Determining difference between monitored current user behavior and previous user behavior when operating analysis device

Abstract

A process of operating an analysis device (100) to analyze a sample, the process comprising: monitoring a current user behavior while operating the analysis device (100); comparing the monitored current user behavior with a previous user behavior; and triggering an action upon determining a difference between the monitored current user behavior and the previous user behavior.

Description

Technical Field

[0001] The present invention relates to a process and a control unit for operating an analytical device for analyzing a sample, and to an analytical device. Background Art

[0002] In liquid chromatography, a fluid sample and an eluent (liquid mobile phase) can be pumped through a conduit and a separation unit (e.g., a chromatographic column in which sample components are separated). The chromatographic column can include materials capable of separating the different components of the fluid sample. The separation unit can be connected to other fluid components (e.g., a sampler or syringe, a detector) via a conduit. Before the fluid sample is introduced into the separation path between the fluid drive unit (particularly a high-pressure pump) and the separation unit, a predefined amount of the fluid sample should be taken into the sampling loop from the sample source (e.g., a sample container) via an injection needle by the corresponding movement of the piston in the metering device. This usually occurs when there is a pressure significantly smaller than the pressure when the separation unit is running. Then, the injection valve is switched to introduce the fluid sample of the intake amount of the sampling loop from the metering path into the separation path between the fluid drive unit and the separation unit for subsequent separation. As a result, the fluid sample is injected into the mobile phase, e.g., a solvent or solvent component. The accurate composition of the mobile phase is important for the precise separation of the fluid sample. In order to accurately define the properties of the processed mobile phase, one or more fluid valves can be implemented in the sample separation device.

[0003] When a separation run is performed on a specific fluid sample on a liquid chromatography device, a separation method (defined by a set of parameter values and a set of commands to be executed) is executed. The execution of the separation run can be completed on a liquid chromatography device composed of multiple modular components that can be selected and connected by the user based on the needs of a specific application.

[0004] DE 102017102679_A1 describes an analysis device for a measuring device. The detection device is used to detect measuring device operating data and associated user-related data before, during, and / or after a measuring operation of the measuring device. Correlations between the detected operating data and the user-related data are analyzed.

[0005] CN 114611086 A discloses reducing the user's login operation and associating the user's identity information with the user's operating behavior on the sample analyzer. The user identity recognition unit collects the operator's target biometric data and compares the target biometric data with the pre-stored biometric data of at least one user to determine the operator's user identity. The operator's operating behavior is established, and an association relationship between the operator's operating behavior and the user identity is established, so that the sample analysis system can actively identify and confirm the operator's identity without performing the operator's login operation. At the same time, the operator's operating behavior is associated with the identity. The operator's operating behavior can be monitored by the operator's identity and can be used for quality improvement and problem analysis of sample detection.

[0006] However, it may happen that when configuring the analytical device for subsequent use, the user mistakenly and unintentionally uses one or more inappropriate components, for example, one or more inappropriate replaceable parts and / or consumables. For example, where a repeatable certification separation run is required (for example, for quality control purposes, certification applications or pharmaceutical applications), the analytical results obtained using inappropriate analytical equipment may not be usable. In addition, valuable samples may be destroyed when using one or more inappropriate replaceable parts and / or consumables. Summary of the Invention

[0007] An object of the present invention is to operate an analytical device in a safe and reliable manner. This object is solved by the independent claims. Further embodiments are indicated by the dependent claims.

[0008] According to an exemplary embodiment, a process for operating an analysis device to analyze a sample is provided, which includes monitoring current user behavior when operating the analysis device, comparing the monitored current user behavior with previous user behavior, and triggering an action when a difference between the monitored current user behavior and the previous user behavior is determined.

[0009] According to another exemplary embodiment of the present invention, a control unit for controlling an analysis device to analyze a sample is provided, the control unit comprising: a monitoring unit configured to monitor a current user behavior when operating the analysis device; a comparison unit configured to compare the monitored current user behavior with a previous user behavior; and a determination unit configured to trigger an action when a difference between the monitored current user behavior and the previous user behavior is determined.

[0010] According to a further exemplary embodiment, an analyzing device is provided, which comprises a control unit configured to perform the process having the above features, or which comprises a control unit having the above features.

[0011] In the context of the present application, the term "analytical device" can specifically refer to any device capable of analyzing a sample (particularly a fluid sample). For example, the analytical device can be a sample separation device configured to separate the different parts of a fluid sample by applying a certain separation technique (particularly liquid chromatography). In the context of the present application, the term "sample separation device" can specifically refer to any device that relates to transporting, analyzing or processing fluid to separate a fluid sample. Fluid can represent a liquid, a gas, or a combination of a liquid and a gas, and can optionally also include solid particles. This fluid can include a mobile phase (for example, a fluid solvent or a solvent component) and / or a fluid sample to be analyzed. The example of a sample separation device is a chemical analysis device, a life science device, or any other biochemical analysis system, for example, a separation device for separating the different components of a sample, particularly a liquid chromatography device. For example, sample separation can be accomplished by chromatography or electrophoresis.

[0012] In the context of this application, the term "analysis method" can specifically refer to instructions for how to analyze a fluid sample for an analysis device. When the analysis method is a separation method, the latter can be executed by a sample separation device to achieve the separation task associated with the analysis method. The analysis method can be defined by a set of parameter values (e.g., temperature, pressure, characteristics of solvent composition, etc.), hardware components of the sample separation device (e.g., the type of separation column used), and an algorithm with commands or instructions executed when executing the analysis method. A set of corresponding technical parameters for operating the sample separation device during sample separation can be known in advance, for example, stored in a database or memory accessible by a control unit that controls the operation of the sample separation device. The physical characteristics or operating parameters that characterize the analysis method can relate to transmission characteristics, which can include parameters such as volume, size, physical parameter values (such as pressure or temperature) and / or physical effects, for example, a friction model occurring in a fluid conduit, wherein the friction effect can be modeled, for example, according to Hagen Poiseuillelaw. More specifically, the parameterization can take into account the dimensions of the sample separation device (e.g., the dimensions of the fluid channel), the volume of the fluid conduit of the sample separation device (e.g., the dead volume), the pump performance of the sample separation device (e.g., the pump power and / or pump capacity), delay parameters for operating the sample separation device (e.g., the delay time after turning on the sample separation device), friction parameters for operating the sample separation device (e.g., characterizing the friction between the wall of the fluid conduit and the fluid flowing through the conduit), flushing performance of the sample separation device (particularly characteristics related to flushing or rinsing the sample separation device before operating the sample separation device or between two subsequent operations), and / or the cooperation of different components of the sample separation device (e.g., characteristics of the gradient applied to the chromatographic column).

[0013] In the context of the present application, the term "sample" can specifically refer to a medium containing the substance to be actually analyzed (for example, a biological sample (such as a protein solution), a pharmaceutical sample, etc.). Specifically, the sample can be a fluid sample. In this context, the fluid can be a liquid and / or gaseous medium, optionally including solid particles. During the sample separation process, the sample (particularly the fluid sample) can be injected, inserted or introduced into the mobile phase. In the context of the present application, the term "mobile phase" can specifically refer to a fluid (particularly a liquid), which is used as a carrier medium to transport the fluid sample from a fluid driver (for example, a high-pressure pump) to a sample separation unit (for example, a chromatographic column) of a sample separation device. For example, the mobile phase can be a (for example, organic and / or inorganic) solvent or a solvent component (for example, water and ethanol).

