CONFIGURABLE DEVICE FOR THE FLEXIBLE PROVISION OF COMPOUNDS AND/OR FUNCTIONS IN A BIOPHARMACEUTICAL PROCESS

Abstract

A configurable device (10) for the flexible provision of connections and/or functions in a biopharmaceutical process comprises a body (20) in which predefined pipe sections (22) and plug-in locations (24) are formed by recesses in the material of the body (20). The configurable device (10) further comprises a plurality of functional elements (26) which are adapted to be inserted into the plug-in locations (24).

Claims

1. A configurable device for flexible provision of connections and/or functions in a biopharmaceutical process, comprising a body in which predefined pipe sections and plug-in locations are formed by recesses in material of the body, and comprising a plurality of functional elements which are adapted to be inserted into the plug-in locations.

2. The configurable device according to claim 1, characterized by a functional element which establishes a connection between two or more pipe sections adjacent to a plug-in location.

3. The configurable device according to claim 2, characterized in that the functional element includes at least one straight duct.

4. The configurable device according to claim 2, characterized in that the functional element includes at least one curved or bent duct.

5. The configurable device according to claim 2, characterized in that the functional element provides at least one pipe branching.

6. The configurable device according to claim 1, characterized by a functional element which blocks a connection between two or more pipe sections adjacent to a plug-in location.

7. The configurable device according to claim 1, characterized by a functional element which includes a valve.

8. The configurable device according to claim 1, characterized by a functional element which includes a sensor for detecting a process parameter.

9. The configurable device according to claim 8, characterized in that the sensor of the functional element is arranged in a main flow path and comes into direct contact with medium flowing through.

10. The configurable device according to claim 1, characterized by a functional element which includes a pump or parts of a pump.

11. The configurable device according to claim 1, characterized by a functional element which includes a filter means, a chromatographic separator, a membrane adsorber or parts thereof.

12. The configurable device according to claim 1, characterized in that the body has connections formed thereon which open into pipe sections in the interior of the body.

13. The configurable device according to claim 1, characterized in that the plug-in locations are accessible via insertion openings (36) on the surface of the body (20).

14. The configurable device according to claim 13, characterized in that at least some of the insertion openings are formed in a top surface of the body.

15. The configurable device according to claim 13, characterized in that the insertion openings and the plug-in locations are substantially equally shaped and dimensioned.

16. The configurable device according to claim 15, characterized in that with regard to their cross-sectional shapes and dimensions the functional elements are adapted to the insertion openings and the plug-in locations such that each functional element can be inserted into any plug-in location.

17. The configurable device according to claim 1, characterized in that pipe sections are arranged at different levels in the body.

18. The configurable device according to claim 17, characterized by at least one functional element that includes at least a first functional section and a second functional section, the first functional section cooperating with pipe sections of a first level and the second functional section cooperating with pipe sections of a second level.

19. The configurable device according to claim 18, characterized in that the functional sections each provide the same function.

20. The configurable device according to claim 18, characterized in that the functional sections provide different functions.

21. The configurable device according to claim 1, characterized in that a positioning means is provided which allows a functional element to be fully inserted only in one predefined orientation.

22. The configurable device according to claim 1, characterized in that the functional elements have an electronic display or a permanent labeling or a symbol on the upper side.

23. The configurable device according to claim 1, characterized in that the pipe sections have a defined diameter.

24. The configurable device according to claim 1, characterized in that the body is formed of a sterilizable plastic material.

25. The configurable device according to claim 1, characterized in that the functional elements are sterilizable.

Description

[0030] Further features and advantages of the invention will be apparent from the following description and from the accompanying drawings, to which reference is made and in which:

[0031] FIG. 1 shows a schematic view of a configurable device according to the invention in a process environment;

[0032] FIG. 2 shows a perspective view of another embodiment of a device according to the invention with functional elements inserted;

[0033] FIG. 3 shows a top view of the device from FIG. 2;

[0034] FIG. 4 shows a sectional view along the section line A-A from FIG. 3;

[0035] FIG. 5 shows a perspective transparent view of a first functional element for use in the device according to the invention;

[0036] FIG. 6 shows a perspective transparent view of a second functional element;

[0037] FIG. 7 shows a perspective transparent view of a third functional element;

[0038] FIG. 8 shows a perspective transparent view of a fourth functional element;

[0039] FIG. 9 shows a perspective transparent view of a fifth functional element; and

[0040] FIG. 10 shows a perspective transparent view of a sixth functional element.

