GB2626180A

GB2626180A - Determining discrepancy between monitored present and prior user behavior when operating analytical device

Info

Publication number: GB2626180A
Application number: GB2300528.3A
Authority: GB
Inventors: Maar Frank; Meixner Jens
Original assignee: Agilent Technologies Inc
Current assignee: Agilent Technologies Inc
Priority date: 2023-01-13
Filing date: 2023-01-13
Publication date: 2024-07-17
Also published as: WO2024150185A1; GB202300528D0

Abstract

A process of operating an analytical device 100 for analysing a sample, the process comprising monitoring a present user behaviour when operating the analytical device. Comparing the monitored present user behaviour with a prior user behaviour, and when determining a discrepancy between the monitored present user behaviour and the prior user behaviour, triggering an action. The behaviour may be associated with another analytical machine and stored in a database. The analytical device may contain consumable parts and be used in chromatography.

Description

DESCRIPTION

DETERMINING DISCREPANCY BETWEEN MONITORED PRESENT AND PRIOR USER BEHAVIOR WHEN OPERATING ANALYTICAL DEVICE

BACKGROUND ART

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

[0002] In liquid chromatography, a fluidic sample and an eluent (liquid mobile phase) may be pumped through conduits and a separation unit such as a column in which separation of sample components takes place. The column may comprise a material which is capable of separating different components of the fluidic sample.

The separation unit may be connected to other fluidic members (like a sampler or an injector, a detector) by conduits. Before the fluidic sample is introduced into a separation path between a fluid drive unit (in particular a high pressure pump) and the separation unit, a predefined amount of fluidic sample shall be intaken from a sample source (such as a sample container) via an injection needle into a sample loop by a corresponding movement of a piston within a metering device. This usually occurs in the presence of a significantly smaller pressure than what the separation unit is run with. Thereafter, an injector valve is switched so as to introduce the intaken amount of fluidic sample from the sample loop of a metering path into the separation path between fluid drive unit and the separation unit for subsequent separation. As a result, the fluidic sample is injected into the mobile phase, such as a solvent or a solvent composition. It is important for a precise separation of the fluidic sample that the composition of the mobile phase is accurate. In order to accurately define properties of a processed mobile phase, one or more fluidic valves may be implemented in a sample separation apparatus.

[0003] When a separation run is carried out for a specific fluidic 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 carried out. The execution of the separation run can be done on a liquid chromatography device composed of a plurality of modular components which can be selected and connected by a user based on the needs of a specific application. -1 -

[0004] However, it may happen that a user erroneously and unintentionally uses one or more inappropriate components, such as one or more inappropriate replaceable parts and/or consumables, when configuring an analytical device for subsequent use. For instance in a scenario in which reproducible certified separation runs are required (for instance for quality control purposes, certified applications or pharmaceutical applications), analysis results may be unusable which have been obtained with inappropriate analytical device equipment. Furthermore, valuable samples may be destroyed when using one or more inappropriate replaceable parts and/or consumables.

DISCLOSURE

[0005] It is an object of the invention to operate an analytical device in a safe and reliable way. The object is solved by the independent claims. Further embodiments are shown by the dependent claims.

[0006] According to an exemplary embodiment, a process of operating an analytical device for analyzing a sample is provided, the process comprising monitoring a present user behavior when operating the analytical device, comparing the monitored present user behavior with a prior user behavior, and when determining a discrepancy between the monitored present user behavior and the prior user behavior, triggering an action.

[0007] According to another exemplary embodiment of the invention, a control unit for controlling an analytical device for analyzing a sample is provided, the control unit comprising a monitoring unit configured for monitoring a present user behavior when operating the analytical device, a comparison unit configured for comparing the monitored present user behavior with a prior user behavior, and a determining unit configured for, when determining a discrepancy between the monitored present user behavior and the prior user behavior, triggering an action.

[0008] According to still another exemplary embodiment, an analytical device is provided which comprises a control unit configured for carrying out a process having the above-mentioned features or which comprises a control unit having the above mentioned features. -2 -

[0009] In the context of this application, the term "analytical device" may particularly denote any apparatus which is capable of analyzing a sample, in particular a fluidic sample. For example, the analytical device may be a sample separation apparatus configured for separating different fractions of a fluidic sample by applying a certain separation technique, in particular liquid chromatography. In the context of the present application, the term "sample separation apparatus" may particularly denote any apparatus which involves the transport, analysis or processing of fluids for separation of a fluidic sample. A fluid may denote a liquid, a gas or a combination of a liquid and a gas, and may optionally also include solid particles. Such a fluid may comprise a mobile phase (such as a fluidic solvent or solvent composition) and/or a fluidic sample under analysis. Examples for sample separation apparatuses are chemical analysis devices, life science apparatuses or any other biochemical analysis system such as a separation device for separating different components of a sample, particularly a liquid chromatography device. For example, the sample separation can be done by chromatography or electrophoresis.

[0010] In the context of the present application, the term "analytical method" may particularly denote an instruction for an analytical device as to how to analyze a fluidic sample. When the analytical method is a separation method, the latter may be for execution by a sample separation apparatus in order to fulfill a separation task associated with the analytical method. An analytical method can be defined by a set of parameter values (for example temperature, pressure, characteristic of a solvent composition, etc.) and hardware components of the sample separation apparatus (for example the type of separation column used) and an algorithm with commands or instructions that are executed when the analytical method is carried out. A corresponding set of technical parameters for operating the sample separation apparatus during sample separation may be pre-known, for instance stored in a database or memory accessible by a control unit controlling operation of the sample separation apparatus. Physical properties or operation parameters characterizing an analytical method may involve a transport characteristic which may include parameters such as volumes, dimensions, values of physical parameters such as pressure or temperature, and/or physical effects such as a model of friction occurring in a fluidic conduit which friction effects may be modeled, for example, according to the Hagen Poiseuille law. More particularly, the parameterization may consider -3 -dimensions of a sample separation apparatus (for instance a dimension of a fluidic channel), a volume of a fluid conduit (such as a dead volume) of the sample separation apparatus, a pump performance (such as the pump power and/or pump capacity) of the sample separation apparatus, a delay parameter (such as a delay time after switching on a sample separation apparatus) of operating the sample separation apparatus, a friction parameter (for instance characterizing friction between a wall of a fluidic conduit and a fluid flowing through the conduit) of operating the sample separation apparatus, a flush performance (particularly properties related to rinsing or flushing the sample separation apparatus before operating it or between two subsequent operations) of the sample separation apparatus, and/or a cooperation of different components of the sample separation apparatus (for instance the properties of a gradient applied to a chromatographic column).

[0011] In the context of the present application, the term "sample" may particularly denote a medium containing the matter which is actually analyzed (for example a biological sample, such as a protein solution, a pharmaceutical sample, etc.). In particular, said sample may be a fluidic sample. In this context, a fluid may be a liquid and/or gaseous medium, optionally comprising solid particles. In the course of a sample separation process, a sample and in particular a fluidic sample may be injected, inserted or introduced into a mobile phase. In the context of the present application, the term "mobile phase" may particularly denote a fluid (in particular a liquid) which serves as a carrier medium for transporting a fluidic sample from a fluid drive (such as a high pressure pump) to a sample separation unit (such as a chromatographic column) of a sample separation apparatus. For example, the mobile phase may be a (for example, organic and/or inorganic) solvent or a solvent composition (for example, water and ethanol).

