Plate freezing bag holder

Abstract

A bag holder for plate freezing of bags containing fluids, such as reactor bags, particularly bags containing biological or chemical reagents, can include genderless bag trays. Each bag tray can include a recess defined in part by a first sidewall and a second sidewall. The recess can be configured to hold a bag. The first sidewall can include a first retention feature and the second sidewall can include a second retention feature having a shape complementary to the first retention feature. The complementary nature of the first and second retention features allows identical bag trays to be mated with each other by each of the respective first and second retention features. The method includes forming first and second bag trays, placing a bag in the first bag tray, mating the second bag tray to the first bag tray, and freezing the bag by a plate freezing process.

Description

[Technical Field]

[0001] The present disclosure is directed to a bag holder for supporting bags during a plate freezing process, and particularly to a bag holder including a non-sexable bag tray that can be coupled to one another. [Background technology]

[0002] Chemical and / or biological processes can be performed in bags, such as bags containing pharmaceutical or biological fluids, bioprocess bags, or the results thereof, and the bags can contain the results thereof. The processing material or the material resulting from the processing may need to be frozen or otherwise kept at a low temperature. The bag may need to be supported throughout the cooling or freezing process to ensure it maintains its integrity or desired shape. Holders can be used to support and shape the bag before, during, and / or after the cooling or freezing process.

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 163,512, filed March 19, 2021, entitled "BAG HOLDER FOR PLATE FREEZING." Summary of the Invention

[0004] The present disclosure is directed to a bag holder for supporting bags during a plate freezing process, and particularly to a bag holder including a non-sexable bag tray that can be coupled to one another.

[0005] The use of a bag holder for plate freezing processes provides a shape with a good contact surface for freezing and secures the bag so that it maintains this shape while the material contained in the bag freezes, for example, even as the aqueous solution expands during freezing. Furthermore, the support provided by the bag holder reduces or prevents the occurrence of bag rupture during the freezing process, making the freezing process and turnaround time more stable. Providing identical bag trays that can be docked together without the need for different male and female trays simplifies the manufacture, storage, and use of the bag holder. The bag holder provides support for the bag while maintaining the bag's integrity and shape, facilitating blast freezing. Identical bag trays may also be designed to nest within each other for easier storage.

[0006] A partial fill rod can be used to depress a portion of the bag to shape the bag during the freezing process when the bag is not filled to or near its full capacity. In such cases, without the partial fill mechanism, the bag may assume an undesirable shape, the contained material may not freeze evenly, or the freezing process may be slow due to the bag moving within the bag holder. By providing a partial fill rod and a mechanism for holding such a partial fill rod, the bag holder can be effectively used in processes where bags are used but not fully filled.

[0007] In one embodiment, a bag holder for supporting a bioprocess bag during freezing includes a bag tray. The bag tray includes a recess partially surrounded by a first sidewall and a second sidewall. The bag tray further includes a neck formed at one end of the recess between the first sidewall and the second sidewall. The neck has a height between the height of a bottom of the recess and the height of at least one of the first sidewall or the second sidewall. The first sidewall includes one or more first retention features, each having a first shape. The second sidewall includes one or more second retention features, each having a second shape. The first and second shapes are adapted to be mechanically mated with each other.

[0008] In one embodiment, the bag tray is a first bag tray, and the bag holder further includes a second bag tray, the second bag tray being identical to the first bag tray. In one embodiment, the first bag tray is configured to be docked to the second bag tray by engagement of a first retention feature of the first bag tray with a second retention feature of the second bag tray, and engagement of the second retention feature of the first bag tray with a first retention feature of the second bag tray. In one embodiment, when the first bag tray is docked to the second bag tray, the bag holder includes an opening that communicates with the neck of the first bag tray.

[0009] In one embodiment, the bag holder further includes a partial fill rod comprising a resilient material and configured to extend from a first side of the bag tray to a second side of the bag tray. The first bag tray includes one or more notches formed in each of the first and second sides, each of the notches configured to accommodate a partial fill rod. In one embodiment, the first sidewall includes a plurality of first retention features and the second sidewall includes a plurality of second retention features, each of the one or more notches being disposed between two of the first retention features or two of the second retention features.

[0010] In one embodiment, the recess includes a flat bottom surface.

[0011] In one embodiment, the bag holder further includes one or more bulkheads around at least a portion of the recess.

[0012] In one embodiment, the bag holder further includes a metal insert that forms part of the recess.

[0013] In one embodiment, the first shape and the second shape are complementary to one another.

[0014] In one embodiment, the bag holder further includes a second bag tray identical to the first bag tray and a partial fill rod configured to hold the partial fill rod between the first bag tray and the second bag tray such that when the first bag tray is mated with the second bag tray, the partial fill rod extends across a space defined by the recess in the first bag tray and the recess in the second bag tray from the first sidewall of the first bag tray to the second sidewall of the first bag tray.

