Piping support device and manufacturing method

Abstract

A tubing support device 100 for tubing in a pharmaceutical manufacturing system. The tubing support device has a body 102 having a first end 104, a second end 106, and a plurality of protrusions. The plurality of protrusions includes a first protrusion 108 disposed at the first end and a second protrusion 110 disposed at the second end. Each of the first and second protrusions includes an opening 112 adapted to receive a fastener. A bore 118 extends from the first end to the second end of the body, the bore being adapted to receive welded tubing such that the body reinforces the tubing, allows the tubing to contain fluid at high pressure, and / or prevents kinking of the tubing.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 63 / 035,439, filed June 5, 2020, the entire contents of which are incorporated herein by reference.

[0002] The field of disclosure relates to piping used in pharmaceutical manufacturing systems, and more particularly to piping support devices for stiffening the piping and methods of making the same. [Background technology]

[0003] The manufacturing of drug substances often requires the use of demanding high-pressure processes. Pressure in welded piping is a limiting factor in some drug substance manufacturing systems. Welding during production is a key element for rapid development of drug substances using large numbers of buffers, cassettes, and columns. Specifically, piping is typically welded during processing as a way to make sterile connections for fluid transfer. However, the current maximum allowable pressure is approximately 15 PSI at the weld, regardless of the type of piping, limiting other drug substance manufacturing system components.

[0004] Some API manufacturing systems include a bioreactor system 10 with several nutrient feed lines 12 entering the bioreactor, as shown in FIG. 1A. However, the lines 12 and other tubing often become kinked due to their placement. For example, the disposable (SU) air break tube 14 is important to the function of the bioreactor system to help keep the permeate line clean. For example, when the pump to the bioreactor is turned off, bacteria can flow backwards from the permeate line. The air break tube 14 prevents backflow of bacteria, allows proper flow of liquid while the pump is running, and prevents undesirable forward siphoning of liquid. Current bioreactor equipment placement and environmental factors make lifting the air break tube 14 and other piping lines 12 less than ideal, as the air break tube 14 and lines 12 often become kinked as a result of their hanging position.

[0005] Other feed lines are located within the pharmaceutical manufacturing system such that they have collisions. For example, as shown in FIG. 1B, some nutrient feed lines 22 (e.g., entering reactor 21 of bioreactor system 10) have flexible gamma irradiation lines, such as disposable reactors, hung over stainless steel bars 23 attached to reactor 21. These lines 22 may carry, for example, media, base, antifoam, and / or glucose. However, this configuration can cause collisions in lines 22, such as at collision points 24.

[0006] Additionally, some conventional disposable bioreactors are now equipped with disposable ATF filtration systems. For example, FIG. 2 shows a portion of another conventional disposable bioreactor system 30 that uses an ATF filtration system. However, the upper assembly 32 to which the elbow piece 34 is attached still requires autoclaving, e.g., steam sterilization by heating, because the elbow piece 34 is typically made from stainless steel and connected in a non-sterile manner. Because autoclaving is not as efficient as using disposable connector assemblies, disposable connector assemblies are used instead.

[0007] A bioreactor system 40 including a disposable connector assembly 42 with gamma irradiated flexible tubing 44 is shown in Figure 3. Often, the gamma irradiated flexible tubing 44 does not have the mechanical strength to support itself when connected to the reactors of the bioreactor system 40. As a result, the flexible tubing 44 often needs to be supported by other structures such as additional tubing or cable ties 46, which also limits high operating pressures during pharmaceutical manufacturing.

[0008] Thus, although disposable processing equipment has many advantages, including the use of sterile, disposable flexible lines, these flexible lines do not have the same mechanical strength as, for example, more traditional stainless steel lines. Summary of the Invention [Means for solving the problem]

[0009] One aspect of the disclosure includes a tubing support device for tubing in a pharmaceutical manufacturing system. The tubing support device comprises a body having a first end, a second end, and a plurality of protrusions. The plurality of protrusions includes a first protrusion disposed at the first end and a second protrusion disposed at the second end, each of the first and second protrusions including an aperture adapted to receive a fastener. A bore extends from the first end to the second end of the body, the bore adapted to receive the tubing such that the body reinforces the tubing, allows the tubing to contain fluid at high pressure, and / or prevents kinking of the tubing.

[0010] Another aspect of the disclosure includes a pharmaceutical manufacturing system. The pharmaceutical manufacturing system includes one or more manufacturing components and one or more fluid lines fluidly coupled to the one or more manufacturing components. The one or more fluid lines include tubing having a tubing support device. The tubing support device includes a body having a first end, a second end, and a plurality of protrusions. The plurality of protrusions includes a first protrusion disposed at the first end and a second protrusion disposed at the second end, each of the first and second protrusions including an opening adapted to receive a fastener. A bore extends from the first end to the second end of the body, the bore adapted to receive the tubing such that the body reinforces the tubing, allows the tubing to contain fluid at high pressure, and / or prevents kinking of the tubing.

[0011] Another aspect of the present disclosure includes a method of manufacturing a tubing support device for a pharmaceutical manufacturing system. The method includes forming a body including a bore and a plurality of protrusions, the bore extending along a length of the body and adapted to receive tubing of the pharmaceutical manufacturing system to reinforce the tubing and / or prevent kinking of the tubing during high pressure operations. The method further includes forming an aperture in at least one of the plurality of protrusions.

[0012] Each of the foregoing exemplary aspects of the present disclosure may further include any one or more of the following features. For example, the body may further include a first body portion and a second body portion coupled to the first body portion. Each of the first and second body portions may include a first end, a second end, a first protrusion disposed at the first end, and a second protrusion disposed at the second end. Each of the protrusions may include an opening.

[0013] In some further aspects, the second body portion may be complementary in shape to the first body portion such that when the first and second body portions are joined together, the openings of the first and second protrusions of the second body portion are aligned with the openings of the first and second protrusions of the first body portion.

[0014] In some other aspects, the body is a sheath and includes a C-shape. The first body portion can include a front half of the sheath and the second body portion can include a rear half of the sheath. Each of the first and second body portions can have the same shape and form a bore when coupled together.

[0015] In another aspect, the body may further include a first tab disposed at a first end of the body and a second tab disposed at a second end of the body, each of the first and second tabs having a slot adapted to receive a fastener for suspending the body, elevating tubing adapted to be received in the bore of the body, and preventing kinking of the tubing.

[0016] In another aspect, the plurality of protrusions can further include a third protrusion extending upwardly from a central portion of the body. The third protrusion can also include an opening adapted to receive a fastener.

[0017] According to another aspect, the body can include a sleeve having a cylindrical shape. Additionally, the body can include an inner surface having a gripping system adapted to contact the welded tubing to further secure the welded tubing within the bore. The gripping system can include a first array of teeth disposed on the inner surface near the first end of the body and a second array of teeth disposed on the inner surface near the second end of the body.

