Storage containers for freezing, thawing and shipping

Abstract

The storage container includes a housing having a bottom, two side walls, a front wall, and a rear wall that form an interior space within the housing. The storage container also includes a lid configured to close the interior space. The two side walls of the housing include rim portions, and the lid includes a rail portion configured to provide non-destructive, deformable locking and unlocking engagement with the rim portions. The rear wall of the housing includes a first segment and a second segment, the second segment being longitudinally separated from the first segment by a distance and connected to the first segment by a secondary bottom such that the second section of the interior space has a larger volume than the first section of the interior space.

Description

[Technical Field]

[0001] The present disclosure is directed to storage containers, such as bag holders, for supporting bags during either the freezing, thawing, or frozen shipping process, particularly storage containers having a design that protects the bags during use, transportation, or shipping and facilitates use and reuse of the storage container. [Background technology]

[0002] Chemical or biological processes can be performed or their results can be contained in bags, such as bags containing pharmaceutical or biological fluids, bioprocess bags, etc. Process materials or materials resulting from the process may need to be frozen or otherwise maintained at low temperatures. Bags may need to be supported throughout the cooling or freezing process to ensure the bag maintains its integrity or desired shape. Holders can be used to support and shape the bag before, during, or after the cooling or freezing process during transport or shipping. Summary of the Invention

[0003] The present disclosure is directed to storage containers, such as bag holders, for supporting bags during either the freezing, thawing, or frozen shipping process, particularly storage containers having a design that protects the bags during use, transportation, or shipping and facilitates use and reuse of the storage container.

[0004] The use of bag holders for plate freezing processes secures the bags in a shape that provides a good contact surface for freezing and can maintain this shape as the material contained within the bag freezes, for example, when aqueous solutions expand during freezing. However, typical bag holders have a generic shape and structure that is not suitable for certain types of bioprocess bags.

[0005] For example, certain types of bags (e.g., made from fluoropolymers) are commonly used for plate freezing and thawing applications, but typical bag holders are designed and constructed around the need for polyethylene (PE) bags, which have higher elasticity than fluoropolymer bags. This can result in fluoropolymer bags experiencing multiple failures in typical bag holders, which can prevent users from using fluoropolymer bags in their processes. In addition, some types of bags have shapes and designs that differ from more common PE bags by having angled edges connected to the bottom edge of the bag. Given the different shapes of such bags, typical bag holders are not suitable for properly securing and protecting the bag, which can lead to bag failure during the freezing, thawing, storage, or transportation process. Furthermore, most bag holders are designed for disposable use. For example, bag holders include plastic or metal tabs that are permanently bent to form the bag holder housing or to secure the lid to the housing. However, after multiple uses, the plastic or metal tabs typically break, creating sharp edges that pose a puncture or cut hazard. Typical bag holders are also made from plastic or other materials, which are not only expensive to manufacture, but also typically not suitable for multiple uses and cleaning. Thus, typical bag holders have at least the following drawbacks: connectors or tubing connected to the bag can be misplaced within the bag holder; fluoropolymer bags have different shapes that can cause the foam and bag to be caught on the leading edge of the lid during the sliding action to close the bag holder; they are expensive to manufacture due to their machined plastic design; they have a disposable design; and the sliding action of the lid makes it difficult to close the interior space with the foam and material bag.

[0006] The embodiments disclosed herein can provide solutions to the above problems by, for example, making the bag holder more sturdy, facilitating use or reuse of the bag holder, and protecting the bag during closure, handling, transport, or shipping.

[0007] The embodiments disclosed herein can also provide flexibility to modify the bag support configuration within the bag holder to improve bag performance, do not use permanently bent metal bend tabs used with typical bag holders, make the bag holder easier to open and close without reducing the effectiveness of the bag holder, and provide a security feature to the bag holder.

[0008] In one embodiment, a storage container for pharmaceutical or biological materials includes a housing and a lid. The housing includes a bottom, two side walls, a front wall, and a rear wall that form an interior space within the housing. The interior space has a first section and a second section disposed above the first section. The lid is configured to close the interior space. The two side walls of the housing include rim portions at the tops of the two side walls, and the lid includes a rail portion configured to provide non-destructive, deformable locking and unlocking engagement with the rim portions of the two side walls. The rear wall of the housing includes a first segment and a second segment disposed above the first segment, the second segment being longitudinally separated from the first segment by a distance and connected to the first segment by a secondary bottom surface such that the second section of the interior space has a larger volume than the first section of the interior space.

[0009] In one embodiment, the rail portions of the lid are also configured to provide sliding engagement with the rim portions of the two side walls.

[0010] In one embodiment, the front wall includes a recessed portion such that the recessed portion projects into the interior space of the housing.

[0011] In one embodiment, the recessed portion includes a handle portion configured to lift, push, or pull the reservoir.

[0012] In one embodiment, a first foam portion is provided within the interior space and configured to conform to the shape of the pharmaceutical or biological material bag. A second foam portion is also provided within the interior space adjacent to the first foam portion and configured to receive any tubing or connections attached to the pharmaceutical or biological material bag. The second foam portion has a lower rigidity than the first foam portion.

[0013] In one embodiment, the first foam portion includes a first portion and a second portion separate from the first portion, the first portion of the first foam portion configured to fit within a first section of the interior space, and the second portion of the first foam portion configured to fit within the second section of the interior space above the first portion of the first foam portion.

[0014] In one embodiment, the shape of the pharmaceutical or biological material bag includes an angled edge connected to the bottom edge of the pharmaceutical or biological material bag.

[0015] In one embodiment, the rim portions of the two side walls and the rail portion of the lid include openings configured to align the lid with the housing and to receive a fastening device for securing the lid to the housing.

[0016] In one embodiment, the securing device includes at least one of a zip tie, a securing pin or lock, or a push rivet.

[0017] In one embodiment, the lid further includes a rear rail portion configured to engage the rear wall of the housing to align the openings in the rim portions of the two side walls with the rail portion of the lid.

[0018] In one embodiment, the lid has one end pivotally connected to the housing such that the rail portions are configured to provide non-destructive and deformable locking and unlocking engagement with the rim portions of the two side walls.

[0019] In one embodiment, the lid is removably attachable to the housing.

[0020] In one embodiment, the rail portion of the lid includes downwardly opening grooves configured to engage with the rim portions of the two side walls.

[0021] In one embodiment, the rail portion further includes a handheld portion connected to a downwardly opening groove for providing a non-destructive and deformable unlocking engagement between the rim portion and the rail portion to remove the lid from the storage container.

[0022] In one embodiment, the housing and lid are formed entirely from metal.

[0023] In one embodiment, the bottom, two side walls, front wall, and rear wall are connected by at least one of self-clinching fasteners, pins, screws, nuts, rivets, or welds.

[0024] In one embodiment, the first foam portion further comprises a partially filled foam portion configured to displace a volume of the pharmaceutical material bag or the biological material bag.

[0025] In one embodiment, a storage container for pharmaceutical or biological materials includes a housing, a lid, a first foam portion, and a second foam portion. The housing includes a bottom, two side walls, a front wall, and a rear wall that form an interior space within the housing. The interior space has a first section and a second section provided above the first section. The lid is configured to close the interior space. The first foam portion is provided within the interior space and is configured to conform to the shape of a pharmaceutical or biological material bag. The second foam portion is provided within the interior space adjacent to the first foam portion and is configured to receive either tubing or a connector attached to the pharmaceutical or biological material bag. The two side walls of the housing include rim portions at the top of the two side walls, and the lid includes a rail portion configured to provide non-destructive and deformable locking and unlocking engagement with the rim portions of the two side walls. The rear wall of the housing includes a first segment and a second segment provided above the first segment. The second segment is longitudinally separated from the first segment by a distance and connected to the first segment by a secondary bottom surface such that the second section of the interior space has a larger volume than the first section of the interior space. The front wall includes a recessed portion such that the recessed portion protrudes into the interior space of the housing and into the second foam portion. The recessed portion includes a handle portion configured to lift, push, or pull the storage container.