[0012] In the context of the present application, the term "present user behavior" may particularly denote a user activity or a user configuration provided during preparing and/or starting of an analysis run for analyzing a sample on an analytical device. Thus, the present user behavior may relate to an analysis run which is not yet started, which is about to be started, or which is presently started. The present user behavior may relate to the definition or selection of a sample to be analyzed, an analysis method to be executed and/or one or more replaceable parts (for example a used chromatographic separation column) and/or consumables (for instance a -4 -solvent composition used as a mobile phase during a chromatographic separation run or a particular solvent container installed on the sample separation apparatus) to be used for sample analysis on the analytical device. The present user behavior may be monitored, i.e. information concerning at least one of the aforementioned elements (that is sample, analysis method, one or more replaceable parts and/or consumables) may be collected. This collection of information may be accomplished using one or more sensors or detectors (for instance an RFID reader for reading an RFID tag on a chromatographic separation column for detecting which chromatographic separation column is presently used by a user or a barcode reader for reading a barcode on a solvent bottle or a vial containing a reference sample) and/or may be received from the user (for instance by a corresponding user input received for example via a graphical user interface, etc.). This may also happen during installation or setting up the device or for instance when loading a sample tray. In other words, components (consumables or a replaceable) may be registered during installation when a barcode or an RFID tag is read or when a user scans the barcode at a dedicated location.

[0013] In the context of the present application, the term "prior user behavior" may particularly denote information concerning a historic, past or previous user activity or user configuration provided in relation to one or more analysis runs for analyzing a sample on an analytical device. Thus, the prior user behavior may relate to one or more analysis runs which have been planned, prepared and/or actually executed in the past. The prior user behavior may relate to the definition or selection of a sample which has been analyzed, an analysis method which has been executed and/or one or more replaceable parts (for example a used chromatographic separation column) and/or consumables (for instance a solvent composition used as a mobile phase during a chromatographic separation run) which has or have been used for sample analysis on the analytical device. The prior user behavior may be based on information which has been sensed or detected and/or received from a user in the past. For example, such information may be stored on and read from a database or data storage device, etc. [0014] In the context of the present application, the term "comparing monitored present user behavior with prior user behavior" may particularly denote a comparison between present and prior user behavior for identifying a full or partial match or a full or partial mismatch between said user behaviors. In particular, the compared present -5 -user behavior and prior user behavior may relate to the same sample (for instance different test volumes of beer brewed in the same brewery using the same recipe, or pharmaceutical test volumes having the same active pharmaceutical ingredient(s)) to be analyzed and to the same analysis method to be executed. For example, the compared present user behavior and prior user behavior may also relate to the same analytical device (for example one and the same liquid chromatography apparatus) on which both the present user behavior and the prior user behavior have occurred. It is however also possible that the compared present user behavior and prior user behavior may relate to different analytical devices (for instance different liquid chromatography apparatuses of the same type) on which the present user behavior and the prior user behavior have occurred. In the latter example, the comparison may be made for example in the context of an analysis method transfer from one analytical device to another or when disassembling a replaceable part (such as a chromatographic separation column) from one analytical device and assembling it to another analytical device.

[0015] In the context of the present application, the term "discrepancy between present user behavior and prior user behavior" may particularly denote a deviation between the present user behavior and the prior user behavior which may be indicative of a potentially inappropriate present user configuration for an analysis run on an analysis device. For example, when a user has used for a plurality of past analysis runs for analyzing a specific sample with a specific analysis method a certain replaceable part (for instance a specific chromatographic separation column) and/or consumable (for example a specific solvent composition of a mobile phase) and is now in the process of using for a present analysis run for analyzing the same specific sample with the same specific analysis method another replaceable part (for instance another chromatographic separation column with other dimension) and/or consumable (for example another solvent composition of a mobile phase), this may be identified as discrepancy being potentially indicative of an inappropriate user configuration. When analyzing whether or not a deviation between a present user behavior and a prior user behavior shall be classified as discrepancy triggering an action (for instance the use of another type of chromatographic separation column although the analyzed sample and the executed analysis method are the same) or shall be classified as minor deviation not triggering an action (for instance the use of -6 -a physically other chromatographic separation column of the same type in different analysis runs), at least one decision criterion may be applied. Such a decision criterion may be predefined or may be dynamically adapted depending on a user behavior monitored over time. In particular, determining whether or not there is a discrepancy between present user behavior and prior user behavior may be carried out based on at least one criterion related to consistency, inconsistency and/or a degree of consistency between the present user behavior and prior user behavior what concerns analytical device equipment selected by the user.

[0016] In the context of the present application, the term "triggering an action" may particularly denote taking a predefined measure as a consequence of an identified discrepancy. For example, different actions may be predefined for different types of discrepancies. For instance, when different types of chromatographic separation columns with different dimensions are to be used for analyzing the same sample with the same analysis method, another action (for instance a more severe action) may be taken as compared with another scenario in which different types of chromatographic separation columns with the same dimension are to be used for analyzing the same sample with the same analysis method. The determination of a discrepancy may be the trigger for the action.

[0017] In the context of the present application, the term "control unit" may particularly denote an entity controlling a process of operating an analytical device.

For example, the control unit may specifically fulfill the task of monitoring a user behavior and triggering an action when a discrepancy between the monitored user behavior and prior user behavior is found. It is however also possible that the control unit, in addition to the aforementioned tasks, controls the analytical device as a whole when analyzing a sample. In particular, a monitoring unit, a comparison unit and/or a determining unit forming part of the control unit may be embodied as different processors or may form different functional parts of a common processor. For example, the control unit and/or its monitoring unit, comparison unit and/or determining unit may be realized in a hard-wired fashion, by software and/or using circuitry connecting different electronic components.

[0018] According to an exemplary embodiment of the invention, an analytical device may be operated for analyzing a sample in a safe and reliable way. This may -7 -be accomplished by monitoring user behavior when the user presently operates the analytical device, for instance for preparing or executing an analysis run for analyzing a sample. Furthermore, the monitored present user behavior may then be compared with a prior user behavior, i.e. a corresponding or similar behavior of the user when preparing or executing an analysis run for analyzing a sample in the past. When, as a result of said comparison, a discrepancy (such as a significant enough deviation) between the monitored present user behavior and the prior user behavior is determined or identified, a corresponding action may be taken. For example, a discrepancy between prior and present user behavior concerning similar or identical analysis runs may be an indicator that a user has selected erroneously and unintentionally one or more inappropriate elements of analytical device equipment, such as one or more inappropriate replaceable parts and/or consumables, for an analysis run which has been executed in the past with one or more other elements of analytical device equipment. When taking an appropriate action (such as the issuance of a warning or a request for confirmation to the user) before executing the analysis run with the inappropriate analytical device equipment, unusable analysis results may be avoided and/or potentially valuable samples may be prevented from being destroyed in a useless analytical run.

[0019] Next, further exemplary embodiments of the process, the control unit and the analytical device will be explained.

[0020] In an embodiment, said monitoring comprises monitoring which analytical device equipment the user presently uses or intends to use for analyzing the sample in accordance with an analysis method to be executed by the analytical device. The mentioned analytical device equipment may comprise one or more modular elements of the analytical device which may be combined in a modular way to thereby configure the analytical device used for an analysis run. In particular, the monitored analytical device equipment may be a used chromatographic separation column in embodiments in which the analytical device is a chromatographic sample separation device. This monitoring concept may be based on the assumption that a user usually uses the same analytical device equipment (in particular the same chromatographic separation column) when analyzing the same sample or type of sample by the same analysis method. If this is not the case, a discrepancy may be present. -8 -

[0021] In an embodiment, said comparing comprises determining whether the analytical device equipment presently used or intended to be used with the analysis method corresponds to prior used analytical device equipment which has been used with the analysis method in the past. Hence, the mentioned comparison may provide a meaningful indicator that the user is likely unintentionally using the wrong analytical device equipment for executing an analysis run for analyzing a sample with an analysis method for which the user has used in the past several times another analytical device equipment.

[0022] In an embodiment, the process comprises determining the presence of a discrepancy when the analytical device equipment presently used or intended to be used with the analysis method is not identical with or is not of the same type as the prior used analytical device equipment. For example, the comparison may lead to the identification of a discrepancy when a user now uses another type of chromatographic separation column with other dimensions for an analysis of the same sample with the same analysis method compared with another chromatographic separation column which the same user has used consistently in the past multiple times for the same analysis.