[0015] In one embodiment, the first bag tray and the second bag tray are configured to allow the partial fill rod to slide in a direction extending from the neck to the rear wall of the recess opposite the neck.

[0016] In one embodiment, a method for manufacturing a bag holder for freezing bioprocess bags includes forming a first bag tray. The first bag tray includes a recess partially surrounded by a first sidewall and a second sidewall. The first bag tray also includes a neck formed at one end of the recess between the first sidewall and the second sidewall, the neck having a height between the height of a bottom of the recess and the height of at least one of the first sidewall or the second sidewall. The first sidewall includes one or more first retention features, each having a first shape. The second sidewall includes one or more second retention features, each having a second shape. The first and second shapes are adapted to be mechanically mated with each other. The method further includes forming a second bag tray identical to the first bag tray.

[0017] In one embodiment, forming the first bag tray includes thermoforming a material.

[0018] In one embodiment, the first side wall and the second side wall each include one or more notches configured to accommodate a partial fill rod.

[0019] In one embodiment, the recess in the first bag tray includes a flat bottom surface.

[0020] In one embodiment, the first bag tray includes one or more partitions around at least a portion of the recess.

[0021] In one embodiment, forming the first bag tray includes providing a metal sheet, the metal sheet forming a portion of the recess.

[0022] In one embodiment, the first bag tray and the second bag tray are configured to hold a partial fill rod between them such that when the first bag tray is mated to the second bag tray, the partial fill rod extends across a space defined by the recess in the first bag tray and the recess in the second bag tray from a first side wall of the first bag tray to a second side wall of the first bag tray. In one embodiment, the first bag tray and the second bag tray are configured to allow the partial fill rod to slide in a direction extending from the neck to a rear wall of the recess opposite the neck. [Brief explanation of the drawings]

[0023] [Figure 1] 1 illustrates a bag tray of a bag holder according to one embodiment. [Figure 2] 1 illustrates an assembled bag holder according to one embodiment. [Figure 3] 2 shows a bag tray according to the embodiment of FIG. 1 together with a bag. [Figure 4] 1 illustrates a bag tray according to one embodiment. [Figure 5] 1 illustrates an assembled bag holder according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0024] The present disclosure is directed to a bag holder for supporting bags during a plate freezing process, and particularly to a bag holder including a non-sexable bag tray that can be coupled to one another.

[0025] FIG. 1 illustrates a bag tray of a bag holder according to one embodiment. The bag tray 100 includes a recess 102. The recess 102 is bounded by a rear wall 104, a front wall 106 including a neck 108, a first side wall 110, and a second side wall 112. The first side wall 110 includes a first retention feature 114. The second side wall 112 includes a second retention feature 116. The rear wall 104 includes a partition wall 118. The front wall 106 includes a tube guide 120. The tube guide 120 includes an opening cutout 122. Optionally, one of the opening cutouts 122 can include a loop 124. A partial fill rod 126 can be included in the bag tray 100. The partial fill rod 126 can be retained within a cutout 128 formed in the first side wall 110 and the second side wall 112.

[0026] The bag tray 100 is configured to form a portion of a bag holder. The bag tray 100 can comprise any suitable material for use in plate freezing. In one embodiment, the material used for the bag tray 100 is rated for use at temperatures of approximately -85°C or less. In one embodiment, the bag tray 100 is formed from one or more melt-processable polymers. In one embodiment, the bag tray 100 comprises polyethylene (PE). In one embodiment, the bag tray 100 comprises high-density polyethylene (HDPE). In one embodiment, the bag tray 100 is a single piece. In one embodiment, the bag tray 100 includes one or more inserts, such as metal inserts, included in the recesses 102 to provide thermal conduction between the freezing plate and the bag contained within the recesses 102. In one embodiment, at least a portion of the bag tray 100 is manufactured by a method including thermoforming. In one embodiment, at least a portion of the bag tray 100 is manufactured by injection molding. In one embodiment, at least a portion of the bag tray 100 is manufactured by injection molding. In one embodiment, at least a portion of the bag tray 100 is formed by casting. In one embodiment, the casting may be a two-part casting. In one embodiment, at least a portion of the bag tray 100 is formed by compression molding.

[0027] The recess 102 is a recess configured to receive a bag contained within a bag holder, including the bag tray 100. In one embodiment, the recess 102 includes a flat bottom configured to contact a freezing plate during the freezing process. In one embodiment, at least a portion of the flat bottom includes a thermally conductive material, such as a metal, positioned to contact the freezing plate and the bag to facilitate the freezing process. The thermally conductive insert can be provided, for example, as an insert covering an opening in the bottom of the recess 102, can be incorporated into the material forming the remainder of the bag tray 100, or can be provided by any other suitable method of providing a thermally conductive material to at least a portion of the recess 102.

