Flow cells for use in fluid management and / or processing systems

Abstract

To provide a flow cell for use in fluid management and / or processing system.SOLUTION: A flow cell of the present invention comprises: a body having an inlet and an outlet; and a fluid flow channel extending from the inlet to the outlet of the body. The body further comprises a receptacle comprising a chamber forming a part of the fluid flow channel of the body, the chamber comprising a first opening for connecting a functional element to the flow cell such that the functional element is in contact with or exposed to a fluid flow passing through the fluid flow channel. A first tubular connector is arranged adjacent to the inlet of the body. A second tubular connector is arranged adjacent to the outlet of the body. The flow cell further comprises a functional element and a fluid flow channel that extends from the first tubular connector to the outlet of the body and the second tubular connector through the body and a receptor. The present invention further relates to fluid management and / or processing system comprising a tubing arrangement and one or more flow cells.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a flow cell for use in a fluid pipe reason and / or is treatment system.

[0002] The present invention further relates to a fluid pipe reason and / or is treatment system comprising a piping structure including one or more flow cells.

Background Art

[0003] A fluid pipe reason and / or is treatment system, such as a bioprocessing system or a filtration system, typically includes a fluid management system including several containers, such as bags or totes, containing various fluids, such as buffer solutions, for use in bioprocessing applications.

[0004] Buffer solutions are typically made at a specified concentration and produced in large quantities for storage in respective totes.

[0005] In typical bioprocessing applications, multiple buffer solutions are used in units of, for example, approximately two thousand liters per buffer solution, corresponding to the demand for each buffer solution.

[0006] Subsequently, the totes are transferred from the buffer solution preparation area to the processing chamber. As a result, a significant installation area is required in the buffer solution preparation area equipped with the bioprocessing operation and buffer solution totes.

[0007] Similar problems also exist in other fluid pipe reason and / or is treatment systems.

[0008] In this field, there is an ongoing need for additional solutions to enhance the management of a wide variety of fluids used in various bioprocessing applications, such as buffer solutions. For example, there is an ongoing need for technologies to efficiently manage the supply of buffer solutions used in bioprocessing applications. [Overview of the Initiative]

[0009] The present invention relates to a fluid tube reason bi / mata is A flow cell for use in a control system is provided. The flow cell according to the present invention comprises a body having an inlet, an outlet, and a fluid channel extending from the inlet to the outlet. The flow cell body further comprises a receiver having a chamber that forms part of the fluid channel of the body. The chamber has a first opening for connecting a functional element to the flow cell such that the functional element is in contact with or exposed to the fluid flow passing through the fluid channel. The flow cell further comprises a first tubular connector located adjacent to the inlet of the body and a second tubular connector located adjacent to the outlet of the body. The flow cell according to the present invention further comprises a fluid channel extending from the first tubular connector through the inlet of the body, the body and the receiver of the body, to the outlet of the body and the second tubular connector.

[0010] In many applications, fluid tubes reason bi / mata is Functional elements are required to control, modify, or otherwise manage the use of fluids processed by a processing system.

[0011] Therefore, the present invention provides a flow cell that can be used in a wide variety of applications, particularly by accommodating a wide variety of functional elements.

[0012] The present invention further provides a fluid processing system comprising a piping structure having one or more flow cells according to the present invention. Detailed description of the invention

[0013] The flow cell according to the present invention preferably provides a fluid channel having a predetermined substantially identical cross-sectional area within and along at least the first and second tubular connectors, but more preferably the cross-sectional area of ​​the fluid channel along the channel substantially matches the cross-sectional area within the first and second tubular connectors.

[0014] In a preferred embodiment of the flow cell of the present invention, the volumetric portion of the chamber of the main body is designed to have a fluid flow channel cross-sectional area greater than or equal to the cross-sectional area of ​​the fluid flow channels in and along the first and second tubular connectors, preferably after the functional elements are installed in the opening and extend into the chamber as necessary.

[0015] Therefore, the flow cell according to the present invention realizes an unobstructed fluid flow through the flow cell, regardless of the type of functional element housed within the opening of the chamber.

[0016] In many embodiments, the tubular connector of the flow cell is directly attached to the main body, and more preferably, the tubular connector is integrally formed with the main body.

[0017] According to a preferred embodiment, the body and / or tubular connector of the fluid flow cell is made of a plastic material, which is preferably selected from polycarbonate, polypropylene, polysulfone, polyethersulfone, polybutylene terephthalate, polyethylene terephthalate, polyetheretherketone, polyetherimide, low-density polyethylene, high-density polyethylene, and silicone (polysiloxane). Alternatively, the body and / or tubular connector of the flow cell may be made of metal, particularly stainless steel.

[0018] According to one embodiment of the flow cell of the present invention, the fluid flow path is linear. As a result, the first and second tubular connectors are positioned in opposing portions of the chambers, which extend apart from each other.

[0019] According to another embodiment, the flow cell comprises a fluid flow path having a curved or arcuate shape, an angled shape, preferably a 90-degree angled shape, or a T-shaped.

[0020] Thus, various embodiments of flow cells having different shapes can be used to adapt to various environments required by a specific fluid pipe reason and / or is the treatment system.

[0021] According to a preferred embodiment of the present invention, the chamber of the receptacle of the flow cell has a second opening facing the first opening, and the second opening is optionally either the inlet or the outlet of the body.

[0022] In many embodiments, the flow cell according to the present invention incorporates a receptacle having a substantially hollow cylindrical chamber.

[0023] According to a further preferred embodiment of the present invention, the receptacle includes a circular protrusion extending away from the body at a first opening of the chamber for receiving a functional element in a sealed state.

[0024] Thus, a simple configuration of the flow cell and the functional element can be obtained according to the requirements of a specific process and / or is the treatment system.

[0025] Furthermore, the first opening of the chamber can accommodate an adapter for positioning one end of the functional element at a predetermined position within the chamber. Thus, the functional element can be accurately positioned to ensure the function of the functional element.

[0026] The functional element that can be used in the flow cell of the present invention may be selected from the various functional elements described above.

[0027] Preferred types of functional elements include static mixers, conductivity sensors, pH sensors, pressure sensors, electrical grounding elements, redox sensors, temperature sensors, capacitance sensors, flow sensors, optical sensors such as UV sensors, and liquid sample collection elements.