[0014] In the context of the present application, the term "current user behavior" can specifically represent the user activity or user configuration provided during the preparation and / or start-up analysis operation to analyze the sample on the analysis device. Therefore, the current user behavior can be related to the analysis operation that has not yet started, is about to start, or is currently started. The current user behavior can be related to the definition or selection of the sample to be analyzed, the analytical method to be performed, and / or one or more replaceable parts (e.g., used chromatographic separation columns) and / or consumables (e.g., the solvent composition used as the mobile phase during the chromatographic separation operation or the specific solvent container installed on the sample separation device) of the sample analysis on the analysis device. The current user behavior can be monitored, that is, information about at least one of the above elements (i.e., sample, analytical method, one or more replaceable parts and / or consumables) can be collected. This information collection can be completed using one or more sensors or detectors (e.g., RFID readers for reading the RFID tags on the chromatographic separation columns to detect which chromatographic separation columns the user is currently using, or barcode readers for reading the barcodes on solvent bottles or the vials containing reference samples), and / or can be received from the user (e.g., by, for example, receiving corresponding user input via a graphical user interface, etc.). This can also occur during installation or setup of the device, or when loading a sample tray, for example. In other words, a component (consumable or replaceable part) can be registered during installation when a barcode or RFID tag is read or when a user scans a barcode at a dedicated location.

[0015] In the context of the present application, term "previous user behavior" can specifically refer to the history, past or previous user activities or user configuration information provided about one or more analysis runs of analyzing a sample on an analytical device. Therefore, previous user behavior can be relevant to one or more analysis runs planned, prepared, and / or actually performed in the past. Previous user behavior can be relevant to the definition or selection of the sample analyzed, the analytical method performed, and / or one or more replaceable parts (for example, used chromatographic separation columns) and / or consumables (for example, solvent components used as mobile phase during chromatographic separation operations) used for sample analysis on the analytical device. Previous user behavior can be based on information that has been perceived or detected and / or received from a user in the past. For example, such information can be stored in and read from a database or data storage device, etc.

[0016] In the context of the present application, the term "comparing the monitored current user behavior with the previous user behavior" can specifically represent the comparison between the current user behavior and the previous user behavior to identify the complete or partial match or complete or partial mismatch between the user behaviors. Specifically, the current user behavior and the previous user behavior being compared can be related to the same sample to be analyzed (for example, different test amounts of beer brewed in the same brewery using the same recipe, or drug test amounts with (one or more) the same active pharmaceutical ingredients) and the same analytical method to be performed. For example, the current user behavior and the previous user behavior being compared can also be related to the same analytical device (for example, the same liquid chromatography device) on which the current user behavior and the previous user behavior both occur. However, it is also possible that the current user behavior and the previous user behavior being compared can be related to different analytical devices (for example, different liquid chromatography devices of the same type) on which the current user behavior and the previous user behavior occur. In the latter example, the comparison can be performed, for example, in the context of an analytical method being transferred from one analytical device to another analytical device, or when a replaceable component (for example, a chromatographic separation column) is disassembled from an analytical device and assembled to another analytical device.

[0017] In the context of the present application, the term "difference between current user behavior and previous user behavior" can specifically refer to a deviation between current user behavior and previous user behavior, which deviation can indicate a potential inappropriate current user configuration for an analytical run on an analytical device. For example, when a user used a certain replaceable component (e.g., a specific chromatographic separation column) and / or consumable (e.g., a specific solvent component of a mobile phase) to analyze a specific sample with a specific analytical method for multiple past analytical runs, and now uses another replaceable component (e.g., another chromatographic separation column with other dimensions) and / or consumable (e.g., another solvent component of a mobile phase) to analyze the same specific sample with the same specific analytical method for the current analytical run, this can be identified as a difference that potentially indicates an inappropriate user configuration. When analyzing whether the deviation between current user behavior and previous user behavior should be classified as a deviation that triggers an action (e.g., using a different type of chromatographic separation column despite the same sample being analyzed and the same analytical method being performed) or as a minor deviation that does not trigger an action (e.g., using a different physical chromatographic separation column of the same type in a different analytical run), at least one decision criterion can be applied. Such decision criteria may be predefined or may be dynamically adjusted based on user behavior monitored over time. Specifically, determining whether there is a discrepancy between current user behavior and previous user behavior may be performed based on at least one criterion related to consistency, inconsistency, and / or degree of consistency between current user behavior and previous user behavior with respect to an analysis device selected by the user.

[0018] In the context of the present application, the term "trigger action" can specifically mean taking predefined measures due to the identified differences. For example, different actions can be predefined for different types of differences. For example, when different types of chromatographic separation columns of different sizes are used to analyze the same sample with the same analytical method, another action (e.g., a more severe action) can be taken compared to another situation where different types of chromatographic separation columns of the same size are used to analyze the same sample with the same analytical method. The determination of the difference can be a trigger for the action.

[0019] In the context of the present application, the term "control unit" can specifically refer to an entity that controls the process of operating an analytical device. For example, a control unit can specifically complete the task of monitoring user behavior and triggering an action when a difference between the monitored user behavior and the previous user behavior is found. However, in addition to the above tasks, it may also be that the control unit controls the analytical device as a whole when analyzing a sample. Specifically, the monitoring unit, comparison unit and / or determination unit that form a part of the control unit can be embodied as different processors, or different functional parts of a common processor can be formed. For example, a control unit and / or its monitoring unit, comparison unit and / or determination unit can be implemented in a hard-wired manner, by software, and / or using circuits connecting different electronic components.

[0020] According to an exemplary embodiment of the present invention, analysis equipment can be operated to analyze samples in a safe and reliable manner. This can be achieved by monitoring the user's current operation analysis equipment (for example, preparing or performing analysis operation to analyze sample). In addition, the current user behavior monitored can then be compared with the previous user behavior (i.e., the corresponding or similar behavior when the user prepared or performed analysis operation to analyze sample in the past). When determining or identifying the difference (for example, sufficiently significant deviation) between the current user behavior monitored and the previous user behavior as a result of the comparison, corresponding action can be taken. For example, the difference between the previous user behavior and the current user behavior about similar or identical analysis operation can indicate that for the analysis operation performed by the analysis equipment equipped with one or more other elements in the past, the user mistakenly and unintentionally selected the analysis equipment equipped with one or more inappropriate elements, for example, one or more inappropriate replaceable parts and / or consumables. When taking appropriate action (for example, issuing a warning or confirmation request to the user) before performing analysis operation using inappropriate analysis equipment, unusable analysis results can be avoided and / or potentially valuable samples can be prevented from being destroyed in useless analysis operation.

[0021] Next, further exemplary embodiments of the process, the control unit and the analyzing device will be explained.

[0022] In an embodiment, the monitoring includes monitoring which analytical equipment the user is currently using or intending to use to analyze the sample according to the analytical method to be performed by the analytical device. The analytical equipment can include one or more modular components of the analytical device, which can be combined in a modular manner to configure the analytical device for analysis. Specifically, in an embodiment in which the analytical device is a chromatographic sample separation device, the monitored analytical device can be the chromatographic separation column used. The monitoring concept can be based on the assumption that the user usually uses the same analytical equipment (particularly the same chromatographic separation column) when analyzing the same sample or the same type of sample by the same analytical method. If this is not the case, there may be differences.

[0023] In an embodiment, the comparison includes determining whether the analytical instrument set currently or intended to be used with the analytical method corresponds to a previously used analytical instrument set that has been used with the analytical method in the past. Thus, the comparison can provide a meaningful indication that a user may be inadvertently using the wrong analytical instrument set to perform an analytical run to analyze a sample using a certain analytical method for which the user has used another analytical instrument set several times in the past.

[0024] In an embodiment, the process includes determining that a difference exists when the analytical equipment currently or intended to be used with the analytical method is not the same or the same type as the analytical equipment previously used. For example, when a user is currently analyzing the same sample with the same analytical method using a different type of chromatographic separation column having different dimensions compared to another chromatographic separation column that the same user has consistently used multiple times in the past for the same analysis, the comparison can identify a difference.