[0028] The rear wall 104 is a wall that partially defines the recess 102. In one embodiment, the recess 102 includes a portion that slopes or curves upward to meet the rear wall 104.

[0029] The front wall 106 is another wall that partially defines the recess 102. In one embodiment, the recess 102 includes a portion that slopes upward toward the front wall 106. The front wall 106 can include a neck 108. The neck 108 can be a relatively recessed portion of the front wall 106 configured to allow a bag neck and / or a tube coupled to a bag to extend from the recess 102 into the tube guide 120 when the bag tray 100 is assembled to the bag holder. In one embodiment, the neck 108 is centered relative to the longitudinal axis L of the bag tray 100. In one embodiment, the front wall 106 outside of the neck 108 can have the same height as the rear wall 104.

[0030] The first sidewall 110 is a wall that partially defines the recess 102 and extends from the rear wall 104 to the front wall 106 on a first side of the recess 102. The second sidewall 112 is another wall that partially defines the recess 102 and extends from the rear wall 104 to the front wall 106 on a second side of the recess 102 that is opposite the first side relative to the longitudinal axis L of the bag tray 100.

[0031] The first retention feature 114 is provided on the first sidewall 110. The first sidewall 110 may include one or more first retention features 114. In one embodiment, as shown in FIG. 1 , three first retention features 114 are provided on the first sidewall 110. The first retention feature 114 may be any suitable structure for forming a mechanical coupling with a complementary retention feature to form a snap fit, press fit, or the like. The first retention feature 114 may include, for example, a slot, a tab, a flange, a detent, a hook, or any other suitable structure for mechanical engagement with another structure. In the embodiment shown in FIG. 1 , the first retention feature 114 includes an upward protrusion with a tab extending outward from a side of the upward protrusion.

[0032] The second retention feature 116 is located on the second side wall 112. The second side wall 112 may include one or more second retention features 116. In one embodiment, as shown in FIG. 1 , three second retention features 116 are located on the first side wall 110. The second retention feature 116 may be any suitable structure for forming a mechanical coupling with a complementary retention feature to form a snap fit, press fit, or the like. The second retention feature 116 may include, for example, a slot, a tab, a flange, a detent, a hook, or any other suitable structure for mechanical engagement with another structure. In the embodiment shown in FIG. 1 , the second retention feature is an opening configured to receive a protrusion and form a snap fit with a tab located on the protrusion.

[0033] The first and second retention features 114 and 116 can each have a complementary shape such that the first retention feature 114 of the bag tray 100 can be mechanically coupled to the second retention feature of a second bag tray identical to the bag tray 100, and the second retention feature 116 of the bag tray 100 can be mechanically coupled to the first retention feature of a second bag tray identical to the first bag tray 100. Non-limiting examples of retention features having complementary shapes include grooves or slots configured to accommodate tabs or flanges, holes or recesses configured to accept detents, etc. As another non-limiting example of complementary shapes of retention features, as shown in FIG. 1 , the first retention feature 114 includes an upward protrusion and an outwardly protruding tab, and the second retention feature 116 includes an opening sized to receive the upward protrusion but to catch the outwardly protruding tab when the upward protrusion is pushed through the opening.

[0034] The partition 118 includes one or more protrusions extending outward, away from the recess 102, from at least a portion of the rear wall 104, the first side wall 110, and / or the second side wall 112. The partition 118 is configured to absorb impact from the bag tray 100 contacting another surface, for example, if the bag holder including the bag tray 100 is dropped or bumped. The partition 118 may include multiple separate portions, such as a central portion of the rear wall 104 and portions extending around corners formed between the rear wall 104 and the first side wall 110 and between the rear wall 104 and the second side wall 112. The partition 118 may have any suitable shape for providing impact protection to the recess 102 and its contents.

[0035] Tube guide 120 defines a space across neck 108 from recess 102. Tube guide 120 is sized so that a tube extending from neck 108 can be routed through the tube guide and into open notch 122. Tube guide 120, like bulkhead 118, can be further configured to absorb shock.

[0036] The opening cutout 122 is a region where the wall of the tube guide 120 is lowered so that when an identical bag tray is placed on top of the bag tray 100, the opening cutout 122 and an opposing opening cutout of an additional bag tray form an opening in the wall of the tube guide 120. In one embodiment, one of the opening cutouts 122 can have a loop 124 extending thereover. The loop 124 is material that defines an opening around and within the opening cutout 122. In one embodiment, the loop 124 can be sized and positioned to be received within an opening cutout of a second bag tray, such as an opening cutout 122 in a second bag tray identical to the bag tray 100 that does not itself include a loop 124. The loop 124 can be used to hold one or more fluid lines extending from a bag before and during assembly of the bag holder including the bag tray 100 so that the fluid lines do not exit the opening cutout 122 before assembly of the bag holder.

