OPTICAL MEASURING APPARATUS, DATA MANAGEMENT METHOD FOR OPTICAL MEASURING APPARATUS, AND DATA MANAGEMENT PROGRAM FOR OPTICAL MEASURING APPARATUS

Abstract

Provided is an optical measuring device that can realize the strict traceability required in the pharmaceutical industry, a data management method for the optical measuring device, and a data management program for the optical measuring device. [Solution] An optical measuring device that can store historical 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 parts that are detachably attached to the optical measuring device main body, and can use and track the historical data when necessary. The optical measuring device has: a recording means that is attached to the managed parts and records the management information of the managed parts; a reading means for reading the management information recorded in the recording means when the managed parts are attached to the optical measuring device main body, or when the managed parts are attached to the optical measuring device main body and measured with the measurement means; and a storage means for storing historical data combining the read management information and the measurement data measured by the measurement means.

Description

[Technical field]

[0001] The present invention relates to an optical measuring device capable of realizing 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, because pharmaceuticals are related to 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 function properly at the time of delivery or periodically. In addition, 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 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 in 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 cell of the polarimeter as a managed part, and does not store history data that combines management information for multiple managed parts 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 by 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, which are capable of realizing 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, which is a combination of measurement data obtained by measuring optical characteristics of a sample using a measuring means of the optical measuring device and management information on a plurality of managed parts that are detachably attached to the optical measuring device body, and can use and track the history data when necessary, Multiple The managed parts each for recording the management information of the managed part, Multiple A recording means; When the part to be managed is attached to the optical measuring device body, or when the part to be managed is attached to the optical measuring device body and measured by the measuring means, the recording means is provided at each of the plurality of managed parts, For reading the management information recorded in the recording means Multiple A reading means; The device 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, a plurality of the managed parts are ,light Sources, filters, standards, cells, thermometers and accessories Select from 2 or more It is preferable that:

[0009] In one aspect of the present invention, it is preferable that the management information is at least one selected from 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.

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

[0011] In one aspect of the present invention, Multiple 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 a daily inspection, a periodic inspection, a qualification inspection, a time for replacing a part to be managed, a time for calibrating a standard sample, a time for repair, and a time requested by 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 required.

[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 an 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 history data is stored in the storage means in a state where modification is prohibited. It is preferred.

[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 optical characteristics of a sample with a measuring means of the optical measuring device and management information of a plurality of managed parts that are detachably attached to the optical measuring device body, and can use and track the history data when necessary, Multiple The managed parts each Can be installed Multiple a recording step of recording management information of the managed parts in a recording means; When the part to be managed is attached to the optical measuring device body, or when the part to be managed is attached to the optical measuring device body and measured by the measuring means, A plurality of reading means are provided at the locations where the recording means is attached in the plurality of managed parts, a reading step of reading the management information recorded in the recording 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 can store history data that combines measurement data obtained by measuring optical characteristics of a sample with a measuring means of the optical measuring device and management information for a plurality of managed parts that are detachably attached to a main body of the optical measuring device, and can use and track the history data when necessary, Multiple The managed parts each Can be installed Multiple recording management information of the managed parts in a recording means; When the part to be managed is attached to the optical measuring device body, or when the part to be managed is attached to the optical measuring device body and measured by the measuring means, A plurality of reading means are provided at the locations where the recording means is attached in the plurality of managed parts, reading the management information recorded in the recording means; The computer is caused to execute a process of storing history data obtained by combining the read management information with the measurement data obtained by the measurement means. Effect 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 conventional art, achieve the above-mentioned objective, and realize the strict traceability required in the pharmaceutical industry. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 is a diagram showing an example of a hardware configuration of an optical measuring device according to the present invention. [Diagram 2] FIG. 2 is a diagram showing an example of a functional configuration of the optical measuring device of the present invention. [Diagram 3] FIG. 3 is a flowchart showing an example of a process 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. [Diagram 5] FIG. 5 is a schematic diagram showing an optical rotation plate, which is an example of a part to be managed by the 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 the 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 of a polarimeter, a recording means, and a reading means. [Figure 8] FIG. 8 is a schematic diagram showing an accessory, which is an example of a part to be managed by the polarimeter, a recording means, and a reading means. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[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 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 managed components that are detachably attached to the optical measuring device body, and can use and track the history data when necessary, and has a recording means, a reading means, and a storage means, and preferably 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 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 body, and can use and track the history 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, historical data that combines measurement data obtained by measuring the optical properties of a sample with the measurement means of the optical measuring device and management information for a plurality of managed parts that are detachably attached to the optical measuring device body can be stored and used, and the historical data can be tracked (provided) when necessary. This makes it possible to realize the strict traceability required in the pharmaceutical industry and to prevent the occurrence of human errors such as inputting errors in the management information for the managed parts, mix-ups when replacing managed parts, missing calibration deadlines, missing replacement deadlines for managed parts, and ordering incorrect managed parts.

