WO2021229915A1 - 検査装置 - Google Patents

検査装置 Download PDF

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Publication number
WO2021229915A1
WO2021229915A1 PCT/JP2021/011185 JP2021011185W WO2021229915A1 WO 2021229915 A1 WO2021229915 A1 WO 2021229915A1 JP 2021011185 W JP2021011185 W JP 2021011185W WO 2021229915 A1 WO2021229915 A1 WO 2021229915A1
Authority
WO
WIPO (PCT)
Prior art keywords
light emitting
emitting element
test body
test
inspection device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2021/011185
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
崇裕 宮戸
仁 清水
覚 入澤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fujifilm Corp
Original Assignee
Fujifilm Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fujifilm Corp filed Critical Fujifilm Corp
Priority to EP21805005.2A priority Critical patent/EP4151986A4/en
Priority to JP2022522536A priority patent/JP7539977B2/ja
Publication of WO2021229915A1 publication Critical patent/WO2021229915A1/ja
Priority to US18/055,582 priority patent/US20230077006A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/01—Arrangements or apparatus for facilitating the optical investigation
    • G01N21/15—Preventing contamination of the components of the optical system or obstruction of the light path
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N21/49—Scattering, i.e. diffuse reflection within a body or fluid
    • G01N21/51—Scattering, i.e. diffuse reflection within a body or fluid inside a container, e.g. in an ampoule
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/251—Colorimeters; Construction thereof
    • G01N21/253—Colorimeters; Construction thereof for batch operation, i.e. multisample apparatus
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour

Definitions

  • the present invention relates to an inspection device including a light emitting element that illuminates an inspection target and a light receiving element that receives light from the inspection target, and inspects the inspection target using light.
  • Patent Document 1 is known as an inspection device that inspects an inspection target using light.
  • the following Patent Document 1 describes a configuration in which a sensor unit on which a light receiving element is mounted is pressed against a measurement stage in which an inspection target is set to reduce a measurement error.
  • Patent Document 1 when the sensor unit is pressed against the measurement stage, the position and orientation of the sensor unit change, and there is a problem that the inspection accuracy is lowered.
  • the present invention has been made in view of the above background, and an object of the present invention is to provide an inspection device capable of improving inspection accuracy.
  • the inspection apparatus of the present invention includes a test body having a circular cross section for accommodating an inspection target, a test body holding portion having an opening having a circular cross section and holding the test body, and a test body.
  • a plurality of light emitting elements that irradiate light from a plurality of directions, a light receiving element that faces the light emitting element via the test body, and the test body that protrudes from the inner wall of the opening into the opening and presses the test body to oppose the test body. It is provided with a pressing member that presses against the inner wall on the side.
  • the light emitting element may include a first light emitting element and a second light emitting element, and the pressing member may press the test piece toward an intermediate point between the first light emitting element and the second light emitting element.
  • the light emitting element includes a third light emitting element arranged at an intermediate point between the first light emitting element and the second light emitting element, and the pressing member may press the test piece toward the third light emitting element.
  • Each of the light emitting elements may have different light emitting colors from each other.
  • the test piece holding portion may be provided with a plurality of openings to hold a plurality of test pieces.
  • the test piece is formed long in the direction perpendicular to the cross section, and the test piece holding portion may hold a plurality of test pieces side by side in the horizontal direction in a posture in which the longitudinal direction is vertical.
  • the test piece may be formed in a cylindrical shape with one end closed.
  • the light emitting elements may be arranged side by side in the horizontal direction.
  • the light emitting element may be one that causes light to enter the subject horizontally.
  • the pressing member may be a member that presses the subject in the horizontal direction.
  • the inspection device of the present invention since the test body containing the inspection target is pressed against the test body holding portion, the inspection accuracy can be improved.
  • the inspection device 10 includes a device main body 11 and a computer 12, and performs optical measurement on the inspection target 13 (see FIG. 2).
  • the inspection target 13 see FIG. 2
  • an example will be described in which the presence or absence of contamination by endotoxin is inspected by performing optical measurement, and if necessary, the content or concentration of endotoxin is measured.
  • the inspection target 13 is a solution in which a lysate reagent and an inspected object or the like are mixed.
  • the test object for example, is an injection such as a vaccine or a blood preparation, or water obtained by recovering endotoxin from a test object such as a syringe or an injection needle, polyethylene glycol, ethylenediamine tetraacetic acid, or the like (so-called recovery solution).
  • a test object such as a syringe or an injection needle, polyethylene glycol, ethylenediamine tetraacetic acid, or the like (so-called recovery solution).
  • it may be blood or body fluid collected from a patient who may have been infected with a gram-negative bacterium or fungus.
  • the lysate reagent is LAL (Limulus Amebocyte Lysate) or TAL (Tachypleus Amebocyte Lysate).
  • the lysate reagent prepared from horseshoe crab blood cell extract can also be used for measuring (1 ⁇ 3) - ⁇ -D-glucan present on the cell wall of fungi, depending on the adjustment of the reagent components. It is used in a test to determine the presence or absence of fungal infection by measuring the (1 ⁇ 3) - ⁇ -D-glucan concentration in the patient's blood or body fluid.
  • the inspection device 10 for endotoxin inspection is (1 ⁇ 3) - ⁇ -D-glucan. It also functions as an inspection device.
  • one test device 10 can test both endotoxin and (1 ⁇ 3) - ⁇ -D-glucan.
  • the device main body 11 is a part of the inspection device 10 including a measurement unit 15 for performing optical measurement of the inspection target 13.
  • the apparatus main body 11 includes a test body 21, a test body holding unit 22, a light emitting unit 23, a light guide unit 24, a light detection unit 26, a display unit 27, an operation unit 28, and the like.
  • the test piece holding unit 22, the light emitting unit 23, the light guide unit 24, and the light detecting unit 26 constitute the measuring unit 15.
  • the test body 21 is a container for accommodating the inspection target 13, and is attached to the test body holding portion 22.
  • the test body 21 is formed in a cylindrical shape with one end closed, the longitudinal direction (direction of the axis of the cylinder) is parallel to the vertical direction, and the test body 21 is tested in a posture in which the closed end side faces downward. It is attached to the body holding portion 22.
  • the test body 21 has a circular cross section. Specifically, when mounted on the measuring unit 15, the cross section in the horizontal direction is circular.
  • the circular cross section means that the outer shape of the cross section is a circle, an ellipse, or a similar closed curve that is generally smooth.
  • the test body 21 is made of heat-resistant glass.
  • the reason why the test piece 21 is made of heat-resistant glass is that, for example, by dry heat sterilization at 250 ° C. or higher and 30 minutes or longer, the test piece 21 before accommodating the test object has endotoxin and (1 ⁇ 3) - ⁇ -D-. This is to avoid containing glucan.
  • the test body holding unit 22 holds a plurality of test bodies 21 side by side.
  • the test piece holding portion 22 has a plurality of openings 31 (openings) arranged in a row in the Y direction.
  • the openings 31 are formed long in the vertical direction (Z direction), and by inserting the test body 21 into each opening 31, the test bodies 21 are held in a state of being lined up in a row.
