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

Abstract

To provide an optical measurement device, a data management method for optical measurement devices, and a data management program for optical measurement devices, which can achieve strict traceability required in the pharmaceutical industry.SOLUTION: An optical measurement device, which stores history data combining measurement data of an optical characteristic of a sample measured by measurement means of the optical measurement device with management information on a plurality of management target components detachably mounted on an optical measurement device body, and can trace the history data when used and required, comprises: recording means attached to the management target component for recording the management information on the management target component; reading means for reading the management information recorded by the recording means when the management target component is mounted on the optical measurement device body, or when the management target component is mounted on the optical measurement device body and measured by the measurement means; and storage means for storing the history data combining the read management information with the measurement data measured by the measurement means.SELECTED DRAWING: None

Description

[Technical Field]

[0001] 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. [Background technology]

[0002] 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 functioning 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.

[0003] For this reason, 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. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 8,908,179 Summary of the Invention [Problem to be solved by the invention]

[0005] However, the technology described in Patent Document 1 treats only the polarimeter cell 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.

[0006] 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. [Means for solving the problem]

[0007] 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 characteristics of a sample with a measuring means of the optical measuring device and management information on a plurality of managed components that are detachably attached to the optical measuring device body, and can use and track the history data when necessary, a recording means attached to the management target component for recording the management information of the management target component; a reading means for reading the management information recorded in the recording means when the management object part is attached to the optical measuring device body or when the management object part is attached to the optical measuring device body and measured by the measuring means; The apparatus further comprises a storage means for storing history data that combines the read management information with the measurement data measured by the measurement means.

[0008] In one aspect of the present invention, the plurality of control parts are most of the control parts that are detachably attached to the optical measurement device body, and preferably include a light source, a filter, a standard sample, a cell, a thermometer, and accessories.

[0009] 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.

[0010] In one aspect of the present invention, the recording means is preferably one of a one-dimensional code, a two-dimensional code, an RFID tag, and an EEPROM.

[0011] In one aspect of the present invention, the reading means is preferably any one of a barcode reader, an RFID reader, an optical camera, and a reading device.

[0012] In one aspect of the present invention, the time of use or 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 at the request of a user.

[0013] In one aspect of the present invention, it is preferable to have a providing means for providing the relevant history data when the use is necessary.

[0014] In one aspect of the present invention, it is preferable that the provision of the history data is 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.

[0015] In one aspect of the present invention, the optical measurement device is preferably any one of a polarimeter, a circular dichroism dispersometer, a linear dichroism dispersometer, a birefringence measurement device, a polarization measurement device, a Raman spectrophotometer, an ultraviolet-visible-near-infrared spectrophotometer, an infrared spectrophotometer, and a spectrofluorometer.

[0016] The data management method of the optical measuring device disclosed in the present invention is a data management method of the optical measuring device that can store history data that combines measurement data obtained by measuring the optical characteristics of a sample with a measurement means of the optical measuring device and management information of a plurality of management target components that are detachably attached to the optical measuring device body, and can use and track the history data when necessary, a recording step of recording management information of the managed component in a recording means attached to the managed component; a reading step of reading the management information recorded in the recording means when the object to be managed is attached to the optical measuring device body or when the object to be managed is attached to the optical measuring device body and measured by the measuring means; and a storage step of storing history data that combines the read management information with the measurement data measured by the measurement means.

[0017] 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 stores history data that combines 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 management target components that are detachably attached to the optical measuring device body, and can be used and, when necessary, can track the history data, recording management information of the object-of-management component in a recording means attached to the object-of-management component; When the object part is attached to the optical measuring device main body, or when the object part is attached to the optical measuring device main body and measured by the optical measuring device, reading the management information recorded in the recording means; The computer is caused to execute a process of storing history data that combines the read management information with the measurement data measured by the measurement means. [Effects of the Invention]

