Optical measurement device, data management method for optical measurement device, and data management program for optical measurement device

Abstract

This optical measurement device is capable of: storing history data in which are combined measurement data obtained by measuring the optical characteristics of a sample, using a measurement means, and management information of a plurality of components to be managed which are detachably attached to a body of the optical measurement device; and tracking the history data when the history data is used or required. The optical measurement device comprises: a plurality of recording means that are respectively attached to a plurality of components to be managed so as to respectively record management information of the components to be managed; a plurality of reading means that are respectively disposed at positions where the recording means are attached to the components to be managed so as to respectively read the management information recorded in the recording means when the components to be managed are mounted on the body of the optical measurement device or when the components to be managed are mounted on the body of the optical measurement device and measurement is performed by the measurement means; and a storage means that stores history data in which the read management information and the measurement data obtained by the measurement performed by the measurement means are combined.

Description

Optical measuring device, data management method for optical measuring device, and data management program for optical measuring device Related Applications

[0001] This application claims priority from Japanese Patent Application No. 2024-15560, filed February 5, 2024, and incorporates by reference all of the contents of that Japanese application.

[0002] The present invention relates to an optical measuring device that can achieve the strict traceability required in the pharmaceutical industry, a data management method for an optical measuring device, and a data management program for an optical measuring device.

[0003] In the pharmaceutical industry, due to the nature of pharmaceuticals that affect human life and health, it is necessary to comply with strict standards known as GxP (Good x practice), and optical measuring devices such as polarimeters used in the manufacture and management of pharmaceuticals must be verified to be operating properly at the time of delivery or periodically.Furthermore, in the pharmaceutical industry, if an abnormality occurs in a manufactured pharmaceutical, it is necessary to fundamentally investigate the cause of the abnormality, so strict traceability is required for the measurement data of optical measuring devices such as polarimeters and the management information of managed parts.

[0004] For example, Patent Document 1 discloses that an information presentation means is fixed to the cell wall of a cuvette (hereinafter sometimes referred to as a "cell") of a polarimeter, on which cell information (shape data such as length, diameter, material, etc.), cell temperature, and cell calibration information are recorded, and when the cell is attached to the polarimeter, the information recorded on the information presentation means is read by a data receiver and transferred to a control unit.

[0005] U.S. Pat. No. 8,908,179

[0006] However, the technology described in Patent Document 1 treats only the cell of the polarimeter as a managed component, and does not store historical data that combines management information for multiple managed components other than the cell that are detachably attached to the polarimeter body with measurement data measured by the measuring means of the polarimeter, making it extremely difficult to achieve the strict traceability required in the pharmaceutical industry.

[0007] The present invention aims to solve the above-mentioned problems in the prior art and to achieve the following objectives: That is, the present invention aims to provide an optical measuring device, a data management method for an optical measuring device, and a data management program for an optical measuring device that can achieve the strict traceability required in the pharmaceutical industry.

[0008] The optical measuring device disclosed in the present invention is an optical measuring device that can store history data that combines measurement data obtained by measuring the optical properties of a sample with a measurement means of the optical measuring device and management information for a plurality of managed components that are detachably attached to the optical measuring device main body, and can use and track the history data when necessary, and has: a plurality of recording means that are attached to the plurality of managed components, respectively, for recording the management information for the managed components; a plurality of reading means that are disposed at the locations where the recording means are attached to the plurality of managed components, respectively, when the managed components are attached to the optical measuring device main body, or when the managed components are attached to the optical measuring device main body and measured with the measurement means, for reading the management information recorded in the recording means; and a storage means for storing history data that combines the read management information with measurement data measured by the measurement means.

[0009] In one aspect of the present invention, the plurality of components to be managed are preferably two or more selected from a light source, a filter, a standard sample, a cell, a thermometer, and accessories.

[0010] In one aspect of the present invention, it is preferable that the management information is at least one selected from the unique number of the managed part, the expiration date and time of the managed part, the replacement date and time of the managed part, the person who replaced the managed part, the calibration information of the standard sample, the calibration information of the thermometer, and the calibration information of the cell.

[0011] In one aspect of the present invention, the plurality of recording means are preferably one of a one-dimensional code, a two-dimensional code, an RFID tag, and an EEPROM.

[0012] In one aspect of the present invention, the plurality of reading means are preferably any one of a barcode reader, an RFID reader, an optical camera, and a reading device.

[0013] In one aspect of the present invention, the time of use / necessity is preferably any one of daily inspection, periodic inspection, qualification inspection, replacement of a part to be managed, calibration of a standard sample, repair, and when requested by a user.

[0014] In one aspect of the present invention, it is preferable to have a providing means for providing relevant history data when used or required.

[0015] In one aspect of the present invention, the provision of the history data is preferably a display of the history data and a warning on a screen of the optical measurement device, or a display of the history data and a warning on a mobile terminal.

[0016] In one aspect of the present invention, the history data is preferably stored in the storage means in a state where it is prohibited from being changed.

[0017] The data management method for an optical measuring device disclosed in the present invention is a data management method for an optical measuring device that stores history data combining measurement data obtained by measuring the optical properties of a sample with a measurement means of the optical measuring device and management information for a plurality of managed components that are detachably attached to the optical measuring device main body, and can use and track the history data when necessary, and includes: a recording step of recording the management information for the managed components in a plurality of recording means attached to the plurality of managed components, respectively; a reading step of reading the management information recorded in the recording means by a plurality of reading means disposed at the locations where the recording means are attached for the plurality of managed components, when the managed components are attached to the optical measuring device main body, or when the managed components are attached to the optical measuring device main body and measured by the measurement means; and a storage step of storing the history data combining the read management information and measurement data measured by the measurement means.

[0018] The data management program for an optical measuring device disclosed in the present invention is a data management program for an optical measuring device that can store history data that combines measurement data obtained by measuring the optical properties of a sample with a measurement means of the optical measuring device and management information for a plurality of managed components that are detachably attached to the optical measuring device main body, and can use and track the history data when necessary, and causes a computer to perform the following processes: record the management information for the managed components in a plurality of recording means attached to the plurality of managed components, respectively; read the management information recorded in the recording means by a plurality of reading means disposed at the locations where the recording means are attached on the plurality of managed components when the managed components are attached to the optical measuring device main body, or when the managed components are attached to the optical measuring device main body and measured by the measurement means; and store the history data that combines the read management information with the measurement data measured by the measurement means.