[0037] The partial fill rod 126 is a rod having a length sufficient to extend across the recess 102 from the first side wall 110 to the second side wall 112. The partial fill rod 126 may include a core rod 130 and a resilient portion 132 surrounding the core rod 130. The resilient portion 132 may be a resilient polymer material, such as a rubber material. The polymer material may be selected to maintain its resilience throughout the temperatures associated with the freezing process in which the bag tray 100 is used. The resilient portion may compress the bags in the bag tray 100 against the surface of the recess 102 so that the bags are maintained in a condition suitable for freezing while being filled to less than full capacity.

[0038] The notches 128 are a plurality of notches formed in the first side wall 110 and the second side wall 112. The notches 128 are provided so that an end of the partial fill rod 126 can be received in one of the notches 128 in each of the first side wall 110 and the second side wall 112 when the partial fill rod extends across the recess 102. Although the embodiment shown in FIG. 1 shows notches 128, the bag tray 100 can include any suitable structure for receiving the partial fill rod 126, such as a channel that can receive the end of the core rod 130 so that the partial fill rod can slide along the channel.

[0039] Figure 2 shows an assembled bag holder according to one embodiment. Bag holder 200 includes bag tray 100 shown in Figure 1 and described above as a first bag tray 100. A second bag tray 100a is coupled to first bag tray 100 to form bag holder 200.

[0040] The second bag tray 100a includes a recess 102a. The recess 102a is at least partially defined by a rear wall 104a, a front wall 106a, a first side wall 110a, and a second side wall 112a. The front wall 106a may include a neck 108a. One or more partitions 118a may be provided on some or all of the rear wall 104a, the first side wall 110a, and the second side wall 112a, and tube guides 120 may be provided on the front wall 106a and some or all of the first and second side walls 110a and 112a.

[0041] When the bag tray 100 and the second bag tray 100a are mated, the recesses 102a and 102a can combine to form the interior space of the bag holder 200. In one embodiment, portions of the rear walls 104 and 104a, the front walls 106 and 106a, and the first and second side walls 110, 110a, 112, and 112a of each of the first and second bag trays 100 and 100a can contact each other to define the interior space. The recesses 102 and 102a of the first and second bag trays 100 and 100a can be sized according to the fill volume of the bag used with the bag holder 200 so that filling the bag is not constrained by the available volume of the interior space or by the shape of the interior space compared to the geometric shape of the bag. The interior space of the bag holder 200 is configured to accommodate a bag, such as a reactor bag. The bag holder 200 can accommodate a bag during a process such as a plate freezing process.

[0042] The second bag tray 100a includes a first retention feature 114a and a second retention feature 116a. The first retention feature 114a has a shape complementary to the second retention feature 116 of the first bag tray 100. The second retention feature 116a has a shape complementary to the first retention feature 114 of the first bag tray 100. The first retention feature 114 of the first bag tray 100 can be mated with the second retention feature 116a of the second bag tray 100a, and the second retention feature 116 of the first bag tray 100 can be mated with the first retention feature 114a of the second bag tray 100a, to secure the first bag tray 100 to the second bag tray 100a and form a bag holder 200.

[0043] In one embodiment, features of the first bag tray 100 and the second bag tray 100a configured to accommodate a partial fill rod, such as the partial fill rod 126 described above and shown in Figure 1, can be combined to hold the partial fill rod in place. For example, as shown in Figure 2, a notch 128a in the second bag tray 100a can be combined with a notch 128 in the first bag tray 100 to hold the end of the partial fill rod in place.

[0044] FIG. 3 illustrates the bag tray according to the embodiment of FIG. 1 with a bag. The bag 300 is placed in the recess 102 of the bag tray 100. The bag 300 includes a bag neck 302, a fitting 304, and a fluid line 306 coupled to the fitting 304. The fluid line is positioned to exit the tube guide 120 for placement within the opening cutout 122. The bag 300 can contain a material to be frozen, such as a solution containing one or more reagents for a chemical or biological process. The bag tray 100 can be assembled with a second bag tray, for example, as shown in FIG. 2, to form a bag holder surrounding the bag 300, with the opening in the opening cutout 122 being the only opening allowing the fluid line 306 to exit the assembled bag holder. The bag holder can support the bag during a freezing process, such as a plate freezing process. In a plate freezing process, the exterior surface of the recess 102 is placed in contact with a freeze plate maintained at a low temperature, which absorbs heat from the contents of the bag 300 to freeze the contents of the bag 300. In one embodiment, an insert 308 may be provided in the recess 102 to improve the containment of the bag 300 by the recess 102, for example, to secure or reduce movement of a lightly or partially filled bag within the recess 102. The insert may be any suitable material for use in a blast freezing process. A non-limiting example of a material used for the insert 308 is polyurethane foam.