[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 where strict traceability is required, and can be appropriately selected depending on the purpose. Examples of the optical measuring device 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] <Managed 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 multiple managed parts means two or more managed parts that are detachably attached to the optical measuring device body, and the types of the managed parts do not matter, so there may be multiple managed parts of the same type. Also, the multiple managed parts are preferably three or more, more preferably the majority of the managed parts (60% or more of the total managed parts; if there are 10 managed parts in total, six or more managed parts), and particularly preferably all of the managed parts. In addition, the parts under management 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, and parts that are inseparable from the optical measuring device body.

[0026] The parts to be managed are parts that are removably 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 of the parts to be managed include light sources, filters, standard samples, cells, thermometers, accessories, etc.

[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 the optical measuring device, and examples thereof include an interference filter, a polarizer, and an analyzer.

[0029] The standard sample is a sample that is periodically measured to check whether the optical measuring device is indicating correct measurement values, and can be appropriately selected depending on the type of the optical measuring device. Examples of the standard sample include a polarimeter's optical rotator plate, an infrared spectrophotometer's standard polystyrene film, and an optical filter for calibration of an ultraviolet-visible-near infrared spectrophotometer.

[0030] The cell is a container in which a sample is filled, and examples of such cells include glass cells, quartz cells, flow cells, and stainless steel (SUS) cells. Glass cells are used for measurements in the visible range above 340 nm, as they are less likely to transmit ultraviolet light with wavelengths of 340 nm or less. On the other hand, quartz cells transmit light of all wavelengths from ultraviolet to visible, but are expensive and therefore mainly used for measurements in the ultraviolet range.

[0031] Examples of the thermometer for measuring the cell temperature, the sample temperature in the cell, the cell holder temperature, and the optical rotatory plate temperature include a temperature probe, a thermocouple, and a temperature sensor.

[0032] The accessories can be appropriately selected depending on the type of the optical measurement device, and examples of the accessories 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 (polarimeter plate), accessories (cell holder), a modulator, a detector, and the like. In order to maintain the measurement accuracy of the angle of rotation in polarimeters, a standard sample solution such as a sucrose solution whose angle of rotation is known in advance is used as the standard sample. However, preparing multiple standard sample solutions with different angles of rotation is time-consuming, and a certain degree of error occurs in the angle of rotation when preparing the standard sample solutions, so an optical rotatory 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 to the primary standard of NIST (National Institute of Standards and Technology) or PTB (Physikalisch-Technische Bundesanstalt; German Physico-Technical Institute), and has been 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 part, and can be appropriately selected depending on the type of managed part. Examples of the 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 of a standard sample, calibration information of a thermometer, calibration information of a cell, etc.

[0036] The unique number of the managed part is an individual number that is uniquely assigned to each managed part by the manufacturer of the optical measuring device, and is also called a serial number.