[0018] In some aspects, at least one tooth of the first and second arrays of teeth can include a base having a first side extending inwardly from the base and a second side extending inwardly from the base, The first and second sides can form an edge for gripping the welded tubing when the welded tubing is positioned within the bore.

[0019] In some other aspects, the first and second arrays of teeth can each extend around an inner surface of the bore near the first and second ends of the body, respectively, forming an annular first array of teeth and an annular second array of teeth.

[0020] In yet another aspect, the body can include a sleeve and an inner surface having a plurality of ridges adapted to contact the tubing to further secure the tubing within the body. Additionally, the inner surface can include a first plurality of ridges disposed on the inner surface near a first end of the body and a second plurality of ridges disposed on the inner surface near a second end of the body. Each of the first and second plurality of ridges can contact the tubing to further secure the tubing within the body.

[0021] In yet another aspect, the body can include a first plurality of ridges disposed near a first end of the body and a second plurality of ridges disposed near a second end of the body.

[0022] In other aspects, the body may include an additively manufactured body comprising an additively manufactured first body portion and an additively manufactured second body portion coupled to the additively manufactured first body portion.

[0023] In yet another aspect, forming the body including the bore and the plurality of protrusions may include forming the body including the bore and the plurality of protrusions using additive manufacturing techniques.

[0024] In another aspect, forming a body including a bore and a plurality of protrusions may include forming a first body portion having a first end, a second end, a first protrusion disposed at the first end, and a second protrusion disposed at the second end, the first body portion being a front half portion of the body. Additionally, the method may further include forming a second body portion having a first end, a second end, a first protrusion disposed at the first end, and a second protrusion disposed at the second end, the second body portion being a rear half portion of the body.

[0025] In yet another aspect, forming the body including the bore and the plurality of protrusions may further include forming a first tab disposed at a first end of the body and a second tab disposed at a second end of the body, and forming a slot in each of the first and second tabs, the slots for receiving a fastener for hanging the body.

[0026] In yet another aspect, forming a body including a bore and a plurality of protrusions may include forming a body having an inner surface with a gripping system having a first array of teeth disposed near a first end of the body and a second array of teeth disposed on the inner surface near a second end of the body, and disposing each of the first and second arrays of teeth about the inner surface of the body.

[0027] The features of the invention which are believed to be novel are set forth with particularity in the appended claims. The invention can be best understood by reference to the following description taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements in the several views. [Brief description of the drawings]

[0028] [Figure 1A] FIG. 1 is a perspective view of a portion of a conventional drug substance manufacturing system having several nutrient feed lines entering a bioreactor. [Figure 1B] FIG. 1B is another perspective view of an add-on line of the conventional pharmaceutical manufacturing system of FIG. 1A. [Diagram 2] FIG. 1 is another perspective view of a portion of a conventional single-use bioreactor system that uses a filtration system. [Diagram 3] FIG. 1 is another perspective view of a portion of a conventional bioreactor system including a disposable connector assembly with gamma irradiated flexible tubing. [Figure 4A] FIG. 1 is a block diagram of an exemplary pharmaceutical manufacturing system including a tubing support device according to an aspect of the present disclosure. [Figure 4B] FIG. 4B is a perspective view of an exemplary welded piping of the pharmaceutical manufacturing system of FIG. 4A. [Diagram 5] FIG. 1 is a perspective view of a tubing support device according to one aspect of the present disclosure. [Figure 6] 6 is a side view of a first body portion of the tubing support device of FIG. 5. [Figure 7] 6 is a side view of a second body portion of the tubing support device of FIG. 5. [Figure 8] 6 is a perspective view of the tubing support device of FIG. 5 with a fastener attached to the tubing support device. [Figure 9] FIG. 13 is a front view of another tubing support device according to another aspect of the present disclosure. [Figure 10] 10 is a cross-sectional view of the tubing support device of FIG. 9 taken along line 10-10 of FIG. 11. [Figure 11] FIG. 10 is a side view of the tubing support device of FIG. [Figure 12] 10 is a perspective view of a portion of the tubing support device of FIG. 9. [Figure 13A] FIG. 13 is a front perspective view of another tubing support device according to another aspect of the present disclosure. [Figure 13B] FIG. 13B is an exploded view of the tubing support device of FIG. 13A. [Figure 14]13B is a perspective view of the tubing support device of FIG. 13A and another tubing support device according to the same embodiment as the tubing support device of FIG. 13A, except for different dimensions. [Figure 15A] FIG. 13B is a perspective view of an exemplary experimental setup using the tubing support device of FIG. 13A and additional cable ties for reinforcement. [Figure 15B] FIG. 15B is a perspective view of a portion of a cable tie of the exemplary experimental apparatus of FIG. [Figure 16A] FIG. 13B is a perspective view of another exemplary experimental setup that uses the tubing support device of FIG. 13A and a thermoplastic sleeve for additional reinforcement. [Figure 16B] FIG. 16B is a perspective view of a thermoplastic sleeve used with the experimental apparatus of FIG. 16A. [Figure 17A] FIG. 13B is a perspective view of another exemplary experimental setup that uses the tubing support device of FIG. 13A and a bar block for additional stiffening. [Figure 17B] FIG. 17B is a perspective view of an exemplary bar block used with the experimental setup of FIG. 17A. [Figure 17C] FIG. 17B is a perspective view of a bar block placed over the tubing and used with the experimental setup of FIG. 17A. [Figure 18] FIG. 1 is a block diagram of a system for additive manufacturing of a piping support device of the present disclosure. [Figure 19] FIG. 20 is another block diagram showing components of the system of FIG. 18. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Tubing support devices, such as either tubing sleeves or tubing sheaths, are designed to reinforce tubing used in pharmaceutical manufacturing systems, such as disposable manufacturing systems and disposable flow kits. The tubing support devices of the present disclosure allow the tubing to contain fluids at very high pressures, allowing the tubing to be commonly used in future disposable manufacturing systems. In addition to increasing the pressure rating, the tubing support device also raises the tubing from another surface to increase sterility and prevent kinking of the tubing. Specifically, in one example, the tubing support device includes a body having a plurality of protrusions, including a first protrusion disposed at a first end of the body and a second protrusion disposed at a second end of the body. Each of the first and second protrusions includes an opening for receiving a fastener, thus securing the tubing support device around the tubing. A bore extends along the length of the body and is adapted to receive the tubing such that the body reinforces the tubing, thereby allowing the tubing to contain fluids at higher pressures than other conventional reinforcement devices and / or preventing kinking of the tubing. Due to manufacturing techniques such as additive manufacturing and materials used, the tubing support device is also approximately half the size and up to nearly 40% lighter than conventional welded reinforcements.