[0045] A method for manufacturing a bag holder can include manufacturing multiple identical bag trays, such as the bag tray 100 shown in FIG. 1 and described above. The bag holder can be used by placing a bag, such as a bag containing a temperature-sensitive reagent, such as a biological or pharmaceutical material, into a recess in the bag tray. A fluid line extending from the bag can then be placed into one of the open cutouts in the bag tray. If one of the open cutouts includes a loop, the fluid line can be directed into the loop. In one embodiment, the bag is placed in the bag tray pre-filled. In one embodiment, the bag is at least partially filled after being placed in the bag tray. The bag can be filled to a partial or full capacity. If the bag is filled to a partial capacity, a partial fill rod can be included and used to hold the bag in place based on the degree of partial fill. In one embodiment, this can include positioning a partial fill rod so that the partial fill rod is within the cutouts formed in the first and second side walls. In one embodiment, this can include placing the partial fill rod in the bag tray and sliding the partial fill rod into place. In one embodiment, the bag holder can be assembled by engaging a first engagement feature of a bag tray containing a bag with a respective complementary engagement feature of another tray. The other tray may be identical to the bag tray containing the bag, with the first and second engagement features of each bag tray respectively engaged with each other. The assembled holder containing the bag can then be placed in a plate freezing system, for example, by placing it on the system's freeze plate, to freeze the contents of the bag.

[0046] FIG. 4 illustrates a bag tray according to one embodiment. The bag tray 400 includes a plate 404 and a recess 402 including an opening 406. A rear wall 408 includes a first rear retention feature 410 and a second rear retention feature 412. A front wall 414 includes a neck 416. A first side wall 418 includes a first lateral retention feature 420. A second side wall 422 includes a second lateral retention feature 424. The rear wall 408 also includes a bulkhead 426. The front wall 412 includes a tube guide 428. The tube guide 428 includes an opening notch 430, a first front retention feature 432, and a second front retention feature 434. A partial fill rod 436 can be retained within the notches 438 formed in the first and second side walls 418, 422.

[0047] Bag tray 400 is a bag tray configured to form a portion of a bag holder. Bag tray 400 can comprise any suitable material for use in plate freezing. In one embodiment, the material used for bag tray 400 is rated for use at temperatures of about -85°C or less. In one embodiment, bag tray 100 is formed from one or more melt-processable polymers. In one embodiment, bag tray 400 comprises polyethylene (PE). In one embodiment, bag tray 100 comprises high-density polyethylene (HDPE).

[0048] The recess 402 is configured to receive a bag during the freezing process. In the embodiment shown in FIG. 4 , the recess 402 includes a plate 404 and an opening 406. The plate 404 may be a thermally conductive material such as a metal, e.g., stainless steel, aluminum, or the like. The opening 406 is formed through the bottom of the recess 402. The plate 404 and / or the opening 406 may provide heat transfer between the freezing surface and the bag placed in the recess 402. In an embodiment, one or both of the plate 404 and the opening 406 may be provided in the recess 402. In an embodiment, the plate 404 and / or the opening 406 may have any suitable arrangement or shape to facilitate freezing when the bag holder including the bag tray 400 is placed on the freezing surface in a plate freezing process.

[0049] The rear wall 408 is a wall that partially defines the recess 402. In one embodiment, the recess 402 includes a portion that slopes or curves upward to meet the rear wall 408. In one embodiment, the area where the recess 402 meets the rear wall 408 can include an integrated hook configured to receive a hanger rod included with a bag used with the bag tray 400. The rear wall 408 includes a first rear retention feature 410 and a second rear retention feature 412. The first rear retention feature 410 and the second rear retention feature 412 can be any suitable pair of retention features having complementary shapes such that the first rear retention feature 410 of one bag tray 400 can form a bond with the second rear retention feature of another bag tray, and the second rear retention feature 412 of one bag tray 400 can form a bond with the first rear retention feature of another bag tray.

[0050] The front wall 414 is another wall that partially defines the recess 402. In one embodiment, the recess 402 includes a portion that slopes upward toward the front wall 414. The front wall 414 may include a neck 416. The neck 416 may be a relatively recessed portion of the front wall 414 configured to allow a bag neck and / or a tube coupled to a bag to extend from the recess 402 into the tube guide 428 when the bag tray 400 is assembled to the bag holder.

