Multifunctional bag port and mating ring for biological treatment system

Abstract

A biological treatment system for performing a biomanufacturing process is provided. In one embodiment, a system includes a single-use bag configured to perform a biological treatment operation using at least one port welded to the single-use bag. The at least one port has a channel for providing a fluid pathway to an interior volume of the disposable bag. The system also includes at least one mating ring. The at least one port includes a first feature configured to engage with a corresponding second feature of the at least one mating ring such that the at least one mating ring can be locked to the at least one port. The mating rings and bag ports are configured to provide a range of structural functionalities to facilitate assembly and use of the biological treatment system.

Description

TECHNICAL FIELD

[0001] Embodiments of the present invention relate generally to bioprocessing systems and methods, and more particularly to modified bag ports on single-use bioprocessing bags and associated mating rings. BACKGROUND

[0002] A wide variety of vessels, devices, components, and unit operations are known for performing biochemical and / or biological processes, and / or manipulating the liquids and other products of such processes. To avoid the time, expense, and difficulty associated with sterilizing vessels used in biopharmaceutical production processes, single-use or disposable bioreactor bags and single-use mixing bags are used as such vessels. For example, biological materials such as animal and plant cells, including, for example, mammalian cells, plant cells, or insect cells, as well as microbial cultures, can be processed using disposable or single-use mixers and bioreactors.

[0003] In the biopharmaceutical industry, single-use or disposable containers are increasingly being used. Such containers can be flexible or collapsible plastic bags that are supported by an external rigid structure, such as a stainless steel enclosure or vessel. The use of sterilized disposable plastic bags eliminates the time-consuming vessel cleaning step and reduces the chance of contamination. The bag can be positioned within the rigid vessel and filled with the desired fluid for mixing. Depending on the fluid being processed, the system can include multiple fluid lines coupled with the bag as well as different sensors, probes, and ports for monitoring, analyzing, sampling, and fluid transfer. For example, multiple ports can typically be located on the front of the bag and can be accessed through openings in the sidewall of the vessel, which provide connection points for sensors, probes, and / or fluid sampling lines.

[0004] In accordance with the state of the art as set forth by Figure 1 In light of the state of the art as set forth by the background section, existing bioprocessing systems 1 include an outer vessel 2 that houses a single-use bag 3. The bag 3 includes ports 4 at openings in the vessel 2 that have standard barbs connected to tubing without additional functionality. In other words, the ports 4 provide a single function - connection to tubing so that the interior volume of the bag can be accessed aseptically. However, when multiple ports 4 are used, a port plate 5 is typically implemented to ensure that the ports 4 are aligned within the openings in the sidewall of the vessel and to support the bag in the unsupported area of the openings in the sidewall of the vessel. Installing such a port plate 5 is cumbersome and often difficult, at least in part because the port plate 5 cannot be fixed to the bag 3.

[0005] Additionally, the port is welded to the bag, which provides a unique opportunity to add structural functionality directly attached to the bag, which has not been contemplated in the art. For example, instead of using a separate probe support structure, which is currently standard in the art, the additional functionality can allow the probe to be directly supported by the bag port.

[0006] In view of the foregoing, the present invention provides a means to add a variety of structural functionality to a bag port, as well as a means to facilitate installation of a bioprocessing component. SUMMARY

[0007] One aspect of the present invention relates to a bioprocessing system comprising: a single-use bag configured to perform a bioprocessing operation; at least one port welded to the single-use bag, the at least one port comprising a passage for providing fluid access to an interior volume of the single-use bag; and at least one mating ring; wherein the at least one port comprises a first feature configured to engage with a corresponding second feature of the at least one mating ring such that the at least one mating ring can be locked to the at least one port.

[0008] In embodiments, the first feature comprises at least one groove and the second feature comprises at least one protrusion, and the at least one mating ring is locked to the at least one port by inserting the at least one protrusion into the at least one groove and rotating the at least one mating ring relative to the at least one port. In other embodiments, the first feature comprises at least one snap lock and the second feature comprises at least one protrusion, and the at least one mating ring is locked to the at least one port by inserting the at least one protrusion into the at least one snap lock.