[0019] According to the present invention, it is possible to provide an optical measuring device, a data management method for an optical measuring device, and a data management program for an optical measuring device, which can solve the above-mentioned problems in the past, achieve the above-mentioned objectives, and realize the strict traceability required in the pharmaceutical industry.

[0020] FIG. 1 is a diagram showing an example of the hardware configuration of an optical measurement device of the present invention. FIG. 2 is a diagram showing an example of the functional configuration of an optical measurement device of the present invention. FIG. 3 is a flowchart showing an example of a processing flow in a data management method for an optical measurement device of the present invention. FIG. 4 is a schematic diagram of a polarimeter that is an embodiment of the optical measurement device of the present invention. FIG. 5 is a schematic diagram showing an optical rotator plate, a recording means, and a reading means, which are examples of components to be managed by the polarimeter. FIG. 6 is a schematic diagram showing a thermometer, a recording means, and a reading means, which are examples of components to be managed by the polarimeter. FIG. 7 is a schematic diagram showing a cell, a recording means, and a reading means, which are examples of components to be managed by the polarimeter. FIG. 8 is a schematic diagram showing an accessory, a recording means, and a reading means, which are examples of components to be managed by the polarimeter.

[0021] (Optical measuring device and data management method for optical measuring device) The optical measuring device of the present invention is an optical measuring device that can store historical data that combines measurement data obtained by measuring the optical properties of a sample using a measuring means of the optical measuring device and management information for a plurality of managed components that are detachably attached to the optical measuring device main body, and can use and track the historical data when necessary, and has a recording means, a reading means, and a storage means, and preferably has a measuring means and a providing means, and further has other means as necessary.

[0022] The data management method for an optical measuring device of the present invention is a data management method for an optical measuring device that stores historical data that combines measurement data obtained by measuring the optical properties of a sample using a measurement means of the optical measuring device and management information for a plurality of managed components that are detachably attached to the optical measuring device main body, and can use and track the historical data when necessary, and includes a recording process, a reading process, and a storage process, and preferably includes a measurement process and a providing process, and further includes other processes as necessary.

[0023] According to the optical measuring device of the present invention and the data management method for the optical measuring device of the present invention, measurement data obtained by measuring the optical properties of a sample using the measuring means of the optical measuring device and management information for multiple managed components that are detachably attached to the optical measuring device main body can be stored and used, and the historical data can be tracked (provided) when necessary.This makes it possible to achieve the strict traceability required in the pharmaceutical industry and to prevent the occurrence of human errors such as inputting incorrect management information for managed components, mixing up managed components when replacing them, missing calibration deadlines, missing replacement deadlines for managed components, and ordering incorrect managed components.

[0024] <Types of Optical Measuring Devices> The optical measuring device is not particularly limited as long as it is a device used in the pharmaceutical industry, which requires strict traceability, and can be appropriately selected depending on the purpose. Examples include a polarimeter, a circular dichroism dispersometer, a linear dichroism dispersometer, a birefringence measuring device, a polarization measuring device, a Raman spectrophotometer, an ultraviolet-visible-near-infrared spectrophotometer, an infrared spectrophotometer, and a spectrofluorometer.

[0025] <Parts to be managed> If only one specific part to be managed is targeted among the parts to be managed that are detachably attached to the main body of the optical measuring device, it will not be possible to achieve the strict traceability required in the pharmaceutical industry. Therefore, multiple parts to be managed that are detachably attached to the main body of the optical measuring device are targeted.

[0026] Here, "multiple managed components" refers to two or more managed components that are detachably attached to the optical measuring device main body. The types of managed components are not important, and multiple managed components of the same type may be included. Furthermore, the number of managed components is preferably three or more, more preferably a majority of the managed components (60% or more of the total managed components; if there are 10 managed components in total, six or more managed components), and even more preferably all of the managed components. Note that managed components that are detachably attached to the optical measuring device main body do not include long-life components (e.g., rotating means, display, computer, etc.) that are attached to the optical measuring device main body during device manufacture and are not generally replaced, or components that are integral and inseparable with the optical measuring device main body.

[0027] The parts to be managed are components that are detachably attached to the optical measuring device body and that constitute the optical measuring device. They are selected appropriately depending on the type of optical measuring device, and examples include light sources, filters, standard samples, cells, thermometers, and accessories.

[0028] The light source can be appropriately selected depending on the type of optical measurement device, and examples include an LED (Light Emitting Diode), a sodium lamp, a halogen lamp, and a combination of a sodium lamp and a mercury lamp.

[0029] The filter can be appropriately selected depending on the type of optical measurement device, and examples thereof include an interference filter, a polarizer, and an analyzer.

[0030] A standard sample is a sample that is measured periodically to confirm whether an optical measuring device is showing correct measurement values, and can be selected appropriately depending on the type of optical measuring device. Examples of a standard sample include an optical rotating plate for a polarimeter, a standard polystyrene film for an infrared spectrophotometer, and an optical filter for calibration of an ultraviolet-visible-near-infrared spectrophotometer.

[0031] A cell is a container into which a sample is filled, and examples include glass cells, quartz cells, flow cells, and stainless steel (SUS) cells. Glass cells are poorly permeable to ultraviolet light with wavelengths of 340 nm or less, so they are used for measurements in the visible range with wavelengths of 340 nm or more. On the other hand, quartz cells transmit light of all wavelengths in the ultraviolet and visible ranges, but are expensive and therefore are mainly used for measurements in the ultraviolet range.

[0032] Examples of thermometers for measuring the cell temperature, the sample temperature in the cell, the cell holder temperature, and the temperature of the optical rotatory plate include a temperature probe, a thermocouple, and a temperature sensor.

[0033] The accessories can be selected appropriately depending on the type of optical measurement device, and examples of such accessories include cell holders, such as Peltier cell holders, thermostatic cell holders, and cell holders for micromeasurements.