[0026] In one embodiment, a method for storing a pharmaceutical material bag or a biological material bag includes providing a first portion of a first foam portion within a first section of an interior space of a housing of a storage container. The housing includes a bottom, two side walls, a front wall, and a rear wall that form the interior space of the housing. The method further includes providing a first portion of a second foam portion within the first section of the interior space adjacent to the first portion of the first foam portion; placing the pharmaceutical material bag or biological material bag over the first portion of the first foam portion and the first portion of the second foam portion such that the pharmaceutical material bag or biological material bag is provided on the first foam portion and tubing and connectors connected to the pharmaceutical material bag or biological material bag are provided on the second foam portion; and providing a second portion of the first foam portion and a second portion of the second foam portion within the second section of the interior space such that the pharmaceutical material bag or biological material bag and tubing and connectors are located between the first and second portions of the first foam portion and the second foam portion. The second section is provided above the first section. The method also includes non-destructively deforming a rail portion of the lid to engage the rail portion of the lid with the rim portions of the upper portions of the two side walls, thereby lockingly engaging the lid with the housing to close the interior space of the housing. The rear wall of the housing includes a first segment and a second segment provided above the first segment. The second segment is longitudinally separated from the first segment by a distance and connected to the first segment by a secondary bottom surface such that the second section of the interior space has a larger volume than the first section of the interior space.

[0027] In one embodiment, the lid is pivotally connected to the housing such that the lid closes the interior space by pivoting the lid until non-destructive deformation of the rail portions of the lid lockingly engages the rim portions of the two side walls.

[0028] In one embodiment, the method further includes non-destructively deforming a rail portion of the lid to provide a locking release engagement of the lid and expose the interior space without damaging the lid.

[0029] The details of one or more embodiments of the disclosure are set forth in the accompanying drawings and description, and in the claims.

[0030] Reference is made to the accompanying drawings which form a part of this disclosure and which illustrate exemplary embodiments in which the systems and methods described herein may be practiced. [Brief explanation of the drawings]

[0031] [Figure 1A] 1 illustrates a storage container with the lid removed, according to one embodiment. [Figure 1B] 1B shows the storage container of FIG. 1A with a lid enclosing the interior space. [Figure 1C] FIG. 1C shows a cross-sectional view of the reservoir of FIG. 1B. [Figure 1D] FIG. 1C shows an enlarged end view of the rear wall of the storage vessel of FIG. 1B. [Figure 1E] FIG. 1C shows an enlarged end view of the front wall of the storage container of FIG. 1B. [Figure 1F] FIG. 1C shows a cross-sectional view of the cavity and handle of the reservoir of FIG. 1E. [Figure 2A] 1 illustrates an assembly of a storage container according to one embodiment. [Figure 2B] 1 illustrates an assembly of a storage container according to one embodiment. [Figure 2C] 1 illustrates an assembly of a storage container according to one embodiment. [Figure 2D] 1 illustrates an assembly of a storage container according to one embodiment. [Figure 2E] 1 illustrates an assembly of a storage container according to one embodiment. [Figure 2F] 1 illustrates an assembly of a storage container according to one embodiment. [Figure 3] 10 shows a storage container according to another embodiment. [Figure 4A] 10 shows a storage container according to yet another embodiment. [Figure 4B] 10 shows a storage container according to yet another embodiment. [Figure 5A]10 shows a storage container according to yet another embodiment. [Figure 5B] 10 shows a storage container according to yet another embodiment. [Figure 6A] 1 illustrates an end view of the rear wall and lid of a storage container according to one embodiment. [Figure 6B] 1 illustrates an end view of the rear wall and lid of a storage container according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0032] Like numbers refer to like parts throughout.

[0033] The present disclosure is directed to storage containers, such as bag holders, for supporting bags during either the freezing, thawing, or frozen shipping process, particularly storage containers having a design that protects the bags during use, transportation, or shipping and facilitates use and reuse of the storage container.

[0034] As defined herein, the phrase "plate freezing process" may refer to a process in which object(s) (e.g., bag holder(s) etc.) are frozen, for example, via plate freezer(s). The plate freezer may be, for example, a hollow plate through which a liquid refrigerant flows. An object can be placed between the two plates and cooled evenly to a freezing temperature. A plate freezer may be ideal for freezing flat objects or brick-shaped packaged objects.

[0035] As defined herein, the phrase "blast freezing process" may refer to a process of freezing object(s) (e.g., bag holder(s), etc.) via, for example, a blast freezer(s). A blast freezer may be, for example, a mechanical system commonly used to freeze products on pallets in bulk. It will be understood that the phrase "thawing process" may refer to a process designed to thaw an object instead of freezing the object.

[0036] As defined herein, the phrase "non-destructive" may refer to a process in which the structure is not destroyed or rendered unusable after repeated use, such that the structure may be reusable. For example, a typical bag holder may include metal or plastic tab(s) for securing the lid to the housing by permanently bending the tab(s). After a set number of permanent bendings of the tab, e.g., more than two bends, or more than five bends, or after exceeding the elastic limit of the material, e.g., permanent bending, the tab breaks and is no longer able to secure the lid, e.g., the tab breaks. In this disclosure, a non-destructive process may refer to elastic deformation of a material such that the material is not destroyed or rendered unusable after repeated use, particularly in a clean room environment. It is understood that the term "flexing" as used herein refers to permanent bending, e.g., beyond the elastic limit, such that the material maintains its shape after bending, e.g., has no elastic recovery force.

[0037] As defined herein, the term "substantially" may refer to a configuration that is similar to or within a tolerance or variation of at least 5% of any stated value.

[0038] The embodiments disclosed herein can provide a robust storage container for pharmaceutical or biological materials designed for either plate freezing, blast freezing, robust frozen shipping, or thawing techniques, particularly when used in a clean room environment.

[0039] FIG. 1A shows a perspective view of a storage container, e.g., a bag holder 100, according to one embodiment, with the lid removed. FIG. 1B shows the storage container 100 of FIG. 1A with the lid attached to close the interior space, according to one embodiment. FIG. 1C shows a cross-sectional view of the storage container 100 of FIG. 1B. FIG. 1D shows an enlarged end view of the rear wall of the storage container 100 of FIG. 1B. FIG. 1E shows an enlarged end view of the front wall of the storage container 100 of FIG. 1B. FIG. 1F shows an enlarged cross-sectional view of the cavity and handle of the storage container 100 of FIG. 1E.

[0040] As shown in FIGS. 1A and 1B, the storage container 100 has a thickness or height in the vertical direction (Y direction). The storage container 100 has a width in the horizontal or lateral direction (X direction). The storage container 100 has a length in the longitudinal direction (Z direction). Here, the phrase "thickness direction" may refer to the Y direction, which indicates the thickness direction of the storage container 100. The phrase "width direction" may refer to the X direction, which indicates the width direction of the storage container 100. The phrase "longitudinal direction" may refer to the Z direction, which indicates the length direction of the storage container 100.

[0041] Storage container 100 includes a housing 110, a lid 120, a first foam portion 130, and a second foam portion 135. It will be appreciated that storage container 100 can include at least one foam portion (130, 135).

