METHOD FOR CONTROLLING FUNCTION ELEMENTS AND DEVICE FOR USE IN BIOPROCESS ENGINEERING AND/OR MEDICAL TECHNOLOGY

Abstract

A method for controlling functional elements and a device for use in bioprocess engineering or medical technology is disclosed. The method includes providing a first functional element, which has a memory, in which items of element information having specifications about the type and the function of the functional element are stored, and providing a second functional element. The method includes connecting the first and the second functional element to a control unit, reading the items of element information out of the first functional element and carrying out a check of the read-out items of element information from the second functional element or using items of information which are stored in the control unit. The first functional element is controlled by the control unit in dependence on the check or in dependence on the items of element information.

Claims

1.-15. (canceled)

16. A method for controlling functional elements in bioprocess engineering or medical technology, comprising the steps of: providing a first functional element, which has a memory in which items of element information are stored and the items of element information comprise specifications about the type and the function of the first functional element; providing a second functional element; connecting the first and the second functional element to a control unit; reading the items of element information out of the first functional element; carrying out a check of the read-out items of element information of the first functional element using items of element information which are read out from the second functional element and/or using items of information which are stored in the control unit; controlling at least one of the first and the second functional element in dependence on the check and/or in dependence on the items of element information; and storing items of process information in the memory of the first functional element.

17. The method as claimed in claim 16, wherein the first and/or the second functional element is selected from a group comprising: a sensor; an actuator; or an apparatus component.

18. The method as claimed in claim 16, wherein the second functional element has a memory in which items of element information are stored and the items of element information comprise specifications about the type and the function of the second functional element.

19. The method as claimed in claim 16, further comprising the steps of: providing one or more further functional elements, wherein one or more or all of the further functional elements each has a memory in which items of element information are stored and the items of element information comprise specifications about the type and the function of the respective functional element; reading the items of element information out of the second functional element; and reading the items of element information out of one, multiple, or all of the further functional elements.

20. The method as claimed in claim 19, wherein when carrying out the check, the read-out items of element information of the second, one, multiple, or all further functional elements are taken into consideration.

21. The method as claimed in claim 16, wherein the specifications about the type of the first functional element comprise whether the respective functional element is designed as a sensor, actuator, or apparatus component; or wherein the specifications about the type of the first functional element comprise a serial number of the respective functional element, comprise an article number of the respective functional element, comprise a type specification of the respective functional element, or comprise specifications about the manufacturing of the respective functional element.

22. The method as claimed in claim 16, wherein the specifications about the function of the first functional element further comprises: specifications about operating parameters of the respective functional element; specifications about compatibilities of the respective functional element with other functional elements; specifications about the usability of the respective functional element in various processes; specifications about the calibration of the respective functional element; specifications about the CE identification of the respective functional element; or specifications about the service intervals to be observed and/or the maximum operating duration of the respective functional element.

23. The method as claimed in claim 16, wherein the items of information which are stored in the control unit comprise: specifications about compatibilities of functional elements; specifications about the usability of functional elements in various processes; specifications about processes to be carried out, such as type and/or duration of the respective process; or specifications of the process parameters to be used in a process.

24. The method as claimed in claim 16, wherein the items of process information further comprise: specifications about a process which was carried out, such as type and/or duration of the process; specifications of the process parameters used in a process; specifications of the operating parameters, using which the respective functional element and/or further functional elements were operated in a process; specifications about further functional elements used together with the respective functional element, in particular the items of element information thereof or parts thereof; or specifications about process results and/or process errors.

25. The method as claimed in claim 19, wherein carrying out the check further comprises the steps of: comparing the compatibilities of functional elements with respect to the joint use thereof, the usability thereof in a planned process, or the usability thereof in a planned process environment; configuring the first, the second, one, or multiple of the further functional elements or a process to be carried out in dependence on the check; storing items of process information in the memory of the control unit; storing items of process information in a memory of an evaluation unit; storing items of service information in the memory of the first and/or the second and/or a further functional element; storing items of customer information in the memory of the first and/or the second and/or a further functional element; or storing items of element information.

26. The method as claimed in claim 16, wherein the memory of the first, the second, or a further functional element is a digital nonvolatile memory, in particular an EEPROM; wherein the memory of the first, the second, or the further functional element is made fluid-tight; wherein the memory of the first, the second, or the further functional element can be sterilized by autoclaved or radiation-sterilized, including beta-sterilized and/or gamma-sterilized; or wherein the memory of the first, the second, and/or the further functional element has a temperature resistance of at least 100 degrees Celsius

27. The method as claimed in claim 26, wherein the memory of the first, the second, and/or the further functional element has a temperature resistance of at least 110 degrees Celsius,

28. The method as claimed in claim 27, wherein the memory of the first, the second, and/or the further functional element has a temperature resistance of at least 120 degrees Celsius.

29. The method as claimed in claim 28, wherein the memory of the first, the second, and/or the further functional element has a temperature resistance of at least 130 degrees Celsius.