[0051] The first side wall 418 and the second side wall 422 each also define a portion of the recess 402. The first side wall 418 includes a first lateral retention feature 420, and the second side wall 422 includes a second lateral retention feature 424. The first lateral retention feature 420 and the second lateral retention feature 424 have complementary shapes such that the first back feature 420 of the bag tray 400 can form a bond with the second lateral retention feature of another bag tray, and the second lateral retention feature 424 of the bag tray 400 can form a bond with the first rear retention feature of another bag tray.

[0052] The rear wall 408 also includes a partition 426. The partition 426 includes one or more protrusions extending outward, away from the recess 402, from at least a portion of the rear wall 408, the first side wall 418, and / or the second side wall 422. The partition 426 is configured to absorb impact from the bag tray 400 contacting another surface, for example, if the bag holder including the bag tray 400 is dropped or bumped. The partition 426 may include multiple separate portions, such as a central portion of the rear wall 408 and portions extending around corners formed between the rear wall 408 and the first side wall 416 and between the rear wall 408 and the second side wall 420. The partition 424 may have any suitable shape for providing impact protection to the recess 402 and its contents.

[0053] The front wall 414 includes a tube guide 428. The tube guide 428 defines a space across the neck 416 from the recess 402. The tube guide 428 is sized so that tubes extending from the neck 416 can be routed through the tube guide and into an opening cutout 430. Similar to the bulkhead 426, the tube guide 428 can be further configured to absorb shock. The tube guide 428 includes the opening cutout 430, a first front retention feature 432, and a second front retention feature 434. The opening cutout 430 is a lowered area in the wall of the tube guide 428 such that, when an identical bag tray is placed on top of the bag tray 400, the opening cutout 430 and the opposing opening cutout of an additional bag tray form an opening in the wall of the tube guide 428. The first front retention feature 432 and the second front retention feature 434 may be any suitable pair of retention features having complementary shapes such that the first front retention feature 432 of the bag tray 400 can form a bond with the second front retention feature of another bag tray, and the second front retention feature 434 of the bag tray 400 can form a bond with the first front retention feature of another bag tray.

[0054] The partial fill rod 436 can be retained within a notch 438 formed in the first side wall 418 and the second side wall 422. The partial fill rod 436 can include a resilient material 440 and a pin 442. The pin 442 can be configured to be received within the notch 438. In the embodiment shown in FIG. 4 , supports 444 can be provided on either side of the resilient material 440, with one of the pins 442 extending through the support 444. Optionally, the partial fill rod 436 can be configured such that the pin 442 can be forced inwardly from the notch 438, for example, by springing the pin 442 or otherwise retaining it by the resilient material. When the pins 442 are pressed inward, the supports 444 can slide along grooves or shoulders 446 formed in the first and second side walls 418 and 422, thereby sliding the partial filler rod 436 between the sets of notches 438. In one embodiment, the pins 442 are configured to be pressed inward by hand. In one embodiment, the pins 442 are configured to be pressed inward using a tool. When the pins 442 are extended to their normal positions, the pins 442 can retain the partial filler rod 436 within a pair of notches 438 in the respective first and second side walls 418 and 422. Alternatively, as in the partial filler rod 126 described above and shown in FIG. 1 , the supports 444 can be omitted and the pins 442 can be replaced with retainer rods, such that the partial filler rod 436 is retained within the notches 438, similar to the retention described above for FIG. 1 .

[0055] Figure 5 shows an assembled bag holder according to one embodiment. The bag holder 500 includes the bag tray 400 shown in Figure 4 and described above as a first bag tray 400. A second bag tray 400a is coupled to the first bag tray 400 to form the bag holder 500.

[0056] The recesses 402a of the second bag tray 400a combine with the recesses 402 of the first bag tray 400 to form an interior space within the bag holder 500. The interior space can be sized according to the fill volume of a bag to be used with the bag holder 500, such that filling the interior space with a bag is not constrained by the available volume of the interior space or by the shape of the interior space compared to the geometric shape of the bag. The interior space of the bag holder 500 is configured to accommodate a bag, such as a reactor bag. The bag holder 500 can accommodate the bag during a process, such as a plate freezing process. The recesses 402a can include plates 404a and / or openings 406a to facilitate freezing, as described above for the plates 404 and / or openings 406 of the bag tray 400.