[0025] In an embodiment, the process includes determining that there is no difference when the analysis equipment equipment currently or intended to be used together with the analysis method is the same or of the same type as the analysis equipment equipment previously used. In this context, the same analysis equipment equipment can represent physically identical equipment (e.g., the same chromatographic separation column, e.g., having the same unique serial number). When the user currently and in the past used the same analysis equipment equipment many times to analyze the same sample with the same analysis method, no difference can be identified, and no other actions need to be taken except performing analysis operations according to user behavior. In addition, the analysis equipment equipment of the same type can represent physically different equipment (e.g., different chromatographic separation columns, e.g., having the same universal product number) with the same properties (particularly with the same size) and therefore interchangeable. When the user currently and in the past used physically different analysis equipment equipment of the same type many times to analyze the same sample with the same analysis method, no difference can be identified, and no other actions need to be taken except performing analysis operations according to user behavior.

[0026] As described above, the analytical equipment can include one or more replaceable parts and / or consumables. A replaceable part can be an analytical equipment configured to be reused. Therefore, a replaceable part can also be replaced from the analytical equipment and can be replaced by another replacement part, wherein the aforementioned replaceable part can be used again in the same or another analytical equipment later. Examples of replaceable parts are chromatographic separation columns or analytical pumps. Consumables can be analytical equipment configured to be only disposable. Examples of consumables are solvent components of a mobile phase that is used for a chromatographic separation run and is subsequently directed to waste (e.g., a first solvent such as water is mixed with a second solvent such as an organic solvent in a predefined mixing ratio).

[0027] In an embodiment, the one or more replaceable parts and / or consumables are selected from the group consisting of:

[0028] - Sample separation unit (e.g., chromatographic separation column)

[0029] - Fluid filters (e.g. for filtering solid particles from solvents or solvent components)

[0030] - Sample holding volume (e.g., the sampling loop of a syringe, in which the fluid sample is temporarily held before being injected into the separation path between the fluid drive and the sample separation unit of a chromatographic sample separation device)

[0031] - an injection needle (e.g., a needle that can be moved between a sample container and a needle seat to draw a fluid sample into a sample holding volume for subsequent injection)

[0032] - a needle hub (e.g., a hub configured to accommodate the aforementioned injection needle)

[0033] - Mobile phase (e.g., the solvent component used as a carrier fluid for the fluid sample to be separated in the chromatographic sample separation path)

[0034] - a fluid valve (e.g., an injection valve, switchable for injecting fluid from a sample holding volume into a chromatographic separation path for subsequent sample separation, or a check valve, for opening and closing a flow path) or a component thereof, e.g., a seal, etc.

[0035] - Tubing (e.g., capillary tubes, such as those connected via fittings)

[0036] - a flow cell (e.g., an at least partially optically transparent component through which a separated fluid sample can flow during its optical detection)

[0037] - Optical detector components (e.g., UV lamp, grating, fluorescence detector, etc.)

[0038] - a fluid drive (eg an analytical pump, for example embodied as a piston pump).

[0039] - Mixers (e.g., inlet mixers for mixing two or more solvents in the generation of a mobile phase, or outlet mixers configured to compensate for heterogeneity in the composition of the mobile phase)

[0040] - Exhaust unit (e.g. for removing dissolved gases from the mobile phase)

[0041] Additionally or alternatively, multiple and / or other replaceable components and / or consumables may be implemented as analytical device equipment.

[0042] In an embodiment, an analysis method defines a set of operating parameter values and a set of device instructions used when operating an analysis device to analyze a sample according to the analysis method. In the context of the present application, the term "operating parameters" can specifically represent parameters in the following set of multiple parameters: the set of parameters is defined and / or exists during the corresponding analysis method and describes the properties that are adjusted or occur during the operation of the analysis device when the analysis method is performed. Such operating parameters can particularly include physical conditions (especially, for example, the pressure and / or temperature at the sample separation unit (e.g., chromatographic column), the wavelength of the detector, integration parameters, etc.), the properties of the fluid used for operation (e.g., the solvent composition of the mobile phase, the gradient curve, etc.), etc. In addition, the term "device instructions" can represent a series of instructions or commands that define how the analysis device performs the analysis method. For example, the device instructions can include control commands to the various parts of the analysis device, defining their expected operations during the execution of the analysis method.

[0043] In an embodiment, the analytical method is a sample separation method, preferably a chromatographic sample separation method. In other words, the analysis of the sample can be its separation into, for example, different parts. This can be achieved by chromatography, preferably by liquid chromatography (e.g., by HPLC) or by gas chromatography. However, other types of sample separation are possible, for example, sample separation by electrophoresis (preferably by capillary electrophoresis).

[0044] In an embodiment, the process includes creating a user habit profile by associating the analytical equipment used with the analytical method, and using the user habit profile when determining whether there is a difference between the monitored current user behavior and the previous user behavior. In order to obtain meaningful information when determining the difference between the current user behavior and the previous user behavior as the basis for triggering a specific action, the difference can be determined based on the deviation of the current user behavior from the user habit profile (which can indicate the user's long-term past behavior). In an embodiment, a one-time difference in the current user behavior compared to a single previous user behavior may not be sufficient to assume a sufficient probability of unintentional inappropriate current user behavior. In order to reduce the risk of triggering an action by mistakenly assuming the presence of inappropriate user behavior, determining the user habit profile as the basis for determining whether a difference actually exists can be very advantageous. First, the user habit profile can be specifically related to the long-term past user behavior related to the specific analytical method used to analyze the specific sample and the specific analytical equipment used for the analysis. Second, it can be advantageous to create the user habit profile based on a sufficiently large number of analytical runs using the specific analytical method used to analyze the specific sample and the specific analytical equipment used in the past. Preferably, the user habit profile can be created based on at least three, preferably at least five, previous analytical runs. For example, a user habit profile can be created based on at least three, preferably at least five consecutive previous analysis runs (particularly without other analyses or analysis methods in between). By taking this measure, the reliability of the determined differences can be improved and the risk of false positives can be advantageously reduced.

[0045] In an embodiment, the process includes monitoring the previous user behavior when operating the analysis device and / or another analysis device before the monitoring current user behavior. Therefore, the information indicating the previous user behavior can be collected in the same manner as the current user behavior (for example, as described above). This also allows the direct comparability of the previous user behavior with the current user behavior. Specifically, user information input and / or information sensed or detected during the historical analysis run can be used for this purpose. In an alternative, the previous user behavior and the current user behavior can be monitored on the same analysis device. This can further improve the direct comparability of the previous user behavior with the current user behavior. In another alternative, the previous user behavior can be collected on one or more analysis devices that are part of or completely different from the analysis device that collects the current user behavior. This can broaden the data basis for determining potential differences. In addition, the latter method can also allow the application of exemplary embodiments in terms of the method transfer of the analysis method from one analysis device to another analysis device. In addition, the latter method can also be applied when the analysis device equipment is disassembled from one analysis device and assembled to another analysis device.

[0046] In an embodiment, the process includes monitoring said previous user behavior when operating said analysis device and / or another analysis device multiple times before said monitoring of the current user behavior. Specifically, the process may include determining that there is a difference only when the monitored current user behavior deviates from the previous user behavior obtained from at least a predefined number of previous user behaviors. For example, before considering the existence of a highly reliable user habit profile, the previous user behavior may be based on historical events of performing the same analysis method at least three times, preferably at least five times to separate the same sample. More specifically, the process may include determining that there is a difference only when the monitored current user behavior deviates from the previous user behavior obtained from at least a predefined number of consecutive times. In such a configuration, it may be necessary, for example, to assume established previous user behavior, i.e., the same configuration or at least the same component is used a predefined number of times (e.g., three or more times). For example, if the configuration and / or component is continuous Such established prior user behavior can be assumed if the column is used two, three, or more times (e.g., for the same sample and / or analytical method), i.e., in two, three, or more consecutive runs without analyzing different samples or using different analytical methods. Thus, for example, an association of a particular column with a particular analytical method can occur when at least the last two, three, or more runs of the particular analytical method have been performed using the particular column.