30. The method as claimed in claim 29, wherein the memory of the first, the second, and/or the further functional element has a temperature resistance of at least 150 degrees Celsius.

31. The use of the method as claimed in claim 16 in bioprocess engineering or medical technology.

32. A device for use in bioprocess engineering or medical technology, comprising: a first functional element, which has a memory in which items of element information are stored and the items of element information comprise items of information about the type and the function of the first functional element; a second functional element; and a control unit; wherein the control unit is designed to read the items of element information out of the first functional element and to carry out a check of the read-out items of element information of the first functional element using items of element information which are read out from the second functional element and/or using items of information which are stored in the control unit; wherein the control unit is designed to control at least one of the first and the second functional element in dependence on the check and/or in dependence on the items of element information; and wherein the control unit is designed to store items of process information in the memory of the first functional element.

33. The use of a device as claimed in claim 32 in bioprocess engineering or medical technology.

34. The method as claimed in claim 16, wherein the functional element has a memory in which items of element information are stored and the items of element information comprise items of information about the type and the function of the first functional element, wherein the functional element is designed to be controlled by the control unit, and wherein the memory is designed to be read out by the control unit or an evaluation unit, and wherein the memory is designed so that items of process information are storable in the memory by the control unit or an evaluation unit.

35. A functional element for a device for use in bioprocess engineering or medical technology as claimed in claim 32, wherein the functional element has a memory in which items of element information are stored and the items of element information comprise items of information about the type and the function of the first functional element, wherein the functional element is designed to be controlled by the control unit, and wherein the memory is designed to be read out by the control unit or an evaluation unit, and wherein the memory is designed so that items of process information are storable in the memory by the control unit or an evaluation unit.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0070] Preferred exemplary embodiments are described by way of example on the basis of the appended Figures. In the Figures:

[0071] FIG. 1 shows a schematic illustration of a flow chart of an example of a method for controlling functional elements in bioprocess engineering and/or medical technology;

[0072] FIG. 2 shows a schematic illustration of an example of a device for use in bioprocess engineering and/or medical technology;

[0073] FIG. 3 shows a schematic illustration of an example of items of element information and items of process information in the memory of a functional element; and

[0074] FIG. 4 shows a schematic illustration of an example of items of information stored in a control unit.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0075] In the Figures, identical or essentially functionally identical elements are provided with the same reference signs. General descriptions generally refer to all embodiments if differences are not explicitly indicated.

[0076] FIG. 1 shows a schematic illustration of a flow chart of an example of a method 1000 for controlling functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340 in bioprocess engineering and/or medical technology. FIG. 2 schematically shows an example of a device for use in bioprocess engineering or medical technology, in the form of the bioreactor 1 here. FIGS. 3 and 4 show examples of items of element information 700 and items of process information 900 in the memory 701 of a functional element (FIG. 3) and an example of items of information 800 stored in a control unit 100 (FIG. 4).

[0077] The method 1000 and its steps are explained hereinafter on the basis of the example shown in FIG. 2 of a device for use in bioprocess engineering and/or medical technology, in the form of a bioreactor 1 here. The method and the device are not restricted to the examples and combinations of features shown here, however.

[0078] The bioreactor 1 shown by way of example in FIG. 2 is connected to a control unit 100 and to an evaluation unit 101. The connection between the bioreactor 1 and the evaluation unit 101 can take place directly or indirectly via the control unit 100, and furthermore the connection between the bioreactor 1 and control unit 100 and the evaluation unit 101 can take place in a wired or wireless manner.

[0079] The bioreactor 1 has multiple functional elements, specifically sensors, actuators, and apparatus components.

[0080] As apparatus components, the bioreactor 1 has a bioreactor vessel 310 and a head plate 320 and an exhaust hose 330 and a gassing hose 340.

[0081] As actuators, the bioreactor 1 has a stirrer 210 and a stirring drive 220 and furthermore a temperature control unit 230 and a heating sleeve 260 for the exhaust hose 330. Further actuators are a gassing probe 250 and a degassing pipe 240.

[0082] The bioreactor 1 moreover has a temperature sensor 110 and a pH sensor 120, which can be connected via lines 112, 122 to further components, for example, to the control unit 100 and/or the evaluation unit 101.

[0083] The exhaust hose 330 and/or the gassing hose 340 can preferably also be connected to media reservoirs (not shown here) or further components. The stirring drive 220 is preferably connected to an energy source (not shown).

[0084] In the example shown in FIG. 2, all functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340 each have a memory, which is illustrated in more detail hereinafter. However, embodiments are also possible in which only one functional element, two functional elements, or multiple functional elements each have a memory.

[0085] For example, the stirrer 210 has a memory 211, the stirring drive 220 has a memory 221. The bioreactor vessel 310 has a memory 311 and the head plate 320 has a memory 321. The temperature control unit 230 has a memory 231. The boundary probe 250 has a memory 251 and the gassing hose 340 connected to the gassing probe 250 has a memory 341. The degassing pipe 240 has a memory 241 and the exhaust hose 330 connected to the degassing pipe 240 has a memory 331. The heating sleeve 260 for the exhaust hose 230 has a memory 261. The two sensors 110, 120 each have a memory 111, 121. Each of the memories 111, 121, 211, 221, 231, 241, 251, 261, 311, 321, 331, 341 of the functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340 can be constructed like the memory 701 shown in FIG. 3 or similarly.