[0028] When the functional element is selected from a conductivity sensor and a pH sensor, preferably, the probe end of the sensor extending into the chamber of the flow cell is positioned to maintain a distance of at least 12 mm, preferably at least 15 mm, from all wall portions of the chamber. Furthermore, all dimensions of the chamber perpendicular to the direction in which the sensor with the probe end extends into the chamber are at least 25 mm, more preferably at least 28 mm, particularly at least 70 mm, and preferably at least 50 mm. If the chamber is hollow and cylindrical, this dimension corresponds to the inner diameter of the chamber. Typically, the diameter of the probe end of such a sensor is about 12 mm.

[0029] The preferred flow cell according to the present invention is designed for single-use. Furthermore, the flow cell may be sterilizable, thus providing opportunities for use as a flow cell in a wide variety of bioprocessing systems that handle fluids designed for use in medical or pharmaceutical applications.

[0030] Furthermore, the flow cell of the present invention may be designed with consideration for a wide variety of functional elements, particularly standard shapes adaptable to sensors. The flow cell of the present invention may also be designed as an integral component of a fluid processing system, particularly by overmolding the same material as the tubing of a piping structure. Moreover, multiple flow cells according to the present invention may be assembled to provide a series of different functional elements to an entity. This can be achieved by directly connecting the tubular connectors of two successive flow cells and overmolding the ends of the connectors without using additional parts.

[0031] As described above, the present invention also provides a fluid tube comprising a somewhat complex piping structure comprising one or more flow cells according to the present invention. reason bi / mata is Regarding the science and engineering system.

[0032] The fluid processing system can form part of a wide variety of bioprocessing systems, preferably a system comprising a buffer solution management and / or identification system, a bulk fill manifold, and a biocontainer assembly for a virus inactivation manifold. Furthermore, the fluid processing system according to the present invention can form part of a filtration system, particularly a depth filtration system, a sterilization filtration system, or a virus filtration system.

[0033] Further aspects and features of the disclosed principle, as well as alternative aspects and features, will be understood from the following detailed description and accompanying drawings. It will also be understood that the flow cells disclosed herein can be used in other and different environments and can be modified in various ways. Therefore, it should be understood that both the above general description and the following detailed description are not intended to limit the scope of the accompanying claims to merely illustrative and descriptive. [Brief explanation of the drawing]

[0034] [Figure 1] A first embodiment of the flow cell according to the present invention is shown. [Figure 2] Another embodiment of the flow cell according to the present invention is shown. [Figure 3] Another embodiment of the flow cell according to the present invention is shown. [Figure 4] This shows a portion of the piping configuration of the fluid management and / or processing system of the present invention, incorporating multiple flow cells of the present invention. [Figure 5A] Two further embodiments of the flow cell of the present invention are shown from a certain perspective. [Figure 5B] Two further embodiments of the flow cell of the present invention are shown from a different perspective. [Figure 5C] Two further embodiments of the flow cell of the present invention are shown from a different perspective. [Figure 5D] Two further embodiments of the flow cell of the present invention are shown from a different perspective. [Figure 6] Further embodiments of the flow cell according to the present invention are shown. [Figure 7] This shows a fluid management and processing system according to the present invention that incorporates multiple flow cells of the present invention. [Figure 8] This shows a piping configuration of the fluid management and processing system of the present invention incorporating multiple flow cells of the present invention. [Figure 9] This shows the fluid management and processing system of the present invention incorporated into a virus inactivation manifold. [Modes for carrying out the invention]

[0035] Figure 1 shows a first embodiment of a flow cell 10 according to the present invention, which comprises a body 12 having an inlet 14 and an outlet 16, and a fluid flow path extending from the inlet 14 to the outlet 16 of the body 12. The inlet 14 and the outlet 16 are located on opposing parts of the body, and the fluid flow path extends linearly from the inlet 14 to the outlet 16.

[0036] The flow cell 10 of the present invention further comprises a first tubular connector 18 and a second tubular connector 20, which are located adjacent to the inlet 14 and outlet 16, respectively.

[0037] The body 12 of the flow cell 10 further includes a receiver 22 having a substantially hollow cylindrical chamber 26 for housing a functional element 24, the chamber 26 forming part of the fluid flow path of the body 12. The chamber 26 has a first opening 28 at one end of the hollow cylindrical portion, allowing the functional element 24 to access the chamber 26. The first opening 28 of the chamber 26 is provided with a circular projection 30 extending away from the body 12 in a direction perpendicular to the flow path of the body 12.

[0038] In the embodiment shown in Figure 1, the main body 12, the first and second tubular connectors 18 and 20, the receiver 22, and the circular projection 30 are formed as a single integrated part from, for example, a silicone material, and are preferably molded.

[0039] The functional element 24 may be a conductivity sensor probe, which is attached to a circular projection 30 of the receiver 22 via a sensor probe support 32. The sensor probe support 32 extends into the circular projection 30 and houses the conductivity sensor probe 24 in a sealed state such that the sensor probe end 24a is positioned within the volume of the chamber 26 and exposed to the fluid flow passing through the fluid channel of the flow cell 10. Preferably, the volume of the chamber 26 is configured such that, even after the conductivity sensor probe 24 is attached within the circular projection 30 and the probe end 24a extends into the chamber 26, the cross-section of the channel within the chamber 26 substantially coincides with the cross-section of the channel in the rest of the flow cell 10.

[0040] Furthermore, it is preferable to design the chamber 26 and adapter 32 such that the probe end 24a of the conductivity sensor 24 maintains a predetermined distance from all wall portions of the chamber 26, and more preferably, the sensing electrode of the probe end 24a of the conductivity sensor 24 is spaced at least 12 mm, most preferably at least 15 mm, from the wall portions of the chamber 26. Based on the general dimensions of the conductivity sensor 24—the diameter of the probe end is generally about 12 mm—the inner diameter of the hollow cylindrical chamber 26 is preferably about 28 mm to about 50 mm.

[0041] The sensor probe support 32 is in sealing contact with the inner surface 34 of the circular projection 30 so that the fluid flow path is completely sealed from the environment of the flow cell 10.