[0018] 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. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a diagram showing an example of the hardware configuration of an optical measurement device according to the present invention. [Figure 2] FIG. 2 is a diagram showing an example of the functional configuration of the optical measurement device of the present invention. [Figure 3] FIG. 3 is a flowchart showing an example of the processing flow in the data management method for the optical measuring device of the present invention. [Figure 4] FIG. 4 is a schematic diagram of a polarimeter, which is an embodiment of the optical measurement device of the present invention. [Figure 5] FIG. 5 is a schematic diagram showing an optical rotation plate, which is an example of a part to be managed by a polarimeter, a recording means, and a reading means. [Figure 6] FIG. 6 is a schematic diagram showing a thermometer, which is an example of a part to be managed by a polarimeter, a recording means, and a reading means. [Figure 7] FIG. 7 is a schematic diagram showing a cell, which is an example of a part to be managed in a polarimeter, a recording means, and a reading means. [Figure 8] FIG. 8 is a schematic diagram showing accessories, which are an example of parts to be managed by a polarimeter, a recording means, and a reading means. DETAILED DESCRIPTION OF THE INVENTION

[0020] (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 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 with management information for multiple managed components that are detachably attached to the optical measuring device body, and can use and track the historical data when necessary, and preferably has a recording means, a reading means, and a storage means, and also has a measurement means and a providing means, and further has other means as necessary.

[0021] 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 with management information for a plurality of managed components that are detachably attached to the optical measuring device body, and can use and track the historical data when necessary, and includes a recording step, a reading step, and a storage step, and preferably includes a measurement step and a providing step, and further includes other steps as necessary.

[0022] 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 a plurality of managed components that are detachably attached to the optical measuring device main body can be stored and used, and the history 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 the wrong managed components.

[0023] <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.

[0024] <Management parts> If only one specific managed part among the managed parts that are detachably attached to the optical measuring device main body is targeted, it will not be possible to achieve the strict traceability required in the pharmaceutical industry. Therefore, the target is multiple managed parts that are detachably attached to the optical measuring device main body.

[0025] Here, the term "plurality of managed parts" refers to two or more managed parts that are detachably attached to the optical measuring device body, and the types of managed parts do not matter, so there may be multiple managed parts of the same type. Furthermore, the number of managed parts is preferably three or more, more preferably the majority of managed parts (60% or more of all managed parts; if there are 10 managed parts in total, six or more managed parts), and particularly preferably all managed parts. Note that the parts to be managed that are detachably attached to the optical measuring device body do not include long-life parts (e.g., rotating means, displays, computers, etc.) that are attached to the optical measuring device body during device manufacture and are not replaced in principle, or parts that are inseparable from the optical measuring device body.

[0026] The parts to be managed are parts that are detachably attached to the optical measuring device body and constitute the optical measuring device, and are selected appropriately depending on the type of optical measuring device, and examples include light sources, filters, standard samples, cells, thermometers, and accessories.

[0027] The light source can be appropriately selected depending on the type of optical measurement device, and examples thereof include an LED (Light Emitting Diode), a sodium lamp, a halogen lamp, and a combination of a sodium lamp and a mercury lamp.

[0028] The filter can be appropriately selected depending on the type of optical measuring device, and examples thereof include an interference filter, a polarizer, and an analyzer.

[0029] The standard sample is a sample that is measured periodically to confirm whether the optical measuring device is showing correct measurement values, and can be appropriately selected depending on the type of optical measuring device. Examples of the 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.

[0030] The cell is a container into which the 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 above 340 nm. On the other hand, quartz cells transmit light of all wavelengths in the ultraviolet and visible ranges, but are expensive and therefore primarily used for measurements in the ultraviolet range.

[0031] 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.

[0032] The accessories can be appropriately selected depending on the type of optical measurement device, and examples thereof include a cell holder, etc. Examples of the cell holder include a Peltier cell holder, a thermostatic cell holder, and a cell holder for micromeasurement.

[0033] When the optical measuring device is a polarimeter, the parts to be managed include, for example, a light source, a filter (interference filter, polarizer, analyzer), a cell, a standard sample (polarimetric plate), accessories (cell holder), a modulator, a detector, and the like. In order to maintain the accuracy of the measurement of optical rotation, polarimeters use standard sample solutions such as sucrose solutions whose optical rotation is known in advance as standard samples. However, preparing multiple standard sample solutions with different optical rotations is time-consuming, and some degree of error occurs in the optical rotation when preparing the standard sample solutions, so optical rotatory plates are 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 to the primary standards of NIST (National Institute of Standards and Technology) or PTB (Physikalisch-Technische Bundesanstalt; German Physik-Technical Institute), and is assigned a value (calibrated).