[0034] When the optical measuring device is a polarimeter, examples of parts to be managed include a light source, filters (interference filter, polarizer, analyzer), cell, standard sample (optical rotation plate), accessories (cell holder), modulator, detector, etc. In order to maintain the measurement accuracy of optical rotation in a polarimeter, a standard sample solution such as a sucrose solution whose optical rotation is known in advance is used as the standard sample, but since it is time-consuming to prepare multiple standard sample solutions with different optical rotations and a certain degree of error occurs in the optical rotation when preparing the standard sample solution, an optical rotation plate is preferably used. The optical rotatory plate used is one that has been accurately measured for its angle of rotation at a wavelength of 589 nm using a standard polarimeter calibrated with the primary standard of NIST (National Institute of Standards and Technology) or PTB (Physikalisch-Technische Bundesanstalt; German Physical-Technical Institute), and a valued (calibrated) optical rotatory plate is used.

[0035] When the optical measurement device is a circular dichroism spectrometer, the parts to be managed include, for example, a light source, a filter, a cell, a standard sample, a cell holder, a detector, and accessories. When the optical measurement device is a Raman spectrophotometer, the parts to be managed include, for example, a light source, a filter, a cell, a standard sample (standard polystyrene film), a cell holder, a diffraction grating, a detector, and accessories. When the optical measurement device is an ultraviolet-visible-near-infrared spectrophotometer, the parts to be managed include, for example, a light source, a filter, a cell, a standard sample (calibration optical filter), a detector, and accessories. When the optical measurement device is an infrared spectrophotometer, the parts to be managed include, for example, a light source, a filter, a cell, a standard sample (standard polystyrene film), a detector, and accessories.

[0036] <Management Information> Management information is information that needs to be managed for a managed part, and can be selected appropriately depending on the type of managed part. Examples of management information include the unique number of the managed part, the expiration date of the managed part, the replacement date and time of the managed part, the person who replaced the managed part, calibration information for a standard sample, calibration information for a thermometer, and calibration information for a cell.

[0037] The unique number of the part to be managed is an individual number that is uniquely assigned to each part to be managed by the manufacturer of the optical measuring device, and is sometimes called a serial number.

[0038] The expiration date of the managed part is the product life of the managed part, and the technical data published by the manufacturer of the managed part can be used.

[0039] The replacement date and time of the managed component is the date and time when the managed component was replaced. The person who replaced the managed component is the name of the person who replaced the managed component. If the reason for replacing the managed component is other than the expiration date of the managed component, the reason for replacing the managed component can also be recorded.

[0040] When the part to be managed is a light source, the management information may include, for example, the type of light source, the unique number of the light source, the expiration date of the light source, the date and time of replacement of the light source, the person who replaced the light source, etc. When the optical measuring device is a polarimeter, the type of light source may include, for example, an LED (Light Emitting Diode), a sodium lamp, a halogen lamp, a combination of a sodium lamp and a mercury lamp, etc.

[0041] When the part to be managed is a filter, examples of the management information include the type of filter, the filter's unique number, the filter's expiration date, the date and time of filter replacement, the person who replaced the filter, etc. When the optical measuring device is a polarimeter, examples of the type of filter include an interference filter, a polarizer, and an analyzer.

[0042] When the part to be managed is a filter, the management information may include, for example, the type of accessory, the unique accessory number, the expiration date of the accessory, the date and time of replacement of the accessory, the person who replaced the accessory, etc. When the optical measurement device is a polarimeter, the accessory may include, for example, a cell holder. Types of cell holders may include, for example, a Peltier cell holder, a constant temperature cell holder, a cell holder for micromeasurement, etc.

[0043] For the standard sample, cell, and thermometer, which are parts to be managed and require periodic calibration, the following calibration information is recorded in the recording means.

[0044] Examples of calibration information for standard samples include the type of standard sample, the standard sample's unique number, the standard sample's calibration value, the calibration date and time of the standard sample, the calibration deadline for the standard sample, the person who performed the calibration, and the date and time the standard sample was replaced. The type of standard sample can be selected appropriately depending on the type of optical measurement device, such as a rotating plate for a polarimeter, a standard polystyrene film for a Raman spectrophotometer and an infrared spectrophotometer, and a calibration optical filter for a UV-Vis-NIR spectrophotometer. The standard sample's unique number is a unique number assigned to each standard sample by the standard sample manufacturer and is sometimes referred to as a serial number. The calibration value of a standard sample is the value at the time the standard sample was calibrated, such as the optical rotation for a rotating plate for a polarimeter, the wavenumber for a standard polystyrene film for an infrared spectrophotometer, and the transmittance (absorbance) for a calibration optical filter for a UV-Vis-NIR spectrophotometer. The calibration date and time of a standard sample is the date and time the standard sample was calibrated. The calibration deadline for a standard sample is the deadline for the next calibration of the standard sample, and is usually determined and managed by the user. The person who calibrated the standard sample is the name of the person who calibrated the standard sample. The replacement date and time of the standard sample is the date and time when the standard sample was replaced.

[0045] Examples of cell calibration information include the cell type, the cell's unique number, the cell's temperature, the calibration value of the cell's optical path length, the date and time of the cell's optical path length calibration, the deadline for the cell's optical path length calibration, the person who performed the cell's optical path length calibration, and the date and time of the cell replacement.

[0046] Thermometers need to be calibrated periodically or as needed to manage the accuracy of temperature measurements. Examples of thermometer calibration information include the type of thermometer, the thermometer's unique number, the thermometer's calibration value, the thermometer's calibration date and time, the thermometer's calibration expiration date, the person who calibrated the thermometer, and the thermometer's replacement date and time.

[0047] <Recording process and recording means> The recording process is a process of recording management information of the managed components to a plurality of recording means attached to each of a plurality of managed components that are detachably attached to the optical measuring device main body, and is preferably performed by the recording means.

[0048] The recording means can be selected appropriately depending on the type, size, shape, and structure of the managed part to which the recording means is attached, and the type of management information to be recorded, and examples include one-dimensional codes, two-dimensional codes, RFID tags, and EEPROMs.