[0042] The housing 110 includes a bottom surface 111, two side walls 112A, 112B, a front wall 113, and a rear wall 114 that form an interior space 115 within the housing 110. In one embodiment, the two side walls include a first side 112A and a second side 112B that may be identical to one another. The bottom surface 111, the two side walls 112A, 112B, the front wall 113, and the rear wall 114 can be connected together using at least one of self-clinching fasteners, such as PEM fasteners, pins, screws, nuts, rivets, or welds at their corners or edges.

[0043] FIG. 1C shows that, in one embodiment, the two side walls 112A, 112B include a rim portion 140 at the top of the side walls 112A, 112B. In one embodiment, the rim portion 140 includes a bent portion that extends outward from the housing and bends inward toward the housing. In one embodiment, the rim portion 140 can have a cross-sectional area that is circular, triangular, rectangular, diamond-shaped, or have other geometric designs. The disclosure herein is not intended to limit the scope of the design of the rim portion 140 but, rather, is provided for understanding the present disclosure; the rim portion 140 can have a variety of designs for engaging with the lid 120, as further described below.

[0044] As shown in FIG. 1D , the rear wall 114 of the housing 110 includes a first segment 114A and a second segment 114B disposed above the first segment 114A. The second segment 114B is longitudinally separated from the first segment 114A by a distance relative to the length of the storage container 100. The second segment 114B is connected to the first segment 114A by a secondary bottom surface 116. The bottom surface 111 and the first segment 114A of the rear wall 114 form a first section of the interior space. An extension of the secondary bottom surface 116 and the second segment 114B form a second section of the interior space above the first section, the second section having a larger volume than the first section. It is understood that the extended section of the storage container 100 can also be considered a stepped section or ledge section, such that the second section has a larger volume than the first section.

[0045] 1E, the front wall 113 has a recessed portion 113A that protrudes into the interior space of the housing 110. The recessed portion 113A may be formed as a hole or opening in the front wall 113, or as a cavity 150 that protrudes or is disposed within the interior space 115.

[0046] FIG. 1F, a cross-sectional view of FIG. 1E, shows that cavity 150 seals interior space 115 with front wall 113. Cavity 150 may be provided as a separate element from storage container 100 or may be formed during the manufacturing of storage container 100. If cavity 150 is provided as a separate element, cavity 150 can be attached or connected to storage container 100 using at least one of self-clinching fasteners, e.g., PEM fasteners, pins, screws, nuts, rivets, or welding. Cavity 150 may include a handle portion 155 configured to lift, push, or pull storage container 100. In one embodiment, handle portion 155 may be a continuous portion formed from curved or angled cavity 150 to facilitate lifting, pushing, or pulling storage container 100. It should be understood that in previous designs of typical bag holders, the typical bag holders had small openings that made it difficult to hold the bag holder for lifting, pushing, or pulling. However, in the present disclosure, because the front wall 113 includes a cavity 150 that protrudes into the interior space, it is understood that the cavity 150 with additional space is configured to provide a comfortable and firm gripping area to facilitate lifting, pushing, or pulling the storage container 100. It is understood that the disclosure of the handle 155 is not intended to be limiting in scope, but is provided to aid in the understanding of the present disclosure. Other handle designs may be considered, for example, in alternative embodiments, as further discussed below.

[0047] The lid 120 is substantially flat and is provided to close the interior space 115 of the housing 110. The lid 120 may be removably attachable and detachable to the housing 110. In one embodiment, the lid 120 is configured to close or expose the interior space 115 by a non-destructive and deformable (and reversible) locking and unlocking engagement with the housing 110. As shown in FIG. 1C , in one embodiment, the lid 120 may include a rail portion 145 configured to engage with the rim portion 140 of the side walls 112A, 112B. In one embodiment, the rail portion 145 may include a downwardly opening groove that is substantially “C” shaped, “U” shaped, or “V” shaped to engage with the rim portion 140 of the side walls 112A, 112B. The rail portion 145 may further include a handheld portion 146 connected to the downwardly opening groove, extending widthwise away from the housing 110, and configured to facilitate gripping or handling of the rail portion 145 for non-destructive and deformable removal or attachment of the lid 120 to the housing 110. In one embodiment, the lid 120 is formed entirely of metal, e.g., stainless steel, so that deformation of the rail portion 145 can be provided in a non-destructive manner, e.g., by the deformation and elastic recovery properties of the lid 120, such that the lid can be provided in locking or unlocking engagement with the rim portion 140 of the side walls 112A, 112B. That is, the rail portion 145 is not permanently deformed, e.g., bent (and unbent), to secure the lid 120 to the housing 110, but rather elastically restored to its original shape. Thus, the lid 120 can be designed and used for several repeated reuses.

[0048] In one embodiment, the lid 120 can also be configured to provide sliding engagement along the rim portion 140 of the housing 110, for example, via an open groove, to close the interior space 115 of the housing 110. In one embodiment, the lid 120 can also be pushed or urged in a downward direction toward the housing 110, such that the rail portion 145 including the handheld portion 146 engages the rim portion 140, elastically deforms, for example, due to the handheld portion extending outward, and then restores, for example, a snap action, such that at least one of the groove of the rail portion 145 or the handheld portion 146 is engaged with the rim portion 140 for securing or attaching the lid 120 to the housing 110.

[0049] 1D , in one embodiment, lid 120 further includes a rear rail portion 122 configured to engage rear wall 114 of housing 110. In one embodiment, rear rail portion 122 is configured to align the lid or any openings in either rim portion 140 or side walls 112A, 112B and rail portion 145 to close interior space 115.

[0050] Thus, in one embodiment, the lid 120 is removably attachable and detachable from the housing 110 via a number of different mechanisms to allow for reuse of the storage container 100 after cleaning, sanitizing, etc. It is also understood that in one embodiment, the lid 120 is not fully attachable and detachable from the housing 110, but rather the lid 120 may be pivotally connected to the housing 110 such that the rail portion(s) 145 can be non-destructively and deformably locked and unlocked from the rim portion(s) 140 of the housing 110, as described further below.

[0051] In one embodiment, openings or holes 160 can be provided in the rail portion 145 of the lid 120 and the rim portions 140 of the two side walls 112A, 112B. The openings or holes 160 are provided to align the lid 120 with the housing 110 and are configured to receive a fastening device (not shown) for securing the lid 120 to the housing 110. The fastening device can include at least one of a zip tie, a fastening pin or lock, or a push rivet, which can secure the storage container 100 for transportation and handling, and whose removal allows access to the interior space 115 and bag by removing the lid 120.

[0052] The first foam portion 130 is configured to conform to the shape of the pharmaceutical or biological material bag and includes an opening for receiving at least a portion of the drug or biological bag, whereby the edge of the drug or biological bag is secured within or between the first foam portion 130. The opening of the first foam portion 130 substantially receives the bag portion having the pharmaceutical or biological material, and is configured so that as the material in the bag freezes, for example, during a plate freezing process in which aqueous solutions expand during freezing, the first foam portion maintains the shape of the bag and provides necessary protection during transport or handling. The first foam portion 130 can include an angled edge at one end of the opening to conform to the shape of the pharmaceutical or biological material bag, with the angled edge connected to the bottom edge, which can include any one of a fitting, connector, tubing, or the like. In one embodiment, the first foam portion 130 also includes a receiving section closer to the front wall 113 to receive the bag end having the fitting, connector, or tubing.

[0053] Second foam portion 135 is provided adjacent first foam portion 130 within the interior space and is configured to receive any tubing or connections attached to the pharmaceutical or biological material bag. Second foam portion 135 may include a recessed portion corresponding to cavity 150. In one embodiment, second foam portion 135 may also include lateral extensions extending longitudinally along each side wall toward the rear wall of housing 110 such that all or most of the tubing, connectors, or combination thereof may be positioned on or between second foam portion 135.