[0047] In an embodiment, the process includes storing user behavior data characterizing the monitored previous user behavior and the monitored current user behavior in a database. For example, such a database can be a mass storage device accessible by a control unit that controls the process of the exemplary embodiment.

[0048] In an embodiment, current user behavior when monitoring operating analytical equipment comprises receiving information from the user and / or detecting the information about the analytical equipment currently in use or intended to use, particularly the sample separation unit currently in use or intended to use, more specifically the chromatographic separation column currently in use or intended to use.Described information can for example be received from the user via a user interface.Such a user interface can for example comprise a touch screen, a keyboard and / or a voice recognition system.Information detection can for example comprise detecting the solvent composition of mobile phase, for example, based on the flow velocity of measurement.In another example, information detection can for example be based on reading the transponder (for example, radio frequency identification tag (RFID tag) or reading bar code) attached to corresponding analytical equipment (for example, chromatographic separation column) by a transponder reader (for example, RFID reader) or a barcode reader of analytical equipment.

[0049] In an embodiment, the action triggered when a difference is determined is different from operating the analysis device to analyze the sample according to the current user behavior. Accordingly, the process may include operating the analysis device to analyze the sample according to the current user behavior when it is determined that there is no difference between the monitored current user behavior and the previous user behavior. In other words, when it is determined that there is no difference, the analysis run may be performed according to the current user behavior, and when it is determined that there is a difference, the analysis run may not be performed, but in contrast, another action will be triggered. When the triggered action results in approval to perform the analysis run according to the current user behavior (for example, by further user instructions of the reply triggering action, or by a superior instance above the user and approving the current user behavior of the reply triggering action), the analysis run may be performed according to the current user behavior.

[0050] In an embodiment, operating the analytical device to analyze the sample includes at least one of the group consisting of: performing an authenticated analysis, performing an analysis requiring documentation, repeating a predefined analysis, performing an analysis of the sample for quality control, performing an analysis of a pharmaceutical sample, and performing an analysis of a valuable sample. In quality-critical scenarios, such as pharmaceutical quality control, it may be crucial that the sample analysis is always repeated under the same conditions to ensure the repeatability of the result. In this case, it may be particularly advantageous to improve the safety of the operation by triggering appropriate actions when there is a difference between the current user behavior and the previous user behavior. In a similar manner, some samples (such as, certain biological samples, considering their long and complex preparation) may be extremely valuable, making it possible for the safety mechanism of exemplary embodiments of the present invention to prevent endangering valuable samples to be very advantageous.

[0051] In an embodiment, the trigger action comprises at least one of the group consisting of:

[0052] - Provide feedback to the user corresponding to the discrepancy (e.g., the user could be asked whether they should actually control the operation of the analytical device based on the current user behavior)

[0053] - Inform the user of the differences (e.g., the user may be informed that the current user behavior deviates significantly from the previous user behavior; the user may also be informed which element(s) of the current user behavior deviates from the previous user behavior, e.g., a used chromatography column)

[0054] - Asking the user to confirm whether analysis of the sample should be performed based on the monitored current user behavior regardless of differences (e.g., the user may be asked whether the analysis run should be performed based on the current user behavior or, alternatively, based on previous user behavior)

[0055] - Flagging analysis runs performed based on monitored current user behavior regardless of discrepancies (e.g., a series of analysis runs may be performed, one or more of which are performed based on previous user behavior, and one or more of which are performed based on deviating current user behavior; the one or more analysis runs performed based on deviating current user behavior may then be flagged as suspicious)

[0056] - Perform analysis of samples based on monitored current user behavior regardless of discrepancies only after prior approval by a superior instance (e.g., a lab administrator may be required to approve current user behavior before executing an analysis run based on deviating current user behavior)

[0057] - performing analysis of a sample according to the monitored current user behavior regardless of discrepancies only if the user profile enables the user to approve said analysis (each user may have an assigned role with assigned authorizations; the analysis device may allow the execution of an analysis run only if the user's authorization according to the assigned user profile allows such execution despite discrepancies between the current user behavior and previous user behavior)

[0058] - Asking the user whether the monitored current user behavior should be classified as consistent with previous user behavior regardless of any differences (e.g., the same chromatography separation column may have been used multiple times based on previous user behavior, and a physically different chromatography separation column of the same product type may now be used based on the current user behavior; if the user approves this deviation, physically different chromatography separation columns of the same product type may be accepted for use in future analytical runs)

[0059] - Issuing a warning (when a discrepancy is identified, the user may be warned, for example, audibly and / or optically)

[0060] Additionally or alternatively, multiple and / or other actions may be triggered.

[0061] In an embodiment, the analytical device is configured as a sample separation device for separating a fluid sample (in particular, a liquid chromatography device, such as an HPLC (high performance liquid chromatography)), and includes a fluid driver (e.g., an analytical pump, such as a high-pressure piston pump) for driving the fluid sample and / or a mobile phase (e.g., a solvent or solvent component) into which the fluid sample is injected, and a sample separation unit (preferably a chromatographic separation column) for separating the fluid sample from the mobile phase. In the context of the present application, the term "fluid driver" may specifically refer to an entity capable of driving a fluid (in particular, a fluid sample and / or a mobile phase). For example, the fluid driver may be a pump (e.g., implemented as a piston pump or a peristaltic pump) or other high-pressure source. For example, the fluid driver may be a high-pressure pump, for example, capable of driving a fluid at a pressure of at least 100 bar, in particular at least 500 bar. In the context of the present application, the term "sample separation unit" may specifically refer to a fluid component through which the fluid sample is transported, and the fluid component is configured such that when the fluid sample is guided through the separation unit, the fluid sample is separated into different groups of molecules or particles. An example of a separation unit is a liquid chromatography column, which is able to capture or delay and selectively release different fractions of a fluid sample.

[0062] In an embodiment, the analysis device may include a syringe configured to inject a fluid sample into a mobile phase to analyze the fluid sample. For example, such a syringe may include a needle that can be moved by a robot, etc., so as to immerse the needle into the sample in the sample container. Thereafter, the sample can be drawn into a sampling loop of the syringe via the needle. This drawing process can be performed by withdrawing a piston of a metering device. Thereafter, the needle can be driven into a needle seat, and the drawn fluid sample can be injected from the sampling loop into a separation path between the fluid driver and a sample separation unit (e.g., a chromatographic separation column).

[0063] In one embodiment, the analytical device includes a fractionation unit configured to collect the analyzed fluid sample. After the fluid sample is separated into its individual fractions in the sample separation device, the separated fractions can be injected into different sample bottles or other sample containers where they can be stored. For example, the separated fractions downstream of the sample separation unit or detector can be directed to the sample container via a fractionation needle.

[0064] The examples can be performed on a commonly available HPLC system, for example, an analytical Agilent 1290 Infinity II LC system or an Agilent 1290 Infinity II preparative LC / MSD system (both provided by applicant Agilent Technologies, Inc. - see www.agilent.com - which are incorporated herein by reference).

[0065] One embodiment of the sample separation device includes a pump having a pump piston that reciprocates in a pump working chamber to compress a liquid in the pump working chamber to a high pressure at which the compressibility of the liquid becomes apparent. The pump can be configured to learn (through operator input, notification from another module of the instrument, etc.) or otherwise obtain solvent properties.