[0034] 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 a light source, a filter, a cell, a standard sample (a calibration optical filter), a detector, and accessories. When the optical measuring device is an infrared spectrophotometer, the parts to be managed include a light source, a filter, a cell, a standard sample (standard polystyrene film), a detector, and accessories.

[0035] <Management information> The management information is information that needs to be managed for the managed component, and can be selected appropriately depending on the type of managed component. Examples of the management information include the unique number of the managed component, the expiration date of the managed component, the replacement date and time of the managed component, the person who replaced the managed component, calibration information of the standard sample, calibration information of the thermometer, and calibration information of the cell.

[0036] 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.

[0037] The expiration date of the managed part is the product life of the managed part, and technical data published by the manufacturer of the managed part can be used.

[0038] The replacement date and time of a management target part is the date and time when the management target part was replaced. The person who replaced the part to be managed is the name of the person who replaced the part to be managed. If the reason for replacing the management target part is other than the expiration date of the management target part, the reason for replacing the management target part can also be recorded.

[0039] 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, and the person who replaced the light source. When the optical measurement device is a polarimeter, the type of light source may be, for example, an LED (Light Emitting Diode), a sodium lamp, a halogen lamp, or a combination of a sodium lamp and a mercury lamp.

[0040] When the part to be managed is a filter, the management information may include, for example, the type of filter, the filter's unique number, the filter's expiration date, the filter replacement date and time, and the person who replaced the filter. When the optical measuring device is a polarimeter, the types of filters include, for example, an interference filter, a polarizer, and an analyzer.

[0041] When the part to be managed is a filter, the management information may include, for example, the type of accessory, the accessory's unique number, the expiration date of the accessory, the date and time of replacement of the accessory, and the person who replaced the accessory. When the optical measurement device is a polarimeter, the accessories include, for example, a cell holder, etc. Types of cell holders include, for example, a Peltier cell holder, a thermostatic cell holder, and a cell holder for micromeasurements.

[0042] 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.

[0043] Examples of calibration information for standard samples include the type of standard sample, the unique number of the standard sample, the calibration value of the standard sample, the calibration date and time of the standard sample, the calibration deadline of the standard sample, the person who performed the calibration of the standard sample, and the replacement date and time of the standard sample. The type of the standard sample can be appropriately selected depending on the type of optical measurement device, and examples thereof include a rotating optical plate for a polarimeter, a standard polystyrene film for a Raman spectrophotometer and an infrared spectrophotometer, and a calibration optical filter for an ultraviolet-visible-near-infrared spectrophotometer. The unique number of the standard sample is an individual number that is uniquely assigned to each standard sample by the manufacturer of the standard sample, and is sometimes called a serial number. The calibration value of the standard sample is a value when the standard sample is calibrated, and examples thereof include the optical rotation in the case of an optical rotation plate of a polarimeter, the wave number in the case of a standard polystyrene film of an infrared spectrophotometer, and the transmittance (absorbance) in the case of an optical filter for calibration of an ultraviolet-visible-near-infrared spectrophotometer. The calibration date and time of the standard sample is the date and time when 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 performed the calibration of the standard sample is the name of the person who performed the calibration of the standard sample. The replacement date and time of the standard sample is the date and time when the standard sample was replaced.

[0044] 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.

[0045] The thermometer must be calibrated periodically or as needed to control the accuracy of the temperature measurement. 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 deadline, the person who calibrated the thermometer, and the thermometer's replacement date and time.

[0046] <Recording process and recording means> The recording step is a step of recording management information of the managed component in a recording means attached to the managed component which is detachably mounted on the optical measuring device body, and is preferably performed by the recording means.

[0047] The recording means can be appropriately selected 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 thereof include one-dimensional codes, two-dimensional codes, RFID tags, and EEPROMs.

[0048] The one-dimensional code is represented by alternating black bars of different thicknesses and white spaces, and is called a "one-dimensional barcode" or "barcode" because information is written only in one direction, horizontally, and there is no information in the vertical direction of the bars. The two-dimensional code has information in both the horizontal and vertical directions, has a high storage density, and can store a lot of information in a small area. Examples of such a code include QR Code (registered trademark). In addition, since the management information recorded in one-dimensional codes and two-dimensional codes cannot be rewritten, if the management information is to be changed, it is necessary to issue a new one-dimensional code or two-dimensional code with the rewritten management information and affix it to the managed component.