[0049] One-dimensional codes are represented by alternating black bars of different thicknesses and white spaces. Information is written only in the horizontal direction, with no information in the vertical direction of the bars, hence the name "one-dimensional barcode" or "barcode." Two-dimensional codes have information in both the horizontal and vertical directions, and have high storage density, allowing a large amount of information to be stored in a small area. Examples of two-dimensional codes include QR Code (registered trademark). Note that the management information stored in one-dimensional and two-dimensional codes cannot be rewritten, so if the management information needs to be changed, a new one-dimensional or two-dimensional code with the rewritten management information must be issued and affixed to the managed component.

[0050] RFID (Radio Frequency Identifier) ​​uses a non-contact RFID (IC) tag that uses radio waves or electromagnetic waves as a medium for information communication, and is therefore not susceptible to being dissolved by organic solvents, as is the case with barcodes. Furthermore, there is no need to connect or route cables. Note that RFID tags are synonymous with IC tags, and are sometimes referred to as RF tags.

[0051] EEPROM (Electrically Erasable Programmable Read-Only Memory) is a type of non-volatile memory. ２ PROM is a type of memory used in computers and other electronic devices to store data, such as configuration information, that must be retained even when the power is turned off.

[0052] The use of an RFID tag or an EEPROM as the recording means allows the management information to be rewritten, which is highly convenient. Note that the management information can be rewritten either within the optical measurement device or by removing the recording means from the optical measurement device.

[0053] The method of attaching the recording means to the component to be managed is not particularly limited and can be appropriately selected depending on the purpose, and examples include attaching a sticker, attaching with an adhesive, fastening with screws, fastening with pins, etc. The recording means may be attached inside the component to be managed, or may be attached externally to the component to be managed.

[0054] <Reading process and reading means> The reading process is a process in which, when the managed part is attached to the optical measuring device main body, or when the managed part is attached to the optical measuring device main body and measured by the measuring means, the management information recorded in the recording means is read by a plurality of reading means respectively arranged at the locations where the recording means are attached on the plurality of managed parts, and is suitably carried out by the reading means.

[0055] According to the reading process, the management information recorded in the recording means of the managed parts can be automatically read without omission, thereby preventing the occurrence of human errors such as inputting the management information of the managed parts incorrectly, mistaking the managed parts when replacing them, missing the calibration deadline, missing the replacement deadline for the managed parts, and ordering the wrong managed parts.

[0056] The reading means can be appropriately selected depending on the type of recording means, and examples include a barcode reader, an RFID reader, an optical camera, and a reading device. A barcode reader is a reading means that reads management information recorded in one-dimensional codes and two-dimensional codes that are recording means. An RFID reader is a reading means that reads management information recorded in an RFID tag that is recording means. An optical camera is a reading means that reads management information recorded in one-dimensional codes and two-dimensional codes that are recording means. A reading device is a means that reads management information recorded in an EEPROM that is recording means.

[0057] Using a non-contact reading method such as an RFID tag and an RFID reader is effective in preventing cable connection, routing, and corrosion caused by water, and can also be applied to small components to be managed, such as cells, thermometers, and optical rotatory plates.

[0058] <Measuring Step and Measuring Means> The measuring step is a step of measuring the optical characteristics of a sample by the measuring means of the optical measuring device to obtain measurement data, and is suitably carried out by the measuring means.

[0059] Measurement data is data obtained by measuring the optical properties of a sample, and refers to raw data of optical property values. Measurement data includes, for example, items such as "measurement data ID," "sample type," "optical property value," "measurement date and time," and "measurer." The "measurement data ID" is a code consisting of numbers "0-9" and letters "A-Z" used to identify measurement data, and is set in advance. The "sample type" includes a standard sample, a normal measurement sample, a control sample, etc. The "optical property value" can be selected appropriately depending on the type of optical measurement device, and examples include the angle of rotation for a polarimeter, the CD value for a circular dichroism spectrometer, and the transmittance (absorbance) for a spectrophotometer. The "measurement date and time" is the date and time the sample was measured. The "measurer" is the name of the person who measured the sample.

[0060] The measuring means is appropriately selected depending on the type of optical measurement device. For example, when the optical measurement device is a "polarimeter," a polarizer is used to convert light from a light source into linearly polarized light, and the linearly polarized light is incident on a sample solution in which a substance to be measured for its optical rotation is dissolved. The linearly polarized light that has passed through the sample solution is incident on an analyzer, and the amount of light that has passed through the analyzer is detected. The analyzer is rotated while detecting the amount of light that has passed through it, and the rotation angle of the analyzer at which the amount of light passing through the analyzer becomes zero can be determined, thereby measuring the angle by which the sample solution has rotated the polarization plane of the linearly polarized light, i.e., the optical rotation of the substance.

[0061] <Storage Step and Storage Means> The storage step is a step of storing history data that combines the management information of the managed parts that have been read and the measurement data measured by the measurement means, and is preferably performed by the storage means.

[0062] The history data is data that combines measurement data and management information, and the combination of the measurement data and management information can be performed by software stored in the computer of the optical measurement device.

[0063] When a part to be managed is attached to the optical measuring device main body, the management information recorded in the recording means can be read, the management information can be saved in a computer, and history data can be created by combining it with measurement data measured by the measurement means. Also, when a part to be managed is attached to the optical measuring device main body and measured by the measurement means, the management information recorded in the recording means can be read, and history data can be created by combining the management information and measurement data.

[0064] It is preferable to store the history data in a state where it is prohibited from being changed in order to realize the strict traceability required in the pharmaceutical industry. There are no particular limitations on the method for storing the history data in a state where it is prohibited from being changed, and any known method can be used as appropriate, such as storing the history data in a read-only state, encrypting the history data, or using a blockchain for the history data.

[0065] There are no particular restrictions on the storage means as long as it is capable of storing historical data, and it can be selected appropriately depending on the purpose. Examples include solid state drives (SSDs) and hard disk drives (HDDs).

[0066] <Providing Step and Providing Means> The providing step is a step of providing the relevant history data when it is used or required, and is suitably performed by the providing means. Examples of times when it is used or required include daily inspection, periodic inspection, qualification inspection, replacement of a part to be managed, calibration of a standard sample, repair, or when requested by a user.

[0067] Examples of the provision by the provision means include displaying the history data and issuing a warning on the screen of the optical measuring device, or displaying the history data and issuing a warning on a mobile terminal.