[0057] The first bag tray 400 and the second bag tray 400a can be held together by retention features having corresponding positions and complementary shapes. The first bag tray 400 and the second bag tray 400a can be mated to each other at their respective rear walls 408, 408a by the first rear retention feature 410 of the first bag tray 400 mating with the second rear retention feature 412a of the second bag tray 400a, and by the second rear retention feature 412 of the first bag tray 400 mating with the first rear retention feature 410a of the second bag tray 400a. The first bag tray 400 and the second bag tray 400a can be docked together along their respective sides by coupling a first side retention feature 420 of the first bag tray 400 with a second side retention feature 424a of the second bag tray 400a, and by coupling a second side retention feature 424 of the first bag tray 400 with a first side retention feature 420a of the second bag tray 400a. The first bag tray 400 and the second bag tray 400a can be docked together at their respective fronts by coupling a first front retention feature 432 of the first bag tray 400 with a second front retention feature 434a of the second bag tray 400a, and by coupling a second front retention feature 434 of the first bag tray 400 with a first front retention feature 434a of the second bag tray 400a.

[0058] When the first bag tray 400 is coupled to the second bag tray 400a, the partial fill rod 436 can be retained within the notches 438 and 438a of the first and second bag trays 400, 400a, respectively. In embodiments in which the supports 444 are provided on the partial fill rod 436, the second bag tray 400a can include grooves or shoulders (not shown) corresponding to the grooves or shoulders 446 shown and described above for the bag tray 400, and the supports 444 can be slidably retained between these grooves or shoulders provided in corresponding portions of both the first and second bag trays 400, 400a.

[0059] In some embodiments, the first bag tray 400 does not include the notch 438, and the partial fill rod 436 is held by friction. The partial fill rod 436 may slide along the first side wall 418 and the second side wall 422 to adjust the amount of material in the bag. In one embodiment, the partial fill rod 436 is adjustable when the first bag tray 400 is not attached to the second bag tray 400a, but the partial fill rod is fixed in place when the first bag tray 400 is attached to the second bag tray 400a.

[0060] In some embodiments, the engagement features of the first sidewall 418 and the second sidewall 422 include raised and / or lowered features that interlock with each other when the first bag tray 400 and the second bag tray 400a are coupled together. The raised and / or lowered features may include passages through them that are formed when the first bag tray 400 and the second bag tray 400a are coupled together. The passages may accommodate retaining rods for holding the first bag tray 400 and the second bag tray 400a together. The passages and their retaining rods may be on either side of the recesses 402, 402a. The retaining rods may be made of any suitable material, such as stainless steel. The first bag tray 400 may include retention mechanisms for holding the retaining rods in place when a bag holder is placed on its side (e.g., vertically). In some embodiments, the retention mechanisms secure the retaining rods when the retaining rods are fully inserted into the passages. The retention feature may be disposed between the raised retention features. The retention feature may be along a passage formed in the raised and / or lowered features. The retention feature may provide friction-based retention of the retention rod.

[0061] In some embodiments, the first bag tray 400 and the second bag tray 400a nest within one another to facilitate stacking while minimizing the space occupied by the stacked trays 400, 400a. Using a single tray design for both halves of the bag holder can simplify production, storage, procurement, etc.

[0062] In some embodiments, the first bag tray 400 includes a handle, which can aid in manipulating or holding the first bag tray 400.

[0063] Aspects: It is understood that any of the embodiments 1-12 can be combined with any of the embodiments 13-20.

[0064] Aspect 1. A bag holder for supporting a bioprocess bag during freezing, comprising: a recess partially surrounded by a first sidewall and a second sidewall; a neck formed at one end of the recess between the first side wall and the second side wall, the neck having a height between the height of the bottom of the recess and the height of at least one of the first side wall or the second side wall; Including, the first sidewall includes one or more first retention features, each of the first retention features having a first shape; the second sidewall includes one or more second retention features, each of the second retention features having a second shape; the first shape and the second shape are adapted to be mechanically mated with one another; Bag Tray A bag holder with

[0065] Aspect 2. The bag holder of aspect 1, wherein the bag tray is a first bag tray and the bag holder further comprises a second bag tray, the second bag tray being identical to the first bag tray.

[0066] Aspect 3. The bag holder of Aspect 2, wherein the first bag tray is configured to be docked to the second bag tray by engagement of a first retention feature of the first bag tray with a second retention feature of the second bag tray, and engagement of the second retention feature of the first bag tray with the first retention feature of the second bag tray.

[0067] Embodiment 4. The bag holder of embodiment 3, wherein the bag holder includes an opening that communicates with the neck of the first bag tray when the first bag tray is docked with the second bag tray.

[0068] Embodiment 5. The bag holder of any of embodiments 1-4, further comprising a partial fill bar comprising a resilient material and configured to extend from a first side of the bag tray to a second side of the bag tray.

[0069] Embodiment 6. The bag holder of embodiment 5, wherein the first side wall includes a plurality of first retention features and the second side wall includes a plurality of second retention features.

[0070] Embodiment 7. The bag holder of any one of embodiments 1 to 6, wherein the recess includes a flat bottom surface.

[0071] Embodiment 8. The bag holder of any of embodiments 1-7, further comprising one or more partitions around at least a portion of the recess.