[0042] The flow cell 10 of the present invention can be sealedly connected to a piping structure (represented here by tube ends 36, 38) via first and second tubular connectors 18, 20 by pipe fittings 40, 42. The pipe fittings 40, 42 may be formed by overmolding the free ends and tube ends 36, 38 of the tubular connectors 18, 20, respectively.

[0043] Figure 2 shows a further embodiment of the flow cell 50 according to the present invention, which comprises a body 52 having an inlet 54 and an outlet 56, and a fluid channel extending from the inlet 54 to the outlet 56 of the body 52. ​​The body 52 of the flow cell 50 comprises a receiver 62 for housing a functional element 64, the functional element 64 may be a pH sensor probe.

[0044] The flow cell 50 of the present invention further comprises a first tubular connector 58 and a second tubular connector 60, which are located adjacent to the inlet 54 and outlet 56, respectively.

[0045] The receiver 62 comprises a substantially hollow cylindrical chamber 66 for housing a functional element, namely a pH sensor probe 64. The chamber 66 forms part of the fluid flow path of the body 52. ​​The chamber 66 has a first opening 68 at one end of the hollow cylindrical portion, allowing the functional element 64 to access the chamber 66. The first opening 68 of the chamber 66 has a circular projection 70 extending away from the body 52. ​​In contrast to the embodiment shown in Figure 1, the chamber 66 of the body 52 of the flow cell 50 has a second opening at the opposite end of the cylindrical portion, which functions as an outlet 56 of the body 52. ​​Thus, the fluid flow path of the body 52 is angled at 90 degrees.

[0046] In the embodiment shown in Figure 2, the main body 52, the first and second tubular connectors 58 and 60, the receiver 62, and the circular projection 70 can be formed as a single integrated component, particularly preferably from a silicone material.

[0047] The main body 52 may have a further tubular connector 72 extending from the main body 52 and the receiver 62 in the direction opposite to the first tubular connector 58. This tubular connector 72 can also function to supply further fluid flow in and out of the chamber 66, but in the embodiment shown in Figure 2, it is closed by a plug 74.

[0048] The pH sensor probe 64 is mounted within the circular projection 70 of the opening 68 via a sensor probe support or holder 76. The sensor probe holder 76 extends into the circular projection 70 to house the pH sensor probe 64 in a sealed state, and as a result, the sensor probe end 64a is positioned within the volume of the chamber 66 and directly exposed to the fluid flow passing through the fluid channel of the flow cell 50. Preferably, the volume of the chamber 66 is configured such that, even after the pH sensor probe 64 is mounted within the circular projection 70 and the end 64a of the probe extends into the chamber 66, the cross-section of the channel within the chamber 66 substantially coincides with the cross-section of the channel in the rest of the flow cell 50.

[0049] The sensor probe holder 76 is in sealing contact with the inner surface of the circular projection 70 so as to completely seal the fluid flow path to the environment of the flow cell 50.

[0050] The flow cell 50 of the present invention can be sealed to a piping structure (represented here by tube ends 78, 80) via first and second tubular connectors 58, 60 by pipe fittings 82, 84. The pipe fittings 82, 84 may be formed by overmolding the free ends and tube ends 78, 80 of the tubular connectors 58, 60, respectively.

[0051] Figure 3 shows another embodiment of the flow cell 100 of the present invention, which comprises a body 102 having an inlet 104 and an outlet 106, and a fluid passage extending from the inlet 104 to the outlet 106 of the body 102. The inlet 104 and the outlet 106 are located on opposing parts of the body 102, and the fluid passage extends linearly from the inlet 104 to the outlet 106.

[0052] The flow cell 100 of the present invention further comprises a first tubular connector 108 and a second tubular connector 110, which are located adjacent to the inlet 104 and outlet 106, respectively.

[0053] The body 102 of the flow cell 100 further includes a receiver 112 having a substantially hollow cylindrical chamber 116, the chamber 116 forming part of the fluid flow path of the body 102. The chamber 116 has a first opening 118 at one end of the hollow cylindrical portion, to which the functional element 114 is connected. The first opening 118 of the chamber 116 has a circular projection 120 extending away from the body 102 in a direction perpendicular to the flow path of the body 102.

[0054] The functional element 114 in Figure 3 is designed as a pressure sensor. The pressure sensor 114 can either directly contact the fluid passing through the flow path of the flow cell 100, or indirectly contact it via the closure element 122, as shown in Figure 3. The closure element 122 is designed to transmit the pressure within the flow cell 100 and may form part of the pressure sensor 114, or it may be designed as a separate component or adapter that is attached to the flow cell 100, i.e., to the opening 118 and the circular projection 120 of the flow cell 100, respectively.

[0055] So far, the structure of the flow cell 100 is substantially equivalent to the structure of the flow cell 10 shown in Figure 1. However, the chamber 116 of the receiver 112 of the flow cell 100 is provided with a second opening 122 located at the end of the hollow cylindrical portion of the chamber 116 and facing the first opening 118. The opening 122 is connected to a third tubular connector 124. Thus, the flow cell 100 may offer additional functionality compared to the flow cell 10 in Figure 1.

[0056] In the embodiment shown in Figure 3, the main body 102, the first, second and third tubular connectors 108, 110, and 124, the receiver 112, and the circular projection 120 are preferably formed as a single integrated part from, for example, a silicone material, and are particularly preferably molded.

[0057] The flow cell 100 of the present invention can be sealed to a piping structure (represented here by tube ends 126, 128, 130) via first, second, and third tubular connectors 108, 110, 124 by pipe fittings 132, 134, 136. This embodiment of the flow cell of the present invention is an example of a flow cell having a T-shaped flow channel. The pipe fittings 132, 134, 136 may be formed by overmolding the free ends of the tubular connectors 108, 110, 124 and the tube ends 126, 128, 130, respectively.

[0058] Figure 4 shows, for example, a fluid tube according to the present invention. reason bi / mata is This shows a cross-section of a portion of the piping structure 150 of the control system. On the right, the piping structure 150 incorporates the flow cell 50 shown in Figure 2 (FIG. 2). On the left, the piping structure 150 is connected to the flow cell 160, which structurally corresponds substantially to the flow cell 50. However, the functional element housed in the flow cell 160 is the conductivity sensor probe 162.