[0037] The term of validity of the managed parts is the product life of the managed parts, and technical data published by the manufacturers of the managed parts can be used.

[0038] The replacement date and time of the managed part is the date and time when the managed part was replaced. The person who replaced the managed part is the name of the person who replaced the managed part. If the reason for replacing the managed part is something other than the expiration date of the managed part, the reason for replacing the managed 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 measurement 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 accessory's expiration date, the accessory's replacement date and time, 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, a cell holder for micromeasurement, etc.

[0042] For the standard sample, cell, and thermometer, which are parts to be managed and need to be calibrated periodically, 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 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 specific 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 of such values ​​include the optical rotation for the optical rotation plate of a polarimeter, the wave number for a standard polystyrene film of an infrared spectrophotometer, and the transmittance (absorbance) for a calibration optical filter 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 the 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 of the recording means 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 since information is written in only one direction, horizontally, and there is no information in the vertical direction of the bars, it is called a "one-dimensional barcode" or "barcode." The two-dimensional code has information in both the horizontal and vertical directions, has a high memory density and can store a large amount 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 and two-dimensional codes cannot be rewritten, when changing the management information, it is necessary to issue a new one-dimensional code or two-dimensional code with the rewritten management information and affix it to the part to be managed.

[0049] The RFID (Radio Frequency Identifier) ​​uses a non-contact type 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. In addition, there is no need to connect or run cables. Note that RFID tags are synonymous with IC tags, and are sometimes called 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 that is used to store data such as configuration information in computers and other electronic devices that must be retained even when the power is turned off.

[0051] Using 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 may be rewritten within the optical measurement device, or the recording means may be removed from the optical measurement device and used for rewriting.

[0052] The method of attaching the recording means to the managed part is not particularly limited and can be appropriately selected depending on the purpose, and examples of the method include attaching a sticker, attaching with an adhesive, screwing, pinning, etc. The recording means may be attached inside the managed part or may be attached externally to the managed part.

[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 automatically read without omission, so that it is possible to prevent the occurrence of human errors such as inputting errors in the management information of the managed parts, mix-ups when replacing managed parts, missing calibration deadlines, missing replacement deadlines for managed parts, and ordering mistakes for 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 a one-dimensional code or a two-dimensional code, which is a recording means. The RFID reader is a reading means that reads the management information recorded in 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, which are the recording means. The reading device is a means for reading the management information recorded in the EEPROM which is the recording means.

[0056] The use of non-contact reading means 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 managed parts 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 a measuring means of the optical measuring device to obtain measurement data, and is suitably performed by the measuring means.

[0058] The measurement data is data obtained by measuring the optical characteristics of a sample, and means raw data of optical characteristic values. The measurement data includes items such as "measurement data ID", "type of sample", "optical characteristic 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 thereof 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 according to the type of the optical measuring device. For example, when the optical measuring device is a "polarimeter", a polarizer is used to convert light from a light source into linearly polarized light, 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 that passes through the analyzer becomes zero is obtained, thereby measuring the angle at 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 obtained by combining the read management information of the managed parts with the measurement data measured by the measurement means, and is preferably performed by the storage means.

[0061] The history data is data in which measurement data and management information are combined, and the measurement data and management information can be combined by software stored in the computer of the optical measuring 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 stored in a computer, and the management information is combined with measurement data measured by the measuring means to create history data. In addition, when the 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 the 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 altered 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 changes are prohibited, and any known method can be used as appropriate. For example, the history data can be stored in a read-only state, the history data can be encrypted, or the history data can be blockchain-based.

[0064] The storage means is not particularly limited as long as it can store history data, and can be appropriately selected depending on the purpose. Examples of the storage means 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 a providing means. The above-mentioned times of use or 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 a user.

[0066] Examples of the provision by the providing means include displaying the history data and providing a warning on a screen of an optical measuring device, or displaying the history data and providing a warning on a mobile terminal.