[0009] In embodiments, the system further comprises a port plate comprising at least one opening corresponding to a location of the at least one port. The at least one opening is aligned with the at least one port, and the at least one mating ring is locked to the at least one port, and the port plate is secured to the single-use bag. The single-use bag is configured to be placed in an outer vessel having an opening corresponding to the location of the at least one port, and the at least one mating ring comprises an alignment feature configured to align the port plate with the opening.

[0010] In embodiments, the at least one mating ring further comprises a probe support configured to physically support a probe attached to the at least one port. The probe support is configured to hold the probe at an angle relative to a longitudinal axis of the passage.

[0011] In embodiments, the system further comprises a protective cover configured to cover the at least one port during shipping, and the cover is secured to the single-use bag when the cover is aligned with the at least one port and the at least one mating ring is locked to the at least one port.

[0012] In embodiments, the system further comprises at least one mating ring, the mating ring further comprising an attachment mechanism configured to attach to a hook or a clip, and the hook or clip is configured to additionally attach to an external structure when attached.

[0013] In embodiments, the at least one port comprises a plurality of ports, and the at least one mating ring comprises a plurality of mating rings, and each of the plurality of mating rings is configured to lock to a respective port of the plurality of ports.

[0014] Another aspect of the present disclosure relates to a method of providing a locking structure on a single-use bioprocessing bag. The method comprises: welding at least one port to a single-use bioprocessing bag, the at least one port comprising a passage for providing fluid access to an interior volume of the single-use bioprocessing bag, wherein the port comprises a first feature; providing at least one mating ring having a second feature; and engaging the first feature with the second feature, thereby locking the at least one mating ring to the at least one port.

[0015] In embodiments, the first feature comprises at least one groove, and the second feature comprises at least one protrusion, and engaging the first feature with the second feature comprises inserting the at least one protrusion into the at least one groove and rotating the at least one mating ring relative to the at least one port.

[0016] In other embodiments, the first feature comprises at least one snap lock, and the second feature comprises at least one protrusion, and engaging the first feature with the second feature comprises inserting the at least one protrusion into the at least one snap lock.

[0017] In embodiments, the method further comprises aligning a port plate with the at least one port prior to engaging the first feature with the second feature, such that the port plate is secured to the single-use bioprocessing bag when the at least one mating ring is locked to the at least one port. The single-use bag is configured to be placed in an outer vessel having an opening corresponding to a location of the at least one port, and the at least one mating ring comprises an alignment feature configured to align the port plate with the opening.

[0018] In embodiments, the at least one mating ring further comprises a probe support configured to physically support a probe attached to the at least one port, and the probe support holds the probe at an angle relative to the channel longitudinal axis.

[0019] In embodiments, the method further comprises attaching a protective cover to the at least one port, and the cover is secured to the single-use bag when the cover is aligned with the at least one port and the at least one mating ring is locked to the at least one port.

[0020] In embodiments, the at least one mating ring further comprises an attachment mechanism, and a hook or clip is attached to the attachment mechanism, the hook or clip being configured to additionally attach to an external structure. BRIEF DESCRIPTION OF DRAWINGS

[0021] The present application will be better understood from reading the following description of non-limiting embodiments, taken in conjunction with the attached drawings, in which: Figure 1 is a perspective view of a bioprocessing system according to the state of the art.

[0022] Figure 2 is a perspective view of a bioprocessing system implementing a modified bag port and attachment mechanism according to an embodiment of the present application.

[0023] Figure 3A and 3B illustrate exploded and assembled views of a modified bag port and mating ring according to an embodiment of the present application.

[0024] Figure 4A and 4B illustrate exploded and assembled views of a modified bag port and mating ring according to other embodiments of the present application.

[0025] Figure 5A and 5B illustrate exploded and assembled views of a modified bag port and mating ring according to additional embodiments of the present application.

[0026] Figure 6 illustrate a modified port and mating ring for aligning and / or securing a port plate to a single-use bag according to embodiments of the present application.

[0027] Figure 7A and 7B illustrate exploded and assembled views of a modified bag port and mating ring with alignment features according to embodiments of the present application.

[0028] Figure 8A and 8BA modified port and mating ring with alignment mechanism for aligning a port and port plate within a vessel opening according to embodiments of the present application are illustrated.

[0029] Figure 9A and 9B An exploded view and an assembled view of a modified bag port and mating ring with probe support according to embodiments of the present application are illustrated.