[0030] 4A, an exemplary pharmaceutical manufacturing system 50 is shown. The exemplary pharmaceutical manufacturing system 50 may include any pharmaceutical drug manufacturing system having one or more manufacturing components 51 and one or more fluid lines 52 fluidly connected to the one or more manufacturing components 51. The one or more fluid lines 52 may include tubing 53 having a tubing support device 54 according to the present disclosure. The tubing 53 of the one or more fluid lines 52 may include flexible tubing, welded tubing, and / or any other tubing that may be used and / or coupled with one or more manufacturing components 51 of the pharmaceutical manufacturing system 50, as shown in FIG. 4B. In single-use processing, the tubing is typically welded as a way to make a sterile connection for fluid transfer in the pharmaceutical manufacturing system 50. As will be appreciated, various other designs of welded tubing different from that shown in FIG. 4B may be used instead and still fall within the scope of the present disclosure. As will also be appreciated, the tubing 53 may be fluidly coupled to various manufacturing components 51 located throughout the pharmaceutical manufacturing system 50. As described below, a pipe support device 54 of the present disclosure may be placed around the pipe 53 to reinforce the pipe 53 .

[0031] According to one aspect of the disclosure, the tubing support device 54 includes a tubing support device 100, as shown in FIG. 5. The tubing support device 100 includes a body 102 having a first end 104 and a second end 106. The body 102 also includes a plurality of protrusions 106, including a first protrusion 108 disposed at the first end 104 and a second protrusion 110 disposed at the second end 106. Each of the first and second protrusions 108, 110 includes an opening 112 adapted to receive a fastener, as will be further described below. Additionally, the plurality of protrusions 106 may further include a third protrusion 114 extending upwardly from a central portion of the body 102. Similar to the first and second protrusions 108, 110, the third protrusion 114 also includes an opening 116 for receiving a fastener, as will be further described below. A bore 118 extends along the length of the body 102 from the first end 104 to the second end 106. The bore 118 is adapted to receive the tubing such that the body 102 reinforces the tubing, thereby allowing the tubing to contain fluid at high pressure and / or prevents the tubing from kinking.

[0032] In one example, the first protrusion 108 extends downwardly and inwardly from the first end 104 of the body 102. Additionally, the second protrusion 110 extends inwardly from the second end 106 of the body 102. Further, in this example, the body 102 is a sheath and includes a rounded shape, such as, for example, a C-shape, with the first end 104 disposed over the second end 106.

[0033] 6 and 7, the body 102 further includes a first body portion 120 (FIG. 6) and a second body portion 122 (FIG. 7) adapted to be coupled to the first body portion 120 to form the body 102 of FIG. 5. As shown in FIG. 6, the first body portion 120 includes a first end 104a, a second end 106a, a first protrusion 108a disposed at the first end 104a, and a second protrusion 110a disposed at the second end 106a. Each of the first and second protrusions 108a, 110a includes an opening 112a adapted to receive a fastener, as will be further described below. A third protrusion 114a extends from a central region of the first body portion 120 and also includes an opening 116a for receiving a fastener. 7, the second body portion 122 similarly includes a first end 104b, a second end 106b, a first protrusion 108b disposed at the first end 104b, and a second protrusion 110b disposed at the second end 106b. Each of the first and second protrusions 108b, 110b of the second body portion 122 also includes an opening 112b. A third protrusion 114b extends from a central region of the second body portion 122 and includes an opening 116b for receiving a fastener.

[0034] The second body portion 122 is complementary in shape to the first body portion 120, for example, as shown in Figures 6 and 7. In one example, each of the first and second body portions 120, 122 of the body 102 is rounded in shape, such as C-shaped. It will be understood that the first and second body portions 120, 122 may alternatively take the form of various other shapes and still be within the scope of the present disclosure. At least, because the first and second body portions 120, 122 are complementary in shape, e.g., have the same shape, the openings 112a of the first and second protrusions 108a, 110a of the first body portion 120 align with the openings 112b of the first and second protrusions 108b, 110b of the second body portion 122 when the first and second body portions 120, 122 are coupled together. This allows a fastener to be placed into the first opening 112a of the first body portion 120 and through the opening 112b of the second body portion 122 to secure the first and second body portions 120, 122 together, as described below.

[0035] In this example, the body 102 of the tubing support device 100 is a sheath, the first body portion 120 is a front half of the sheath, and the second body portion 122 is a rear half of the sheath. When the first and second body portions 120, 122 are coupled together, the first and second body portions 120, 122 of the body 102 form a bore 118 adapted to receive the tubing 52, as shown in FIG.

[0036] 6 and 7, each of the first and second body portions 120, 122 includes a first tab 124a, 124b disposed at the first end 104a, 106b and a second tab 126a, 126b disposed at the second end 104b, 106b, respectively. Each of the first tabs 124a, 124b includes a slot 128a, 128b adapted to receive a fastener, and each of the second tabs 126a, 126b includes a slot 128a, 128b also adapted to receive a fastener. Thus, the first and second tabs 124a, 124b, 126a, 126b can raise tubing disposed within the bore 118 of the body 102 and prevent kinking of the tubing.

[0037] 8, the tubing support device 100 of FIGS. 5-7 is shown with fasteners 130 disposed on each of the projections 108, 110, 114. Specifically, the fasteners 130 are disposed in and through the openings 112, 112a, 112b (FIGS. 5-7) disposed in each of the projections 108, 110, 114 to, for example, couple the first body portion 120 (FIG. 6) to the second body portion 122 (FIG. 7) together. In one example, the fasteners 130 are screws that fasten the first and second body portions 120, 122 together and around the welded tubing. In this example, there are three screws 130. It should be understood that various other fasteners capable of securing the first body portion 120 to the second body portion 122 (e.g., to assemble the body 102 of the tubing support device 100) can be used instead and still be within the scope of the present disclosure.

[0038] In one example, the body 102 of the piping support device 100 comprises an additively manufactured body 102. The first body portion 120 is an additively manufactured first body portion 120, and the second body portion 122 is an additively manufactured second body portion 122 as well. The additively manufactured body 102 and the additively manufactured first and second body portions 120, 122 may be additively manufactured according to any known additive manufacturing technique, such as using a 3D printer, as described further below. Alternatively, the body 102 of the piping support device 100 may be made by injection molding, casting, or any other readily available known manufacturing process and still fall within the scope of the present disclosure.

[0039] Now, referring to Figures 9-12, another piping support device 200 according to another embodiment of the present disclosure is shown. The piping support device 200 includes many features similar or the same as the piping support device 100 of Figures 5-8. Thus, the parts of the piping support device 200 that are the same as the parts of the piping support device 100 are numbered 100 more than the parts of the piping support device 100. Unlike the piping support device 100 of Figures 5-8, which includes a C-shaped design, for example, the piping support device 200 is a sleeve and includes a rectangular cylindrical shape. In addition, the piping support device 200 can include a single part. Further differences between the piping support device 200 and the piping support device 100 will be further described and understood below.