[0072] Embodiment 9. The bag holder of any of embodiments 1-8, further comprising a metal insert forming a portion of the recess.

[0073] Embodiment 10. The bag holder of any one of embodiments 1 to 9, wherein the first shape and the second shape are complementary to each other.

[0074] Aspect 11: A second bag tray identical to the first bag tray; Partial filling rod and Furthermore, A bag holder as described in aspects 1 to 10, wherein the first bag tray and the second bag tray are configured to be able to hold a partial fill rod between the first bag tray and the second bag tray such that when the first bag tray is mated with the second bag tray, the partial fill rod extends across a space defined by the recess in the first bag tray and the recess in the second bag tray from the first side wall of the first bag tray to the second side wall of the first bag tray.

[0075] Aspect 12. A bag holder as described in aspect 11, wherein the first bag tray and the second bag tray are configured to allow the partial fill rod to slide in a direction extending from the neck to the rear wall of the recess opposite the neck.

[0076] Embodiment 13. A method of manufacturing a bag holder for freezing bioprocess bags, comprising: a recess partially surrounded by a first sidewall and a second sidewall; a neck formed at one end of the recess between the first side wall and the second side wall, the neck having a height between the height of the bottom of the recess and the height of at least one of the first side wall or the second side wall; Including, the first sidewall includes one or more first retention features, each of the first retention features having a first shape; the second sidewall includes one or more second retention features, each of the second retention features having a second shape; The first shape and the second shape can be mechanically mated to each other. forming a first bag tray; forming a second bag tray identical to the first bag tray; A method comprising:

[0077] Embodiment 14. The method of embodiment 13, wherein forming the first bag tray comprises thermoforming or injection molding a material.

[0078] Embodiment 15. The method of any of embodiments 13-14, wherein each of the first side wall and the second side wall is configured to accommodate a partial fill rod.

[0079] Embodiment 16. The method of any one of embodiments 13-15, wherein the recess in the first bag tray comprises a flat bottom.

[0080] Embodiment 17. The method of any of embodiments 13-16, wherein the first bag tray includes one or more partitions around at least a portion of the recess.

[0081] Embodiment 18. The method of any one of embodiments 13-17, wherein forming the first bag tray includes providing a metal sheet, the metal sheet forming a portion of the recess.

[0082] Embodiment 19. The method of any of embodiments 13-18, wherein the first bag tray and the second bag tray are configured such that when the first bag tray is mated with the second bag tray, the partial fill rod can be held between the first bag tray and the second bag tray such that the partial fill rod extends across a space defined by the recess in the first bag tray and the recess in the second bag tray from the first side wall of the first bag tray to the second side wall of the first bag tray.

[0083] Embodiment 20. The method of any of embodiments 13-19, wherein the first bag tray and the second bag tray are configured to allow the partial fill rod to slide in a direction extending from the neck to the rear wall of the recess opposite the neck.

[0084] The embodiments disclosed in this application are to be considered in all respects as illustrative and not restrictive. The scope of the present invention is indicated by the appended claims, rather than by the foregoing description, and all changes that come within the meaning and range of equivalence of the claims are intended to be embraced therein.

Claims

1. 1. A bag holder for supporting a bioprocess bag during freezing, the bag holder comprising a bag tray, the bag tray comprising: a recess partially surrounded by a first sidewall and a second sidewall; a neck formed at one end of the recess between the first sidewall and the second sidewall, the neck having a height between a height of a bottom of the recess and a height of at least one of the first sidewall or the second sidewall; a tube guide including an opening notch formed in each of a region between the neck and the first sidewall and a region between the neck and the second sidewall, the tube guide being sized so that a tube extending from the neck can be routed through the tube guide and into the opening notch; the first sidewall includes one or more first retention features, each of the first retention features having a first shape; the second sidewall includes one or more second retention features, each of the second retention features having a second shape; the opening notch is formed along the first sidewall and the second sidewall; the first shape and the second shape are adapted to be mechanically mated with each other; Bag holder.

2. 10. The bag holder of claim 1, wherein the bag tray is a first bag tray and the bag holder further comprises a second bag tray, the second bag tray being identical to the first bag tray.

3. 3. The bag holder of claim 2, wherein the first bag tray is configured to be docked to the second bag tray by engagement of the first retention feature of the first bag tray with the second retention feature of the second bag tray, and engagement of the second retention feature of the first bag tray with the first retention feature of the second bag tray.

4. The bag holder of claim 1 , further comprising a partial fill bar comprising a resilient material and configured to extend from a first side of the bag tray to a second side of the bag tray.

5. 5. The bag holder of claim 4, wherein the first side wall includes a plurality of the first retention features and the second side wall includes a plurality of the second retention features.

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