  • the test body holding portion 22 has six openings 31, and by inserting the test body 21 into all of these, the six test body 21 can be held at the same time. ..
  • the test body holding unit 22 may hold 7 or more or 5 or less test bodies 21. Further, the test body holding portion 22 has a heater 32 on the lower surface (the surface on the negative side in the Z direction).
  • the test body holding unit 22 By controlling the on / off of the heater 32, the temperature of the test body holding unit 22 and the test body 21 held by the test body holding unit 22 can be maintained within a predetermined temperature or a predetermined temperature range. Therefore, the test body holding portion 22 also functions as a so-called constant temperature bath.
  • the light emitting unit 23 irradiates the test body 21 held by the test body holding unit 22 with the light used for the inspection.
  • the light guide unit 24 is formed in a square cylinder shape that surrounds an optical path of light from the light emitting unit 23 to the test body 21.
  • One open end of the light guide unit 24 is connected to the test piece holding unit 22, and the other open end is connected to the light emitting unit 23.
  • the light emitting unit 23 is attached to the subject holding unit 22 via the light guide unit 24.
  • the light emitting unit 23 includes a light emitting element 41V (first light emitting element), a light emitting element 41B (second light emitting element), and a light emitting element 41R (third light emitting element).
  • These light emitting elements 41V, 41B, 41R are, for example, LEDs (light emission diodes), and by emitting light, the test body 21 is irradiated with light.
  • the light emitting elements 41V, 41B, 41R irradiate the test body 21 with light in the horizontal direction.
  • the test body holding portion 22 is provided with an opening 42 between the test body 21 and the light emitting elements 41V, 41B, 41R so as to have a range in which at least the test body 21 is exposed to the light emitting elements 41V, 41B, 41R. Therefore, the light from the light emitting elements 41V, 41B, 41R is horizontally incident on the test body 21 through the opening 42.
  • the light emitting element 41R is used, for example, when inspecting by a turbidimetric method, and the light emitted by the light emitting element 41R is, for example, red.
  • one light emitting element 41R is provided for each test body 21.
  • the light emitting element 41R is provided substantially in front of each test body 21.
  • the front of the test body 21 is a position where the optical axis is parallel to the X direction (the direction perpendicular to the Y direction (the direction in which the test bodies 21 are arranged)) and the optical axis passes through the center of the test body 21. Is.
  • the light emitting elements 41V and 41B are selected and used, for example, when inspecting by a colorimetric method.
  • the light emitted by the light emitting element 41V is, for example, purple
  • the light emitted by the light emitting element 41B is, for example, blue.
  • the light emitting elements 41V and 41B are alternately arranged at a constant pitch with the light emitting element 41R interposed therebetween in the Y direction (the direction in which the test bodies 21 are arranged).
  • the light emitting elements 41V, 41B, the light emitting element 41B, the light emitting element 41R, the light emitting element 41V, the light emitting element 41R, the light emitting element 41B, ... 41R is arranged. That is, the light emitting element 41R is arranged at an intermediate point between the light emitting element 41V and the light emitting element 41B.
  • the light emitting element 41V is provided for each of the two test bodies 21, and the light from one light emitting element 41V is applied to the two test bodies 21.
  • the light emitting element 41B is also provided for each of the two test bodies 21, and the light from one light emitting element 41B is applied to the two test bodies 21.
  • the light emitting elements 41V and 41B are arranged at positions not in front of the test body 21, and are directed toward the test body 21 from an oblique direction inclined with respect to the optical axis of the light emitting element 41R. Irradiate with light.
  • the light emitting elements 41V may be provided one by one for each test body 21.
  • the example of irradiating the two test bodies 21 with the light from one light emitting element 41B has been described, the light emitting elements 41B may be provided one by one for each test body 21.
  • the plurality of test bodies 21 may be irradiated with the light from one light emitting element 41R.
  • the photodetector 26 is a light receiving element 53 that receives light emitted from the light emitting elements 41V, 41B, 41R and transmitted through the test body 21 (inspection target) or scattered when passing through the test body 21 (inspection target 13). Be prepared.
  • the light receiving element 53 is, for example, an optical sensor such as a PD (Photo Diode), and is provided for each test body 21.
  • the photodetector unit 26 receives the light receiving element 53 at a position where light transmitted through each of these test bodies 21 can be received. It is equipped with.
  • test body holding portion 22 is provided with an opening 43 having a range in which at least the light receiving element 53 is exposed to the test body 21 side between the test body 21 and the light receiving element 53. Therefore, the light transmitted through the test body 21 reaches the light receiving element 53 through the opening 43.
  • the test piece holding part 22 is provided with a test piece pressing part 60.
  • the test body pressing portion 60 includes an urging member 61 and a pressing member 62, which are housed in the case 63. Then, by attaching the case 63 to the test body holding portion 22, the test body pressing portion 60 is attached to the test body holding portion 22.
  • one set of the urging member 61 and the pressing member 62 is provided for one opening 31 (the opening 31 on which the test body 21 is mounted). That is, in this embodiment, six sets of the urging member 61 and the pressing member 62 are provided. Further, in the present embodiment, three sets of the urging member 61 and the pressing member 62 are housed in one case 63. That is, in this embodiment, two cases 63 are provided.
  • the pressing member 62 is provided with a pressing end 62B at one end of the shaft 62A.
  • the pressing end 62B is formed of a slidable material such as POM (polyoxymethylene).
  • POM polyoxymethylene
  • the tip portion of the pressing end 62B is spherical, but as shown in FIG. 6, the tip portion of the pressing end 62B may be planar. Further, as shown in FIGS. 7 and 8, the tip of the pressing end 62B may be curved. In FIG. 7, the tip of the pressing end 62B is a curved surface having a central convex shape, and in FIG. 8, the tip of the pressing end 62B is a curved surface having a central concave shape.