[0040] 9, tubing support device 200 includes a body 202 having a first end 204 and a second end 206. Body 202 includes a plurality of protrusions including a first protrusion 208 disposed at first end 204 and a second protrusion 210 disposed at second end 206. 207Each of the first and second protrusions 208, 210 includes an opening 212 adapted to receive a fastener, such as the fastener 130 described above with respect to the tubing support device 100. Additionally, the plurality of protrusions 206 may further include a third protrusion 214 extending upward from a central portion of the body 202. Similar to the first and second protrusions 208, 210, the third protrusion 214 also includes an opening 216 for receiving a fastener, such as the fastener 130. As shown in FIGS. 10 and 11, the bore 218 extends along the length of the body 202 from the first end 204 to the second end 206. The bore 218 is adapted to receive the tubing such that the body 202 reinforces the tubing, allows the tubing to contain fluid at increased pressure, and / or prevents kinking of the tubing. In one example, the first protrusion 208 extends downward from the first end 204 of the body 202. In addition, a second protrusion 210 similarly extends downwardly from the second end 206 of the body 202 .

[0041] 10, the body 202 of the tubing support device 200 further includes an inner surface 232 having a gripping system 234 adapted to contact the tubing (when the tubing is disposed within the tubing support device 200) and further secure the tubing within the bore 218. The gripping system 234 includes a first array of teeth 236 disposed on the inner surface 232 near the first end 204 of the body 202. The gripping system 234 further includes a second array of teeth 238 disposed on the inner surface 232 near the second end 206 of the body 202. The first and second arrays of teeth 236, 238 extend around the inner surface 232 of the body 202 forming an annular first array of teeth 236a and an annular second array of teeth 238a. For example, FIG. 11 illustrates the first array of teeth 236 extending around the entire inner surface 232 of the body 202 at the first end 204. In a similar manner, the second array of teeth 238 similarly extends around the entire inner surface 232 of the body 202 at the second end 204. In one example, as shown in FIG. 11 , the first array of teeth 236, 236a includes eight rows 240 of teeth spaced equidistantly around the inner surface 232 of the body 202.

[0042] In addition, referring now to FIG. 12, each row of teeth 240 can include four teeth 242, with each tooth 242 including a base 244 having a first sidewall 246 extending inwardly and upwardly from the base 244 and a second sidewall 248 extending inwardly and upwardly from the base 244. The first and second sidewalls 246, 248 of each tooth 242 form an edge 250 that grips the tubing when the tubing is placed within the bore 218 of the body 202. Although these features are described for two arrays of teeth 236, 238 (FIG. 10), it will be understood that two or more teeth 242 and / or all teeth can include the same shapes and features. Alternatively, each tooth 242 can take the form of any other different shape and / or have fewer or more teeth in each array and still fall within the scope of the present disclosure.

[0043] In one example, similar to the pipe support device 100, the body 202 of the pipe support device 200 can also include an additively manufactured body 202. The body 202 is additively manufactured according to any known additive manufacturing technique, such as using a 3D printer. Alternatively, the body 202 of the pipe support device 200 can be made by injection molding, casting, or any other readily available known manufacturing process and still fall within the scope of the present disclosure.

[0044] 13A-14, another piping support device 300 according to another embodiment of the present disclosure is shown. The piping support device 300 includes many features similar or identical to the piping support device 100 of FIGS. 5-8. Thus, the parts of the piping support device 300 that are the same as the parts of the piping support device 100 are numbered 100 higher than the parts of the piping support device 100. Unlike the piping support device 100 of FIGS. 5-8, which includes a C-shaped design, for example, the piping support device 200 is a sleeve and includes a rectangular cylindrical shape. In addition, there is no third protrusion extending from the body of the piping support device 300. Further differences between the piping support device 300 and the piping support device 100 will be further described and understood below.

[0045] 13A and 13B, the tubing support device 300 includes a body 302 having a first end 304 and a second end 306. The body 302 also includes a plurality of protrusions 306 including a first protrusion 308 disposed at the first end 304 and a second protrusion 310 disposed at the second end 306. Each of the first and second protrusions 308, 310 , Tome The body 302 includes an opening 312 adapted to receive a fastener. As shown in FIGS. 13B and 14 , a bore 318 extends along the length of the body 302 from the first end 304 to the second end 306. The bore 318 is also adapted to receive tubing such that the body 302 strengthens the tubing, allows it to contain fluids at high pressure, and / or prevents kinking of the welded tubing. In one example, a first protrusion 308 extends upwardly from the first end 304 of the body 202. Additionally, a second protrusion 310 is similarly configured to extend upwardly from the first end 304 of the body 202. 302 Extending upwardly from a second end 306 of the

[0046] 13B, the body 302 further includes a first body portion 320 and a second body portion 322 adapted to be coupled to the first body portion 320 to form the body 302 of FIG. 13A. As shown in FIG. 13B, the first body portion 320 includes a first end 304a, a second end 306a, a first protrusion 308a disposed at the first end 304a, and a second protrusion 310a disposed at the second end 306a. Each of the first and second protrusions 308a, 310a includes an opening 312a adapted to receive a fastener, as will be further described below. The second body portion 322 similarly includes a first end 304b, a second end 306b, a first protrusion 308b disposed at the first end 304b, and a second protrusion 310b disposed at the second end 306b. Each of the first and second projections 308b, 310b of the second body portion 322 also includes an opening 312b.

[0047] The second body portion 322 is also complementary in shape to the first body portion 320. In one example, each of the first and second body portions 320, 322 of the body 302 is rectangular in shape. It will be understood that the first and second body portions 320, 322 may instead take the form of various other shapes and still be within the scope of the present disclosure. The openings 312a of the first and second protrusions 308a, 310a of the first body portion 320 align with the openings 312b of the first and second protrusions 308b, 310b of the second body portion 322 when the first and second body portions 320, 322 are joined together. This allows the fastener 330 to be placed in the openings 312a of the first body portion 320 and through the openings 312b of the second body portion 322 to secure the first and second body portions 320, 322 together.

[0048] In this example, the body 302 of the tubing support device 300 is a sleeve. The first body portion 320 is the front half of the sleeve, and the second body portion 322 is the rear half of the sleeve. When the first and second body portions 320, 322 are coupled together, the first and second body portions 320, 322 of the body 302 form a bore 318 adapted to receive the tubing. Furthermore, in one example, the second body portion 322 is further coupled to the first body portion 320 by at least one hinge 352 disposed at a bottom region of each of the first body portion 320 and the second body portion 322. In this example, three hinges 352 are disposed at a bottom region of the first and second body portions 320, 322 to rotatably couple the first and second body portions 320, 322 together, which are further secured to each other via fasteners 330 as described above.

[0049] In one example, the body 302 of the piping support device 300 comprises an additively manufactured body 302. The first body portion 320 is an additively manufactured first body portion 320 and the second body portion 322 is an additively manufactured second body portion 322 as well. The additively manufactured body 302 and the additively manufactured first and second body portions 320, 322 may be additively manufactured according to any known additive manufacturing technique, such as using a 3D printer, as described further below. Alternatively, the body 302 of the piping support device 300 may be made by injection molding, casting, or any other readily available known manufacturing process and still fall within the scope of the present disclosure.