[0030] Figure 10A and 10B An exploded view and an assembled view of a modified bag port and mating ring with probe support according to other embodiments of the present application are illustrated.

[0031] Figure 11A and 11B An exploded view and an assembled view of a modified bag port and mating ring with attachment mechanism according to other embodiments of the present application are illustrated.

[0032] Figure 12A and 12B An exploded view and an assembled view of a modified port plate and mating ring for securing a protective cover for packaging and / or shipping according to embodiments of the present application are illustrated. DETAILED DESCRIPTION

[0033] Reference will now be made in detail to the exemplary embodiments of the present application, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0034] As used herein, the terms "flexible" or "collapsible" refer to a structure or material that is soft or bendable without breaking, and can also refer to a material that is compressible or expandable. One example of a flexible structure is a bag formed from polyethylene film. The terms "rigid" and "semi-rigid" are used interchangeably herein to describe a "non-collapsible" structure, i.e., a structure that does not fold, collapse or otherwise deform under normal forces to significantly reduce its elongate dimension. Depending on the context, "semi-rigid" can also indicate a structure that is more flexible than a "rigid" element, such as a bendable tube or conduit, but is still a structure that does not collapse longitudinally under normal conditions and forces.

[0035] As used herein, “vessel” means a flexible bag, flexible container, semi-rigid container, rigid container, or flexible / semi-rigid tubing, as appropriate. As used herein, the term “vessel” is intended to encompass bioreactor vessels with flexible or semi-rigid walls or wall sections, single-use flexible bags, and other containers or tubing commonly used in biological or biochemical processes, including, for example, cell culture / extraction systems, mixing systems, culture medium / buffer preparation systems, and filtration / extraction systems (e.g., chromatographic and tangential flow filtration systems) and their associated flow paths. As used herein, the term “bag” means, for example, a flexible or semi-rigid container or vessel used as a bioreactor or for mixing internal contents. As used herein, the term “consumable” or “consumable component” means a device or component intended for periodic replacement due to wear or use.

[0036] Embodiments of the present invention provide a biological treatment system, and in particular a biological treatment system 10 (hereinafter referred to as the "biological treatment system" or the "system"). System 10 includes an outer container 30 configured to receive a disposable bag 100. The bag 100 includes at least one port 110 configured to be located in an opening 31 in the outer container 30. As will be described in more detail below, the port 110 is modified to engage with a mating ring 150, thereby allowing the mating ring 150 to be locked to the at least one port 110. Thus, when the opening 171 in the port plate 170 is aligned with the at least one port 110, the mating rings(a plurality of) can be connected to the port 110, securing the port plate 170 in place during use. Furthermore, as further described below, additional modifications to the at least one port 100 provide additional functionality not previously seen in the art.

[0037] Figure 3A and 3B An assembly diagram illustrating the modified port 110 and mating ring 150 according to an embodiment of the present invention is provided. Figure 3B ) and exploded diagram ( Figure 3A Port 110 includes a proximal end formed as a barb 111 having a channel 112 therein. Channel 112 provides fluid passage to the internal volume of the disposable bag 100. The distal end is welded to the disposable bag 100 and includes a body portion 113. Body 113 includes a first feature configured to engage with a mating ring 150. In the illustrated embodiment, the first feature is a torsion lock 115, which includes at least one opening 116 and a groove 117 formed in body 113. The mating ring 150 has a generally flattened annular shape. The mating ring 150 includes a second feature in the form of at least one protrusion 151 extending from the circumference of the annular shape toward the center of the mating ring 150.

[0038] To lock port 110 to mating ring 150, protrusion(s) 151 are inserted into opening(s) 116, and mating ring 150 is rotated (e.g., counterclockwise) such that protrusion(s) 151 travel through recess(s) 117 until they abut against sidewall 118 of body 113. Rotation can be facilitated by tab 155 (e.g., a user can rotate mating ring 150 by grasping and rotating tab 155). Once protrusion(s) 151 abut against sidewall 118, the top surface 119 of body 113 extends over recess(s) 117 (e.g., see...). Figure 3B The mating ring 150 is prevented from separating from port 110 (i.e., it is locked).