[0068] Examples of the warning include when the expiration date of a part to be managed has passed, when the calibration deadline of a standard sample has passed, when the measurement value of a standard sample is outside a set numerical range, and when a warning is issued before the expiration date of a part to be managed or the calibration deadline of a standard sample (for example, "The expiration date will be reached in three months"). There are no particular restrictions on the warning method as long as it can notify the user and the administrator of an abnormality, and it can be selected appropriately depending on the purpose, and examples include displaying a warning mark on the screen, sounding a warning sound from a speaker, flashing a light, etc.

[0069] The optical measuring device of the present invention can be used in connection with a management system that manages the usage status of the optical measuring device. Examples of management systems include a Laboratory Information Management System (LIMS) and an Enterprise Resource Planning (ERP). The inclusion of a management system allows historical data that combines measurement data measured by the measuring means of the optical measuring device with management information for multiple managed components to be collected centrally from the optical measuring device to the LIMS to the ERP. This prevents human errors such as input errors in the management information for managed components, mis-identification of managed components when replacing them, missing calibration deadlines, missing replacement deadlines for managed components, and ordering the wrong managed components.

[0070] <Other Steps and Means> The other means are not particularly limited and can be selected appropriately depending on the purpose, and examples thereof include communication means, input means, etc. The other steps are not particularly limited and can be selected appropriately depending on the purpose, and examples thereof include a communication step, input step, etc.

[0071] The communication means is not particularly limited as long as it is capable of communicating with the outside of the optical measurement device, and any known means may be used as appropriate, such as a transceiver.

[0072] There are no particular limitations on the input means as long as it can accept various requests to the optical measurement device, and any known means can be used as appropriate, such as a keyboard, mouse, touch panel, or microphone.

[0073] (Data management program for optical measuring device) The data management program for optical measuring device of the present invention is a data management program for optical measuring device that can store history data that combines measurement data obtained by measuring the optical properties of a sample with a measurement means of the optical measuring device and management information for a plurality of managed components that are detachably attached to the optical measuring device main body, and can use and track the history data when necessary, and causes a computer to perform the following processes: recording the management information for the managed components in a plurality of recording means attached to the plurality of managed components, respectively; reading the management information recorded in the recording means by a plurality of reading means that are respectively arranged at the locations where the recording means are attached for the plurality of managed components when the managed components are attached to the optical measuring device main body, or when the managed components are attached to the optical measuring device main body and measured by the measurement means; and storing the history data that combines the read management information with the measurement data measured by the measurement means.

[0074] The data management program for an optical measuring device of the present invention can be, for example, a program that causes a computer to execute the data management method for an optical measuring device of the present invention. Furthermore, a preferred aspect of the data management program for an optical measuring device of the present invention can be, for example, the same as a preferred aspect of the data management method for an optical measuring device of the present invention.

[0075] The data management program for the optical measuring device of the present invention can be created using various known programming languages ​​depending on the configuration of the computer system used and the type and version of the operating system.

[0076] The data management program for the optical measuring device of the present invention may be recorded on a recording medium such as an internal hard disk or an external hard disk, or on a recording medium such as a CD-ROM (Compact Disc ROM), a DVD-ROM (Digital Versatile Disk ROM), an MO disk (Magneto-Optical disk), an SD card, or a USB memory (USB (Universal Serial Bus) flash drive). Furthermore, when the data management program for the optical measuring device of the present invention is recorded on the above-mentioned recording medium, it can be used directly or by installing it on a hard disk via a recording medium reading device possessed by a computer system, as necessary. Furthermore, the management program for the optical measuring device of the present invention may be recorded in an external storage area (such as another computer) accessible from the computer system via an information communication network. In this case, the data management program for the optical measuring device of the present invention recorded in the external storage area can be used directly from the external storage area via an information and communication network or by installing it on a hard disk, as necessary. The data management program for the optical measuring device of the present invention may be divided into programs for each process and recorded on multiple recording media.

[0077] <Computer-readable recording medium> A computer-readable recording medium related to the present invention has recorded thereon a data management program for the optical measuring device of the present invention. The computer-readable recording medium related to the present invention is not particularly limited and can be appropriately selected depending on the purpose, and examples include an internal hard disk, an external hard disk, a CD-ROM, a DVD-ROM, an MO disk, an SD card, and a USB memory. Furthermore, the computer-readable recording medium related to the present invention may be a plurality of recording media on which the data management program for the optical measuring device of the present invention is recorded, divided into arbitrary processing sections.

[0078] An example of the technology disclosed in the present invention will be described in more detail below using an example configuration of the optical measurement device of the present invention, a flowchart, etc. Fig. 1 shows an example hardware configuration of the optical measurement device of the present invention. In the optical measurement device 100, for example, a control unit 101, a main memory device 102, an auxiliary memory device 103, an I / O interface 104, a communication interface 105, an input device 106, an output device 107, and a display device 108 are connected via a system bus 109.

[0079] The control unit 101 performs calculations (arithmetic operations, comparison operations, etc.), controls the operation of hardware and software, etc. The control unit 101 may be, for example, a CPU (Central Processing Unit), part of a machine used in the data management method for the optical measuring device of the present invention, or a combination of these. The control unit 101 realizes various functions by executing a program (e.g., a data management program for the optical measuring device of the present invention) loaded into the main memory device 102, etc. The processes performed by the measurement unit consisting of the measurement means of the optical measuring device of the present invention, the recording unit consisting of the recording means of the optical measuring device, the reading unit consisting of the reading means of the optical measuring device, and the storage unit consisting of the storage means of the optical measuring device can be performed by the control unit 101, for example.

[0080] The main memory device 102 stores various programs and also stores data necessary for executing the various programs. The main memory device 102 may include, for example, at least one of a ROM (Read Only Memory) and a RAM (Random Access Memory). The ROM stores various programs, such as a BIOS (Basic Input / Output System). The ROM is not particularly limited and can be selected appropriately depending on the purpose, and examples of the ROM include a mask ROM and a PROM (Programmable ROM). The RAM functions as a working area in which various programs stored in the ROM or the auxiliary memory device 103 are deployed when the control unit 101 executes them. There are no particular limitations on the RAM, and it can be appropriately selected depending on the purpose. Examples include DRAM (Dynamic Random Access Memory) and SRAM (Static Random Access Memory).

