JP7601466B1 - OPTICAL MEASURING APPARATUS, DATA MANAGEMENT METHOD FOR OPTICAL MEASURING APPARATUS, AND DATA MANAGEMENT PROGRAM FOR OPTICAL MEASURING APPARATUS - Google Patents

Abstract

The present invention provides an optical measuring device capable of achieving 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 that combines measurement data obtained by measuring the optical properties of a sample with a measurement means of the optical measuring device and management information for a plurality of managed 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 that combines the read management information with the measurement data measured by the measurement means.
[Selection diagram] None

Description

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 the optical measuring device, and a data management program for the optical measuring device.

In the pharmaceutical industry, because pharmaceuticals relate to human life and health, they must 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, the cause of the abnormality must be fundamentally investigated, so strict traceability must be implemented for the measurement data of optical measuring devices such as polarimeters and the management information of managed parts.

For example, Patent Document 1 discloses that an information presentation means is fixed to the cell wall of the cuvette (hereinafter sometimes referred to as the "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 that 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.

U.S. Pat. No. 8,908,179

However, the technology described in Patent Document 1 treats only the polarimeter cell as a managed part, and does not store historical 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 polarimeter's measurement means, making it extremely difficult to achieve the strict traceability required by the pharmaceutical industry.

The present invention aims to solve the above-mentioned problems in the past and 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.

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 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,
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;
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.

In one aspect of the present invention, the plurality of parts to be managed are preferably two or more selected from a light source , a filter, a standard sample, a cell, a thermometer, and an accessory.

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.

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

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

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.

In one aspect of the present invention, it is preferable to have a provision means for providing the relevant history data when the use or need arises.

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 the screen of the optical measuring device, or a display of the history data and a warning on a mobile terminal.

In one aspect of the present invention, it is preferable that the history data is stored in the storage means in a state in which modification is prohibited .

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 measurement means of the optical measuring device and management information for a plurality of managed parts that are detachably attached to the main body of the optical measuring device, and can use and track the history data when necessary,
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;
and a storage step of storing history data that combines the read management information with the measurement data measured by the measurement means.

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 the history data 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 ,
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.

The present invention provides 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 solve the above-mentioned problems in the past, achieve the above-mentioned objectives, and realize the strict traceability required in the pharmaceutical industry.

FIG. 1 is a diagram showing an example of a hardware configuration of an optical measuring device according to the present invention. FIG. 2 is a diagram showing an example of a functional configuration of the optical measuring device of the present invention. FIG. 3 is a flow chart showing an example of a process flow in the data management method for the optical measuring device of the present invention. FIG. 4 is a schematic diagram of a polarimeter which is an embodiment of the optical measurement device of the present invention. 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. 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. FIG. 7 is a schematic diagram showing a cell, which is an example of a part to be managed by a polarimeter, a recording means, and a reading means. 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.

(Optical measuring device and data management method for optical measuring device)
The optical measuring device of the present invention is an optical measuring device that can store historical data that combines measurement data obtained by measuring the optical properties of a sample using a measurement means of the optical measuring device and management information for a plurality of managed components that are detachably attached to the optical measuring device main body, and can use and track the historical data when necessary, and 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.

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 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 for multiple managed parts that are detachably attached to the optical measuring device body, and can use and track the history data when necessary, and includes a recording process, a reading process, and a storage process, and preferably includes a measurement process and a providing process, and further includes other processes as necessary.

The optical measuring device of the present invention and the data management method for the optical measuring device of the present invention store and use historical data that combines measurement data obtained by measuring the optical properties of a sample with the measuring means of the optical measuring device and management information for multiple managed parts that are detachably attached to the optical measuring device body, and track (provide) the historical data 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 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 the wrong managed parts.

<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.

<Managed parts>
If only one specific managed part among the managed parts that are removably 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 removably attached to the optical measuring device main body.

Here, the multiple managed parts means two or more managed parts that are detachably attached to the optical measuring device body, and the type of the managed parts does 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 to be managed that are removably attached to the optical measuring device main body do not include long-life parts (e.g., rotating means, displays, computers, etc.) that are attached to the optical measuring device main body during device manufacture and are not replaced in principle, or parts that are inseparable from the optical measuring device main body.

The parts to be managed are parts that are removably attached to the main body of the optical measurement device and that constitute the optical measurement device. They are selected appropriately depending on the type of optical measurement device, and examples of the parts to be managed include light sources, filters, standard samples, cells, thermometers, and accessories.

The light source can be appropriately selected depending on the type of optical measurement device, and examples include LEDs (Light Emitting Diodes), sodium lamps, halogen lamps, and combinations of sodium lamps and mercury lamps.

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

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

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

Examples of thermometers that measure the cell temperature, the sample temperature in the cell, the cell holder temperature, and the optical rotatory plate temperature include temperature probes, thermocouples, and temperature sensors.

The accessories can be selected appropriately depending on the type of optical measurement device, and examples of the accessories include a cell holder. Examples of the cell holder include a Peltier cell holder, a thermostatic cell holder, and a cell holder for micromeasurements.