[0023] In an embodiment, the process comprises determining the absence of a discrepancy when the analytical device equipment presently used or intended to be used with the analysis method is identical with or is of the same type as the prior used analytical device equipment. In this context, an identical analytical device equipment may denote the physically identical equipment (for example one and the same chromatographic separation column, for instance having the one and the same unique serial number). When a user uses, presently and a plurality of times in the past, one and the same analytical device equipment for analyzing the same sample with the same analysis method, no discrepancy can be identified and no other action needs to be taken apart from executing the analytical run in accordance with the user behavior. Moreover, analytical device equipment of the same type may denote physically different equipment (for example different chromatographic separation columns, for instance having the same generic product number) having the same properties (in particular having the same dimensions) and being therefore substitutable. When a user uses, presently and a plurality of times in the past, physically different analytical device equipment of the same type for analyzing the -9 -same sample with the same analysis method, no discrepancy can be identified and no other action needs to be taken apart from executing the analytical run in accordance with the user behavior.

[0024] As already mentioned above, the analytical device equipment may comprise one or more replaceable parts and/or consumables. Replaceable parts may be analytical device equipment which are configured for repeated use. Thus, replaceable parts may also be replaced from an analytical device and may be substituted by another replaced part, wherein the aforementioned replaceable part may be used later again in the same or in another analytical device. Examples for a replaceable part are a chromatographic separation column or an analytical pump.

Consumables may be analytical device equipment configured for single use only. An example for a consumable is a solvent composition (for instance a first solvent such as water and a second solvent such as an organic solvent to be mixed in a predefined mixing ratio) of a mobile phase used for a chromatographic separation run and being thereafter guided to a waste.

[0025] In an embodiment, the one or more replaceable parts and/or consumables is or are selected from a group consisting of: [0026] -a sample separation unit (for example, a chromatographic separation column) [0027] -a fluid filter (for example for filtering solid particles out of a solvent or solvent composition) [0028] -a sample accommodation volume (for example a sample loop of an injector in which a fluidic sample is temporarily accommodated before being injected into a separation path between a fluid drive and a sample separation unit of a 25 chromatographic sample separation apparatus) [0029] -an injection needle (for example a needle which can be moved between a sample container and a needle seat for intaking fluidic sample into a sample accommodation volume for subsequent injection) [0030] -a needle seat (for example a seat configured for accommodating the aforementioned injection needle) [0031] -a mobile phase (for example a solvent composition used as a carrier fluid for fluidic sample to be separated in a chromatographic sample separation path) [0032] -a fluidic valve (for instance an injector valve being switchable for injecting a fluid from a sample accommodation volume into a chromatographic separation path 5 for subsequent sample separation or a check valve for opening and closing a flow path) or parts thereof such as sealings of the like [0033] -tubing (for example a capillary, for instance connected by a fitting) [0034] -a flow cell (such as an at least partially optically transparent member through which a separated fluidic sample may flow during an optical detection thereof) [0035] -an optical detector component (for instance an ultraviolet light lamp, a grating, a fluorescence detector, etc.) [0036] -a fluid drive (for instance an analytical pump, for example embodied as piston pump).

[0037] -a mixer (for example an inlet mixer for mixing two or more solvents in the generation of a mobile phase or an outlet mixer configured to compensate inhomogeneities in the mobile phase composition) [0038] -a degassing unit (for instance for removing gas dissolved in a mobile phase) [0039] Additionally or alternatively, a plurality of and/or other replaceable parts and/or consumables may be implemented as analytical device equipment.

[0040] In an embodiment, the analysis method defines a set of operation parameter values and a set of device instructions used when operating the analytical device for analyzing the sample in accordance with the analysis method. In the context of the present application, the term "operation parameter" may particularly denote a parameter of a set of multiple parameters defining a and/or being present during a respective analytical method and describing a property adjusted or occurring during operation of an analytical device when executing an analytical method. Such operation parameters can include in particular a physical condition (in particular pressure and/or temperature, for instance at a sample separation unit such as a chromatographic column, a wavelength of a detector, integration parameters, etc.), properties of fluids used for operation (for instance a solvent composition of a mobile phase, a gradient profile, etc.), etc. Furthermore, the term "device instructions" may denote a sequence of instructions or commands defining how an analytical method is to be carried out by an analytical device. For example, said device instructions may comprise control commands to various pads of the analytical device defining their intended operation during executing the analytical method.

[0041] In an embodiment, the analysis method is a sample separation method, preferably a chromatographic sample separation method. In other words, the analysis of the sample may be its separation, for instance into different fractions. This may be accomplished by chromatography, preferably by liquid chromatography (for example by an HPLC) or by gas chromatography. Other kinds of sample separation are however possible, for example sample separation by electrophoresis (preferably by capillary electrophoresis).

[0042] In an embodiment, the process comprises creating a user habit profile by linking used analytical device equipment with the analysis method, and using said user habit profile when determining whether there is a discrepancy between the monitored present user behavior and the prior user behavior. In order to obtain meaningful information when determining a discrepancy between present user behavior and prior user behavior as a basis for triggering a specific action, the determination of a discrepancy may be made dependent on a deviation of the present user behavior from a user habit profile which may be indicative of a long-term behavior of the user in the past. In embodiments, a one-time discrepancy of a present user behavior in comparison with a single prior user behavior may not be enough for assuming a sufficient likelihood of an unintentional inappropriate present user behavior. In order to reduce the risk that a triggered action wrongly assumes that an inappropriate user behavior is present, it may be highly advantageous to determine a user habit profile as a basis for the determination whether a discrepancy is in fact present. Firstly, a user habit profile may be specifically related to a long-term past user behavior concerning a specific analytical method for analyzing a specific sample in combination with a specific analytical device equipment used for this analysis. Secondly, it may be advantageous when the user habit profile is created based on a sufficiently large number of analysis runs with the specific analytical method for analyzing the specific sample in combination with the specific analytical device equipment in the past. Preferably, a user habit profile may be created based on at least three, preferably based on at least five prior analysis runs. For example, a user habit profile may be created based on at least three, preferably based on at least five prior analysis runs in series (in particular with no other analysis or analysis method in between). By taking this measure, the reliability of a determined discrepancy may be increased and the risk of a false alarm may be advantageously reduced.

[0043] In an embodiment, the process comprises, before said monitoring of the present user behavior, monitoring said prior user behavior when operating said analytical device and/or another analytical device. Hence, information indicative of the prior user behavior may be collected in the same way as the collection of the present user behavior, for example as described above. This also allows a direct comparability of prior user behavior with present user behavior. In particular, a user input of information and/or sensed or detected information during historic analysis runs may be used for that purpose. In one alternative, the prior user behavior and the present user behavior may be monitored on an identical analytical device. This may further improve the direct comparability of prior and present user behavior. In another alternative, prior user behavior may be collected on one or more analytical devices being partially or entirely different from an analytical device on which the present user behavior is collected. This may broaden the data basis for determining a potential discrepancy. Furthermore, the latter approach may also allow to apply exemplary embodiments in terms of method transfer for transferring an analytical method from one analytical device to another analytical device. Moreover, the latter mentioned approach can also be applied when analytical device equipment is disassembled from one analytical device and is assembled to another analytical device.

[0044] In an embodiment, the process comprises, before said monitoring of the present user behavior, monitoring said prior user behavior when operating said analytical device and/or another analytical device a plurality of times. In particular, the process may comprise determining the existence of a discrepancy only when the monitored present user behavior deviates from a prior user behavior derived from at least a predefined plurality of times of the prior user behavior. For example, the prior user behavior may be based on at least three, preferably at least five, historic events of executing the same analytical method for separating the same sample before considering the existence of a highly reliable user habit profile. More specifically, the process may comprise determining the existence of a discrepancy only when the monitored present user behavior deviates from a prior user behavior derived from at least a predefined plurality of times in series. In such a configuration, it may be for instance necessary for assuming an established prior user behavior that the same configuration or at least the same component was used a pre-defined number of times (for example, three or more times) in series. For instance, such an established prior user behavior may be assumed if said configuration and/or component was used two, three or more times in series (e.g. for the same sample and/or analysis method), i.e. without a run analyzing a different sample or using a different analysis method within the series of the two, three or more runs. Accordingly, the linking of e.g. a particular column and a particular analysis method may happen when the at least last two, three or more runs of the particular analysis method have been conducted with exactly the particular column.