[0059] Furthermore, the piping structure 150 shown in Figure 4 includes an additional flow cell 100 according to the present invention, which houses a pressure sensor 114 as a functional element. The flow cell 100 is described in more detail above in relation to Figure 3 (FIG. 3).

[0060] The flow cell 100 also provides the possibility of connecting an air filter 170 to the piping structure 150 for a ventilation integrity test of the structure 150.

[0061] Figure 4 shows that the flow cell of the present invention enables multifunctional control with minimal piping and installation area. Your visitIt will be easy to see how the and / or processing means are assembled. In this embodiment, the flow cells of the present invention are directly connected (series-connected) to each other by overmolding adjacent tubular connectors.

[0062] Figures 5A to 5D show two further embodiments of the flow cell according to the present invention.

[0063] Figures 5A to 5C show a cross-sectional view and two different perspective views of the flow cell 200, respectively.

[0064] Figure 5A shows a cross-sectional view of a flow cell 200 comprising a main body 202 having an inlet 204 and an outlet 206, and a fluid flow path extending from the inlet 204 to the outlet 206 of the main body 202. The inlet 204 and outlet 206 are located on opposite sides of the main body 202, and the fluid flow path extends linearly from the inlet 204 to the outlet 206.

[0065] The flow cell 200 of the present invention further comprises a first tubular connector 208 and a second tubular connector 210, which are located adjacent to the inlet 204 and outlet 206, respectively.

[0066] The body 202 of the flow cell 200 further comprises a receiver 212 having a substantially hollow cylindrical chamber 216 for housing functional elements 214, where the functional elements 214 take the form of static mixed elements.

[0067] Chamber 216 also forms part of the fluid flow path of the main body 202. Chamber 216 has a first opening 218 at one end of a hollow cylindrical section, allowing the static mixing element 214 to access the chamber 216. The first opening 218 of chamber 216 has a circular projection 220 that extends away from the main body 202 in a direction perpendicular to the flow path of the main body 202. The static mixer 214 is sealed and mounted to the circular projection 220 of the receiver 212. The static mixer 214 has three mixing fins 222 that project into the chamber 216, thereby creating turbulent fluid flow, and as a result, the components of the fluid passing through the flow cell 200 are completely mixed.

[0068] In the embodiments shown in Figures 5A to 5C, the main body 202, the first and second tubular connectors 208 and 210, the receiver 212, and the circular projection 220 are formed as a single, integrated component from, for example, a silicone material, and are particularly molded.

[0069] Preferably, the volumetric portion of the chamber 216 is configured such that, even after the static mixer 214 is mounted within the circular projection 220 and the mixing fins 222 of the static mixer 214 extend into the chamber 216, the cross-section of the flow path within the chamber 216 substantially matches or is larger than the cross-section of the flow path in the rest of the flow cell 200.

[0070] The flow cell 200 of the present invention can be sealed to, for example, a flexible piping structure (represented here by tube ends 224, 226) via first and second tubular connectors 208, 210 by pipe fittings 228, 230. The pipe fittings 228, 230 may be formed by overmolding the free ends and tube ends 224, 226 of the tubular connectors 208, 210, respectively.

[0071] Figure 5D shows a modified version of flow cell 200 in the form of flow cell 250, where the fluid flow path is not linear like that of flow cell 200, but has a structure with a 90-degree angle.

[0072] The flow cell 250 according to the present invention comprises a body 252 having an inlet 254 and an outlet 256, and a fluid channel extending from the inlet 254 to the outlet 256 of the body 252. The body 252 of the flow cell 250 comprises a receiver 262 that provides a chamber 266 for housing a functional element 264, the functional element 264 may be a static mixer.

[0073] The flow cell 250 of the present invention further comprises a first tubular connector 258 and a second tubular connector 260, which are located adjacent to the inlet 254 and outlet 256, respectively.

[0074] The chamber 266 of the receiver 262 is substantially hollow cylindrical in shape for housing functional elements such as a static mixer 264. The chamber 266 forms part of the fluid flow path of the body 252. The chamber 266 has a first opening 268 at one end of the hollow cylindrical portion, allowing the static mixer 264 to access the chamber 266. The receiver 262 has a circular projection 270 extending away from the body 252 at the first opening 268 of the chamber 266.

[0075] In contrast to the embodiments shown in Figures 5A to 5C, the chamber 266 of the body 252 of the flow cell 250 has a second opening at the opposing ends of the cylindrical portion that functions as an outlet 256 of the body 252. Thus, the fluid flow path of the body 252 is angled at 90 degrees.

[0076] In the embodiment shown in Figure 5D, the main body 252, the first and second tubular connectors 258 and 260, the receiver 262, and the circular projection 270 are formed as a single, integrated part from, for example, a silicone material, and are particularly preferably molded.

[0077] The static mixer 264 is sealed within the circular projection 270 of the receiver 262, and the mixing fins 272 of the mixer extend into the chamber 266. Thus, the mixing fins 272 are exposed to the fluid flow passing through the fluid channels of the flow cell 250, completely mixing the components of the fluid passing through the flow cell 250. Preferably, the volume of the chamber 266 is configured such that, even after the static mixer 264 is installed within the circular projection 270 and the mixing fins 272 of the static mixer 264 extend into the chamber 266, the cross-section of the flow channels within the chamber 266 substantially matches or is larger than the cross-section of the flow channels in the rest of the flow cell 250.

[0078] The flow cell 250 of the present invention can be sealed to a piping structure (represented here by tube ends 278, 280) via first and second tubular connectors 258, 260 by pipe fittings 282, 284. The pipe fittings 282, 284 may be formed by overmolding the free ends and tube ends 278, 280 of the tubular connectors 258, 260, respectively.

[0079] Figure 6 shows a further embodiment of the flow cell 300 according to the present invention, the flow cell 300 comprising a body 302 having an inlet 304 and an outlet 306, and a fluid flow path extending from the inlet 304 to the outlet 306 of the body 302. The body 302 of the flow cell 300 comprises a receptacle 312 for housing a functional element 314, the functional element 314 may be an electrical grounding element.

[0080] The flow cell 300 of the present invention further comprises a first tubular connector 308 and a second tubular connector 310, which are located adjacent to the inlet 304 and outlet 306, respectively.