  • openings 64 and 65 are formed in the case 63, and the pressing member 62 is housed in the case 63 with the shaft 62A protruding from the opening 64 and the pressing end 62B protruding from the opening 65. It is slidably supported in the Y direction (horizontal direction, in which the pressing end 62B protrudes from the opening 65 and in the direction in which the pressing end 62B is housed in the case 63).
  • the urging member 61 is a coil spring in the present embodiment, and urges the pressing member 62 in a direction in which the pressing end 62B protrudes from the opening 65.
  • test body pressing unit 60 is provided on the side opposite to the light emitting unit 23 with the opening 31 on which the test body 21 is mounted. Then, in the present embodiment, the pressing end 62B is urged toward the light emitting element 41R by the urging member 61.
  • An opening 66 is formed in the test body holding portion 22.
  • the pressing member 62 projects the pressing end 62B into the opening 31 in which the test body 21 is mounted through the openings 65 and 66 by the urging of the urging member 61. Then, the test body 21 is pressed toward the inner wall of the inner wall of the opening 31 opposite to the pressing member 62 (in the present embodiment, the light emitting element 41R (inner wall on the light emitting element 41R side)). As a result, the test body 21 is supported in close contact with a predetermined position (in this embodiment, the inner wall on the light emitting element 41R side) of the inner wall of the opening 31.
  • test body 21 When the test body 21 is mounted in the opening 31, the test body 21 presses the pressing end 62B toward the inside of the case 63, and the pressing end 62B opposes the urging of the urging member 61 inside the case 63. Move towards. As a result, the test body 21 can be attached to the opening 31. Further, by pulling the shaft 62A protruding from the opening 64 of the case 63, the pressing end 62B is moved toward the inside of the case 63 against the urging of the urging member 61, and the test body 21 is attached to the opening 31. You can also do it.
  • the opening 31 for mounting the test body 21 is formed to have an outer diameter one size larger than that of the test body 21 in order to smoothly mount the test body 21, but as described above, the test body is formed by the test body pressing portion 60. By pressing 21, the test piece 21 does not rattle in the opening 31. Further, the test body 21 can be supported at a predetermined position of the opening 31 (in this embodiment, a position of the inner wall of the opening 31 that is in close contact with the inner wall on the light emitting element 41R side). As a result, measurement (inspection) can be performed with high accuracy.
  • test body 21 rattles in the opening 31 or the position of the test body 21 varies, the state of refraction of light when passing through the side wall of the test body 21 changes (light emitting element 41V). , The optical path of the light from 41B, 41R to the light receiving element 53 changes), so that the measurement results will be different even for the same test piece 21, and / or the measurement error will be large. Problems will arise.
  • the test body 21 is pressed by the test body pressing unit 60 to support the test body 21 at a predetermined position of the opening 31, so that the above-mentioned problems can be prevented. ..
  • both the test body 21 and the opening 31 to which the test body 21 is mounted have a circular cross section. Therefore, it is possible to prevent variations in the moving destination (support position of the test body 21) when the test body 21 is pressed. That is, the test body 21 is pressed and moves in a direction away from the pressing member 62 and is supported at the destination, but the test body 21 is pressed because both the test body 21 and the opening 31 have a circular cross section.
  • the destination is limited to one of the inner walls of the opening 31 that is farthest from the pressing member 62. Then, by being able to support the test body 21 at this limited one point (preventing variation in the support position of the test body 21), it is possible to perform measurement (inspection) with higher accuracy.
  • the display unit 27 is, for example, an indicator indicating whether or not the inspection can be executed and / or the progress of the inspection. Further, the display unit 27 can be a display screen such as a liquid crystal panel, a touch panel, or the like.
  • the operation unit 28 is a switch or the like for directly giving an operation instruction to the device main body 11.
  • the display unit 27 is a touch panel
  • at least a part of the operation unit 28 can be formed by using a graphical user interface displayed on the touch panel.
  • the computer 12 is a part of the inspection device 10 that controls each part of the device main body 11 and performs analysis or determination using measurement data (signals and the like acquired from the light receiving element 53) acquired from the device main body 11. Specifically, the computer 12 acquires measurement data from the measurement unit 15 and analyzes or the like using the measurement data to generate data capable of determining the presence or absence of endotoxin or determining the presence or absence of endotoxin. In the present embodiment, the computer 12 is provided separately from the device main body 11, but a part or all of the functions of the computer 12 can be incorporated into the device main body 11.
  • the inspection device 10 can perform endotoxin inspection by a colorimetric method and a turbidity method.
  • the colorimetric method is an inspection method for identifying the presence or absence of endotoxin by measuring the activation of the lysate reagent by endotoxin by the absorbance at a specific wavelength. Since the measuring unit 15 includes two types of light emitting elements, a light emitting element 41V and a light emitting element 41B, for inspection by the colorimetric method, the inspection is performed by subtracting disturbances other than the colorimetric reaction by using both of them. The accuracy can be improved.
  • the turbidimetry method is an inspection method for identifying the presence or absence of endotoxin by measuring the change in turbidity of a sample gelled by activation of a lysate reagent by endotoxin.
  • the light emitting element 41 for each test piece 21 is used.
  • the test body 21 is pressed by the pressing member 62 to be supported at a predetermined position of the opening 31, so that the measurement (inspection) can be performed with high accuracy. ..
  • the inspection device 10 performs an endotoxin test, but the present invention can be used for a device other than the endotoxin test for detecting transmitted light, scattered light, or the like. Further, in the above embodiment, the inspection device 10 includes one measurement unit 15, but the inspection device 10 may include a plurality of measurement units 15 in the device main body 11.