[0054] The first foam portion 130 and the second foam portion 135 may include corresponding connecting portions, e.g., an insert portion of the first foam portion 130 between the lateral extension portions of the second foam portion 135, for providing engagement and securement of the first foam portion 130 and the second foam portion 135, and may provide support and protection for the bag and at least one of fittings, connectors, tubing, etc. during handling, freezing, and transport of the bag.

[0055] 1C , in one embodiment, first foam portion 130 can include first portion 131 and second portion 132 separate from first portion 131. First portion 131 of first foam portion 130 is configured to fit within a first section of interior space 115, and second portion 132 is configured to fit within a second section of interior space 115 above the first portion of first foam portion 130. Second portion 132 of first foam portion 130 has a larger volume than first portion 131 of first foam portion 130 and fits within interior space 115 including an extension of the housing on secondary bottom surface 116, e.g., abutting rear wall 114B, while first portion 131 abuts rear wall 114A. Thus, first part 131 and second part 132 can be used to sandwich or close a pharmaceutical material bag or biological material bag between first part 131 and second part 132 and provide support, protection, or structure to the shape of the pharmaceutical material bag or biological material bag during freezing, transportation, or handling.

[0056] Similarly, the second foam portion 135 can include a first portion and a second portion that can be a mirror image of one another or can have different configurations to fit the interior space 115 of the housing 110. Thus, the second foam portion 135 can provide support and protection for any of the fittings, connectors, tubing, etc. that are connected to the material bag by having something sandwiched or provided between the first and second portions.

[0057] First foam portion 130 and second foam portion 135 can be made of polyurethane, polyethylene, polyvinylidene fluoride, copolymers thereof, combinations thereof, etc. It will be understood that the material of first foam portion 130 and second foam portion 135 can be any suitable material that can withstand a wide range of temperatures (e.g., as low as or about -85°C or below without breaking), is suitable for deforming to conform to the shape of the bag (not shown) or its components at room temperature, acts as a barrier to help secure the bag, and can act as a cushion for the bag and its components during freezing, thawing, or shipping processes.

[0058] In one embodiment, the second foam portion 135 can be made of a foam having a lower stiffness than the first foam portion 130. In one embodiment, the second foam portion 135 is made of the same foam material as the first foam portion 130, but with a higher plasticizer content. In one embodiment, the second foam portion 135 is made of a different material than the first foam portion 130. The stiffness level of the second foam portion 135 is selected so that the second foam portion 135 can immobilize and cushion any of the bag attachments or components of the bag, such as tubing, connector(s), clamp(s), etc., that are stiffer than the bag, e.g., bioprocess bag.

[0059] In one embodiment, the housing 110 and lid 120 of the storage container 100 can be made of metal. In one embodiment, the metal can be steel, such as stainless steel (e.g., Society of Automotive Engineers (SAE) 304 stainless steel, etc.). It will be appreciated that the material of the housing 110 and lid 120 can be any suitable material that provides sufficient robustness, is cost-effective, and provides sufficient thermal conductivity. The storage container 100 can be sufficiently robust to be handled, e.g., dropped after freezing, without the storage container or the bags contained therein suffering severe damage, such as breakage of the storage container 100 or bursting or puncturing of the bags contained therein.

[0060] 2A-2F show the assembly of a storage container 200, which can include the same features as storage container 100 of FIGS. 1A-1F, with a pharmaceutical or biological material bag 280, such as an Aramus™ bag from Entegris Inc., according to one embodiment. Storage container 200 provides better protection during handling, more consistent freezing / thawing, and reduced storage density, as described in further detail below.

[0061] 2A shows providing a storage container 200 including a housing 210. The housing 210 includes a bottom 211, two side walls 212A, 212B, a front wall 213, and a rear wall 214 that form an interior space 215 within the housing 210. The bottom 211, the two side walls 212A, 212B, the front wall 213, and the rear wall 214 can be connected together using at least one of self-clinching fasteners, such as PEM fasteners, pins, screws, nuts, rivets, or welding at the corners or edges thereof.

[0062] 2B , when assembled, a first portion 231 of the first foam portion 230 can be disposed or provided in a first section of the interior space 215 above the bottom surface 211 of the housing 210 of the storage container 200 in the thickness direction. A first portion of the second foam portion 235 can also be provided in a first section of the interior space 215 adjacent to the first portion of the first foam portion 230 in, for example, the Z direction.

[0063] 2C further illustrates the storage container 200 when further assembled in the thickness direction, e.g., the Y direction, where a pharmaceutical or biological material bag 280, e.g., an Aramus™ bag, can be disposed or placed above or over the first portion 231 of the first foam portion 230. Any of the tubing can be wound into a loose coil and disposed or placed above the first portion of the second foam portion 235. Additionally, any clamps on the tubing can be positioned in a horizontal orientation to fit within the shell, preferably disposed on the second foam portion 235. In one embodiment, the majority of the tubing and clamps are disposed on the second foam portion 235, and the pharmaceutical or biological material bag is disposed on the first foam portion 230.

[0064] When the storage container 200 is further assembled in FIG. 2D , the second portion 232 of the first foam portion 230 and the second portion of the second foam portion 235 can be disposed or provided above the respective first portions and the pharmaceutical material bag or biological material bag 280 within the second section of the interior space 215, such that the pharmaceutical material bag or biological material bag 280 and tubing and connectors are between the respective first and second portions of the first foam portion 230 and the second foam portion 235.

[0065] 2E, in one embodiment, first foam portion 230 can include a partially filled foam portion 233 configured to engage a pharmaceutical or biological material bag (not shown) when the pharmaceutical or biological material bag is partially filled and inserted into storage container 200. In conventional bags, when the pharmaceutical or biological material bag is underfilled, the pharmaceutical or biological material bag does not properly or fully engage with the metal surface of storage container 200 for proper freezing of the material in, for example, a plate freezer. However, in this embodiment, partially filled foam portion 233 is configured to displace at least a partial volume within the pharmaceutical or biological material bag, such that the total volume of the pharmaceutical or biological material bag is reduced, and the partial volume is formed to displace the pharmaceutical or biological material bag and the material therein and ensure proper engagement with the metal surface of storage container 200 for freezing. That is, the partially filled foam portion 233 is configured to raise or increase the height of a partial volume of the pharmaceutical material bag or biological material bag for better contact with the metal portion of the storage container 200, thereby determining the volume of the bag or portion thereof. In one embodiment, the partially filled foam portion 233 is not included; rather, the first foam portion 230 is configured, designed, or modifiable to reduce the overall volume of the pharmaceutical material bag or biological material bag; for example, the shape of the first foam portion 230 can be modified to reduce and displace the volume of material within the pharmaceutical material bag or biological material bag, for example, isolating fluid in a particular region of the pharmaceutical material bag or biological material bag, and it is understood that the height of the bag can be raised or increased. In one embodiment, it is also understood that the lid 220 can include a protrusion or structure that displaces the volume of material within the pharmaceutical material bag or biological material bag to determine the volume of the bag or portion thereof.