[0081] The receiver 312 includes a substantially hollow cylindrical chamber 316 for housing functional elements such as an electrical grounding element 314. The chamber 316 forms part of the fluid flow path of the main body 302. The chamber 316 has a first opening 318 at one end of the hollow cylindrical portion, allowing the functional element 314 to access the chamber 316. The first opening 318 of the chamber 316 includes a circular projection 320 that extends away from the main body 302. The electrical grounding element 314 is mounted in a sealed state within the circular projection 320.

[0082] The chamber 316 of the body 302 of the flow cell 300 has a second opening at the opposing ends of the cylindrical section, which functions as the outlet 306 of the body 302. Thus, the fluid flow path of the body 302 is angled at 90 degrees.

[0083] In the embodiment shown in Figure 6, the main body 302, the first and second tubular connectors 308 and 310, the receiver 312, and the circular projection 320 are formed as a single integrated part from, for example, a silicone material, and are particularly preferably molded.

[0084] The main body 302 may have a further tubular connector 322 extending from the main body 302 and the receiver 312 of the main body in opposing directions to the first tubular connector 308. This tubular connector 322 can also function to supply further fluid flow in and out of the chamber 316, but in the embodiment shown in Figure 6, it is closed by a plug 326.

[0085] The electrical grounding element 314 is mounted within the circular projection 320 of the opening 318 so that its lower surface 324 contacts the volume of the chamber 316. The grounding wire 336 of the electrical grounding element 314 extends through the electrical grounding element 314 to the lower surface 324 and is in direct contact with the fluid flow guided through the flow cell 300.

[0086] The volume portion of the chamber 316 is preferably configured such that the cross-section of the flow path within the chamber 326 is larger than the cross-section of the flow path in the rest of the flow cell 300.

[0087] The flow cell 300 of the present invention can be sealedly connected to a piping structure (represented here by tube ends 328, 330) via first and second tubular connectors 308, 310 by pipe fittings 332, 334. The pipe fittings 332, 334 may be formed by overmolding the free ends and tube ends 328, 330 of the tubular connectors 308, 310, respectively.

[0088] Figure 7 shows a fluid management system according to the present invention, which is in particular designed as a bulk-fill manifold 400. The manifold 400 comprises a complex piping structure and incorporates a plurality of flow cells according to the present invention. Further components, including the piping structure and flow cells according to the present invention, are assembled on a cabinet 402 which is preferably mounted on a skid 404, as shown in Figure 7, and the skid 404 is preferably designed to include a movable support plate.

[0089] The fluid management system 400 receives liquid from a first storage tank (not shown) via tube 406, which is to be processed and distributed into several containers, bags, or bottles. Tube 406 extends to a pump mounted on a support 402, which, during operation, supplies fluid to a bulk fill manifold.

[0090] As shown in Figure 7, one front of cabinet 402 is , enter A piping structure 410 is provided, which includes an outlet port 412 and an inlet line 414. The inlet line 414 incorporates a flow cell 416 according to the present invention. Yes, the flow cell 416 incorporates a temperature sensor module as a functional element.

[0091] The inlet line 414 is connected to the pump 418, which functions to supply fluid flow from the inlet 412 to the piping structure 410 and the components connected thereto.

[0092] The piping structure 410 is connected to the pump 418 by a supply line 420, which serves as a fluid passage to the first filter element 422. The inlet portion of the filter element 422 is connected to a liquid detector 426 and a vent / air filter 428, the vent / air filter 428 which functions to discharge air from the piping structure 410 when the bulk fill manifold starts operating. A valve 425 is provided between the liquid detector 426 and the vent / air filter 428, which opens when discharging air from the piping structure 410 and closes during normal operation of the fluid management system 400. Another flow cell 424 according to the present invention is incorporated in the supply line 420, which houses a pressure sensor as a functional element.

[0093] The piping structure 410 further includes a line 430 connecting the outlet of filter 422 to the inlet of a subsequently positioned filter 432. The connecting line 430 also incorporates a flow cell 434 according to the present invention, which may house a pressure sensor as a functional element. The filter element 432 also includes a liquid detector 436 and a vent / air filter 438 that serves the same purpose as the vent / air filter 428. A valve 435 is provided between the liquid detector 436 and the vent / air filter 438, which opens when air is discharged from the piping structure 410 and closes during normal operation of the fluid management system 400.

[0094] At the outlet of filter 432, a line 440 is further provided, connecting the outlet of filter 432 to the inlet of filter 442. In this case as well, line 440 is provided with a flow cell 444 according to the present invention, and the flow cell 444 incorporates a pressure sensor as a functional element. The piping structure 410 includes a liquid detector 446 and a vent / air filter 448, for the same purposes as described above for the vents and air filters of filter elements 422 and 432. A valve 445 is provided between the liquid detector 446 and the vent / air filter 448, which opens when air is discharged from the piping structure 410 and closes during the normal operation of the fluid management system 400.

[0095] The outlet 450 of the filter element 442 is provided with a connection line 452 that connects a piping structure 410 to a further piping structure intended to allow multiple receivers to be releasably connected to a bulk fill manifold 400 that receives the fluid filtered through three subsequent filters 422, 432, and 442.

[0096] As will be explained in more detail in relation to Figure 8 below, the fluid tube according to the present invention reason bi / mata is The filtration system comprises a piping configuration having one or more flow cells according to the present invention. The system may include a single-use manifold configured to be removablely mounted to the cabinet, such that the manifold is arranged to operate with pneumatic and automated equipment housed within the cabinet of the inline dilution skid.

[0097] The manifold may be configured to be operably positioned with a so-called water for injection (WFI) pump, buffer solution pump, control valve, and control unit, which are housed within the cabinet of the dilution skid. The manifold is typically configured to selectively mix a supply of at least one concentrated buffer solution with a supply of WFI to produce a buffer solution having desired buffer solution characteristics for use, for example, in a bioprocessing application. After use in the intended bioprocessing application, the manifold can be detached from the in-line dilution skid and replaced with another single-use manifold having a similar structure.

[0098] Figure 8 shows an embodiment of the manifold 600 suitable for use in a buffer solution management system constructed according to the present invention. The manifold 600 shown in Figure 8 is in the form of a single-use inline buffer solution dilution manifold. The manifold 600 is configured to be detachably mounted to an inline dilution skid of a buffer solution management system.