[0050] In another example, each of the first body portion 320 and the second body portion 322 includes an inner surface having at least one ridge. In particular, as shown in FIG. 13B, the first body portion 320 includes an inner surface 354a and the second body portion includes an inner surface 354b. A plurality of ridges are disposed on the inner surface 354a of the first body portion 320 at both the first end 304a and the second end 306a of the first body portion 320. In this example, a first plurality of ridges 356a is disposed on the inner surface 354a at the first end 304a of the first body portion 320 and a second plurality of ridges 358a is disposed on the inner surface 354a at the second end 306a of the first body portion 320. Similarly, a plurality of ridges are disposed on the inner surface 354b of the second body portion 322 at each of the first and second ends 304b, 306b. In this example, a first plurality of ridges 356b are disposed on the inner surface 354b at the first end 304b of the second body portion 322, and a second plurality of ridges 358b are disposed on the inner surface 3454b at the second end 306b of the second body portion 322.

[0051] Each of the plurality of ridges 356a, 356b, 358a, 358b serves to secure the connection between the body 302 of the tubing support device 300, which in this example may be a sleeve, and the tubing 53, as described above (see, for example, FIG. 4B). In one example, each of the plurality of ridges 356a, 356b, 358a, 358b may include six ridges. It will be understood that more or fewer ridges may be used instead and still be within the scope of the present disclosure. Further, although a plurality of ridges 356a, 356b, 358a, 358b are disposed on each of the first ends 304a, 304b and second ends 306a, 306b of each of the first and second body portions 320, 322, respectively, it will also be understood that the plurality of ridges 356a, 356b may instead be disposed on only one end, such as only the first ends 304a, 304b or only the second ends 306a, 306b, and still be within the scope of the present disclosure.

[0052] 14, the tubing support device 300 of FIGS. 13A and 13B is shown along with another exemplary tubing support device 400. The tubing support device 400 includes all of the same features as the tubing support device 300, except that the tubing support device 400 is a larger device. In particular, the diameter of the bore 418 of the tubing support device 400 is larger than the diameter of the bore 318 of the tubing support device 300 of FIGS. 13A and 13B. Thus, the tubing support device can be sized to accommodate the dimensions of various sizes of tubing, such as, for example, welded tubing, that are adapted to be placed within the bore of the tubing support device.

[0053] 15A-17C, various experimental tests were performed using tubing support device 300 as an example of a support device to ensure that tubing placed within tubing support device 300 can safely operate at pressures of 58 PSI or greater. The experimental setup for the first experiment is shown in FIGS. 15A and 15B. In this first experiment, the tubing is welded #73 C-flex tubing 510 and tubing support device 300 is size #73 tubing support device 300. The experimental setup also includes a Quattro flow pump 520, at least one pressure gauge 522, several valves 524, such as 3 / 4 inch valves, and cable ties 526. More specifically, a recirculation loop using C-flex tubing was developed and is shown in FIG. 15A. The recirculation loop includes Quattro flow pump 520, pressure gauge 522, tubing support device 300, and a DIW supply vessel 528 connected in series with valve 524. The tubing support device 300 was secured onto the welded tubing 510. During testing at 20 PSI and 30 PSI, the welded tubing 510 had no visible leaks. At 40 PSI, the cable ties broke and a leak was detected (the welded tubing 510 in the tubing support device 300 was connected to the hose barb with only a single cable tie). After additional cable ties were added for reinforcement, no other leaks or cable tie failures occurred at 40 PSI. Again, no leaks were observed during testing at 50 PSI, and at 60 PSI, noticeable expansion of the tubing was noted at the cable tie interface, as shown, for example, in FIG. 15B.

[0054] 16A and 16B, a second experiment was again conducted using the tubing support device 300, but with a thermoplastic sleeve instead of a cable tie. In the second experiment, PureWeld #73 tubing 610, which includes welded tubing, is used along with a Quattro flow pump 620, a pressure gauge 622, at least one ¾ inch valve 624, the tubing support device 300, and a thermoplastic sleeve 626. Specifically, a recirculation loop using PureWeld tubing was developed. The loop includes a Quattro flow pump 620, a pressure gauge 622, the tubing support device 300, and a DIW supply vessel 628 connected in series with the valve 624. The tubing support device 300 was secured onto the welded tubing 610. During testing, there was no observable expansion or leakage in the welded tubing from pressures of 20 PSI to 75 PSI. At 85 PSI, the tubing bulged around the connector joints. However, the welded tubing showed no signs of leakage or expansion.

[0055] 17A-17C, a third experiment was conducted using a tubing support device 300 and bar block rather than cable ties. In the third experiment, PureWeld #24 tubing 710 including welded tubing was used along with Quattro flow pump 620, pressure gauge 622, ½ inch valve, size #24 tubing support device 300, and bar block 760. More specifically, a recirculation loop was developed using PureWeld tubing 710. The loop included Quattro pump 620 (FIG. 16A), pressure gauge 622, tubing support device 300, and DIW supply vessel 628 connected in series with valve 626 (FIG. 16). During testing, pressure was maintained at 80 PSI for 15 minutes, then 75 PSI for 120 minutes. Results showed that there was no observable expansion or leakage in the welded tubing 710 when pressure was maintained at any point within the range of 20 PSI to 75 PSI. When the pressure was maintained at 80 PSI, there was again no observable expansion or leakage in the welded piping.

[0056] The fourth and fifth experiments were conducted with welded piping without the use of the piping support device 300. For example, in the fourth experiment, a recirculation loop was developed using #24 PureWeld piping, which also included a DIW supply vessel connected in series with the Quattro pump, pressure gauge, piping assembly, and valve. No piping support device was used. Pressure was maintained at 90 PSI for 10 minutes and at 85-90 PSI for 15 minutes. Results showed that there was no observable expansion or leakage when pressure was applied at any value between 20 PSI and 75 PSI. Additionally, very little expansion, less than a few millimeters, occurred around the connector joints when pressure was applied at 90 PSI. In the fifth experiment, a recirculation loop was developed using #73 PureWeld piping, e.g., welded piping, which also included a DIW supply vessel connected in series with the Quattro pump, pressure gauge, piping assembly, and valve. No piping support device was used. Results showed that the welded piping could not withstand 90 PSI for more than a few minutes. Significant expansion was observed in the welded tubing. There was no visible expansion in the bar block.

[0057] Experimental results from five experiments indicate that pressure ratings are dependent on, for example, the type of piping, connectors, and use of the piping support device 300. Additionally, the data suggests that a 4 bar pressure rating is achievable for PureWeld welded piping size #24 (without a piping support device such as an exoskeleton) and size #73 with the piping support device 300. In the first and second experiments, the PureWeld #73 piping support device 300 with a thermoplastic sleeve is suitable for achieving a 4 bar operating pressure, with the thermoplastic sleeve providing greater system isolation based on static pressure testing and reducing exposure of the system to the environment. In the third and fourth experiments, PureWeld #24 piping with a weld in the piping support device 300 and bar block is suitable for achieving a 4 bar operating pressure. The PureWeld #24 piping with a weld and bar block can maintain a 1.5X operating pressure (60 PSI) up to 90 PSI without the piping support device 300. Additionally, the PureWeld #73 pipe weld and bar block without the pipe support device 300 was unable to withstand 90 PSI and there was slight expansion around the bar block.