[0066] The sample separation unit of the sample separation device preferably includes a chromatographic column that provides a stationary phase (see, for example, http: / / en.wikipedia.org / wiki / Column_chromatography). The column can be a glass or steel tube (e.g., with a diameter of 50 μm to 5 mm and a length of 1 cm to 1 m) or a microfluidic column (such as disclosed in EP 1577012 or in the Agilent 1200 Series HPLC-Chip / MS system provided by the applicant, Agilent Technologies). As the individual components propagate through the column containing the eluent at different speeds, they are retained differently by the stationary phase and at least partially separated from one another. At the end of the column, they elute one by one, or at least not completely simultaneously. The eluent may also be collected in a series of fractions throughout the chromatography process. The stationary phase or adsorbent in column chromatography is typically a solid material. The most common stationary phases for column chromatography are silica gel, surface-modified silica gel, and less commonly, alumina. Cellulose powder has been frequently used in the past. Other possible methods include ion exchange chromatography, reversed-phase chromatography (RP), affinity chromatography, or expanded bed adsorption (EBA). The stationary phase is usually a finely ground powder or gel and / or is microporous to increase the surface area.

[0067] Mobile phase (or eluent) can be a mixture of pure solvents or different solvents (for example, water and an organic solvent, such as ACN, acetonitrile). Mobile phase can be selected for example to adjust the retention of the compound of interest and / or the amount of the mobile phase for running chromatography. Mobile phase can also be selected so that the different compounds or parts of the fluid sample can be effectively separated. Mobile phase can comprise an organic solvent, for example, methanol or acetonitrile, usually diluted with water. For gradient operation, water and organic matter are transported in separate bottles, and a gradient pump delivers the planned mixture to the system from these bottles. Other common solvents can be isopropyl alcohol, THF, hexane, ethanol, and / or its arbitrary combination or any combination of these solvents and above-mentioned solvents.

[0068] The fluid sample analyzed by the sample separation device according to an exemplary embodiment of the present invention may include, but is not limited to, any type of process liquid, natural sample (e.g., juice), body fluid (e.g., plasma), or it may be the result of a reaction such as from a fermentation broth.

[0069] The pressure in the mobile phase, as generated by the fluid driver, may be in the range of 2-200 MPa (20 to 2000 bar), particularly 10-150 MPa (150 to 1500 bar), more particularly 50-120 MPa (500 to 1200 bar).

[0070] The sample separation device (eg, an HPLC system) may also include a detector for detecting the separated compounds of the fluid sample. For example, a fluorescence or UV-Vis detector may be implemented.

[0071] Embodiments of the present invention may be embodied or supported, in part or in whole, by one or more suitable software programs that may be stored on or otherwise provided by any type of data carrier and that may be executed in or by any suitable data processing unit. The software programs or routines may preferably be applied in or by a control unit. BRIEF DESCRIPTION OF THE DRAWINGS

[0072] By referring to the following more detailed description of the embodiments in conjunction with the accompanying drawings, other objects and many accompanying advantages of the embodiments of the present invention will be easily recognized and better understood. Features that are essentially the same or similar in function will be represented by the same reference symbols.

[0073] Figure 1 A sample separation device according to an embodiment of the present invention is shown, in particular for use in high performance liquid chromatography (HPLC).

[0074] Figure 2 A schematic diagram illustrating a process performed on a sample separation device according to an exemplary embodiment is shown.

[0075] The illustrations in the drawings are schematic.

[0076] Before describing the drawings in further detail, some basic considerations of the invention will be outlined based on the exemplary embodiments that have been developed.

[0077] Traditionally, analytical equipment can be configured by combining interchangeable components (e.g., chromatographic separation columns, switching valves, injection loops, pump heads, detector types, etc.). Different configurations can affect the process and, therefore, the analytical results. Interchangeability can lead to incompatibilities between analytical methods and individual components.

[0078] For example, a chromatographic separation method may be performed using a certain chromatographic separation column. When the same chromatographic method is performed again, the intention is to use the same column, or at least the same type of column. To this end, the user must manually track which column was used with which chromatographic separation method and / or which sample in accordance with convention to prevent accidental mismatching of the chromatographic separation column and the chromatographic separation method, thereby avoiding unexpected or invalid results. The same situation can be applied to other consumables or replaceable parts of the analytical equipment, such as filters, sampling loops, injection needles, needle seats, solvents (which can be prepared for specific methods), or valves.

[0079] According to an exemplary embodiment of the present invention, the current user behavior when operating an analytical device to analyze a sample is monitored. This can be done before starting an analytical run to analyze the sample based on the current user behavior. The monitored current user behavior can be compared with previous user behavior. Specifically, the latter can indicate, for example, user habits (i.e., habits that the user of the analytical device may have practiced many times in the past), which involve performing sample analysis using a certain analytical method, and the current user behavior is also related to this analytical method. If a difference is determined by comparing the monitored current user behavior with the previous user behavior, an action can be triggered, rather than simply executing the analytical method to analyze the sample based on the instructions provided by the current user behavior. Advantageously, this can allow the analytical device to be operated in a safe and reliable manner. Specifically, it can reliably prevent users from mistakenly and unintentionally using one or more inappropriate components, such as one or more inappropriate replaceable parts and / or consumables. This can have the greatest advantage for applications that require repeatable, certified separation runs (e.g., for quality control purposes, certified applications, or pharmaceutical applications). In addition, exemplary embodiments can protect valuable samples from being destroyed by the use of one or more inappropriate replaceable parts and / or consumables.

[0080] For example, exemplary embodiments of the present invention can learn from past user behavior regarding the use of replaceable components and / or consumables of an analytical device. For example, if a user always uses analytical device equipment X (e.g., a certain solvent or separation column, such as in the context of a certain analytical method) and the analytical device detects that analytical device equipment Y is about to be used (e.g., another solvent or another type of separation column, such as in the context of the same analytical method), an action is triggered. Such an action can be feedback sent to the user to verify or check whether analytical device equipment Y should actually be used.

[0081] In order to be able to perform such a check automatically, it may be advantageous if the configuration of the analytical equipment is known (e.g., by means of one or more RFID tags or barcodes). On the other hand, it may be advantageous if additional data is available and rules are defined in advance to enable an assessment of compatibility (e.g., the number of injections performed on a column and its upper limit, or the temperature setting of the analytical method and the maximum permissible temperature of the column).

[0082] According to an exemplary embodiment, it may be advantageous to maintain a record of the compatibility assessment, wherein for each analysis performed, it is recorded which analysis method was performed using which configuration of the analysis device. Preferably, the configuration includes all interchangeable components of the analysis device set. Based on this data set, it is possible to check at the beginning of each analysis run whether a change has occurred in the combination of analysis method and configuration of the analysis device (i.e., the analysis device set). If such a difference is detected, it may result in a user query, as a result of which the analysis can be released or rejected.

[0083] According to an exemplary embodiment of the present invention, an analytical device (e.g., HPLC) can be provided that monitors user behavior (about the analytical device), for example, certain components of the installation, change, etc. The analytical device can also provide feedback to the user based on previous monitoring of, for example, the analytical device (e.g., which analytical method is running or has been running) and user interaction (e.g., a specific user who always uses a certain chromatographic separation column will now use a different column). This can allow for avoiding errors or incorrect measurements that may endanger expensive samples. Advantageously, exemplary embodiments of the present invention can monitor user behavior and can draw conclusions based on changes in monitored user behavior.

