Rigid frame bag

Abstract

We provide bioprocess bags for containing bioprocess fluids. [Solution] The bioprocess bag comprises a frame having a first opening and a second opening, a first film layer joined to the frame so as to cover the first opening, and a second film layer joined to the frame so as to cover the second opening. The frame, the first film layer, and the second film layer form a sealed space for containing the bioprocess fluid. The frame is provided between the first film layer and the second film layer.

Description

Technical Field

[0001] This specification claims priority based on U.S. Provisional Patent Application No. 63236994 filed on August 25, 2021.

[0002] The present disclosure relates to bioprocess bags and / or bags for containing pharmaceutical fluids, biological fluids and the like, and in particular to a bag provided with a rigid frame that supports the bag during freezing, thawing, and / or frozen transportation processes. Background Art

[0003] Chemical and / or biological processes can be carried out in bags such as bioprocess bags or bags for containing pharmaceutical fluids or biological fluids, or the results of such processes can be contained in the bags. Process materials, or materials obtained from processes, may need to be frozen or otherwise maintained at low temperatures. To ensure the integrity of the bag or the maintenance of a desired shape, it may be necessary to support the bag throughout the cooling or freezing process. Summary of the Invention

[0004] The present disclosure relates to bioprocess bags and / or bags for containing pharmaceutical fluids, biological fluids and the like, and in particular to a bag provided with a rigid frame that supports the bag during freezing, thawing, and / or frozen transportation processes.

[0005] Certain types of bags, such as those made of fluoropolymers, are used in plate freezing and thawing applications, and bag holders are designed and constructed to meet the needs of fluoropolymer bags. As bag volumes continue to shrink for use in some low-volume applications, the ratio of fitting size to small bag size can eventually become undesirable.

[0006] Embodiments disclosed herein provide a stackable, compact structure that, by providing a bag with a rigid frame (or shell), can reduce overall costs by eliminating the need for a separate bag holder, enhance the usefulness of the bag by achieving a constant fluid / bag height (e.g., a consistent freezing profile throughout), achieve efficient freezing and / or thawing volumes, and ensure ease of handling and transport, as well as increased gas permeability.

[0007] In one embodiment, a bioprocess bag for containing a bioprocess fluid comprises a frame having a first opening and a second opening, a first film layer joined to the frame so as to cover the first opening, and a second film layer joined to the frame so as to cover the second opening. The frame, the first film layer, and the second film layer form a sealed space for containing the bioprocess fluid. The frame is provided between the first film layer and the second film layer.

[0008] In specific embodiments, the frame, the first film layer, and the second film layer are made from the same or compatible material. For example, the frame, the first film layer, and the second film layer can each be made from a fluoropolymer. In some embodiments, the first film layer and / or the second film layer can be a single-layer film or a multi-layer film.

[0009] Furthermore, the minimum and maximum thickness of the frame can be varied, for example, depending on the desired final volume. For instance, the minimum frame thickness can be 1 / 30,000 of an inch or approximately 1 / 30,000 of an inch, and the maximum frame thickness can be, for example, 3 inches or approximately 3 inches.

[0010] The minimum and maximum thicknesses of the first or second film layer may also be varied, for example, depending on the properties of the film and / or the conditions under which the film is supplied. For example, the minimum thickness of the first film layer, the second film layer, or both may be 1 / 3000 of an inch or about 1 / 3000 of an inch. The maximum thickness of the first film layer and / or the second film layer may be 1 / 25000 of an inch or about 1 / 25000 of an inch.

[0011] In some embodiments, the bioprocess bag further comprises at least one attachment. The at least one attachment is configured to fill the bioprocess bag with bioprocess fluid and / or to discharge the bioprocess fluid from the bioprocess bag. In one embodiment, the at least one attachment and frame are integrally formed, for example, using injection molding.

[0012] The bioprocess bag may further comprise a cap which may have at least one fitting cover configured to protect at least one fitting. The cap may be configured to cover a first film layer covering a first opening, or a second film layer covering a second opening of the frame. In some embodiments, the cap may be made of plastic or stainless steel and preferably has a flat surface.

[0013] In one embodiment, the frame includes an interlocking mechanism. For example, the bioprocess bag may further include a cap having an interlocking mechanism. The interlocking mechanisms of the frame and the cover can be configured to interlock with each other using snap-fit ​​connections.