[0039] Figure 4A and 4B An assembly diagram illustrating a modified port 110 and mating ring 150 according to another embodiment of the present invention is provided. Figure 4B ) and exploded diagram ( Figure 4A ). Figure 4A and 4B Implementation examples and Figure 3A and 3B The embodiments are similar, but the body 113 does not include the planar top surface 119. Instead, the plurality of openings 116 and the plurality of recesses 117 are formed by sidewall sections 118' (e.g., in the form of upright protrusions) and lateral protrusions 119'. Figure 4A and 4B Other features of the embodiments and Figure 3A and 3B The embodiments are the same or substantially the same, and for the sake of brevity, their disclosures are omitted.

[0040] Additionally, the protrusion 151 and / or the torsion lock 115 may further include an additional locking mechanism that prevents the mating ring 150 from rotating in the opposite direction (e.g., clockwise) and unlocking from the port 110. The additional locking mechanism may take the form of a mechanical lock (e.g., a snap-fit ​​engagement), a magnetic lock (e.g., providing magnets of opposite polarity in each of the port 110 and the mating ring 150), or other equivalent securing means (e.g., once the port and the mating ring are engaged, the user can glue them together). However, it is explicitly stated that no additional locking mechanism is required to fully lock the mating ring 150 to the port 110 for the purposes of this invention. Specifically, the torsion lock 115 and the protrusion(s) 151 provide sufficient mechanical restraint to provide the improved functionality as described herein.

[0041] Figure 5A and 5B An assembly diagram illustrating a modified port 110 and mating ring 150 according to other embodiments of the present invention is provided. Figure 5B ) and exploded diagram (Figure 5A Unlike the torsion lock feature 115 implemented for securing port 110 to mating ring 150, this embodiment implements snap-lock 120. Specifically, body 133 includes a first feature that includes at least one snap-lock 120 around its periphery. Each snap-lock 120 includes a tab 121 and a recess 123. The geometry of the snap-locks 120 is such that the inner sidewall 152 of the mating ring can snap into the snap-locks 120. In a particular embodiment, the snap-locks 120 may be spaced apart from each other around the periphery of body 113 such that protrusions 151 engage in the spaces between the snap-locks 120, which helps ensure that the mating ring does not rotate once locked to port 110. Furthermore, these spacings can advantageously be used as alignment guides for the bag ports during the port welding process. The barbed bag port welding fixture may have complementary features located in the fixture alignment plate that interact with these bag port alignment structures to define the port welding orientation on the bag. Additionally, features on the bag film panel can be used to align the panel with the port welding fixture, and bag panel features, such as other existing bag port openings or special alignment holes, can be used to align the bag film panel.

[0042] To lock port 110 to mating ring 150, the user presses the mating ring against port 110. Upon doing so, the snap-lock 120 bends, allowing the mating ring 150 to pass through and sit within recess 123. Because recess 123 is recessed from tabs 121, tabs are allowed to bend back to their original positions (e.g., see...). Figure 5B This allows them to hold the mating ring 150 in the (multiple) grooves 123.

[0043] While the above embodiments illustrate specific examples of modified port 110 and mating ring 150, the invention is not limited thereto. For example, the number of protrusions 151, twist locks 115, and snap locks 120 may vary. Furthermore, in any embodiment of the invention, tabs 155 may be implemented or omitted, and protrusions may take the form of pins 131 (e.g., see...). Figure 9A Furthermore, other mechanisms for attaching the mating ring 150 to the port 110 are also envisioned. For example, magnetic material could be located on (or embedded in) the port 110 and the mating ring 150 without the use of mechanical fastening. By placing magnets of opposite polarity in the port 110 and the mating ring 150, the port 110 and the mating ring 150 can be magnetically coupled and thus locked to each other.

[0044] As described above, and refer to Figure 6Because the port plate 170 cannot be secured to the biological processing system 10, aligning the port plate 170 in the opening 32 of the vessel is often difficult. Specifically, and in accordance with the current state of the art, the probe port plate is not tightly positioned / located around the barbed bag port. During part of the bag assembly process, when tubing, probe adapters, etc., are attached to these bag ports, some clearance passage is required near the probe plate surface. Therefore, even after the probe adapter and other tubing have been attached to the port, the probe port plate moves freely relative to the bag port. Cable ties attached to the tubing attached to the probe port provide some restraint, but not enough to completely restrain movement. Typically, the cable ties can pass through an opening in the plate between the port tubing and the opening, and move between the bag and the port plate. This keeps the probe port and the bag away from the probe port plate on the sidewall of the bag, forming a recess that causes wrinkling and thus creates unnecessary stress on the bag in that area. However, the modified port 110 and mating ring 150 of the present invention provide an easier and more advantageous way to align the port plate 170. As illustrated, when the port plate 170 is to be attached to the bioprocessing system, the user first aligns the opening 171 of the port plate 170 with the port 110. After alignment, a mating ring 150 can be attached to the port 110 (as described above), thereby locking and securing the port plate 170 to the disposable bag 100. Without this locking mechanism, the port plate 170 would float freely around and become misaligned with the port 110.