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Optical Measuring Cells (AREA)
PCT/JP2021/011185 2020-05-15 2021-03-18 検査装置 Ceased WO2021229915A1 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP21805005.2A EP4151986A4 (en) 2020-05-15 2021-03-18 INSPECTION DEVICE
JP2022522536A JP7539977B2 (ja) 2020-05-15 2021-03-18 検査装置
US18/055,582 US20230077006A1 (en) 2020-05-15 2022-11-15 Test device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2020-085897 2020-05-15
JP2020085897 2020-05-15

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US18/055,582 Continuation US20230077006A1 (en) 2020-05-15 2022-11-15 Test device

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Publication Number Publication Date
WO2021229915A1 true WO2021229915A1 (ja) 2021-11-18

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PCT/JP2021/011185 Ceased WO2021229915A1 (ja) 2020-05-15 2021-03-18 検査装置

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US (1) US20230077006A1 (https=)
EP (1) EP4151986A4 (https=)
JP (1) JP7539977B2 (https=)
WO (1) WO2021229915A1 (https=)

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JP2006322854A (ja) 2005-05-19 2006-11-30 Fujifilm Holdings Corp 全反射減衰を利用した測定装置及びその押し付け量調整方法
JP2007322685A (ja) * 2006-05-31 2007-12-13 Kyocera Mita Corp 液体現像剤の濃度測定装置およびそれを有する湿式画像形成装置
JP2008522215A (ja) * 2004-11-24 2008-06-26 バッテル メモリアル インスティチュート 細胞撮像用の光学システム
CN103674858A (zh) * 2013-09-18 2014-03-26 江西龙天茶业有限公司 一种茶水汤色快速检测方法及装置
JP2018128604A (ja) * 2017-02-09 2018-08-16 オリンパス株式会社 顕微鏡装置

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JP2008522215A (ja) * 2004-11-24 2008-06-26 バッテル メモリアル インスティチュート 細胞撮像用の光学システム
JP2006322854A (ja) 2005-05-19 2006-11-30 Fujifilm Holdings Corp 全反射減衰を利用した測定装置及びその押し付け量調整方法
JP2007322685A (ja) * 2006-05-31 2007-12-13 Kyocera Mita Corp 液体現像剤の濃度測定装置およびそれを有する湿式画像形成装置
CN103674858A (zh) * 2013-09-18 2014-03-26 江西龙天茶业有限公司 一种茶水汤色快速检测方法及装置
JP2018128604A (ja) * 2017-02-09 2018-08-16 オリンパス株式会社 顕微鏡装置

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Title
See also references of EP4151986A4

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Publication number Publication date
JP7539977B2 (ja) 2024-08-26
EP4151986A4 (en) 2023-07-05
JPWO2021229915A1 (https=) 2021-11-18
EP4151986A1 (en) 2023-03-22
US20230077006A1 (en) 2023-03-09

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