contour of the interior surface of the mold.

[008] Embodiments of the present disclosure include a rigid container. The rigid container comprises a wall, a tank plate, a mixing element, and an auxiliary component, e.g., a port. The tank plate is integrated into the wall of the rigid container without a weld seam between the tank plate and the wall. The mixing element is disposed on an interior of the rigid container. The auxiliary component, e.g., the port, is integrated into the wall, without a weld seam between the port and the wall. BRIEF DESCRIPTION OF THE DRAWINGS

[009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and, together with the description, serve to explain the disclosed subject matter.

[010] FIG. 1A illustrates a front view of an example assembly for agitating a material, consistent with various embodiments of the present disclosure.

[Oil] FIG. IB illustrates a diagrammatic representation of a cross-section of the assembly of FIG. 1 A, consistent with various embodiments of the present disclosure.

[012] FIG. 2 depicts a flowchart of a method for manufacturing a rigid carrier, consistent with various embodiments of the present disclosure.

[013] FIG. 3A illustrates a cross-section of an example tank plate placed within a mold, consistent with various embodiments of the present disclosure.

[014] FIG. 3B illustrates a diagrammatic representation of the connection area shown in FIG. 3A, consistent with various embodiments of the present disclosure.

[015] FIG. 3C illustrates an example of a tank plate, consistent with various embodiments of the present disclosure.

[016] FIGs. 4A-4C illustrate an example molding technique including an auxiliary component, consistent with various embodiments of the present disclosure.

[017] FIG. 5 illustrates an example spring- suspended drive unit, consistent with various embodiments of the present disclosure.

[018] FIGs. 6-7 illustrate portions of the spring-suspended drive unit of FIG. 5, consistent with various embodiments of the present disclosure.

DETAILED DESCRIPTION

[019] Embodiments of the present disclosure generally relate to rigid carriers and mixing equipment used in pharmaceutical manufacturing. In particular, embodiments of the present disclosure relate to devices and methods for manufacturing rigid carriers (e.g., carboys) used in storing, transporting, mixing, stirring, or agitating pharmaceutical material. Additionally, or alternatively, embodiments of the present disclosure may also be used in non-pharmaceutical material applications.

[020] Disclosed embodiments may include an assembly for storing, transporting, and/or agitating a material. The assembly may embody a pharmaceutical mixer, a chemical compound mixing apparatus, or any other apparatus for storing, transporting, and/or mixing materials. In some embodiments, the assembly may be used in pharmaceutical manufacturing to agitate, blend, or mix components of pharmaceuticals, drugs, and other compounds in a formulation.

[021] Referring to FIG. 1A, an example assembly 100 is provided, consistent with various embodiments of the present disclosure. Assembly 100 may include a rigid container, such as carboy 110, a plurality of connectors 120, and configured to be supported by a platform 130.

[022] A carboy may pertain to a rigid container used for transporting, carrying, storing, or otherwise containing liquids or other materials. Examples of materials may include, but are not limited to, water or other chemical substances, one or more powders, active ingredients, resins, dyes, or other liquid, gel, or solid materials. In some embodiments, the carboy may also contain gases (e.g., oxygen, carbon dioxide). For example, carboy 110 may contain a powdered substance, water, and oxygen. Assembly 100 may also include a mixer 140, as shown in FIG. IB. For example, a powdered substance may be contained within carboy 110, and be dissolved or dispersed within water or other liquid using mixer 140. Oxygen, nitrogen, ambient air, or other gas may comprise the remaining space in carboy 110.

[023] Furthermore, carboy 110 may be made of any suitable material for transporting carrying, storing, or containing liquids, including polymers. Plastic materials may include, but are not limited to, polypropylene (PP), high-density polyethylene (HDPE), polycarbonate (PC), and polyethylene terephthalate (PET). It is contemplated that the material, e.g., the type of polymer, may be selected based its properties for manufacturing (e.g., melt temperature, liquid phase viscosity, solid phase hardness, etc.) as well as its properties for use (e.g., bio or chemical compatibility, inertness, permeability, etc.).

[024] FIG. IB illustrates a diagrammatic representation of a cross-section of the example assembly 100 of FIG. 1A, consistent with various embodiments of the present disclosure. As shown in FIG. IB, mixer 140 and a tank plate 150 may be respectively contained within and integrated into a wall of carboy 110. As shown in FIG. IB, carboy 110 may be supported by platform 130 (e.g., carboy 110 may be placed on top of platform 130) via an integrated tank plate 150 of carboy 110 and a spring-suspended drive unit 510 of platform 130 (as described in more detail below).