[0014] In another embodiment, the bioprocess bag comprises a frame containing a bioprocess fluid and having a front opening and a plurality of additional openings; a plate configured to cover the front opening; and a first film layer, a second film layer, and a third film layer bonded to the frame, each covering one of the plurality of additional openings. In this embodiment, the frame, the plate, the first film layer, the second film layer, and the third film layer form a sealed space for containing the bioprocess fluid. Alternatively, the bioprocess bag may further comprise a fourth film layer and a fifth film layer. The first film layer, the second film layer, the third film layer, the fourth film layer, and the fifth film layer are each bonded to the frame, each covering one of the plurality of openings. The frame, the plate, the first film layer, the second film layer, the third film layer, the fourth film layer, and the fifth film layer form a sealed space for containing the bioprocess fluid. In this embodiment, the plate may include at least one attachment configured to fill a bioprocess bag with bioprocess fluid and / or discharge the bioprocess fluid from the bioprocess bag. The plate and frame may also be integrally formed using injection molding or the like.

[0015] The disclosure also relates to a method for forming a bioprocess bag for containing a bioprocess fluid. The method includes forming a frame having a first opening and a second opening; forming a first film layer and a second film layer; joining the first film layer to the frame so as to cover the first opening; joining the second film layer to the frame so as to cover the second opening; and forming a sealed space for containing a bioprocess fluid with the frame, the first film layer and the second film layer. The frame is provided between the first film layer and the second film layer.

[0016] In one embodiment, the method further includes forming a cap having a flat surface and interlocking the cap and frame using a snap-fit ​​connection. The method may further include covering at least one fixture with at least one fixture cover of the cap. The method may further include covering a first film layer covering a first opening, or a second film layer covering a second opening of the frame, with the cap.

[0017] Refer to the accompanying drawings, which form part of this disclosure and illustrate various embodiments that can carry out the bioprocess bags and methods described herein. It should be understood that these drawings are not necessarily drawn to scale and may, in some cases, present somewhat simplified representations of various preferred features illustrating the fundamental principles of this disclosure. For example, specific design features of this disclosure, including certain dimensions, orientations, positions, and shapes, will be determined in part by the intended use and operating environment. A non-limiting and non-exclusive description will be made with reference to the following drawings. [Brief explanation of the drawing]

[0018] [Figure 1] This is a plan perspective view of a rigid frame bag according to one embodiment. [Figure 2] Figure 1 is a bottom perspective view of a rigid frame bag according to one embodiment. [Figure 3] This is a plan perspective view of a rigid frame bag according to another embodiment. [Figure 4] This is a plan perspective view of a rigid frame bag according to another embodiment. [Figure 5] This is a plan perspective view of a rigid frame bag according to another embodiment. [Figure 6] This is a plan perspective view of a rigid frame bag according to another embodiment. [Figure 7] This is a plan perspective view of a rigid frame bag according to another embodiment. [Figure 8]It is a perspective view of integrally stacked rigid frame bags according to one embodiment. [Figure 9] It is a perspective view of integrally stacked rigid frame bags according to another embodiment. [Figure 10] It is a top perspective view of a rigid frame bag according to one embodiment. [Figure 11] It is a top perspective view of a cassette according to one embodiment. [Figure 12] It is a bottom perspective view of the cassette of Figure 11 according to one embodiment. [Figure 13] It is a perspective view of a 3D rigid frame bag according to one embodiment. [Figure 14] It is a perspective view of a 3D rigid frame bag according to another embodiment. [Figure 15] It is a flowchart illustrating a method of forming a bioprocess bag for containing a bioprocess fluid according to one embodiment. Description of Embodiments

[0019] Like reference numerals denote like parts throughout the drawings.

[0020] The present disclosure relates to bioprocess bags and / or bags for containing pharmaceutical fluids, biological fluids and the like, and specifically to bags provided with a rigid frame that supports the bag during freezing, thawing, and / or frozen transportation processes.

[0021] The following definitions are applicable throughout this disclosure. Where defined herein, the phrase “frame” may mean, for example, a rigid structure that at least partially surrounds or confines an object or a space within an object. In one embodiment, the frame may be injection-molded and have a thickness sufficient to give rigidity to the bioprocess bag. For example, the frame may have a minimum thickness of 0.03 inches or about 0.03 inches. The frame may also have a maximum thickness of 3 inches or about 3 inches. In one embodiment, the frame may have a width or diameter (for a circular object) of 1.5 inches or about 1.5 inches.