[0045] In an embodiment, the process comprises storing user behavior data characterizing said monitored prior user behavior and said monitored present user behavior in a database. For instance, such a database may be a mass storage device accessible by a control unit controlling the process of an exemplary embodiment.

[0046] In an embodiment, monitoring the present user behavior when operating the analytical device comprises receiving information from the user and/or detecting information concerning analytical device equipment presently used or intended to be used, in particular a sample separation unit presently used or intended to be used, more particularly a chromatographic separation column presently used or intended to be used. Said information may be received from the user for example via a user interface. Such a user interface may comprise, for example, a touchscreen, a keypad and/or a voice-recognition system. The detection of information may for instance comprise detecting a solvent composition of mobile phase, for instance based on measured flow rates. In another example, the detection of information may for instance be based on reading out a transponder (such as a radio frequency identification tag, RFID tag or reading a barcode) attached to a respective analytical device equipment (for example a chromatographic separation column) by a transponder reader (for instance an RFID reader) or a barcode reader of the analytical device.

[0047] In an embodiment, the triggered action in the event of a determined discrepancy is different from operating the analytical device for analyzing the sample in accordance with the present user behavior. Correspondingly, the process may comprise, when determining no discrepancy between the monitored present user behavior and the prior user behavior, operating the analytical device for analyzing the sample in accordance with the present user behavior. In other words, an analysis run may be executed in accordance with the present user behavior when no discrepancy is determined, and the analysis run may be not executed but in contrast to this another action will be triggered when a discrepancy is determined. When the triggered action leads to the result that execution of the analysis run in accordance with the present user behavior is approved (for instance by a further user instruction in reply to the triggered action or by a superordinate instance superior to the user and approving the present user behavior in reply to the triggered action), the analysis run may be executed in accordance with the present user behavior.

[0048] In an embodiment, operating the analytical device for analyzing the sample comprises at least one of the group consisting of executing a certified analysis, executing an analysis which requires documentation, repeatedly executing a predefined analysis, executing an analysis of the sample for quality control, executing an analysis of a pharmaceutical sample, and executing an analysis of a valuable sample. In quality critical scenarios, for instance pharmaceutical quality control, it may be of utmost importance that a sample analysis is always and repeatedly carried out under the same conditions for guaranteeing reproducibility of results. In such a scenario, the enhanced safety of operation due to the triggering of an appropriate action in the event of a frequency between present and prior user behavior may be particularly advantageous. In a similar way, some samples (for instance certain biological samples, in view of long and complex preparation thereof) may be extremely valuable, so that the safety mechanism of exemplary embodiments of the invention preventing jeopardizing of valuable samples may be highly advantageous as well.

[0049] In an embodiment, triggering the action comprises at least one of the group consisting of: [0050] -giving feedback to the user corresponding to the discrepancy (for example, the user may be asked whether operation of the analytical device shall be in fact controlled in accordance with the present user behavior) [0051] -informing the user about the discrepancy (for instance, the user may be informed that the present user behavior significantly deviates from the prior user behavior; it is also possible to inform the user which element(s) of the present user behavior deviate(s) from the prior user behavior, for example a used chromatographic separation column) [0052] -asking the user for confirmation whether or not an analysis of the sample shall be executed in accordance with the monitored present user behavior despite the discrepancy (for instance, the user may be asked whether an analysis run shall be carried out in accordance with the present user behavior or alternatively in accordance with prior user behavior) [0053] -marking an analysis run executed in accordance with the monitored present user behavior despite the discrepancy (for example, a sequence of analysis runs may be executed, one or more of which being executed in accordance with prior user behavior and one or more of which being executed in accordance with a deviating present user behavior; the one or more suspicious analysis runs executed in accordance with the deviating present user behavior may then be marked) [0054] -executing an analysis of the sample in accordance with the monitored present user behavior despite the discrepancy only upon prior approval of a superordinate instance (for instance, approval of the present user behavior by a lab manager may be required before executing an analysis run in accordance with the deviating present user behavior) [0055] -executing an analysis of the sample in accordance with the monitored present user behavior despite the discrepancy only when a user profile enables the user to approve said analysis (each user may have an assigned role with assigned authorizations; only when the authorization of the user according to an assigned user profile allows to execute an analysis run despite a discrepancy between present user behavior and prior user behavior, the analysis device may allow such an execution) [0056] -asking the user whether the monitored present user behavior shall be classified as compliant with prior user behavior despite the discrepancy (for instance, an identical chromatographic separation column may have been used multiple times according to prior user behavior, and a physically other chromatographic separation column of however the same product type may now be used in accordance with present user behavior; provided the user approves this deviation, also the use of physically other chromatographic separation columns of the same product type may be accepted in future analysis runs) [0057] -issuing a warning (a user may be warned, for instance acoustically and/or optically, when a discrepancy is identified) [0058] Additionally or alternatively, a plurality of and/or other actions may be triggered.

[0059] In an embodiment, the analytical device is configured as sample separation apparatus (in particular a liquid chromatography device, such as an HPLC (high performance liquid chromatography)) for separating the fluidic sample and comprises a fluid drive (for example an analytical pump, such as a high-pressure piston pump) for driving the fluidic sample and/or a mobile phase (such as a solvent or solvent composition) in which the fluidic sample is injected, and a sample separation unit (preferably a chromatographic separation column) for separating the fluidic sample in the mobile phase. In the context of the present application, the term "fluid drive" may particularly denote an entity capable of driving a fluid, in particular the fluidic sample and/or the mobile phase. For instance, the fluid drive may be a pump (for instance embodied as piston pump or peristaltic pump) or another source of high pressure. For instance, the fluid drive may be a high-pressure pump, for example capable of driving a fluid with 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 particularly denote a fluidic member through which a fluidic sample is transferred and which is configured so that, upon conducting the fluidic sample through the separation unit, the fluidic sample will be separated into different groups of molecules or particles. An example for a separation unit is a liquid chromatography column which is capable of trapping or retarding and selectively releasing different fractions of the fluidic sample.

[0060] In an embodiment, the analytical device may comprise an injector being configured to inject the fluidic sample into mobile phase for analyzing the fluidic sample. For instance, such an injector may comprise a needle being movable by a robot or the like to immerse the needle into sample in a sample container. Thereafter, sample may be aspirated through the needle into a sample loop of the injector. This intake process may be carried out by withdrawing a piston of a metering device.

Thereafter, the needle may be driven in a needle seat, and the aspirated fluidic sample may be injected from the sample loop into a separation path between a fluid drive and a sample separation unit (such as a chromatographic separation column).

[0061] In an embodiment, the analytical device comprises a fractionation unit being configured to collect analyzed fluidic sample. After separating a fluidic sample in fractions in a sample separation apparatus, the separated fractions may be filled in different sample vials or other sample containers where they can be stored. For example, the separated fractions downstream of a sample separation unit or of a detector may be guided through a fractionating needle into sample containers.

[0062] Embodiments may be implemented in conventionally available HPLC systems, such as the analytical Agilent 1290 Infinity II LC system or the Agilent 1290 Infinity II Preparative LC/MSD system (both provided by the applicant Agilent Technologies -see www.aniIent,cc.)m -which shall be incorporated herein by reference).