[0049] The 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 the effects of being dissolved by organic solvents, as is the case with barcodes. Furthermore, no cable connection or routing is required. Note that RFID tags are synonymous with IC tags and are sometimes referred to as RF tags.

[0050] The 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.

[0051] Using an RFID tag or 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.

[0052] 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 thereof 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.

[0053] <Reading process and reading means> The reading process is a process of reading the management information recorded in the recording means when the part to be managed is attached to the optical measuring device main body, or when the part to be managed is attached to the optical measuring device main body and measured by the measuring means, and is preferably performed by the reading means.

[0054] According to the reading process, the management information recorded in the recording means of the managed parts can be read automatically and 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.

[0055] The reading means can be appropriately selected depending on the type of the recording means, and examples thereof include a barcode reader, an RFID reader, an optical camera, and a reading device. The barcode reader is a reading means for reading management information recorded in one-dimensional codes and two-dimensional codes, which are recording means. The RFID reader is a reading means that reads the management information recorded on the RFID tag, which is a recording means. The optical camera is a reading means for reading the management information recorded in the one-dimensional code and two-dimensional code that are recording means. The reading device is a means for reading the management information recorded in the EEPROM, which is the recording means.

[0056] 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.

[0057] <Measurement process and measurement means> The measuring step is a step of measuring the optical characteristics of the sample by the measuring means of the optical measuring device to obtain measurement data, and is suitably carried out by the measuring means.

[0058] The measurement data is data obtained by measuring the optical properties of a sample, and means raw data of optical property values. The measurement data includes, for example, items such as "measurement data ID," "type of sample," "optical property value," "measurement date and time," and "measurer." The "measurement data ID" is a code consisting of numbers "0 to 9" and letters "A to Z" for identifying the measurement data, and is set in advance. The "type of sample" may be a standard sample, a normal measurement sample, a control sample, or the like. The "optical property value" can be appropriately selected depending on the type of optical measuring 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 when the sample was measured. The "measurer" is the name of the person who measured the sample.

[0059] 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 for which the optical rotation is to be measured 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.

[0060] <Storage process 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.

[0061] 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.

[0062] When a part to be managed is attached to the optical measuring device body, the management information recorded in the recording means is read, the management information is saved in a computer, and the management information is combined with the measurement data measured by the measuring means to create history data. Furthermore, when a part to be managed is attached to the optical measuring device body and measured by the measuring means, the management information recorded in the recording means can be read, and the management information and measurement data can be combined to create history data.

[0063] It is preferable that the history data be stored in a state where it cannot be changed, in order to achieve 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 changes are prohibited, 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 blockchaining the history data.

[0064] The storage means is not particularly limited as long as it can store historical data, and can be appropriately selected depending on the purpose. Examples include a solid state drive (SSD) and a hard disk drive (HDD).

[0065] <Providing process and providing means> The providing step is a step of providing the relevant history data when used or required, and is suitably performed by providing means. The above-mentioned times of use and necessity include, for example, daily inspections, periodic inspections, qualification inspections, replacement of parts to be managed, calibration of standard samples, repairs, or when requested by the user.

[0066] 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.

[0067] Examples of the warning include when the expiration date of the part to be managed has passed, when the calibration deadline of the standard sample has passed, when the measurement value of the standard sample is outside the set numerical range, and when a warning is issued before the expiration date of the part to be managed or the calibration deadline of the standard sample (for example, "The expiration date will be reached in 3 months"). The warning method is not particularly limited as long as it can notify the user and the administrator of the abnormality, and can be selected appropriately depending on the purpose. For example, a warning mark can be displayed on the screen, a warning sound can be emitted from a speaker, or a flashing light can be used.

[0068] The optical measuring device of the present invention can be used by connecting it to a management system that manages the usage status of the optical measuring device. Examples of the management system include a Laboratory Information Management System (LIMS) and an Enterprise Resource Planning (ERP). With the above management system, historical data that combines measurement data measured by the measurement means of the optical measuring device with management information for multiple managed parts can be collected centrally from the optical measuring device → LIMS → ERP, thereby preventing the occurrence of human errors such as input errors in management information for managed parts, mix-ups when replacing managed parts, missing calibration deadlines, missing replacement deadlines for managed parts, and ordering the wrong managed parts.