[0022] Where defined herein, the term “film” can refer to a thin, flexible piece of, for example, plastic or any other suitable material. Preferably, the film is thin enough to be flexible enough to allow the fluid contained in the bag to expand and / or contract as needed during filling or dispensing, but thick enough to withstand a variety of handling and processing conditions without easily breaking. The film typically undergoes a manufacturing process different from injection molding. In one embodiment, the film has a minimum thickness of 0.003 inches or about 0.003 inches. In another embodiment, the film has a maximum thickness of 0.025 inches or about 0.025 inches.

[0023] Some embodiments of this disclosure are described in detail with reference to the accompanying drawings so that the advantages and features of this application may be more readily understood by those skilled in the art. Terms such as “near,” “far,” “top,” “bottom,” “left,” and “right” as used in this application are defined according to typical viewing angles for those skilled in the art and for the convenience of explanation. These terms are not limited to specific directions.

[0024] Those skilled in the art will recognize that, with respect to such and other processes and methods disclosed herein, the functions performed in such processes and methods may be performed in different orders. Furthermore, the outlined steps and operations are provided merely as examples, and some of such steps and operations may be optional, condensed into fewer steps and operations, or expanded into additional steps and operations without prejudice to the essence of the embodiments of this disclosure.

[0025] Figures 1 to 7 and Figure 10 are perspective views of various frames and rigid frame bags according to some embodiments. For example, Figure 1 is a plan perspective view of a rigid frame bag 100, and Figure 2 is a bottom perspective view of the rigid frame bag of Figure 1 with the film layer removed to show the frame features.

[0026] Thus, as shown in Figure 1, the rigid frame bag 100 is formed by comprising a frame 110 and a film layer 105 (showing only the upper layer) bonded to the frame 110. In this embodiment, the frame and film can be made of the same material or compatible material. Compatible material can be referred to as the same material or different materials having similar sufficient properties to the materials to be bonded (or welded, bonded, etc.) to each other. For example, the frame 110 and / or film 105 can be made of a fluoropolymer, which is an organic polymer containing fluorine atoms, such as polytetrafluoroethylene. It will be recognized that fluoropolymers can be rigid or hard at room temperature but will not become any harder when subjected to freezing temperatures. As such, fluoropolymer bags can therefore be used for freezing and thawing applications. It will also be recognized that the rigid frame bag 100 can be made of a material with a desired level of purity suitable for applications such as pharmaceuticals or bioprocesses, capable of withstanding a wide temperature range, including up to liquid nitrogen temperatures. For example, the material for the rigid frame bag is preferably not polyethylene (PE). Each film layer can be a single-layer film or a multi-layer film. A single-layer film can be a film made from one material, while a multi-layer film can contain two or more individual layers of the same or different materials.

[0027] The frame of a rigid frame bag can take on a variety of different shapes, and this shape is then applied to the overall shape of the bag. For example, the rigid frame and the resulting bag may have a rectangular shape with rounded edges, a circular shape, or any other suitable shape. Various shapes are shown in Figures 1 to 6.

[0028] More specifically, as shown in Figures 1 to 6 and Figure 10, the periphery of the frame 110 can form a sealed space having one or more openings or holes exposed to the external space. For example, as shown in Figure 2, the frame 110 includes a first opening 110A and a second opening 110B. The first and second openings form through holes around the frame. A first film layer (not shown) can be joined to the frame 110 so as to cover the first opening 110A, and a second film layer (not shown) can be joined to the opposite side of the frame 110 so as to cover the second opening 110B. The frame, the first film layer, and the second film layer form a sealed space for containing a bioprocess fluid. In this way, the frame is provided between the first and second film layers to form the interior of a bag having a volume determined by the size of the frame and the film. For example, a sealed space suitable for containing a bioprocess fluid may have a volume ranging from 200 milliliters or about 200 milliliters to 20 liters or about 20 liters.

[0029] In another embodiment, the frame 110 may have a single opening. In this embodiment, the frame structure may form a recess, and the film layer may be bonded to the frame so as to cover the opening. The frame and the film layer may form a sealed space for containing a bioprocess fluid.