[0099] The manifold 600 includes tubing, a single-use pump head, sensors, and connectors, which are configured to selectively mix at least one concentrated buffer solution with WFI to produce a diluted buffer solution that is within a predetermined tolerance range with respect to a given buffer solution characteristic (e.g., pH), as will be described in more detail below.

[0100] The manifold 600 includes two single-use pump heads 602 and 604, one of which (pump head 602) supplies at least one buffer solution concentrate, and the other (pump head 604) supplies WFI for mixing with the buffer solution concentrate within the manifold 600 to produce a diluted buffer solution according to a predetermined buffer solution recipe.

[0101] The manifold 600 is positioned together with the dilution skid control unit to enable automated operation of the buffer solution management system, for example, by changing the pump speed / ratio in response to at least one sensor feedback loop to realize a desired buffer solution recipe from multiple buffer solution recipe libraries, selectively operating control valves according to a predetermined operating sequence, and coordinating with the operation of other units to respond to the demand for buffer solution.

[0102] The manifold 600 includes a plurality of buffer solution inlet ports 606a to 606f, a WFI inlet port 608, single-use pumps 602 and 604, at least one buffer solution characteristic sensor, such as a conductivity sensor 610, a plurality of buffer solution outlet ports 612a to 612f corresponding to the numbers of the buffer solution inlet ports 606a to 606f, and a drain outlet port 614. The manifold 600 includes a piping structure 616 configured to interact with a plurality of control valves (not shown), so that a control unit operates the control valves to open, close, or redirect the flow of liquid through the manifold 600 to perform various buffer solution management sequences.

[0103] Piping structure 612 has a buffer solution inlet line 618, a WFI inlet line 620, a discharge line 622, and a drain line 624. Piping structure 616 interconnects the various ports 606a-606f, 612a-612f of manifold 600 and is associated with control valves for controlling the flow of buffer solution and WFI through manifold 600. Piping structure 616 may comprise a plurality of flexible tubular lines. Flexible tubular lines can be made of any suitable material such as silicone or thermoplastic elastomer (TPE).

[0104] The manifold 600 includes six buffer solution inlet ports 606a–606f that are in fluid communication with the buffer solution inlet line 618. Control valves (not shown) are placed between each of the buffer solution inlet ports 606a–606f and the buffer solution inlet line 618 to selectively control the flow of concentrated buffer solution through each of the buffer solution inlet ports 606a–606f toward the buffer solution inlet line 618. A buffer solution pump 602 is associated with the buffer solution inlet line 618. The buffer solution pump 602 can operate to pump at least one selected concentrated buffer solution from the concentrated buffer solution rack tower through the buffer solution inlet line 618.

[0105] The buffer solution inlet line 618 and the WFI inlet line 620 are fluidly connected to each other via a mixing joint 626 and a first drain joint 628. In the embodiment shown in Figure 8, the mixing joint 626 is in the form of a flow cell according to the present invention, has a T-shaped fluid channel, and incorporates a static mixer as a functional element. A control valve (not shown) is located upstream of the first drain joint 628 of both the buffer solution inlet line 618 and the WFI inlet line 620.

[0106] The WFI inlet port 608 may be fluid-connected to a suitable WFI supply source (not shown). The WFI supply source may include a WFI tank. Alternatively, WFI may be supplied using an on-site WFI generator. The WFI pump 604 may be operated to pump the WFI supply from the WFI supply source through the WFI inlet line 620.

[0107] The manifold 600 includes six buffer solution outlet ports 612a to 612f, which are in fluid communication with the discharge line 622. Control valves (not shown) are placed between each of the buffer solution outlet ports 612a to 612f and the discharge line 622, and selectively control the flow of diluted buffer solution through each of the buffer solution outlet ports 612a to 612f from the manifold 600 to a diluted buffer solution rack tower (not shown).

[0108] The discharge line 622 is in fluid communication with both the buffer solution inlet line 618 and the WFI inlet line 620 via a mixing joint 626. The discharge line 622 is in fluid communication with the drain line 624 via a second drain joint 630. Control valves (not shown) are located both upstream and downstream of the second drain joint 630 of the drain line 624.

[0109] At least one sensor is associated with the discharge line and is configured to sense a value of the buffer solution characteristic (in this case, a conductivity sensor 632), generate a buffer solution characteristic signal indicating the sensed value of the buffer solution characteristic, and transmit the buffer solution characteristic signal to a control unit. The control unit can use the received buffer solution characteristic signal to control the operation of the buffer solution management system.

[0110] In addition to the first conductivity sensor 610, a pressure sensor 634 and a pH sensor 636 housed in the flow cell according to the present invention are each associated with the discharge line 622 and transmit the first conductivity signal, pressure signal, and pH signal, respectively, to the control unit.

[0111] The buffer solution management program can use at least one of the conductivity signal and the pH signal to determine whether the buffer solution passing through the discharge line 622 is within a predetermined tolerance range for a given specification of the desired buffer solution. The buffer solution management program may also use the pressure signal from the pressure sensor 634 to determine whether the manifold 600 is operating below a predetermined maximum pressure for safe operation.

[0112] The discharge line 622 also has a soundness test line 638 through which it is in fluid communication. As will be understood by those skilled in the art, the soundness test line 638 can be used to perform other appropriate sampling and testing of the buffer solution being generated.

[0113] The drain outlet port 614 is in fluid communication with the drain line 624. Fluid can be discharged from the drain line 624 through the drain outlet port 614 to a suitable tank or facility drain.

[0114] A second conductivity sensor 632 is associated with the drain line 624 and is configured to transmit a second conductivity signal to the control unit. The second conductivity signal can be used to configure a buffer solution management program to identify liquid passing through the drain line 624 as WFI.

[0115] The control unit is configured to automatically control the operation of at least one of the buffer solution pump 602 and the WFI pump 604 in response to information received via at least one sensor feedback loop in order to produce a desired buffer solution. The control unit is configured to control the pump speed / volume displacement of at least one of the buffer solution pump 602 and the WFI pump 604 to adjust the ratio of concentrated buffer solution to WFI blended together in the discharge line 624 in order to achieve a desired buffer solution recipe.