[0045] According to other embodiments, and as by Figure 7A and 7B As illustrated, the mating ring 150 may include at least one alignment feature 172. The alignment feature 172 may be in the form of an arcuate sidewall extending around a portion of the periphery of the mating ring 150. Figure 8A and 8B As explained, alignment feature 172 may be located on mating ring 150 adjacent to the periphery of opening 31 in vessel 30. Thus, alignment feature 172 further aids in aligning port plate 170 with opening 31. More specifically, currently there is no mechanism on the bag and / or probe plate assembly to precisely control the position of the probe port plate relative to the vessel opening. The bag port in the area of ​​the probe port plate is one of the primary areas of interaction between the user and the disposable bag. This interface would be improved if the probe port plate could be easily, accurately, and repeatably positioned relative to the vessel opening. The current state of the art requires the user to manually maintain this alignment during bag installation by using visual markings on the probe port plate to align with the recessed opening in the vessel wall. It would be desirable to make this alignment more precise and less dependent on manual intervention by the user, as achieved by the present invention implementation of port 110 and mating ring 150 with associated alignment features(s) 172.

[0046] In addition to providing means for securing port board 170, mating ring 150 may include additional features to support other functionality. Figure 9A and Figure 9B In the embodiments illustrated, the mating ring may include a probe support 180 configured to physically support a probe attached to port 110. The probe support 180 may include an arm 181 extending from the proximal surface 157 of the mating ring 150. The arm 181 terminates at a bracket 182. The geometry of the arm 181 and the bracket 182 is such that when the probe is attached to port 110, the probe is held at a specific angle relative to the longitudinal axis of the channel 112 of port 110. In embodiments, the angle is between 5 and 30 degrees. In a preferred embodiment, the angle is 15 degrees. In contrast, and in accordance with the art, the user places a bag inside an outer container and manually aligns the markings on the probe port plate with the recessed opening in the container wall. The probe support rod attached to the container is then manually adjusted to raise it to a position below the probe body, thereby moving the probe to a recommended angle (e.g., 15 degrees). However, the angle is set visually by the user, the probe support rod can only be set by the user at one of several discrete height settings, and the probe port plate on the bag itself is manually positioned by the user. All these manual adjustments lead to inaccuracies in the final setting of the sensor angle. In contrast, this probe support 180 avoids all these manual operations. Specifically, the present invention provides features that allow for consistent and repeatable installation of the probe on a disposable bag 100.

[0047] Figure 10A and 10B It clarified Figure 9A and 9B Variations of the embodiments. As illustrated, the angle guide 180 may include an arm 181 attached to the proximal surface 157 at two locations. The arm 181 extends outward from the proximal surface 157, bends to create a bracket 182', and extends further rearward toward and attaches to the proximal surface 157. In this embodiment, the angle guide 180 serves to limit the maximum probe angle by preventing the probe from lifting more than 5-30 degrees. In a preferred embodiment, the angle is 15 degrees.

[0048] In addition to providing the functions described above, the mating ring 150 may further include an attachment mechanism 190, such as by... Figure 11A and 11B As explained, attachment mechanism 190 is configured to be secured to hook or clip 191 (see, for example, see...). Figure 11BHooks or clips 191 can then be attached to an external structure. Thus, the port 110 located at the top of the disposable bag 100 can be used as an anchor or support. For example, as is the case in the art, tubing connected to the bag port at the top of the bag is draped (sometimes called draped) over a tubing management arm at the top of the bag to provide some level of organization for the tubing itself. The tubing can also provide a secondary function to help support the top of the bag during bag mounting and inflation, but this is a cumbersome way to support the bag, and using tubing as a support increases the possibility of compromising the integrity of the tubing. Similarly, using tubing as a bag support mechanism allows the user to drape the tubing anywhere along its length, affecting the location (height) at which the bag is supported. Therefore, the user can drape the tubing to a support rod at a location far from the bag, and thus the bag will be essentially unsupported during inflation. In contrast, the attachment mechanism 190, in conjunction with the hook or clip 191, allows the user to attach the hook or clip 191 to the tubing management arm (or other external structure) to provide direct support for the bag during installation and expansion, eliminating the need to use the tubing itself as a physical support. This provides a more repeatable, reliable, and secure means of securing the bag during expansion. Furthermore, by eliminating the need for the tubing to function as a support mechanism, the tubing can be suspended anywhere along its length.