[0081] The auxiliary storage device 103 is not particularly limited as long as it can store various types of information and can be appropriately selected depending on the purpose. Examples of the auxiliary storage device 103 include a solid state drive (SSD) and a hard disk drive (HDD). The auxiliary storage device 103 may also be a portable storage device such as a CD drive, a DVD drive, or a BD (Blu-ray (registered trademark) Disc) drive. The data management program for the optical measurement device of the present invention is stored in the auxiliary storage device 103, loaded into RAM (main memory) of the main storage device 102, and executed by the control unit 101.

[0082] The I / O interface 104 is an interface for connecting various external devices, and enables input and output of data from, for example, a CD-ROM, a DVD-ROM, an MO disk, an SD card, a USB memory, and the like.

[0083] The communication interface 105 is not particularly limited, and any known interface may be used as appropriate, such as a wireless or wired communication device.

[0084] The input device 106 is not particularly limited as long as it can accept input of various requests and information to the optical measurement device 100, and any known device can be used as appropriate, such as a keyboard, a mouse, a touch panel, a microphone, etc. Furthermore, if the input device 106 is a touch panel (touch display), the input device 106 can also serve as the display device 108.

[0085] The output device 107 is not particularly limited and may be any known device, such as a printer. The display device 108 is not particularly limited and may be any known device, such as a liquid crystal display or an organic EL display.

[0086] An example of the functional configuration of the optical measurement device of the present invention is shown in Fig. 2. As shown in Fig. 2, the optical measurement device 100 includes a communication function unit 120, an input function unit 130, an output function unit 140, a display function unit 150, a memory function unit 160, and a control function unit 170.

[0087] The communication function unit 120 transmits and receives various data to and from external devices, for example. The communication function unit 120 may also receive data from external devices, for example. The input function unit 130 receives various instructions for the optical measuring device 100, for example. The input function unit 130 also receives information regarding history data to be tracked, for example. The output function unit 140 prints out the relevant history data, for example. The display function unit 150 displays the relevant history data on a display, for example.

[0088] The memory function unit 160 has, for example, a program storage DB 161 that stores various programs, and a historical data DB 162 that stores historical data that combines management information of the managed components that have been read and measurement data measured by the measurement unit.

[0089] The control function unit 170 has a measurement unit 171 consisting of the measurement means of the optical measuring device, a recording unit 172 consisting of the recording means of the optical measuring device, a reading unit 173 consisting of the reading means of the optical measuring device, and a storage unit 174 consisting of the storage means of the optical measuring device. The control function unit 170 executes, for example, various programs stored in the program storage DB 161 of the memory function unit 160, and controls the operation of the entire optical measuring device 100.

[0090] The measuring unit 171 performs a process of obtaining measurement data obtained by measuring the optical properties of a sample using, for example, a measuring means of an optical measuring device. The recording unit 172 performs a process of recording management information for the managed components in, for example, multiple recording units attached to the managed components. The reading unit 173 performs a process of reading the management information recorded in the recording unit 172 using multiple reading units disposed at the locations where the recording units are attached on the managed components, for example, when the managed components are attached to the optical measuring device main body or when the managed components are attached to the optical measuring device main body and measured by the measuring unit 171. The storage unit 174 performs a process of storing history data that combines the read management information with the measurement data measured by the measuring unit 171.

[0091] 3 is a flowchart showing an example of the process flow in the data management method for an optical measuring device of the present invention. The process flow in the data management method for an optical measuring device will be described below with reference to the functional configuration diagram of the optical measuring device in FIG.

[0092] The data management method for an optical measuring device of the present invention stores historical data that combines measurement data obtained by measuring the optical properties of a sample using the measurement means of the optical measuring device with management information for multiple managed components that are detachably attached to the optical measuring device main body, and performs processing to track the historical data when used or required.

[0093] In step S101, the recording unit 172 of the control function unit 170 in the optical measuring device 100 records management information of the managed components in the multiple recording units 172 attached to the multiple managed components, respectively, and then the process proceeds to S102.

[0094] In step S102, when a managed part is attached to the optical measuring device main body, or when a managed part is attached to the optical measuring device main body and measured by the measuring part 171 of the control function part 170 in the optical measuring device 100, the reading part 173 of the control function part 170 in the optical measuring device 100 reads the management information recorded in the recording part 172 using multiple reading parts respectively arranged at the locations where the recording parts are attached in multiple managed parts, and then the processing proceeds to S103.

[0095] In step S103, the storage unit 174 of the control function unit 170 in the optical measuring device 100 stores historical data that combines the management information of the managed parts that were read and the measurement data measured by the measurement unit 171 of the control function unit 170 in the optical measuring device 100, and then terminates this process.

[0096] In the following examples, a polarimeter, which is one embodiment of the optical measurement device of the present invention, will be specifically described, but the present invention is not limited to these examples in any way.

[0097] Figure 4 is a schematic diagram of a polarimeter, which is one embodiment of the optical measurement device of the present invention. In this polarimeter 10 of Figure 4, a light source 7, an interference filter 8, a polarizer 9, a modulator 11, a cell 5, an analyzer 12, a rotation means 13, and a detector 14 are arranged along the optical path. Note that the order of the modulator 11 and the cell 5 may be reversed. In this polarimeter 10, an optical rotatory plate 1, which is a standard sample, is placed in the position of the cell 5 during inspection, calibration, etc.

[0098] The light source 7 is an LED (Light Emitting Diode) that emits monochromatic light, and emits light when power for lighting is supplied from a lighting circuit (not shown). Note that the light source 7 may be a sodium lamp, a halogen lamp, a mercury lamp, or the like, in addition to an LED.

[0099] The interference filter 8 is a bandpass optical filter that passes light of the wavelength used to measure the optical rotation (e.g., 589 nm) and blocks light of other wavelengths. The polarizer 9 is a polarizing plate that passes only linearly polarized light components parallel to a single transmission axis, and converts the light emitted by the light source 7, which passes through the interference filter 8 and enters it, into linearly polarized light. This generates linearly polarized light. The polarizer 9 is fixed within the polarimeter, and the direction of the transmission axis specific to the polarizer 9 is also fixed, so the polarization plane of the polarized light generated by the polarizer 9 is constant.