[0066] As seen in Figures 2B and 2C, the rear wall 214 of the housing 210 includes a first segment 214A and a second segment 214B disposed above the first segment 214A. The second segment 214B is separated from the first segment 214A by a distance longitudinally, e.g., in the Z direction, relative to the length of the storage container 200. The second segment 214B is connected to the first segment 214A by a secondary bottom surface 216. The bottom surface 211 and the first segment 214A of the rear wall 214 form a first section of the interior space. An extension of the secondary bottom surface 216 and the second segment 214B form a second section of the interior space above the first section, the second section having a larger volume than the first section. It will be appreciated that the extension section of storage container 200 can also be considered a stepped section or ledge section, such that the second section has a larger volume than the first section and can provide first and second portions of first foam portion 230 and second foam portion 235.

[0067] 2F of the final assembled state of the storage container 200, the lid 220 is attached to the housing 210. In one embodiment, the two side walls 212A, 212B include a rim portion 240 at the top of the side walls 212A, 212B. In one embodiment, the rim portion 240 may include a bent portion that extends outward from the housing and bent inward toward the housing.

[0068] The lid 220 may be removably attachable and detachable to the housing 210. In one embodiment, the lid 220 is configured to close or expose the interior space 215 through non-destructive and deformable (and reversible) locking and unlocking engagement with the housing 210. As shown in FIG. 2F , in one embodiment, the lid 220 may include a rail portion 245 configured to engage with the rim portion 240 of the side walls 212A, 212B to close the interior space 215. The rail portion 245 may further include a handheld portion 246 connected to the downwardly opening groove, extending widthwise away from the housing 210, and configured to facilitate gripping or handling of the rail portion 245 for non-destructive and deformable removal or attachment of the lid 220 to the housing 210.

[0069] In one embodiment, the lid 220 can be attached to and detached from the housing 210 in several different ways. For example, the lid 220 can be configured to provide sliding engagement along the rim portion 240 of the housing 210, for example, via an open groove, to close the interior space 215 of the housing 210. In one embodiment, the lid 220 can also be pushed or urged in a downward direction toward the housing 210, such that the rail portion 245 including the handheld portion 246 engages the rim portion 240, elastically deforms, for example, due to the handheld portion extending outward, and then restores, for example, a snap action, such that at least one of the groove of the rail portion 245 or the handheld portion 246 engages with the rim portion 240 for securing or attaching the lid 220 to the housing 210. Similarly, the lid 220 can be detached or removed from the housing 210 by elastically deforming the rail portion 245 of the lid 220 to disengage the rim portion 240 of the housing 210, for example, by grasping the handheld portion 246 and lifting the lid 220 to expose the interior space 215, so that the lid can be provided in unlocking engagement without damaging the lid, particularly in a clean room environment where the operator is wearing equipment, e.g., gloves, to prevent contamination of the clean room.

[0070] FIG. 3 illustrates a reservoir 300 according to one embodiment, which may include the same or similar features as reservoirs 100, 200 of FIGS. 1A-2F, the differences of which are discussed below.

[0071] Storage container 300 includes a housing 310, a lid 320, a first foam portion (e.g., 130, 230), and a second foam portion (e.g., 135, 235). Housing 310 includes a bottom 311, two side walls 312A, 312B, a front wall 313, and a rear wall 314 that form an interior space within housing 310.

[0072] While the rear wall 314 is shown as a single wall, it is understood that the rear wall 314 of the housing 310 can include a first segment and a second segment disposed above the first segment, as described above with respect to other embodiments. The second segment is longitudinally separated from the first segment by a distance relative to the length of the storage container 300. The second segment is connected to the first segment by a secondary bottom surface. The bottom surface of the rear wall 314 and the first segment form a first section of the interior space. An extension of the secondary bottom surface and the second segment form a second section of the interior space above the first section, the second section having a larger volume than the first section. It is understood that the extended section of the storage container 300 can also be considered a stepped or ledge section, such that the second section has a larger volume than the first section.

[0073] The front wall 313 of this embodiment does not have a recessed portion that protrudes into the interior space of the housing 310. Rather, the front wall 313 includes a handle portion 355 configured to lift, push, or pull the storage container 300. In one embodiment, the handle portion 355 can be a handle pivotally connected to the front wall 313. Thus, the handle can extend from the front wall 313 to facilitate lifting, pushing, or pulling the storage container 300. It should be understood that in previous designs of typical bag holders, the typical bag holder had a small opening that made it difficult to hold the bag holder for lifting, pushing, or pulling. However, in the present disclosure, because the front wall 313 includes the handle portion 355, it should be understood that the handle portion 355 is configured to provide a comfortable, firm gripping area to facilitate lifting, pushing, or pulling the storage container 300.

[0074] The lid 320 can be substantially planar and can be provided to close the interior space of the housing 310. The lid 320 can be removably attachable and detachable to the housing 310. In one embodiment, the lid 320 is configured to close or expose the interior space by non-destructive and deformable (and recoverable) locking and unlocking engagement with the housing 310. In one embodiment, the lid 320 includes a rail portion 345 configured to engage with the rim portions (e.g., 140, 240) of the side walls 312A, 312B. Because the lid 320 is formed entirely of metal, e.g., stainless steel, it is understood that deformation of the rail portion 345 can be provided in a non-destructive manner, such that, for example, the deformation and elastic recovery properties of the lid 320 can provide the lid in locking or unlocking engagement with the rim portions (e.g., 140, 240) of the side walls 312A, 312B. That is, rail portion 345 is not permanently deformed, e.g., bent (and unbent), to secure lid 320 to housing 310. Thus, lid 320 can be designed and used for several repeated reuses.

[0075] In one embodiment, the lid 320 can also be configured to provide sliding engagement, for example, via an open groove, along a rim portion (e.g., 140, 240) of the housing 310 to close the interior space of the housing 310. In one embodiment, the lid 320 can also be pushed or urged downwardly toward the housing 310 such that the rail portion 345 is configured to engage the rim portion (e.g., 140, 240), for example, due to the outwardly extending handheld portion, to elastically deform, and then restore, for example, a snap action, such that the rail portion 345 is engaged with the rim portion (e.g., 140, 240) for securing or attaching the lid 320 to the housing 310.

[0076] 4A and 4B illustrate a reservoir 400 according to one embodiment, which may include the same or similar features as any of the reservoirs described above, the differences being described below.

[0077] The storage container 400 includes a housing 410, a lid 420, a first foam portion (e.g., 130, 230), and a second foam portion (e.g., 135, 235). The housing 410 includes a bottom 411, two side walls 412A, 412B, a front wall 413, and a rear wall 414 that form an interior space 415 within the housing 410.

[0078] In one embodiment, the lid 420 is pivotally connected to one of the side walls 412A, 412B. For example, in one embodiment, the lid 420 is pivotally connected to the side wall 412B via a living hinge, a pin and hinge connection, or the like, that allows the lid 420 to pivot between open and closed positions to close or expose the interior space 415 of the housing 410. The other side wall, for example, 412A, includes a rim portion 440 at the top of the side wall 412A. In one embodiment, the rim portion 440 includes a bent or shaped portion that extends outward from the housing 410.

[0079] While the rear wall 414 is shown as a single wall, it is understood that the rear wall 414 of the housing 410 can include a first segment and a second segment disposed above the first segment, as described above with respect to other embodiments. The second segment is longitudinally separated from the first segment by a distance relative to the length of the storage container 400. The second segment is connected to the first segment by a secondary bottom surface. The bottom surface of the rear wall 414 and the first segment form a first section of the interior space. An extension of the secondary bottom surface and the second segment form a second section of the interior space above the first section, the second section having a larger volume than the first section. It is understood that the extended section of the storage container 400 can also be considered a stepped or ledge section, such that the second section has a larger volume than the first section.