[0084] More specifically, exemplary embodiments of the present invention can ensure that the correct chromatographic separation column is used for a predetermined chromatographic separation method. The number of times a chromatographic separation column or other replaceable parts and / or consumables (more generally, analytical equipment) are used can be tracked based on the (one or more) chromatographic separation methods performed using the analytical device. Utilizing the same analytical equipment (e.g., consumables) to perform the same chromatographic separation method for more than a predefined number of times can cause the analytical device to notify or warn the user when the user attempts to perform the chromatographic separation method using different analytical equipment (e.g., consumables) after the chromatographic separation method has previously been performed a predefined number of times. Advantageously, this can ensure that invalid results are not produced due to the use of an inappropriate chromatographic separation column with a specific chromatographic separation method. In addition, exemplary embodiments can mitigate the risk of using an inappropriate sample separation column to analyze a sample. Advantageously, the user does not need to know which chromatographic separation column belongs to which chromatographic separation method, and the process can be performed by, for example, a control unit of the analytical device. Further advantageously, efficiency can be improved by reducing the downtime of the analytical device.

[0085] In the following, a specific example of an exemplary embodiment will be explained: a chromatographic separation column C used with a chromatographic separation method is associated with the chromatographic separation method during and / or after the first analytical run, for example, via storing information in a database. After the chromatographic separation method has previously been executed a predefined number of times (for example, three or more times) using chromatographic separation column C, when the same chromatographic separation method is to be executed using a different chromatographic separation column, the user is prompted to verify whether the user actually intends to use this different chromatographic separation column with the chromatographic separation method. At this point, the user may realize that the user has inadvertently used the wrong chromatographic separation column and can now select or install the correct chromatographic separation column. However, the user can also confirm that a new or different chromatographic separation column should be used with the chromatographic separation method from now on. The new chromatographic separation column is associated with the chromatographic separation method and / or replaces the previous chromatographic separation column.

[0086] In an advantageous embodiment, a predetermined analytical run can be checked relative to the installed chromatographic separation columns. For example, such verification can be performed for all components (or for all components considered relevant), particularly including all consumables and / or replaceable parts. It can be checked whether all chromatographic separation columns that should be used with the upcoming analytical run or sequence have been installed. This can be done particularly for chromatographic separation columns that have been associated with a chromatographic separation method. The user can be notified or asked for instructions.

[0087] Advantageously, information about the chromatographic separation column used can be read from a label or can be input by a user. This information can be a complete data set describing the parameters of the chromatographic separation column or an identifier that can be used to retrieve the parameters of the chromatographic separation column from a database.

[0088] According to an exemplary embodiment of the present invention, it is possible to monitor how a user operates an analysis device. Based on the monitoring results, an action can be triggered, for example, feedback can be provided to the user. Specifically, the user's past habits regarding the operation of the analysis device can be associated. More specifically, an analysis application (e.g., an analysis method for analyzing a sample) can be associated with a component of the analysis device (particularly the chromatographic separation column used). When it is determined that the current user behavior differs from the user's past habits regarding the analysis device, a user query can be triggered to inquire whether the deviation from the user's habits identified by the user is an actual intention.

[0089] Established user habits may be assumed when a specific analysis run has been performed at least a predefined number of times (e.g., at least three times).Such user-related analysis runs may be defined by the analysis method in conjunction with the sample to be analyzed and in conjunction with the analysis device equipment used to operate the analysis device.

[0090] Referring now in more detail to the accompanying drawings, Figure 11 depicts a schematic diagram of an overall analysis apparatus 100 according to an exemplary embodiment of the present invention. The illustrated analysis apparatus 100 is configured as a chromatographic sample separation device 10. Although Figure 1 Not shown, but another exemplary embodiment of the present invention may utilize an analytical device 100 configured as an electrophoretic separation device. A fluid driver 20 (e.g., a piston pump) receives a mobile phase from a solvent supply 25 via an exhaust unit 27, which exhausts and thereby reduces the amount of dissolved gases in the mobile phase. The fluid driver 20 drives the mobile phase through a separation unit 30 (e.g., a chromatographic column) comprising a stationary phase. A sampler or syringe 40 (implementing a fluid valve 95) may be provided in the fluid driver 20 and the separation unit 30 to introduce or add a sample fluid (commonly referred to as sample introduction) to the mobile phase, thereby providing the fluid sample and mobile phase toward a separation path where the actual sample separation occurs. Prior to loading the fluid sample into the syringe 40, the fluid sample may be contained in a sample container 130. The stationary phase of the separation unit 30 is configured to separate compounds of the sample fluid. A detector 50 is provided to detect the separated compounds of the sample fluid. A fractionation unit 60 may be provided to output the separated compounds of the sample fluid in the sample container (not shown).

[0091] Although the mobile phase can consist of only one solvent, the mobile phase can also be a mixture of multiple solvents. This mixing can be low-pressure mixing performed by a mixer 97 arranged upstream of the fluid drive 20, so that the fluid drive 20 has received and pumped the mixed solvent as the mobile phase. Alternatively, the fluid drive 20 can include multiple separate pumping units, wherein the multiple pumping units each receive and pump a different solvent or mixture, so that the mixing of the mobile phase (such as received by the sample separation unit 30) occurs at high pressure and downstream of the fluid drive 20 (or as part of it). The composition of the mobile phase can remain constant over time, the so-called isocratic mode, or vary over time, the so-called gradient mode.

[0092] A data processing unit or control unit 70 (which may be a PC or workstation) can be coupled (as indicated by the dashed arrow) to one or more devices in the analytical device 100 to receive information and / or control operations. For example, the control unit 70 can control the operation of the fluid driver 20 (e.g., setting control parameters) and receive information from it regarding actual operating conditions (e.g., the output pressure at the pump outlet, etc.). Optionally, the control unit 70 can also control the operation of the solvent supply 25 (e.g., setting the solvent or solvent mixture to be supplied) and / or the exhaust unit 27 (e.g., setting control parameters and / or transmitting control commands), and can receive information from them regarding actual operating conditions (e.g., the solvent composition supplied over time, the vacuum level, etc.). The control unit 70 can also control the operation of the sampling unit or injector 40 (e.g., controlling sample injection or synchronizing sample injection with the operating conditions of the fluid driver 20). The separation unit 30 can also be controlled by the control unit 70 (e.g., selecting a specific flow path or column, setting the operating temperature, etc.), and in turn send information (e.g., operating conditions) to the control unit 70. Accordingly, the detector 50 can be controlled by the control unit 70 (e.g., regarding spectral or wavelength settings, setting time constants, starting / stopping data acquisition) and send information (e.g., regarding detected sample compounds) to the control unit 70. The control unit 70 can also control the operation of the fractionation unit 60 (e.g., incorporating data received from the detector 50) and provide data backup.

[0093] Figure 1 The control unit 70 shown may be a workstation. However, other embodiments of the present invention may implement the control unit 70 on a server, for example, in a shared server configuration. Similarly, information about which consumables, replaceables, or common components are installed on which analytical device or installed on the analytical device, and their association with a particular method, may be stored on and accessed from a server or another type of control unit 70.

[0094] As previously described, the control unit 70 is configured to control the analysis device 100 to analyze a fluid sample (which may be a liquid sample (e.g., when performing liquid chromatography) or a gas sample (e.g., when performing gas chromatography). Furthermore, the control unit 70 provides a function that ensures that a user who operates the analysis device 100 in a manner that deviates from long-standing user habits will receive feedback as a warning. The user can then confirm the deviation from user habits so that the analysis device 100 will continue according to the user's instructions, or can change the instructions for operating the analysis device 100 if the deviation from long-standing user habits was unintentional.

[0095] In order to provide this function, the control unit 70 includes a monitoring unit 110, which is configured to monitor the current user behavior when operating the analysis device 100. In addition, the comparison unit 112 of the control unit 70 is configured to compare the monitored current user behavior with the previous user behavior. In addition, the determination unit 114 of the control unit 70 is configured to trigger an action when the result of the comparison unit 112 indicates a significant difference between the monitored current user behavior and the previous user behavior. For example, the monitoring unit 110, the comparison unit 112 and the determination unit 114 can be separate processors. However, it is also possible that the functions of the monitoring unit 110, the comparison unit 112 and the determination unit 114 are integrated in one or more common processors or in a part of a processor. The functions can also be partially or wholly integrated in software.