[0063] One embodiment of a sample separation apparatus comprises a pump having a pump piston for reciprocation in a pump working chamber to compress liquid in the pump working chamber to a high pressure at which compressibility of the liquid becomes noticeable. This pump may be configured to know (by means of operator's input, notification from another module of the instrument or similar) or elsewise derive solvent properties.

[0064] The sample separation unit of the sample separation apparatus preferably comprises a chromatographic column (see for instance rittalie,a.vvihjpgdip.oraiwihilQpIumr: phrpm@to.graphy) providing a stationary phase. The column may be a glass or steel tube (for instance with a diameter from 50 pm to 5 mm and a length of 1 cm to 1 m) or a microfluidic column (as disclosed for instance in EP 1577012 or the Agilent 1200 Series HPLC-Chip/MS System provided by the applicant Agilent Technologies). The individual components are retained by the stationary phase differently and at least partly separate from each other while they are propagating at different speeds through the column with the eluent. At the end of the column they elute one at a time or at least not entirely simultaneously. During the entire chromatography process the eluent may be also collected in a series of fractions. The stationary phase or adsorbent in column chromatography usually is a solid material. The most common stationary phase for column chromatography is silica gel, surface modified silica gel, followed by alumina. Cellulose powder has often been used in the past. Also possible are ion exchange chromatography, reversed-phase chromatography (RP), affinity chromatography or expanded bed adsorption (EBA). The stationary phases are usually finely ground powders or gels and/or are microporous for an increased surface.

[0065] The mobile phase (or eluent) can be a pure solvent or a mixture of different solvents (such as water and an organic solvent such as ACN, acetonitrile). It can be chosen for instance to adjust the retention of the compounds of interest and/or the amount of mobile phase to run the chromatography. The mobile phase can also be chosen so that the different compounds or fractions of the fluidic sample can be separated efficiently. The mobile phase may comprise an organic solvent like for instance methanol or acetonitrile, often diluted with water. For gradient operation water and organic is delivered in separate bottles, from which the gradient pump delivers a programmed blend to the system. Other commonly used solvents may be isopropanol, THF, hexane, ethanol and/or any combination thereof or any combination of these with aforementioned solvents.

[0066] A fluidic sample analyzed by a sample separation apparatus according to an exemplary embodiment of the invention may comprise but is not limited to any type of process liquid, natural sample like juice, body fluids like plasma or it may be the result of a reaction like from a fermentation broth.

[0067] The pressure, as generated by the fluid drive, in the mobile phase may range from 2-200 MPa (20 to 2000 bar), in particular 10-150 MPa (150 to 1500 bar), and more particular 50-120 MPa (500 to 1200 bar).

[0068] The sample separation apparatus, for instance an HPLC system, may further comprise a detector for detecting separated compounds of the fluidic sample. For example, a fluorescence or a UV-Vis detector may be implemented.

[0069] Embodiments of the invention can be partly or entirely embodied or supported by one or more suitable software programs, which can be stored on or otherwise provided by any kind of data carrier, and which might be executed in or by any suitable data processing unit. Software programs or routines can be preferably applied in or by the control unit.

BRIEF DESCRIPTION OF DRAWINGS

[0070] Other objects and many of the attendant advantages of embodiments of the present invention will be readily appreciated and become better understood by reference to the following more detailed description of embodiments in connection with the accompanied drawings. Features that are substantially or functionally equal or similar will be referred to by the same reference signs.

[0071] Figure 1 shows a sample separation apparatus in accordance with embodiments of the present invention, particularly used in high performance liquid chromatography (HPLC).

[0072] Figure 2 shows a scheme of a process for execution on a sample separation apparatus according to an exemplary embodiment.

[0073] The illustration in the drawing is schematically.

[0074] Before describing the figures in further detail, some basic considerations of the present invention will be summarized based on which exemplary embodiments 20 have been developed.

[0075] Conventionally, an analysis device can be configured by combining interchangeable components (for example chromatographic separation column, switching valve, injection loop, pump head, detector type, etc.). The different configurations can affect the flow and consequently results of the analysis.

Interchangeability can lead to incompatibilities between an analysis method and individual components.

[0076] For example, a chromatographic separation method may be executed with a certain chromatographic separation column. It may be intended to use the identical column or at least a column of the same type when performing the same chromatographic operation method again. For this purpose, the user must conventionally track manually which column was used with which chromatographic separation method and/or with which sample to prevent an unintended mismatch of chromatographic separation column and chromatographic separation method in order to avoid unintended or invalid results. The same situation may apply for other consumables or replaceable parts of the analytical device, like for instance filters, sample loops, injection needles, needle seats, solvents (which may be prepared for a particular method) or valves.

[0077] According to an exemplary embodiment of the invention, a present user behavior when operating an analytical device for analyzing a sample is monitored.

This may be done before starting an analysis run for analyzing the sample in accordance with the present user behavior. The monitored present user behavior may be compared with a prior user behavior. In particular, the latter may be indicative for example for a user habit (i.e. a habit of a user of the analytical device which may have been practiced a plurality of times in the past) concerning sample analysis by a certain analysis method to which also the present user behavior relates. If a discrepancy is determined by the comparison between the monitored present user behavior and the prior user behavior, an action may be triggered rather than merely executing the analytical method for analyzing the sample in accordance with instructions provided by the present user behavior. Advantageously, this may allow to operate an analytical device in a safe and reliable way. In particular, it may be reliably prevented that a user erroneously and unintentionally uses one or more inappropriate components, such as one or more inappropriate replaceable parts and/or consumables. This may be of utmost advantage for applications in which reproducible certified separation runs are required (for instance for quality control purposes, certified applications or pharmaceutical applications). Furthermore, exemplary embodiments may protect valuable samples from being destroyed by the use of one or more inappropriate replaceable parts and/or consumables.

[0078] For example, exemplary embodiments of the invention may learn from past behavior of users with respect to the use of replaceable parts and/or consumables of an analytical device. For example, if a user always used analytical device equipment X (for example a certain solvent or separation column, for example in the context of a certain analytical method) and the analytical device detects that analytical device -21 -equipment Y is to be used (for example another solvent or another type of separation column, for example in the context of the same analytical method), an action is triggered. Such an action may be a feedback sent to the user to verify or check whether analytical device equipment Y should in fact be used.

[0079] In order to be able to carry out such a check automatically, it may be advantageous that the configuration of analytical device equipment is known (for example with the help of one or more RFID tags or barcodes). On the other hand, it may be advantageous that additional data is available and that rules are defined in advance in order to be able to carry out an assessment of compatibility (for example the number of injections performed on a column and its upper limit, or the temperature setting of the analysis method and the maximum permissible temperature of the column).

[0080] According to an exemplary embodiment, it may be advantageous to keep a record for the assessment of compatibility, in which, for each analysis performed, it is logged which analytical method was executed with which configuration of the analysis device. Preferably, said configuration includes all interchangeable components of analytical device equipment. Based on this data set, it may be checked at the start of each analysis run whether there has been a change in the combination of analytical method and configuration of the analysis device (i.e. analytical device equipment). If such a discrepancy is detected, this may lead to a user query, as a result of which the execution of the analysis can be released or rejected.

[0081] According to an exemplary embodiment of the invention, an analytical device (for example an HPLC) may be provided which monitors user behavior (with respect to the analytical device), such as certain components being installed, changed, etc. The analytical device may also provide feedback to the user based on a previous monitoring for example of the analytical device (for example, which analytical method is running or has been running) as well as user interaction (for example, a specific user who had always used a certain chromatographic separation column is now going to use a different column). This may allow avoiding wrong or erroneous measurements which may jeopardize expensive samples. Advantageously, an exemplary embodiment of the invention may monitor user behavior and may render conclusions based on variations in the monitored user -22 -behavior.