[0041] FIG. 1 illustrates, by way of example, a configurable disposable device 10 for a flexible provision of connections and functions in a biopharmaceutical process environment. The process environment here includes a pump 12, a filtration device with a filter capsule 14, a standard disposable container 16, and a standard disposable container with a mixing unit 18.

[0042] The configurable device 10 is used, for one thing, to provide the fluidic connections, required for the process to be carried out, between the components of the process environment such that the components only need to be connected to given connections of the device 10 in a simple manner using simple hose lines. For another thing, the configurable device 10 itself provides specific process functions.

[0043] The structure and the mode of operation of the configurable device 10 will be discussed below on the basis of an exemplary embodiment which should in no way be understood in a limiting sense and which is shown in FIGS. 2, 3 and 4.

[0044] The device 10 essentially consists of a preferably solid plastic body 20, in which a plurality of permanently predefined pipe sections 22 and plug-in locations 24 for insertable functional elements 26 are formed. The pipe sections 22 and the plug-in locations 24 are essentially formed by recesses in the material of the body 20.

[0045] The body 20 here has a cubic basic shape with a top surface 28, a bottom surface 30 and side surfaces 32. The side surfaces 32 have a plurality of connections 34 formed thereon, which open into pipe sections 22 in the interior of the body 20. As is apparent from FIGS. 2, 3 and 4, the connections 34 and the pipe sections 22 are arranged in two levels.

[0046] The plug-in locations 24 of the configurable device 10 are accessible via insertion openings 36 in the top surface 28 of the body 20. A functional element 26 can be inserted into each plug-in location 24. Basically, however, it is also possible to leave plug-in locations 24 free. The insertion openings 36 for the plug-in locations 24 are preferably all of the same shape and dimensions. Different types of functional elements 26 are provided, which, however, are preferably all adapted to the insertion openings 36 and the plug-in locations with regard to their cross-sectional shapes and dimensions such that each functional element 26 can basically be introduced into any of the insertion openings 36 and received in the associated plug-in location 24.

[0047] In its simplest form, a functional element 26, when in its inserted state, can block the connection between two or more pipe sections 22 adjacent to the plug-in location 24. An example of such a functional element 26 in the form of a plug is shown in FIG. 5. Seals make sure that the plug-in location 24 is sealed off from the pipe sections 22 that open into it, the seals being in the form of two O-rings 38 here which, in the inserted state of the plug, are arranged above and below the pipe sections 22.

[0048] FIG. 6 shows a different functional element 26, which can be used to establish a fluid communication between two opposite pipe sections 22 in the same level (2 ways). To this end, a straight duct 40 is formed between the O-rings 38 in the functional element 26.

[0049] A positioning means here provides for a correct orientation of the duct 40 when the functional element 26 is in its inserted stateas is also the case with other functional elements 26 for which a correct orientation is required for providing the function. This positioning means may take the form of an oblong web 42 on the lower side of the functional element 26, as shown here as an example. The web 42 is matched with a corresponding groove of the plug-in locations 24 in the nature of a tongue-and-groove connection, so that in the correct installation state, an anti-rotation device for the functional element 26 is formed in the plug-in location 24. However, other positioning means are also possible.

[0050] A further example of a functional element 26 is shown in FIG. 7. Here, a pipe branching in the form of two intersecting ducts 40 is formed (4 ways).

[0051] The functional elements 26 shown in FIGS. 5 to 7 are dimensioned such that when in the inserted state, they cooperate with the pipe sections 22 of the upper level.