[0116] A buffer solution management system constructed according to the principles of the present invention can reduce the space required in the buffer solution preparation room compared to conventional approaches. For example, in applications using relatively large quantities of buffer solution at its original concentration, such as 2,000 L, only 200 L totes (based on a 10-fold dilution) can be used. In applications using a total of 20,000 L of buffer solution for one campaign, a buffer solution management system constructed according to the principles of the present invention can use 2,000 L of concentrated buffer solution (based on a 10-fold dilution).

[0117] A second conductivity signal is transmitted to the control unit for use in the buffer solution management program to determine whether the diluted buffer solution passing through the drain line is within the specifications of the selected buffer solution recipe. Since mixing can continue while the mixture of concentrated buffer solution and WFI passes through the drain line 624, it may be useful to monitor the second conductivity signal to determine whether the diluted buffer solution is within the specifications of the desired recipe and to reduce the amount of solution diverted to the drain line 624.

[0118] When the control unit determines that the dilution buffer solution generated in the manifold is within the specifications of the desired buffer solution recipe, the control unit can operate manifold 600 to move it to a selected surge biocontainer in the dilution buffer solution rack tower. The dilution buffer solution stored in the selected surge biocontainer is ready to be transferred to the operational process.

[0119] Figure 9 shows the configuration of the virus inactivation manifold 700, and the fluid tube according to the present invention. reason bi / mata is Further examples of the system are shown. The virus inactivation manifold 700 is incorporated into a cabinet 702 mounted on a skid 704.

[0120] Similar to the configuration already described in relation to Figure 7, the cabinet 702 supports a piping configuration 706 used to receive and supply a fluid that is treated, for example, with an acid or base for virus inactivation.

[0121] The piping structure 706 includes a tube structure 708 that connects several pump heads 710, 712, and 714 with a plurality of flow cells according to the present invention that house various functional elements.

[0122] For example, line 720 is provided with a flow cell 722 according to the present invention, which houses a pH sensor as a functional element. Further flow cells (not shown) according to the present invention may be incorporated into the piping structure 708 to provide an opportunity to further control the quality of the fluid being processed, housing functional elements such as a static mixer, conductivity sensor, pressure sensor, capacitance sensor, redox sensor, and optionally an electrical grounding element.

[0123] Therefore, the flow cell according to the present invention is a completely different fluid tube from the complex tube system described above in the embodiments shown in Figures 7 to 9. reason bi / mata is It is clear that this can be used in a control system because the piping configuration shown in these diagrams can have multiple control functions, allowing the entire system to be easily assembled in a small footprint.

[0124] All references cited herein, including publications, patent applications, and patents, are incorporated by reference to the same extent as if the entire description of the invention were contained herein (particularly in the following claims), where each reference is shown to be incorporated by reference individually and specifically, and is so as to if the entire description of the invention were contained herein, and should be interpreted as including both singular and plural forms unless otherwise specifically noted herein or clearly inconsistent with the context.

[0125] The terms “comprising,” “having,” “including,” and “containing” are, unless otherwise noted, interchangeable terms (i.e., “including, but not limited to, these.” The enumeration of ranges of values ​​herein is intended merely as a simple way to refer individually to each distinct value within the range unless otherwise noted herein, and each distinct value is incorporated herein as if it were individually listed herein. All methods described herein may be carried out in any preferred order unless otherwise noted herein or otherwise clearly contradictory by context. Any and all examples or exemplary language provided herein (e.g., “like”) is intended merely to facilitate a better understanding of the invention and does not limit the scope of the invention unless specifically claimed. Language within the specification should not be construed as indicating any non-claimed element essential to the practice of the invention.

[0126] Preferred embodiments of the present invention are described herein, including the best modes known to the inventors for carrying out the invention. Modifications of these preferred embodiments may become apparent to those skilled in the art by reading the preceding description. The inventors anticipate that those skilled in the art will use such modifications as needed, and the inventors intend to carry out the invention in ways other than those specifically described herein. Accordingly, the invention includes all modifications and equivalents of the subject matter enumerated in the claims appended herein, as permitted by applicable law. Furthermore, any combination of the above elements in all possible modifications is encompassed by the invention unless otherwise specifically noted herein or clearly contradicts the context. [Explanation of symbols]