[0069] <Other steps and other means> The other means is not particularly limited and can be appropriately selected depending on the purpose, and examples thereof include communication means and input means. The other steps are not particularly limited and can be appropriately selected depending on the purpose, and examples thereof include a communication step and an input step.

[0070] The communication means is not particularly limited as long as it is capable of communicating with the outside of the optical measuring device, and any known means may be used as appropriate, such as a transceiver.

[0071] The input means is not particularly limited 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, a mouse, a touch panel, or a microphone.

[0072] (Data management program for optical measuring devices) The data management program for an optical measuring device of the present invention is a data management program for an optical measuring device that stores history data that combines 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 management target components that are detachably attached to the optical measuring device body, and can be used and, when necessary, can track the history data, recording management information of the object-of-management component in a recording means attached to the object-of-management component; When the object part is attached to the optical measuring device main body, or when the object part is attached to the optical measuring device main body and measured by the optical measuring device, reading the management information recorded in the recording means; The computer is caused to execute a process of storing history data that combines the read management information with the measurement data measured by the measurement means.

[0073] 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.

[0074] 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.

[0075] 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 reader possessed by a computer system, as necessary. The management program for the optical measuring device of the present invention may also be recorded in an external storage area (such as another computer) accessible from the computer system via an information and 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 or by installing it on a hard disk from the external storage area via an information and communication network, as necessary. The data management program for the optical measuring device of the present invention may be divided into programs for any process and recorded on a plurality of recording media.

[0076] <Computer-readable recording medium> A computer-readable recording medium according to the present invention stores a data management program for the optical measuring device according to 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 for each arbitrary process.

[0077] An example of the technology disclosed in the present invention will be described in more detail below using a configuration example and a flow chart of the optical measurement device of the present invention. FIG. 1 shows an example of the hardware configuration of an optical measurement device according to 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.

[0078] The control unit 101 performs calculations (arithmetic operations, comparison operations, etc.), and controls the operation of hardware and software. The control unit 101 may be, for example, a CPU (Central Processing Unit), or may be part of a machine used in the data management method for an optical measuring device of the present invention, or may be a combination of these. The control unit 101 realizes various functions by executing a program (such as a data management program for the optical measuring device of the present invention) that has been loaded into the main storage device 102 or the like. The processing 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, for example, by the control unit 101.

[0079] 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), etc. There are no particular limitations on the ROM, and it can be selected appropriately depending on the purpose, and examples include mask ROM and PROM (Programmable ROM). The RAM functions as a working area in which various programs stored in, for example, the ROM or the auxiliary storage device 103 are deployed when they are executed by the control unit 101. There are no particular limitations on the RAM, and it can be selected appropriately depending on the purpose, and examples thereof include DRAM (Dynamic Random Access Memory) and SRAM (Static Random Access Memory).

[0080] 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, and examples thereof 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. A 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] The output device 107 is not particularly limited, and any known device can be used as appropriate, such as a printer. The display device 108 is not particularly limited, and any known display device can be used as appropriate, such as a liquid crystal display or an organic EL display.

[0085] FIG. 2 shows an example of the functional configuration of the optical measurement device of the present invention. As shown in FIG. 2, the optical measuring device 100 includes a communication function unit 120, an input function unit 130, an output function unit 140, a display function unit 150, a storage function unit 160, and a control function unit 170.

[0086] The communication function unit 120 transmits and receives various types of data to and from external devices, for example, and may also receive data from external devices, for example. The input function unit 130 receives, for example, various instructions for the optical measurement device 100. The input function unit 130 also receives, for example, information regarding history data to be tracked. The output function unit 140 prints out the relevant history data, for example. The display function unit 150 displays, for example, the relevant history data on a display.

[0087] The memory function unit 160 has, for example, a program storage DB 161 that stores various programs, and a history data DB 162 that stores history data that combines management information of the managed components that have been read and measurement data measured by the measurement unit.

[0088] 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 storage function unit 160, and controls the operation of the entire optical measuring device 100.