[0067] Examples of the warning include when the expiration date of a managed part 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 managed part or the calibration deadline of a standard sample (for example, "The expiration date is in 3 months"). The warning method is not particularly limited as long as it can notify users and managers of the abnormality, and can be appropriately selected depending on the purpose. For example, a warning mark can be displayed on the screen, a warning sound can be emitted from a speaker, a light can flash, etc.

[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-mentioned management system, historical data combining measurement data measured by the measurement means of the optical measuring device and management information for multiple managed parts can be collected in a centralized manner from optical measuring device → LIMS → ERP, thereby preventing the occurrence of human errors such as input errors in the management information for managed parts, mix-ups when replacing managed parts, missing calibration deadlines, missing replacement deadlines for managed parts, and ordering mistakes for managed parts.

[0069] <Other steps and other means> The other means is not particularly limited and can be appropriately selected depending on the purpose. Examples of the other means include communication means and input means. The other steps are not particularly limited and can be appropriately selected depending on the purpose. Examples of the other steps 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 input 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 can store history data that combines measurement data obtained by measuring optical characteristics of a sample with a measuring means of the optical measuring device and management information for a plurality of managed parts that are detachably attached to a main body of the optical measuring device, and can use and track the history data when necessary, Multiple The managed parts each Can be installed Multiple recording management information of the managed parts in a recording means; When the part to be managed is attached to the optical measuring device body, or when the part to be managed is attached to the optical measuring device body and measured by the measuring means, A plurality of reading means are provided at the locations where the recording means is attached in the plurality of managed parts, reading the management information recorded in the recording means; The computer is caused to execute a process of storing history data obtained by combining the read management information with the measurement data obtained by the measurement means.

[0073] The data management program for the optical measuring device of the present invention may be, for example, a program for causing a computer to execute the data management method for the optical measuring device of the present invention. Also, a preferred aspect of the data management program for the optical measuring device of the present invention may be, for example, similar to a preferred aspect of the data management method for the 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 of 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 (Universal Serial Bus (USB) 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 by installing it directly or on a hard disk via a recording medium reading device of the 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 by installing it directly or on a hard disk via an information and communication network from the external storage area as necessary. The data management program for the optical measuring device of the present invention may be divided for each arbitrary process and recorded on a plurality of recording media.

[0076] <Computer-readable recording medium> A computer-readable recording medium according to the present invention records 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. Examples of the computer-readable recording medium 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 in a divided form for each arbitrary process.

[0077] Hereinafter, an example of the technique disclosed in the present invention will be described in further detail 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 measuring 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 a 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) 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. As the main memory device 102, for example, one having at least one of a Read Only Memory (ROM) and a Random Access Memory (RAM) can be used. The ROM stores various programs such as a BIOS (Basic Input / Output System), etc. The ROM is not particularly limited and can be appropriately selected depending on the purpose, and examples thereof include a mask ROM and a 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 appropriately selected depending on the purpose, and examples of the RAM 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 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. The data management program of the optical measurement device of the present invention is stored in the auxiliary storage device 103, loaded into the RAM (main memory) of the main storage device 102, and executed by the control unit 101, for example.

[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] There are no particular limitations on the communication interface 105, 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 various requests and information input 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. In addition, when the input device 106 is a touch panel (touch display), the input device 106 can also serve as the display device 108.

[0084] There are no particular limitations on the output device 107, and any known device may be used as appropriate, such as a printer. There are no particular limitations on the display device 108, and any known display device may 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 measuring device of the present invention. 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 storage function unit 160, and a control function unit 170.