[025] Referring to FIG. 2, embodiments of the present disclosure may include a method 200 for manufacturing a rigid carrier, such as carboy 110. Method 200 may include placing polymer inside a mold, wherein components configured to be integrated into a wall of carboy 110 are placed in the interior of the mold, step 210. In some embodiments, the polymer may be viscous, molten, or in any malleable state that may be conducive to blow-molding or clamshell molding of the polymer against an interior surface of the mold. Additionally, or alternatively, the polymer may be extruded directly into the mold. Furthermore, in some embodiments, tank plate 150 and/or auxiliary components, such as port 122 or connector 120, may be contained or held in place in the interior of the mold.

[026] Method 200 may include expanding the polymer against the mold, step 220. In some embodiments, expanding the polymer may include blowing compressed gas into the interior of the mold and causing the polymer to expand against and interface with an interior surface of the mold. Method 200 may include forming at least one aperture in the polymer, step 230, wherein the at least one aperture is aligned with a port or component. An aperture may pertain to an opening, hole, channel, or gap formed in the wall of the carboy to provide a desired opening to the interior of the carboy after molding. Additionally, or alternatively, the aperture may be formed by any suitable tool including — but not limited to — a stylus or needle, a hollow needle with or without compressed gas, or other suitable tool for forming an aperture in the wall of the expanded polymer. It is contemplated that the tool may be relatively cool and configured to displace malleable polymer to form an aperture.

Alternatively, it is contemplated that the tool may be relatively hot (i.e., at or above a temperature configured to melt the polymer) and configured to displace malleable, partially solid, or solid polymer to form an aperture in the wall of the expanded polymer. For example, a stylus may be inserted through the wall of the mold and through the interior of a port connection to displace a portion of the expanded polymer that would otherwise cover the port opening.

[027] FIGs. 3A-3C and 4A-4C provide examples of methods for manufacturing a rigid carrier, such as carboy 110, having integrated components therein.

[028] FIG. 3 A illustrates an example tank plate 150 placed within mold 340. In some embodiments, tank plate 150 includes a port (identified as 414a and shown in FIG. 4A). Furthermore, in some embodiments, mixer 140 may be assembled onto tank plate 150 before or after tank plate 150 is placed in mold 340. Mixer 140 may be rotatably supported on tank plate 150.

[029] As shown in FIG. 3A, tank plate 150 may be placed on, or held by, fixture 310. Fixture 310 may include any tool that may hold tank plate 150 during the manufacturing process, such as, but not limited to, a mandrel. Furthermore, as shown in FIG. 3A, polymer (identified as reference number 330) may be extruded or otherwise placed into mold 340. Compressed gas may be blown into the interior of mold 340 such that the polymer expands against the interior of mold 340 and interfaces with an interior surface of mold 340. [030] Tank plate 150 may be preformed and include a plurality of lateral protrusions. The lateral protrusions may be configured to engage with, melt into, or otherwise be captured by the polymer during manufacturing, such that a seamless connection (or joint) between tank plate 150 and the expanded polymer, and thus the wall of carboy 110 post manufacturing, is formed. In some embodiments, the lateral protrusions may include prongs protruding from the tank plate. Additionally, or alternatively, in some embodiments, the lateral protrusions may include a relatively thin rim protruding from the perimeter of the tank plate. It is contemplated that the lateral protrusion may be of any suitable shape for engaging with, melting into, or otherwise being captured by the polymer during manufacturing such that the tank plate can be integrated within the body or wall of the carboy. Furthermore, in some embodiments, tank plate 150 may be formed of a material that is chemically compatible with polymer 330. Non-limiting examples of tank plate materials may include, polypropylene (PP), high-density polyethylene (HDPE), polycarbonate (PC), and polyethylene terephthalate (PET).

[031] FIG. 3B illustrates a diagrammatic representation of a connection area 320 shown in FIG. 3A, consistent with various embodiments of the present disclosure. As shown in FIG. 3B, tank plate 150 may include a lateral protrusion 350. Lateral protrusion 350 may interface with fixture 310. In some embodiments, lateral protrusion 350 and/or tank plate 150 may be made of the same material as the expanded polymer, and lateral protrusion 350 may melt and chemically bond with the polymer. In other embodiments, lateral protrusion 350 and/or tank plate 150 may be made of a different material than the polymer. FIG. 3C illustrates an example of tank plate 150 having lateral protrusions 350, consistent with various embodiments of the present disclosure. It is contemplated that the connection between tank plate 150 and polymer 330 may form a seamless, leak-tight (or leak-proof) joint.