[0100] The modulator 11 is a Faraday coil that modulates the polarization plane of linearly polarized light. This Faraday coil is located at a position where the optical path passes through it and is connected to an oscillator that generates an alternating current. The oscillator supplies an alternating current of a predetermined frequency to the Faraday coil, and the Faraday coil generates an oscillating magnetic field inside when supplied with the alternating current. The oscillating magnetic field causes the polarization plane of the linearly polarized light passing through the Faraday coil to oscillate at an amplitude and frequency that correspond to the alternating current.

[0101] The modulated linearly polarized light that has passed through the modulator 11 passes through a cell 5 filled with a liquid sample, and then passes through an analyzer 12. The cell 5 is a transparent cell into which the liquid sample is poured, and is positioned at a position where the light path passes through the liquid sample. The linearly polarized light generated when light from the light source 7 passes through a polarizer 9 is incident on the cell 5.

[0102] The analyzer 12 is a polarizing plate having a single transmission axis, and is rotated by a rotation stage serving as a rotation means 13 and installed with its angle adjusted so that the polarization direction of the polarizer 9 and the transmission axis direction of the analyzer 12 are perpendicular to each other. Of the linearly polarized light incident on the analyzer 12, only the linearly polarized component parallel to the transmission axis passes through the analyzer 12.

[0103] The linearly polarized light that has passed through the analyzer 12 is incident on the detector 14. The detector 14 is configured using a light-receiving element such as a photomultiplier tube (PMT) or a photodiode, and when it detects light, it outputs a detection signal that indicates the amount of detected light as a voltage. The intensity of the light-receiving signal output by the light-receiving element corresponds to the amount of light received by the light-receiving element. Based on the electrical signal obtained by the detector 14, the angle of rotation is calculated by a computer 15.

[0104] When there is no sample solution in the cell 5 and the transmission axes of the polarizer 9 and the analyzer 12 are perpendicular to each other, all light is blocked by the analyzer 12 and the light receiving element cannot detect it. When a sample solution having optical rotation is injected into the cell 5, the polarization plane of the linearly polarized light is rotated by the sample solution, and the linearly polarized light component parallel to the transmission axis of the analyzer 12 passes through the analyzer 12, and the light receiving element detects the light. In this state, the analyzer 12 is rotated by the rotation means 13, and the rotation angle of the analyzer 12 is calculated until the polarization plane of the linearly polarized light that has passed through the sample solution is perpendicular to the transmission axis of the analyzer 12. The calculated rotation angle is the angle by which the sample solution in the cell 5 rotates the polarization plane of the linearly polarized light, and this is the optical rotation of the sample solution.

[0105] A polarimeter control (measurement) program and a data management program for the optical measurement device of the present invention are running on the computer 15. The display 16 displays data, warnings, and the like.

[0106] In the polarimeter 10 of FIG. 4, the parts to be managed that are detachably attached to the polarimeter body include the light source 7, interference filter 8, polarizer 9, modulator 11, cell 5, optical rotatory plate 1, analyzer 12, and detector 14.

[0107] Each of the multiple management target components, namely, the light source 7, interference filter 8, polarizer 9, modulator 11, cell 5, optical rotator 1, analyzer 12, and detector 14, is equipped with a recording means 2 on which management information is recorded. When each management target component is attached to the optical measuring device main body, or when each management target component is attached to the optical measuring device main body and measured, the management information recorded in the recording means 2 is read by multiple reading means 3 disposed at the locations where the recording means of the multiple management target components are attached. The read management information is transferred to a computer 15 via a reading controller 17. Measurement data measured by the measurement means is transferred to the computer 15. Software in the computer 15 combines the management information and measurement data to create history data. This history data is stored in a history data DB 162 in the computer 15.

[0108] The acquired history data can be sent to a Laboratory Information Management System (LIMS) as needed. In the case of one-to-one communication such as RS232C, the data is sent as plain text, but when via an in-house LAN, it is sent as binary data along with format information. When the history data is sent to the LIMS, it is not stored in the computer, which reduces management costs such as backing up the history data. The history data acquired by the LIMS is sent to the ERP, where it is possible to issue a voucher for re-calibration to the user, taking into account calibration information, production information, and the expiration date of the calibration.

[0109] The plurality of recording means 2 may be one-dimensional codes, two-dimensional codes, RFID tags, or EEPROMs.

[0110] As the plurality of reading means 3, any one of a barcode reader, an RFID reader, an optical camera, and a reading device is used in correspondence with the recording means 2.

[0111] 5 is a schematic diagram showing an optical rotator plate 1, recording means 2, and reading means 3, which are examples of components to be managed by the polarimeter 10. An RFID tag is attached to the optical rotator plate 1 as recording means 2, and the RFID tag records management information such as the type of optical rotator plate, the optical rotator plate's unique number, the optical rotator plate's calibration value (angle of rotation), the date and time the optical rotator plate was calibrated, the calibration deadline for the optical rotator plate, the person who calibrated the optical rotator plate, and the date and time the optical rotator plate was replaced. While a one-dimensional code or a two-dimensional code can also be used as recording means 2, an RFID tag is highly convenient because it is contactless and the management information can be rewritten.

[0112] When the optical rotatory plate 1 is attached to the polarimeter body, the RFID reader serving as reading means 3 reads the management information from the RFID tag attached to the optical rotatory plate 1, and the read management information is combined with the measurement data measured by the measuring means to generate history data, which is then stored in the history data DB 162.

[0113] 6 is a schematic diagram showing a thermometer 4, which is an example of a part to be managed by the polarimeter 10, a recording means 2, and a reading means 3. An RFID tag is attached to this thermometer 4 as the recording means 2, and the RFID tag records management information such as the type of thermometer, the thermometer's unique number, the thermometer's calibration value (temperature), the thermometer calibration date and time, the thermometer calibration expiration date, the person who calibrated the thermometer, and the thermometer replacement date and time. While a one-dimensional code or a two-dimensional code can also be used as the recording means 2, an RFID tag is highly convenient because it is contactless and the management information can be rewritten.