[0086] The communication function unit 120 transmits and receives various data to and from an external device, for example. The communication function unit 120 may also receive data from an external device, for example. The input function unit 130 receives, for example, various instructions for the optical measurement device 100. In addition, the input function unit 130 receives, for example, information regarding history data to be tracked. The output function unit 140, for example, prints out the corresponding history data. The display function unit 150 displays, for example, the corresponding 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 parts 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 a measurement means of the optical measuring device, a recording unit 172 consisting of a recording means of the optical measuring device, a reading unit 173 consisting of a reading means of the optical measuring device, and a storage unit 174 consisting of a storage means of the optical measuring device. The control function unit 170 executes various programs stored in the program storage DB 161 of the storage function unit 160, for example, 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, a measurement means of an optical measurement device. The recording unit 172 performs a process of recording management information of the managed part in a recording means attached to the managed part, 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 a process of storing history data that combines, for example, the management information that has been read and the measurement data measured by the measurement unit 171 .

[0090] 3 is a flowchart showing an example of a process flow in the data management method for the optical measuring device of the present invention. Hereinafter, the process flow in the data management method for the optical measuring device will be described 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 a plurality of managed components that are detachably attached to the main body of the optical measuring device, 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 management information of the managed component in the recording unit 172 attached to the managed 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 transitions 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 managed parts that have been 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. EXAMPLES

[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] Fig. 4 is a schematic diagram of a polarimeter which is an embodiment of the optical measurement device of the present invention. In the polarimeter 10 of Fig. 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. The order in which the modulator 11 and the cell 5 are arranged may be reversed. In this polarimeter 10, the optical rotatory plate 1 which is a standard sample is placed at 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, other than an LED.

[0098] The interference filter 8 is a bandpass optical filter that passes light of a wavelength (for example, 589 nm) used in measuring 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 disposed at a position where the optical path passes through it, and is connected to an oscillator that transmits an AC current. The oscillator supplies an AC current of a predetermined frequency to the Faraday coil, and the Faraday coil generates an oscillating magnetic field inside when the AC current is supplied to it. The oscillating magnetic field causes the polarization plane of the linearly polarized light that passes through the Faraday coil to oscillate at an amplitude and frequency according to the AC 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 disposed at a position where the light path passes through the liquid sample. Linearly polarized light generated by the light from the light source 7 passing 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 the light is blocked by the analyzer 12 and the light receiving element cannot detect the light. 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 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 rotated by the rotation means 13 until the polarization plane of the linearly polarized light that has passed through the sample solution and the transmission axis of the analyzer 12 are perpendicular to each other is calculated. 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 light 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 a light source 7, an interference filter 8, a polarizer 9, a modulator 11, a cell 5, an optical rotatory plate 1, an analyzer 12, and a detector 14.

[0106] The parts to be managed, namely the light source 7, the interference filter 8, the polarizer 9, the modulator 11, the cell 5, the optical rotator 1, the analyzer 12, and the detector 14, are each fitted with a recording means 2 in which management information is recorded, and when each part to be managed is attached to the optical measuring device body, or when each part to be managed is attached to the optical measuring device body and measured, the management information recorded in the recording means 2 is read by the reading means 3. 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 of 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 history data can be sent to a Laboratory Information Management System (LIMS) if necessary. 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 together with format information. When historical data is sent to the 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 issue vouchers for re-calibration, etc. to users, taking into account calibration information, production information, and calibration expiration dates.

[0108] As the recording means 2, any one of a one-dimensional code, a two-dimensional code, an RFID tag, and an EEPROM is used.

[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 an example of parts to be managed by the polarimeter 10. An RFID tag is attached to the optical rotator plate 1 as the recording means 2, and the following management information is recorded on the RFID tag: the type of optical rotator plate, the optical rotator plate's unique number, the optical rotator plate's calibration value (angle of rotation), the calibration date and time of the optical rotator plate, the calibration deadline for the optical rotator plate, the person who calibrated the optical rotator plate, and the replacement date and time of the optical rotator plate. Although a one-dimensional code or a two-dimensional code can also be used as the recording means 2, an RFID tag is contactless and allows the management information to be rewritten, making it highly convenient.