When the optical measuring device is a polarimeter, the parts to be managed include, for example, a light source, filters (interference filters, polarizers, analyzers), cells, standard samples (polarimeter plates), accessories (cell holders), modulators, detectors, 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 optical rotation at a wavelength of 589 nm using a standard polarimeter calibrated with the primary standard of NIST (National Institute of Standards and Technology) or PTB (Physikalische-Technische Bundesanstalt; German Physikalische Technische Bundesanstalt), and that has been assigned a value (calibrated).

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.

<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.

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 sometimes called a serial number.

The expiration date 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.

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.

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.

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.

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 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.

For the control parts that need to be calibrated periodically, such as standard samples, cells, and thermometers, the following calibration information is recorded in the recording means.

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 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.

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.

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.

<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.

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 include one-dimensional codes, two-dimensional codes, RFID tags, and EEPROMs.

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, and examples of such codes include QR Codes (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.

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, so unlike barcodes, it is not susceptible to being dissolved by organic solvents, etc. Also, there is no need to connect or run cables. Note that RFID tags are synonymous with IC tags, and are sometimes called RF tags.

The EEPROM (Electrically Erasable Programmable Read-Only Memory) is a type of non-volatile memory, also written as E ² PROM, and is used in computers and other electronic devices to store data that should be retained even when the power is turned off, such as setting information.

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.

The method of attaching the recording means to the managed component is not particularly limited and can be appropriately selected depending on the purpose. For example, the method can be by attaching a sticker, attaching with adhesive, screwing, pinning, etc. The recording means can be attached inside the managed component or externally to the managed component.

<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.

The reading process allows the management information recorded in the recording means of the managed parts to be automatically read without omission, which prevents 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.

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.

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 managed parts such as cells, thermometers, and optical rotatory plates.

<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.

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 in the case of a polarimeter, the CD value in the case of a circular dichroism spectrometer, and the transmittance (absorbance) in the case of 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.

The measuring means is appropriately selected according to 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 is found, thereby making it possible to measure 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.

<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.

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 measuring device.

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.

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.

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 solid state drives (SSDs) and hard disk drives (HDDs).

<Providing step 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.
Examples of the time of use or necessity include daily inspection, periodic inspection, qualification inspection, replacement of parts to be managed, calibration of standard samples, repair, or at the request of the user.

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

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 three 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.

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 measuring means of the optical measuring device and management information for a plurality of managed parts can be collected in a centralized manner from the optical measuring device → LIMS → ERP, thereby making it possible to prevent 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.

<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.

There are no particular limitations on the communication means as long as it is capable of communicating with the outside of the optical measurement device, and any known means may be used as appropriate, such as a transceiver.

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

(Data management program for optical measuring device)
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 measurement 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 the history data 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 ,
The computer is caused to execute a process of storing history data obtained by combining the read management information with the measurement data measured by the measurement means.

The data management program for the optical measuring device of the present invention can be, for example, a program that causes a computer to execute the data management method for the optical measuring device of the present invention. Furthermore, a preferred aspect of the data management program for the optical measuring device of the present invention can be, for example, similar to a preferred aspect of the data management method for the optical measuring device of the present invention.

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.

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 may be recorded on a recording medium such as a CD-ROM (Compact Disc ROM), a DVD-ROM (Digital Versatile Disk ROM), an MO disk (Magneto-Optical disk), an SD card, or a USB memory (USB (Universal Serial Bus) flash drive).
Furthermore, when the data management program for the optical measuring device of the present invention is recorded on the above-mentioned recording medium, it can be used directly or by installing it on a hard disk via a recording medium reading device 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 directly or by installing it 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.

<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.

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.

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.

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. Examples of the RAM include a dynamic random access memory (DRAM) and a static random access memory (SRAM).

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

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

There are no particular limitations on the communication interface 105, and any suitable known interface may be used, such as a wireless or wired communication device.

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, or a microphone. In addition, if the input device 106 is a touch panel (touch display), the input device 106 can also serve as the display device 108.

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

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 .

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.

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 the management information of the managed parts that have been read and the measurement data measured by the measurement unit.

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

The measurement unit 171 performs processing to obtain measurement data obtained by measuring the optical characteristics of a sample using, for example, a measurement unit 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 a managed part is attached to the optical measuring device main body, or when a managed part is attached to the optical measuring device main body and measured by the measuring 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 .

Here, FIG. 3 is a flowchart showing an example of the process flow in the data management method for the optical measuring device of the present invention. Below, the process flow in the data management method for the optical measuring device will be explained with reference to the functional configuration diagram of the optical measuring device in FIG. 2.

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 measuring means of the optical measuring device with management information for multiple managed parts that are detachably attached to the optical measuring device body, and uses and tracks the historical data when necessary.

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 managed part in the recording unit 172 attached to the managed part, and then the process proceeds to S102.

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 managed part is attached to the optical measuring device body, or when the managed part is attached to the optical measuring device body and measured by the measuring unit 171 of the control function unit 170 in the optical measuring device 100, and then the process proceeds to S103.