[0080] The front wall 413 has a recessed portion 413A that protrudes into the interior space 415 of the housing 410. The recessed portion 413A can be formed from a hole or opening in the front wall 413, or can be formed as a cavity that protrudes or is disposed within the interior space 415. The cavity can include a handle portion configured to lift, push, or pull the storage container 400. It is understood that the disclosure of the handle is not intended to be limiting in scope, but is provided to aid in understanding the present disclosure. Other handle designs may be considered, for example, as further discussed above in alternative embodiments.

[0081] The lid 420 can be substantially planar and can be provided to close the interior space 415 of the housing 410. In one embodiment, the lid 420 is configured to close or expose the interior space 415 by non-destructive and deformable (and recoverable) locking and unlocking engagement with the housing 410. In one embodiment, the lid 420 includes a rail portion 445 configured to engage with the rim portion 440 of the side wall 412A. Because the lid 420 is formed entirely of metal, e.g., stainless steel, or molded plastic, it is understood that deformation of the rail portion 445 can be provided in a non-destructive manner, e.g., by the deformation and elastic recovery properties of the lid 420, such that the lid can be provided in locking or unlocking engagement with the rim portion 440 of the side wall 412A. That is, the rail portion 445 is not permanently deformed, e.g., bent (and unbent), to secure the lid 420 to the housing 410. Thus, the lid 420 can be designed and used for several repeated reuses.

[0082] 4A, rail portion 445 may be provided as a staggered portion for engagement / disengagement with rim portion 440 having a structure corresponding to the staggered portion. It will be appreciated that rail portion 445 and rim portion 440 may also be provided as a single piece extending the entire length of the storage container, e.g., in the Z direction.

[0083] In one embodiment, the housing 410 and lid 420 of the storage container 400 can be made of metal. In one embodiment, the metal can be steel, such as stainless steel (e.g., Society of Automotive Engineers (SAE) 304 stainless steel, etc.). It will be appreciated that the material of the housing 410 and lid 420 can be any suitable material that provides sufficient robustness, is cost-effective, and provides sufficient thermal conductivity. The storage container 400 can be sufficiently robust to be handled, e.g., dropped after freezing, without the storage container or the bag contained therein suffering severe damage, such as breakage of the storage container 400 or bursting or puncturing of the bag contained therein.

[0084] In another embodiment, rim portion 440 can be provided as an insert within housing 410. For example, rim portion 440 can be formed from a plastic or molded plastic design having a foam portion and a second interior space for receiving a material bag and can be configurable to hold different types of material bags. In another embodiment, rim portion 440 can be a single piece insertable into the side wall of housing 410. Thus, because rim portion 440 is insertable into and removable from storage container 400, rim portion 440 can facilitate use and reuse of storage container 400; for example, if rim portion 440 is damaged, only rim portion 440 can be replaced, or rim portion 440 can be removed for cleaning / disinfecting storage container 400.

[0085] 5A and 5B illustrate a reservoir 500 according to one embodiment, which may include the same or similar features as any of the reservoirs described above, the differences being described below.

[0086] The storage container 500 includes a housing 510, a lid 520, a first foam portion (e.g., 130, 230), and a second foam portion (e.g., 135, 235). The housing 510 includes a bottom 511, two side walls 512A, 512B, a front wall 513, and a rear wall 514 that form an interior space within the housing 510.

[0087] While the rear wall 514 is shown as a single wall, it is understood that the rear wall 514 of the housing 510 can include a first segment and a second segment disposed above the first segment, as described above with respect to other embodiments. The second segment is longitudinally separated from the first segment by a distance relative to the length of the storage container 500. The second segment is connected to the first segment by a secondary bottom surface. The bottom surface of the rear wall 514 and the first segment form a first section of the interior space. An extension of the secondary bottom surface and the second segment form a second section of the interior space above the first section, the second section having a larger volume than the first section. It is understood that the extended section of the storage container 500 can also be considered a stepped or ledge section, such that the second section has a larger volume than the first section.

[0088] The front wall 513 of this embodiment does not have a recessed portion that protrudes into the interior space of the housing 510. Rather, a cavity 550 is formed within the interior space 515. The cavity 550 can seal the interior space 515 along an inner wall (not shown) of the housing 510. The cavity 550 can be provided as a separate element from the storage container 500 or can be formed during the manufacture of the storage container 500. If the cavity 550 is provided as a separate element, the cavity 550 can be attached or connected to the storage container 500 using at least one of self-clinching fasteners, such as PEM fasteners, pins, screws, nuts, rivets, or welding. The cavity 550 can be formed as a handle portion configured to lift, push, or pull the storage container 500. It should be understood that in previous designs of typical bag holders, the typical bag holders had small openings that made it difficult to hold the bag holder for lifting, pushing, or pulling. However, in the present disclosure, since the storage container 500 includes a cavity 550 provided in the interior space, it is understood that the cavity 550 with additional space is configured to provide a comfortable and firm gripping area to facilitate lifting, pushing, or pulling the storage container 500.

[0089] The lid 520 can be substantially planar and can be provided to close the interior space 515 of the housing 510. In one embodiment, the lid 520 is configured to close or expose the interior space 515 by non-destructive and deformable (and recoverable) locking and unlocking engagement with the housing 510. In one embodiment, the lid 520 includes a rail portion 545 configured to engage with the rim portions (e.g., 140, 240, 440) of the side walls 512A, 512B. Because the lid 520 is formed entirely of metal, e.g., stainless steel, or molded plastic, it is understood that deformation of the rail portion 545 can be provided in a non-destructive manner, e.g., by the deformation and elastic recovery properties of the lid 520, such that the lid can be provided in locking or unlocking engagement with the rim portions of the side walls 512A, 512B. That is, the rail portion 545 is not permanently deformed, e.g., bent (and unbent), to secure the lid 520 to the housing 510. Thus, the lid 520 can be designed and used for several repeated reuses. In one embodiment, the lid 520 can include a hole or opening in the lid 520 that corresponds to the cavity 550 in the interior space 515.

[0090] In one embodiment, the lid 520 can also be configured to provide sliding engagement along a rim portion (e.g., 140, 240, 440) of the housing 510 to close the interior space 515 of the housing 510. In one embodiment, the lid 520 can also be pushed or urged downwardly toward the housing 510 such that the rail portion 545 engages the rim portion (e.g., 140, 240, 440), e.g., due to the outwardly extending handheld portion, and is configured to elastically deform and then restore a snap action, e.g., such that the rail portion 545 engages the rim portion for securing or attaching the lid 520 to the housing 510.

[0091] In one embodiment, the rail portion 545 can be provided as a staggered portion for engagement / disengagement with a rim portion (e.g., 140, 240, 440) having a structure corresponding to the staggered portion. It will be appreciated that the rail portion 545 and rim portion can also be provided as a single piece extending the entire length of the storage container, e.g., in the Z direction.

[0092] 6A and 6B illustrate a reservoir 600 according to one embodiment, which may include the same or similar features as any of the reservoirs described above, the differences being described below.

[0093] As shown in FIG. 6A , the lid 620 includes a rear rail portion 622 configured as a fixed portion adjacent to the rear wall 614. The rear rail portion 622 is configured to engage the rear wall 614 to hold the lid 620 in place and align it with the housing 610 of the container 600. In one embodiment, the rear rail portion 622 has an open groove that is "C," "U," or "V" shaped to engage with the rear wall 614. The rear wall 614 of the housing 610 includes a first segment 614A and a second segment 614B disposed above the first segment 614A. The second segment 614B is longitudinally separated from the first segment 614A by a distance relative to the length of the storage container 600. The second segment 614B is connected to the first segment 614A by a secondary bottom surface 616.