[0058] 18, a system 800 for additive manufacturing any one of the aforementioned piping support devices 100, 200, 300 is shown. The system 800 can include a scanning device 814 communicatively coupled to the communication network 812, such as a communication network 812, a wireless network, and a design system 820 communicatively coupled to the scanning device 814 and also to the communication network 812. In one example, the scanning device 814 can scan a portion of a piping, such as a welded piping, or another portion of a drug substance manufacturing system that requires reinforcement, to create a piping-specific scan of the piping support device 100, 200, 300. The scanning device 814 can include one or more of a variety of known computing devices, such as, for example, an iPad, iPod, iPhone, or other smart phone, tablet, or other device with such scanning capabilities. In some examples, the piping-specific scan can later be used to create the piping support device via a 3D printer, as described further below.

[0059] The system 800 further includes a 3D printer 816 for additively manufacturing the piping support device 100, 200, 300, and an output distribution center 818 for distributing the final, completed piping support device 100, 200, 300. The system 800 further includes a design system 820 that is communicatively coupled to both the scanning device 814 and the 3D printer 816. In one example, the design system 820 is communicatively coupled via a communications network 812, such as a wireless network 812. As shown, the design system 820 includes one or more computing devices 822 that can receive data specific to the piping support device 100, 200, 300, such as data corresponding to the scanning of the welded piping section via the scanning device 814. At least one computing device 822 of the design system 820 can then transmit the piping-specific design to a 3D printer 816, such as via a wireless network 812, and instruct the 3D printer 816 to additively manufacture one of the aforementioned piping support devices 100, 200, 300.

[0060] 19 , in one example, the scanning device 814 includes one or more processors 824 that implement a scanning module stored in a memory 825 of the scanning device 814. The scanning device 814 may also include a user input 826 and a network interface 827, such that the scanning device 814 may be communicatively coupled to, for example, a wireless network 812 and in communication with a design system 820. The scanning device 814 further includes a transmitter 828 and a receiver 829, such that the transmitter 828 may transmit scanned data corresponding to a pipe-specific scan (e.g., of a desired welded pipe) to the design system 820 for processing, as described further below. Additionally, the scanning device 814 may also include a display 830, such that the scanned data corresponding to, for example, a desired welded pipe may be displayed.

[0061] Similarly, the one or more computing devices 822 of the system 820 also include one or more processors 831 that implement modules stored in a memory, such as memory 832 of the computing device 822, to receive and process data, such as data corresponding to a piping-specific scan from the scanning device 814. The computing device 822 may also include a user input 833 and a network interface 834, which enables the computing device to be communicatively coupled to the wireless network 821 and to communicate with both the scanning device 814 and the 3D printer 816. The design system computing device 822 may also include a transmitter 835 and a receiver 836, where the transmitter 835 transmits processed data associated with the piping-specific scan (e.g., from the scanning device 814) or the piping support device 100, 200, 300 to the 3D printer 816 and instructs the 3D printer 816 to print the piping support device according to the transmitted data. The receiver 836 receives scan data from the scanning device 814, which is processed by one or more processors 831 of the computing device 822 and used to implement the operation of the 3D printer 816. The computing device 822 also includes a display 837, on which data, such as data from the scanning device 814 and data processed by the computing device 822, can be displayed.

[0062] 19 , the 3D printer 816 is communicatively coupled to both the scanning device 814 and the design system 820. The 3D printer 816 includes one or more processors 838 that implement a piping support device profile that is created and then transmitted from the design system's computing device 822 to the 3D printer 816 and stored in the memory 839 of the 3D printer 816. The piping support device design profile that may be stored in the memory 839 of the 3D printer 816 includes a design protocol that is executed by the one or more processors 838 of the 3D printer 816. The 3D printer 816 may also include a user input 840 and a network interface 841, which may, for example, allow the 3D printer 816 to be communicatively coupled to the wireless network 812. The 3D printer 816 further includes a transmitter 842, a receiver 843 for receiving data from the design system 820, for example regarding a piping support device profile, and a display 844, which may include the user input 840 or may be separate therefrom.

[0063] Each of the processors 824, 831, and 838 may be a general-purpose processor, a digital signal processor, an ASIC, a field programmable gate array, a graphics processing unit, an analog circuit, a digital circuit, or other known or later developed processor. The processor 824 of the scanning device 814 may operate according to a profile stored in the memory 825 of the scanning device 814, for example. The memories 825, 832, 839 may be volatile or non-volatile memory. The memories 825, 832, 839 may include one or more of read-only memory ("ROM"), random access memory ("RAM"), flash memory, electronically erasable program read-only memory ("EEPROM"), or other types of memory. The memories 825, 832, 839 may include optical, magnetic (hard drive), or any other form of data storage.

[0064] In one example, the piping support device design protocol is part of a piping specific design profile stored in memory 832, 839 and includes a set of executable instructions to control the 3D printer 816 to print the piping support device 100, 200, 300. The piping support device design protocol can be stored on memory 832, 839 as computing logic including one or more routines and / or subroutines embodied as computer readable instructions stored on memory 832, 839. The processor 831, 838 can execute the logic to cause the processor 831, 838 to obtain the profile and control the 3D printer 816 according to the piping support device design profile. In particular, the piping support device design protocol can specify the size, shape and / or volume of the piping support device, as well as the timing of the 3D printing, among other parameters.

[0065] In view of the above, it will be appreciated that the tubing support device 54, 100, 200, 300 of the present disclosure may be manufactured according to the following exemplary method. In particular, in one example, a method of manufacturing a tubing support device for a pharmaceutical manufacturing system 50 includes forming a body 102, 202, 302 including a bore 118, 218, 318 and a plurality of protrusions 106, 206, the bore 118, 218, 318 extending along a length of the body 102, 202, 302 and adapted to receive the tubing 52 (FIG. 4A) of the pharmaceutical manufacturing system 50 to reinforce the welded tubing 52 and prevent kinking of the welded tubing 52 during high pressure operation. The method further includes forming an opening 112, 112a, 112b, 212, 312 in at least one protrusion 108, 110, 208, 210, 308, 310 of the plurality of protrusions.

[0066] In some examples, forming the body 102, 202, 302 including the bore 118, 218, 318 and the plurality of protrusions 106, 206 includes forming the body 102, 202, 302 using an additive manufacturing technique, such as any of those described herein. In another example, forming the body 102, 202, 302 including the bore 118, 218, 318 includes forming a first body portion 120 having a first end 104a, a second end 106a, a first protrusion 108a disposed on the first end 104a, and a second protrusion 110a disposed on the second end 106a. Additionally, the method further includes forming a second body portion 122 having a first end 104b, a second end 106b, a first protrusion 108b disposed on the first end 104b, and a second protrusion 110b disposed on the second end 106b, the second body portion being a rear half of the body 102. Additionally, in one example, forming the second body portion 122 having the first end 104b, the second end 106b, the first protrusion 108b disposed on the first end 104b, and the second protrusion 110b disposed on the second end 106b includes forming the second body portion 122 having a shape complementary to the first body portion 120. The method may also further include forming the first body portion 120, 220 using additive manufacturing techniques, and forming the second body portion 122, 222 using additive manufacturing techniques.