[0052] FIGS. 8 to 9 show functional elements 26 which each fulfill two functions. In the inserted state, a first functional section 44 cooperates with the pipe sections 22 of the upper level and a second functional section 46 cooperates with the pipe sections 22 of the lower level. The functional element 26 of FIG. 8 has a duct 40 with a branch connection 48 (3 ways) in both functional sections 44, 46. The functional element 26 shown in FIG. 9 has a curved duct 40 (bend) in both functional sections 44, 46. The functional element 26 of FIG. 10 has a pipe branching in the form of two intersecting ducts 40 (4 ways) in both functional sections 44, 46.

[0053] A functional element 26 may basically include one, two or even more than two functional sections 44, 46. It is also possible for the functional sections 44, 46 of a functional element 26 to have different functions realized therein. The functions are also not limited to the blocking or connecting of pipe sections 22 in the body 20. Rather, the functional elements 26 may contain, for example, a valve (switching or proportional valve) and/or a sensor for sensing temperature, pressure, pH value, flow, conductivity, viscosity and/or other process-relevant parameters. Pumps, filter devices and other hardware components provided for carrying out the process can also basically be realized. A functional element 26 may also contain only part of a hardware component, for example specific parts of a pump or of a valve, which are designed for single use and are sterilizable. In this case, the other part of the functional component, for example a drive, is located outside the device 10 and is connected in a suitable manner (electrically, mechanically, hydraulically, pneumatically, . . . ) to the part received in the functional element 26. For this purpose, appropriate lines are provided, which are led through on the upper side of the functional element 26. Such lines, in particular signal and/or control lines, may also be provided if the functional element 26 is connected to another component of the process setup outside the body 20.

[0054] On their upper sides, the functional elements 26 each carry an electronic display 50 or permanent letterings and/or symbols that provide information on the functions implemented in the functional sections 44, 46.

[0055] The body 20 of the configurable device 10 may, of course, include less or more than two levels with connections 34 and pipe sections 22. The connections 34, pipe branches 22 and plug-in locations 24 need not necessarily be arranged in defined levels either. Furthermore, provision may be made that the insertion openings 36 for the functional elements 26 are provided on different surfaces of the body 20, so that the functional elements 26 are inserted into the body 20 in different directions.

[0056] Owing to the selectable equipping with functional elements 26, the device 10 can be used to implement different process setups with individually configurable flow paths and components, with the functional elements 26, in particular the sensors, as in-line components, intentionally coming into direct contact with the fluid flowing through the pipe sections 22.

[0057] The pipe sections 22 in the body 20 have a predetermined, defined diameter and are sturdy enough to reliably withstand a predefined maximum pressure. This maximum pressure is primarily determined by the diameter of the pipe sections 22 and the thickness of the material surrounding them.

[0058] The body 20 of the configurable device 10 is made from a sterilizable plastic material, for example using an injection molding method or with the aid of a 3D printer. The body 20 may be provided as a one-piece block or assembled from a plurality of individual parts, in particular by adhesive bonding or ultrasonic welding.

[0059] The body 10 with the connections 34 and the pipe branches 22 as well as the functional elements 26 can be sterilized both individually and as a ready-configured device 10 with functional elements 26 already inserted, if appropriate even in a packaged state, so that the entire configured device 10 can be delivered to the customer ready for connection and operation. But it is also possible for the customer to equip the body 20 with the functional elements 26, in which case the sterilization can take place before or after the equipping process. If applicable, the customer may also produce the body 20 himself/herself in accordance with the manufacturer's specifications.

LIST OF REFERENCE NUMBERS

[0060] 10 configurable device [0061] 12 pump [0062] 14 filter capsule [0063] 16 disposable container [0064] 18 disposable container with mixing unit [0065] 20 body [0066] 22 pipe section [0067] 24 plug-in location [0068] 26 functional element [0069] 28 top surface [0070] 30 bottom surface [0071] 32 side surface [0072] 34 connection [0073] 36 insertion opening [0074] 38 O-ring [0075] 40 duct [0076] 42 web [0077] 44 first functional section [0078] 46 second functional section [0079] 48 branch connection [0080] 50 display