[0030] In another embodiment shown in Figure 7, the periphery of the frame 110 can form a partially sealed space in which an opening or hole is exposed to the external space. In this embodiment, the frame 110 may have a first opening 110A, a second opening 110B, and a third opening 110C. The first and second openings form through holes around the frame 110. A first film layer (not shown) can be joined to the frame so as to cover the first opening 110A, and a second film layer (not shown) can be joined to the frame so as to cover the second opening 110B. In addition, a third film layer (not shown) can also be joined to the frame 110 so as to cover the third opening 110C. In this way, the frame, the first film layer, the second film layer, and the third film layer form a sealed space for containing a bioprocess fluid.

[0031] In various embodiments, the rigid frame bag may include one or more fixtures. Each fixture may include one or more valves as required depending on the application. The fixtures are configured to fill the rigid frame bag with bioprocess fluid or to discharge the bioprocess fluid from the rigid frame bag. The bioprocess fluid can be guided in or out of the rigid frame bag through the fixture, for example, when the valve of the fixture is open (or pressed to open). The fixtures and frame may be made of the same or compatible material. In one embodiment, the fixtures and frame may be integrally formed into a single piece, for example, by injection molding.

[0032] As shown in Figures 1 to 6, the rigid frame bag 100 may have one or more fittings 112 along the perimeter of the frame 110. For example, the rigid frame bags in Figures 2 and 3 have two fittings, while those shown in Figures 4 and 5 have three. Each fitting may be configured to either fill the rigid frame bag with bioprocess fluid or to connect to a tube (such as a silicone tube) to drain the bioprocess fluid from the rigid frame bag. Alternatively, as shown in Figure 6, the frame 100 may have one fitting 112 that can be connected to a connector 130 having a specific fitting, which can then be connected to suitable tubing. In this way, the connector 130 can be attached to the fitting 112, for example, to fill the rigid frame bag and to remove it for transport or storage. If the contents are to be dispensed from the bag, the same or a different connector can be attached to the fitting 112.

[0033] In addition, as shown in Figures 3 and 10, the frame 110 may be equipped with one or more interlocking mechanisms 116 to secure the frame to the cap cassette. For example, the interlocking mechanism 116 shown in Figure 10 can work in cooperation with the interlocking mechanism 216 of the cap 200 shown in Figure 11 to secure the frame to the cap, which will be described in more detail below.

[0034] The rigidity of the frame forming the rigid frame bag allows for the stacking of multiple bags. For example, Figures 8 and 9 are perspective views of stacks 800 and 900, respectively, containing multiple individual rigid frame bags 100. By stacking the rigid frame bags in this way, the film layer of the bags can be protected during storage and transport.

[0035] In some embodiments, a cassette or container (such as a cover or cap) may be included to cover, protect, and / or seal the fixtures, such as those discussed above, from the external environment. The use of a cassette allows, for example, the fixtures of a rigid frame bag to be kept clean. Figure 11 is a plan perspective view of the cassette 200, while Figure 12 is a bottom perspective view of the cassette of Figure 11. As shown, the cassette 200 may also include one or more interlocking mechanisms 216. When in use, the interlocking mechanism 116 of the frame 100 (see Figure 10) and the interlocking mechanism 216 of the cassette 200 are configured to interlock with each other using snap-fit ​​connections that can be coupled or attached, for example, by rotation.

[0036] As shown, the cassette is configured to cover the frame or rigid frame bat, thereby protecting the integrity of the bag. For example, the cassette 200 shown in Figure 11 is configured to cover a first film layer covering the first opening 110A of the frame 110 shown in Figure 10, or a second film layer covering the second opening 110B of the frame 110. In one embodiment, the cassette may have a flat surface 210, which can facilitate the easy transport and / or storage of the rigid frame bag. For example, the cassette may be made of plastic to protect the rigid frame bag. In another embodiment, the cassette may be made of metal (e.g., stainless steel) to facilitate the freezing and / or thawing process of the contents of the rigid frame bag.