[0067] In another example, forming the body 102 having multiple protrusions includes forming a first tab 124a, 124b disposed at a first end 104a, 104b of the body 102 and a second tab 126a, 126b disposed at a second end 106b of the body 102, and forming slots 128a, 128b in each of the first and second tabs 124a, 124b, 126a, 126b, the slots 128a, 128b receiving fasteners for hanging the body 102. Forming the body 102, 202 having multiple protrusions 106, 206 includes forming a first protrusion 108, 208 disposed at a first end 104, 204 of the body 102, 202, forming a second protrusion 110, 210 disposed at a second end 106, 206 of the body 102, 202, and forming a third protrusion 114, 214 extending upwardly from a central portion of the body 102, 202.

[0068] Furthermore, in another example, forming the body 202 having the multiple protrusions 206 includes forming the body 202 having an inner surface 232 with a gripping system 234 having a first array of teeth 236 disposed near the first end 204 of the body 202 and a second array of teeth 238 disposed on the inner surface 232 near the second end 206 of the body 202, and disposing each of the first and second arrays of teeth 236, 238 around the inner surface 232 of the body 202.

[0069] In one example, each of the acts of the manufacturing method described above can use one or more additive manufacturing techniques. In general, an additive manufacturing technique can be any additive manufacturing technique or process that builds a three-dimensional object by adding successive layers of material onto material. An additive manufacturing technique can be performed by any suitable machine, such as a 3D printer 816 (FIG. 18), or a combination of machines, such as the system 800 described above. An additive manufacturing technique typically includes or can use a computer, three-dimensional modeling software (e.g., computer-aided design, or CAD, software), machinery, and layer-forming materials. Once a CAD model is created, the machinery can read the data from the CAD file and add successive layers of (e.g.) liquid, powder, or sheet material, layer by layer, to produce the three-dimensional object. Additive manufacturing techniques can include any of a number of techniques or processes, such as, for example, stereolithography ("SLA") processes, fused deposition modeling ("FDM") processes, multi-jet modeling ("MJM") processes, selective laser sintering ("SLS") processes, electron beam additive manufacturing processes, and arc welding additive manufacturing processes. In some embodiments, the additive manufacturing process can include a directed energy laser deposition process. Such a directed energy laser deposition process can be performed by a multi-axis computer numerically controlled ("CNC") lathe equipped with directed energy laser deposition capabilities.

[0070] Additionally, the piping support device 100, 200, 300 can be made from a variety of robust materials, including but not limited to VeroWhitePlus (RDG835), with a smooth material finish and compliant with GMP manufacturing. The type and finish of the material used may vary from this exemplary material, so long as the material is robust and still within the scope of the present disclosure. Additionally, in some examples, the size of the piping support device 100, 200, 300 is half the size and lightweight, such as up to 40% weight reduction, compared to conventional welded reinforcement devices, due at least in part to the materials used and the additive manufacturing techniques therefor. As discussed above, the size of the piping support device 100, 200, 300 can be adapted to various piping.

[0071] In view of the foregoing, the following advantages of the tubing support device 100, 200, 300 and its manufacturing method will be appreciated. For example, the tubing support device 100, 200, 300 allows the tubing to contain fluid at very high pressures, such as up to 85 PSI, without any observable adverse effects. This allows welded tubing to be commonly used in future disposable manufacturing systems. In addition to increasing the pressure rating, the tubing support device 100, 200, 300 also elevates the tubing from another surface, increasing sterility and preventing kinking of the welded tubing. Due to the additive manufacturing techniques and materials used, the tubing support device 100, 200, 300 is also approximately half the size and up to nearly 40% lighter than traditional welded reinforcements. Additionally, the tubing support device 100, 200, 300 reduces the need for additional support tubing and cable ties commonly used in conventional systems, for example, and reduces any malformations while the tubing is draped over the reactor and other system components.

[0072] While the present invention has been shown and described with reference to various preferred embodiments, it will be apparent that certain changes and modifications in addition to those described above can be made. This patent covers all embodiments of the teachings of the disclosure that fall fully within the scope of permissible equivalents. It is therefore intended to protect all changes and modifications that may occur to those skilled in the art.

[0073] The following additional considerations also apply to the above description. Throughout this specification, multiple instances may implement components, operations, or structures described as one instance. Although individual operations of one or more methods are illustrated and described as separate operations, one or more of the individual operations may be performed simultaneously, and there is no requirement that the operations be performed in the order illustrated. Structures and functions presented as separate components in an exemplary configuration may also be implemented as combined structures or components. Similarly, structures and functions presented as one component may be implemented as separate components. These and other modifications, improvements, additions, and improvements are within the scope of the subject matter of this specification.

[0074] Unless otherwise indicated, discussions herein using words such as "processing," "computing," "calculating," "determining," "presenting," "displaying," and the like may refer to machine (e.g., computer) operations or processes that manipulate or transform data represented as physical (e.g., electronic, magnetic, or optical) quantities in one or more memories (e.g., volatile memory, non-volatile memory, or a combination thereof), registers, or other machine components that receive, store, transmit, or display information.

[0075] As used herein, a reference to "one implementation," "one embodiment," "implementation," or "embodiment" means that a particular element, feature, structure, or characteristic described in connection with an implementation is included in at least one implementation. The appearances of the phrases "in one implementation" or "in one embodiment" in various places in the specification do not necessarily all refer to the same embodiment.

[0076] Some implementations may be described using the term "coupled" and its derivatives. For example, some implementations may use the term "coupled" to indicate that two or more elements are in direct physical or electrical contact. However, the term "coupled" may also mean that two or more elements are not in direct contact with each other, but still co-operate or interact with each other. Implementations are not limited in this context.

[0077] As used herein, the terms "comprises," "comprising," "including," "including," "having," "having," or other variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, article, or apparatus that includes a list of elements is not necessarily limited to only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Furthermore, unless expressly stated to the contrary, "or" refers to an inclusive "or" rather than an exclusive "or." For example, a condition A or B is satisfied by any of the following: A is true (or present) and B is false (or absent), A is false (or absent) and B is true (or present), and both A and B are true (or present).

[0078] Furthermore, the use of "a" or "an" is used to describe elements and components of implementations herein. This is done merely for convenience and to give a general sense of the invention. This description should be read to include one or at least one, and the singular also includes the plural unless otherwise clearly meant.

[0079] Moreover, the claims at the end of this patent application are not intended to be construed under 35 U.S.C. ...