[0089] The measurement unit 171 performs processing to obtain measurement data obtained by measuring the optical characteristics of a sample using, for example, the measurement means of an optical measurement device. The recording unit 172 performs a process of recording management information of the managed component in a recording means attached to the managed component, for example. The reading unit 173 performs a process of reading the management information recorded in the recording unit 172, for example, when the part to be managed is attached to the optical measuring device main body, or when the part to be managed is attached to the optical measuring device main body and measured by the measuring unit 171. The storage unit 174 performs processing to store history data that combines the read management information with the measurement data measured by the measurement unit 171, for example.

[0090] 3 is a flowchart showing an example of the processing flow in the data management method for an optical measuring device of the present invention. The processing 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.

[0091] 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 characteristics of a sample using a measurement means of the optical measuring device with management information for multiple managed components that are detachably attached to the optical measuring device body, and performs processing to track the historical data when used or required.

[0092] In step S101, the recording unit 172 of the control function unit 170 in the optical measuring device 100 records the management information of the management target component in the recording unit 172 attached to the management target component, and then the process proceeds to S102.

[0093] In step S102, the reading unit 173 of the control function unit 170 in the optical measuring device 100 reads the management information recorded in the recording unit 172 when the part to be managed is attached to the optical measuring device main body, or when the part to be managed is attached to the optical measuring device main body and measured by the measuring unit 171 of the control function unit 170 in the optical measuring device 100, and then proceeds to S103.

[0094] 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 read managed parts with 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. [Example]

[0095] 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.

[0096] 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 an optical path. Note that the order of arrangement 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.

[0097] 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.

[0098] The interference filter 8 is a bandpass optical filter that passes light of a wavelength (for example, 589 nm) used to measure the angle of rotation and blocks light of other wavelengths. Polarizer 9 is a polarizing plate that transmits only linearly polarized light components parallel to a single transmission axis, and converts the light emitted by light source 7 and passed through interference filter 8 into linearly polarized light. This generates linearly polarized light. Polarizer 9 is fixed within the polarimeter, and the direction of the transmission axis specific to polarizer 9 is also fixed, so the polarization plane of the polarized light generated by polarizer 9 is constant.

[0099] 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.

[0100] 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 a liquid sample is poured, and is placed at a position where the light path passes through the liquid sample. Linearly polarized light generated when light from the light source 7 passes through the polarizer 9 is incident on the cell 5.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] In the computer 15, a control (measurement) program for the polarimeter and a data management program for the optical measurement device of the present invention are running. The display 16 displays data, warnings, and the like.

[0105] 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 rotator plate 1, analyzer 12, and detector 14.

[0106] The components to be managed, namely, the light source 7, interference filter 8, polarizer 9, modulator 11, cell 5, optical rotator 1, analyzer 12, and detector 14, are each fitted with a recording means 2 in which management information is recorded. When each component to be managed is attached to the optical measuring device main body, or when each component to be managed is attached to the optical measuring device main body and measured, the reading means 3 reads the management information recorded in the recording means 2. The read management information is transferred to the computer 15 via the reading controller 17. The measurement data measured by the measurement means is transferred to the computer 15. The software in the computer 15 combines the management information and the measurement data to create history data. This history data is stored in the history data DB 162 in the computer 15.

[0107] The obtained historical data can be sent to a LIMS (Laboratory Information Management System) as needed. In the case of one-to-one communication such as RS232C, it is sent as plain text, but when going via an in-house LAN, it is sent as binary data along with format information. When historical data is sent to a LIMS, it is not stored on the computer, which reduces management costs such as backing up historical data.The historical data acquired by the LIMS is sent to the ERP, where it is possible to take into account calibration information, production information, and calibration expiration dates, and issue vouchers to users for recalibration, etc.

[0108] The recording means 2 may be one of a one-dimensional code, a two-dimensional code, an RFID tag, and an EEPROM.

[0109] As the 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.

[0110] 5 is a schematic diagram showing an optical rotator plate 1, a recording means 2, and a reading means 3, which are examples of components to be managed by a polarimeter 10. An RFID tag is attached to the optical rotator plate 1 as the 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 one-dimensional or two-dimensional codes can also be used as the recording means 2, RFID tags are highly convenient because they are contactless and the management information can be rewritten.

[0111] 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.