[0082] More specifically, an exemplary embodiment of the invention may ensure use of a correct chromatographic separation column for a scheduled chromatographic separation method. The number of usages of a chromatographic separation column or other replaceable parts and/or consumables -more generally analytical device equipment -may be tracked in relation with the chromatographic separation method(s) performed with the analytical device. Performing the same chromatographic separation method with an identical analytical device equipment (for instance consumable) more than a pre-defined number of times may cause the analytical device to notify or warn the user in case the user is trying to perform said chromatographic separation method with a different analytical device equipment (for instance consumable), after the chromatographic separation method has previously been performed for the pre-defined number of times. Advantageously, this may ensure that no invalid results occur due to the use of inappropriate chromatographic separation columns with a particular chromatographic separation method. Furthermore, exemplary embodiments may mitigate the risk of using an inappropriate sample separation column for the analysis of a sample. Advantageously, a user does not need to know which chromatographic separation column belongs to which chromatographic separation method for executing the process by a control unit, for instance of an analytical device. Further advantageously, it may be possible to increase efficiency by reducing downtime of the analytical device.

[0083] 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 linked to this chromatographic separation method during and/or after the first analysis run, for example via storing the information in a database. When the same chromatographic separation method is to be performed with a different chromatographic separation column after the chromatographic separation method has previously been performed with chromatographic separation column C for a predefined number of times (for example, three or more times), then the user is prompted to verify whether the user actually intends to use the different chromatographic separation column with that chromatographic separation method. At this point, the user may recognize that the user has unintentionally used the wrong chromatographic separation column and can now select or install the right chromatographic separation column. The user may, however, also confirm that from now on the new or different chromatographic separation column should be used with this chromatographic separation method. The new chromatographic separation column is linked to the chromatographic separation method and/or replaces the previous chromatographic separation column.

[0084] In an advantageous embodiment, it may be possible to check scheduled analysis runs versus installed chromatographic separation columns. For example, such a verification may be done for all components (or for all components being considered relevant), in particular including all consumables and/or replaceables. It may be checked whether all chromatographic separation columns are already installed which shall be used with the upcoming analytical runs or sequence. This may be done in particular for chromatographic separation columns which were already linked to a chromatographic separation method. A user may be notified or asked for instructions.

[0085] Advantageously, the information about the used chromatographic separation column may be read from a tag or may be input by a user. This information can be the complete data set describing the chromatographic separation column parameters or an identifier that can be used for getting the chromatographic separation column parameters from a data base.

[0086] According to an exemplary embodiment of the invention, it may be monitored how the user operates an analysis device. Depending on the monitoring result an action may be triggered, for instance a feedback may be given to the user. In particular, past habits of the user in relation to the operation of the analytical device may be linked. More specifically, an analytical application (such as an analytical method for analyzing a sample) may be linked with components (in particular a used chromatographic separation column) of the analytical device. When determining a discrepancy of a present user behavior in comparison with past habits of the user in relation to the analytical device, a user query may be triggered asking the user whether or not the identified deviation from the user habits are actually intended.

[0087] An established user habit may be assumed when a specific analysis run has been executed at least a predefined plurality of times (for example at least three times). Such a user-related analysis run may be defined by an analysis method in combination with a sample to be analyzed and in combination with analytical device equipment used for operating the analytical device.

[0088] Referring now in greater detail to the drawings, Figure 1 depicts a general schematic of an analytical device 100 according to an exemplary embodiment of the invention. The illustrated analytical device 100 is configured as a chromatographic sample separation apparatus 10. Although not shown in Figure 1, another exemplary embodiment of the invention may use an analytical device 100 being configured as an electrophoresis separation device. A fluid drive 20 (such as a piston pump) receives a mobile phase from a solvent supply 25 via degassing unit 27, which degases and thus reduces the amount of dissolved gases in the mobile phase. The fluid drive 20 drives the mobile phase through a separation unit 30 (such as a chromatographic column) comprising a stationary phase. A sampler or injector 40, implementing a fluidic valve 95, can be provided between the fluid drive 20 and the separation unit 30 in order to subject or add (often referred to as sample introduction) a sample fluid into the mobile phase so that a fluidic sample and mobile phase may be provided towards a separation path where actual sample separation occurs. Before loading the fluidic sample into injector 40, the fluidic sample may be contained in a sample container 130. The stationary phase of the separation unit 30 is configured for separating compounds of the sample liquid. A detector 50 is provided for detecting separated compounds of the sample fluid. A fractionation unit 60 can be provided for outputting separated compounds of sample fluid in sample containers (not shown).

[0089] While the mobile phase can be comprised of one solvent only, it may also be mixed from plural solvents. Such mixing might be a low pressure mixing executed by a mixer 97 provided upstream of the fluid drive 20, so that the fluid drive 20 already receives and pumps the mixed solvents as the mobile phase. Alternatively, the fluid drive 20 may comprise plural individual pumping units, with plural of the pumping units each receiving and pumping a different solvent or mixture, so that the mixing of the mobile phase (as received by the sample separation unit 30) occurs at high pressure and downstream of the fluid drive 20 (or as part thereof). The composition of the mobile phase may be kept constant over time, the so called isocratic mode, or varied over time, the so called gradient mode.

[0090] A data processing unit or control unit 70, which can be a PC or workstation, may be coupled (as indicated by the dotted arrows) to one or more of the devices in the analytical device 100 in order to receive information and/or control operation. For example, the control unit 70 may control operation of the fluid drive 20 (for example setting control parameters) and receive therefrom information regarding the actual working conditions (such as output pressure, etc. at an outlet of the pump). Optionally, the control unit 70 may also control operation of the solvent supply 25 (for example setting the solvent/s or solvent mixture to be supplied) and/or the degassing unit 27 (for example setting control parameters and/or transmitting control commands) and may receive therefrom information regarding the actual working conditions (such as solvent composition supplied over time, vacuum level, etc.). The control unit 70 may further control operation of the sampling unit or injector 40 (for example controlling sample injection or synchronization sample injection with operating conditions of the fluid drive 20). The separation unit 30 may also be controlled by the control unit 70 (for example selecting a specific flow path or column, setting operation temperature, etc.), and send -in return -information (for example operating conditions) to the control unit 70. Accordingly, the detector 50 may be controlled by the control unit 70 (for example with respect to spectral or wavelength settings, setting time constants, start/stop data acquisition), and send information (for example about the detected sample compounds) to the control unit 70. The control unit 70 may also control operation of the fractionation unit 60 (for example in conjunction with data received from the detector 50) and provides data back.

[0091] The control unit 70 shown in Figure 1 may relate to a workstation. However, other embodiments of the invention may implement the control unit 70 on a server, for instance in a shared server configuration. Likewise, information about which consumables, replaceables, or in general components, are installed to or on which analytical device and its association to a particular method may be stored on and may be accessible from the server or from another type of control unit 70.

[0092] As already mentioned, the control unit 70 is configured for controlling the analytical device 100 for analyzing a fluidic sample (which may be a liquid sample, for example when carrying out liquid chromatography, or a gaseous sample, for instance when executing gas chromatography). Moreover, control unit 70 provides a functionality ensuring that a user operating the analytical device 100 in a way which deviates from a long-term prior user habit, will receive a feedback as sort of warning. The user may then confirm the deviation of the user habit, so that the analytical device 100 will proceed as instructed by the user, or may change the instructions to operate the analytical device 100 in the event that the deviation of long-term user habit was unintentional.

[0093] In order to provide this functionality, the control unit 70 comprises a monitoring unit 110 which is configured for monitoring a present user behavior when operating the analytical device 100. Furthermore, a comparison unit 112 of the control unit 70 is configured for comparing the monitored present user behavior with a prior user behavior. Beyond this, a determining unit 114 of the control unit 70 is configured for triggering an action, when the results of the comparison unit 112 indicates a significant discrepancy between the monitored present user behavior and the prior user behavior. For instance, monitoring unit 110, comparison unit 112, and determining unit 114 may be separate processors. It is however also possible that the functionality of monitoring unit 110, comparison unit 112, and determining unit 114 is integrated in one or more common processors or in part of a processor. Said functionality may also be integrated partially or entirely in software.