[0094] 6B, a cross-sectional view of FIG. 6A, the second segment 614B of the rear wall 614 includes a lip 614C having a corresponding shape, e.g., a C-shape, for engaging with the rear rail portion 622 of the lid 620. Thus, not only is the lid 620 fixedly aligned with the housing 610, but such a design also allows the lid 620 to be pivoted relative to the housing 610 and partially attached thereto, e.g., an open groove configured to engage and provide at least a partial attachment.

[0095] Thus, a storage container, particularly a bag holder, for pharmaceutical or biological materials is provided that has numerous advantages over the conventional design of typical bag holders. For example, the storage container can be used for plate freezing, can be used for certain fluoropolymer bags, such as Entegris Inc.'s Aramus™ bag assembly, the storage container is made entirely of sheet metal and foam for a more cost-effective design and cleanability, the storage container has a lid that can slide or snap on / off in a non-destructive and deformable manner, the lid has a handheld portion for manual placement and removal of the lid, the foam portion is designed to increase the area over which tubing and connectors are positioned, the storage container does not include any bends in the metal or plastic parts to avoid a puncture hazard after part failure, the handle is enlarged for a better grip, the storage container has a ledge or stepped section to facilitate assembly of the storage container, the storage container is designed for multiple use, and the storage container has a more space-efficient design that is compatible with a blast freezer. Such a storage container design is particularly beneficial for use in clean room environments where operators wear equipment, such as hoods, gloves, etc., to prevent contamination of the clean room, such as airborne organisms, particles, dust, etc., which can make the storage container difficult to grasp, hold, or manipulate, e.g., open or close.

[0096] Aspects: Any of embodiments 1-17 can be combined with embodiment 18 and any of embodiments 19-21, and vice versa.

[0097] Aspect 1: A storage container for pharmaceutical or biological materials, comprising: a housing having a bottom, two side walls, a front wall, and a rear wall that form an internal space within the housing, the internal space having a first section and a second section provided above the first section; and a lid configured to close the internal space, wherein the two side walls of the housing include rim portions at upper portions of the two side walls, and the lid includes rail portions configured to provide non-destructive and deformable locking and unlocking engagement with the rim portions of the two side walls, and the rear wall of the housing includes a first segment and a second segment provided above the first segment, the second segment being separated from the first segment by a distance in the longitudinal direction and connected to the first segment by a secondary bottom such that the second section of the internal space has a larger volume than the first section of the internal space.

[0098] Embodiment 2: The storage container of embodiment 1, wherein the rail portions of the lid are also configured to provide sliding engagement with the rim portions of the two side walls.

[0099] Embodiment 3: The storage container of any one of embodiments 1-2, wherein the front wall includes a recessed portion such that the recessed portion protrudes into the interior space of the housing.

[0100] Embodiment 4: The storage container of embodiment 3, wherein the recessed portion comprises a handle portion configured to lift, push, or pull the storage container.

[0101] Aspect 5: A storage container described in any one of Aspects 1 to 4, further comprising: a first foam portion provided within the interior space and configured to conform to the shape of the pharmaceutical material bag or biological material bag; and a second foam portion provided within the interior space adjacent to the first foam portion and configured to receive any tubing or connections attached to the pharmaceutical material bag or biological material bag, wherein the second foam portion has lower rigidity than the first foam portion.

[0102] Aspect 6: A storage container as described in Aspect 5, wherein the first foam portion includes a first portion and a second portion separate from the first portion, the first portion of the first foam portion configured to fit within a first section of the interior space, and the second portion of the first foam portion configured to fit within the second section of the interior space above the first portion of the first foam portion.

[0103] Aspect 7: A storage container according to aspect 5, wherein the shape of the pharmaceutical material bag or biological material bag includes an angled edge connected to the bottom edge of the pharmaceutical material bag or biological material bag.

[0104] Aspect 8: A storage container as described in Aspect 5, wherein the first foam portion further comprises a partially filled foam portion configured to displace a volume of the pharmaceutical material bag or biological material bag.

[0105] Embodiment 9: A storage container described in any one of embodiments 1 to 8, wherein the rim portions of the two side walls and the rail portion of the lid include openings, the openings configured to align the lid with the housing and configured to receive a fastening device for fastening the lid to the housing.

[0106] Embodiment 10: The storage container of embodiment 9, wherein the fastening device includes at least one of a zip tie, a fastening pin or lock, or a push rivet.

[0107] Embodiment 11: A storage container as described in embodiment 9, wherein the lid further includes a rear rail portion configured to engage with the rear wall of the housing and align the openings in the rim portions of the two side walls with the rail portion of the lid.

[0108] Aspect 12: A storage container described in any one of aspects 1 to 11, wherein the lid has one end pivotally connected to the housing such that the rail portion is configured to provide non-destructive and deformable locking and unlocking engagement with the rim portions of the two side walls.

[0109] Embodiment 13: The storage container of any one of embodiments 1-11, wherein the lid is removably attachable to the housing.

[0110] Embodiment 14: A storage container described in any one of embodiments 1 to 13, wherein the rail portion of the lid includes downwardly opening grooves configured to engage with the rim portions of the two side walls.

[0111] Aspect 15: A storage container as described in Aspect 14, wherein the rail portion further includes a handheld portion connected to the downwardly opening groove to provide a non-destructive and deformable unlocking engagement between the rim portion and the rail portion to remove the lid from the storage container.

[0112] Embodiment 16: The storage container of any one of embodiments 1-15, wherein the housing and lid are formed entirely from metal.

[0113] Embodiment 17: A storage container described in any one of embodiments 1 to 16, wherein the bottom, two side walls, front wall, and rear wall are connected by at least one of self-clinching fasteners, pins, screws, nuts, rivets, or welds.

[0114] Aspect 18: A storage container for a pharmaceutical material or biological material, comprising: a housing having a bottom, two side walls, a front wall, and a rear wall that form an interior space within the housing, the interior space having a first section and a second section provided above the first section; a lid configured to close the interior space; a first foam portion provided within the interior space and configured to conform to the shape of a pharmaceutical material bag or biological material bag; and a second foam portion provided within the interior space adjacent to the first foam portion and configured to receive any tubing or connections to be attached to the pharmaceutical material bag or biological material bag, wherein the two side walls of the housing have rims at the top of the two side walls. the lid includes a rail portion configured to provide non-destructive and deformable locking and unlocking engagement with the rim portions of the two side walls; the rear wall of the housing includes a first segment and a second segment provided above the first segment, the second segment being longitudinally separated from the first segment by a distance and connected to the first segment by a secondary bottom surface such that the second section of the interior space has a larger volume than the first section of the interior space; the front wall includes a recessed portion such that the recessed portion protrudes into the interior space of the housing and into the second foam portion; and the recessed portion includes a handle portion configured to lift, push, or pull the storage container.

[0115] Aspect 19: A method for storing a pharmaceutical material bag or a biological material bag, comprising: providing a first portion of a first foam portion within a first section of an interior space of a housing of a storage container, the housing comprising a bottom, two side walls, a front wall, and a rear wall that form an interior space within the housing; providing a first portion of a second foam portion within the first section of the interior space adjacent to the first portion of the first foam portion; positioning the pharmaceutical material bag or biological material bag over the first portion of the first foam portion and the first portion of the second foam portion such that the pharmaceutical material bag or biological material bag is provided on the first foam portion and tubing and connectors connected to the pharmaceutical material bag or biological material bag are provided on the second foam portion; and providing a first foam portion within a second section of the interior space provided above the first section. a second portion of the first foam portion and a second portion of the second foam portion, wherein the pharmaceutical material bag or biological material bag, and tubing and connectors are located between the first and second portions of the first foam portion and the second foam portion; and non-destructively deforming a rail portion of the lid to engage the rail portion of the lid with rim portions at the top of the two side walls, thereby providing a locking engagement of the lid with the housing to close the interior space of the housing, wherein the rear wall of the housing includes a first segment and a second segment provided above the first segment, the second segment being separated longitudinally by a distance from the first segment and connected to the first segment by a secondary bottom surface, such that the second section of the interior space has a larger volume than the first section of the interior space.