[0096] The monitoring tasks performed by the monitoring unit 110 may also include monitoring which analytical instrument 102 the user is currently using or intends to use to analyze a sample according to the analytical method 104. The analytical instrument 102 may be any one or any combination of the replaceable components shown by reference lines 25, 27, 97, 20, 40, 95, 30, 50, and 60. Additionally or alternatively, the analytical instrument 102 may also include one or more consumables, such as a mobile phase supplied to the fluid driver 20. Furthermore, additionally or alternatively, other replaceable components may form part of the analytical instrument 102, such as a sample loop or any other type of sample holding volume 128 for temporarily holding a sample from a sample container 130. The sampling needle 124 and / or metering device 126 (e.g., a syringe pump) used by the analytical instrument 102 to draw a fluid sample from the sample container 130, and / or the needle seat 122 for receiving the sampling needle 124, and / or the tubing 132, etc., may also be monitored.

[0097] The analytical method 104 to be performed can be a chromatographic separation method, i.e., a set of parameter values and commands to be applied to the analytical device 100 during the execution of a specific analytical run to separate a specific fluid sample. As shown, a plurality of different analytical methods 104, 104', etc. can be stored in a database 106 (e.g., a mass storage device). The control unit 70 can access the database 106 to obtain a data set representing the corresponding analytical method 104, 104', etc.

[0098] Figure 1 Also shown is an input / output user interface 136 via which a user may input data, information, and instructions to the analysis device 100 , and via which notifications, messages, queries, etc. may be displayed to the user.

[0099] Returning to the functionality of the comparison unit 112, the latter can be configured to determine whether the following two correspond to each other: an analysis device equipment 102 (e.g., a chromatographic separation column) currently or intended to be used with the analysis method 104 selected by the user for separating a sample (e.g., a sample including a specific active pharmaceutical ingredient), and an analysis device equipment 102 (e.g., a chromatographic separation column used for a previous analysis) previously used with the same analysis method 104 for separating the same sample (i.e., a pharmaceutical sample including the same active pharmaceutical ingredient) on the same analysis device 100.

[0100] In addition, the determination unit 114 can also be configured to determine that a difference exists when the analysis device set 102 currently or intended to be used with the analysis method 104 for separating the sample is different from or not of the same type as a previously used analysis device set 102 used in conjunction with the same analysis method 104 for separating the same type of drug sample. In short, taking the analysis device set 102 as an example, when different types of chromatographic separation columns are used on the same analysis device 100 to analyze the same type of sample with the same analysis method 104, a difference can be assumed. Given this difference, it is reasonable to assume that the user has mistakenly or unintentionally selected the wrong chromatographic separation column for the current separation run. Given the determined difference, the determination unit 114 can trigger an appropriate predefined action, as described below. However, the control unit 70 can avoid executing the analysis run indicated by the user in view of the determined difference, unless the processing of the triggering action results in the analysis run still being executed, as also described below. Accordingly, the determination unit 114 can be configured to determine that there is no discrepancy when the analysis device assembly 102 currently or intended to be used with the analysis method 104 for separating the drug sample is the same as or of the same type as a previously used analysis device assembly 102. Therefore, for an analysis run separating the same drug sample using the same analysis method 104 on the analysis device 100, consistent user behavior can be determined if the user intended to use a physically identical chromatographic separation column, or at least a chromatographic separation column of the same type and size, as in multiple previous corresponding separation runs separating the same drug sample using the same analysis method 104 on the analysis device 100. In this case, there is no indication that the user made an incorrect selection of the analysis device assembly 102, and the analysis run can be performed as instructed by the user.

[0101] In order to broaden the data base so that the determination unit 114 can make a meaningful judgment on whether a sufficiently serious difference can be obtained, the control unit 70 can be configured to create a user habit profile 140 by associating the used analysis device equipment 102 with the analysis method 104. The user habit profile 140 can be stored in the database 106 for access by the control unit 70. The user habit profile 140 can include a data set indicating which separation method 104, 104', ... has been used by which analysis device 100, 100' on which analysis device 102 to separate which sample for multiple historical analysis runs. For example, the analysis device 100' can be another chromatographic sample separation device. The user habit profile 140 can be accessed and used by the comparison unit 112 and / or the determination unit 114 when comparing the monitored current user behavior with the previous user behavior (as recorded by the user habit profile 140) and / or determining whether there is a difference between the monitored current user behavior and the previous user behavior. The user habit profile 140 can reflect the user habits in multiple previous or historical separation runs under the same or comparable settings. In order to determine the data for creating the user habit profile 140, the monitoring unit 110 may be configured to monitor the previous user behavior when operating the analysis device 100 before monitoring the current user behavior. It is also possible that the data for creating the user habit profile 140 is obtained from the monitored analysis runs performed on one or more other analysis devices 100'... In order to obtain meaningful user habits, rather than an abnormal one-time adjustment to create the user habit profile 140, the previous user behavior may be monitored multiple times when operating the analysis device 100 and / or another analysis device 100'... Advantageously, the determination unit 114 may be configured to determine that there is a difference only when the monitored current user behavior deviates from the previous user habits obtained from at least a predefined number of previous user behaviors (preferably at least three or even at least five times).

[0102] As previously described, the determination unit 114 may be configured to operate the analysis device 100 to analyze the sample based on the current user behavior when it is determined that there is no difference between the monitored current user behavior and the previous user behavior. In other words, the analysis run may be performed as requested or adjusted by the user in the absence of a determined difference.

[0103] However, the determining unit 114 may be configured to trigger an action when determining that there is a difference between the current user behavior and the previous user behavior. Different from operating the analysis device 100 to analyze the sample according to the current user behavior, the action triggered when determining the difference can reflect the following fact: the current user behavior is determined to be possibly inappropriate, suspicious, wrong or unintentional. A suitable triggering action can be to provide feedback corresponding to the difference to the user, for example, via the input / output user interface 136. For example, the user can be informed that the current user behavior significantly deviates from the previous user behavior. Via the input / output user interface 136, the user can be asked to confirm whether the analysis of the sample should still be performed according to the monitored current user behavior despite the existence of the difference. When the user confirms that the analysis should be performed according to the monitored current user behavior, the analysis will be performed accordingly. When the user understands that the current user behavior is due to an error (for example, if the user accidentally assembles the wrong chromatographic separation column in the analysis device 100), the user can cancel the intended analysis run and can prepare the correction configuration of the analysis device 100 to perform the correct analysis run.

[0104] In another scenario (with, for example, a configuration with a multiple column selection valve and in which the correct column is installed, but the user inadvertently selects or assigns the wrong column), the system can be configured to determine that the correct column is available and can suggest or provide the option of assigning the correct column.

[0105] Figure 2 A schematic diagram illustrating a process performed on the sample separation device 10 according to an exemplary embodiment is shown. Figure 2 The embodiment of FIG. 1 relates to selecting a chromatographic separation column as an example of the selected analytical equipment 102. Figure 2 , showing different scenarios: using the same chromatographic separation column (i.e., a chromatographic separation column that is physically identical to the chromatographic separation column used previously) is indicated by reference symbol 200. The same chromatographic separation column can have the same unique serial number. Using the same type of chromatographic separation column (i.e., a chromatographic separation column that is physically different from the chromatographic separation column used previously but has the same characteristics and dimensions) is indicated by reference symbol 202. The chromatographic separation column of the same type can have the same product model. Using a different type of chromatographic separation column (i.e., a chromatographic separation column that is physically different from the chromatographic separation column used previously but has different characteristics and dimensions) is indicated by reference symbol 204. The different types of chromatographic separation columns can have different product models.