[0094] The monitoring task executed by the monitoring unit 110 may also comprise monitoring which analytical device equipment 102 the user presently uses or intends to use for analyzing the sample in accordance with an analysis method 104. The mentioned analytical device equipment 102 may be any or any combination of the replaceable parts shown with reference line 25, 27, 97, 20, 40, 95, 30, 50, 60. Additionally or alternatively, the mentioned analytical device equipment 102 may also comprise one or more consumables, such as the mobile phase supplied to the fluid drive 20. Further additionally or alternatively, also other replaceable parts may form part of the analytical device equipment 102, for instance a sample loop or any other kind of sample accommodation volume 128 for temporarily accommodating sample from sample container 130. Also sample needle 124 and/or metering device 126 (for instance a syringe pump) for aspirating fluidic sample from sample container 130 and/or needle seat 122 for receiving sample needle 124, and/or tubing 132, etc. may be monitored analytical device equipment 102.

[0095] The analysis method 104 to be executed may be a chromatographic separation method, i.e. a set of parameter values and commands applied to the analytical device 100 during carrying out a specific analysis run for separating a specific fluidic sample. As shown, a plurality of different analysis methods 104, 104', etc. may be stored in a database 106 such as a mass storage device. Control unit 70 may access database 106 for obtaining a data set characterizing a respective analysis method 104, 104', ...

[0096] Figure 1 also shows an input/output user interface 136 via which a user may input data, information and instructions to analytical device 100 and via which a notification, a message, a query or the like may be displayed to the user.

[0097] Coming back to the functionality of comparison unit 112, the latter may be configured for determining whether the analytical device equipment 102, for instance the chromatographic separation column, presently used or intended to be used with the analysis method 104 selected by the user for separating the sample (for example a sample comprising a certain active pharmaceutical ingredient) corresponds to prior used analytical device equipment 102 (for example a chromatographic separation column used for a former analysis) with the same analysis method 104 for separating the same sample (i.e. a pharmaceutical sample comprising the same active pharmaceutical ingredient) on the same analytical device 100.

[0098] Furthermore, the determining unit 114 may be further configured for determining the presence of a discrepancy when the analytical device equipment 102 presently used or intended to be used with the analysis method 104 for separating said sample is not identical with or is not of the same type as the prior used analytical device equipment 102 used in combination with the same analysis method 104 for separating the same type of pharmaceutical sample. To put it shortly, a discrepancy may be assumed when the same type of sample is analyzed with the same analysis method 104 on the same analysis device 100 using different types of chromatographic separation columns as an example for analytical device equipment 102. In view of this discrepancy, it may be reasonably assumed that the user erroneously or unintentionally selected the wrong chromatographic separation column for the present separation run. In view of the determined discrepancy, the determining unit 114 may trigger an appropriate predefined action, as described below. However, the control unit 70 may, in view of the determined discrepancy, refrain from executing the analytical run instructed by the user unless the processing of the triggered action leads to the result that the analytical run should be nevertheless executed, as described below as well. Correspondingly, the determining unit 114 may be configured for determining the absence of a discrepancy when the analytical device equipment 102 presently used or intended to be used with the analysis method 104 for separating said pharmaceutical sample is identical with or is of the same type as the prior used analytical device equipment 102. Hence, if a user intends to use -for an analysis run on the analytical device 100 using the same analysis method 104 for separating the same pharmaceutical sample -the physically identical chromatographic separation column or at least a chromatographic separation column of the same type and dimension as for a plurality of prior corresponding separation runs on the analytical device 100 using the same analysis method 104 for separating the same pharmaceutical sample, a consistent user behavior may be determined. In such a scenario, there is no indication that an erroneous selection of analytical device equipment 102 has been made by user, so that the analytical run may be executed as instructed by the user.

[0099] In order to broaden the basis of data for a meaningful determination whether or not a sufficiently severe discrepancy can be concluded by the determining unit 114, the control unit 70 may be configured for creating a user habit profile 140 by linking used analytical device equipment 102 with the analysis method 104. User habit profile 140 may be stored in database 106 for access by control unit 70. User habit profile 140 may comprise data sets indicating, for a plurality of historically executed analysis runs, which separation method 104, 104', ... has been used for the separation of which sample by which analytical device equipment 102 on which analytical device 100, 100'. For instance, analytical device 100' may be another chromatographic sample separation device. Said user habit profile 140 may be accessed and used by the comparison unit 112 and/or by the determining unit 114 when comparing monitored present user behavior with prior user behavior (as documented by user habit profile 140) and/or for determining whether there is a discrepancy between the monitored present user behavior and the prior user behavior. The mentioned user habit profile 140 may reflect a user habit in a plurality of prior or historical separation runs under identical or comparable settings. In order to determine data for creating user habit profile 140, the monitoring unit 110 may be configured for, before said monitoring of the present user behavior, monitoring said prior user behavior when operating said analytical device 100. It is also possible that data for creating user habit profile 140 is derived from monitored analytical runs executed on one or more other analytical devices 100', . In order to derive meaningful habits of the user rather than exceptional one-time adjustments for creating user habit profile 140, it may be possible to monitor said prior user behavior when operating said analytical device 100 and/or other analytical devices 100', ... a plurality of times. Advantageously, the determining unit 114 may be configured for determining the existence of a discrepancy only when the monitored present user behavior deviates from a prior user habit derived from at least a predefined plurality of times of the prior user behavior, preferably at least three or even at least five times.

[00100] As already mentioned, the determining unit 114 may be configured for, when determining no discrepancy between the monitored present user behavior and the prior user behavior, operating the analytical device 100 for analyzing the sample in accordance with the present user behavior. In other words, an analytical run may be executed as requested or adjusted by the user in the absence of a determined discrepancy.

[00101] However, the determining unit 114 may be configured for triggering an action in the event of a determined discrepancy between present and prior user behavior. Rather than operating the analytical device 100 for analyzing the sample in accordance with the present user behavior, the action triggered upon determining a discrepancy may reflect the fact that the present user behavior has been determined to be possibly inappropriate, suspicious, erroneous or unintentional. One appropriate triggered action may be to give feedback to the user, for example via the input/output user interface 136, corresponding to the discrepancy. For instance, the user may be informed that the present user behavior deviates significantly from the prior user behavior. Via the input/output user interface 136, the user may be asked for confirmation whether or not an analysis of the sample shall be executed in accordance with the monitored present user behavior despite the discrepancy. When a user confirms that the analysis shall be executed in accordance with the monitored present user behavior, the analysis will be executed correspondingly. When the user, being confronted with the feedback, understands that the present user behavior is the result of an error (for instance if the user has unintentionally assembled the wrong -30 -chromatographic separation column in the analytical device 100), the user may cancel the intended analysis run and may prepare a corrected configuration of the analytical device 100 for executing a correct analysis run.

[00102] In another scenario with a configuration with for instance a multi-column selection valve and where the correct column is installed but the user has unintentionally selected or assigned a wrong column, the system may be configured to determine that the right column is available and may suggest or offer the option to assign the correct column.

[00103] Figure 2 shows a scheme of a process for execution on a sample separation apparatus 10 according to an exemplary embodiment. The embodiment of Figure 2 relates to the selection of a chromatographic separation column as an example for selected analytical device equipment 102. According to Figure 2, different scenarios are shown: The use of an identical chromatographic separation column, i.e. the physically identical chromatographic separation column as used before, is indicated by reference sign 200. Said identical chromatographic separation column may have one and the same unique serial number. The use of a chromatographic separation column of the same type, i.e. a physically different chromatographic separation column as used before but having the same characteristics and dimensions, is indicated by reference sign 202. Said chromatographic separation columns of the same type may have the same product type number. The use of a chromatographic separation column of a different type, i.e. a physically different chromatographic separation column as used before but having different characteristics and dimensions, is indicated by reference sign 204. Said chromatographic separation columns of different types may have different product type numbers.