[0037] In another embodiment, the rigid frame bag described herein may comprise a frame including a plurality of openings. Specific examples are shown in perspective views of 3D rigid frame bags 300 and 400, respectively, including a plurality of openings or facets 310A to 310F, in Figures 13 and 14. One of the openings, such as opening 310F, can be covered with a plate 318 to provide further rigidity to the 3D structure, and may further comprise a mounting fixture 312 located in the center of the plate. It will be recognized that the rigid frame bag 300 may comprise one or more mounting fixtures, and that the other openings other than opening 310F can be covered with plates. As shown, the frame 310 includes three or more or any preferred number of openings or facets. For example, the frame 310 may have a pyramidal shape, a cubic shape, a hexahedral shape, etc. A film layer can be bonded to the frame 310 to cover openings 310A to 310E, except for opening 310F which is covered with plate 318. The frame, plate, and film layer can form a sealed space for containing bioprocess fluids.

[0038] In this embodiment, the plate 318, frame 310, and / or mounting fixture 312 can be made from the same material or a compatible material. Specifically, the plate 318, frame 310, and / or mounting fixture 312 can be integrally formed using injection molding or the like. Furthermore, the rigid frame bag 400 can have a similar structure and / or functionality to the rigid frame bag 300 and the others described above, except that the rigid frame bag 400 has more openings and creates a larger three-dimensional shape.

[0039] Figure 15 is a flowchart illustrating a method 600 for forming a bioprocess bag for containing a bioprocess fluid. Various blocks are shown as individual blocks, but may be divided into additional blocks, combined into fewer blocks, or eliminated depending on the desired implementation. The bioprocess bag can be any of the rigid frame bags described above, including those shown in Figures 1 to 14.

[0040] As shown in the flowchart of Figure 15, method 600 can be started in 610, 620, or 650. Block 610 may refer to forming a frame having an opening. Block 620 may refer to forming a film layer. Block 650 may refer to forming a cassette such as the cassette 200 in Figures 11 and 12.

[0041] Blocks 610 and 620 may be followed by block 630. Block 630 may refer to joining the film layer to the frame so as to cover the opening of the frame. Block 630 may be followed by block 640.

[0042] Block 640 may refer to the formation of a sealed space for containing a bioprocess fluid by a frame and film layer. Block 660 may follow blocks 640 and 650.

[0043] Block 660 may refer to, for example, linking the cassette and frame using a snap-fit ​​or any other suitable mechanism. Block 660 may also refer to covering the fittings with a fitting cover on the cap. Block 660 may further refer to covering one or more sides of the frame with the cassette and / or covering one or more layers of the film with the cassette. In this way, method 600 can provide a bag that is expandable in volume, has flexible connections, has good drainage, and / or uses less construction material (e.g., plastic).

[0044] Pattern: It is understood that any one of embodiments 1 to 18 can be combined with any one of embodiments 19 to 22 and 23 to 26. Any one of embodiments 19 to 22 can be combined with any one of embodiments 23 to 26.

[0045] Embodiment 1. A bioprocess bag for containing a bioprocess fluid, comprising a frame having a first opening and a second opening, a first film layer joined to the frame so as to cover the first opening, and a second film layer joined to the frame so as to cover the second opening, wherein the frame, the first film layer, and the second film layer form a sealed space for containing the bioprocess fluid, and the frame is provided between the first film layer and the second film layer.

[0046] Embodiment 2. The bioprocess bag according to Embodiment 1, wherein the frame, the first film layer, and the second film layer are made of the same material or a compatible material.

[0047] Embodiment 3. A bioprocess bag according to Embodiment 1 or Embodiment 2, wherein the frame, the first film layer, and the second film layer are made of a fluoropolymer.

[0048] Embodiment 4. A bioprocess bag according to any one of Embodiments 1 to 3, wherein the first film layer is a single-layer film and the second film layer is a single-layer film.

[0049] Embodiment 5. A bioprocess bag according to any one of Embodiments 1 to 3, wherein the first film layer is a multilayer film.

[0050] Embodiment 6. A bioprocess bag according to any one of Embodiments 1 to 3 and 5, wherein the second film layer is a multilayer film.

[0051] Embodiment 7. A bioprocess bag according to any one of Embodiments 1 to 6, wherein the minimum thickness of the frame is 1 / 30,000 of an inch or approximately 1 / 30,000 of an inch.

[0052] Embodiment 8. A bioprocess bag according to any one of Embodiments 1 to 7, wherein the maximum frame thickness is 3 inches or approximately 3 inches.

[0053] Embodiment 9. A bioprocess bag according to any one of Embodiments 1 to 8, wherein the minimum thickness of the first film layer or the second film layer is 1 / 3000th of an inch or approximately 1 / 3000th of an inch.

[0054] Embodiment 10. A bioprocess bag according to any one of Embodiments 1 to 9, wherein the maximum thickness of the first film layer or the second film layer is 1 / 25,000 of an inch or approximately 1 / 25,000 of an inch.

[0055] Embodiment 11. A bioprocess bag according to any one of embodiments 1 to 10, further comprising at least one attachment configured to fill the bioprocess bag with a bioprocess fluid or to discharge a bioprocess fluid from the bioprocess bag.

[0056] Embodiment 12. The bioprocess bag of Embodiment 11, wherein at least one mounting fixture and frame are integrally formed using injection molding.

[0057] Embodiment 13. A bioprocess bag according to Embodiment 11 or Embodiment 12, further comprising a cap having at least one attachment cover, wherein the at least one attachment cover is configured to protect at least one attachment.

[0058] Embodiment 14. A bioprocess bag according to any one of Embodiments 1 to 13, wherein the frame is equipped with an interlocking mechanism, the bioprocess bag is equipped with a cap equipped with an interlocking mechanism, and the interlocking mechanism of the frame and the interlocking mechanism of the cover are configured to interlock with each other using snap-fits.

[0059] Embodiment 15. The bioprocess bag according to Embodiment 14, wherein the cap is configured to cover a first film layer covering a first opening, or a second film layer covering a second opening of the frame.

[0060] Embodiment 16. A bioprocess bag according to Embodiment 14 or Embodiment 15, wherein the cap has a flat surface.

[0061] Embodiment 17. A bioprocess bag according to any one of Embodiments 14 to 16, wherein the cap is made of plastic.

[0062] Embodiment 18. A bioprocess bag according to any one of Embodiments 14 to 17, wherein the cap is made of stainless steel.

[0063] Embodiment 19. A bioprocess bag for containing a bioprocess fluid, comprising a frame having a front opening and a plurality of openings, a plate configured to cover the front opening, and a first film layer, a second film layer, and a third film layer joined to the frame so as to cover each of the plurality of openings, wherein the plate, frame, first film layer, second film layer, and third film layer form a sealed space for containing the bioprocess fluid.

[0064] Embodiment 20. A bioprocess bag according to Embodiment 19, further comprising a fourth film layer and a fifth film layer, wherein the first film layer, the second film layer, the third film layer, the fourth film layer, and the fifth film layer are each joined to a frame so as to cover each of the multiple openings, and the frame, plate, first film layer, second film layer, third film layer, fourth film layer, and fifth film layer form a sealed space for containing a bioprocess fluid.

[0065] Embodiment 21. A bioprocess bag according to Embodiment 19 or Embodiment 20, wherein the plate further comprises at least one attachment, the at least one attachment configured to fill the bioprocess bag with bioprocess fluid or to discharge the bioprocess fluid from the bioprocess bag.

[0066] Embodiment 22. A bioprocess bag according to any one of Embodiments 19 to 21, wherein the plate and frame are integrally formed using injection molding.

[0067] Embodiment 23. A method for forming a bioprocess bag for containing a bioprocess fluid, comprising: forming a frame having a first opening and a second opening; forming a first film layer and a second film layer; joining the first film layer to the frame so as to cover the first opening; joining the second film layer to the frame so as to cover the second opening; and forming a sealed space for containing a bioprocess fluid by the frame, the first film layer, and the second film layer, wherein the frame is provided between the first film layer and the second film layer.

[0068] Embodiment 24. The method of Embodiment 23, further comprising forming a cap having a flat surface and interlocking the cap and frame using a snap fit.

[0069] Embodiment 25. The method of Embodiment 24, further comprising covering at least one fixture with at least one fixture cover of the cap.

[0070] Embodiment 26. The method of Embodiment 24 or Embodiment 25, further comprising covering a first film layer covering a first opening, or a second film layer covering a second opening of the frame, with a cap.

[0071] The examples disclosed herein should be considered in all respects to be illustrative and not limiting. The terms used herein are intended to describe, and not limit, specific embodiments. The terms “a,” “an,” and “the” include their plural forms unless otherwise specified. The term “or” includes “and / or” unless otherwise specified. The terms “comprises” and / or “comprising,” as used herein, identify the presence of a specified feature, integer, process, operation, element, and / or component, but do not exclude the presence or addition of one or more other features, integers, processes, operations, elements, and / or components.