[0049] Furthermore, by implementing the attachment mechanism 190 and the hook or clip 191, the port 110 at the top of the bag can be secured in a specific location, facilitating the attachment of a sensor (or other component) to the port 110. Similarly, by securing the location of the port 110, the internal structure of the disposable bag 100 can be provided in a specific and desired orientation. For example, by orienting the disposable bag 100 and the top-mounted port 110, internal tubes, orifices, nozzles, etc., can be precisely positioned in specific locations within the disposable bag 100.

[0050] Still regarding the above functions, and as by Figure 12A and 12BAs illustrated, the modified port(s) 110 and associated mating ring(s) 150 are configured to provide a means for securing the protective cap 195 to the disposable bag 100. As shown, the protective cap 195, in the form of a box, covers the port 110, such that after the box is aligned with the port 110, the mating rings 150 can be attached to the port 110, thereby locking the protective cap to the port 110 and the disposable bag 100. This is particularly advantageous when the disposable bag needs to be transported. Specifically, and in accordance with the current state of the art, the complete bag assembly needs to be folded in such a way that the tubing attached to the bag port can be packaged without damaging the folded bag assembly. This typically requires winding the tubing, securing the tubing bundle with some kind of cable tie, and covering any exposed cable tie ends or potentially sharp connector end caps with bubble wrap (sometimes called bubble pads) to prevent them from damaging the bag during transport and handling. Some exposed tubing and connectors are packaged in small bags. Sensor ports with their special hygiene accessories also require packaging to prevent damage during transport and handling, and to prevent damage to the bag when the bag assembly is folded. All these packaged tubing, connectors, etc., are carefully placed within the bag assembly, but there is no easy way to ensure that all these materials do not move during transport and handling. This complex packaging requires the user to remove a significant amount of bubble wrap, cable ties, and other packaging materials from the bag assembly before placing the bag in the container. In contrast, by implementing modified port(s) 110 and mating ring(s) 150, a protective cap 195 can be installed simply and easily, protecting the ports, tubing, connectors, etc., without the aforementioned complex packaging. Furthermore, this protective cap 195 reduces the amount of packaging material required, thus providing a more sustainable solution for transport and handling.

[0051] It is explicitly stated that any of the above features can be combined such that any port 110 welded to the disposable bag 100 provides any or all of the aforementioned functions. For example, the mating ring 150 may include any combination of the alignment feature 170, the probe support 180, and the attachment mechanism 190. Similarly, the locking feature for any of the foregoing embodiments may take the form of the aforementioned twist lock 115, snap lock 120, or other equivalent locking mechanism.

[0052] It should be noted that the above description describes a modified port 110 and associated mating ring 150 to provide additional functionality not currently seen in the art. This additional functionality offers numerous advantages compared to existing technologies, including, but not limited to, improved usability and installation of disposable bags, easy customization, and reduced costs and complexities associated with transportation.

[0053] As used herein, an element or step referred to in the singular and beginning with "a" or "one" should be understood to not exclude a plural of said element or step, unless such exclusion is expressly stated. Furthermore, reference to "an embodiment" of the invention is not intended to be construed as excluding the existence of additional embodiments also incorporated into the referenced features. Moreover, unless expressly stated to the contrary, embodiments that "comprise," "include," or "have" an element or plurality of elements having a particular property may include additional such elements that do not have that property.

[0054] This draft specification uses examples to disclose several embodiments of the invention, including the best mode, and also enables those skilled in the art to practice embodiments of the invention, including making and using any apparatus or system and performing any incorporated methods. The patentable scope of the invention is defined by the claims and may include other examples that would occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that are indistinguishable from the literal language of the claims, or if they include equivalent structural elements that are not substantially different from the literal language of the claims.