In step S103, the storage unit 174 of the control function unit 170 in the optical measuring device 100 stores history data that combines the management information of the managed parts that was 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 ends this process.

In the following example, a polarimeter, which is one embodiment of the optical measurement device of the present invention, is specifically described, but the present invention is not limited to this example in any way.

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

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 light source other than an LED, such as a sodium lamp, a halogen lamp, or a mercury lamp.

The interference filter 8 is a bandpass optical filter that passes light of a wavelength (for example, 589 nm) used in measuring the optical rotation and blocks light of other wavelengths.
The 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 the light source 7 and passed through the interference filter 8 into linearly polarized light. This generates linearly polarized light. The polarizer 9 is fixed within the polarimeter, and the direction of the transmission axis specific to the polarizer 9 is also fixed, so the polarization plane of the polarized light generated by the polarizer 9 is constant.

The modulator 11 is a Faraday coil that modulates the polarization plane of linearly polarized light. This Faraday coil is placed at a position where the optical path passes through it, and is connected to an oscillator that emits 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 that passes through the Faraday coil to oscillate at an amplitude and frequency that corresponds to the alternating current.

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.

The analyzer 12 is a polarizing plate with a single transmission axis, and is rotated by a rotation stage as a rotation means 13 and installed with the 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.

The linearly polarized light that passes through the analyzer 12 is incident on the detector 14. The detector 14 is composed of light-receiving elements such as photomultiplier tubes (PMTs) and photodiodes, and when it detects light, it outputs a detection signal that indicates the amount of light detected 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. The angle of rotation is calculated by the computer 15 based on the electrical signal obtained by the detector 14.

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 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 is calculated until the polarization plane of the linearly polarized light that passed through the sample solution and the transmission axis of the analyzer 12 are perpendicular to each other. 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.

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.

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

The parts 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 on 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.

The obtained history data can be sent to a Laboratory Information Management System (LIMS) as necessary. In the case of one-to-one communication such as RS232C, the data is sent as is in plain text, and in the case of passing through an in-house LAN, the data is sent as binary data together with format information.
When history data is sent to the LIMS, it is not stored in the computer, so management costs such as backing up the history data can be reduced. The history data acquired by the LIMS is sent to the ERP, and taking into account calibration information, production information, and the expiration date of the calibration, it is possible to issue a voucher for re-calibration, etc. to the user.

The recording means 2 may be a one-dimensional code, a two-dimensional code, an RFID tag, or an EEPROM.

As the reading means 3, a barcode reader, an RFID reader, an optical camera, or a reading device is used in correspondence with the recording means 2.

Figure 5 is a schematic diagram showing the optical rotator plate 1, recording means 2, and reading means 3, which are examples 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 date and time of calibration of the optical rotator plate, the expiration date of the calibration of the optical rotator plate, the person who calibrated the optical rotator plate, and the date and time of replacement of the optical rotator plate. Although a one-dimensional or two-dimensional code can also be used as the recording means 2, an RFID tag is contactless and the management information can be rewritten, making it highly convenient.

When the optical rotation plate 1 is attached to the polarimeter body, the management information of the RFID tag attached to the optical rotation 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 then stored in the history data DB 162.

Figure 6 is a schematic diagram showing a thermometer 4, a recording means 2, and a reading means 3, which are an example of a managed part of the polarimeter 10. 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's replacement date and time. Although a one-dimensional or two-dimensional code can also be used as the recording means 2, an RFID tag is contactless and the management information can be rewritten, making it highly convenient.

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 then stored in the history data DB 162.

Figure 7 is a schematic diagram showing a cell 5, which is an example of a managed part of the 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: cell type, cell unique number, cell temperature, calibration value of the cell's optical path length, date and time of calibration of the cell's optical path length, deadline for calibration of the cell's optical path length, person who calibrated the cell's optical path length, and date and time of cell replacement. Although a one-dimensional code or two-dimensional code can also be used as the recording means 2, an RFID tag is contactless and the management information can be rewritten, making it highly convenient.

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.

Figure 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, 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.

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 then stored in the history data DB 162.

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

Claims (11)

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: 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. The optical measurement device according to claim 2, wherein 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. 2. The optical measurement device according to claim 1, wherein the plurality of recording means are any one of a one-dimensional code, a two-dimensional code, an RFID tag, and an EEPROM. The optical measurement device according to claim 1 , wherein the plurality of reading means are any one of a barcode reader, an RFID reader, an optical camera, and a reading device. 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. The optical measuring device according to claim 6, further comprising a providing means for providing the relevant historical data when used or required. The optical measuring 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 measuring device, or a display of the history data and a warning on a mobile terminal. The optical measuring device according to any one of claims 1 to 8, wherein the optical measuring device is any one of a polarimeter, a circular dichroism dispersometer, a linear dichroism dispersometer, a birefringence measuring device, a polarimeter, a Raman spectrophotometer, an ultraviolet-visible-near infrared spectrophotometer, an infrared spectrophotometer, and a spectrofluorometer. 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 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 read management information with the measurement data obtained by the measurement means;
13. A data management method for an optical measuring device, comprising: 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: