DE202018104472U1 - Device arrangement for providing a medium used in the production of a biopharmaceutical product - Google Patents

Abstract

Device arrangement (10) for providing a medium used in the production of a biopharmaceutical product, in particular a nutrient medium or a buffer or a feed solution, with a container (12) or line system (20) in which the medium is produced in a manufacturing process, a first measuring device (14) for measuring at least one characteristic for the medium multivariate parameter during the manufacturing process; and an evaluation and control device (18) connected to the first measuring device (14) and arranged to check the identity of the medium using the measurement of the multivariate parameter during the manufacturing process and to output information depending on the result of the verification during the manufacturing process and / or to influence the manufacturing process.

Description

The invention relates to a device arrangement for providing a medium used in the context of a production of a biopharmaceutical product, in particular a nutrient medium or a buffer or a feed solution.

In the production of a biopharmaceutical product based on the cultivation of microorganisms or parts of such organisms, such as certain cells or tissues of animals, especially mammals, and plants, various media are typically used: a nutrient medium is used to aid growth and / or multiplication and contains all the nutrients that are necessary for the metabolism of the cells. During the culture, a feed solution containing important nutrients, vitamins, amino acids or trace elements can be "fed". A buffer, ie a substance mixture for pH stabilization, is needed as a basis for nutrient media and for various tasks in downstream processing, d. H. for process steps for the separation and purification of cell cultivation products in order to ensure or increase the purity of the end products.

One particularly important piece of information for the correct production of such media, especially in the context of "Good Manufacturing Practice" (GMP), is the use of raw materials or intermediates having correct, desired properties and quality attributes. For example, the composition of the medium used for cell culture is of crucial importance for the process and product quality of the cultivation. The production of cell culture media, in particular on a production scale (large volume), is nowadays usually carried out by dissolving or mixing a concentrate (solid mixture, usually in powder form, or stock solution) in ultrapure water (English: Water for Injection, abbreviation: WFI) , Directly before the start of the culture, further additives, in particular unstable constituents, such as glutamine, are optionally added.

Normally, in the medium production in a batch process (English: batch mode), the high-purity water in a container, eg. B. in a reusable stainless steel tank or in a disposable plastic bag, presented before the concentrate is added and mixed via an access. Typical components of the concentrate for a nutrient medium are vitamins, amino acids, trace elements, salts, lipids, nutrients or other ingredients such as insulin. The number of different components often varies in the range of several dozen to 100. For animal cell cultures usually chemically defined components, so no complex components such as yeast extract, whey powder, etc. are used.

In order to achieve the desired concentration and the desired quality of the medium, usually the pH and / or the electrical conductivity of the mixture in the container is determined with known recipe and the desired target value by adding water, concentrate and / or liquid acid or alkali set. For this purpose, corresponding sensors are provided on the container.

The preparation of the medium, in particular for large reactors, but can also be done in a continuous or quasi-continuous process. With such a manufacturing process, the medium should be made available continuously and "on demand". In this case, a so-called "in-line" mixture is provided for the production by means of a mixing tool integrated in a line system. The sensor system, in particular for pH, conductivity or flow determination, is then also integrated downstream in the line system. Alternatively or additionally, a measurement "on-line", ie in a bypass path, possible.

In any case, it is assumed that the correct weight or volume of the concentrate as well as the correct adjustment of the pH value and / or the conductivity value will also ensure the correct quality of the medium. However, it is possible that individual components vary within the concentrate. For example, it is known from the experience that powder-based concentrates generally have greatly varying levels of ingredients. Fluctuations in the composition may also be due to media components with low durability. In these cases, it is not ensured that setting the desired pH or conductivity value also achieves the desired quality of the medium, since different mixture compositions can give the same pH and conductivity value. It is therefore possible that the actual quality of the medium deviates significantly from the target quality and leads to a qualitatively and / or quantitatively unsatisfactory product or process.

In contrast to a batch process, in a continuous or quasi-continuous process management no additional release analysis can take place by sampling and examination. But even in the case of a batch process, the repeated removal of a sample from a storage container and its investigation by means of suitable methods is very cumbersome and time-consuming.

The problems outlined above apply equally to the production of buffers and feed solutions.

The object of the invention is to provide a possibility to make the process of providing a medium used in the context of a cultivation, in particular a nutrient medium or a buffer or a feed solution, lower risk and qualitatively secure.

This object is achieved by a device arrangement having the features of claim 1. Advantageous and expedient embodiments of the device arrangement according to the invention are specified in the subclaims.

• - Herstellen des Mediums aus mehreren Bestandteilen, insbesondere durch Mischen der Bestandteile, in einem Herstellungsprozess;
• - Messen wenigstens eines für das Medium charakteristischen multivariaten Parameters während des Herstellungsprozesses;
• - Überprüfen der Identität des Mediums unter Heranziehen der Messung des multivariaten Parameters während des Herstellungsprozesses; und
• - Ausgeben von Informationen und/oder Beeinflussen des Herstellungsprozesses in Abhängigkeit vom Ergebnis der Überprüfung der Identität des Mediums während des Herstellungsprozesses.

In the context of the invention, a method is disclosed for providing a medium used in the context of a production of a biopharmaceutical product, in particular a nutrient medium or a buffer or a feed solution. This deployment process involves the following steps:

• - Producing the medium of several components, in particular by mixing the components, in a manufacturing process;
• Measuring at least one multivariate parameter characteristic of the medium during the manufacturing process;
• - checking the identity of the medium using the measurement of the multivariate parameter during the manufacturing process; and
• - Output of information and / or influencing the manufacturing process depending on the result of the verification of the identity of the medium during the manufacturing process.

This delivery method is based on the understanding that the risk of providing a medium that does not meet the specified quality requirements can be minimized if the review of the medium during the manufacturing process is fundamentally expanded, so that a clear statement about the quality is possible. This is achieved by examining the medium based on the measurement of a multivariate parameter. By a multivariate parameter is meant here abstractly a parameter which, unlike a univariate parameter, depends on several variables, this plurality of variables being measured simultaneously, i. H. in the same measuring process.

An example of a multivariate parameter in the sense of the invention is a spectrum measured by a spectrometer, i. H. spectroscopic data, which together form a complex data type. An absorption or emission spectrum of the medium under investigation depends on its composition, ie on the individual components of the medium and thus on several variables.

The measurement and evaluation of such a multivariate parameter allows the desired identity verification, since the multivariate parameter provides a sufficiently clear "fingerprint" of the medium, which then z. B. can be compared with reference data. Successful identity verification ensures that the medium under investigation has the desired quality.

It should be emphasized that the verification of the identity during the production of the medium - within the meaning of the invention, this is to be understood as a preparation of the medium or the like - is performed. This makes it possible, if necessary, to intervene in the manufacturing process in a corrective manner. This eliminates the expense of subsequent sampling and their investigation. In addition, the provision process ensures that no large quantities of the medium need to be disposed of, unless it is subsequently determined that the medium produced does not meet the quality requirements.

According to a first variant of the provisioning method, the multivariate parameter is measured in situ in a container filled with the medium by means of a measuring device coupled to the container. This first variant of the method is suitable for the case in which the production process is a batch process, ie when a defined amount of substance is produced (batch production). The multivariate parameter is then measured exactly where the medium is mixed together during production (in situ).

According to an alternative second variant of the provisioning method, the multivariate parameter in a line system is measured in-line by means of a measuring device integrated into the line system. This second process variant is suitable for the case that the manufacturing process is a continuous or quasi-continuous process. The multivariate parameter is then measured in the main flow path of the manufacturing process (in-line). Alternatively or additionally, a measurement in a bypass path is possible (on-line).

Thus, in both variants of the method an immediate verification of the identity of the medium is made possible without a sample being taken out of the system and outside of the system Production process must be investigated. The review is much more integrated into the manufacturing process.

As already indicated, a spectroscopic measuring method, in particular a molecular-spectroscopic measuring method, which supplies a spectrum from which so much information about the medium can be found out, that gives sufficient selectivity and is unique, is particularly suitable for the determination of a multivariate parameter Quality assessment is possible.

• - Ramanspektroskopie;
• - Mittelinfrarotspektroskopie (MIR);
• - Nahinfrarotspektroskopie (NIR);
• - UV-Absorptionsspektroskopie;
• - Fluoreszenzspektroskopie;
• - Streuspektroskopie.

Preferred is a spectroscopic measurement method based on at least one of the following spectroscopy techniques:

• Raman spectroscopy;
• - mid-infrared spectroscopy (MIR);
• Near-infrared spectroscopy (NIR);
• - UV absorption spectroscopy;
• - fluorescence spectroscopy;
• - Scattering spectroscopy.

An ongoing, d. H. Repeated measurement of the multivariate parameter during the manufacturing process is advantageous in order to observe the quality of the medium not only at specific points but over a longer period of time. This can either ensure that the quality of the medium does not change unnoticed during production, or it can be determined during the manufacturing process, if and where appropriate. when a desired quality of the medium has been achieved.

Preferably, the measurement data of the multivariate parameter are acquired and processed in real time. As a result, delays in the ongoing manufacturing process can be avoided, since it can be intervened immediately in the manufacturing process if necessary. In addition, the rejects during medium production can be reduced to a minimum, which is of particular importance given the economic value of the medium.

Depending on the nature of the multivariate parameter and the chosen measurement technique, checking the identity of the medium can take place in different ways. In general, it makes sense to perform a comparison of the measured multivariate parameter with comparison data related to the multivariate parameter, which are stored in a database. The comparison data may in particular be reference data, e.g. B theoretical ideal values or limits of permissible value ranges or the like

According to a special and particularly effective evaluation technique in the context of identity verification, the measured data of a recorded spectrum are compared with scores of at least one target spectrum from the database using a predetermined metric in the scorer space.

The provisioning procedure provides that, depending on the result of the verification of the identity of the medium, the manufacturing process is influenced. This can be done by controlling at least one connected process component, in particular by outputting corresponding control signals to the process component. So can automatically, d. H. Intervene in the manufacturing process without operator interaction, controlling or regulating.

Provisioning method can be supplemented by additionally measuring at least one univariate parameter during the manufacturing process and including the measured value in the verification of the identity. This measure can further increase the safety of the manufacturing process, since the identity check is extended by an additional criterion.

• - pH-Wert;
• - elektrische Leitfähigkeit;
• - Temperatur
• - Trübung;
• - Farbe;
• - Kapazität;
• - Fluss.

The additional univariate parameter is preferably one of the following values that can be measured reliably in a proven manner:

• - PH value;
• - electric conductivity;
• - temperature
• - turbidity;
• - Colour;
• - capacity;
• - River.

Alternatively or additionally, to minimize the risk, at least one further multivariate parameter may also be measured during the production process and the measured value included in the verification of the identity.

The invention provides a device arrangement for providing a medium used in the context of a production of a biopharmaceutical product, in particular a nutrient medium or a buffer or a feed solution. The device arrangement according to the invention is set up in particular for carrying out the provisioning method described above.

The device arrangement according to the invention comprises a container or a conduit system in which the medium is produced in a manufacturing process, and a first Measuring device for measuring at least one characteristic for the medium multivariate parameter during the manufacturing process. The device arrangement further comprises an evaluation and control device connected to the first measuring device, which is set up to check the identity of the medium using the measurement of the multivariate parameter during the production process and to output information depending on the result of the verification during the production process and / / or to influence the manufacturing process.

Depending on whether a batch process or a (quasi) continuous production process is to be carried out with the device arrangement according to the invention, either a first embodiment is advantageous in which the first measuring device is coupled to the container, or a second embodiment in which the first measuring device is integrated into the line system.

The trends of recent years in the biopharmaceutical industry, for various reasons that will not be discussed here, are increasingly in the direction of using single-use components. These are now used even in the commercial "Good Manufacturing Practice" (English: Good Manufacturing Practice, abbr .: GMP) in the production of pharmaceuticals. In this context, a device arrangement is desirable in which as many disposable components are used.

In particular, the container or the line system are preferably disposable components or essentially formed of disposable components.

The first measuring device may also comprise disposable components. In the case of a device arrangement designed for a batch process, these are those components which are mounted directly on the container or arranged in the container. In the case of a device arrangement which is designed for a (quasi-) continuous production process, these are those components which come into direct contact with the medium flowing through in the line system.

In view of the particular suitability of measured spectra as multivariate parameters, the first measuring device preferably comprises a spectroscopic measuring system, in particular a molecular-spectroscopic measuring system. Such a measuring system can be coupled via an optical access to the container or the pipe system. The optical access can be designed as an optical window on the container or in the form of a transparent flow cell in the line system of the device arrangement.

In order to allow a continuous monitoring of the quality of the produced medium, the first measuring device is set up for the continuous measurement of the multivariate parameter.

Particularly advantageous is an evaluation and control device which is set up so that it can record and process the measurement data of the first measuring device in real time. This allows a quick and targeted intervention in the manufacturing process before a larger amount of rejects is produced.