[0112] 6 is a schematic diagram showing a thermometer 4, which is an example of a part to be managed by polarimeter 10, a recording means 2, and a reading means 3. This thermometer 4 has an RFID tag attached as recording means 2, and the RFID tag records the following management information: 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 performed the thermometer calibration, and the thermometer replacement date and time. While one-dimensional or two-dimensional codes can also be used as recording means 2, RFID tags are highly convenient because they are contactless and the management information can be rewritten.

[0113] 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.

[0114] 7 is a schematic diagram showing a cell 5, which is an example of a component to be managed by polarimeter 10, a recording means 2, and a reading means 3. An RFID tag is attached to this cell 5 as the recording means 2, and the RFID tag records the following management information: 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 or 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.

[0115] 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 the history data DB 162.

[0116] 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 type of cell holder, its unique number, the temperature of the cell holder, and the date and time the cell holder was attached are recorded in the two-dimensional code as management information. A one-dimensional code or an RFID tag can also be used as the recording means 2.

[0117] When the cell holder is attached to the polarimeter body, the barcode reader serving as 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. [Explanation of symbols]

[0118] 1 Optical rotation plate 2. Recording Method 3 Reading means 4 thermometer 5 cells 6 Accessories 7 light source 8 Interference Filters 9 Polarizer 10 Polarimeter 11 Modulator 12 Analyzer 13 Rotation means 14 Detector 15. Computer 16 Display 17 Reading Controller 100 Optical measurement equipment 101 Control section 102 Main storage 103 Auxiliary storage device 104 I / O interfaces 105 Communication Interface 106 Input Device 107 Output Device 108 Display device 109 System Bus 160 Memory function unit 161 Program storage database 162 Historical Data DB 170 Control Function Unit 171 Measuring section 172 Recording Department 173 Reading unit 174 Storage Department

Claims

1. An optical measuring device that can store history data that combines measurement data obtained by measuring optical characteristics of a sample with a measurement means of the optical measuring device and management information for a plurality of management target components that are detachably attached to a main body of the optical measuring device, and can use and track the history data when necessary, a recording means attached to the management target component for recording the management information of the management target component; a reading means for reading the management information recorded in the recording means when the management object part is attached to the optical measuring device body or when the management object part is attached to the optical measuring device body and measured by the measuring means; a storage means for storing history data obtained by combining the read management information with the measurement data measured by the measurement means; An optical measuring device comprising:

2. 2. The optical measurement device according to claim 1, wherein the plurality of control parts are most of the control parts that are detachably attached to the optical measurement device body, and include a light source, a filter, a standard sample, a cell, a thermometer, and accessories.

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

4. 2. The optical measurement device according to claim 1, wherein the recording means is 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 reading means is any one of a barcode reader, an RFID reader, an optical camera, and a reading device.

6. 2. 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 a user.

7. 7. The optical measurement device according to claim 6, further comprising providing means for providing the relevant history data when used or required.

8. The optical measurement device according to claim 7 , wherein the provision of the history data is 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.

9. The optical measurement device according to any one of claims 1 to 8, wherein the optical measurement device is any one of a polarimeter, a circular dichroism dispersometer, a linear dichroism dispersometer, a birefringence measurement device, a polarization measurement device, 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, which can store history data that combines measurement data obtained by measuring optical characteristics of a sample with a measurement means of the optical measuring device and management information for a plurality of management target components that are detachably attached to the optical measuring device body, and can use and track the history data when necessary, a recording step of recording management information of the managed component in a recording means attached to the managed component; a reading step of reading the management information recorded in the recording means when the object to be managed is attached to the optical measuring device body or when the object to be managed is attached to the optical measuring device body and measured by the measuring means; a storage step of storing history data obtained by combining the read management information with the measurement data measured by the measurement means; 10. A data management method for an optical measuring device, comprising:

11. A data management program for an optical measuring device that can store history data that combines measurement data obtained by measuring optical characteristics of a sample with a measurement means of the optical measuring device and management information for a plurality of management target components that are detachably attached to a main body of the optical measuring device, and can use and track the history data when necessary, recording management information of the object-of-management component in a recording means attached to the object-of-management component; When the object part is attached to the optical measuring device body, or when the object part is attached to the optical measuring device body and measured by the measuring means, reading the management information recorded in the recording means; a process of storing history data obtained by combining the read management information with the measurement data measured by the measurement means; A data management program for an optical measuring device, characterized by causing a computer to execute the above.

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