[0116] Aspect 20: The method of aspect 19, wherein the lid is pivotally connected to the housing such that the lid closes the interior space by pivoting the lid until non-destructive deformation of the rail portion of the lid engages with the rim portions of the two side walls.

[0117] Embodiment 21: The method of embodiment 19, further comprising non-destructively deforming a rail portion of the lid to provide a locking release engagement of the lid and expose the interior space without damaging the lid.

[0118] The examples disclosed in this application should be considered in all respects as illustrative and not restrictive. The terms used herein are intended to describe particular embodiments and not as limiting. The terms "a," "an," and "the" include the plural unless expressly indicated otherwise. The terms "comprises" and / or "comprising," as used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, and / or components. The term "or," as used herein, includes any alternative or combination of alternatives as understood by the term "and / or," and is not intended as the exclusion of any one of the alternatives.

[0119] With respect to the foregoing description, it should be understood that changes may be made in details, particularly in matters of materials of construction used and shape, size, and arrangement of parts without departing from the scope of the present disclosure. The specification and described embodiments are exemplary only, the true scope and spirit of the present disclosure being indicated by the following claims.

Claims

1. 1. A storage container for pharmaceutical or biological materials, comprising: a housing having a bottom, two side walls, a front wall, and a rear wall that define an interior space within the housing, the interior space having a first section and a second section disposed above the first section; a lid configured to close the interior space, the two side walls of the housing include rim portions at the tops of the two side walls, and the lid includes rail portions configured to provide non-destructive and deformable locking and unlocking engagement with the rim portions of the two side walls; The rear wall of the housing includes a first segment and a second segment provided above the first segment, the second segment being longitudinally separated from the first segment by a distance and connected to the first segment by a secondary bottom surface such that the second section of the interior space has a larger volume than the first section of the interior space.

2. The storage container of claim 1 , wherein the rail portions of the lid are also configured to provide sliding engagement with the rim portions of the two side walls.

3. The storage container of claim 1 , wherein the front wall includes a recessed portion such that the recessed portion projects into the interior space of the housing.

4. The storage container of claim 3 , wherein the recessed portion includes a handle portion configured to lift, push, or pull the storage container.

5. a first foam portion provided within the interior space and configured to conform to the shape of the pharmaceutical or biological material bag; a second foam portion provided within the interior space adjacent to the first foam portion and configured to receive any tubing or connections attached to the pharmaceutical or biological material bag; The storage container of claim 1 , wherein the second foam portion has a lower stiffness than the first foam portion.

6. 6. The storage container of claim 5, wherein the first foam portion includes a first portion and a second portion separate from the first portion, the first portion of the first foam portion configured to fit within the first section of the interior space, and the second portion of the first foam portion configured to fit within the second section of the interior space above the first portion of the first foam portion.

7. 6. The storage container of claim 5, wherein the shape of the pharmaceutical or biological material bag includes an angled edge connected to a bottom edge of the pharmaceutical or biological material bag.

8. 6. The storage container of claim 5, wherein the first foam portion further comprises a partially filled foam portion configured to displace a volume of the pharmaceutical or biological material bag.

9. 2. The storage container of claim 1, wherein the rim portions of the two side walls and the rail portions of the lid include openings configured to align the lid with the housing and to receive a fastening device for securing the lid to the housing.

10. The storage container of claim 9 , wherein the securing device comprises at least one of a zip tie, a securing pin or lock, or a push rivet.

11. 10. The storage container of claim 9, wherein the lid further includes a rear rail portion configured to engage the rear wall of the housing to align the openings in the rim portions of the two side walls with the rail portion of the lid.

12. 2. The storage container of claim 1, wherein the lid has one end pivotally connected to the housing such that the rail portions are configured to provide the non-destructive and deformable locking and unlocking engagement with the rim portions of the two side walls.

13. The storage container of claim 1 , wherein the lid is removably attachable to the housing.

14. The storage container of claim 1 , wherein the rail portion of the lid includes downwardly opening grooves configured to engage the rim portions of the two side walls.

15. 15. The storage container of claim 14, wherein the rail portion further includes a handheld portion connected to the downwardly opening groove for providing a non-destructive and deformable unlocking engagement between the rim portion and the rail portion to remove the lid from the storage container.

16. 10. The storage container of claim 1, wherein the housing and the lid are formed entirely from metal.

17. 10. The storage container of claim 1, wherein the bottom, the two side walls, the front wall, and the rear wall are connected by at least one of self-clinching fasteners, pins, screws, nuts, rivets, or welds.

18. 1. A storage container for pharmaceutical or biological materials, comprising: a housing having a bottom, two side walls, a front wall, and a rear wall that define an interior space within the housing, the interior space having a first section and a second section disposed above the first section; a lid configured to close the interior space; a first foam portion provided within the interior space and configured to conform to the shape of the pharmaceutical or biological material bag; a second foam portion provided within the interior space adjacent to the first foam portion and configured to receive any tubing or connections attached to the pharmaceutical or biological material bag; the two side walls of the housing include rim portions at the tops of the two side walls, and the lid includes rail portions configured to provide non-destructive and deformable locking and unlocking engagement with the rim portions of the two side walls; the rear wall of the housing includes a first segment and a second segment provided above the first segment, the second segment being longitudinally separated from the first segment by a distance and connected to the first segment by a secondary bottom surface such that the second section of the interior space has a larger volume than the first section of the interior space; a storage container, wherein the front wall includes a recessed portion such that the recessed portion protrudes into the interior space of the housing and into the second foam portion, and the recessed portion includes a handle portion configured to lift, push, or pull the storage container.

19. 1. A method for storing pharmaceutical or biological material bags, comprising: providing a first portion of a first foam portion within a first section of an interior space of a housing of a storage container, the housing having a bottom surface, two side walls, a front wall, and a rear wall that form the interior space within the housing; providing a first portion of a second foam portion within the first section of the interior space adjacent to the first portion of the first foam portion; placing the pharmaceutical or biological material bag over the first portion of the first foam section and the first portion of the second foam section such that the pharmaceutical or biological material bag is provided on the first foam section and tubing and connectors connected to the pharmaceutical or biological material bag are provided on the second foam section; providing a second portion of the first foam portion and a second portion of the second foam portion within a second section of the interior space provided above the first section, whereby the pharmaceutical material bag or biological material bag, and the tubing and the connector are located between the first and second portions of the first and second foam portions; and non-destructively deforming a rail portion of a lid to engage the rail portion of the lid with rim portions of the upper portions of the two side walls to provide a locking engagement of the lid with the housing to close the interior space of the housing; The rear wall of the housing includes a first segment and a second segment provided above the first segment, the second segment being longitudinally separated from the first segment by a distance and connected to the first segment by a secondary bottom surface such that the second section of the interior space has a larger volume than the first section of the interior space.

20. 20. The method of claim 19, wherein the lid is pivotally connected to the housing such that the lid closes the interior space by pivoting the lid until non-destructive deformation of the rail portion of the lid lockingly engages the rim portion of the sidewall.

21. 20. The method of claim 19, further comprising non-destructively deforming the rail portion of the lid to provide a locking release engagement of the lid and expose the interior space without damaging the lid.

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