[0114] When the thermometer 4 is attached to the polarimeter body, the RFID reader serving as the reading means 3 reads the management information from the RFID tag attached to the thermometer, and the read management information and the measurement data measured by the measuring means are combined to generate history data, which is then stored in the history data DB 162.

[0115] 7 is a schematic diagram showing a cell 5, which is an example of a part to be managed by the polarimeter 10, the recording means 2, and the reading means 3. An RFID tag is attached to this cell 5 as the recording means 2, and the RFID tag records management information such as the cell type, the cell's unique number, the cell's temperature, the calibration value of the cell's optical path length, the date and time of calibration of the cell's optical path length, the deadline for calibrating the cell's optical path length, the person who calibrated the cell's optical path length, and the date and time of cell replacement. While a one-dimensional code or a two-dimensional code can also be used as the recording means 2, an RFID tag is highly convenient because it is contactless and the management information can be rewritten.

[0116] When the cell is attached to the polarimeter body, the RFID reader serving as reading means 3 reads the management information from the RFID tag attached to the cell, and the read management information is combined with the measurement data to create history data, which is then stored in history data DB 162.

[0117] 8 is a schematic diagram showing an accessory 6, which is an example of a part to be managed by the polarimeter 10, a recording means 2, and a reading means 3. A cell holder is used as the accessory 6. A two-dimensional code is attached to this cell holder as the recording means 2, and the two-dimensional code records management information such as the type of cell holder, the cell holder's unique number, the cell holder's temperature, and the date and time the cell holder was attached. A one-dimensional code or an RFID tag can also be used as the recording means 2.

[0118] When the cell holder is attached to the polarimeter body, the barcode reader serving as the reading means 3 reads the management information of the two-dimensional code attached to the cell holder, and the read management information and the measurement data measured by the measuring means are combined to generate history data, which is then stored in the history data DB 162.

[0119] REFERENCE SIGNS LIST 1 Optical rotator plate 2 Recording means 3 Reading means 4 Thermometer 5 Cell 6 Accessories 7 Light source 8 Interference filter 9 Polarizer 10 Polarimeter 11 Modulator 12 Analyzer 13 Rotating means 14 Detector 15 Computer 16 Display 17 Reading controller 100 Optical measuring device 101 Control unit 102 Main memory device 103 Auxiliary memory device 104 I / O interface 105 Communication interface 106 Input device 107 Output device 108 Display device 109 System bus 160 Memory function unit 161 Program storage DB 162 History data DB 170 Control function unit 171 Measurement unit 172 Recording unit 173 Reading unit 174 Storage unit

Claims

1. An optical measuring device that can store history data combining measurement data obtained by measuring the optical characteristics of a sample with a measurement means of the optical measuring device and management information for a plurality of managed components that are detachably attached to the optical measuring device main body, and can use and track the history data when necessary, comprising: a plurality of recording means that are attached to the plurality of managed components, respectively, for recording the management information of the managed components; a plurality of reading means that are disposed at the locations where the recording means are attached on the plurality of managed components, respectively, for reading the management information recorded in the recording means when the managed components are attached to the optical measuring device main body, or when the managed components are attached to the optical measuring device main body and measured with the measurement means; and storage means for storing history data combining the read management information with the measurement data measured by the measurement means.

2. The optical measurement device according to claim 1, wherein the plurality of components to be managed are two or more selected from the group consisting of a light source, a filter, a standard sample, a cell, a thermometer, and accessories.

3. The optical measuring device of claim 2, wherein the management information is at least one selected from the unique number of the managed part, the expiration date of the managed part, the replacement date and time of the managed part, the person who replaced the managed part, calibration information of the standard sample, calibration information of the thermometer, and calibration information of the cell.

4. The optical measuring device according to claim 1, wherein the plurality of recording means are one of a one-dimensional code, a two-dimensional code, an RFID tag, and an EEPROM.

5. The optical measuring device according to claim 1, wherein the plurality of reading means are any one of a barcode reader, an RFID reader, an optical camera, and a reading device.

6. The optical measuring device according to claim 1, wherein the time of use or necessity is any one of daily inspection, periodic inspection, qualification inspection, replacement of a part to be managed, calibration of a standard sample, repair, and at the request of the user.

7. An optical measuring device according to claim 6, further comprising providing means for providing the relevant historical data when used and required.

8. The optical measuring device according to claim 7, wherein the provision of the history data is a display and warning of the history data on a screen of the optical measuring device, or a display and warning of the history data on a mobile terminal.

9. The optical measuring device according to any one of claims 1 to 8, wherein the optical measuring device is any one of a polarimeter, a circular dichroism dispersometer, a linear dichroism dispersometer, a birefringence measuring device, a polarimeter, a Raman spectrophotometer, an ultraviolet-visible-near-infrared spectrophotometer, an infrared spectrophotometer, and a spectrofluorometer.

10. A data management method for an optical measuring device that can store history data combining measurement data obtained by measuring the optical characteristics of a sample with the measurement means of the optical measuring device and management information for a plurality of managed components that are detachably attached to the main body of the optical measuring device, and can use and track the history data when necessary, comprising: a recording step of recording management information for the managed components in a plurality of recording means attached to each of the plurality of managed components; a reading step of reading the management information recorded in the recording means by a plurality of reading means disposed at the locations where the recording means are attached on the plurality of managed components, respectively, when the managed components are attached to the main body of the optical measuring device or when the managed components are attached to the main body of the optical measuring device and measured by the measurement means; and a storage step of storing history data combining the read management information with the measurement data measured by the measurement means.

11. A data management program for an optical measuring device that can store history data combining measurement data obtained by measuring the optical characteristics of a sample with the measurement means of the optical measuring device and management information for multiple managed components that are detachably attached to the main body of the optical measuring device, and can use and track the history data when necessary, wherein the program causes a computer to perform the following processes: recording the management information for the managed components in multiple recording means attached to each of the multiple managed components; reading the management information recorded in the recording means by multiple reading means disposed at the locations where the recording means are attached on the multiple managed components when the managed components are attached to the main body of the optical measuring device or when the managed components are attached to the main body of the optical measuring device and measured by the measurement means; and storing history data combining the read management information with the measurement data measured by the measurement means.

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