The evaluation and control device preferably has access to a database in which comparison data relating to the multivariate parameter are stored, so that the identity check can be carried out with uniform, comprehensible criteria.

According to a preferred embodiment of the device arrangement according to the invention, the evaluation and control device is connected to at least one process component used in the manufacturing process. In order to permit automatic intervention in the production process, if necessary, the evaluation and control device for controlling the process component is set up as a function of the result of checking the identity of the medium, in particular by outputting corresponding control signals to the process component.

The evaluation and control device of the device arrangement according to the invention can be part of a process control entity, in particular a SCADA system, or comprise such a process control entity, depending on the viewpoint.

An even more reliable identity check can be achieved with an embodiment of the device arrangement according to the invention in which at least one second measuring device for measuring a univariate parameter characteristic of the medium is coupled to the container or the line system.

• - pH-Wert;
• - elektrische Leitfähigkeit;
• - Temperatur;
• - Trübung;
• - Farbe;
• - Kapazität;
• - Fluss.

The second measuring device is set up in particular for measuring one of the following variables:

• - PH value;
• - electric conductivity;
• - temperature;
• - turbidity;
• - Colour;
• - capacity;
• - River.

Alternatively or additionally, at least one further first measuring device for measuring a further multivariate parameter characteristic of the medium can also be coupled to the container or the line system.

• - 1 eine schematische Darstellung einer ersten Ausführungsform einer erfindungsgemäßen Vorrichtung zur Bereitstellung eines im Rahmen einer Kultivierung eingesetzten Mediums;
• - 2 eine schematische Darstellung einer zweiten Ausführungsform der erfindungsgemäßen Vorrichtung; und
• - 3a, 3b, 3c ein beispielhaftes Ablaufdiagramm eines Verfahrens zur Bereitstellung eines im Rahmen einer Kultivierung eingesetzten Mediums.

Further features and advantages of the invention will become apparent from the following description and from the accompanying drawings, to which reference is made. In the drawings show:

• - 1 a schematic representation of a first embodiment of a device according to the invention for providing a medium used in the context of a cultivation;
• - 2 a schematic representation of a second embodiment of the device according to the invention; and
• - 3a . 3b . 3c an exemplary flowchart of a method for providing a used in the context of a cultivation medium.

In 1 is a first embodiment of a device arrangement 10 shown, which is suitable for a batch process. The device arrangement 10 includes a container 12 which is intended for the production of a nutrient medium for the cultivation of microorganisms or of parts of such organisms, in particular animal cells. The container 12 but may also be provided for the production or processing of another medium used in the cultivation, in particular a buffer or a feed solution. The container 12 is preferably a disposable component, in particular a sterilized plastic bag. In the container 12 For example, further process components, preferably also disposable components, may be present, such as a stirrer for mixing the medium.

To the container 12 is at least a first measuring device 14 coupled to measure a multivariate parameter characteristic of the medium. The first measuring device 14 can consist of several components, which do not necessarily have to be combined in a single device. An example of a coupling of such a measuring device 14 to the container is an optical access 14a on the container 12 for an outside of the container 12 arranged spectroscopic measuring system 14b , which will be discussed in more detail below.

To the container 12 can still at least a second measuring device 16 be coupled to measure a univariate parameter characteristic of the medium. For example, sensors for measuring the pH, electrical conductivity, turbidity, color or capacity of the medium in the wall of the container 12 be introduced. Other arrangements of such measuring devices 16 on the container 12 are possible. All directly on the container 12 attached or in the container 12 arranged components of the second measuring devices 16 are preferably disposable components.

All measuring equipment 14 . 16 are with an evaluation and control device 18 connected under any connection is any possibility of transmission of the measurement data of the measuring devices to the evaluation and control device to understand.

The evaluation and control device 18 is able, at least the measurement data of the first measuring device 14 to measure and process the multivariate parameter in real time. Ideally, this applies to the measurement data of all measuring devices 14 . 16 ,

The evaluation and control device 18 has access to at least one database in which comparison data related to the multivariate parameter (s) is stored.

• - Anzeigen von Warnungen (optisch und/oder akustisch);
• - Steuern von angebundenen Prozesskomponenten, insbesondere durch Ausgabe entsprechender Steuersignale.

In addition, the evaluation and control device 18 able to influence an ongoing process, in particular through at least one of the following actions:

• - displaying warnings (visually and / or acoustically);
• - Controlling connected process components, in particular by outputting corresponding control signals.