[0127] 10…Flow cell, 12…Main body, 14…Inlet, 16…Outlet, 18…First tubular connector, 20…Second tubular connector, 22…Receptor, 24…Functional element, 24a…Sensor probe end, 26…Chamber, 28…First opening, 30…Protrusion, 32…Sensor probe support, adapter, 34…Inner surface, 36…Tube end, 38…Tube end, 40…Tube fitting, 42…Tube fitting, 50…Flow cell, 52…Main body, 54…Inlet, 56…Outlet, 58…First tubular connector, 60…Second tubular connector, 62…Receptor, 64…Functional element, pH sensor probe, 64a 116...Sensor probe end, 66...Chamber, 68...First opening, 70...Protrusion, 72...Tubular connector, 74...Plug, 76...Sensor probe support, holder, 78...Tube end, 80...Tube end, 82...Tube fitting, 84...Tube fitting, 100...Flow cell, 102...Body, 104...Inlet, 106...Outlet, 108...First tubular connector, 110...Second tubular connector, 112...Receiving element, 114...Functional element, pressure sensor, 116...Chamber, 118...First opening, 120...Protrusion, 122...Closing element, second opening, 124...Third tubular connector, 126...Tube Tube end, 128...Tube end, 130...Tube end, 132...Pipe fitting, 134...Pipe fitting, 136...Pipe fitting, 150...Piping structure, 160...Flow cell, 162...Conductivity sensor probe, 170...Air filter, 200...Flow cell, 202...Main body, 204...Inlet, 206...Outlet, 208...First tubular connector, 210...Second tubular connector, 212...Receiving container, 214...Functional element, static mixing element, static mixer, 216...Chamber, 218...First opening, 220...Protrusion, 222...Mixing fin, 224...Tube end, 226...Tube end, 2 28...pipe fitting, 230...pipe fitting, 250...flow cell, 252...main body, 254...inlet, 256...outlet, second opening, 258...first tubular connector, 260...second tubular connector, 262...receiver, 264...functional element, static mixer, 266...chamber, 268...first opening, 270...projection, 272...mixing fin, 278...tube end, 280...tube end, 282...pipe fitting, 284...pipe fitting, 300...flow cell, 302...main body, 304...inlet, 306...outlet, 308...first tubular connector, 310...second tubular connector, 312...receiver,314…Functional element, electrical installation element, 316…Chamber, 318…First opening, 320…Protrusion, 322…Tubular connector, 324…Underside of functional element, 326…Plug, 328…Tube end, 330…Tube end, 332…Tube fitting, 334…Tube fitting, 336…Grounding wire, 400…Bulk fill manifold, 402…Cabinet, 404…Skid, 406…Tube, 410…Piping structure, 412…Inlet port, 414…Inlet line, 416…Flow Cell, 418…Pump, 420…Supply line, 422…Filter element, 424…Flow cell, 425…Valve, 426…Liquid detector, 428…Vent / air filter, 430…Connection line, 432…Filter element, 434…Flow cell, 435…Valve, 436…Liquid detector, 438…Vent / air filter, 440…Connection line, 442…Filter element, 444…Flow cell, 445…Valve, 446…Liquid detector, 448…Vent / air filter, 45 0…Filter element outlet, 600…Manifold, 602…Pump head, WFI pump, 604…Pump head, WFI pump, 606a~606f…Buffer solution inlet port, 608…WFI inlet port, 610…Conductivity sensor, 612…Piping structure, 612a~612f…Buffer solution outlet port, 614…Drain outlet port, 616…Piping structure, 618…Buffer solution inlet line, 620…WFI inlet line, 622…Discharge line, 624…Drain Line, 626…Mixing joint, 628…First drain joint, 630…Second drain joint, 632…Second conductivity sensor, 634…Pressure sensor, 636…pH sensor, 638…Health test line, 700…Virus inactivation manifold, 702…Cabinet, 704…Skid, 706…Piping structure, 708…Tube structure, Piping structure, 710…Pump head, 712…Pump head, 714…Pump head, 720…Line, 722…Flow cell,

Claims

1. A piping configuration for use in a fluid management and / or processing system, comprising two or more flow cells, wherein the two or more flow cells comprise at least a first flow cell, a second flow cell, and a third flow cell, and each of the flow cells comprises A body having an inlet, an outlet, and a fluid channel extending from the inlet to the outlet, further comprising a receiver having a chamber forming a portion of the fluid channel of the body, wherein the chamber has a first opening for connecting the functional element to the flow cell such that the functional element is in contact with or exposed to the fluid flow passing through the fluid channel, A first tubular connector is positioned adjacent to the inlet of the main body, A second tubular connector is positioned adjacent to the outlet of the main body, Functional elements and, The device comprises a fluid flow path extending from the first tubular connector to the inlet of the main body, through the main body and the receiver of the main body, to the outlet of the main body, and to the second tubular connector, The first opening is provided with a projection extending away from the main body in order to receive the functional element in a sealed state. The main body, the first tubular connector, and the second tubular connector are formed as a single integrated component. One of the two or more flow cells has a functional element that is different from the functional element of another of the two or more flow cells. The first flow cell is equipped with a conductivity sensor as a functional element, The second flow cell is equipped with a pressure sensor as a functional element. The third flow cell is equipped with a pH sensor as a functional element. The second flow cell is a piping structure positioned between the first flow cell and the third flow cell.

2. The piping structure according to claim 1, wherein the functional element is selected from a static mixer, conductivity sensor, pH sensor, pressure sensor, electrical grounding element, redox sensor, temperature sensor, capacitance sensor, optical sensor, flow sensor, and liquid sample collection element.

3. The piping structure according to claim 1 or 2, wherein the fluid flow path in each of the two or more flow cells has a predetermined cross-sectional area at least within the first tubular connector and the second tubular connector, and along the first tubular connector and the second tubular connector.

4. The piping structure according to claim 3, wherein the volume portion of the chamber of the body of each of the two or more flow cells is designed to have a fluid flow path cross-sectional area greater than or equal to the cross-sectional area of ​​the fluid flow path within and along the first and second tubular connectors.

5. The piping structure according to claim 4, wherein one functional element is a conductivity sensor and another functional element is a pH sensor, and the probe end of one functional element extending into the chamber is positioned such that the distance from the wall portion of the chamber is 12 mm or more, and all dimensions of the chamber perpendicular to the direction in which the sensor having the probe end extends into the chamber are 25 mm or more.

6. The piping structure according to any one of claims 1 to 5, wherein the tubular connector is directly attached to the body of each of the two or more flow cells.

7. The piping structure according to any one of claims 1 to 6, wherein each of the two or more flow cells' bodies and / or tubular connectors are made of metal or plastic material.

8. The piping structure according to any one of claims 1 to 7, wherein the fluid passage of each of the two or more flow cells is linear, or the fluid passage of each of the two or more flow cells is arc-shaped, curved, angled, or T-shaped.

9. The piping structure according to any one of claims 1 to 8, wherein the chamber of each of the two or more flow cells has a second opening facing the first opening.

10. The piping structure according to any one of claims 1 to 9, wherein the chamber of each of the two or more flow cells is hollow and cylindrical in shape.

11. The piping structure according to any one of claims 1 to 10, wherein the projection comprises a circular projection extending away from the main body to receive the functional element.

12. The piping structure according to any one of claims 1 to 11, wherein the first opening of the chamber houses an adapter for positioning one end of the functional element in a predetermined position.

13. The piping configuration according to any one of claims 1 to 12, wherein each of the two or more flow cells is designed for single use and / or for sterilization.

14. A fluid management and / or processing system comprising a piping structure according to any one of claims 1 to 13.

15. A fluid management and / or processing system according to claim 14, forming part of a bioprocessing system, a filtration system, a bulk fill manifold, or a virus inactivation manifold.

16. A piping structure according to any one of claims 1 to 13, comprising an inlet port and an inlet line incorporating one of the two or more flow cells.

17. The piping structure according to claim 16, which includes a pump connected to the inlet line and configured to supply flow from the inlet port to the piping structure.

18. The fluid management and / or processing system according to claim 14 or 15, wherein the piping structure is located within a bulk fill manifold.

Images