[032] As shown in FIG. 4A, a polymer (identified as reference number 330) may be expanded against a port 414a that is held in place within wall 330 of the mold. Port 414a may include any suitable shape and be configured to connect to auxiliary equipment (e.g., tubing) to deliver material to or remove material from a manufactured carboy. Port 414a may be preformed, and may be made of any suitable plastic material such as, but not limited to, polypropylene (PP), high-density polyethylene (HDPE), polycarbonate (PC), and polyethylene terephthalate (PET). It is contemplated that any auxiliary component may be integrated into a wall of carboy 110, including — but not limited to — ports, barbs, plates, lugs, handles, supports, or fixation devices. [033] As shown in FIG. 4B, the polymer may be expanded against at least a portion of the port 414a. In some embodiments, port 414a may include lateral protrusions similar to those of tank plate 150, as discussed above, to engage with, melt into, or otherwise be captured by the polymer and integrated into the wall of the carboy.

[034] As shown in FIG. 4C, a tool, such as a stylus 440 shown, may be inserted through port 414a (or any other auxiliary component) to displace or remove polymer material that was expanded across an opening of port 414a. It is contemplated that any suitable device may be inserted through port 414a (or any other auxiliary component) such that an aperture may be formed such that it is aligned with the opening of port 414a (or any other auxiliary component). In some embodiments, a hollow needle may be inserted through port 414a, and compressed gas may be blown through the hollow needle, such that the aperture is formed and/or to assist in expanding or otherwise displacing the expanded polymer.

[035] Embodiments of the present disclosure may also include spring-suspended drive units. Carboy 110 may be supported on platform 130, which may include a spring-suspended drive unit. As shown in FIG. 5, a drive unit 510 may be mounted to platform 130 via one or more spring suspensions 520. In use, a carboy (not shown in FIG. 5) may be placed on top of platform 130 such that drive unit 510 aligns with a tank plate integrated into the wall of the carboy. The drive unit may be configured to impart or transfer rotational motion to a mixer head supported within the carboy by the integrated tank plate. It is contemplated that the drive unit may impart or transfer rotational motion via one or more magnets that interact with magnets or magnetic material disposed in the mixer head. Additionally, or alternatively, it is contemplated that spring-suspended drive unit 510 may accommodate manufacturing tolerances in the form, orientation, or locations of the tank plate (not shown) or other features of a carboy. This accommodation may help align an axis of rotation of the drive unit with an axis of rotation of the mixer head, which may help reduce or eliminate wear between rotating surfaces.

[036] As shown in FIG. 5, spring-suspended drive unit 510 may include a flange 510a, and one or more spring suspensions 520. Each spring suspension 520 may include a first spring (not referenced in FIG. 5) disposed between an upper surface of platform 130 or a flange supported by platform 130 (i.e., between platform 130 and a carboy, as shown in FIG. 7) to permit limited movement of spring-suspended drive unit 510 toward platform 130. It is contemplated that a plurality of spring suspensions (e.g., three or four spring suspensions equally or non-equally spaced apart from one another), each of which may, depending on alignment, tolerances, and loading, adjust a different amount to allow spring-suspended drive unit 510 to tilt. That is, each spring suspension of a plurality of spring suspensions may adjust a different amount (e.g., height) to allow spring-suspended drive unit 510 to tilt in multiple degrees of freedom, which may allow spring-suspended drive unit 510 to accommodate manufacturing tolerances in the form, orientation, or locations of the tank plate (not shown) or other features of a carboy. It is also contemplated that the springs of the plurality of spring suspensions 520 may be the same type of spring, have the same spring constant, may be different types of springs, or have different spring constants, depending on the desired application. In some embodiments, spring suspensions may include one or more springs, e.g., a conical spring, a wave spring, or any other biasing member. Two spring suspensions 520 are illustrated in FIG. 5.

[037] As shown in FIG. 6, each spring suspension 520 may also include a second spring (not referenced in FIG. 6) disposed between a lower surface of platform 130 or a flange supported by platform 130 (i.e., on a side of platform 130 opposite a carboy as shown in FIG. 7) to permit limited movement of spring-suspended drive unit 510 away from platform 130. As described in more detail below, spring suspensions 520 may include rods and bolts to hold the end of the second springs. Four spring suspensions 520 are illustrated in FIG. 6.