[0106] Referring to block 210 , a first method run may be performed using a chromatographic separation method 104 .

[0107] Referring to box 212 , the chromatographic separation column used is associated with the separation method 104 .

[0108] Referring to block 214 , the next analysis run is performed.

[0109] Referring to box 216, a series of analysis runs using the same column, the same column, the same column, and another column have been performed. This can result in a trigger event, for example, issuing feedback such as "You have used a different type of column for the last three times. Are you sure you want to continue using another column?"

[0110] Referring to box 218, a series of analysis runs have been performed using the same column, the same column, the same column, and different columns on the same type of entity. This may result in an output such as "Should this column be added as a new associated column to this method?"

[0111] Referring to box 220, a series of analysis runs have been performed using the same column, the same column, the same column, and the same column. Since no differences were found, no action is triggered and no notification is displayed.

[0112] Referring to box 222, a series of analysis runs have been performed using different columns on entities of the same type, different columns on entities of the same type, different columns on entities of the same type, and different columns on entities of the same type. Since no differences were found, no action is triggered and no notification is displayed.

[0113] Referring to block 224, a series of analysis runs have been performed utilizing different columns on the same type of entity, different columns on the same type of entity, different columns on the same type of entity, and other columns. This can result in a triggering event, for example, issuing feedback such as, "You have used a different type of column three times in the last three times. Are you sure you want to continue using a different type of column?"

[0114] Referring to block 226, a series of analysis runs using different types of columns, different types of columns, and different types of columns have been performed. Since no differences were found, no action is triggered and no notification is displayed. For example, the corresponding user may develop a new analysis method.

[0115] It should be noted that the term "comprising" does not exclude other elements or features, and "a" or "an" does not exclude a plurality. In addition, elements described in conjunction with different embodiments may be combined. It should also be noted that reference signs in the claims should not be construed as limiting the scope of the claims.

Claims

1. A process for operating an analytical device (100) to analyze a sample, the process comprising: monitoring current user behavior when operating the analysis device (100); Comparing the monitored current user behavior with previous user behavior; as well as Upon determining a difference between the monitored current user behavior and the previous user behavior, an action is triggered.

2. The process of claim 1, wherein: The monitoring includes monitoring which analysis device (102) a user is currently using or intends to use to analyze the sample according to an analysis method (104) to be performed by the analysis device (100).

3. The process of claim 2, wherein: The comparison includes determining whether the analytical equipment set (102) currently or intended to be used with the analytical method (104) corresponds to a previously used analytical equipment set (102) that has been used with the analytical method (104) in the past.

4. The process of claim 3, wherein: The process includes determining that a discrepancy exists when the analytical equipment set (102) currently or intended for use with the analytical method (104) is not the same or is not the same type as the previously used analytical equipment set (102).

5. The process according to claim 3 or 4, wherein: The process includes determining that there are no differences when the analytical equipment set (102) currently or intended to be used with the analytical method (104) is the same or of the same type as the previously used analytical equipment set (102).

6. A process according to any one of claims 2 to 5, wherein The analytical instrument assembly (102) includes one or more replaceable components and / or consumables.

7. The process of claim 6, wherein: The one or more replaceable components and / or consumables are selected from the group consisting of: a sample separation unit (30), a fluid filter, a sample holding volume (128), an injection needle (124), a needle seat (122), a mobile phase, a fluid valve (95), a tubing, a flow cell, an optical detector assembly, and a fluid driver (20).

8. A process according to any one of claims 2 to 7, wherein The analysis method (104) defines a set of operating parameter values and a set of device instructions for use in operating the analysis device (100) to analyze the sample according to the analysis method (104).

9. A process according to any one of claims 2 to 8, wherein The analytical method (104) is a sample separation method, preferably a chromatographic sample separation method.

10. A process according to any one of claims 2 to 9, wherein The process includes: Creating a user habit profile (140) by associating the used analysis equipment (102) with the analysis method (104); and The user habit profile (140) is used in determining whether there is a difference between the monitored current user behavior and the previous user behavior.

11. The process according to any one of claims 1 to 10, wherein The process includes monitoring the previous user behavior when operating the analysis device (100) and / or another analysis device (100') before monitoring the current user behavior.

12. The process according to any one of claims 1 to 11, wherein The process includes monitoring the previous user behavior when operating the analysis device (100) and / or another analysis device (100') a plurality of times before monitoring the current user behavior.

13. The process according to any one of claims 1 to 12, wherein The process includes storing user behavior data characterizing the previous user behavior and the monitored current user behavior in a database (106).

14. The process according to any one of claims 1 to 13, wherein The process includes determining that a difference exists only when the monitored current user behavior deviates from previous user habits obtained from at least a predefined number of previous user behaviors.

15. The process of claim 14, wherein: The predefined multiple times are at least three times.

16. The process according to any one of claims 1 to 15, comprising at least one of the following features: in, Monitoring the current user behavior when operating the analysis device (100) comprises receiving information from the user and / or detecting information about analysis device equipment (102) currently in use or intended to be used, in particular information about the sample separation unit (30) currently in use or intended to be used, more particularly information about the chromatographic separation column currently in use or intended to be used; wherein the triggered action is different from operating the analysis device (100) to analyze the sample according to the current user behavior; wherein the process includes, when it is determined that there is no difference between the monitored current user behavior and the previous user behavior, operating the analysis device (100) to analyze the sample according to the current user behavior; wherein operating the analysis device (100) to analyze the sample comprises at least one of the group consisting of: performing a certified analysis, performing an analysis requiring documentation, repeatedly performing a predefined analysis, performing an analysis on the sample for quality control, performing an analysis on a pharmaceutical sample, and performing an analysis on a valuable sample; wherein triggering the action comprises at least one item from the group consisting of: providing feedback corresponding to the difference to the user; informing the user of the difference; asking the user to confirm whether analysis of the sample should be performed based on the monitored current user behavior regardless of the difference; marking the analysis run performed based on the monitored current user behavior regardless of the difference; performing analysis of the sample based on the monitored current user behavior regardless of the difference only after prior approval by a superior instance; performing analysis of the sample based on the monitored current user behavior regardless of the difference only when a user profile enables the user to approve the analysis; asking the user whether the monitored current user behavior should be classified as consistent with previous user behavior regardless of the difference; and issuing a warning.

17. An analysis device (100) comprising a control unit (70) configured to perform the process according to any one of claims 1 to 16 or a control unit (70) according to claim 20.

18. The analysis device (100) according to claim 17, the analysis device (100) being configured as a sample separation device (10) for separating the sample and comprising: a fluid driver (20) for driving a mobile phase and driving the sample when the sample is injected into the mobile phase; A sample separation unit (30) is used to separate the sample in the mobile phase.

19. The analytical device (100) according to claim 17 or 18, wherein The analytical device (100) comprises at least one of the following features: The analysis device (100) is configured as a chromatographic sample separation device, in particular a liquid chromatography sample separation device, a gas chromatography sample separation device, or a supercritical fluid chromatography sample separation device; The analytical device (100) includes a detector (50) configured to detect the separated sample; The analytical apparatus (100) comprises a fractionator unit (60) configured to collect separated portions of the sample; The analytical device (100) includes a syringe (40) configured to inject the sample into the mobile phase; The analysis device (100) is configured as an electrophoresis device, in particular a capillary electrophoresis device.

20. A control unit (70) for controlling an analysis device (100) to analyze a sample, the control unit (70) comprising: a monitoring unit (110) configured to monitor current user behavior when operating the analysis device (100); a comparison unit (112), configured to compare the monitored current user behavior with the previous user behavior; as well as A determination unit (114) is configured to trigger an action when a difference between the monitored current user behavior and the previous user behavior is determined.

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