Claims

1. 1. A piping support device for piping in a pharmaceutical manufacturing system, comprising: a body having a first end, a second end, and a plurality of protrusions, the plurality of protrusions including a first protrusion disposed at the first end and a second protrusion disposed at the second end, each of the first and second protrusions including an opening adapted to receive a fastener; a bore extending from the first end to the second end of the body, the bore adapted to receive tubing such that the body reinforces the tubing, thereby allowing the tubing to contain fluid at high pressure and / or preventing kinking of the tubing; Equipped with the body including: (1) a first tab disposed at the first end of the body and a second tab disposed at the second end of the body, each of the first tab and the second tab having a slot adapted to receive a fastener for hanging the body; (2) an inner surface having a gripping system adapted to contact the tubing to further secure the tubing within the body, the gripping system including a first array of teeth disposed on the inner surface near the first end of the body and a second array of teeth disposed on the inner surface near the second end of the body; (3) an inner surface having a plurality of ridges at the first end and the second end of the body, the plurality of ridges adapted to contact the tubing to further secure the tubing within the body; Including one of Piping support devices.

2. 2. The piping support device of claim 1, wherein the body further comprises a first body portion and a second body portion coupled to the first body portion, each of the first and second body portions comprising a first end, a second end, a first protrusion disposed at the first end, and a second protrusion disposed at the second end, each of the first protrusion and the second protrusion of the first body portion and the second body portion comprising an opening.

3. 3. The piping support device of claim 2, wherein the second body portion is complementary in shape to the first body portion such that when the first and second body portions are joined together, the openings of the first and second protrusions of the second body portion are aligned with the openings of the first and second protrusions of the first body portion.

4. 4. The piping support device of claim 2 or 3, wherein the body is a sheath and comprises a C-shape, the first body portion is a front half portion of the sheath and the second body portion is a rear half portion of the sheath, and each of the first and second body portions have the same shape and form the bore when joined together.

5. A tubing support device as described in any one of claims 1 to 4, wherein each of the first and second tabs suspends the body, lifts the tubing adapted to be received within the bore of the body, and receives a fastener for preventing kinking of the tubing.

6. The piping support device of claim 2 or 3, wherein the plurality of projections further includes a third projection extending upwardly from a central portion of the body, the third projection including an opening adapted to receive a fastener.

7. The tubing support device of claim 6 , wherein the body is a sleeve having a cylindrical shape, the body including the gripping system.

8. 8. The tubing support device of claim 7, wherein at least one tooth of the first and second arrays of teeth includes a base having a first side extending inwardly from the base and a second side extending inwardly from the base, the first and second sides forming an edge for gripping the tubing when the tubing is positioned within the bore, and the first and second arrays of teeth each extend around the inner surface of the bore near the first and second ends of the body, respectively.

9. 9. The piping support device of any one of claims 1 to 8, wherein the body comprises an additively manufactured body comprising an additively manufactured first body portion and an additively manufactured second body portion coupled to the additively manufactured first body portion.

10. 1. A pharmaceutical manufacturing system comprising: One or more manufacturing components; one or more fluid lines fluidly coupled to the one or more manufacturing components, the one or more fluid lines including piping having a piping support device, the piping support device comprising: a body having a first end, a second end, and a plurality of protrusions, the plurality of protrusions including a first protrusion disposed at the first end and a second protrusion disposed at the second end, each of the first and second protrusions including an opening adapted to receive a fastener; a bore extending from the first end to the second end of the body, the bore receiving the tubing such that the body reinforces the tubing, thereby allowing the tubing to contain fluid at high pressure and / or preventing kinking of the tubing; one or more fluid lines comprising: Equipped with the body including: (1) a first tab disposed at the first end of the body and a second tab disposed at the second end of the body, each of the first tab and the second tab having a slot adapted to receive a fastener for hanging the body; (2) an inner surface having a gripping system that contacts the tubing to further secure the tubing within the body, the gripping system including a first array of teeth disposed on the inner surface near the first end of the body and a second array of teeth disposed on the inner surface near the second end of the body; (3) an inner surface having a plurality of ridges at each of the first and second ends of the body, the plurality of ridges contacting the tubing to further secure the tubing within the body; Including one of Pharmaceutical manufacturing systems.

11. 11. The system of claim 10, wherein the body further comprises a first body portion and a second body portion coupled to the first body portion, each of the first and second body portions including a first end, a second end, a first protrusion disposed at the first end, and a second protrusion disposed at the second end, each of the first and second protrusions of the first and second body portions including an aperture having a catch.

12. 12. The system of claim 11, wherein the body is a sheath and comprises a C-shape, the first body portion is a front half of the sheath and the second body portion is a rear half of the sheath, and each of the first and second body portions have the same shape and form the bore when coupled together.

13. 13. The system of claim 10, wherein each of the first and second tabs has a fastener for suspending the body, lifting the tubing received within the bore of the body, and preventing kinking of the tubing.

14. 12. The system of claim 10 or 11, wherein the body is a sleeve having a cylindrical shape and the body includes one of (1) or (2): (1) the gripping system; or (2) a plurality of ridges at each of the first end and the second end of the body, the plurality of ridges including a first plurality of ridges disposed on the inner surface near the first end of the body and a second plurality of ridges disposed on the inner surface near the second end of the body, each of the first and second plurality of ridges contacting the piping to further secure the piping within the body.

15. 1. A method of manufacturing a tubing support device for a pharmaceutical manufacturing system, comprising: forming a body including a bore and a plurality of protrusions, the bore extending along a length of the body and adapted to receive tubing of a pharmaceutical manufacturing system to reinforce the tubing and prevent kinking of the tubing during high pressure operations; forming an aperture in at least one of the plurality of projections, the aperture adapted to receive a fastener; Including, Forming the body including a bore and a plurality of protrusions includes forming a body having an inner surface with one of: (1) a gripping system having a first array of teeth disposed near a first end of the body and a second array of teeth disposed on the inner surface near a second end of the body, with each of the first array of teeth and the second array of teeth disposed about the inner surface of the body; or (2) a first plurality of ridges disposed near the first end of the body and a second plurality of ridges disposed near the second end of the body. method.

16. 16. The method of claim 15, wherein forming the body including the bore and the plurality of protrusions includes using additive manufacturing techniques to form the body including the bore and the plurality of protrusions having an opening in at least one of the protrusions.

17. forming a body including a bore and a plurality of projections; forming a first body portion having a first end, a second end, a first protrusion disposed at the first end of the first body portion, and a second protrusion disposed at the second end of the first body portion, the first body portion being a front half of the body; forming a second body portion having a first end, a second end, a first protrusion disposed at the first end of the second body portion, and a second protrusion disposed at the second end of the second body portion, the second body portion being a rear half portion of the body; 17. The method of claim 15 or 16, comprising:

18. 18. The method of any one of claims 15 to 17, wherein forming the body including the bore and the plurality of protrusions further comprises: forming a first tab disposed at a first end of the body and a second tab disposed at a second end of the body; and forming a slot in each of the first and second tabs, the slots for receiving a fastener for hanging the body.

Images