[038] Spring-suspended drive unit 510 may be made of any suitable material including stainless steel, aluminum, copper, bronze, brass, or any other corrosion resistant metal. Platform 130 may be made of any suitable plastic material including, but not limited to, polyethylene terephthalate (PET or PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC or vinyl), low-density polyethylene (LDPE), or polystyrene (PS). Furthermore, in some embodiments, platform 130 may be made of any suitable corrosion resistant metal such as, but not limited to, stainless steel, aluminum, copper, bronze, or brass.

[039] As shown in FIG. 7, a mixer head 140 may be supported on tank plate 150, which may be integrated into the wall of carboy 110. Tank plate 150 may be configured to accommodate a drive unit, e.g., spring-suspended drive unit 510. Flange 510a may be mounted to platform 130 via one or more spring suspensions 520 (two of which are illustrated in FIG. 7). Each spring suspension 520 may include a first spring disposed between an upper side of platform 130 and spring suspended drive unit 510. Each spring suspension 520 may include a second spring disposed between a lower side of platform 130 and the end of a suspension rod. The first and second springs may be supported on respective ends thereof directly by platform 130 or by one or more flanges 560. Each of spring suspensions 520 may include a rod having one end thereof connected to flange 510a of spring suspended drive unit 510 and another end thereof cantilevered below platform 130. The cantilevered end of each rod may include a flange 580a and/or bolt 580b to hold one end of a respective second spring.

[040] While illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as nonexclusive. Further, the steps of the disclosed methods can be modified in any manner, including reordering steps and/or inserting or deleting steps.

[041] Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as example only, with a true scope and spirit of the disclosed embodiments being indicated by the following claims.

Claims

WHAT IS CLAIMED IS:

1. An assembly configured to contain a material, the assembly comprising: a rigid carrier manufactured by: placing polymer inside a mold; expanding the polymer against at least portions of an interior surface of the mold, at least portions of a tank plate, and at least portions of an auxiliary component, wherein the tank plate and the auxiliary component are predisposed within the mold; and forming at least one aperture in the polymer, wherein the at least one aperture is aligned with the at least one auxiliary component.

2. The assembly of claim 1, further including a mixing element disposed on an interior of the rigid carrier.

3. The assembly of claim 1, wherein the mixing element is rotatably supported by the tank plate.

4. The assembly of claim 1, further including a spring-suspended drive unit disposed on an exterior of the rigid carrier, the spring-suspended drive unit configured to interact with the mixing element to transfer rotational movement thereto.

5. The assembly of claim 1, wherein the tank plate is preformed and includes at least one lateral protrusion.

6. The assembly of claim 5, wherein the at least one lateral protrusion is configured to be melted into the wall.

7. The assembly of claim 5, wherein the at least one lateral protrusion is configured to interact with the polymer.

8. The assembly of claim 1, wherein the auxiliary component is preformed.

9. The assembly of claim 1, wherein the auxiliary component is port.

10. The assembly of claim 1, further including extruding the polymer into the mold.

11. The assembly of claim 1, wherein the rigid carrier is further manufactured by delivering compressed gas into the interior of the mold to expand the polymer.

12. The assembly of claim 1, wherein the rigid carrier is further manufactured by inserting a stylus through the mold and the auxiliary component and forming an aperture with the stylus.

13. The assembly of claim 12, wherein the stylus is a hollow needle and wherein the rigid carrier is further manufactured by blowing compressed gas through the hollow needle.

14. A method for manufacturing a rigid carrier, the method comprising: placing polymer inside a mold; expanding the polymer against at least portions of the interior surface of the mold, at least portions of a tank plate predisposed within the mold, and at least portions of an auxiliary component predisposed within the mold; and forming at least one aperture in the polymer, wherein the at least one aperture is aligned with the auxiliary component.

15. The method of claim 14, further including delivering compressed gas into the interior of the mold to expand the polymer.

16. The method of claim 14, wherein the tank plate includes at least one lateral protrusion.

17. The method of claim 14, wherein the at least one auxiliary component includes a barb.

18. A rigid container, comprising: a wall defining an interior region; a tank plate integrated into the wall, the wall void of a weld seam between the tank plate and the wall; and a port integrated into the wall, the wall void of a weld seam between the port and the wall.

19. The rigid container of claim 18, further including a mixing element disposed on the interior region.

20. The rigid container of claim 19, wherein the mixing element is rotatably supported on the tank plate.