[0111] When the optical rotatory plate 1 is attached to the polarimeter body, the management information of the RFID tag attached to the optical rotatory plate 1 is read by the RFID reader serving as the reading means 3, and the read management information is combined with the measurement data measured by the measuring means to generate history data which is 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. An RFID tag is attached to this thermometer 4 as the 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's calibration date and time, the thermometer's calibration deadline, the person who calibrated the thermometer, and the thermometer replacement date and time. Although 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.

[0113] When the thermometer 4 is attached to the polarimeter body, the management information of the RFID tag attached to the thermometer is read by the RFID reader serving as the reading means 3, and the read management information is combined with the measurement data measured by the measuring means to generate history data which is stored in the history data DB 162.

[0114] 7 is a schematic diagram showing a cell 5, which is an example of a part 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 following management information is recorded on the RFID tag: the cell type, the cell's unique number, the cell's temperature, the calibration value of the cell's optical path length, the calibration date and time of the cell's optical path length, the calibration deadline for the cell's optical path length, the person who calibrated the cell's optical path length, and the cell replacement date and time. Although 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.

[0115] When the cell is attached to the polarimeter body, the management information of the RFID tag attached to the cell is read by the RFID reader serving as the reading means 3, and the read management information is combined with the measurement data to generate 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, the recording means 2, and the 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, the unique number of the cell holder, 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 management information of the two-dimensional code attached to the cell holder is read by the barcode reader serving as the reading means 3, and the read management information is combined with the measurement data measured by the measuring means to generate history data which is stored in the history data DB 162. [Explanation of symbols]

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

Claims

1. An optical measuring device capable of storing history data, which is a combination of measurement data obtained by measuring optical characteristics of a sample using a measuring means of the optical measuring device and management information for a plurality of managed parts detachably mounted on a main body of the optical measuring device, and utilizing the history data and tracking the history data when necessary, comprising: a plurality of recording means attached to the plurality of managed parts, respectively, for recording the management information of the managed parts; a plurality of reading means, which are respectively disposed at the locations where the recording means are attached on the plurality of managed parts when the managed parts are attached to the optical measuring device body or when the managed parts are attached to the optical measuring device body and measured by the measuring means, for reading the management information recorded in the recording means; a storage means for storing history data obtained by combining the management information read and the measurement data obtained by the measurement means; An optical measuring device comprising:

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

3. 3. The optical measuring device according to claim 2, wherein the management information is at least one selected from 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. The optical measuring device as described in claim 1, wherein the multiple recording means are any one of a one-dimensional code, a two-dimensional code, an RFID tag, and an EEPROM.

5. The optical measuring device as described in claim 1, wherein the multiple reading means are 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 at the time of use or need.

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 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, which can store history data that combines measurement data obtained by measuring optical characteristics of a sample with a measuring means of the optical measuring device and management information for a plurality of managed parts that are detachably attached to a 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 of the managed parts in a plurality of recording means attached to the plurality of managed parts, respectively; a reading step of reading the management information recorded in the recording means by a plurality of reading means respectively disposed at the locations where the recording means are attached in the plurality of managed parts when the managed parts are attached to the optical measuring device body or when the managed parts are attached to the optical measuring device body and measured by the measuring means; a storage step of storing history data obtained by combining the management information that has been read and the measurement data obtained by the measurement means; 13. A data management method for an optical measuring device, comprising:

11. A data management program for an optical measuring device, which can store history data that combines measurement data obtained by measuring optical characteristics of a sample with a measuring means of the optical measuring device and management information for a plurality of managed parts 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 managed parts in a plurality of recording means attached to the plurality of managed parts, respectively; When the part to be managed is attached to the optical measuring device body, or when the 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 is read by a plurality of reading means respectively disposed at the locations where the recording means are attached in the plurality of parts to be managed, a process of storing history data obtained by combining the management information that has been read and the measurement data obtained by the measurement means; A data management program for an optical measuring device, comprising:

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