[00104] Referring to a block 210, a first-time method run may be executed with a certain chromatographic separation method 104.

[00105] Referring to a block 212, a used chromatographic separation column is linked to this separation method 104.

[00106] Referring to a block 214, next analytical runs are carried out.

-31 - [00107] Referring to a block 216, a sequence of analytical runs with identical column, identical column, identical column and other column has been carried out. This may lead to a triggered event such as the issuance of a feedback like "The last three times you used another kind of column. Are you sure you want to proceed with the other column?".

[00108] Referring to a block 218, a sequence of analytical runs with identical column, identical column, identical column and a physically different column of the same type has been carried out. This may lead to an output like "Should this column be added as new linked column to this method?".

[00109] Referring to a block 220, a sequence of analytical runs with identical column, identical column, identical column and identical column has been carried out. Since no discrepancy is found, no action is triggered and no notification is displayed.

[00110] Referring to a block 222, a sequence of analytical runs with physically different column of the same type, physically different column of the same type, physically different column of the same type and physically different column of the same type has been carried out. Since no discrepancy is found, no action is triggered and no notification is displayed.

[00111] Referring to a block 224, a sequence of analytical runs with physically different column of the same type, physically different column of the same type, physically different column of the same type and other column has been carried out.

This may lead to a triggered event such as the issuance of a feedback like "The last three times you used another type of column. Are you sure you want to proceed with the other type of column?".

[00112] Referring to a block 226, a sequence of analytical runs with column of different type, column of different type and column of different type has been carried out. Since no discrepancy is found, no action is triggered and no notification is displayed. For example, a corresponding user may develop a new analysis method.

[00113] It should be noted that the term "comprising" does not exclude other elements or features and the "a" or "an" does not exclude a plurality. Also elements described in association with different embodiments may be combined. It should also -32 -be noted that reference signs in the claims shall not be construed as limiting the scope of the claims.

-33 -

Claims

CLAIMS1. A process of operating an analytical device (100) for analyzing a sample, the process comprising: monitoring a present user behavior when operating the analytical device (100); comparing the monitored present user behavior with a prior user behavior; and when determining a discrepancy between the monitored present user behavior and the prior user behavior, triggering an action.
2. The process according to claim 1, wherein said monitoring comprises monitoring which analytical device equipment (102) the user presently uses or intends to use for analyzing the sample in accordance with an analysis method (104) to be executed by the analytical device (100).
3. The process according to claim 2, wherein said comparing comprises determining whether the analytical device equipment (102) presently used or intended to be used with the analysis method (104) corresponds to prior used analytical device equipment (102) which has been used with the analysis method (104) in the past.
4. The process according to claim 3, wherein the process comprises determining the presence of a discrepancy when the analytical device equipment (102) presently used or intended to be used with the analysis method (104) is not identical with or is not of the same type as the prior used analytical device equipment (102).
5. The process according to claim 3 or 4, wherein the process comprises determining the absence of a discrepancy when the analytical device equipment (102) presently used or intended to be used with the analysis method (104) is identical with or is of the same type as the prior used analytical device equipment (102).
The process according to any of claims 2 to 5, wherein the analytical device equipment (102) comprises one or more replaceable parts and/or consumables. -34-
7. The process according to claim 6, wherein the one or more replaceable parts and/or consumables is or are selected from a group consisting of a sample separation unit (30), a fluid filter, a sample accommodation volume (128), an injection needle (124), a needle seat (122), a mobile phase, a fluidic valve (95), tubing, a flow cell, an optical detector component, and a fluid drive (20).
8. The process according to any of claims 2 to 7, wherein the analysis method (104) defines a set of operation parameter values and a set of device instructions used when operating the analytical device (100) for analyzing the sample in accordance with the analysis method (104).
9. The process according to any of claims 2 to 8, wherein the analysis method (104) is a sample separation method, preferably a chromatographic sample separation method.
10. The process according to any of claims 2 to 9, wherein the process comprises: creating a user habit profile (140) by linking used analytical device equipment (102) with the analysis method (104); and using said user habit profile (140) when determining whether there is a discrepancy between the monitored present user behavior and the prior user behavior.
11 The process according to any of claims 1 to 10, wherein the process comprises, before said monitoring of the present user behavior, monitoring said prior user behavior when operating said analytical device (100) and/or another analytical device (100').
12 The process according to any of claims 1 to 11, wherein the process comprises, before said monitoring of the present user behavior, monitoring said prior user behavior when operating said analytical device (100) and/or another analytical device (100') a plurality of times.
13 The process according to any of claims 1 to 12, wherein the process comprises storing user behavior data characterizing said prior user behavior and said monitored present user behavior in a database (106).
-35 - 14 The process according to any of claims 1 to 13, wherein the process comprises determining the existence of a discrepancy only when the monitored present user behavior deviates from a prior user habit derived from at least a predefined plurality of times of the prior user behavior.
15. The process according to claim 14, wherein the predefined plurality of times is at least three.
16. The process according to any of claims 1 to 15, comprising at least one of the following features: wherein monitoring the present user behavior when operating the analytical device (100) comprises receiving information from the user and/or detecting information concerning analytical device equipment (102) presently used or intended to be used, in particular concerning a sample separation unit (30) presently used or intended to be used, more particularly concerning a chromatographic separation column presently used or intended to be used; wherein the triggered action is different from operating the analytical device (100) for analyzing the sample in accordance with the present user behavior; wherein the process comprises, when determining no discrepancy between the monitored present user behavior and the prior user behavior, operating the analytical device (100) for analyzing the sample in accordance with the present user behavior; wherein operating the analytical device (100) for analyzing the sample comprises at least one of the group consisting of executing a certified analysis, executing an analysis which requires documentation, repeatedly executing a predefined analysis, executing an analysis of the sample for quality control, executing an analysis of a pharmaceutical sample, and executing an analysis of a valuable sample; wherein triggering the action comprises at least one of the group consisting of giving feedback to the user corresponding to the discrepancy, informing the user about the discrepancy, asking the user for confirmation whether or not an analysis of the sample shall be executed in accordance with the monitored -36-present user behavior despite the discrepancy, marking an analysis run executed in accordance with the monitored present user behavior despite the discrepancy, executing an analysis of the sample in accordance with the monitored present user behavior despite the discrepancy only upon prior approval by a superordinate instance, executing an analysis of the sample in accordance with the monitored present user behavior despite the discrepancy only when a user profile enables the user to approve said analysis, asking the user whether the monitored present user behavior shall be classified as compliant with prior user behavior despite the discrepancy, and issuing a warning.
17 An analytical device (100) comprising a control unit (70) configured for carrying out a process according to any of claims 1 to 16 or a control unit (70) according to claim 20.
18. The analytical device (100) according to claim 17, configured as sample separation apparatus (10) for separating the sample and comprising: a fluid drive (20) for driving a mobile phase and the sample when injected in the mobile phase; a sample separation unit (30) for separating 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 analytical device (100) is configured as a chromatography sample separation apparatus, in particular a liquid chromatography sample separation apparatus, a gas chromatography sample separation apparatus, or a supercritical fluid chromatography sample separation apparatus; the analytical device (100) comprises a detector (50) configured to detect the separated sample; the analytical device (100) comprises a fractioner unit (60) configured to collect separated fractions of the sample; the analytical device (100) comprises an injector (40) configured to inject the -37 -sample in the mobile phase; the analytical device (100) is configured as an electrophoresis device, in particular a capillary electrophoresis device.A control unit (70) for controlling an analytical device (100) for analyzing a sample, the control unit (70) comprising: a monitoring unit (110) configured for monitoring a present user behavior when operating the analytical device (100); a comparison unit (112) configured for comparing the monitored present user behavior with a prior user behavior; and a determining unit (114) configured for, when determining a discrepancy between the monitored present user behavior and the prior user behavior, triggering an action.-38 -