The evaluation and control device 18 is part of a process control instance, e.g. A supervisory control and data acquisition (SCADA) system, or includes such a process control entity.

2 shows a second embodiment of the device arrangement 10 , which is suitable for continuous or quasi-continuous process control. Here, in contrast to the first embodiment, the at least one first measuring device 14 for measuring the characteristic of the medium multivariate parameter not coupled to a container, but in a line system 20 integrated, ie at least one for the measurement relevant part of the first measuring device 14 is located in the flow path of the medium.

For example, the device arrangement 10 a disposable hose system with aseptic connections, a static mixer 22 and an optical flow cell 14c for coupling a spectroscopic measuring system 14b include.

Again, at least a second measuring device 16 for measuring a characteristic of the medium univariate parameter in the line system 20 be integrated. For example, sensors for measuring the pH and / or the electrical conductivity of the medium can be introduced as flow measuring cells.

At least those components which come into direct contact with the flowing medium are preferably sterilized disposable components.

The following will be with the first or second embodiment of the device arrangement 10 explained method for providing a medium used in the context of a cultivation. In the 3a . 3b and 3c are shown by means of a detailed example possible procedures of the provision method in an overall diagram, wherein in the following explanation not all in the 3a to 3c details will be discussed.

In the production of the medium (nutrient medium, buffer or feed solution), in addition to a measurement of a univariate physical or physicochemical variable characteristic for the medium, such as pH, conductivity, temperature, turbidity, color, capacity, in a manufacturing process set up for this purpose etc., in the container 12 or in the pipe system 20 using the second measuring device 16 also a measurement of a characteristic for the medium multivariate parameter using the first measuring device 14 to verify the identity of the medium. The verification of the identity of the medium is basically possible solely by evaluating the measurement of the multivariate parameter. In addition, the result of the measurement of one or more univariate parameters or further multivariate parameters can also be included in the review. In the following, for the sake of simplicity, initially only the measurement and evaluation of a multivariate parameter will be considered.

The measurement of the multivariate parameter takes place, depending on the embodiment, in situ, ie in the container 10 , in which the essential steps of the manufacturing process (filling of the starting materials, mixing or dissolving, etc.) take place, or in-line, ie in the line system 20 through which the medium flows in the manufacturing process. Alternatively or additionally, a measurement in a bypass path is possible (on-line).

For the measurement of the multivariate parameter, preference is given to using a spectroscopic measuring method, in particular a molecular spectroscopic method. A spectrum obtained with such a measuring method represents a "fingerprint" of the medium with sufficient selectivity to the individual important molecular species of the medium with a sufficient sensitivity (detection limit) of the constituents. Concretely, one of the following spectroscopy techniques can be used: Raman spectroscopy, mid-infrared spectroscopy (MIR), near-infrared spectroscopy (NIR), ultraviolet absorption spectroscopy and fluorescence spectroscopy, scattered spectroscopy.

The spectrum of the medium is during the manufacturing process - at least during the implementation of the essential manufacturing steps - from the first measuring device 14 continuously, ie repeatedly at regular or irregular intervals, recorded and sent to the evaluation and control device 18 transmitted. There, after possibly necessary data pretreatment steps (eg scatter correction, smoothing, etc.), a comparison of the respective measured spectrum with a predetermined ideal spectrum previously stored in the database for this individual finished medium is carried out.

In addition or as an alternative to the spectral data, it is also possible to specify scores (comparison values) for specific "target mixtures". The multivariate analysis in this case includes a calculation of z. B. PCA and / or PLS scores of the spectrum and a comparison of the spectrum based on a metric in the Scoreraum with scores of at least one target spectrum from the database (eg Euclidean distance, Mahalanobis distance, Hotellings T-squared distribution, etc. ). PCA stands for "Principal Component Analysis" and PLS for "Partial Least Squares" regression.

If the measured spectrum lies within a certain range of a suitable comparison metric (eg correlation matrix), the process control is returned with the information of reaching or the presence of the correct spectral identity (fingerprint) of the mixture. The positive result can then be displayed to the specialist personnel. But it can also be an active intervention in the manufacturing process by the evaluation and control device 18 This can be done, for example, by having the production process continue with the current settings or by completing the current process step as successfully completed and possibly initiating a subsequent process step.