[0086] In the example shown in FIG. 1 of the method 1000 for controlling functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340 in bioprocess engineering and/or medical technology, in step 1001a, firstly a first functional element, here in the form of the bioreactor vessel 310, for example, is provided and in step 1001b a second functional element, here, for example, in the form of the stirrer 210, is provided and in step 1001c, the further fraction elements, for example, in the form of the further functional elements 110, 120, 220, 230, 240, 250, 260, 320, 330, 340 mentioned by way of example with reference to FIG. 2, are provided.

[0087] In step 1002, the functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340 are connected to the control unit 1000, preferably in a wired or wireless manner.

[0088] In step 1003a, items of element information 700 are read out from the memory 311 of the first functional element in the form of the bioreactor vessel 310. In step 1003b, items of element information are read out from the memory 211 of the second functional element in the form of the stirrer 210. In step 1003c, the further items of element information are read out from the memories 111, 121, 221, 231, 241, 251, 261, 321, 331, 341 of the further functional elements 110, 120, 220, 230, 240, 250, 260, 320, 330, 340.

[0089] In step 1004, a check is carried out of the read-out items of element information 700 from the various functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340 or the memories 111, 121, 211, 221, 231, 241, 251, 261, 311, 321, 331, 341 thereof and/or using items of information 800 which are stored in the control unit 100.

[0090] In step 1005 one or more of the functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340 and/or a process to be carried out are preferably configured in dependence on the check carried out in step 1004.

[0091] In step 1006, the functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340 are then controlled, in particular, by means of the control unit 100, in dependence on the check carried out in step 1004 and/or in dependence on the elementary functions 700.

[0092] In steps 1007a, 1007b, 1007c, items of process information 900 are then stored in the memory 111, 121, 211, 221, 231, 241, 251, 261, 311, 321, 331, 341 of the functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340.

[0093] In step 1008a, items of process information 900 are then preferably also stored in the memory of the control unit 100 and/or in step 1008b, items of process information 900 are stored in a memory of the evaluation unit 101.

[0094] In step 1008c, items of service information 780 and/or items of customer information 790 are preferably stored in the memory 111, 121, 211, 221, 231, 241, 251, 261, 311, 321, 331, 341 of one or more functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340.

[0095] The memory 701, shown, by way of example, in FIG. 3, contains items of element information 700, items of process information 900, items of service information 780, and items of customer information 790. Preferably, one, two, multiple, or all of the memories 111, 121, 211, 221, 231, 241, 251, 261, 311, 321, 331, 341 of the functional elements 110, 120, 210, 220, 230, 240, 250, 260, 310, 320, 330, 340 can be designed like the memory 701 shown, by way of example, in FIG. 3.

[0096] The items of element information 700 preferably comprise specifications 710 about the type of the functional element and/or specifications 720 about option of the functional element. The specifications 710 about the type of the functional element can comprise, for example, a serial number 711, an article number 712, or a type specification 713. The specifications 720 about the function of the functional element can comprise, for example, specifications 721 about the operating parameters, specifications 722 about compatibilities, specifications 723 about the usability of the respective functional element in various processes, specifications 724 about the calibration of the respective functional element, specifications 721 about the CE identification of considered functional element, specifications 700 sixth 20 about service intervals to be maintained and/or maximum operating duration of the functional element.

[0097] The items of process information 900 can preferably include specifications 910 about a process carried out, specifications 920 of process parameters used in a process, specifications 930 of the operating parameters using which functional element was operated in a process, and/or specifications 940 about further functional elements used together with the functional element and/or specifications 950 about process results and/or process errors.

[0098] Furthermore, items of service information 780 and/or items of customer information 790 can be stored in the memory 701.

[0099] The items of information 800 stored in a memory of the control unit 100 can comprise, for example, specifications 810 about compatibilities of functional elements, specifications 820 about the usability of functional elements in various processes, specifications 830 about processes to be carried out, and/or specifications 840 of the process parameters to be used in a process.

[0100] Preferably, the items of element information 700, the items of process information 900, the items of service information 780, and/or the items of information 790 below in a memory 701 of a functional element can each only be supplemented and/or changed by an authority authorized for this purpose. For example, the authorization for supplementing and/or changing items of service information 780 can be restricted to service personnel authorized for this purpose. Items of customer information 790, in contrast, can also be changed or supplemented by customers, for example. Items of element information 700, for example, can preferably only be supplemented and/or changed by the manufacturer or by authorities authorized by him or her.

[0101] Using the solution described here, it is possible advantageously and efficiently, among other things, to increase the process reliability and facilitate maintaining quality guidelines such as GMP and to create documentation required for this purpose more easily.