[0072] With regard to the foregoing, it should be understood that detailed changes to the construction materials used, as well as the shape, size, and arrangement of components, may be made without departing from the scope of this disclosure. This specification and the embodiments described herein are illustrative only, and the true scope and intent of this disclosure are shown in the claims below.

Claims

1. A bioprocess bag for containing bioprocess fluids, A frame having a first opening and a second opening, A first film layer is joined to the frame so as to cover the first opening, It comprises a second film layer joined to the frame so as to cover the second opening, The frame, the first film layer, and the second film layer form a sealed space for containing the bioprocess fluid. A bioprocess bag in which a frame is provided between a first film layer and a second film layer.

2. The bioprocess bag according to claim 1, wherein the frame, the first film layer, and the second film layer are made of the same material or a compatible material.

3. The bioprocess bag according to claim 1, wherein the frame, the first film layer, and the second film layer are made of a fluoropolymer.

4. The bioprocess bag according to claim 1, wherein the first film layer is a single-layer film and the second film layer is a single-layer film.

5. The bioprocess bag according to claim 1, wherein the first film layer is a multilayer film.

6. The bioprocess bag according to claim 1, wherein the second film layer is a multilayer film.

7. The bioprocess bag according to claim 1, wherein the minimum thickness of the first film layer or the second film layer is 1 / 3000th of an inch or about 1 / 3000th of an inch.

8. The bioprocess bag according to claim 1, wherein the maximum thickness of the first film layer or the second film layer is 1 / 25,000 of an inch or about 1 / 25,000 of an inch.

9. A bioprocess bag configured to fill with bioprocess fluid, or to discharge bioprocess fluid from a bioprocess bag. at least one mounting bracket The bioprocess bag according to claim 1, further comprising the features described above.

10. The bioprocess bag according to claim 9, wherein at least one mounting fixture and frame are integrally formed using injection molding.

11. A cap having at least one mounting cover, A cap comprising at least one mounting cover configured to protect at least one mounting fixture. The bioprocess bag according to claim 9, further comprising:

12. The frame has an interlocking mechanism, and the bioprocess bag, Equipped with a cap with an interlocking mechanism, The bioprocess bag according to claim 1, wherein the frame interlocking mechanism and the cover interlocking mechanism are configured to interlock with each other using snap-fits.

13. The bioprocess bag according to claim 12, wherein the cap is configured to cover a first film layer covering a first opening, or a second film layer covering a second opening of the frame.

14. A bioprocess bag for containing bioprocess fluids, A frame having a front opening and multiple openings, A plate configured to cover the front opening, It comprises a first film layer, a second film layer, and a third film layer, which are joined to the frame so as to cover each of the multiple openings, A bioprocess bag in which a plate, a frame, a first film layer, a second film layer, and a third film layer form a sealed space for containing a bioprocess fluid.

15. The present invention further comprises a fourth film layer and a fifth film layer, The first film layer, the second film layer, the third film layer, the fourth film layer, and the fifth film layer are joined to the frame so as to cover each of the multiple openings. The frame, plate, first film layer, second film layer, third film layer, fourth film layer, and fifth film layer form a sealed space for containing the bioprocess fluid. The bioprocess bag according to claim 14.

16. The bioprocess bag according to claim 14, wherein the plate comprises at least one attachment, the at least one attachment configured to fill the bioprocess bag with bioprocess fluid or to discharge the bioprocess fluid from the bioprocess bag.

17. The bioprocess bag according to claim 14, wherein the plate and frame are integrally formed using injection molding.

18. A method for forming a bioprocess bag for containing a bioprocess fluid, To form a frame having a first opening and a second opening, To form a first film layer and a second film layer, The first film layer is joined to the frame so as to cover the first opening. The second film layer is joined to the frame so as to cover the second opening, and This includes forming a sealed space for containing a bioprocess fluid using a frame, a first film layer, and a second film layer. A method in which a frame is provided between a first film layer and a second film layer.

19. To form a cap having a flat surface, and Use snap-fit ​​to connect the cap and frame. The method according to claim 18, further comprising:

20. Covering the first film layer covering the first opening, or the second film layer covering the second opening of the frame, with a cap. The method according to claim 18, further comprising:

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