However, if the measured spectrum is not within the desired range of the comparison metric, ie if the result of the identity check is negative, the evaluation and control device responds 18 by issuing an optical and / or acoustic warning and / or by a targeted control of connected process components. For example, the evaluation and control device 18 stop a batch process completely or switch a valve so that the unsatisfactory medium is directed into a containment vessel. The evaluation and control device 18 assigns in this case a manual sampling and examination. According to a quantitative approach, the evaluation and control device 18 set up so that it recognizes and analyzes the error that led to a negative identity check and then controls appropriate control circuits. Depending on the need identified, in this way the selective or quantitative intake of high purity water, concentrate (powder or stock solution) or other missing or underrepresented ingredient such as glucose, glutamine, other amino acids, etc., is adjusted accordingly to compensate for the error ,

As a result, a positive identity check ensures that the medium produced has the desired composition and properties. Negative identity verification at least informs the staff that the medium does not (yet) have the desired quality, and the manufacturing process can be intervened accordingly (manually or automatically).

Of course, the measurement and evaluation of the multivariate parameter based on a particular spectroscopic technique can be suitably combined with the measurement and evaluation of a univariate parameter (pH, electrical conductivity, etc.) and / or another multivariate parameter (other spectroscopic technique) , For example, the scores of the multivariate techniques can be combined with the measured univariate parameters and then a comparison of the total fingerprint thus obtained compared with a predetermined ideal overall fingerprint from the database.

LIST OF REFERENCE NUMBERS

10

device configuration

12

container

14

first measuring device

14a

optical access

14b

spectroscopic measuring system

14c

optical flow cell

16

second measuring device

18

Evaluation and control device

20

line system

22

static mixer

Claims (14)

Device arrangement (10) for providing a medium used in the context of a production of a biopharmaceutical product, in particular a nutrient medium or a buffer or a feed solution, with a container (12) or conduit system (20) in which the medium is produced in a manufacturing process, a first measuring device (14) for measuring at least one characteristic for the medium multivariate parameter during the manufacturing process; and an evaluation and control device (18) connected to the first measuring device (14) and arranged to check the identity of the medium using the measurement of the multivariate parameter during the manufacturing process and to output information depending on the result of the verification during the manufacturing process and / or to influence the manufacturing process. Device arrangement (10) according to Claim 1 , characterized in that the first measuring device (14) to the container (12) is coupled or integrated into the conduit system (20). Device arrangement (10) according to Claim 1 or 2 , characterized in that the container (12) and the conduit system (20) are disposable components or are formed substantially from disposable components. Device assembly (10) according to any one of the preceding claims, characterized in that the first measuring device (14) comprises components which are mounted directly on the container (12) or arranged in the container (12), and that these components are disposable components. Device arrangement (10) according to one of Claims 1 to 3 , characterized in that the first measuring device (14) comprises components which come in the line system (20) directly in contact with the medium flowing through, and that these components are disposable components. Device arrangement (10) according to one of the preceding claims, characterized in that the first measuring device (14) comprises a spectroscopic measuring system (14b), in particular a molecular spectroscopic measuring system, which is connected to the container (12) via an optical access (14a, 14c). or the line system (20) is coupled. Device arrangement (10) according to one of the preceding claims, characterized in that the first measuring device (14) is set up for the continuous measurement of the multivariate parameter. Device arrangement (10) according to one of the preceding claims, characterized in that the evaluation and control device (18) is arranged so that it can detect and process the measurement data of the first measuring device (14) in real time. Device arrangement (10) according to one of the preceding claims, characterized in that the evaluation and control device (18) has access to a database in which the comparison data related to the multivariate parameters are stored. Device arrangement (10) according to one of the preceding claims, characterized in that the evaluation and control device (18) is connected to at least one process component used in the manufacturing process and is adapted to control the process component depending on the result of the verification of the identity of the medium, in particular by outputting appropriate control signals to the process component. Device arrangement (10) according to one of the preceding claims, characterized in that the evaluation and control device (18) is part of a process control entity, in particular a SCADA system, or comprises a process control entity. Device arrangement (10) according to one of the preceding claims, characterized in that at least one second measuring device (16) for measuring a univariate parameter characteristic of the medium is coupled to the container (12) or the line system (20). Device arrangement (10) according to Claim 12 , characterized in that the second measuring device (16) is arranged to measure one of the following variables: pH; - electric conductivity; - temperature - turbidity; - Colour; - capacity; - River. Device arrangement (10) according to one of the preceding claims, characterized in that at least one further first measuring device (14) for measuring a further multivariate parameter characteristic of the medium is coupled to the container (12) or the line system (20).

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