Claims

1. A biological treatment system, comprising: Single-use bags configured to perform biological treatment operations; At least one port welded to the disposable bag, the at least one port including a channel for providing a fluid passage to the internal volume of the disposable bag; At least one paired ring; The at least one port includes a first feature configured to engage with a corresponding second feature of the at least one mating ring, such that the at least one mating ring can be locked to the at least one port.

2. The biological treatment system according to claim 1, in, The first feature includes at least one groove, and the second feature includes at least one protrusion. Specifically, the at least one mating ring is locked to the at least one port by inserting the at least one protrusion into the at least one groove and rotating the at least one mating ring relative to the at least one port.

3. The biological treatment system according to claim 1, in, The first feature includes at least one latch, and the second feature includes at least one protrusion. Specifically, the at least one protrusion is inserted into the at least one snap lock to lock the at least one mating ring to the at least one port.

4. The biological treatment system according to any one of the preceding claims further includes: A port board, comprising at least one opening corresponding to the location of the at least one port; Wherein, when the at least one opening is aligned with the at least one port and the at least one mating ring is locked to the at least one port, the port plate is secured to the disposable bag.

5. The biological treatment system according to claim 4, in, The disposable bag is configured to be placed in an outer container having an opening corresponding to the location of the at least one port, and The at least one mating ring includes an alignment feature configured to align the port board with the opening.

6. The biological treatment system according to any one of the preceding claims, in, The at least one mating ring further includes a probe support or an angle guide, the probe support being configured to physically support a probe attached to the at least one port.

7. The biological treatment system according to claim 6, in, The probe support or angle guide is configured to keep the probe at a certain angle relative to the longitudinal axis of the channel.

8. The biological treatment system according to any one of the preceding claims further includes a protective cover configured to cover the at least one port during transport. in, The cap is secured to the disposable bag when the cap is aligned with the at least one port and the at least one mating ring is locked to the at least one port.

9. The biological treatment system according to any one of the preceding claims, in, The at least one mating ring further includes an attachment mechanism configured to attach to a hook or clip, and When the hook or clip is attached, it is configured to be attached to an external structure.

10. The biological treatment system according to any one of the preceding claims, in, The at least one port includes multiple ports, and the at least one mating ring includes multiple mating rings. Each of the plurality of pairing rings is configured to be locked to a corresponding port among the plurality of ports.

11. A method for providing a locking feature on a single-use bioprocessing bag, the method comprising: At least one port is welded to the single-use bioprocessing bag, the at least one port including a channel for providing a fluid passage to the internal volume of the single-use bioprocessing bag, wherein the port includes a first feature; Provide at least one mating ring, the at least one mating ring having a second feature; and The first feature is engaged with the second feature such that the at least one mating ring is locked to the at least one port.

12. The method according to claim 11, in, The first feature includes at least one groove, and the second feature includes at least one protrusion. The engagement of the first feature with the second feature includes inserting the at least one protrusion into the at least one groove and rotating the at least one mating ring relative to the at least one port.

13. The method according to claim 11, in, The first feature includes at least one latch, and the second feature includes at least one protrusion. The engagement of the first feature with the second feature includes inserting the at least one protrusion into the at least one snap lock.

14. The method according to any one of claims 11-13, further comprising: Before engaging the feature with the second feature, the port plate is aligned with the at least one port such that the port plate is secured to the disposable biological treatment bag when the at least one mating ring is locked to the at least one port.

15. The method according to claim 14, wherein, The disposable bag is configured to be placed in an outer container having an opening corresponding to the location of the at least one port, and The at least one mating ring includes an alignment feature configured to align the port board with the opening.

16. The method according to any one of claims 11-15, in, The at least one mating ring further includes a probe support configured to physically support a probe attached to the at least one port, and The probe support keeps the probe at a certain angle relative to the longitudinal axis of the channel.

17. The method according to any one of claims 11-16, further comprising: Attach the protective cover to the at least one port. The cap is secured to the disposable bag when the cap is aligned with the at least one port and the at least one mating ring is locked to the at least one port.

18. The method according to any one of claims 11-17, in, The at least one mating ring further includes an attachment mechanism, and A hook or clip is attached to the attachment mechanism, the hook or clip being configured to be attached to an external structure.

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